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Page 1

Xxxxxxx slug here 2008

International
Hospital
ICT DEVELOPMENTS
Federation
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Hospital
H
o
and Healthcare Innovation Book
2009/2010
www.ihf-fih.org

Pro-Brook Publishing
The International
Hospital
Federation
Reference
Book
2008/2009
International
Hospital
Federation
Reference
Book
2008/2009067
1

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Page 2

Introduction

Sterile Barrier Systems


ensure optimal reliability of use
in hospitals and other health care institutions.
A correctly designed sterilization package
manufactured from reliable materials is an important
part of the overall chain of action aiming to assure
and improve patient safety.

See-Through Peel
Pouches & Rolls

Wrapping Sheets:
Paper & Nonwoven

Chemical Indicator
Products and Tapes

Equipment & Other


Accessory Products

NE

New Unique Products to make Your daily work easier:

SMX - High Performance


ProWraps

Helix
Challenge Test

Daily Control
B & D Type Test Pack

Seal
Control Sheet

For inner and outer wraps


for medium and large
trays and gown sets.

For a charge control


and as a steam penetration test for hollow
instruments with small
lumina.

A new generation test


for steam penetration
and air leak detection.

Operational qualication
of a sealing process
required by ISO standard.

More information available:

www.wipak.com

www.steriking.info

2 International Hospital Federation Reference Book 2008/2009

e-Mail: steriking@wipak.com

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Page 3

Contents

Contents

07

09

Foreword

Innovation and cinical specialities

Jos Carlos Abraho

54

Burn management
M Davey, B Ayeni, Y Ying and MJ Duncan

68

Cardiovascular risk factor trends and options for


reducing future coronary heart disease mortality in the
United States of America
Simon Capewell, Earl S Ford, Janet B Croft, Julia A
Critchley, Kurt J Greenlund and Darwin R Labarthe

76

The breast service psychosocial model of care project


Lauren K Williams PhD and G Bruce Mann

81

Supporting cancer control for indigenous Australians:


initiatives and challenges for Cancer Councils
Shaouli Shahid, Kerri R Beckmann and Sandra
C Thompson

88

Company profile: Technology of the 21st Century


Pioneers in Diagnostic Imaging: Reliability and
advanced technology add value and increase safe
diagnosis
Shimadzu Europa GmbH

90

Breast Cancer a review for African surgeons


Adisa Adeyinka Charles MD and Alexandra M Easson

109

Responding to challenges in physical therapy


Catherine Sykes, Brenda Myers, Marilyn Moffat and
Tracy Bury

112

Population based surgery in low and middle income


countries
David A Spiegel, Richard Gosselin, Adam Kushnerand
Stephen Bickler

118

Company profile: Wipak Medical Steriking


specialized packaging for hospital sterilization
WIPAK Medical

Introduction
Eric de Roodenbeke

Innovation and strategy

14

Creativity and innovation in healthcare management


Kenneth Hekman

17

A comprehensive risk and emergency management


programme for hospitals: a new approach
Marcel R Dubouloz

25

The Accelerating Access Initiative: experience with a


multinational workplace programme in Africa
S Van der Borght, V Janssens, MF Schim van der Loeff,
A Kajemba, H Rijckborst, JMA Lange and TF Rink
de Wit

28

Strategy to enhance influenza surveillance worldwide


Justin R Ortiz, Viviana Sotomayor, Osvaldo C Uez,
Otavio Oliva, Deborah Bettels, Margaret McCarron,
Joseph S Bresee and Anthony W Mounts

34

Global control of hepatitis B virus: does treatment


induced antigenic change affect immunization?
C John Clements, Ben Coghlan, Mick Creati, Stephen
Locarnini, Richard S Tedder and Joseph Torresie

41

46

Using satellite images of environmental changes to


predict infectious disease outbreaks
Timothy E Ford, Rita R Colwell, Joan B Rose, Stephen
S Morse, David J Rogers and Terry L Yates
Use of unstructured event-based reports for global
infectious disease surveillance
Mikaela Keller, Michael Blench, Herman Tolentino, Clark
C Freifeld, Kenneth D Mandl, Abla Mawudeku, Gunther
Eysenbach and John S Brownstein

Hospital and Healthcare Innovation Book 2009/2010 3

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Page 4

Contents

Healthcare transformation

We'll take
you there.

Your radiology department and your path to digital is unique. Yet, your goal to provide the highest level of
care is shared worldwide. We know. Found in 1 of every 2 hospitals, Agfa HealthCare works alongside
radiologists every day. Our systematic steps to integrated digital radiology allow you to advance at your own
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digital workflows for radiology, mammography, cardiology and the healthcare enterprise. So as you consider
your chosen path, let our proven experience support your next step, and every step after that.
Learn more about our proven solutions. Visit www.agfa.com/healthcare.

Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V. or its affiliates. All rights reserved.

4 International Hospital Federation Reference Book 2008/2009

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Page 5

Contents

Innovation in patient care

IHF reference

120

Surgical Site Infections (SSIs), antimicrobial agents,


universal precautions and post-exposure prophylaxis
Jonathan Samuel and Wakisa Mulwafu

132

About the International Hospital Federation

136

The IHF Governing Council

Have we created an alternative MSD risk from a


reliance on hoisting solutions? An academic review of
patient handling research
M Fray

137

The Secretariat Staff

139

IHF Members

144

Corporate member profiles

127

Editorial Staff

Subscription Office

Executive Editor:
Eric de Roodenbeke, PhD
Desk Editor:
Sheila Anazonwu, BA(Hons), MSc

International Hospital Federation


c/o MB Associates
52 Bow Lane, London EC4M 9ET, UK
Telephone: +44 (0) 20 7236 0845
Fax: +44 (0) 20 7236 0848

Editorial Board
ISBN 0 900590 40 8

Dr Ren Peters
Dutch Hospital Association
Norberto Larroca
Camara Argentina de Empresas de Salud
Dr Harry McConnell
Griffith University School of Medicine (Australia)
Dr Persephone Doupi
STAKES

Published by Pro-Brook Publishing Limited for


the International Hospital Federation
13 Church Street,
Woodbridge,
Suffolk IP12 1DS, UK
Telephone: +44 (0) 1394 446006
Fax: +44 5601 525315
Internet: www.pro-brook.com

Editorial Office
Immeuble JB SAY,
13 Chemin du Levant,
01210 Ferney Voltaire, France
Email: info@ihf-fih.org
Internet: www.ihf-fih.org

Copyright
Text International Hospital Federation or
otherwise stated 2009

For advertising enquiries contact


Pro-Brook Publishing Limited
on +44 (0) 1394 446006

All rights reserved.

changes to details in the text or in sponsored


material.

No part of this publication may be reproduced,


stored in a retrieval system, or transmitted in any
form or by any means, electronic, mechanical,
photo-copying, recording or otherwise without
the permission of the Publisher.
The information contained in this publication is
believed to be accurate at the time of
manufacture. Whilst every care has been taken
to ensure that the text and listing information is
correct, the Publisher and International Hospital
Federation can accept no responsibility, legal or
otherwise, for any errors or omissions or for

The products and services advertised are those


of individuals or companies and are not
necessarily endorsed by the or connected with
the International Hospital Federation. The views
expressed in this publication are not necessarily
those of the Publisher or of the International
Hospital Federation.
Applications for reproduction should be made in
writing to the Publisher.

Hospital and Healthcare Innovation Book 2009/2010 5

Project1:Layout 1

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Page 1

Internation
nal Hospital Federa
F
tion
Hospital and Healthccare Association
n Leadership Summit
u
1-2 June 2010
Palmer Ho
H use Hotel, Chicaggo (USA)
The 2nd IHF Hospital and Health
t care Association Leadership Summit, will take place June 1st to
2 , 2010, in the Palmer House hotel in Chicago (USA).
Thiss event is an opportunity to
o share experiences and kn
nowledge with colleagues from around
the world an
a d will help to strengthen ties
t between hospital leaderrs. It is both a unique occassion to meet
other leader
e s of hospital and healthcarre organizations as well as a platform for free exchange of ideas - a
priority for IHF (Constitution, article 1.3
3).
Thee event is open to IHF Full Members (maximum 2 people from each organization). Associate
members are als
l o welc
l ome, but sub
bjectt to availilability
it . IHF Co
C rporate
t Partners
t
are allso
o in
i vited
it d to
participate in the 2-day event
nd

Program
mme
Day One: Tuesday, 1 June
Hospi
s tal Safety and Disaster prepar
e edness
Role of first-line hospitals
Perrspective of globalization of car
c e
Role of healthcare facilities for education

Day Two: Wednesday, 2 June


Ethical hospita
  
Acccreditation: how does qualityy of care fits with the accred
ditation? International persp
pectives and
evolution of process.
Settting up international peer-reeviewing exercise on hospitaal and healthcare performan
nces: a
futu
ure for IHF?
High 5 initiative for Patient Safeety: Which role for IHF?
Perrspectives for IHF
Please contact Sev Lucas ((ssev@ihff---ffih.org
g)) at the IHF Secreta
ariat for a detailed programme and
reegistrration info
f rmation.

07 Foreword:2009 IHF ref 5

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Page 7

Foreword

Foreword
JOSE CARLOS DE SOUZA ABRAHAO, MD
President, International Hospital Federation

ealthcare delivery to populations is constantly subject to change. With globalization,


technological advances and new developments, large numbers of people can be
reached quicker, with increasingly specialized and skilled levels in delivery of care.
This scenario, which is being transformed by pursuit of healthier lifestyles, reduction in
alcohol and tobacco consumption, and promotion of physical activity, is also a reflection of
the strategies implemented in the field of preventive medicine.
The International Hospital Federation (IHF), to echo these trends, has renamed the
International Hospital Federation Reference Book Hospital and Healthcare Innovation
Book. In this renamed publication, the articles featured, highlight advancement and
developments in healthcare delivery and health services management. Through this
medium of exchange in knowledge, ideas and practices, it is hoped that the innovations
may serve to ensure a better future for the sector and that high quality standards are
maintained in service delivery.
From this edition, leaders and professionals will gain knowledge in activities in the
treatment of breast cancer; the management of burn patients; trends and alternatives to
reduce the risks of heart diseases; and strategies for surveillance and immunization against
infectious and contagious diseases such as the Influenza A (H1N1).
Within the scope of sustainability, it is worth drawing attention to the role green actions
should play in planning of healthcare facilities. The advancement in technology can be an
ally in controlling the effects caused by environmental changes. An example is the use of
satellite imagery in the monitoring of climatic and environmental conditions around the
world, in order to predict and prevent the emergence of infectious and contagious diseases.
These and other issues are featured in this first edition of Hospital and Healthcare
Innovation Book. We hope that this exchange of knowledge produces new strategies and
creates opportunities for healthcare managers around the world. Beyond the differences
between countries, all health services are facing and will face, over the coming years, the
challenge of developing ways to ensure provision of better healthcare to their population.
With this thought we hope to contribute in a dynamic and innovative way for the future of
health.
We wish you all a good read. J

Hospital and healthcare Innovation Book 2009/2010 07

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Page 67

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Page 9

Introduction

Introduction
ERIC DE ROODENBEKE, PhD
Chief Executive Officer, International Hospital Federation

nnovation does involve a revolution, but rather the appropriate


use of inventions to enhance the result of a process.
Opportunities for innovation are very frequent in health services
and this is the reason why International Hospital Federation (IHF)
has decided to rename its reference yearbook The Hospital and
Healthcare Innovation Book. This move is not to look more
fashionable or to present a cutting edge image, but it is simply to
emphasis the potential of adopting new approaches to enhance
hospital performance. As a vehicle for cross fertilization of
knowledge, IHF must also show that decision makers should not
only constantly think out of the box but should also rely on
activities that have achieved successful results in a given
environment.
Innovation does not involve systematically experimenting but it
is more often customizing and introducing, at full scale or within a
new environment, that which has been proven effective or initiated
locally at a small scale. Innovation also presents leaders of health
services the opportunity to observe evolution in the various
healthcare related activities both beyond and across borders. This
annual publication offers a chance to gain an insight into matters
that would not ordinarily feature as priority in your daily schedule.
It is the role of IHF to highlight all dimensions that may affect
strategic development of healthcare facilities both in the
developed and developing world. Because healthcare facilities
confront life and death issues, there is little room for unproven
experiences. There should, however, be readiness and openness
to either explore or implement novel processes that may result in
improved performance.
It is also the role of IHF to encourage and assist decisionmakers of the individual facility in making choices as well as
influencing policy-makers whose choices wrongly influence
performance in service delivery.
In this edition, you will have the opportunity to read how
creativity can be applied to management and should not only be
considered as the territory of artists. It is obvious that by bringing
creativity in the organization, top managers can both engage the
staff and create an extraordinary movement and stimulation. In an
ever rapidly evolving world, it is important to reconcile the need to
rely on data and the capacity to look for new approaches that
cannot be documented.
On the other hand, the reader will discover a new approach in
risk and emergency confrontation. This concept is contrary to that
of creativity, as it addresses the ways in which processes to

reduce vulnerability and response to any potential disaster, can be


reconciled in hospitals and healthcare facilities. This year, as past
years, has witnessed catastrophes and with each event, the
capacity of healthcare facilities to respond immediately to
emergencies, has made a difference in survival and treatment of
the injured. This very comprehensive article should be considered
as a key tool for hospital decision-makers, with which to ensure
they take seriously their role and responsibility in providing safety
to the population they serve. If responding to the demand for care
is an obvious function of hospitals it is not always the same for
providing safety to the population. Recognition of this factor,
before rather than after the occurrence of a disaster, is possible
through advocating for and adoption of a comprehensive
approach. Funding should not be an issue if politicians are
convinced of such a role. Response to fire threats is an accepted
priority around the world and fairly well resourced, healthcare
decision-makers should, therefore, make a case for having a
similar support when it comes to health threat.
This year communicable diseases have been very much under
the spotlight with the H1N1 flu threat. Although, to date, this threat
has failed to manifest as a real public health issue when the death
toll is compared with that from annual seasonal flu epidemics,
hospitals and healthcare facilities have, nevertheless, been on the
front line to respond. The IHF has surveyed major hospital and
healthcare associations and found that they have all been involved
in one form or another in the response strategies developed (Full
survey results: www.ihf-fih.org). Enhancement of influenza
surveillance in order to avoid excessive and costly mobilization
should be the way forward, in order to prevent the consequences
of lack of preparedness. When reading the other articles related
to infectious diseases you will appreciate and come to understand
emerging issues, one of which addresses the issue of coverage by
immunization. The work done on hepatitis B vaccine provides a
warning with regards to the use of treatment in facilities, which may
stimulate resistance and thereby result in a reduction in the
coverage of immunization programmes. The change in
environment has an impact in the development of communicable
diseases. Satellite images can help to shape adequate responses
ahead of time, not through major investment but just by appropriate
use of existing technologies. While advanced technology should
not be disregarded the appropriate use of low-technology has still
to be better mastered. The existing event-based outbreak
systems can provide large support in decision-making by
Hospital and Health-care Innovation Book 2009/2010 09

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Page 10

Introduction

monitoring the evolution of an outbreak.


All countries are currently facing the double burden of diseases
with the growing importance of non-communicable diseases
(NCDs) in the emerging and developing world. For this reason
there is need to attach much importance to matters relating to
responses to injuries like burn management as well as to
cardiovascular risks and cancer, for such population groups in a
deprived area of a rich country like Australia. We also have an
opportunity to reflect on the fact that although enhanced medical
knowledge helps in improving outcomes, illness is also related to
psychosocial conditions. Failure to fully appreciate this treatment
source can undermine potential success.
The article which argues that surgery should be considered as
part of the primary care package of services, demonstrates how
by reconsidering the place of intervention and the role of health
professionals, it is possible to provide response without mobilizing
massive resources. The Human resource shortage calls
professions to reconsider their ability to respond to growing
challenges. By featuring the article on physical therapy, IHF has
sought also to expose the diversity of skills needed in caring for
patients. In relation with the role of physical therapists the issue of
patient handling shows the importance of using best practices to
face this situation while protecting the health of workers.
Last but not least, it was not possible to cover a large spectrum
of issues without having an article related to patient safety.
Appropriate use of recommendations can make a big difference in
results. Innovation can be simple things but well and
systematically implemented.
Finally, as there is now greater recognition of the role of the
private sector in supporting health, it was important to highlight the
role companies can play for the health of their workers. It is usual
that in remote places where companies have a large workforce
that they create their own facilities which in return benefit the
population. For HIV treatments, it is also obvious that employers
should play an important role in providing access.
Like in any approach that covers a large spectrum of issues, it
can be argued that there is not enough or too much on a topic and
that some important topics are missing. This 2009/2010 edition is
not intended to be comprehensive, but as mentioned above, it is
to provide insight to decision-makers and enable them to embrace
and absorb the full spectrum of available knowledge.
I do hope you will have a pleasant reading and that one or
another article will be a sparkle triggering innovation in your
facility. J

10 Hospital and Health-care Innovation Book 2009/2010

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Page 11

Innovation and strategy

14

Creativity and innovation in Healthcare management


Kenneth Hekman

17

Comprehensive risk and emergency management


programme for hospitals: a new approach
Dr Marcel R Dubouloz

25

The Accelerating Access Initiative: experience with a


multinational workplace programme in Africa
S Van der Borght, V Janssens, MF Schim van der Loeff,
A Kajemba, H Rijckborst, JMA Lange and TF Rink
de Wit

28

Strategy to enhance Influenza surveillance worldwide


Justin R Ortiz, Viviana Sotomayor, Osvaldo C Uez,
Otavio Oliva, Deborah Bettels, Margaret McCarron,
Joseph S Bresee and Anthony W Mounts

34

Global control of hepatitis B virus: does treatment


induced antigenic change affect immunization?
C John Clements, Ben Coghlan, Mick Creati, Stephen
Locarnini, Richard S Tedder and Joseph Torresie

41

Using satellite images of environmental changes to


predict infectious disease outbreaks
Timothy E Ford, Rita R Colwell, Joan B Rose, Stephen
S Morse, David J Rogers and Terry L Yates

46

Use of unstructured event-based reports for global


infectious disease surveillance
Mikaela Keller, Michael Blench, Herman Tolentino, Clark
C Freifeld, Kenneth D Mandl, Abla Mawudeku, Gunther
Eysenbach and John S Brownstein

Hospital and Healthcare Innovation Book 2009/2010 11

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Page 14

Innovation and strategy: creativity

Creativity and innovation in


healthcare management
ARTICLE BY BY KENNETH HEKMAN, MBA
President, Health Development International

Creativity may be one of the most misunderstood topics in management. Creativity is usually associated with artists,
those rare people who seem to be endowed with a mystical ability to make aesthetic sense out of colour, texture, shape
and form. In the managers world, creativity is typically limited to picking out artworks for the walls of a new office or
selecting a designer to develop a new logo.

ome managers even find the topic of creativity to be


threatening. In the logical world where decisions are based
on statistical and financial data, working with abstractions
rather than policies and procedures can be threatening. If artists
do not use familiar methods, how can we measure their outcomes
or judge their work? Likewise, how can creative geniuses
appreciate managers logic and business acumen? We just dont
talk the same language.
But artists, writers and inventors work with concepts that
healthcare managers can benefit from learning. Their tools and
language may be different, but their results can inspire, inform and
enrich people in all walks of life.

Why innovate?
One area where artists and healthcare managers can agree is that
the world is changing. Change is constant. Futurists tell us that
knowledge is increasing at exponential rates and that we must get
accustomed to the idea of change with increasing speed. In a
single generation, we have seen the development of personal
computers, faxes, email and the internet, with each creation
bringing us closer to real-time transactions and communication
options unimagined a few decades earlier. Change is the one
constant in every aspect of our work and relationships.
Change is often disruptive. It challenges routine ways of thinking
and working. It makes us uncomfortable and requires us to adopt
unfamiliar processes as we adapt to a new ways of thinking and
working. Health care delivery seems to be at the apex of disruptive
change. Laparoscopic surgical techniques are making some
open-incision methods obsolete. New pharmaceutical options are
reducing the length of hospital stays. A global recession is proving
to challenge personal values and adjust priorities for funding
agencies.
Change can also stimulate creativity. Artists sometimes look for
opportunities by studying contrasts and conflicts between light
and dark, young and old, clean and dirty. Healthcare managers
can also look for opportunities brought about by change. Eastern
bloc countries are finding opportunities to improve healthcare
14 Hospital and Healthcare Innovation Book 2009/2010

delivery by adopting free market enterprise business models in


contrast to the former state-run institutions. African hospitals are
looking for ways to prevent malaria so they can reallocate limited
inpatient resources for other diseases. Asian healthcare leaders
are seeking ways to improve service attitudes of healthcare
workers in an effort to stem the tide of conflicts from dissatisfied
patients. Changes and conflicts stimulate adaptive ideas and
behaviours. Healthcare managers who embrace changes and
learn from conflicts are more able to anticipate the consequences
and adapt more rapidly.
Just as physicians on the cutting-edge of medical research find
new diagnostic and treatment options for combatting disease, so
also healthcare managers on the cutting-edge of innovative
management techniques lead the way in discovering methods for
improving clinical outcomes, gaining efficiencies and building
healthier communities. Healthcare managers who are constantly
searching for best practices worthy of adoption at their own
hospitals and clinics gain a competitive advantage over others and
advance the standards for quality of care and organizational
performance. Innovators create new paradigms that make other
methods obsolete. They introduce fresh ways of thinking and
acting that advance civilization itself.

What makes innovators different?


Innovative healthcare managers can be found in every country and
organizational setting. Innovation or creativity is not constrained by
the presence of resources. In my experience as a healthcare
consultant and trainer on five continents, some of the most
innovative healthcare managers are those who become
resourceful because of resource constraints. Adversity can
stimulate invention rather than stifle it.
Everett M Rogers, author of Diffusion of Innovations describes
innovators as the earliest adopters of new technology and ideas.1
He describes them as venturesome, eager to try new ideas,
sometimes desiring the hazardous, the rash, the daring and the
risky. They comprise only about 2.5% of the population. Another
13.5% are early adopters. They are more respectable opinion

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Page 15

Innovation and strategy: creativity

leaders and are viewed as role models by their peers.


Some of the most innovative healthcare managers exhibit the
following qualities:
 They are consistently curious and eager to learn. Their
commitment to continuous learning also requires them to
abandon ideas that are no longer useful or that get in the way
of advancing knowledge and understanding. They invest in
themselves and their teams by expanding their management
skills, exploring trends in healthcare and in other industries,
visiting other organizations and reading a wide variety of
management literature. They may take online courses and
local workshops to learn from leading experts in healthcare
management and to extend their network with other healthcare
managers. They may engage a mentor to help them honestly
assess their competence and to guide their career path.
 They foster a freedom to experiment, even if it means there
will be failures. Innovative healthcare managers understand
that employees grow and thrive when they have opportunities
to express their ideas and try new methods for improving
patient care. They also understand the need to preserve and
protect patient safety, and they strike a healthy balance
between experimentation and tradition by regularly reviewing
policies and procedures. The key is to create an environment
where employees feel safe in suggesting new ideas that
advance the standards for quality assurance.
 Innovative managers dare to take a creative approach to
ordinary decisions. Nobel Prize winner, Albert Szent-Gyrgyi,
said, Discovery consists of looking at the same thing as
everyone else and seeing something different. For the
healthcare manager, that might mean looking at the pressure
of competition and seeing a niche that others have overlooked.
A creative administrator might view patient complaints as
opportunities for service improvements or look at compliance
challenges for their potential to improve clinical quality.
Discovery can be a simple thing like playing with scheduling
options to improve throughput or being open to fresh ideas
from employees to reduce turnover. The creative healthcare
manager looks beyond traditional problems to see something
different. They conduct brainstorming sessions to draw out
the best ideas of front-line staff. The technique, which was
translated at a workshop in Latin America as a thunderstorm
of ideas, empowers employees to take personal responsibility
for solving problems. Front-line staff members encounter
operational problems first and often see solutions before
managers do.
 Innovators commit to strategic planning for their organizations.
They devote a few days each year to assemble department
supervisors and the management team to evaluate how well
the organization is serving its community. They analyze the
trends impacting the hospitals future, assess their readiness to
meet new challenges and set goals for achieving
improvements in operations and in service to the community.
Every organization can benefit from planning. It takes
courageous leadership to initiate the process and follow
through with the plan, applying creative solutions to business
development challenges.

Examples
Innovators can be found in the executive suites and on the front

lines in healthcare delivery systems. Creative managers are


sometimes recognized for their innovation by public awards, but
unsung heroes can also be found in the daily experiences at
hospitals, clinics and public health programmes in every culture.
Here are a few examples:
 Quint Studer became the administrator of a hospital in Florida
USA based on his reputation for improving patient satisfaction
at his previous employer. When he started, he approached
employees, one at a time to introduce himself. He said, Hi.
My name is Quint Studer. Im the new administrator here and I
work for you. What can I do for you today? A nurse asked
him to trim the bushes near where she parked her car so it
would be safer for her when she finished her shift after dark.
While she worked, he had the bushes trimmed and put up a
small fence. She was impressed that this administrator cared
about her safety and shared the story with her co-workers. He
earned their trust for other, more significant changes as time
went on.2
 An engineer at a hospital in the Philippines looked for a way to
assure a reliable flow of oxygen from the central supply area to
the surgical suites. He developed a simple pipeline and
adapted a water pump by reversing the polarity to convert it to
a low-cost, highly reliable tool for delivering the vital resource
to where it was needed most. While this method may not be
fully compliant with requirements in all countries, it was efficient
and effective in this setting.
 At Park Nicollet, a medical clinic in Minnesota USA, inventory
of medications was the third highest expense. Managing the
inventory was crucial to the financial health of the organization
as much as keeping current medications was vital to patient
care. Managers found that at three departments in one
location, approximately 628 individual containers of medication
were stored with an overall price tag of US$ 32,513. Of this
amount, 28% were high-cost, low-use medications - items
regularly stocked but infrequently used. By setting up a system
that automatically signaled when new items were needed,
improvement teams eliminated 29% of the stock in one
location and reduced cost by 50%.3
 At Selian Lutheran Hospital in Tanzania, managers were
frustrated that only 50% of HIV-AID patients in nearby villages
would comply with the requirement for regular visits to the
clinic to receive the medications needed to keep them alive.
They rallied the assistance of some of the more responsible
patients to become mentors to their co-sufferers. The
voluntary adherence counselors befriended others with HIVAIDS and raised the compliance rate to 90%.4
Examples like these may sound like simple common sense, but
common sense often fails to become common practice.
Innovative healthcare managers search for ways to improve clinical
outcomes, employee engagement, resource usage and the
satisfaction of patients, visitors and staff at every opportunity. They
recognize that simple tactics can sometimes yield exponential
results.

I think I can
If ingenuity doesnt come naturally, you are not alone; but the good
news is that creativity appears to be a learned behavior. Creativity
begins with a positive attitude, confidence and belief in your
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Innovation and strategy: creativity

abilities. Roger von Oech, author of A Whack on the Side of the


Head,5 describes an extraordinary insight from the experience of a
major oil company. The management team was concerned about
why some of their research and development people seemed to
have more productive and better ideas than others. They brought
in psychologists to study educational backgrounds, where people
grew up, favourite colours and other issues. After three months of
study, the psychologists concluded that the chief factor that
separated the two groups was that the creative people thought of
themselves as creative, and the less creative people didnt. Those
who held a creative self-concept allowed themselves to get into an
innovative frame of mind and to play with their knowledge. Those
who didnt embrace their creativity were either too practical or
were caught in routines in their thinking.
Healthcare managers can learn to be creative, and their
innovation can lead to improvements in clinical quality, financial
results and community impact. Approaching problems with an
innovative frame of mind can yield surprising results and restore
a fresh motivation for making a difference as a healthcare
manager. J
Kenneth Hekman is the President of Health Development
International, a US-based global healthcare management training
and consulting partner with IHF. www.healthdevelopment.org

16 Hospital and Healthcare Innovation Book 2009/2010

References
Everett M Rogers, Diffusion of Innovations, New York: The Free Press, 2003
Quint Studer, Hardwiring Excellence, Fire Starter Publishing, 2003
John Black with David Miller, The Toyota Way to Healthcare Excellence, Health Administration
Press, 2008
4.
Based on personal conversations with Mark Jacobson, MD, Administrator at Selian Lutheran
Hospital, Arusha, Tanzania in 2006
5.
Roger von Oech, A Whack on the Side of the Head, Creative Think, 1983
1.
2.
3.

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Innovation and strategy: risk management

A comprehensive risk and emergency


management programme for
hospitals: a new approach
ARTICLE BY MARCEL R DUBOULOZ
Senior Medical Consultant, Health Development Counseling and Audit (HDCA) Geneva

This article looks at risk management in hospitals and the management of emergencies and disasters. It
considers the models and policies that exist in private companies and the core components of a risk
management strategy for hospitals. Building on this knowledge the author puts forward a new plan for
hospitals called the Comprehensive Risk and Emergency Management Programme (CREMP) and explains the
advantages of this approach.

he World Health Organization (WHO) has, over the years,


advocated adoption, by all Members States, laws and
regulations for safer hospitals during major crisis and
disasters. The United Nations International Strategy for Disaster
Reduction (UNISDR) and WHO launched the 2008-2009
campaign for safe hospitals, the primary focus of which is the
reduction in vulnerabilities1, that result in major loss of life,
services in hospitals. Global indicators show that lack or weak
management of vulnerabilities in hospitals lead to catastrophic
loss in services in both high and low-income countries. The 2009
World Health Day was dedicated to safe hospitals. Besides
providing care, hospitals also have a major role to play in
management of public health programmes during disasters and
health crisis. With hospitals acting as key sources of information in
the surveillance system2, priority is now increasingly being given to
development of the concepts of continuity of delivery of essential
services and surge capacity. Hospitals are not isolated islands:
therefore the objective should be to develop a global health
system, prepared for disasters and major emergencies. There
must be a continuum between the concept of safer hospitals
(focus on reducing vulnerabilities) and mass casualty
management. Management of hospital vulnerabilities is best
addressed and controlled when brought into the broader concept
of hospital risk management.

Risk management in hospitals


Many countries, over the years, have developed complex laws and
regulations to regulate and control medical and other healthrelated activities3, such as medical practice, blood safety, quality
assurance, safety and security, and accreditation. Ministries of
Health (MoH) and/or specialized governmental institutions are
often the bodies mandated to monitor compliance4. The majority
of countries, however, have yet to develop exhaustive
administrative and technical guidelines for full implementation of
such policies as well as to identify and produce documentation on
best practices.

Management of emergencies and disasters


Many countries have developed national multi-sectoral policies on
management of emergencies5, particularly for mass casualty
management (MCM) also referred as Comprehensive
Emergency Management Programme6 (CEMP). The Ministry of
Interior or a special Unit in the office of the Prime Minister is usually
entrusted with the responsibility of developing and implementing
the policies, from conception of plans to response management7.
Some countries or States in USA have also adopted similar
CEMPs for major governmental Institutions8. The trend is more
and more to decentralize the response capacity9 for MCMs. In
these countries usually the MoHs have also developed their
respective MCM policies, Emergency Medical Services (EMS)
policies, and Hospital Emergency Response Plans10. The
increasing trend is towards development of management of
emergencies in hospitals within the framework of CEMPs11.
Risk management in hospitals
In parallel to development of the emergency (disaster)
management strategies, many hospitals have introduced risk
management approaches usually under the umbrella of
Comprehensive12 Risk Management Programmes13, the targets of
which are regulated risks14,15, with the creation of specific
committees for the different regulated risks. Many countries have
national policies on risk management in hospitals, with technical
guidelines for implementation16. The risks incorporated in these
policies are primarily routine medical and clinical risks and the
regulated risks. Disasters are not included in these programmes.
Hospital accreditation is also a risk management-related
regulatory tool applied in many countries. The prerequisite,
however, for accreditation is the existence of a risk management
programme as well as the existence of a hospital disaster plan.
Often the process of accreditation is linked to the concept of
quality assurance. Various methods (including checklists17) are
used to assess and monitor. Development of quality improvement
strategies is gaining in importance with MoHs and hospitals. There
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Figure 1: Risk management cycle in hospitals Source: HDCA 2009

are many methods and software available for managing these


different hospital programmes (risks management; quality
assurance; safety). Increasing numbers of hospitals appoint a full
time Risk Manager to contribute to the development,
implementation and the management of such programmes. Also,
many universities, professional associations and private schools
offer training courses for Hospital Risks Managers18,19. Although
the exact structure of a given hospital risk management
programme depends on the size of the facility and the scope of
patient care and other services it offers, several key structural
components are common and necessary for all hospital risk
management programmes. Part of the business of hospital risks
management is in connection with vulnerabilities. This is a
complex issue as hospitals have various types of vulnerabilities
that, when they interact with hazards or threats (the source of risk),
can contribute to create risks. WHO has published several key
documents on this particular issue20,21 and launched a campaign in
200822 as a direct contribution to improve awareness in this area
and to advocate for the further development of existing hospital
risk management programmes. The ISO 31000 (under
preparation) on Risk Management will be a major step forward in
promoting the adoption of risk management principles as a routine
part of the management of hospitals.
Models and policy in private companies
Most of what is practiced in hospitals as risk management comes
from the experiences gathered in the private sector over many
years and much literature exists on these issues. Business
18 Hospital and Healthcare Innovation Book 2009/2010

continuity, business safety, enterprise risk management, and


comprehensive risk management are concepts that have been
applied by private companies for many years. Most of the private
companies have adopted this strategic approach to ensure
business sustainability and prosperity and to avoid preventable
losses while others are specialized in offering services aimed at
assisting the companies to manage risks. The notion of
business continuity (continuity of operations for hospitals:
continuity in the delivery of essential services) is given increasing
priority in these programmes together with greater attention to IT.
Business process management is the newly adopted strategy in
this area by private companies for ensuring the success of
business continuity and risk management.

The diversity of models and conceptual frameworks in


hospital risk management programmes and in hospital
emergency (disaster) management
The great diversity of concepts and programmes in risk
management and emergency management allows countries to
adopt models that best suit the local context. Nevertheless there
are several major problematic issues in the two areas of hospital
risk management and hospital emergency response plans (ERP;
including contingency plans):
 The Terminology. Unfortunately there is no international
consensus on the key terms (e.g. emergency; risks23;
vulnerabilities; readiness; prevention; mitigation, recovery, safe
hospital, essential services and so fort). It is therefore very
difficult to compare existing risk management programmes

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Innovation and strategy: risk management

Figure 2: Comprehensive risk and emergency management programme Source: HDCA 2008

(applicable to hospitals, private business or governmental


institutions) or existing hospital ERPs. The various UN
Agencies (ISDR; OCHA; WHO, etc.) have not yet agreed on a
common terminology (adding to the existing confusion).
 The great diversity of conceptual frameworks. There are
several different conceptual frameworks dealing with the
concepts of business continuity (continuity of operations for
institutional agencies such as hospitals) and risk management;
vulnerability analysis and reduction; hospital risks
management. It is difficult to compare the various existing
models due to the absence of clear indicators for assessing
their usefulness, their effectiveness and their efficiency. The
strategies adopted to pilot these programmes in hospitals also
differ from one country to another or even from one hospital to
the other in the same country. The indicators used to assess
and monitor these programmes and the classification of types
of risks also vary from one model to the other. In addition, the
concept of ERP varies greatly from one country to other one:
management systems; components24 of the ERPs. The
absence of universal references and best practices. There are
no internationally agreed best practices, either for hospital risk
management programmes or for hospital ERP. There are many
different references in use and none of them claim to be of
universal value.
 The diversity of standards. Although there are international
standards (ISO) for many activities, each country has
developed its own standards for hospital risks management
(regulated risks).

 The great diversity of methodology, IT and software. In


private businesses, risk management programmes have long
been managed by using high technology and software. There
are many computerized systems that are available for
managing programmes and managing information25. They all
have strengths and weaknesses. The data that are collected
and processed vary greatly according to the IT used. There are
several methods to assess the risks (especially to quantify the
risks. Many different scales are in use to rank the risks). Many
methods that are used in quality assurance process (which
also includes a component on risk identification and
management) are also used in RMP in hospitals.
 The absence of a link between the hospital risk
management programme and hospitals management
during disasters and major crisis. Existing hospital risk
management programmes focus mainly on the safety of
patients and equipment and quality of medical care and
services. There are very few programmes that also make
mention of risks arising from disasters. There are no
programmes that make clear and functional links between risk
management programmes and emergency management
during major crisis and disasters. In other words there are no
programmes that clearly identify and specify the links between
the Hospital Risk Management Programme and the ERP (of
course the plan is made to facilitate the management of the
response during emergencies). During disasters26 hospitals
have not only to focus on continuity of operations (especially
for essential services) but they also must focus on the capacity
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of the hospital to provide more such services (surge capacity)


in order to contribute to the management of mass casualty
situations. Medical surge capacity and medical surge capability
is a key emerging concept for preparing hospitals to respond
in disaster situations27.

The core components28 of risk management programmes29


in hospitals
Although the exact structure of a given hospital risk management
programme depends on the size of the facility and the scope of
patient care and other services it offers, several key components
are common and necessary to all hospital risk management
programmes. It is, therefore, possible to identify some core
components that are found in most existing programmes. The
components selected in each model depend on the goal and
objectives of the institutional programme. The hospital risk
management programme, like other hospital functions, requires
certain documented policies and procedures to ensure programme
consistency and uniformity. The plans, policies and procedures are
usually approved and adopted in accordance with established
hospital policy and in accordance with the existing laws and
governmental monitoring mechanisms30. The most common
objectives found in hospital risks management programmes are:
 to identify and to prevent cause of injury or harm to patients,
visitors, and employees and to treat the causes and or
consequences should an adverse event happen;
 to identify, to prevent or to manage events that can jeopardize
the safety and security of the equipment and of the
environment;
 to manage as efficiently as possible the claims and lawsuits so
that subsequent financial losses of the institution are minimized;
 to contribute to quality improvement of services offered.
In order to implement a risk management programme, as in any
significant project in hospitals, the first step is usually to start with:
 a census of existing regulations and laws applicable to the
hospital (including safety and security) and to medical care and
nursing services;
 the establishment of the institutional long term vision, goal and
objectives of the risk management programme;
 the establishment of the planning committee and the
identification and the description of the various components of
the programme. This includes the strategic choice (when
applicable) to decide how this risk management programme
will include or not some other already existing programmes,
such as quality assurance and accreditation; safety and
security; clinical care safety; blood safety, drug safety;
occupational medicine, etc. Usually all these existing
programmes are integrated into this new comprehensive31 risk
management programmes. A major issue that the planning
committee has to thoroughly discuss is the management of
information. Indeed, hospital risk management programmes
require the management of a huge quantity of data and an
efficient system to computerize them. Clear indicators32 must
be identified and defined in order to monitor the programme
and to revise the components of the programme when
necessary;
 identification of criteria for defining and classifying the events
(critical event, etc.).
20 Hospital and Healthcare Innovation Book 2009/2010

The various components most frequently found in hospital risk


management programmes are:
 Organization and Programme Management System
Organogramme.
Roles and responsibilities of the various stakeholders. In
almost all HRMP a Hospital Risk Manager (HRM) is
appointed. This is a key position in the institution33.
Coordination mechanisms and management of information.
Because of the wide range of risk management functions and
the diversity of necessary activities, both formal and informal
mechanisms for coordination and information exchange
must exist between the risk management programme and
other hospital departments and functions34. Coordination
extends also to the outside world with local safety and rescue
agencies (such as fire and ambulance services) and with
governmental institutions having a normative role or a
supervisory role (quality assurance; accreditation, etc.).
Methods and processes for risk assessment. There must
be a system in place with the necessary tools and methods.
The main steps are: 1) identification of risks; (2) analysis of
risks identified; (3) treatment of risks; and (4) evaluation of
risks treatment strategies: (5) ongoing monitoring (see figure
135). There are many different methods for qualifying and
quantifying risks36. Anyway an important step in identifying
risk is to identify the hazards (or threats) that can engender
risks when interacting with existing vulnerabilities37 for that
hazard. It is also vital to develop surveillance functions (early
detection as much as possible; sentinel events, etc.) and
monitoring functions in order to investigate all significant
events, and to also assess the effectiveness of the treatment
options and the evolution of the context and hazards. The
notion of readiness is unfortunately sometimes mixed up
with the notion of resilience in these programmes.
Readiness is the major outcome of Emergency
Preparedness Programmes. The use of modern technology
contributes to safer management of the processes.
Funding of the programme and links with administration and
finance department.
Training activities for key stakeholders of the programme and
staff of the hospital.
Logistics and resources.
 Description of regulated risks and safety of medical
activities38 that are often included into the HRMP:
blood safety;
drug safety;
nosocomial infection;
security measures and security equipment (especially for fire,
gas, chemicals and nuclear products);
critical39 equipment safety (including backup systems;
redundancy, etc.);
clinical and medical safety (including activities performed by
medical staff as well as the sustainability of the provision of
these services by ensuring that the necessary environment40
is adequate);
professional risks: those risks experienced especially by
medical staff (doctors, nurses, etc.) performing clinical
activities in relation with patient care.
 Besides the above-mentioned regulated risks, there are

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Innovation and strategy: risk management

other non-regulated risks and emerging risks that occur more


frequently, with sometimes great potential for severe
consequences and substantial losses. Many HRMP do not
include the non-regulated risks and are limited to only the
regulated risks and the safety procedures that are necessary
for quality assurance and accreditation. The trend,
nevertheless, seems to be towards increasing consideration of
non-regulated risks as part of the business.
 Information management. This is a major component as
HRMP requires management of l many data. Several key
issues must be solved:
selection of the necessary and useful data (what, when, who;
forms, use of computers; etc.);
quality of data (from collection to processing and use in the
decision making process) and of the source of data;
confidentiality of data (data concerning patients; sensitive
data concerning the hospital);
reporting mechanisms of any event that has a link with the
Programme (especially critical events, sentinel and precursor
events41).
Use of modern technology42. The use of modern technology for
managing information facilitates the management of data
pertaining to the HRMP and the data collected as routine activity.
It enhances early detection of emerging risks (detection of signals),
adverse events and precursor events (software intranet based or
internet based).

The emergency response plans of hospitals (disaster plans)


In many countries the MoH has defined its policy on Hospital
Emergency Response Plans (from preparation of the ERP to the
validation of the Plans). Contingency plans43 (e.g. internal fire;
bomb threat; Avian Influenza Pandemic, chemical incidents, etc.)
are either included in the overall Hospital ERP as contingency
procedures (SOP and Supplemental Emergency Response Plans
of the various units and departments of the Hospital) or
developed as contingency plans. Unfortunately in many
countries the situation is chaotic: lack of national policy of the
MoH (only few hospitals develop an ERP); lack of validation of
the plans that are developed (no standardization; many plans are
only paper documents that will never survive a real emergency).
WHO has recommended a list of elements that must be included
in the ERP of hospitals44. WHO has also developed toolkits for
developing hospital ERP.

Comprehensive Risk and Emergency Management


Programme (CREMP) for Hospitals: the new approach45.
The rationale for the integration of hospital risk management
programmes (as a sub-programme) and hospital emergency
management (as a sub-programme) into a cohesive overall
Programme
Many elements of the conceptual framework of Comprehensive
Emergency Management used by communities (and
governmental institutions at national or sub-national levels) can
be applied to the management of hospitals during crisis and
major emergencies. The preparation, the activation, and the use
of the hospital ERP often mirror46 the existing systems and
mechanisms used in the wider community or at sectoral level,
especially when focusing on special functions such as Incident

Management Systems; EOC; Incident Command Group; logistic


management; information management, etc. The adoption of a
CREMP by hospitals must be based on the assessment of
existing hazards (and threats) that could possibly affect the
activities of the hospital or the assets (either impacting on them or
requiring an important surge capacity in delivering essential47
service). In the context of Comprehensive Emergency
Management in MCM, WHO advocates for capacity building at
community level and for decentralization. The safe and efficient
decentralization of the response capacity to sub-national levels
and to community levels requires a clear national policy (and its
application guidelines) and clear mechanism for transfer of
authority, resources and financial means. Hospitals are a major
assets to consider in MCM.
The systems and the structures of the CREMP
Clear rationale exists for integration of the Emergency
Management System, as described in the ERP of the hospital,
together with the various programmes dealing with risk
management into an overall comprehensive programme. The
general conceptual framework and the overall organization as
well as the links between the components of these different subprogrammes are presented in the Figure 2. Emergency
Management Australia (Governmental Agency) has already paved
the way in this direction by combining together the subprogrammes of quality assurance and emergency risk
management48. In this new conceptual framework, the notion of
critical infrastructure is defined as follows: A service, facility or a
group of services or facilities, the loss of which will have severe
adverse effects on the physical, social, economic or
environmental well being or safety of the community. It is
particularly interesting to note that this notion also includes a
group of services or facilities. Medical surge capacity largely
depends on the effectiveness of the networks (as recommended
by ADPC49) that each hospital develops with the other
stakeholders50.
The main elements that of the various programmes (Quality
Assurance; Emergency Management/ ERP; Hospital Risk
Management Programme) are:
 hazard and threat identification and assessment;
 risk analysis (that requires also identification of vulnerabilities);
 development and implementation of risk treatment options
(which includes vulnerability reduction);
 monitoring mechanisms;
 coordination and management systems.
The advantages of the CREMP
The main advantages of adopting this integrated strategy in
hospitals are:
 Many management systems required for Emergency.
Management/ERP and Risk Management Programmes/Quality
Assurance are very similar. Indeed the management of severe
events in Risk Management Programmes and the
management of crisis during disasters require the mobilization
of a Command Group and the development of an Incident
Action Plan; the mobilization of resources (especially trained
staff); the activation of special procedures and SOP; the
management of information, etc. The pre-establishment of
such structures and systems for responding to both situations
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will enhance efficiency and effectiveness, and will contribute to


the rationalization of the cost (from equipment to training of
key staff) and will facilitate the development of relevant and
useful training activities
 Many functions in both management systems are similar so
that the use of common tools and methods (such as modern
technology) will enhance the reaction capacity as early as
possible (allowing for the selection of efficient treatment
options as early as possible in order to prevent, to mitigate as
many as possible adverse consequences).
 Complementarities can be identified so that the acquisition of
new resources can be rationalized and adequately selected, as
well as training of staff.
 The integration of the various Committees for regulated risks
(e.g. Blood Safety Committee) into a cohesive whole, although
the these technical Committees should still work in their field of
competence.
 The appointment of an Hospital Risk Manager in charge of
contributing to the management of both Sub-Programmes is
recommended.
 The process for identifying vulnerabilities, hazards and risk is
similar to all these programmes so that it is advisable to look
for synergy and complementarities:
development of common procedures and tools;
data collection and reporting procedures;
data processing and information sharing;
training of stakeholders;
information management systems for hospital internal use
and for coordination and reporting to higher levels.
 Collection of many data as routine procedures are needed in
all the sub-programmes to ensure surveillance, early warning,
and the monitoring of both the efficiency of the programmes
and of the management of risks.
 The management of information51 and the integration of all
elements are now possible by using common integrated
technology.
 The pooling and sharing of information will contribute to
improve the early identification of potentially severe adverse
events or of infrequent events (such as cluster of unusual
diseases or a new threat).
 In many activities of these sub-programmes, the staff is the
same, therefore enabling rationalization of training, awareness
raising and development of a sense of ownership and
stewardship.
 Many treatment options are partly similar in these subprogrammes so that it is possible to use existing resources
more efficiently (avoiding unnecessary duplication) or to acquire
new resources in a coordinated manner.
 Development of common terminology and of institutional
culture of risk and emergency management.
 Promotion of common national standards among all hospitals.
 Promotion of cross-fertilized cooperation and coordination
(avoiding vertical approach) within the hospital.
 Enhancement of integration strategy of activities from all
departments and units of the hospital.
 Contribution to quality improvement.
 Rationalization of the use of resources and of acquisition of
new resources.
 Contribution to a better understanding by the MoH of the
22 Hospital and Healthcare Innovation Book 2009/2010

actual problems and the priorities in the country, and


identification of priority areas for further development (from
policy making to monitoring and normative activities).
 Contribution to an increased readiness of the health sector to
respond to major emergencies and to detect new threats.
 Contribution to better management of public health by the
MoH. The creation of a national risk observatory fed by all
hospitals in the country is recommended so that the MoH has
a comprehensive view of the real context and of the priorities.
This will also contribute to revision of national policies when
necessary and to the development of national programmes
when required. The development of this integrated CREMP in
each hospital must also aim at contributing to a more efficient
management of public health by the MoH and the provincial
health departments.
 Contribution to a more efficient management of resources
such as selection by the MoH of equipment (safety; efficiency;
costs, etc.) for hospitals.
 Contribution to the development of efficient cooperation
between hospitals (creation of networks of hospitals) in
prevention as well as in response and crisis management.
 CREMP will also contribute to identify the actual strengths and
weaknesses of each hospital member of the network as
services providers during crisis (either for receiving patients or
as back up for logistics).
 The identification of best practices applicable either to one of
the Sub-Programmes or to both.
 Cross-sectional sharing of lessons learned.
Conclusion: Major issues that need further discussion at country
level for developing this new approach

Pre-requisite for launching CREMP project in an hospital


First of all it should be clear that without a national policy (prepared
by the MoH) on regulated risks and quality assurance on the one
hand and an ERP on the other, hospitals would be undertaking
major risks in considering implementation of an CREMP.
Awareness-raising among all categories of staff is absolutely
necessary in order to promote a strong sense of ownership by the
hospital and of the stewardship by the MoH. It would, therefore,
be advisable that there be agreement at administrative and care
delivery decision-making levels on the necessity and on the
rationale for developing the two Sub-Programmes and for their
integration.
In the case of hospitals with existing CRM and ERP SubProgrammes (even though these may be if limited to a few
regulated risks), launching of such a new approach for a new
Integrated CREMP, is facilitated. It is still necessary, however, to
engage strong commitment from key staff of both SubProgrammes.

Planning committee (roles, responsibilities; composition,


activities) for integration of the two Sub-Programmes
As in any major hospital project, it is vital to set up a planning
committee. Indeed a CREMP will involve many stakeholders inside
and outside of the hospital. As there is no international model for
such a CREMP, each hospital will have to identify what are the
exact planning activities that will be conducted either during the
development of the two Sub-Programmes or for ensuring the

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Innovation and strategy: risk management

efficient integration of the two Sub-Programmes when they


already exist. This Committee will have to decide on key issues
such as: management structure of the CREMP and of the two
Sub-Programmes; the level of integration of the two SubProgrammes; common information management systems;
methods and tools to be used for assessing risks (even if there
are already methods and tools in use; integration would call for a
new approach), etc. It is important that all key stakeholders of the
two Sub-Programmes are represented in the Committee, either
as permanent members or as temporary advisers when
necessary. Cross-fertilised participation by managerial and clinical
staff is necessary.

Methodology for assessing risks and ranking risks

Management structure and systems

Administrative support

Many hospitals already have a RMP and an ERP. These


Programmes, where they exist, have their own management
structure although some key functions (such as the director of the
hospital: chief of security, etc.) are members of both structures.
The challenge here is to integrate as much as possible the
management structure for all risks (including the risk arising from
disasters) into one single command structure. Both Programmes
require the technical expertise of different stakeholders in parallel
to the presence of a common core management group.
Therefore it is necessary to consider running two SubProgrammes as complementary and in synergy and to integrate
them into one single command structure of the CREMP.
Depending on the size of the hospital and the services it provides,
the complexity of the two Sub-Programmes will vary and therefore
the composition of the management board of each of them.
Hospitals should consider the appointment of a Hospital Risk
Manager (highly qualified; adequately trained; having a high
position in the hierarchy; appropriate authority).

The support from and direct involvement of Administration


(including HR, Finance, etc.) is necessary as in any major project
in hospitals. The clear identification of the roles of the various
stakeholders is necessary (especially in Administration).

Methodology for assessing vulnerabilities


There are many different methods for assessing the vulnerabilities
of communities, hospitals and systems, areas in which private
companies, for many years, have been very active. It is necessary
that hospitals desiring to develop a CREMP, select the methods
that best suit their facilities needs. Selection must be done also in
coordination with the local community, other hospitals that are
members of the local network, and in accordance with the policy
of the MoH (when available). The use of simple techniques
(qualitative) for the first estimate, is recommended for small-sized
hospitals. Very sophisticated computerized quantitative
techniques do not add much in terms of programme development
and in effectiveness of the whole process of risk management.
However, computerization of data is of paramount importance
(see information management). WHO has published a system for
assessing hospital vulnerabilities52. Nevertheless, it is
recommended that external vulnerabilities (present in the
surrounding community or in the system in which the hospital is a
member) that can impact on hospital activities, be included. When
selecting a method, the Planning Committee must consider the
resources that will be necessary as well as the competencies of
staff involved.

Methodology for identifying the hazards and threats


Selection of the methods that can be used must be done
according to validated pre-established criteria.

It is vital that all hospitals in one country use the same


methodology. Training activities must be considered for those in
charge of contributing to either identification or treatment of risks.

Roles, functions, responsibilities and composition of the


Incident Command Group ICG (the brain of the two SubProgrammes); activation; resources; location of the
Command Room
These issues are usually discussed during the development of the
ERP. But is is necessary to identify the specific components and
the systems pertaining to a CREMP.

Logistic support
The two Sub-Programmes require resources (from back-up
systems and equipment to sophisticated technology). The
rationalization of the acquisition, mobilization, monitoring of
resources must be a continuous effort, including necessary
training of staff.

Information management
The management of information in both Sub-Programmes is a
complex issue as it involves different systems. For integration of
these systems the following issues need to be discussed:
i. data: selection, processing, reporting;
ii. software and IT;
iii. ongoing surveillance activities and special surveillance
during health crisis (e.g. syndromic based, active reporting);
iv. links with the national observatory for hospital risks;
v. links with national policy making;
vi. links with quality assurance and accreditation.
Management of information also includes sharing of information
with the MoH (health system and its management). This includes
the mechanisms for sharing the information and development of
new structures53 at national level, to enable management of the
information gathered by hospitals. Development of a CREMP will
involve many stakeholders from different programmes (quality
assurance; blood safety, etc..) and therefore require integration of
all efforts and existing systems into a cohesive whole. This does
not mean that the various existing programmes are no longer
necessary. They need to be complementary and coordinated. The
development of a more comprehensive and more coordinated
policy on all these issues will contribute to the development of
CREMP by hospitals.

Monitoring process
Monitoring will consist of a complex set of activities in this new
concept of CREMP. The main elements that would need
addressing are:
 assessment of implemented risk treatment options (in both
Sub-Programmes)
 assessment of the Programme, involving
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Innovation and strategy: risk management

1. reorientation and revision


2. new technologies
3. evolution of context, risks, and vulnerabilities

Training activities and exercises


As in any activity, staff is the key resource. Training of staff is of
paramount importance. Exercises (from exercising the ERP to
security, etc.) are vital. Training and exercises must be developed
in a systemic approach. Much guidance from the MoH is needed
in this area. This is a weak element in hospital preparedness at the
moment almost everywhere around the world.

Implementation of risk management processes


Finally, in management of risks by private companies, there is
increasing use of the conceptual framework of Business
Management Processes. Hospitals seeking to develop a CREMP
can certainly benefit in the use of this approach. J
References
1.

In WHO vision there are three main categories of vulnerabilities : structural ; non structural ;
and functional vulnerabilities
2.
Which goes much beyond the management of communicable diseases only
3.
E.g. in France, these laws and regulations are regularly updated and completed: Scurit
sanitaire dans les tablissements de sant: rglementation applicable version n 5 juillet
2005
4.
Conformity of the practices with the existing legal framework
5.
Many different names are used such as crisis management, emergency management,
disaster management.
6.
A comprehensive emergency management programme. A model for state & territorial courtsColorado 2007
7.
Decentralization of the response capacity is a common finding in these countries
8.
The University Hospital of Houston has a well defined CEMP
9.
Mass Casualty Management Systems: strategies and guidelines for building health sector
capacity. WHO; 2007
10.
Often these plans are called Disaster Plans . The national policy of the MOH on Hospital
Disaster Plan for Mass Casualty Management is to link pre-hospital and hospital activities
11.
Usually a comprehensive approach (from prevention to recovery) and all hazards
12.
Although these programmes are usually not comprehensive for they target only limited
risks such as regulated risks
13.
State University of New York Upstate Medical University; University Hospital, Syracuse. 2008
14.
Examples of regulated risks: blood safety; nosocomial infection prevention ; fire procedures
15.
identifying and preventing exposure of patients, visitors or employees to risks that could
either cause injury in hospitals, jeopardize safety and security or result in costly claims and
lawsuits.
16.
Developped by the MoH in its normative role
17.
Usually the focus in on requirements for accreditation only. An audit in Canada in 2004
shown that ERP fulfilling criteria for accreditation were not functional plans. These checklist
do not guarantee that the ERP will be effective.
18.
For example: Health Care Risk Management: Training Programme organized by Ontario
Hospital Association (September 2008)
19.
Medical Professional Liability. by the American Academy of Orthopedic Surgeons. 2006
20.
WHO / WPRO Toolkit on Hospital Emergency Response Plan , 2009
21.
Safer hospitals: WHO campaign 2008-2009
22.
Safer hospital: WHO campaign 2008-2009
23.
E.g. in some programmes risk (harmful consequences) is mixed up with the source of risk
(hazard)
24.
roles and responsibilities of the various management structures; organisation of work during
crisis; triage protocols, etc.
25.
The same situation than for managing EMS Systems (the introduction of modern IT is a very
important step forward)
26.
When the ERP is activated
27.
which is often not yet included into RMP in hospitals.
28.
In some HRMP the components are called functions of the Programme
29.
Overview. There are many books on that particular issues
30.
the hospitals risk management programme, policies are adopted by both the governing
board and hospital administration
31.
So called although this programme do not include the management of services during
disasters so that there is no link between this comprehensive programme and the ERP
and contingency plans
32.
Four categories of indicators are usually used: process; activities; structure; results

24 Hospital and Healthcare Innovation Book 2009/2010

References continued
33.

The risk manager in a healthcare organization must maintain sufficient authority and respect
to enact the changes in clinical practice, policy, and procedures and in employee and
medical staff behaviors that are necessary to fulfill the essential functions of the risk
management programme. The American Academy of Orthopedic Surgeons, 2004.
34.
The American Academy of Orthopedic Surgeons, 2004.
35.
Developed by HDCA-Geneva (Health Development Counseling and Audit)
36.
Some frequent methods: Qualitative and Quantitative Failure Modes and Effects Analysis
FMEA. Failure Modes, Effects, and Criticality Analysis FMECA provides information to
quantify, prioritize and rank failure modes. Qualitative and Quantitative Fault Tree Analysis
(FTA). Probabilistic Risk Assessment (PRA). Delphi Technique
37.
Of the systems ; procedures ; human behavior ; skills and abilities of medical staff ; etc.
38.
In many countries these risks and the medical activities are precisely defined by the MOH
through a bulk of laws and regulations
39.
This is not limited to only costly equipment but also to equipment that is critical for ensuring
quality medical care and services (e.g. power backup system ; refrigeration towers, etc.)
40.
For instance that the equipment for intubation is available and adequate ; that the theater
room has a backup system for electrical power, etc.)
41.
Here again the identification of indicators is critical. Precursor events are important for they
should prompt an early treatment option (mitigation, response, etc.) while countermeasures
can control the risks generated by the events before they develop into a severe situation
42.
Many software are available that integrate all components (functions) of HRMP and that
allow for managing information in a systematic and holistic way
43.
Some hospitals have only one ERP and contingency procedures instead of separate
contingency plans
44.
Mass Casualty Management Systems: strategies and guidelines for building health sector
capacity. WHO; 2007
45.
Proposed by HDCA - Geneva
46.
E.g. the use of the concept of Incident Management System
47.
Under the concept of critical services during disasters more and more MOH also include
the services needed by people suffering from chronic non-communicable diseases requiring
regular treatment (haemodialysis, severe cardiac conditions, etc.).
48.
Critical infrastructure emergency risk management and assurance, 2003.
49.
Strategy and Recommendations in Developing EMS Systems; ADPC, 2005
50.
For instance in more and more countries Hospital are regrouped in network
51.
Disasters or critical adverse events can be seen as primarily a failure to adequately
manage information (WPRO).
52.
Hospital Safety Index, PAHO, 2007 (computerized system). Free download possible.

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Innovation and stategy: Accelerating Access Initiative

The Accelerating Access Initiative:


experience with a multinational
workplace programme in Africa
ARTICLE BY S VAN DER BORGHT
Heineken International Health Affairs, Amsterdam, Netherlands
V JANSSENS
PharmAccess Foundation, Amsterdam, Netherlands
MF SCHIM VAN DER LOEFF
GGD (Public health service), Amsterdam, Netherlands
A KAJEMBA
GGD (Public health service), Amsterdam, Netherlands
H RIJCKBORST
Heineken International Health Affairs, Amsterdam, Netherlands
JMA LANGE
PharmAccess Foundation, Amsterdam, Netherlands
TF RINK DE WIT
PharmAccess Foundation, Amsterdam, Netherlands

Problem: A multinational company with operations in several African countries was committed to offer antiretroviral treatment
to its employees and their dependants. Approach The Accelerating Access Initiative (AAI), an initiative of six pharmaceutical
companies and five United Nations agencies, offered the possibility of obtaining brand antiretroviral drugs (ARVs) at 10% of
the commercial price. PharmAccess, a foundation aimed at removing barriers to AIDS treatment in Africa, helped to establish
an HIV policy and treatment guidelines, and a workplace programme was rolled out from September 2001.
Local setting: Private sector employers in Africa are keen to take more responsibility in HIV prevention and AIDS care. An
important hurdle for African employers remains the price and availability of ARVs.
Relevant changes: The programme encountered various hurdles, among them the need for multiple contracts with multiple
companies, complex importation procedures, taxes levied on ARVs, lack of support from pharmaceutical companies in
importation and transportation, slow delivery of the drugs, lack of institutional memory in pharmaceutical companies and
government policies excluding the company from access to ARVs under the AAI.
Lessons learned: The launch of the AAI enabled this multinational company to offer access to ARVs to its employees and
dependants. The private sector should have access to these discounted drugs under the AAI. A network of local AAI offices
should be created to assist in logistics of drugs ordering, purchase and clearance. No taxes should be levied on ARVs.

IV is the largest threat to adult survival in sub-Saharan


Africa. According to UNAIDS, 33 million people were living
with HIV by December 2007, of whom 22 million were in
sub-Saharan Africa. In 2007 an estimated 1.5 million sub- Saharan
Africans died of AIDS and an estimated 1.9 million became
infected with HIV.1 Several international initiatives were launched to
increase funding for antiretroviral therapy. This has led to a
spectacular increase in access to antiretroviral drugs (ARVs) in
Africa: by April 2007 an estimated 28% of eligible HIV patients in
sub-Saharan Africa were on ARVs.2 One initiative that aimed to
increase access was the Accelerating Access Initiative (AAI). This
paper reports practical experiences of a multinational company
with the AAI.

Approach
In May 2000 five United Nations organizations United Nations
Population Fund (UNFPA), United Nations Childrens Fund
(UNICEF), WHO, The World Bank and the Joint United Nations
Programme on HIV/AIDS (UNAIDS) announced a partnership

with five pharmaceutical companies to address the lack of


affordable HIV medicines in resourcepoor settings.3 This
partnership, the AAI,4 was committed to offer ARVs at about 10%
of the commercial price to the public sector and nongovernmental
organizations that complied with three conditions (correct use, no
mark-up, no backflow of drugs to markets in developed
countries). By September 2006, an estimated 424 000 Africans
were treated with ARVs provided through AAI arrangements,5
most of them in public sector treatment programmes.
In July 2001, multinational brewing company Heineken
International, with headquarters in the Netherlands and operating
companies (OPCOs) in several African countries, decided to
include ART among the medical benefits for employees and their
dependants, including children. The company, itself selling a
brand beer, preferred to purchase brand ARVs, and accepted that
this would make the programme more expensive. The AAI price
reductions made the provision of ARVs to employees and
dependants affordable for the company. A partnership was
established with PharmAccess, a foundation specialized in
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Innovation and stategy: Accelerating Access Initiative

p g

company,
Table 1: Test results
and20012008
treatment uptake in six sub-Saharan African countries in the workplace programme of a multinational company,
20012008

Countries with
operating companies
with operational HIV
workplace programme
Burundi
Congo
Democratic Republic
of the Congo
Nigeria
Rwanda
Sierra Leone
Total

Adult target
population as of
1 January 2008

Number of HIV
tests done in
adults a

Number of
HIV infections
diagnosed

Male/female
ratio of HIV
diagnoses

Cumulative number
of patients who
started ARV therapy
as of 25 July 2008

Male/female
ratio of
patients on
ARV therapy

1059
1214
3040

1283
980
3828

77
68
64

1.40
1.61
1.06

57
38
28

1.38
1.85
1.42

3889
1000
130
10 332

5605
949
64
12 709

154
115
4
482

1.33
1.74
only male
1.45

77
73
0
273

1.19
1.25
0
1.34

ARV, antiretroviral
a Some people might have been tested more than once. Due to turnover of the workforce, it cannot be calculated which proportion of the current workforce has been tested

removing barriers to AIDS treatment in Africa.


PharmAccess conducted assessments, provided training,
helped define treatment protocols, provided laboratory support,
established a web-based database for patient follow-up6 and
conducted monitoring, evaluation and quality control.
PharmAccess interacted with AAI to guarantee a continuous
availability of ARVs at the OPCOs. The programme was gradually
rolled out at 14 OPCOs in 6 countries: Burundi, the Congo, the
Democratic Republic of the Congo, Nigeria, Rwanda and Sierra
Leone. The average size of the workforce per OPCO varied
between 200 and 500 employees; including spouses and children,
the total target population was 30 000 of which 10 332 were
adults (Table 1). Through the companys voluntary counselling and
testing programme, 531 infections were diagnosed among
employees and dependants, and 273 HIV patients had started
highly active ARV therapy (HAART) by mid- 2008.
PharmAccess arranged purchase and shipment of ARVs and
the OPCOs organized customs clearance and storage. The
chosen first and second line regimens implied procurement of
eight drugs from six different pharmaceutical companies.
PharmAccess signed agreements with these six companies.
Because neither the pharmaceutical companies nor PharmAccess
had local offices in most of the six countries, the local OPCO had
to clear the goods at customs. If the products were not yet
registered in the country, the OPCO had to arrange temporary
import permits. In the rare cases that a pharmaceutical company
had a local office, this did not assist in ordering and receiving
drugs for the company. It was difficult to import newer ARVs as
they were usually not registered.

Challenges
After some time it became possible in some countries to purchase
ARVs (both generic and brand) locally. If the drugs were
prequalified by WHO, the OPCOs obtained ARVs locally through
government agencies. The Ministry of Health in one country felt
that drugs purchased with a grant from the Global Fund to fight
AIDS, Tuberculosis and Malaria should not be re-sold, so it
stopped the provision of drugs to the OPCO. The same
government declined to provide free ARVs to the OPCO, arguing
that a for-profit private company should not have access to free
26 Hospital and Healthcare Innovation Book 2009/2010

drugs. Given these challenges, the company sometimes


purchased generic ARVs. Generic drug companies were generally
more helpful than brand pharmaceutical companies in the
importation of products through their local representatives. For
newer drugs, the AAI was the only source of supply.
Procuring ARVs was complex. Several pharmaceutical
companies had not yet developed AAI-agreement documents and
practicalities differed from one to another. Sometimes a
pharmaceutical company insisted that PharmAccess should sign
one agreement per country rather than one general agreement
covering all sub-Saharan countries. The high turnover of staff in
the pharmaceutical companies affected institutional memory; at
times PharmAccess had to explain AAI procedures to new staff at
pharmaceutical companies.
The price discount that was obtained was different per product
and per company and varied between 77% and 93%. The doorto-door delivery time of small ARV orders varied between 1 and 5
months. Despite the explicit assurance that pharmaceutical
companies would carry transport costs of ARVs, this was not
always the case in practice. Surprisingly none of the
pharmaceutical companies ever requested PharmAccess to
provide evidence of drug flows or absence of mark-up.

Lessons learned
The AAI was set up as a public sector, country-led process.7 This
implied that the private sector in most African countries could not
benefit from the AAI. We argue that allowing the African private
sector employers, private clinics and private health insurance
companies to obtain ARVs through AAI will contribute to more
sustainable access for all patients in sub-Saharan Africa.8
Private sector employers in Africa are keen to take more
responsibility in HIV prevention and AIDS care.9 An important
hurdle for African employers remains the price of ARVs; allowing
them access to ARVs under the AAI would make a big difference.
The overstretched African public health care sector would
indirectly benefit from this, allowing increased access for the poor.
The second sector that would benefit from AAI support is the
private health care sector. Private clinics in Africa provide care to a
substantial and increasing part of the population.10 National
governments should allow these clinics to use ARVs obtained

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Innovation and stategy: Accelerating Access Initiative

Box 1: Lessons learned

The private sector should have access to discounted ARVs


under the AAI.
A network of local AAI offices should be created to assist in
logistics of drugs ordering, purchase and clearance.
No taxes should be levied on ARVs.

and Gilead Sciences in 2004.


Funding: The Workplace programme is funded by Heineken
International. Competing interests: None declared.
References
2008 report on the global AIDS epidemic. Geneva: UNAIDS; 2008.
World health report 2006: working together for health [Statistical annexes]. Geneva: WHO;
2006.
3.
New public/private sector effort initiated to accelerate access to HIV/AIDS care and treatment
in developing countries [media release]. Geneva: UNAIDS; 2000. Available from:
www.essentialdrugs.org/edrug/archive/200005/ msg00027.php [accessed on 23 July 2009]
4.
Merck & Co. Inc. announces significant reductions in prices of HIV medicines to help speed
access in developing world [media release]. Whitehouse Station, NJ: Merck & Co Inc.; 2001.
Available from: www.cptech.org/ip/ health/firm/merck.html [accessed on 23 July 2009].
5.
Accelerating Access Initiative (AAI): fact sheet. Geneva: International Federation of
Pharmaceutical Manufacturers & Associations (IFPMA); 2007. Available from:
www.ifpma.org/site_docs/Health/AAI_Factsheet_Jan_07_ Q3_2006.pdf [accessed on 23
July 2009].
6.
Clevenbergh P, Van der Borght S, Janssens V, van Cranenburgh K, Kitenge Lubangi C,
Gahimbaza L, et al. Database-supported teleconferencing: an additional clinical mentoring
tool to assist a multinational company HIV/AIDS treatment program in Africa. HIV Clin Trials
2006;7:255-62. PMID:17162320 doi:10.1310/hct0705-255
7.
Sturchio JL. Partnership for Action: the experience of the Accelerating Access Initiative, 20002004, and lessons learned. In: Attaran A, Granville B, eds. Delivering essential medicines: the
way forward. London: Chatham House; 2004. pp. 116-151.
8.
Caines K, Lush L. Impact of public-private partnerships addressing access to
pharmaceuticals in selected low and middle income countries: a synthesis report from
studies in Botswana, Sri Lanka, Uganda and Zambia. Geneva: Initiative on Public-Private
Partnerships for Health; 2004.
9.
Private sector declaration against HIV/AIDS. In: World Economic Forum, Bangkok, July 2004.
Available from: www.weforum.org/pdf/Initiatives/ Bangkok2004_AIDS_Declaration.pdf
[accessed on 23 July 2009].
10.
Marek T, OFarrel C, Yamamota C, Zable I. Trends and opportunities in publicprivate
partnerships to improve health service delivery in Africa [Working paper series 33646, Africa
Region Human Development]. Washington, DC: The World Bank; 2005.
11.
Brugha R. Antiretroviral treatment in developing countries: the peril of neglecting private
providers. BMJ 2003;326:1382-4. PMID:12816829 doi:10.1136/bmj.326.7403.1382
12.
Schellekens OP, Lindner ME, van Esch JP, van Vugt M, Rinke de Wit TF. Health care insurance
for Africa. Ned Tijdschr Geneeskd 2007;151:2680-4. PMID:18179087
1.
2.

AAI, Accelerated Access Initiative; ARV, antiretroviral drugs.

through AAI. The quality of the performance of these clinics should


be assessed and monitoring is needed regarding markups on
drugs; all private clinics providing ARVs should comply with
national treatment standards.11
The third entity requiring access to AAI is the private health
insurance sector in Africa. Private health insurance Africa but this
situation is changing in several countries.12 Health insurance and
managed care may be instrumental in making African health care
more self-supporting and less dependent on external donors.
Therefore, African health maintenance organizations and health
insurance companies should be given access to AAI-discounted
ARVs. The launch of the AAI in the year 2000 enabled this
multinational to provide ARV therapy to its employees, their
spouses and children in Africa. The companys experience with the
AAI indicates the need for local AAI offices in African countries.
Such offices could facilitate ordering, clearance and channel bulkprocurement of ARVs for the three private sector actors named
previously.
Registration of drugs is often problematic, importation is highly
complex and taxes are being levied on ARVs. These issues should
be addressed by African governments. The lessons learned are
summarized in Box 1.

Recommendations
The AAI has led to substantial price reductions of brand drugs and
increased access to ARVs. Administrative, logistical and regulatory
hurdles have meant that the full potential of the AAI has not been
fulfilled. The following four recommendations are made to
strengthen the AAI and increase access to affordable good quality
drugs in sub-Saharan Africa. (i) AAI eligibility should be extended
beyond the public sector. Local private clinics, health insurers and
health maintenance organizations should get access to AAI ARVs,
under specific conditions. (ii) Governments should waive taxes on
ARVs, simplify and harmonize the drug registration process and
certify private clinicians. (iii) Private companies and non-profit
organizations that wish to provide ART to their employees and
dependants should be encouraged to do so and should benefit
from AAI. (iv) The pharmaceutical companies within AAI should
support the creation of a network of local AAI distributors of ARVs.
International donor funds should invest in this network. J
Acknowledgements
JMA Lange & TF Rinke de Wit are also affiliated with the Center
for Poverty-related Communicable Diseases (CPCD),
Academic Medical Center (AMC), University of Amsterdam,
Meibergdreef 9, 1100 DE Amsterdam, the Netherlands. The
pharmaceutical companies in the AAI were, initially, BoehringerIngelheim, Bristol Myers Squibb, GlaxoSmithKine, Merck&Co
and F Hoffman-LaRoche. Abbott Laboratories joined in 2001
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Innovation and policy: disease surveillance

Strategy to enhance influenza


surveillance worldwidei
ARTICLE BY JUSTIN R ORTIZ,
University of Washington, Seattle, Washington, USA
VIVIANA SOTOMAYOR,
Ministerio de Salud, Santiago, Chile
OSVALDO C UEZ,
Instituto Nacional de Epidemiologa, Mar del Plata, Argentina
OTAVIO OLIVA,
Pan American Health Organization, Washington, DC
DEBORAH BETTELS, MARGARET McCARRON, JOSEPH S BRESEE and ANTHONY W MOUNTS
Centers for Disease Control and Prevention, Atlanta, Georgia, USA

The emergence of a novel strain of influenza virus A (H1N1) in April 2009 focused attention on influenza surveillance
capabilities worldwide. In consultations before the 2009 outbreak of influenza subtype H1N1, the World Health Organization
had concluded that the world was unprepared to respond to an influenza pandemic, due in part to inadequate global
surveillance and response capacity. We describe a sentinel surveillance system that could enhance the quality of influenza
epidemiologic and laboratory data and strengthen a countrys capacity for seasonal, novel, and pandemic influenza detection
and prevention. Such a system would 1) provide data for a better understanding of the epidemiology and extent of seasonal
influenza, 2) provide a platform for the study of other acute febrile respiratory illnesses, 3) provide virus isolates for the
development of vaccines, 4) inform local pandemic planning and vaccine policy, 5) monitor influenza epidemics and
pandemics, and 6) provide infrastructure for an early warning system for outbreaks of new virus subtypes.

he emergence of a novel strain of influenza virus A (H1N1) in


April 2009 and its subsequent rapid global spread have
focused attention on influenza surveillance capabilities
worldwide1. A consultation convened by the World Health
Organization (WHO) in 2005 had previously concluded that the
world was unprepared to respond to an influenza pandemic, due
in part to inadequate global surveillance and response capacity2.
The International Health Regulations 2005 call for strengthened
surveillance for all events that may constitute a public health
emergency of international concern; such events include
individual human cases of influenza caused by a new subtype of
influenza virus A3. As part of the International Health Regulations
2005 core surveillance and response capacity requirements, each
Member State must develop and maintain capabilities to detect,
assess, and report disease events nationally and internationally to
WHO within 48 hours of confirmation. However, reviews of
national pandemic planning indicate that surveillance systems are
often inadequate to support current preparedness strategies 48.
WHO has existing surveillance guidelines to help Member States
implement universal surveillance for novel and pandemic
influenza9, but the guidelines lack the specificity that would enable
many countries to establish operational surveillance plans. Quality
influenza surveillance systems are needed to enable countries to
better understand influenza epidemiology, including disease
incidence and severity, and help them implement appropriate
prevention strategies. The challenges experienced by the United
States and Mexico to rapidly determine the extent and severity of
illness of the 2009 novel influenza A (H1N1) outbreak highlighted

28 Hospital and Healthcare Innovation Book 2009/2010

the need for systems that can reliably produce these estimates.
Furthermore, global strategies to address other vaccinepreventable diseases have acknowledged the importance of
establishing local disease burden (effects, severity, amount of
illness, and costs) as a first step toward decisions about the
introduction of vaccines into new countries. We describe a generic
guideline for collecting data on severe acute respiratory infection
(SARI), influenza-like illness (ILI), and laboratory-confirmed
influenza that can be implemented in limited-resource settings.

Current situation
Global Influenza surveillance
For 60 years, the WHO Global Influenza Surveillance Network
(GISN) has provided virologic information used in the biannual
process of selecting strains for the Northern and Southern
Hemisphere influenza vaccine formulations. However, its capacity
to provide epidemiologic data or an alert of an emerging pandemic
is limited. GISN currently comprises 122 National Influenza
Centers in 87 countries and 4 WHO Collaborating Centres for
Reference and Research on Influenza10. Although this system has
proven to be valuable, tropical and resource-limited countries
(particularly in Africa) are underrepresented11.
Influenza in developing countries
Virus transmission or clinical presentation may be altered by
i

A prior version of this protocol was presented in poster form at the Options for the
Control of Influenza Conference in Toronto, Ontario, Canada, 17 June, 2007.

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differences in cultural practices, the environment, geography,


human genetics, and social structures. Enhanced influenza
surveillance can permit assessment of a number of factors that
may affect disease activity: population density, differences in
prevalence and spectrum of chronic illness, proximity of the young
and elderly, low proportion of elderly in the population, low school
attendance, and school schedules that may not correspond with
peak transmissibility season. The effectiveness of control measures
such as social distancing and vaccination may differ between
developed and developing settings because of these factors.
Available epidemiologic evidence suggests that influenza is
common in tropical regions and contributes substantially to
disability and use of healthcare resources1216. Data describing the
seasonality and epidemiology of influenza in tropical areas are
limited; however, some tropical countries report year-round human
influenza activity12, unlike in temperate regions where transmission
occurs with marked seasonality. Because of these limited data,
most of the understanding of seasonal influenza is derived from
epidemiologic data collected in western Europe and North
America. Nevertheless, estimates of a pandemic impact indicate
that most deaths will be in developing countries and that more
than half will occur in southern Asia and sub-Saharan Africa17. A
better understanding of the epidemiology of influenza in these
areas would facilitate country-appropriate pandemic planning and
vaccine policy development.

Objectives
The

most

efficient

process

for

producing

high-quality

epidemiologic data for influenza-associated illness is sentinel


surveillance. The primary limitation of most existing influenza
sentinel-site networks that track ILIs has been that they often
provide little epidemiologic data, do not produce data on disease
incidence, and are focused on mild disease, which supports the
notion that influenza is a benign disease. We propose that
influenza surveillance should capture severe influenza outcomes
as a primary measure. Hospital-based sentinel surveillance is the
most efficient way to collect clinical data and laboratory specimens
from persons with a prevalent and severe infectious disease.
Carefully placed sentinel sites can provide adequate information
on the epidemiology of influenza without the need for
comprehensive national case ascertainment or reporting.
Placing surveillance sites where population data are known
would permit calculation of population-based estimates of disease
rates according to age and other demographic variables. In
addition, collection of clinical specimens from persons from whom
epidemiologic data are also collected would ensure virus strain
surveillance and provide isolates that can be used for vaccine
development. A sentinel surveillance system can be used to
monitor >1 disease, can be sustainable, and can integrate with
and build upon existing systems. The system objectives are 1)
describe the disease impact and epidemiology of severe, acute,
febrile respiratory illness and define the proportion that is
associated with influenza; 2) provide influenza virus isolates for
monitoring changes in viral antigens and development of new
vaccines; 3) contribute data for local pandemic planning and
making decisions regarding vaccine policy; 4) provide

Table 1: Influenza sentinel surveillance case definitions*

CASE

DEFINITION CRITERIA

Influenza-like illness

ALL OF THE FOLLOWING


Sudden onset of fever >38C, AND
Cough or sore throat, AND
Absence of other diagnoses

Severe acute respiratory


infection in persons >5 years
of age

ALL OF THE FOLLOWING


Sudden onset of fever >38C, AND
Cough or sore throat, AND
Shortness of breath or difficulty breathing, AND
Requires hospitalization

Severe acute respiratory


infection in persons <5 years
of age

EITHER
IMCI criteria for pneumonia
Any child 2 mo to 5 y of age with cough or difficult breathing and:
breathing faster than 60 breaths/min (infants <2 mo)
breathing faster than 50 breaths/min (212 mo)
breathing faster than 40 breaths/min (15 y)
OR
IMCI criteria for severe pneumonia
Any child 2 mo to 5 y of age with cough or difficult breathing and any of the following general danger signs:
unable to drink or breastfeed
vomits everything
convulsions
lethargic or unconscious
chest indrawing or stridor in a calm child
AND
Requires hospital admission

*Surveillance guidelines use the existing World Health Organization (WHO) case definition for Influenza-like Illness (19), and incorporate WHO guidance
to define severe acute respiratory infection in adults and children (9,18,19). IMCI, Integrated Management of Childhood Illness.

Hospital and Healthcare Innovation Book 2009/2010 29

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infrastructure for an early warning system for outbreaks of new


subtypes of influenza A viruses and new strains of existing
subtypes; and 5) serve as a monitoring tool for pandemic influenza.

Components and processes


Case definitions
These surveillance guidelines use the existing WHO case definition
for ILI and incorporate WHO guidance to define SARI in adults and
children (Table 1). The case definitions fit within the existing
framework for pandemic early warning, use existing definitions for
ease of adoption, and rely on physical examination findings that do
not require laboratory or radiographic criteria. In addition, SARI
definitions may capture a broad spectrum of severe influenzaassociated illness, including exacerbations of asthma, chronic
obstructive pulmonary disease, and decompensated congestive
heart failure, which may account for 75% of hospitalized influenza
patients16,20,21.
Sentinel site selection
Ideally, sites should represent a wide cross-section of ethnic and
socioeconomic groups and should be in different climatic regions.
Placement of sites in areas where the population denominator can
be ascertained or estimated will facilitate incidence estimates.
Ultimately, the choice of sentinel hospitals will often be based on
practical issues such as human resources, communication
infrastructure, and availability of specimen transport and testing.
There is no ideal number of surveillance sites; the number chosen
by a particular country will depend in part on sustainability and
resources available.
Data Collection
Minimum data elements are outlined in Table 2. Data collected
should be adequate for routine public health surveillance and
description of key epidemiologic features of disease. Data can be
broadened to include clinical signs and symptoms, potential
exposures, laboratory data, and therapies.
Specimen collection
Respiratory specimens should be collected early from all SARI
patients, following established protocols24. If resources do not
allow collection from all patients, an unbiased systematic sampling
scheme should be established. To develop quality estimates of
incidence and severity, data and specimens from all or most SARI
patients from a few facilities would be preferred over a small
sample of SARI patients from multiple facilities.
Because seasonality, attack rates, and public health priorities
differ from country to country, there is no generic number of
specimens to be collected by each site. The number must be
determined by the primary surveillance objective (e.g.,
understanding of seasonality, risk factor analysis, or determination
of clinical outcomes) and must represent climatic and geographic
regions. For example, a country with coastal, mountainous, and
tropical regions may have different influenza activity in each region
and may thus require more surveillance sites and increased
specimen collection than neighbors or similarly sized countries.
Therefore, the number of specimens collected must be
approached on a case-by-case basis and depends on objectives
of a country, country-specific geographic and climatic issues, and
public health priorities.
30 Hospital and Healthcare Innovation Book 2009/2010

Table 2: Sample data collection from cases of severe acute


respiratory infection and influenza-like illness*

RECOMMENDED ESSENTIAL MINIMUM DATA FOR SARI SURVEILLANCE


General information
Unique identification number
Medical record number
Name (of patient and parents name, if a minor)
Date of birth
Sex
Address
Date of onset of symptoms
Date of collection of epidemiologic data
Suspected novel influenza case
Inpatient or outpatient
Clinical signs and symptoms
Fever >38C
Cough
Sore throat
Shortness of breath/difficulty breathing
Other clinical danger signs (19,22,23)
Type of specimen collected and date of collection
Throat swab specimen, date of collection
Nasal swab specimen, date of collection
Other specimen (if collected), date of collection
Preexisting medical conditions
Liver disease
Kidney disease
AIDS, cancer, or other immunocompromised state
Neuromuscular dysfunction
Diabetes
Heart disease
Lung disease
Smoking history
Optional data collection for SARI surveillance
General information
Diarrhea
Encephalopathy
Exposure
Occupation of patient
136
Part of an outbreak investigation
Contact with sick or dead poultry or wild birds
Contact with friend or family who has SARI
Travel in an area known to have endemic circulation of
avian influenza (H5N1)
Other high-risk exposure (e.g., eating raw or undercooked
poultry products in an area of influenza virus [H5N1]
circulation)
Vaccine/treatment history
Vaccination against influenza within the past year
Currently taking antiviral medicine
*SARI, severe acute respiratory infection; ILI, influenza-like illness.

Integration into national reporting systems


In countries with established national disease reporting systems,
such as the Integrated Disease Surveillance Reporting system
used in Africa25, sentinel surveillance for SARI can be incorporated
into the existing system. Because Integrated Disease Surveillance
Reporting is generally a passive surveillance program, a few select
sites should serve as embedded sentinel sites; intensive training
and close follow-up should be conducted to ensure the quality of

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the reported data.


Outpatient surveillance
The highest priority should be to collect data on SARI cases
because they contain the most influenza-associated disability and
premature death. However, if resources permit, data collection at
sentinel sites should be expanded to include ambulatory patients
with ILI. Because the number of cases at ambulatory care sites is
likely to be large, case counts would be aggregated, and clinical
specimens and epidemiologic data would be collected from only a
small sample of patients. Weekly case counts should be
categorized by age group according to well-studied age-range
categories (623 months, 24 years, 517 years, 1849 years,
5064 years, and >65 years)26. Patients chosen to give detailed
epidemiologic data and clinical specimens should be selected in
as unbiased a manner as possible. The selection protocol must
take into account local health-seeking behavior, such as
differential use of evening and weekend clinics. Ideally, the weekly
total number of patients seen by clinics would also be collected by
age group to allow for proportion of ILI to be calculated. Rapid
system expansion can compromise the quality of collected data;
therefore, ILI surveillance should emphasize quality data collection
from a few well-run sites.
Laboratory testing
Clinical specimens should be collected from a high proportion of
SARI patients and a systematic sample of ILI patients. These
specimens can be processed in sentinel site laboratories, but
further analyses may require their transport to additional
laboratories. Ideally, specimens would be tested for evidence of
influenza viruses by reverse transcriptionPCR (RT-PCR). A subset
of specimens should undergo viral culture and antigenic
characterization. Surveillance data should be submitted to WHO
FluNet, and, if possible, national laboratories should work with a
WHO Collaborating Center laboratory to submit sample virus
isolates for vaccine strain selection.
In countries where influenza spreads in seasonal epidemics, it
may be adequate to collect less epidemiologic data and fewer
specimens for laboratory testing by sampling a smaller proportion
of SARI patients during the noninfluenza season. Knowledge of
SARI rates outside influenza season will permit comparisons
between peak season and baseline rates. Noninfluenza season
rates of SARI can also be monitored by public health authorities,
because anomalies in SARI rates could represent outbreaks in
need of investigation. However, high-quality, year-round data will
be required for >1 season before assumptions can be made about
seasonality in a region.
Nasal and nasopharyngeal specimens have a higher yield for
influenza virus detection in ILI cases than do oropharyngeal
specimens27. However, the relative sensitivity of nasal versus
oropharyngeal swabs to detect influenza virus infection in SARI
cases is unknown. If both are collected, specimens can be placed
in the same tube of viral transport media for processing. If SARI
patients are intubated, endotracheal aspirates can also be used.
Specimens can be frozen at 70C for storage and possible future
assessment of other respiratory pathogens.
The sensitivity and specificity of any test for influenza will depend
on the laboratory performing the test, the quality of the clinical
specimen, the manner in which the specimen is processed, and

the type of specimen collected. Generally, RT-PCR testing of


respiratory specimens is the most sensitive laboratory test for
influenza virus, but it is relatively expensive and is not useful for
antigenic characterization28. If the proper primers and probes are
used, RT-PCR can determine influenza virus A subtype and can
detect novel influenza virus A subtypes. Fluorescent antibody
tests, although less expensive, are less sensitive and specific than
RT-PCR27. Rapid point-of-care tests are less sensitive and specific
than RT-PCR or fluorescent antibody tests and are not generally
recommended for use by sentinel surveillance. Virus culture has
been the diagnostic standard for identifying influenza virus. Culture
sensitivity depends on proper specimen handling and the
experience of the laboratory. Virus culture should be performed on
at least a sample of specimens to provide material for antigenic
determination and potential isolates for vaccine production.

Data analysis and reporting


Timely analysis and reporting of surveillance data will facilitate
treatment decisions by clinicians and control measures by public
health officials. It will also encourage continued reporting of cases
by clinicians in the surveillance system. Weekly reports of clinical
and laboratory confirmed case counts should be disseminated
throughout the surveillance system to participating healthcare
providers and all stakeholders during peak seasons. The
frequency of reports and the extent to which they are
disseminated will depend on data timeliness and public health
priorities. Sentinel surveillance reporting mechanisms should use
existing public health communications systems and augment
other reporting mechanisms such as FluNet through WHO GISN29.
Basic analyses of surveillance data should include weekly
frequencies of SARI and laboratory-confirmed influenza cases as
well as the proportion of tested patients, by age group, who are
influenza virus positive. If possible, proportions of SARI and
influenza cases per total of weekly sentinel hospital admissions
should be reported. Reports with case frequencies and
proportions during prior weeks and years will demonstrate trends
over time. At least once annually, analyses of surveillance data to
determine risk factors for disease should be reported. These
reports should use collected data on concurrent conditions and
populationbased rates, if these can be determined.
Understanding the epidemiology of severe influenzaassociated
disease is essential for decisions related to vaccine
recommendations. These data are prioritized in the guidelines
because many developing countries have limited funds and
competing healthcare priorities. However, data collected during
SARI surveillance alone will be inadequate to describe aspects of
influenza epidemiology such as transmission dynamics, costs, and
occurrence of mild disease.

Evaluation and auality assurance


The usefulness of surveillance data will depend directly on the
quality of the data; every system should have a quality assurance
program. Quality indicators will reflect such attributes as system
acceptability, timeliness, completeness, and representativeness of
collected data. These attributes should be assessed routinely. In
addition, the system should undergo regular data audits and
systematic field evaluation. In 2001, the Centers for Disease
Control and Prevention published comprehensive guidelines for
the evaluation of public health surveillance systems30.
Hospital and Healthcare Innovation Book 2009/2010 31

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These guidelines serve as a template for sentinel surveillance


evaluation and quality recommendations. Several key quality
indicators are recommended in the following section and in Table 3.
Data validity
Regular field evaluations and audits at a facility level must be a
standard component of the system. This process can determine
that cases are being counted appropriately, that reported cases
meet the case definition, and that sampling procedures are being
used uniformly without evidence of bias. Data values recorded in
the surveillance system can be compared with standard chartreview values by a retrospective review of a sample of medical
records. If a sampling procedure is used for specimen collection,
audits can ensure that procedures are uniform and unbiased.
Additionally, audits can determine whether clinical specimens are
being taken, stored, processed, tested (if appropriate), and
shipped properly and in a timely manner from all those who meet
sampling criteria.
Observance of expected trends in reporting and disease activity
can provide an additional means of assessing data quality.
Although it is not possible to define expected values for some
parameters, such as the percentage of specimens testing positive
for influenza virus or the number of SARI cases occurring in a
given facility, aberrations in the data over time or substantial
differences between facilities can signal problems at a given site.
Trends assessed may include number of cases reported by
month, number of specimens submitted by month, percentage of
influenzapositive specimens, and number and percentage of SARI
and ILI cases tested.
Timeliness
To be useful, collection and reporting of surveillance data must be
timely. Timeliness of the following activities is appropriate for
routine measurement as quality indicators for surveillance sites:
data reporting, specimen shipment to the laboratory for testing,
receipt of specimens by the laboratory, laboratory processing and
testing of specimens, and reporting of laboratory results.
One way to quantify timeliness is to calculate the percentage of
times that a site achieves targets for specific intervals, for example,
the percentage of times that a site sends reports or specimens to
the appropriate place within a specified time frame. A hypothetical
system may choose as a goal that 80% of data reports be sent
within 48 hours of the reporting deadline or that 80% of specimens
be shipped within 48 hours of specimen collection. Likewise, for
the laboratory, the percentage of samples that are tested and have
final results within a target time frame can be calculated. Targets
will depend on site-specific circumstances and public health
priorities.
A similar quality metric that can be used is the calculation of the
average time to accomplish surveillance activities. For example, a
hypothetical site that is chronically late in sending data every
month might average several days between the deadline for
receipt (the day of the week or month on which reports are due)
and actual receipt of data. For laboratory specimen processing,
the average number of days between receipt of specimens and
the reporting of the results can be measured and followed similarly.
Site time averages can be compared to identify sites that are
underperforming and to target improvements. Either percentages
of sites achieving timeliness targets or time lag averages can also
32 Hospital and Healthcare Innovation Book 2009/2010

Table 3: Influenza surveillance evaluation and recommended


quality indicators*

1. Timeliness
a. Several time intervals are appropriate for routine
measurement as quality indicators. These include the
duration of time from
i. Target date for data reporting from the sentinel site to the
next administrative level until the actual reporting date
ii. Target date for data reporting from the next
administrative level to the national level until the actual
reporting date
iii. Date of specimen collection at facility until shipment to
laboratory
iv. Date of result availability in laboratory until date of report
to referring institution and physician
v. Date of receipt of specimen in the laboratory until result
availability
b. Metrics. Two metrics can be used to reflect timeliness
indicators:
i. Percentage of time that a site achieves target for
timeliness
ii. Average number of days for each interval over time for
each site
2. Completeness
a. Percentage of reports received from each site with complete
data
b. Percentage of data reports that are received
c. Percentage of reported cases that have specimens
collected
3. Audit. Regular field evaluations and audits at facility level of a
subset of medical records to ensure
a. Cases are being counted appropriately and not being
underreported
b. Reported cases fit the case definition
c. Epidemiologic data are correctly and accurately abstracted
d. Respiratory samples are being taken, stored, processed,
tested, and shipped properly and in a timely fashion from all
those who meet sampling criteria
e. Sampling procedures are being done uniformly without
evidence of bias
4. Data to be followed and observed for aberrations over time
a. Number of cases reported by month for each site
b. Number of specimens submitted by month for each site
c. Percentage of specimens that are positive for influenza
d. Number and percent of ILI and SARI cases tested
*ILI, influenza-like illness; SARI, severe acute respiratory illness.

be used as a quality metric to be followed over time.


Completeness
Indicators of completeness can be determined by analyzing
reported data. They may include percentage of reports received
from each site with complete data, percentage of total expected
data reports received, and percentage of total expected cases
that have specimens submitted to the laboratory (depends on
sampling scheme devised for sites).

Pandemic early warning systems and monitoring


Emergence of new subtypes of influenza virus A in human
populations is unusual and unlikely to be detected by a sentinel
surveillance system, except by chance or if transmission is
sustained. Control of a pandemic caused by the introduction of a

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new subtype of influenza virus A will require early detection and


recognition of the event. Although sentinel surveillance as a standalone system may not accomplish this, it has value in establishing
the infrastructure necessary to respond to a pandemic. In addition
to providing a basic understanding of the epidemiology of
influenza transmission and risk, a routine reporting system would
produce an infrastructure for reporting, specimen processing and
testing, and data collection and analysis. It would make data
interpretation more routine (and thus more manageable in the face
of a pandemic emergency) and drive interest in influenzaassociated disease and vaccination.
After a novel strain of influenza emerges, monitoring its course
is necessary to determine whether cases are increasing or
decreasing, to detect changes in patient age distribution or other
epidemiologic characteristics, to detect changes in mortality rates,
and to monitor changes in susceptibility to antiviral agents. In the
midst of an outbreak, national monitoring may not be necessary or
feasible, and most, if not all, critical information can be gained from
a few sentinel sites. Emergence of a new strain of influenza
increases the data needs of health policy makers. Historical
surveillance data for comparison can facilitate the understanding
of answers to critical questions such as severity of the outbreak
related to a new strain and its potential to adversely affect
healthcare delivery. An existing surveillance infrastructure also
provides the platform needed to describe the clinical course of
emerging pathogens, risk factors for severe outcomes, and
effectiveness of control measures.

Conclusions
Surveillance for SARIs can provide critical understanding of the
contribution of influenza infection to the global burden of disease,
provide a platform for the study of other common respiratory
pathogens, and strengthen public health infrastructure. Such a
system should be a part of a routine surveillance program to
provide data needed for allocation of scarce healthcare
resources. J
Acknowledgements
We thank the following people for their help with this project:
Lynnette Brammer, Clovis Heitor Tigre, Thais Dos Santos, Melania
Flores, Erika Garcia, Diane Gross, Monica Guardo, Ann Moen, Josh
Mott, Camelia Savulescu, David Shay, Tim Uyeki, John C. Victor,
and the manuscript peer reviewers. Dr Ortiz is a research fellow at
the University of Washington and PATH (Program for Appropriate
Technology and Health). His research interest is the clinical
epidemiology of respiratory infections found in tropical regions.

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Petric M, Comanor L, Petti CA. Role of the laboratory in diagnosis of influenza during seasonal
epidemics and potential pandemics. J Infect Dis. 2006;194(Suppl 2):S98110. DOI:
10.1086/507554
29.
World Health Organization. FluNet. 2008 [cited 2008 Oct 20]. Available from
http://gamapserver.who.int/GlobalAtlas/PDFFactory/Flu- Net/index.asp?rptGrp=1
30.
Centers for Disease Control and Prevention. Updated guidelines for evaluating public health
surveillance systems: recommendations from the guidelines working group. MMWR Morb
Mortal Wkly Rep. 2001;50:136.
2.

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Global control of hepatitis B virus:


does treatment induced antigenic
change affect immunization?
ARTICLE BY C JOHN CLEMENTS
Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
BEN COGHLAN
The Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, Victoria, Australia
MICK CREATI
The Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, Victoria, Australia
STEPHEN LOCARNINI
Research & Molecular Development, Victorian Infectious Diseases Reference Laboratory, North Melbourne, Victoria, Australia
RICHARD S TEDDER
Virus Reference Department, Centre for Infections, Health Protection Agency, Colindale, London, England
JOSEPH TORRESIE
Department of Infectious Diseases, Austin Hospital, Heidelberg, The University of Melbourne, Parkville, Victoria, Australia

Since its widespread introduction, the hepatitis B vaccine has become an essential part of infant immunization programmes
globally. The vaccine has been particularly important for countries where the incidence of hepatitis B virus-related
hepatocellular carcinoma is high. Effective treatment options for individuals with chronic hepatitis B infection were limited
until 1998 when lamivudine, the first nucleoside analogue drug, was introduced. As a single treatment agent, however,
lamivudine has a significant drawback: it induces lamivudine-resistant hepatitis B virus strains that may pose a risk to the
global hepatitis B immunization programme. Mutations associated with drug treatment can cause changes to the surface
antigen protein, the precise part of the virus that the hepatitis B vaccine mimics. However, the emergence of antiviral drug
associated potential vaccine escape mutants (ADAP-VEMs) in treated patients does not necessarily pose a significant,
imminent threat to the global hepatitis B immunization programme. Nonetheless, there is already evidence that current
treatment regimens have resulted in the selection of stable ADAP-VEMs. Treatment is currently intended to prevent the longterm complications of hepatitis B virus infection, with little consideration given to potential adverse public health impacts.
To address individual and public health concerns, trials are urgently needed to find the optimal combination of existing
drugs that are effective but do not induce the emergence of ADAP-VEMs. This paper examines the mechanism of antiviral
drug-selected changes in the portion of the viral genome that also affects the surface antigen, and explores their potential
impact on current hepatitis B immunization programmes.

ince its widespread introduction in 1983, the hepatitis B


vaccine has become an essential part of infant
immunization programmes globally, and is the key
component of the global hepatitis B control programme for the
World Health Organization.1 Infection with hepatitis B virus (HBV)
can cause acute liver disease, as well as chronic infection that may
lead to liver failure or hepatocellular carcinoma. The vaccine has
been particularly important for countries where the incidence of
HBV-related hepatocellular carcinoma is high. In effect, the
hepatitis B vaccine was the worlds first anticancer vaccine.
Effective treatment options for individuals with chronic hepatitis
B infection were limited until 1998 when lamivudine, the first
nucleoside analogue drug, was approved for treatment. Newer
agents have been developed, but lamivudine remains the
mainstay therapy in many countries with high HBV prevalence
because of its safety, efficacy and low cost. As a single treatment
agent, however, lamivudine has a significant drawback:
monotherapy has resulted in the appearance of lamivudineresistant HBV strains, a phenomenon that has been observed with

34 Hospital and Healthcare Innovation Book 2009/2010

single-drug regimens used to treat other infections such as


tuberculosis and human immunodeficiency virus (HIV) infection.2
The emergence of these drug-resistant strains limits therapeutic
options for individuals chronically infected with HBV; moreover, the
spread of these strains may pose a risk to the global hepatitis B
immunization programme. Mutations associated with drug
treatment can cause changes to the surface antigen protein, the
precise portion of the virus that the hepatitis B vaccine mimics.
This article examines the mechanism of antiviral drug-selected
changes in the part of the viral genome that also affects the
surface antigen, and explores their potential impact on current
hepatitis B vaccine programmes (Box 1).

Features of the hepatitis B virus


HBV is an enveloped, partly double-stranded DNA virus
containing a compact, circular genome of overlapping reading
frames (Figure 1). Human HBV causes both acute and longterm
infections, including chronic and neoplastic liver disease. The virus
exists as eight genotypes labelled A to H, with varied geographical

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distributions. Differences between genotypes involve


approximately 8% of the genomic sequence.35 HBV uses an
encoded enzyme reverse transcriptase to replicate its viral
genome. Reverse transcription is an error-prone process that
generates a large number of nucleotide changes within the viral
genome. This process results in new, closely-related viral species;
as a result, at any given time in a particular host the viral population
consists of a swarm of similar but discrete viruses.6,7

Hepatitis B vaccine escape mutants


The hepatitis B vaccine is an effective means of preventing HBV
infection, producing protective levels of antibodies in up to 95% of
recipients.8 The envelope gene of HBV produces proteins of three
different lengths: two larger proteins, preS1 and preS2, as well as
the smaller S protein. The commercially available hepatitis B vaccine
used in most programmes is a yeast-derived recombinant surface
antigen of the small S protein alone. Antibodies elicited by the
hepatitis B vaccine specifically target the a determinant of the
surface antigen (Figure 1). It has been recognized that the
administration of hepatitis B vaccine can increase the mutation rate
of the virus. In high-prevalence countries such as China, Thailand
and Taiwan, monitoring for more than a decade has shown that
hepatitis B immunization programmes have increased the incidence
of HBV variants with mutations in the surface antigen protein9,10 even
as they reduce the overall burden of chronic hepatitis B infection.11
Mutations in and around the a determinant may lead to an
alteration in the antigenicity of the surface antigen protein so that
antibodies directed against the surface antigen protein may fail to
neutralize the virus.1220 Infection of immunized individuals with a
vaccine escape mutant (VEM)20 is therefore possible. VEMs are
typically characterized by the presence of single-amino-acid
changes in the S protein.12,21 Some of these variants are associated
with high levels of viraemia and have persisted in the host for more
than 10 years, suggesting they are stable and transmissible variants.
In addition, the antibody responses against the surface antigen
protein elicited by the recombinant yeast-derived vaccine now in use
are weaker and more specific than those achieved with the previous
plasma-derived surface antigen vaccine.2224 In Taiwan, up to 28% of
children with chronic hepatitis B infection also harbour hepatitis B
surface antigen mutants. So VEMs capable of causing infection in
fully immunized individuals are not uncommon in countries with high
rates of endemic HBV infection and universal hepatitis B infant
immunization programmes.12,20 However, to date the emergence of
VEMs has not had a known negative impact on any countrys
immunization programme.25

Box 1: Glossary of terms related with hepatitis B


viral replication ADAP-VEM
Antiviral drug-associated potential vaccine escape mutant.
a determinant
A specific region of the hepatitis B virus surface antigen. Neutralizing
antibodies that recognize this antigen must form for the vaccine to
provide protection against the disease.
Code
The verb to code for denotes the process of providing the genetic
template for a specific protein.
Codon
Groups of three amino acids (nucleotides) that together form a unit of
genetic code in a DNA or RNA molecule.
Envelope gene
A gene which codes for the surface antigen (envelope) of the hepatitis B
virus.
Genome
The complete set of genes or genetic material (DNA and RNA) present in
a cell or organism.
Genotype
The genetic constitution of an organism.
Monotherapy
Treatment with a single therapeutic agent.
Polymerase
An enzyme that acts in the polymerization of new DNA or RNA during the
processes of replication and transcription.
Reading frame
A non-overlapping set of three-nucleotide sequence codons in DNA or
RNA. whether reading starts with the first, second or third base in the
sequence. For example, with the nucleotide sequence TGCTGCTGC, the
three possible reading frames are TGC TGC TGC, GCT GCT GCT and CTG
CTG CTG.
Surface antigen
The outer envelope protein of the hepatitis B virus.
Transcriptase
An enzyme that catalyzes the formation of RNA from a DNA template
during transcription.
Reverse transcription
Genetic copying in the reverse direction in a small number of species
(e.g. human immunodeficiency and hepatitis B viruses) compared with
transcription in other species.
Vaccine escape mutant
A viral strain that has undergone changes in antigenicity that make the
vaccinegenerated antibody response ineffective in vivo.

Treatment of HBV infection


Five oral antiviral agents have been approved by the United States
Food and Drug Administration for the treatment of chronic
hepatitis B infection: lamivudine, adefovir, entecavir, telbivudine
and tenofovir.26,27 The same agents are licensed in the United
Kingdom and Europe. Each of these nucleoside analogue drugs
has an excellent safety and efficacy profile. Effective long-term
suppression of HBV replication by these agents is associated with
histological and clinical improvement. Before the approval of these
direct antiviral agents, interferon, an immune potentiator, had been
used to treat chronic hepatitis B infection.28 However, interferon
was not consistently successful when used as monotherapy.26,27
More recently, standard interferon has been replaced by interferon

conjugated with polyethylene glycol (PEGIFN). This combination


administered for 48 weeks achieves a sustained response rate in
about 30% of patients.29,30 The combination of PEG-IFN plus
lamivudine29,30 does not improve the virological response compared
with PEG-IFN alone. However, compared with lamivudine
monotherapy, this combination was more effective in preventing the
emergence of lamivudine-resistant HBV.31 The combination of PEGIFN with more potent nucleoside and nucleotide analogues such as
entecavir or tenofovir needs to be tested.

Problems with HBV drug therapy


The HBV genome is circular and organized into four open reading
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of chronic hepatitis B infection results in mutations in the


HBV genome that can have an impact on public health (Fig.
2). However, the emergence of such ADAP-VEMs in treated
patients does not necessarily pose a significant, imminent
Polymerase
Terminal Protein
Spacer
GFA
BCDE
RNA asH
threat to the global hepatitis B immunization programme. For
protein
instance, some ADAP-VEMs selected by lamivudine have
Surface antigen
PreS1
PreS2
S
been shown to be less fit virologically; that is, they are rapidly
protein
replaced when the drug is removed and are unlikely to be a
dominant or co-dominant viral population in terms of virus
transmission.29 For a new viral species to pose a threat to an
immunization programme, we propose that it must display
the following characteristics: (i) it must be a stable mutant, (ii)
the changes in antigenicity must be sufficient to prevent the
antibody generated by the vaccine from neutralizing it (i.e. it
must be a true ADA-VEM), (iii) it must be transmissible,
Figure 1: Genome structure of the hepatitis B virus showing
cause infection in immunized individuals and have
overlapping reading frames of the polymerase and surface antigen
opportunities to spread and (iv) it must cause acute or
chronic disease in infected individuals. Of these four
characteristics, to date we have evidence that three have
been fulfilled, although we do not know if ADAP-VEMs have
Can infect nave (anti-HBs-ve)
the same propensity to cause disease as do strains of HBV
individuals with VEMs
that are already circulating. However, given the high rate of
HBV drug resistance and the discovery of ADAP-VEMs in
individuals who have received lamivudine therapy, we
suggest at least two features of HBV treatment programmes
may increase the likelihood that an ADAP-VEM of public
Selects for VEMs
Individual with
health importance will emerge. The first feature of such
chronic HBV treated
with NA
programmes that can increase the risk is the type of antiviral
agent. Lamivudine, although it is relatively inexpensive, has
Can infect HepB-immunized (anti-HBs-ve)
individuals with VEMs
been shown to rapidly result in the selection of primary
antiviral drug-resistant polymerase variants.
These variants in turn also select for compensatory
mutations,
some of which may have altered surface
Figure 2: Potential impact of hepatitis B vaccine escape mutants and
antiviral drug-associated potential vaccine escape mutants on public health
antigens.33,34,39 In contrast, the likelihood that mutants will be
generated seems to be much lower for newer agents such
frames that overlap each other. As a consequence of this
as entecavir, and for combination therapies including PEG-IFN,
arrangement, the part of the polymerase gene that codes for the
although the risk is not zero.30,35,38,40 All of these newer medications,
reverse transcriptase enzyme the target of antiviral therapy
however, are more expensive and their long-term efficacy is still
overlaps the neutralization domain of the surface gene that codes
being established. Consequently, for the foreseeable future many
for the S protein the target of antibodies elicited by the hepatitis
countries, especially in the Asia-Pacific region, will probably
B vaccine (Figure 1). Treatment of HBV-infected individuals with
continue to treat chronic hepatitis B infection with lamivudine even
nucleoside analogues results in mutations in the polymerase gene,
though it is no longer considered the first-line treatment, and
many of which are associated with alterations in the a
despite the fact that drug resistance may rapidly emerge.41 The
3234
determinant of the surface antigen.
proliferation of medications and substandard drugs, as has
Resistance to lamivudine is,
occurred with treatments for malaria (for instance), is an additional
in fact, common in patients on monotherapy, appearing in from
risk as treatment programmes expand in developing countries.
15% after the first year of treatment to 67% when used
The second potentially problematic feature of current treatment
continuously for 4 years.35 The genomic changes can be stable,
programmes is the way patients are selected. Antiviral drugs are
and in at least one case a drug-resistant strain has been
the only long-term treatment option for chronic hepatitis B
transmitted to another individual.36 Consequently, in populations
infection,40 and many investigators have argued that all patients
where lamivudine has been widely used to treat patients
continuously for periods of several years, viruses with alterations in
who are viraemic should be treated. Because of the strong
the surface antigen are likely to occur relatively frequently, and
correlation between HBV viral load and the likelihood of developing
some will be antiviral drug-associated potential vaccine escape
cirrhosis and hepatocellular carcinoma, reducing viral replication
mutants (ADAP-VEMs). Although drug-driven changes in the S
as early as possible after infection is likely to be beneficial. In
protein have been well described, the effect of these changes on
addition to being costly, this approach may generate antiviral drug
the antigenicity of the surface antigen has been little studied.37,38
resistance since current agents never lead to eradication of the
virus, but only to control of replication. This effect, in turn, can
complicate second-line therapies and may favour the appearance
Public health risk of escape mutants
of ADAPVEMs. Treatment in industrialized countries is therefore
The use of nucleoside and nucleotide analogues in the treatment
Points of action of
nucleos(t)ide analogues

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usually reserved for patients likely to respond to therapy and those


who have advanced disease.41 However, there is no consensus
globally regarding which patients to treat, and WHO has not yet
produced international recommendations to guide therapy (Daniel
Lavanchy, personal communication, 2008). Inappropriate inclusion
criteria, improper application of these criteria or lack of compliance
with treatment could greatly influence the emergence of both drug
resistance and ADAP-VEMs. The public health risk of treatment
programmes in different populations may also depend upon
features of the circulating viral genotype. There is evidence that the
genotype of the virus influences the speed and frequency of
development of resistance to treatment, which may in turn
influence the likelihood that ADAP-VEMs will emerge. For
example, genotype A-1 (common in northwestern Europe and
North America) more frequently develops surface protein changes
with lamivudine therapy than genotype D-1 (concentrated in
Mediterranean countries but distributed globally).42 The viral
genotype also influences how frequently infected individuals
develop antibodies to the hepatitis B e antigen (HBeAg). During
the natural history of chronic hepatitis B, persons infected with
genotype D-1 are more likely to become HBeAg-negative than
those infected with genotype A-1.43 In general, when HBeAg is
detectable in the blood, the infection is more transmissible. Among
children born to mothers who are HBeAg-positive, 90% will
become infected whereas only 10% of children born to HBeAgnegative mothers will become infected. The disease process can
also be more active and more rapidly progressive in HBeAgpositive individuals,43 although disease progression may also be
influenced more by the underlying HBV genotype than by HBeAg
status alone.44,45 The proportion of infected individuals who are
HBeAg-positive could therefore influence the total numbers of
persons treated with antiviral medications, the risk of generating
ADAPVEMs and the subsequent risk of secondary transmission of
these mutants. Given these features, the likelihood that escape
mutants will emerge as a result of HBV treatment programmes is
probably greatest in settings of high HBV prevalence, where
treatment is widely available and where regimens are inappropriate
or adherence is uneven. Escape mutants may also appear in
settings where HIV/HBV co-infection is prevalent since HIV is
known to increase HBV replication,46 but it has not been confirmed
that co-infection alters the rate of developing resistance. Within
these settings there may be subgroups of particular interest. For
example, the efficiency of transmission from an HBeAg-positive
mother to her child during the perinatal period creates a very high
risk for chronic hepatitis B infection. This risk makes it important to
monitor for ADAP-VEMs among treated women of childbearing
age, especially if lamivudine is used as monotherapy, since neither
hepatitis B immunoglobulin nor active immunization would prevent
infection with an ADAP-VEM transmitted from mother to child. In
addition, the child may then spread the ADAP-VEM to other
children, immunized or not. Subsequent treatment of chronic
hepatitis B in all persons infected when young is also complicated
if they have been infected with a drug-resistant strain. On the other
hand, it has been estimated that the proportion of all HBV
infections acquired among children more than 5 years of age
ranges from 10% where prevalence of hepatitis B infection is high
to as much as 90% where prevalence is low.47 These numbers
suggest that monitoring for ADAP-VEMs may be needed in other
populations in addition to HBVinfected HBeAg-positive women of

childbearing age. Geographical sites of high risk for the


emergence of ADAP-VEMs of public health importance should be
mapped. To this end, official and unofficial treatment programmes
that already record the type of antiviral treatment, treatment criteria
and the extent of substandard medications could be combined
with descriptive epidemiology (e.g. high burden of disease, viral
genotype, proportion of HBV-infected individuals with surface
antigen positivity) to identify high-risk settings.

Discussion
In this article we raise the possibility of a threat to the global
hepatitis B immunization programme because of the use of
lamivudine and other nucleoside or nucleotide analogue
therapeutic agents to treat individuals with chronic hepatitis B
infection. Although the threat is theoretical, there is already
evidence that current treatment regimens have resulted in the
selection of stable ADAP-VEMs. Even though the transmission of
ADAPVEMs to individuals immunized with HBV vaccine has been
observed in only one case,36 VEMs generated by hepatitis B
vaccine have spread more widely and caused infection in
previously immunized individuals.
Knowing this, what should our response be now? At the very
least, we must learn more about ADAP-VEMs, their transmissibility
and their potential to cause infection and disease in immunized
individuals. This will require virological surveillance and clinical
follow-up of infected individuals and those undergoing treatment,
and also, possibly, surveillance of their close contacts. The initial
focus of these activities should be highrisk settings until the level
of risk is defined and understood better. Incident cases of HBV in
these situations could also be examined for VEMs, especially if a
new case is epidemiologically linked to an individual undergoing
treatment for chronic hepatitis B infection. Follow-up of such
cases of HBV, however, would depend on the availability of testing,
and currently no suitable commercial tests are available.
At present, treatment aims to prevent the long-term
complications of HBV infection, with little consideration given to
potential adverse public health impacts. The number of potent
antiviral agents is limited, their development by manufacturers is
episodic and trials that have evaluated combination therapies are
lacking. Because of these factors, monotherapy remains the usual
practice in most settings. As with other infections, more potent
combination therapies for HBV would reduce the chance of
drugresistance and lead to early and longer-lasting control of HBV
replication. Such therapies would not only benefit the individual
but would also simultaneously reduce the likelihood that ADAPVEMs of global public health significance will emerge. Trials are
urgently needed to identify the optimal combination of existing
drugs that can address both individual and public health needs.
International therapeutic guidelines for chronic hepatitis B such as
those issued by the Asian-Pacific Association for the Study of the
Liver,48 the European Association for the Study of the Liver
International Consensus Conference49 and the American
Association for the Study of Liver Disease50 should ideally consider
both of these elements, and will need to be refined as more is
learned about ADAP-VEMs. More effective novel agents are clearly
needed that target other parts of the virus.
It is still essential to prevent the spread of wild, vaccine-sensitive
strains of HBV. Well-tested measures such as safe sex and
avoiding the risks associated with injection drug use will also help
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to reduce horizontal transmission of both the wild virus and VEMs.


Hepatitis B immunization for infants of mothers with HBV will
reduce perinatal transmission of the wild virus but may not prevent
transmission of VEMs. The global hepatitis B immunization
programme will continue to reduce new incident infections of
hepatitis B and the burden of chronic HBV disease globally,
although it is simultaneously generating VEMs. One simulation has
predicted that the spread of VEMs selected out by immunization
would result in relatively few new infections for the foreseeable
future.51 However, it is not yet clear whether the emergence of
ADAP-VEMs in a population will be speeded up by the
simultaneous use of both the vaccine and treatment. Of course,
hepatitis B vaccines that incorporate HBV proteins not altered by
immunization or drug therapy are the ultimate solution to prevent
the appearance of viral escape mutants generated by vaccines or
antiviral drugs. J
Acknowledgements
We thank Paul Desmond, the director of Gastroenterology
Department of St Vincents Hospital, Melbourne, Australia, for
advice on clinical and pharmacological aspects that affect
treatment of individuals with chronic hepatitis B infection.
Originally published in Bulletin of the World Health Organization;
Article DOI: 10.2471/BLT.08.065722

38 Hospital and Healthcare Innovation Book 2009/2010

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PMID:8113769 doi:10.1099/0022- 1317-75-2-443
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Papaevangelou G, Dandolos E, Roumeliotou-Karayannis A, Richardson SC. Immunogenicity of
recombinant hepatitis B vaccine. Lancet 1985;1:455-6. PMID:2857828 PMID:2857828
doi:10.1016/S0140-6736(85)91171-7
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Stevens CE, Taylor PE, Tong MJ, Toy PT, Vyas GN, Nair PV, et al. Yeastrecombinant hepatitis B
1.

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Jilg W, Schmidt M, Deinhardt F. Prolonged immunity after late booster doses of hepatitis B
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PMID:17256718 doi:10.1002/hep.21513
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Thomas H, Foster G, Platis D. Mechanisms of action of interferon and nucleoside analogues.
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Marcellin P, Lau GK, Bonino F, Farci P, Hadziyannis S, Jin R, et al. Peginterferon alfa-2a
alone, lamivudine alone, and the two in combination in patients with HBeAg-negative
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Lau GK, Piratvisuth T, Luo KX, Marcellin P, Thongsawat S, Cooksley G, et al. Peginterferon
Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J
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Schalm SW, Heathcote J, Cianciara J, Farrell G, Sherman M, Willems B, et al. Lamivudine
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Yeh CT, Chien RN, Chu CM, Liaw YF. Clearance of the original hepatitis B virus YMDD-motif
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33.
Torresi J, Earnest-Silveira L, Civitico G, Walters T, Lewin SR, Fyfe J, et al. Restoration of
replication phenotype of lamivudine resistant hepatitis B virus mutants by compensatory
changes in the fingers sub-domain of the viral polymerase selected as a consequence of
mutations in the overlapping S gene. Virology 2002;299:88-99. PMID:12167344
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Torresi J, Earnest-Silveira L, Deliyannis G, Edgtton K, Zhuang H, Locarnini SA, et al. Reduced
antigenicity of the hepatitis B virus HBsAg protein arising as a consequence of sequence
changes in the overlapping polymerase gene that are selected by lamivudine therapy.
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Hoofnagle JH, Doo E, Liang TJ, Fleischer R, Lok ASF. Management of Hepatitis B: Summary
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PMID:17393513 doi:10.1002/hep.21627
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Thibault V, Aubron-Olivier C, Agut H, Katlama C. Primary infection with a lamivudine-resistant

hepatitis B virus. AIDS 2002;16:131-3. PMID:11741175 PMID:11741175


doi:10.1097/00002030-200201040- 00020
37.
Janssen HL, van Zonneveld M, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, et al.
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chronic hepatitis B: a randomised trial. Lancet 2005;365:123-9. PMID:15639293
PMID:15639293 doi:10.1016/S0140-6736(05)17701-0
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Locarnini S, Hatzakis A, Heathcote J, Keeffe EB, Liang TJ, Mutimer D, et al. Management of
antiviral resistance in patients with chronic hepatitis B. Antivir Ther 2004;9:679-93.
PMID:15535405 PMID:15535405
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Torresi J. The virological and clinical significance of mutations in the overlapping envelope
and polymerase genes of hepatitis B virus. J Clin Virol 2002;25:97-106.
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Sheldon J, Soriano V. Hepatitis B virus escape mutants induced by antiviral therapy. J
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Papatheodoridis GV, Hadziyannis SJ. Review article: current management of chronic hepatitis
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doi:10.1046/j.1365-2036.2003.01810.x
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Sheldon J, Ramos B, Garcia-Samaniego J, Rios P, Bartholomeusz A, Romero M et al.
Selection of hepatitis B virus (HBV) vaccine escape mutants in HBV-infected and HBV/HIV
co-infected patients failing antiretroviral drugs with anti-HBV activity. J Acquir Immune Defic
Syndr 2007;46:279-82. PMID:18167643 PMID:18167643
doi:10.1097/QAI.0b013e318154bd89
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Fung SK, Lok AS. Hepatitis B virus genotypes: do they play a role in the outcome of HBV
infection? Hepatology 2004;40:790-2. PMID:15382157 PMID:15382157
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Liu C-J, Kao J-H, Chen D-S. Therapeutic implications of hepatitis B virus genotypes. Liver
Int 2005;25:1097-107. PMID:16343058 PMID:16343058 doi:10.1111/j.14783231.2005.01177.x
45.
Toan NL, Song L, Kremsner PG, Duy D, Binh V, Koeberlein B, et al. Impact of the hepatitis B
virus genotype and genotype-mixtures on the course of liver disease in Vietnam. Hepatology
2006;43:1375-84. PMID:16729315 PMID:16729315 doi:10.1002/hep.21188
46.
Matthews GV, Bartholomeusz A, Locarnini S, Ayres A, Sasaduesz J, Seaberg E, et al.
Characteristics of drug resistant HBV in an international collaborative study of HIV-HBVinfected individuals on extended lamivudine therapy. AIDS 2006;20:863-70. PMID:16549970
PMID:16549970 doi:10.1097/01.aids.0000218550.85081.59
47.
Alter MJ. Epidemiology of hepatitis B in Europe and worldwide. J Hepatol 2003;39:S64-9.
PMID:14708680 PMID:14708680 doi:10.1016/S0168- 8278(03)00141-7
48.
Liaw YF, Leung N, Kao JH, Piratvisuth T, Gane E, Han KH, et al. Asian- Pacific consensus
statement of the management of chronic hepatitis B: a 2008 update. Hepatology
International 2008.
49.
Proceedings of the European Association for the Study of the Liver (EASL) International
Consensus Conference on Hepatitis B. 14-16 September, 2002. Geneva, Switzerland. J
Hepatol 2003;39 Suppl 1;S1-235. PMID:14964189 PMID:14964189
50.
Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2007;45:507-39. PMID:17256718
PMID:17256718 doi:10.1002/hep.21513
51.
Wilson JN, Nokes DJ, Carman WF. The predicted pattern of emergence of vaccine-resistant
hepatitis B: a cause for concern? Vaccine 1999;17:973- 8. PMID:10067705 PMID:10067705
doi:10.1016/S0264-410X(98)00313-2

Hospital and Healthcare Innovation Book 2009/2010 39

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Innovation and strategy: infectious disease surveillance

Using satellite images of


environmental changes to predict
infectious disease outbreaks
ARTICLE BY TIMOTHY E FORD,
University of New England, Biddeford, Maine, USA
RITA R COLWELL,
University of Maryland, College Park, Maryland, USA and Johns Hopkins University Bloomberg School of Public Health, Baltimore,
Maryland, USA
JOAN B ROSE,
Michigan State University, East Lansing, Michigan, USA
STEPHEN S MORSE,
Mailman School of Public Health, Columbia University, New York, USA
DAVID J ROGERS,
Oxford University, Oxford, UK
TERRY L YATES,
University of New Mexico, Albuquerque, New Mexico, USA

Recent events clearly illustrate a continued vulnerability of large populations to infectious diseases, which is related
to our changing human-constructed and natural environments. A single person with multidrug-resistant tuberculosis
in 2007 provided a wake-up call to the United States and global public health infrastructure, as the health
professionals and the public realized that todays ease of airline travel can potentially expose hundreds of persons to
an untreatable disease associated with an infectious agent. Ease of travel, population increase, population
displacement, pollution, agricultural activity, changing socioeconomic structures, and international conflicts
worldwide have each contributed to infectious disease events. Today, however, nothing is larger in scale, has more
potential for long-term effects, and is more uncertain than the effects of climate change on infectious disease
outbreaks, epidemics, and pandemics. We discuss advances in our ability to predict these events and, in particular,
the critical role that satellite imaging could play in mounting an effective response.

tmospheric chemists and climate modelers have little doubt


that the earths climate is changing. Concomitant with rising
carbon dioxide levels and temperatures, severe weather
events are increasing, which can lead to substantial rises in sea
level, flooding, increased droughts, and forest fires1. In recent
decades, infectious diseases have resurged, and previously
unrecognized agents of disease have been characterized2.
Evidence is accruing that these phenomena may in part be linked
to environmental change3. Several questions have emerged from
events that have occurred over the past 20 years: was
cryptosporidiosis inevitable in Milwaukee, Wisconsin, USA, in
1993, and was Escherichia coli O157 infection inevitable in
Walkerton, Ontario, Canada, in 2000? Both events were preceded
by heavy rains; had highly concentrated sources of pathogens in
the form of untreated sewage and animal waste, respectively; and
had vulnerable infrastructure. Although the situations were
perhaps more complex, could we have predicted epidemic
cholera in South America in 1991 after a 100-year absence and
the emergence of a new strain of potentially pandemic cholera in
India in 1992?
A considerable body of knowledge has accumulated over the
past decade or so about the relationships between environment
and disease, yet far more information and resources are needed if

we are to develop effective early warning systems through


environmental surveillance and modeling as well as appropriate
emergency response. In the United States, we face a crisis in
funding that not only affects basic and applied research in this field
but also undermines our ability to deploy remote sensing
technologies that provide the most promising means for
monitoring our environment. Using examples of waterborne and
vectorborne disease, we will discuss how remote sensing
technology can be used for disease prediction. We will then
examine the lessons learned from these examples and provide
recommendations for future modeling.

Waterborne disease
Water and climate go hand in hand, with precipitation and extreme
events known to be associated with waterborne outbreaks4.
Flooding is the most frequent natural weather disaster (30%46%
of natural disasters in 20042005), affecting >70 million persons
worldwide each year (data for 20055).
The most common illnesses associated with floods described in
the literature are diarrhea, cholera, typhoid, hepatitis (jaundice),
and leptospirosis. Unusual illnesses such as tetanus have also
been reported. The etiologic agents identified include
Cryptosporidium spp., hepatitis A virus, hepatitis E virus,
Hospital and Healthcare Innovation Book 2009/2010 41

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Innovation and strategy: infectious disease surveillance

cholera were much higher than predicted in


January 1998 and January 1999, yet many of
the predicted peaks closely aligned with actual
incidence. Because the model is constantly
being improved and the satellite data are
becoming increasingly accurate through ground
truthing (real-time collection of information on
location), we believe that satellite imaging
provides tremendous promise for prediction of
cholera, weeks and even months in advance of
an epidemic.
Knowing when an outbreak is likely to occur
can inform public health workers to stress basic
hygiene and sanitation and to implement simple
mitigation efforts such as filtration of water with
sari cloth, which in some areas is credited with
reducing deaths from cholera by >50%10.
Although remote sensing technology is currently
still a research tool, the example of cholera
prediction through its use provides a compelling
Figure 1: Modeling cholera outbreaks in Bangladesh. Adapted from RR Colwell and
J Calkins, unpub. data.
argument to maintain and adequately fund our
satellite programmes; unless this is done, this
extraordinary effort at disease prediction will fail. Some of the
Leptospira spp., Salmonella spp., and Vibrio spp. Severe
critical needs that must be met to predict the effect of
outbreaks of cholera, in particular, have been directly associated
environmental change on waterborne disease include the
with flooding in Africa and in West Bengal, India6,7.
following:
A rise in sea level, combined with increasingly severe weather
 better knowledge of disease incidence and pathogen
events, is likely to make flooding events commonplace worldwide.
excretion;
The Climate Change 2001 Synthesis Report from the
Intergovernmental Panel on Climate Change8 suggests that the
 better characterization of the pathogens in sources (e.g.,
combined sewer overflows, septic tanks) and these sources
average annual numbers of persons affected by coastal storm
surges will increase from <50 million at present sea levels to 250
vulnerabilities to climate change;
million by the 2080s, assuming a 40-cm rise in sea level. Even with
 better monitoring of sewage indicators to gather source,
enhanced protection through engineering interventions, this
transport, and exposure information (event monitoring);
number is anticipated to reach 100 million persons. The initial
 improved understanding of sediments and other pathogen
proportion of deaths from these events is huge, but without
reservoirs;
extreme vigilance and better monitoring and response, major
 more quantitative data for risk assessment; and
epidemic waterborne diseases will continue to occur. Factors that
 better health surveillance data. In turn, this information can be
promote waterborne disease overcrowding, lack of sanitation,
used to better use ground truthing in combination with remote
lack of clean water, certain domestic animal practices, waste
sensing technologies as predictors of waterborne disease
disposalare exacerbated by flooding.
outbreaks.

Using satellite technology to model prediction of Cholera


outbreaks
Effective prediction depends on many factors, not just the
prediction of an event. Cholera may be the most studied and best
understood of the waterborne diseases and, perhaps in hindsight,
we could have predicted the occurrence of cholera in South
America in 19919. Models for cholera prediction, although country
specific, are constantly improving. For example, considerable
work has gone into predicting outbreaks of cholera in Bangladesh.
Remote imaging technologies developed by the US National
Aeronautics and Space Administration have been used to relate
sea surface temperature, sea surface height, and chlorophyll A
levels to cholera outbreaks (Figure 1) (RR Colwell and J Calkins,
unpub. data). This process used a composite environmental
model that demonstrated a remarkable similarity between
predicted rates based on these three parameters and actual
cholera incidence. These data are far from perfect and
considerable uncertainty still remains. For example, rates of
42 Hospital and healthcare Innovation Book 2009/2010

Vectorborne disease
Other emerging and reemerging infectious diseases also are
environmentally driven. Many are zoonotic, vector- 1342 Emerging
borne, or both, and have complex life histories that make
predicting disease emergence or reemergence particularly difficult.
An insect or rodent vector can make it almost inevitable that a
pathogen will be globally transported by plane or boat. With
environmental change, disease range, prevalence, and seasonality
may change in direct relationship to the vector or animal host.
Therefore, to understand the life cycle of a pathogen and the risks
of disease emergence, all stages of that life cycle and the life
cycles of its intermediate hosts must be considered.
To date, predicting vectorborne diseases has proved to be
complex. Although climate change and other environmental
stressors are major components, separation from human factors
is difficult. Climate change undoubtedly affects the distribution of
disease, but changes in human behaviour that increase exposure
risk are also critical factors. umilo et al.11 reported that climatic

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Innovation and strategy: infectious disease surveillance

variables explain only 55% of spatial variation in tick-borne


encephalitis in the Baltic States, which have seen an increase in
disease incidence over the past 3 decades. These authors report
that changes in predation pressure on intermediate hosts and
shifting socioeconomic conditions that increase or decrease
peoples visits to forests (for recreation, work, or berry and
mushroom harvesting) are important factors in disease
distribution12.
Effective modeling of future risk for vectorborne disease
outbreaks needs to take into account human behaviour that
increases exposure, as well as other factors that effect the ecology
of the vectors, such as predation pressure and habitat change.
Coupled with remote sensing technologies that monitor
environmental and climatic changes, human observations of
population movement and distribution will be necessary.
Malaria also presents a challenge. This disease continues to
devastate sub-Saharan Africa and other parts of the developing
world. Substantial resources over the past several decades have
gone toward eradication, vaccination, treatment, and, more
recently, prediction of malaria outbreaks. Satellite imaging has
been used to predict the distribution of 5 of the 6 Anopheles
gambiae complex species that are responsible for much of the
malaria transmission in Africa13. However, human factors again
make accurate prediction of disease events complex. Prediction of
a disease event is complicated by host immunity effects, which
can result in cycles of infection that would appear to bear no
relationship to environmental variables.
To predict malaria outbreaks, remote sensing technologies need
to be coupled with a better understanding of how specific
populations are effected by host immunity, which could allow
population susceptibility at any given time to be estimated.

satellite imagery to the environmental variables being measured


(i.e., vegetation, soil type, soil moisture) and their relation to rodent
population dynamics.
However, this work does demonstrate the utility of remote
satellite imaging and the increasingly important role it can and
should play in disease prediction. In 2006, Glass et al.17reported
strong predictive strength from logistic regression modeling of LTM
imagery from one year, when estimating risk of HPS the following
year, for the years 1992 2005. Their risk analysis for 2006, based
on Landsat imagery for 2005, when precipitation levels increased
dramatically over prior drought years, suggested an increased risk
for HPS, particularly in northern New Mexico and southern
Colorado. This prediction was unfortunately borne out in the early
part of 2006 when 9 cases of HPS occurred within the first 3
months, 6 of those cases in New Mexico and Arizona. However,
the anticipated threat to Colorado did not occur, with a fairly
typical number of 6 cases, compared with a total of 11 cases for
the state in 200518.
However, these results are not necessarily a failure of prediction.
In fact, they may illustrate that an early warning system serves to
reduce exposure of persons to the deermice habitat. For example,
USA Today highlighted HPS risks with a June 8, 2006, article
titled Officials warn of increased threat of hantavirus
(www.usatoday.com/news/ health/2006-06-08-hantavirus-x.htm).
The role of the popular press is hard to quantify but undoubtedly
does have an effect on human behavior patterns. Many health
departments in the western states produce health advisories
warning the public about the risks of exposure to the virus through
inhalation of dust contaminated with rodent urine, feces, or saliva.
The popular press may serve an important role in increasing
awareness of a heightened health risk, which, in turn, promotes
greater compliance with health advisories.

Using satellite technology to model Hantavirus Pulmonary


Syndrome

Lessons learned and recommendations for future modeling

Although considerable uncertainty exists in disease prediction


through remote sensing technology, particularly for vectorborne
disease as discussed above, satellite technology has been applied
with some success to predictive modeling for cases of hantavirus
pulmonary syndrome (HPS). The 1993 outbreak of HPS in the
southwestern United States was believed to be linked to
environmental conditions and, in particular, to abnormally high
rainfall that resulted in increased vegetation with a subsequent
explosion in the rodent populations. Several research groups have
subsequently modeled conditions that led to an HPS outbreak,
with mixed success. Engelthaler et al.14 looked at 10 years of data
on monthly precipitation and daily ambient temperature in the
Southwest region (19861995) in relation to HPS cases
(19931995). They found that cases tended to cluster seasonally
and temporally by biome type and elevation and only indirectly
demonstrated a possible association between the 1992/1993 El
Nio precipitation events and HPS. Glass et al.15,16 were also
unable to make a definitive link with precipitation events in their
analyses of HPS in the southwestern United States. They did,
however, find a relationship between Landsat Thermatic Mapper
(LTM) images recorded by satellite in 1992 and HPS risk the
following year. LTM generates numbers that represent reflected
light in 6 bands, 2 of which were associated with decreased risk
and 1, in the mid-infrared range, with increased risk. The authors
admit that considerable ground truthing is necessary to relate

The scientific community has a relative consensus that epidemic


and pandemic disease risks will be exacerbated by environmental
changes that destabilize weather patterns, change distribution of
vectors, and increase transport and transmission risk. Predictive
modeling may lead to improved understanding and potentially
prevent future epidemic and pandemic disease. Many respiratory
infections are well known as highly climate dependent or seasonal.
Although we are not yet able to predict their incidence with great
precision, we may well be able to do this in the future.
Meningococcal meningitis (caused by Neisseria meningitidis) in
Africa is probably the best known example. In the diseaseendemic so-called meningitis belt (an area running across subSaharan Africa from Senegal to Ethiopia), this is classically a dry
season disease, which ceases with the beginning of the rainy
season, likely as a result of changes in host susceptibility19. Many
other infectious diseases show strong seasonality or association
with climatic conditions20. Perhaps one of the most interesting is
influenza, which is thought of as a wintertime disease in temperate
climates but shows both winter and summer peaks in subtropical
and tropical regions21. Although the reasons for seasonality are
often poorly understood, the close dependence of such diseases
on climatic conditions suggests that these, too, are likely to be
amenable to prediction by modeling and remote sensing22. When
we consider influenza, it is hard not to think about the future risks
from pandemic influenza. Public health agencies in the United
Hospital and healthcare Innovation Book 2009/2010 43

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Innovation and strategy: infectious disease surveillance

States and around the world are focusing on influenza


preparedness, notably concerning influenza virus A
Satellite imaging
(SST, SSH, chlorophyll A, soil moisture, vegetation indices)
subtype H5N1, which has captured attention because
it causes severe disease and death in humans but as
yet has demonstrated only very limited and inefficient
Ground truthing
(real-time measurements of soil, water, and other environmental parameters)
human-to-human transmission. The severity of the
disease raises images of the 1918 influenza epidemic
Vector/intermediate host biology
on an unimaginably vast scale if the virus were to adapt
and ecology
Pathogen biology and ecology
to more efficient human-to-human transmission. Can
(e.g., biofilm mode of growth,
predictive modeling using satellite or other imaging of
association with plankton,
Pathogen biology and ecology
environmental variables help in prediction of future
plasmid biology)
influenza pandemics? Xiangming Xiao at the University
of New Hampshire was funded in 2006 by the National
Human host biology and ecology
(e.g., population susceptibility/immunity,
Institutes for Health to lead a multidisciplinary and
exposure patterns)
multi-institutional team to use remote satellite imaging
to track avian flu. Xiao et al. have used satellite
Predictive model of disease
imagederived vegetation indices to map paddy rice
23
agriculture in southern Asia . They believe that a similar
approach can be used in conjunction with the more Figure 2: Components of a predictive model of infectious disease based on
traditional approach of analyzing bird migration satellite imaging to assess environmental change. SST, sea surface
patterns and poultry production24,25 to map potential hot temperature; SSH, sea surface height.
spots of virus transmission26.
cholerae cul-been isolated from the Ganges River in India for the
An interesting question is why did we not see disease epidemics
first time31. Indications are that it is metabolically different from E.
in Indonesia, following the devastating tsunami disaster of
December 2004? Could rapid public health intervention be
coli O157 isolated from other parts of the world, but the conditions
credited with minimizing spread of disease? In the case of Aceh
that have led to these differences are as yet unclear. From the
Province, many communities reported diarrhea as the main cause
above studies, risk for transmission of virulence genes is likely to
of illness (in 85% of children <5 years of age), but no increases in
be high, but studies of conditions promoting transmission and
deaths were reported, and no outbreaks of cholera or other
approaches to modeling resultant disease risks are in their infancy.
potentially epidemic diseases occurred27. Given the massive scale
New epidemic strains could potentially occur through mutation of
existing epidemic strains or through gene transfer. Environmental
of the disaster, was this likely? In some towns, more than two
stressors such as chemical contaminants are thought to
thirds of the population died at the time of impact, almost 100%
accelerate both mutation rates and gene transfer32. Thus, the
of homes were destroyed, and 100% of the population lacked
27
access to clean water and sanitation . To a large extent, the
degree of chemical pollution may need to be a component of
disease models (in addition to other stressors). The scientific
Australian army and other groups are to be credited with rapidly
community is a long way from incorporating environment-gene
deploying environmental health teams to swiftly implement public
interactions into predictive models and clarifying the risks posed to
health measures, including provision of safe drinking water, proper
human society from emerging diseases. However, investigation of
sanitary facilities, and mosquito control measures28. Widespread
these parts of the pathogens ecology should remain on the
fecal pollution of the surface waters was shown, yet the saltiness
national research agenda as we move forward with developing
of the potable water supply after the disaster made much of the
predictive models of disease outbreaks.
water unpalatable.
Current modeling of infectious diseases is by necessity
Wells were vulnerable, perhaps to other etiologic agents of fecal
retrospective. Environmental parameters measured by remote
origin including viruses and Shigella spp., with greater probability of
satellite imaging show the greatest promise for providing global
infection than Vibrio spp., thus leading to the widespread diarrhea.
coverage of changing environmental conditions. With current
The most important lesson from the Asian tsunami is that disease
imaging technologies, we can measure sea surface temperature,
epidemics can be prevented by public health intervention.
sea surface height, chlorophyll A levels, and a variety of vegetation
Unfortunately, most flooding events, and other conditions that
and soil indices, in addition to many other physical, biologic, and
promote infectious disease epidemics, do not receive the same
chemical parameters of the earths surface and atmosphere. A
global media attention. A tsunami captures the imagination of the
variety of these parameters can be incorporated in complex
world in a way that weeks of rainfall in the Sudan or a rise in sea
mathematical models, together with biotic and ecologic variables
surface temperature cannot. However, if climatologic data can be
of the pathogen and host life cycles, to correlate environment with
used to predict future disease outbreaks, public health interventions
outbreaks of disease (Figure 2). However, we are still far from
can be mobilized in a more timely and proactive manner.
being able to accurately predict future disease events on the basis
A continuing concern is the conditions that result in newly
of existing environmental conditions.
emergent virulent strains of pathogens. Faruque et al. have
Successful predictive modeling of disease and the
provided molecular evidence that V. cholerae O139 strains are
establishment of early warning systems have reached a critical
derived from O1 strains through genetic modification29. In addition,
junction in development. As we improve our understanding of the
Chakraborty et al. in Kolkata have seen the presence and
biology and ecology of the pathogen, vectors, and hosts, our
expression of virulence genes in several environmental strains of V.
44 Hospital and healthcare Innovation Book 2009/2010

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Innovation and strategy: infectious disease surveillance

ability to accurately link environmental variables, particularly those


related to climate change, will improve. What has become clear
over the past few years is that satellite imaging can play a critical
role in disease prediction and, therefore, inform our response to
future outbreaks. We conclude that infectious disease events may
be closely linked to environmental and global change. Satellite
imaging may be critical for effective disease prediction and thus
future mitigation of epidemic and pandemic diseases. We cannot
stress too strongly our belief that a strong global satellite
programme is essential for future disease prediction. J
Acknowledgments
This article is dedicated to Terry L Yates, an outstanding scientist
and colleague whose substantial contributions to vectorborne and
zoonotic disease research, in particular, his work on the ecology of
hantavirus, will always be remembered. TEF was supported in part
by grant no. P20 RR-16455-06 from the National Center for
Research Resources, a component of the National Institutes of
Health (NIH). SMM was supported by Centers for Disease Control
and Prevention cooperative agreements A1010-21/21,
U90/CCU224241 (Centers for Public Health Preparedness) and
U01/CI000442, the Arts and Letters Foundation, and NIH/National
Institute for Allergy and Infectious Disease cooperative agreement
5U54AI057158 (Northeast Biodefense Center Regional Center of
Excellence for Biodefense and Emerging Infectious Diseases
Research). R.R.C. was supported in part by grant no. S0660009
from the National Oceanic and Atmospheric Administration Dr Ford
is Vice President for Research and Dean of Graduate Studies at the
University of New England (UNE), in Biddeford and Portland,
Maine, USA. He has conducted research on environmental
microbiology, environmental health, and waterborne disease for the
past 28 years and was founding director of the program in Water
and Health at the Harvard School of Public Health. At UNE, he
anticipates supporting programs that link terrestrial and marine
ecosystems with human health.
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Colwell RR, Huq A, Islam MS, Aziz KMA, Yunus M, Khan NH, et al. Reduction of cholera in
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umilo D, Asokliene L, Bormane A, Vasilenko V, Golovljova I, Randolph S. Climate change
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Engelthaler DM, Mosley DG, Cheek JE, Levy CE, Komatsu KK, Ettestad P, et al. Climatic and
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Glass GE, Shields TM, Parmenter RR, Goade D, Mills JN, Cheek J, et al. Predicted hantavirus
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First hantavirus case reported for 2006Coloradans urged to take precautions. Boulder (CO):
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Jamieson C. Preventing the second wave. Operation Sumatra Assist, Australian Government,
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Chakraborty S, Mukhopadhyay AK, Bhadra RK, Ghosh AN, Mitra R, Shimada T, et al. Virulence
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Martinez RJ, Wang Y, Raimondo MA, Coombs JM, Barkay T, Sobecky PA. Horizontal gene
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11.

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Use of unstructured event-based


reports for global infectious
disease surveillance
ARTICLE BY MIKAELA KELLER,
Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, Boston, Massachusetts, USA,
Childrens Hospital Boston and Harvard Medical School
MICHAEL BLENCH,
Public Health Agency of Canada, Ottawa, Ontario, Canada
HERMAN TOLENTINO
Centers for Disease Control and Prevention, Atlanta, Georgia, USA
CLARK C FREIFELD
Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, Boston, Massachusetts, USA,
Childrens Hospital Boston and Harvard Medical School
KENNETH D MANDL
Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, Boston, Massachusetts, USA,
Childrens Hospital Boston and Harvard Medical School
ABLA MAWUDEKU,
Public Health Agency of Canada, Ottawa, Ontario, Canada
GUNTHER EYSENBACH
University of Toronto, Toronto, Ontario, Canada and University Health Network, Toronto
AND JOHN S BROWNSTEIN
Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, Boston, Massachusetts, USA,
Childrens Hospital Boston and Harvard Medical School

Free or low-cost sources of unstructured information, such as Internet news and online discussion sites, provide detailed local
and near real-time data on disease outbreaks, even in countries that lack traditional public health surveillance. To improve
public health surveillance and, ultimately, interventions, we examined three primary systems that process event-based
outbreak information: Global Public Health Intelligence Network, HealthMap, and EpiSPIDER. Despite similarities among
them, these systems are highly complementary because they monitor different data types, rely on varying levels of
automation and human analysis, and distribute distinct information. Future development should focus on linking these
systems more closely to public health practitioners in the field and establishing collaborative networks for alert verification
and dissemination. Such development would further establish event-based monitoring as an invaluable public health
resource that provides critical context and an alternative to traditional indicator-based outbreak reporting.

nternational travel and movement of goods increasingly


facilitates the spread of pathogens across and among nations,
enabling pathogens to invade new territories and adapt to new
environments and hosts.13 Officials now need to consider
worldwide disease outbreaks when determining what potential
threats might affect the health and welfare of their nations4. In
industrialized countries, unprecedented efforts have built on
indicator-based public health surveillance, and monitoring of
clinically relevant data sources now provides early indication of
outbreaks5. In many countries where public health infrastructure is
rudimentary, deteriorating, or nonexistent, efforts to improve the
ability to conduct electronic disease surveillance include more
robust data collection methods and enhanced analysis

46 Hospital and Healthcare Innovation Book 2009/2010

capability.6,7 However, in these parts of the world, basing timely and


sensitive reporting of public health threats on conventional
surveillance sources remains challenging. Lack of resources and
trained public health professionals poses a substantial
roadblock.810 Furthermore, reporting emerging infectious diseases
has certain constraints, including fear of repercussions on trade
and tourism, delays in clearance through multiple levels of
government, tendency to err on the conservative side, and
inadequately functioning or nonexistent surveillance infrastructure.11
Even with the recent enactment of international health
regulations in 2005, no guarantee yet exists that broad
compliance will be feasible, given the challenges associated with
reporting mechanisms and multilateral coordination.12 In many

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Innovation and policy: infectious disease surveillance

countries, free or low-cost sources of unstructured information,


including Internet news and online discussion sites (Figure 1),
could provide detailed local and near real-time data on potential
and confirmed disease outbreaks and other public health
events.9,10,1318 These event-based informal data sources provide
insight into new and ongoing public health challenges in areas that
have limited or no public health reporting infrastructure but have
the highest risk for emerging diseases19. In fact, event-based
informal surveillance now represents a critical source of epidemic
intelligence almost all major outbreaks investigated by the World
Health Organization (WHO) are first identified through these
informal sources.9,13
With a goal of improving public health surveillance and,
ultimately, intervention efforts, we (the architects, developers, and
methodologists for the information systems described herein)
reviewed 3 of the primary active systems that process
unstructured (free-text), event-based information on disease
outbreaks: The Global Public Health Intelligence Network (GPHIN),
the HealthMap system, and the EpiSPIDER project (Semantic
Processing and Integration of Distributed Electronic Resources for
Epidemics [and disasters]; www.epispider.net). Our report is the
result of a joint symposium from the American Medical Informatics
Association Annual Conference in 2007. Despite key differences,
all 3 systems face similar technologic challenges, including 1) topic
detection and data acquisition from a high-volume stream of event
reports (not all related to disease outbreaks); 2) data
characterization, categorization, or information extraction; 3)

information formatting and integration with other sources; and 4)


information dissemination to clients or, more broadly, to the public.
Each system tackles these challenges in unique ways, highlighting
the diversity of possible approaches and public health objectives.
Our goal was to draw lessons from these early experiences to
advance overall progress in this recently established field of eventbased public health surveillance. After summarizing these
systems, we compared them within the context of this new
surveillance framework and outlined goals for future development
and research.

The GPHIN project


Background
GPHIN took early advantage of advancements in communication
technologies to provide coordinated, near realtime, multisource,
and multilingual information for monitoring emerging public health
events.20,21 In 1997, a prototype GPHIN system was developed in
a partnership between the government of Canada and WHO. The
objective was to determine the feasibility and effectiveness of
using news media sources to continuously gather information
about possible disease outbreaks worldwide and to rapidly alert
international bodies of such events. The sources included
websites, news wires, and local and national newspapers
retrieved through news aggregators in English and French. After
the outbreak of severe acute respiratory syndrome (SARS), a new,
robust, multilingual GPHIN system was developed and was
launched November 17, 2004, at the United Nations.

Epidemic curve

SMS messaging
Microblogging
Emailing
Internet searching
Social networking
Internet chatting
Time

Blogging
Online news reporting
Video/radio news reporting
Health expert reporting

Figure 1: Hypothetical timing of informal electronic sources available during an outbreak. SMS, short message service

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Innovation and policy: infectious disease surveillance

Data Acquisition
Automated process
The GPHIN software application retrieves relevant articles every 15
minutes (24 hours/day, 7 days/week) from news-feed aggregators
(Al Bawaba [www.albawaba.com] and Factiva [www. factiva.com])
according to established search queries that are updated regularly.
The matching articles are automatically categorized into >1 GPHIN
taxonomy categories, which cover the following topics: animal,
human, or plant diseases; biologics; natural disasters; chemical
incidents; radiologic incidents; and unsafe products. Articles with
a high relevancy score are automatically published on the GPHIN
database. The GPHIN database is also augmented with articles
obtained manually from openaccess web sites. Each day, GPHIN
handles 4,000 articles. This number drastically increases when
events with serious public health implications, such as the fi nding
of melamine in various foods worldwide, are reported.
Human analysis process
Although the GPHIN computerized processes are essential for the
management of information about health threats worldwide, the
linguistic, interpretive, and analytical expertise of the GPHIN
analysts makes the system successful. Articles with relevancy
below the publish threshold are presented to a GPHIN analyst,
who reviews the article and decides whether to publish it, issue an
alert, or dismiss it. Additionally, the GPHIN analyst team conducts
more in-depth tasks, including linking events in different regions,
identifying trends, and assessing the health risks to populations
around the world.

Data Dissemination
Machine translation
English articles are machine-translated into Arabic, Chinese
(simplifi ed and traditional), Farsi, French, Russian, Portuguese,
and Spanish. Non-English articles are machine-translated into
English. GPHIN has adopted a best-of-breed approach in
selecting engines for machine translation. The lexicons associated
with the engines are constantly being improved to enhance the
quality of the output. As such, the machine-translated outputs are

edited by the appropriate GPHIN analysts. The goal is not to


obtain a perfect translation but to ensure comprehensibility of the
essence of the article.
Information access
Users can view the latest list of published articles or query the
database by using both Boolean and translingual metadata search
capabilities. In addition, notifications about events that might have
serious public health consequences are immediately sent by email
to users in the form of an alert.
Project results
As an initial assessment of data collected during July 1998
through August 2001, WHO retrospectively verified 578
outbreaks, of which 56% were initially picked up and disseminated
by GPHIN.9 Outbreaks were reported in 132 countries,
demonstrating GPHINs capacity to monitor events occurring
worldwide, despite the limitation of predominantly English (with
some French) media sources. One of GPHINs earliest
achievements occurred in December 1998, when the system was
the fi rst to provide preliminary information to the public health
community about a new strain of influenza in northern Peoples
Republic of China20. During the SARS outbreak, declared by WHO
in March 2003, the GPHIN prototype demonstrated its potential as
an early-warning system by detecting and informing the
appropriate authorities (e.g., WHO, Public Health Agency of
Canada) of an unusual respiratory illness outbreak occurring in
Guangdong Province, China, as early as November 27, 2002.
GPHIN was further able to continuously monitor and provide
information about the number of suspected and probable SARS
cases reported worldwide on a near real-time basis. GPHINs
information was 2-3 days ahead of the official WHO report of
confirmed and probable cases worldwide.
In addition to outbreak reporting, GPHIN has also provided
information that enabled public health officials to track global
effects of the outbreak such as worldwide prevention and control
measures, concerns of the general public, and economic or
political effects. GPHIN is used daily by organizations such as

Table 1: Characteristics of three primary systems that process event-based informal data sources*

DATA SOURCES
(LANGUAGES)

DATA
CHARACTERIZATION

INFORMATION FORMATTING

ACCESS

GPHIN

Factiva, Al Bawaba
(9 languages)

Automatic and
human

Categorization, machine
translation, geocoded

Subscription
only

Boolean and
metadata query
system (native)

Email alert

HealthMap

Google News,
Automatic
Moreover, ProMED,
WHO, EuroSurveillance
(4 languages)

Categorization,geocoded,
time coded, extra
information

Open

Mapping, faceted
browsing (native)

RSS feed

EpiSPIDER

ProMED, GDACS, CIA Automatic


Factbook (English only)

Categorization,
geocoded, time coded,
extra information

Open

Web exhibits,
faceted browsing
(imported)

RSS, JSON
KML feeds

SYSTEM

DATA DISSEMINATION
USER INTERFACE

*GPHIN, Global Public Health Intelligence Network; WHO, World Health Organization; RSS, Really Simple Syndication; EpiSPIDER, Semantic
Processing and Integration of Distributed Electronic Resources for Epidemics (and disasters); GDACS, Global Disaster Alert Coordinating System; CIA,
Central Intelligence Agency; JSON, JavaScript object notation; KML, keyhole markup language.

48 Hospital and Healthcare Innovation Book 2009/2010

FORMAT

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Innovation and policy: infectious disease surveillance

WHO, the US Centers for Disease Control and Prevention (CDC),


and the UN Food and Agricultural Organization.

The HealthMap Project


Background
Operating since September 2006, HealthMap22,23 is an Internetbased system designed to collect and display information about
new outbreaks according to geographic location, time, and
infectious agent2426. HealthMap thus provides a structure to
information flow that would otherwise be overwhelming to the user
or obscure important elements of a disease outbreak.
Healthmap.org receives 100010 000 visits/day from around
the world. It is cited as a resource on sites of agencies such as the
United Nations, National Institute of Allergy and Infectious
Diseases, US Food and Drug Administration, and US Department
of Agriculture. It has also been featured in mainstream media
publications, such as Wired News and Scientific American,
indicating the broad utility of such a system that extends beyond
public health practice.24,26 On the basis of usage tracking of
HealthMaps Internet site, we can infer that its most avid users
tend to come from government-related domains, including WHO,
CDC, European Centre for Disease Prevention and Control, and
other national, state, and local bodies worldwide. Although the
question of whether this information has been used to initiate
action will be part of an in-depth evaluation, we know from
informal communications that organizations (ranging from local
health departments to such national organizations as the US
Department of Health and Human Services and the US
Department of Defense) are leveraging the HealthMap data stream
for day-to-day surveillance activities. For instance, CDCs
BioPHusion Program incorporates information from multiple data
sources, including media reports, surveillance data, and informal
reports of disease events and disseminates it to public health
leaders to enhance CDCs awareness of domestic and global
health events.27

for user-friendly access to the original report. HealthMap also


addresses the computational challenges of integrating multiple
sources of unstructured information by generating meta-alerts,
color coded on the basis of the data sources reliability and report
volume. Although information relating to infectious disease
outbreaks is collected, not all information has relevance to every
user. The system designers are especially concerned with limiting
information overload and providing focused news of immediate
interest. Thus, after a first categorization step into locations and
diseases, a second round of category tags is applied to the
articles to improve filtering. The primary tags include 1) breaking
news (e.g., a newly discovered outbreak); 2) warning (initial
concerns of disease emergence, e.g., in a natural disaster area; 3)
follow-up (reference to a past outbreak); 4) background/context
(information on disease context, e.g., preparedness planning); and
5) not disease-related (information not relating to any disease25 are
filtered from display]). Duplicate reports are also removed by
calculating a similarity score based on text and category matching.
Finally, in addition to providing mapped content, each alert is
linked to a related information window with details on reports of
similar content as well as recent reports concerning either the
same disease or location and links for further research (e.g., WHO,
CDC, and PubMED).
Project results
HealthMap processes an average of 133.5 disease alerts/day
(95% confidence interval [CI] 124.1142.8); 50% are categorized
as breaking news (65.3 reports/day). Looking 30 days back
(default display), the system displays >800 breaking news alerts
for any given day. From October 2006 through November 20,
2007, HealthMap had processed >35,749 alerts across 171
disease categories and 202 countries or semiautonomous or
overseas territories. Most alerts come from news media (92.8%),
followed by ProMED (6.5%) and multinational agencies (0.7%).

The EpiSPIDER Project


Data acquisition
The system integrates outbreak data from multiple electronic
sources, including online news wires (e.g., Google News), Really
Simple Syndication (RSS) feeds, expertcurated accounts (e.g.,
ProMED-mail, a global electronic mailing list that receives and
summarizes reports on disease outbreaks)18, multinational
surveillance reports (e.g., Eurosurveillance), and validated offi cial
alerts (e.g., from WHO). Through this multistream approach,
HealthMap casts a unifi ed and comprehensive view of global
infectious disease outbreaks in space and time. Fully automated,
the system acquires data every hour and uses text mining to
characterize the data to determine the disease category and
location of the outbreak. Alerts, defined as information on a
previously unidentified outbreak, are geocoded to the country
scale with province-, state-, or city-level resolution for select
countries. Surveillance is conducted in several languages,
including English, Spanish, Russian, Chinese, and French. The
system is currently being ported to other languages, such as
Portuguese and Arabic.
Data dissemination
After being collected, the data are aggregated by source, disease,
and geographic location and then overlaid on an interactive map

Background
The EpiSPIDER project was designed in January 2006 to serve as
a visualization supplement to the ProMED-mail reports. Through
use of publicly available software, EpiSPIDER was able to display
topic intensity of ProMED-mail reports on a map. Additonally,
EpiSPIDER automatically converted the topic and location
information of the reports into RSS feeds. Usage tracking showed,
initially, that the RSS feeds were more popular than the maps.
Transforming reports to a semantic online format (W3C Semantic
Web) makes it possible to combine emerging infectious disease
content with similarly transformed information from other Internet
sites such as the Global Disaster Alert Coordinating System
(GDACS) website (www.gdacs.org). The broad effects of disasters
often increase illness and death from communicable diseases,
particularly where resources for healthcare infrastructure have
been lacking28,29. By merging these 2 online media sources
(ProMED-mail and GDACS), EpiSPIDER demonstrates how
distributed, event-based, unstructured media sources can be
integrated to complement situational awareness for disease
surveillance.
Data acquisition and dissemination
EpiSPIDER connects to news sites and uses natural language
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processing to transform free-text content into structured


information that can be stored in a relational database. For
ProMED reports, the following fields are extracted: date of
publication; list of locations (country, province, or city) mentioned
in the report; and topic. EpiSPIDER parses location names from
these reports and georeferences them using the georeferencing
services of Yahoo Maps (http:// maps.yahoo.com), Google Maps
(http://maps.google.com), and Geonames (www.geonames.org).
Each news report that has location information can be linked to
relevant demographic- and health-specific information (e.g.,
population, per capita gross domestic product, public health
expenditure, and physicians/1,000 population). EpiSPIDER
extracts this information from the Central Intelligence Agency (CIA)
Factbook
(www.cia.gov/library/
publications/the-worldfactbook/index.html) and the United Nations Development Human
Development Report (http://hdr.undp.org/en) Internet sites. This
feature provides different contexts for viewing emerging infectious
disease information. By using askMEDLINE30, EpiSPIDER also
provides context-sensitive links to recent and relevant scientific
literature for each ProMED-mail report topic. After EpiSPIDER
extracts the previously described information, it automatically
transforms it to other formats, e.g., RSS, keyhole markup
language(KML; http://earth.google.com/ kml), and JavaScript
object notation (JSON, a human-readable format for representing
simple data structures; www. json.org). Publishing content using
those formats enables the semantic linking of ProMED-mail
content to country information and facilitates EpiSPIDERs
redistribution of structured data to services that can consume
them. Continuing along this transformation chain, the SIMILE
Exhibit API (http://simile.mit.edu) that consumes JSON-formatted
data fi les enables faceted browsing of information by using scatter
plots, Google Maps, and timelines. Recently, EpiSPIDER began
outsourcing some of its preprocessing and natural language
processing tasks to external service providers such as OpenCalais
(www.opencalais. com) and the Unifi ed Medical Language
System (UMLS) web service for concept annotation. This action
has enabled the screening of noncurated news sources as well.
Project results
Built on open-source software components, EpiSPIDER has been
operational since January 2006. In response to feedback from
users, additional custom data feeds have been incorporated, both
topic oriented (by disease) and format specific (KML, RSS,
GeoRSS), as has semantic annotation using UMLS concept
codes. For example, the EpiSPIDER KML module was developed
to enable the US Directorate for National Intelligence to distribute
avian infl uenza event-based reports in Google Earth KML format
to consumers worldwide and also to enable an integrated view of
ProMED and World Animal Health Information
Database reports
EpiSPIDER is used by persons in North America, Europe,
Australia, and Asia, and it receives 5090 visits/hour, originating
from 150200 sites and representing 3050 countries worldwide.
EpiSPIDER has recorded daily visits from the US Department of
Agriculture, US Department of Homeland Security, US Directorate
for National Intelligence, US CDC, UK Health Protection Agency,
and several universities and health research organizations. In the
latter half of 2008, daily access to graphs and exhibits surpassed
50 Hospital and Healthcare Innovation Book 2009/2010

access to data feeds. EpiSPIDERs semantically linked data were


also used for validating syndromic surveillance information in
OpenRODS (http://openrods. sourceforge.net) and populating
disease detection portals, like www.intelink.gov and the Research
Triangle Institute (Research Triangle Park, NC, USA).

Discussion
Despite their similarities, the 3 described event-based public
health surveillance systems are highly complementary; they
monitor different data types, rely on varying levels of automation
and human analysis, and distribute distinct information. GPHIN,
being the longest in use, is probably the most mature in terms of
information extraction. In contrast, HealthMap and EpiSPIDER,
being comparatively recent programs, focus on providing extra
structure and automation to the information extracted. Their
differences and similarities, summarized in the Table, can be
analyzed according to multiple characteristics: What data sources
do they consider? How do they extract information from those
sources? And in what format is the information redistributed and
how?
For completeness, the broadest range of sources is critical.
GPHINs data comes from Factiva and Al Bawaba, which are
subscription-only news aggregators. Their strategy is to rely on
companies that sell the service of collecting event information from
every pertinent news stream.
In contrast, HealthMaps strategy is to rely on open-access
news aggregators (e.g., GoogleNews and Moreover) and curated
sources (e.g., ProMED and EuroSurveillance). EpiSPIDER, until
recently, has concentrated on curated sources only (e.g., ProMED,
GDACS, and CIA Factbook). This distinction between free and
paid sources raises the question of whether the systems have
access to the same event information.
After the data sources have been chosen, the next step is to
extract useful information among the incoming reports. First, at the
level of the report stream, the system must fi lter out reports that
are not disease related and categorize the remaining (diseaserelated) reports into predefi ned sets. Then, at a second level of
triage, the information within each retrieved alert (e.g., an events
location or reported disease) is assessed. GPHIN does this data
characterization through automatic processing and human
analysis, whereas HealthMap and EpiSPIDER rely mainly on
automated techniques (although a person performs a daily scan of
all HealthMap alerts and a sample of EpiSpider alerts).
After a report in the data stream is determined to be relevant, it
is processed for dissemination. GPHIN automatically translates
the reports into different languages and grants its clients access to
the database through a custom search engine. GPHIN also
decides which reports should be raised to the status of alerts and
sent to its clients by email. HealthMap provides a geographic and
temporal panorama of ongoing epidemics through an openaccess user interface. It automatically filters out the reports that do
not correspond to breaking alerts. The remaining alerts are
prepared for display (time codes and geocodes as well as disease
category and data source) to allow faceted browsing and are
linked to other information sources (e.g., the Wikipedia definition of
the disease). These data are also provided as daily email digests
to users interested in specific diseases and locations. Although
GPHIN and HealthMap provide their own user interface,
EpiSPIDER explores conventional formats for reports, adding

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Innovation and policy: infectious disease surveillance

time-coding, geocoding, and country metadata for automatic


integration with other information sources and versatile browsing
by using existing open-source software. These reports are
displayed under the name of Web Exhibits and include, for
example, a mapping and a timeline view of the reports and a
scatter plot of the alerts with respect to the originating countrys
human development index and gross domestic product per
capita.
A division arises between the HealthMap and EpiSPIDER
strategies and the GPHIN strategy regarding the level of access
granted to users. This division is due in part to the access policies
of the data sources used by the systems, as discussed previously.
A discrepancy also exists in the amount of human expertise, and
thus in the cost, required by the systems. These differences also
raise the question of whether information from one system is more
reliable than that of the others. Undertaking an evaluation of the
systems in parallel is a critical next step. Also, all 3 systems are
inherently prone to noise because most of the data sources they
use or plan to use (Figure 1) for surveillance are not verified by
public health professionals, so even if the system is supervised by
a human analyst, it might still generate false alerts. False alerts
need to be mitigated because they might have substantial undue
economic and social consequences. Eventbased disease
surveillance may also benefit from algorithms linked by ontology
(formal representation of a set of concepts within a domain and
the relationships between those concepts) detecting precursors of
disease events. Measurement and handling of input datas
reliability is a critical research direction.
Future development should focus on linking these systems
more closely to public health practitioners in the field and
establishing collaborative networks for alert verification and
dissemination. Such development would ensure that event-based
monitoring further establishes itself as an invaluable public health
resource that provides critical context and an alternative to more
traditional indicator-based outbreak reporting. J
Acknowledgments
HealthMap (MK, CCF, KDM, JSB) is funded in part by a research
grant from Google.org and by R21LM009263-01 from the National
Library of Medicine, National Institutes of Health; GPHIN (MB, AM)
is supported by the Government of Canada (Public Health Agency
of Canada); EpiSPIDER is funded in part by a fellowship grant from
the Oak Ridge Institute for Science Education, US Department of
Energy.
Reprint acknowledgment
Keller M, Blench M, Tolentino H, Freifeld CC, Mandl KD, Mawudeku
A, et al. Use of unstructured event-based reports for global
infectious disease surveillance. Emerg Infect Dis. DOI:
10.3201/eid1505.081114 2009 May; [Epub ahead of print]

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Hospital and Healthcare Innovation Book 2009/2010 51

M0736_2008_TAKEYOU_new.pdf

09-03-2010

15:42:38

Healthcare transformation

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Innovation in clinical specialities

54

Burn management
M Davey, B Ayeni, Y Ying and MJ Duncan

68

Cardiovascular risk factor trends and options for


reducing future coronary heart disease mortality in the
United States of America
Simon Capewell, Earl S Ford, Janet B Croft, Julia A
Critchley, Kurt J Greenlund and Darwin R Labarthe

76

The breast service psychosocial model of care project


Lauren K Williams PhD and G Bruce Mann

81

Supporting cancer control for indigenous Australians:


initiatives and challenges for Cancer Councils
Shaouli Shahid, Kerri R Beckmann and Sandra
C Thompson

88

Company profile: Technology of the 21st Century


Pioneers in Diagnostic Imaging: Reliability and
advanced technology add value and increase safe
diagnosis
Shimadzu Europa GmbH

90

Breast Cancer a review for African surgeons


Adisa Adeyinka Charles MD and Alexandra M Easson

109

Responding to challenges in physical therapy


Catherine Sykes, Brenda Myers, Marilyn Moffat and
Tracy Bury

112

Population based surgery in low and middle income


countries
David A Spiegel, Richard Gosselin, Adam Kushnerand
Stephen Bickler

118

Company profile: Wipak Medical Steriking


Specialized Packaging for Hospital Sterilization
WIPAK Medical

Hospital and Healthcare Innovation Book 2009/2010 53

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Innovation and clinical specialities: burns

Burn management
ARTICLE BY M DAVEY AND B AYENI (PICTURED)
McMaster University, Hamilton, Ontario, Canada
Y YING AND MJ DUNCAN
Department of Plastic Surgery, Childrens Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Pepita, 6 years old, was thrown into a fire by another child two years earlier and sustained an 8% burn of her
lower back. The burn was initially thought to be superficial, but, months later, the wound is still open and has
never been grafted. Pepita cannot stand upright because she has flexion contractures of both hips and one
knee. Instead, she has to crawl. Her groin was not burned, and the burn on her knee was only a minor one.
Her contractures are the result of failing to ensure that she used her unburnt and minimally burnt limbs
during the acute stage of her injury. She has now been abandoned by her family1.

he devastating effects of burns are long lasting at both an


individual and societal level. These impacts are
compounded in resource-poor settings, where the human
and material resources necessary to deal with this complex public
health problem are lacking. Developing nations are
disproportionately affected 95% of the 322,000 global firerelated deaths in 2002 occurred in low to middle-resource
countries.2 A structured and comprehensive approach to burn
care must be applied to resource-poor settings in order to improve
outcomes.
A combination of improved management and prevention
strategies has resulted in important declines in morbidity and
mortality in the developed world. A recent US study demonstrated
a 50% decline in burn-related mortality and hospital admissions
over a 20 year period.3 Patients are frequently surviving even the
most devastating burns due to advances in infection control,
antimicrobial and biologic wound coverings, as well as a better
understanding of resuscitation and the systemic effects of burn
physiology and associated lung injury in burn patients. However,
a stark contrast is seen when comparing the burn related mortality
rates in high and low-income countries. For example, the WHO
Global Burden of disease database has reported an over 10 fold
difference between mortality rates in South East Asia and Europe
(11.6 vs 0.7 per 100 000 population respectively).2
Unfortunately, without adequate resources in first-aid, acute
surgical management and rehabilitation facilities, patients that do
survive their burn injuries in developing countries often have poor,
disfiguring and disabling long term outcomes. A Ghanaian study
found that 18 % of childhood burns patients had suffered a
physical impairment or disability.4
As surgeons working in or supporting those who work in
resource-poor countries, it is imperative that we understand the
region-specific risk factors associated with burns, support
preventative measures and provide rapid and appropriate
resuscitation, surgical treatment and rehabilitation.

54 Hospital and Healthcare Innovation Book 2009/2010

Etiology and epidemiology


In order to understand and overcome the challenges in the
management and prevention of burns in low-income countries, a
close look at the epidemiology and causal factors involved is
required. It is also necessary to understand the local economic
constraints and the available healthcare infrastructure.
There exist numerous hospital or clinic-based studies describing
epidemiological characteristics of their burn population. Forjuoh
has published a review of 117 articles from 34 low and middleincome countries.5 The majority of these studies dealt with the
pediatric population, with the highest incidence of burns occurring
in infants and toddlers (ages 0-4 years) who are dependant on
others for their care. In a study from Angola which looked at all age
groups, the pediatric population accounted for as much as one
third of all burn victims.6 A comprehensive population-based study
in Ghana identified and calculated the strength of specific risk
factors found in childhood burns; the presence of a pre-existing
impairment such as epilepsy was associated with 6.7 greater odds
of a burn, a finding supported by many other studies.7 Other risk
factors identified in case-control studies include history of a burn
or burn-death in a sibling, low income, illiteracy, poor living
conditions (overcrowding, lack of water supply) and careless
practices (cooking equipment within reach of children).7, 8, 9, 10 All
these reflect the importance of identifying and developing
prevention strategies that reach marginalized populations.
In many countries in Africa and Asia, young women are also at
particular risk. A reversal of gender distribution is seen compared
to most other injury mechanisms. Women in East Asia account for
26% of the burn deaths worldwide, the highest burn mortality
rates of any population (16.9 per 100 000 population per year)5, 11.
This risk is attributed to the domestic role of women cooking in the
home, using unsafe ground-level stoves oil-lanterns or open-fires
and frequently wearing highly flammable (yet inexpensive)
synthetic, loose clothing12. Some authors have found that violence
against women is a frequent underlying causal factor in fatal burns,

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Innovation and clinical specialities: burns

often billed as suicide in newlywed young women.13


Most burns occur in the home, commonly in the cooking area,
accounting for the high proportion of scald burns, followed by
flame burns. Combined, they account for over 80% of all burns
seen in low-income countries4. Electrical burns are also frequently
seen in low-income areas where building codes may be less
stringent and homes may be built near high tension wires.
Although most studies report higher burn rates in urban settings,
this could be due to a publication bias, with few district hospitals
having the means to carry out and publish results.14 Given the lack
of first-aid resources and longer distances to travel to medical care
in rural settings, it is not surprising that outcomes are worse in
these locations. This is intuitively understood and is illustrated in a
South African study showing that the average pre-hospital delay
was 42 hrs in rural South Africa, with high rates of wound infection
(22%), contractures (6%) and prolonged length of stay15.

Prevention
At a population health level, the true magnitude of the problem is
not well defined with few standardized comprehensive statistical
collection systems in many low-income countries. Some authors
suggest that the global estimated death rate is a gross
underestimation14. It is widely accepted that the social and
economic costs of burn injuries to low-income populations are
great and efforts to develop, evaluate, and implement prevention
strategies specific to the local cultural and economic settings are
urgently needed. Successful examples have been shown to work
in developed countries such as Norway, where with a communitybased prevention program, the rate of burn-related hospital
admissions was reduced by 52%.5
With over 2 billion people worldwide preparing meals using
rudimentary traditional stoves or open fires5, much interest has
been directed toward developing safer domestic appliances and
energy sources.14 An example of such a strategy is the inexpensive
redesigned flat kerosene lamp, designed by burn surgeon Dr.
Wijaya Godakumbura of Sri Lankas Safe Bottle Lamp Project.16
Although outcome studies have not formally been performed, with
over 600 000 lamps distributed and accompanying community
based education addressing basic fire-safety, this project is
anticipated to have a major impact on the incidence of lamprelated accidents.
Recognizing the complexity of the issue and its regional
challenges, the WHO, in collaboration with international partner
agencies, developed in 2008 an evidence-based global strategy
for burn prevention and care.5

Pathophysiology of burns
There are several processes involved in the local tissue responses
after a burn. An increase in vascular permeability leads to the loss
of water, electrolytes, proteins and heat.11 The complement and
coagulation cascades are activated and this results in thrombosis
and the release of histamine and bradykinin. These mediators
cause an increase in capillary leak and interstitial edema in distant
organs and soft tissue. In addition, the activation of the
inflammatory cascade can lead to immune dysfunction. All of
these responses increase the patients susceptibility to sepsis and
multiple organ failure.17 These systemic responses are significant
once a burn exceeds 20 percent of the patients body surface.
Hypovolemia, immunosuppression, bacterial translocation from

the gut, and Acute Respiratory Distress Syndrome (ARDS) can


ensue.11

Initial management
Primary survey
The rapid implementation of the ABCs of trauma management
(airway, breathing, circulation) also applies to burns. The initial
physical examination of the burn victim should focus on assessing
the airway and the patients hemodynamic status, as well as
estimating the size and depth of the burn. Airway edema can
result in airway obstruction and death. One hundred percent
oxygen should be administered from the outset. If there are any
concerns about the adequacy of the airway, prompt endotracheal
intubation is mandated.18 In addition, signs of inhalational injuries
should be quickly recognized.
If there are concerns of cervical spine injuries, nasotracheal
intubation can be performed because it has the advantages of
decreased cervical spine manipulation and the tube can be easily
secured by suturing it to the nasal septum. The disadvantage of
nasotracheal tubes is that they tend to be of smaller caliber, which
are not as good for suctioning, and may increase the risk of
sinusitis. In difficult cases, fiber-optic bronchoscopy (if available)
can prove to be an invaluable tool in securing the airway. Vocal
cords, directly injured from smoke, may be resistant to usual
topical anesthesia and care must be exercised to avoid
laryngospasm. Consideration should be given to securing the
tube to the teeth with wires (or heavy sutures), rather than risking
further damage to burned facial skin with tie-tapes.
Once the airway has been addressed, the next step is to place
two large-bore (at least 14 gauge) peripheral intravenous catheters
through non-burned viable tissue. If necessary, these catheters
can be placed through burned skin because the eschar is still
sterile in the acute phase and more importantly, death can result
from delays in fluid resuscitation. A Foley catheter should be
placed to monitor urine output because this is the most
straightforward and reliable indicator of intravascular volume
status in the majority of these patients. Associated life-threatening
injuries such as cardiac tamponade, pneumothorax, hemothorax,
and flail chest must be identified and treated quickly18 Tetanus
toxoid should also be administered routinely to all burn patients,
depending on immune status.
Assessment of injury
Quantifying the extent (Figures 1 & 2) of the burn is crucial in
determining subsequent management. Burns are dynamic injuries,
and damage to the skin can continue for 24 to 48 hours after the
initial injury due to edema, coagulation of small vessels, pressure,
desiccation, and infection. Thus daily evaluation is of paramount
importance in reassessing burn depth and success of excision17.
Superficial burns (1st degree) are generally red, painful, and
involve the most superficial aspect of the skin; as such, they are
not included in the calculation of total body surface area (TBSA).
These blanch to the touch19 and have an intact epidermal barrier. Examples include sunburn or a minor scald from a kitchen
accident. These burns will heal spontaneously, will not require
operative treatment, and will not result in scarring. Treatment is
aimed at comfort with the use of soothing topical salves with or
without aloe and oral non-steroidal anti-inflammatory agents.
Surgery is not required for these patients.20
Hospital and Healthcare Innovation Book 2009/2010 55

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Innovation and clinical specialities: burns

Partial-thickness (2nd
degree) burns involve
the
dermis
and
the epidermis. Partialthickness
injuries
classified into two types:
superficial and deep. All
second-degree injuries
involve some amount of
dermal damage, and
the division is based on
the depth of injury into
this structure.
Figure 1: Burn Depth Burns are usually
Superficial
dermal
classified into superficial, superficial
burns are erythematous,
partial thickness, deep partial thickness
painful, may blanch to
and full thickness. Here we have given
then letters A, B, C, D and E 1
touch, and often blister.
Examples
include
scald injuries from overheated
bathtub water and flash flame
burns from open carburetors.
These wounds will spontaneously
re-epithelialize from retained
epidermal structures in the rete
ridges, hair follicles, and sweat
glands in 714 days. The injury
will cause some slight skin
discoloration.
Figure 2: Adult compared to
Deep dermal burns into the
child burn surface areas
reticular dermis will appear more
pale and mottled, will not blanch to touch, but will remain painful to
pinprick. These burns will usually heal in 1428 days by reepithelialization from hair follicles and sweat gland keratinocytes,
often with severe scarring. Some of these will require surgical
treatment20.
A full-thickness (3rd degree) burn generally is identified by a dry
and leathery appearance, although a plastic-like texture and a
hemorrhagic or purpuric pattern may also be seen. Classically, fullthickness burn wounds have been described as insensate,
although there is often mixed distribution patterns which make
sensation determination less reliable as a defining characteristic.19
Deep dermal and full-thickness burns require excision and
grafting with autograft skin to heal the wounds in a timely fashion19,
thus minimizing morbidity from protein loss, sepsis, and
contracture. Since all the elements of the epidermis have been
obliterated in full-thickness wounds, healing can occur only
through wound contraction and/or spreading epithelialization from
the wound edges. In a sizable wound, this process will take weeks
to months to years to complete.21
Fourth-degree burns involve other organs beneath the skin,
such as fat, muscle, bone, and the brain.
In adults, the rule of nines can be used to quickly estimate the
size of a burn. The anterior and posterior trunk is each l8%, each
of the lower extremities is 18%, each upper extremity is 9%, and
the head is 9%. This is depicted clearly in Figure 2. Unfortunately,
the rule of nines is somewhat inaccurate in children and may
overestimate burn size because the head accounts for a greater
portion of the body surface area (BSA). In a 2-year-old child, this is
19% of the TBSA Diagrams such as the Lund and Browder charts
56 Hospital and Healthcare Innovation Book 2009/2010

Figure 3: Lund and Browder chart11

(Figure 3) are more accurate and should be used for calculating the
burn size in children.18 In small burns, the surface of the patients
hand can be used to estimate the extent of the burn; it represents
approximately 1% of the TBSA (from fingertips to wrist).
Patient selection
Patient selection is the key to improving the outcomes of burn
injury within the resource constraints of a given environment. The
mortality of a given size of burn injury increases in infants and the
elderly. It is difficult to cite what size of burn constitutes a lethal
injury as mortality varies so much around the world, but local
experience will suggest what magnitude of injury is likely to be
survivable given the treatments available. For patients with clearly
lethal burn/inhalation injury it is humane to withhold fluid
resuscitation and airway intervention and provide palliation with
dressings and generous amounts of intravenous morphine.
Depending on circumstances it may be prudent to ask a
colleague to examine the patient and note their concurrence with
the lethality of the prognosis. Patients with severe, but not clearly
lethal burn injuries pose a difficult problem: they can consume an
inordinate amount of scarce hospital resources (ICU days, total
length of stay, dressing supplies, nursing and operating room
time), and still die or have dreadful outcomes. Consultation and
possible referral to a burn centre is helpful. Treatment with pain
control, dressings, prevention of infection, nutritional support,
good splinting and early mobilization of affected joints, and careful
selection of patients for surgical intervention is a sound
policy. Small but potentially disabling burns, especially in children,
should be the main focus of surgical attention. It is in this group
of patients that early surgery, meticulous graft care, splinting,
pressure garments and aggressive physiotherapy will produce the
most gratifying (and cost effective) outcomes.
Fluid resuscitation
The most commonly used formula for adults, for fluid resuscitation
after a burn, is the Parkland formula. To calculate daily fluid
requirements, a crystalloid solution at the rate of 4 mL/kg/%TBSA
burn is given intravenously. The first half of the calculated amount
of fluid is administered within the first 8 hours after the burn, and
the remaining is given over the next 16 hours. In the first 24 hours
post-burn, the initial resuscitation fluid is Lactated Ringers, which
is isotonic to plasma.

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In children, maintenance requirements must be added to the


resuscitation formula, and should be provide as a dextrose
containing solution for infants due to the risk of hypoglycemia if
they are not drinking. The addition of maintenance is less
important in adults due to the large volumes and low risk of
hypoglycemia. One formula that accounts for the maintenance
requirements is the Shiners Burns Hospital SBH-Galveston
Formula, which calls for initial resuscitation with 5000 mL/m2 BSA
burn/d + 2000 mL/m2 BSA/d of Lactated Ringers solution.18 See
http://www.halls.md/body-surface-area/bsa.htm to express BSA
in M2. Again, the first half is administered within the first 8 hours
post-burn, and the remaining is given over the next 16 hours.
Another option to intravenous fluids, in cases of less severe
burns or where intravenous solutions are at a premium, includes
oral rehydration solution. The WHO describes a method for
preparation of an electrolyte-balanced solution62. Although very
time consuming, IV fluids may also be prepared on site at low
cost.63
It is important to remember that these are only guidelines, and
the infusion volumes must be titrated on a regular basis. Urine
output is the usual indicator of adequate resuscitation. Urine
output in a child should be maintained at 1 mL/kg/h. In an adult,
0.5 mL/kg/h is sufficient (unless myoglobinuria is suspected in
which case it should be over 2 mL/kg/h). It is essential to avoid
over-aggressive resuscitation, which may lead to increased
extravascular hydrostatic pressure and pulmonary edema. This is
especially important in patients who have a cardiac history, as well
as patients with a concomitant inhalation injury, because they will
also have increased pulmonary vascular permeability.
Administration of colloid or hypertonic solutions decreases the
total amount of fluid requirements in the first 24 hours post-injury;
however, no clear advantages in long-term outcomes over isotonic
crystalloid resuscitations have been clinically documented. In
general, crystalloid resuscitation with isotonic Lactated Ringers is
the best option in the acute phase.18
If a patient is having increased fluid requirements, it should raise
suspicion of concomitant inhalation injury, a delay in resuscitation,
or another associated injury. It must be reiterated that the most
important thing is to begin resuscitation as soon as possible after
the time of injury. Unfortunately, delays in adequate resuscitation
are common and lead to increased fluid requirements because of
additive perfusion-reperfusion injury, which lead to unnecessary
loss of life.18
Escharotomy
With circumferential full thickness, or deep partial thickness burns,
there must be a high index of suspicion for compartment
syndrome. The decreased skin compliance does not
accommodate the extreme edema from the inflammatory
response. Swelling increases with fluid resuscitation and it is
much better to release a limb with early escharotomies than to
discover too late that compartment syndrome and myonecrosis
have set in. The diagnosis of compartment syndrome in a burned
patient is challenging. Pallor is difficult to determine because the
eschar often is discolored, soot stained and can be pale and
leathery or red and plastic-like to the touch. Most burn wounds are
painful to the touch, unless an area of pure full thickness exists.
Paresthesia and paralysis are late findings of compartment
syndrome and are impossible to address in a patient that may be

paralyzed or sedated.
The absence of a pulse
is similarly too late
of a finding. Delayed
escharotomies can lead
to
muscle
necrosis
and limb loss. Sufficient
release can usually be
noted as soon as the
dermis
is
released,
as the wound opens
and
subcutaneous
tissue
bulges
out.
Escharotomies may need
to be done on any limb.
(Figure 4) Escharotomy
may be done with a
scalpel or diathermy
blade. While it is true that Figure 4: Escharotomy lines
full thickness burns are
usually insensate, it is not true that escharotomy can routinely be
performed without some kind of pain control. Ketamine or
fentanyl and versed are safe and effective. The incision should go
through skin but not into fascia or muscle. The mid-medial and
mid-lateral lines of each limb are incised. A small T where the
incision meets normal skin will ease constriction at the end of the
incision.
Thoracic escharotomies are also occasionally required for
improving chest-wall compliance and facilitate ventilation. This
may require multiple incisions across the chest, both longitudinally
and transversely to allow full chest expansion. Figure 4 shows
possible thoracic escharotomy lines, but more lines may be
required for very deep constricting burns.
In electrical injury, the final extent of tissue injury can be difficult
to predict. Frequent assessments and surgical debridements are
required often in the face of progressive myonecrosis. With any
high voltage electrical injury, the index of suspicion for a deep
injury should be high. The skin wound is not a reliable indicator of
the underlying damage. These injuries will require a fasciotomy,
with release of all muscle compartments to minimize muscle
damage. Patients should also be monitored for myoglobinuria
which will require treatment with increasing urine output,
alkalinization of the urine, and sometimes with very cautious use of
diuretics. Untreated myoglobinuria can lead to deposition in the
glomerular tubules and renal failure.

Inhalation injury
Inhalation injuries are associated with severe burns and poor
outcomes. A retrospective review in Cape Town, South Africa
found that inhalation injury was present in 63% of severe burn
patients (>30% TBSA), which resulted in a mortality rate of 76%.21
However, it is believed that inhalation injuries are more frequently
seen in high income countries due to the high prevalence of house
burns, where victims are confined to enclosed spaces. Alcohol
and smoking account for over half the deaths in developing
countries, so prolonged exposure to smoke may occur as a result
of intoxication. The prevalence of inhalational injury in low to
middle income countries is unknown, but suspected to be lower.
The reason for differences in prevalence is unclear, whether due to
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under diagnosis20 or a true difference given that the vast majority


of burns occur outdoors. Researchers have found prevalence
rates of inhalational injury in South Africa of 2.2 % of pediatric burn
patients19 and 14.5% of adult burn patients.21
Successful management of inhalation injuries relies on early
suspicion and resuscitation, as well as minimizing post-injury
complications such as bronchopneumonia and acute respiratory
distress syndrome (ARDS).
In the early resuscitation phase (< 36hrs), it is key to suspect
inhalation injury, consider early intubation and empirically
oxygenate these patients. Patients who have had prolonged
exposure to smoke (ie. trapped indoors), loss of consciousness,
flash burns with singed facial hair, carbonaceous sputum,
hoarseness should all be closely observed for impending airway
obstruction. Suspicion should also be high in patient with facial
scald injuries, where airway compromise is often misdiagnosed.
Scald burns can be associated with direct thermal injury to the
upper airway from ingestion of hot liquids or steam inhalation.19
Intubation with a large endotracheal tube (to enable suctioning)
should be done in patients with stridor, increased work to
breathing, respiratory distress, hypoxia, hypercapnea, deep burns
to the face or edema/erythema of the oropharynx on
laryngoscopic exam. Respiratory distress may not develop for
several hours, and intubation should be performed in the case of
transfer in high risk patients even in absence of stridor as
obstruction may progress quickly as a result of airway
inflammation from injury or edema from resuscitation.22
Smoke inhalation injury is often associated with significant
carbon monoxide exposure, resulting in carboxyhemoglobinemia.

Carbon monoxide poisonings account for the majority of deaths,


which occur at the scene or early in the pre-hospital phase.
Asphyxia or anoxic brain injury develop quickly; as the oxygencarrying capacity of the blood is decreased. The clinical
manifestations of carbon monoxide poisoning are non-specific
and can include headache, malaise, confusion, dyspnea, seizures
and loss of consciousness. The diagnosis of carbon monoxide
poisoning may be hard to confirm, given its imprecise
presentation, unavailable carboxyhemoglobin levels, and
misleading O2 saturation measurement. Conventional pulse
oxymetry monitors are unable to distinguish O2 saturation from CO
saturation, and therefore the patient may have a falsely normal O2
saturation reading. Patients may also appear pink/red and wellperfused, classically described as cherry red. PaO2 should be
confirmed by blood gas if possible. Clinical suspicion is the
mainstay for diagnosis and treatment. Given poor outcomes
associated with neurologic findings or loss of consciousness in the
setting of carbon monoxide poisoning23, administration of high flow
oxygen should be used liberally to reverse tissue hypoxia and to
accelerate the displacement of carbon monoxide (as well as
cyanide) from their binding sites. The half-life of
carboxyhemoglobin can be decreased from 240 minutes to 75-80
minutes by using 100% FiO2 instead of room air (21% FiO2).24
In the post-resuscitation phase (2-5 days) many competing
factors can contribute to exacerbate pulmonary insufficiency.
Direct thermal injury or exposure to bronchopulmonary toxins from
smoke exposure can lead to airway edema, inflammatory changes
and activation of systemic inflammatory response, as well as
disruption of the muco-ciliary transport, increased capillary

Table 1: Burn Wound Dressings [Modified from Sabiston33]

Antimicrobial Salves
Silver sulfadiazine (Flamazine, Silvadene)
Mafenide acetate (Sulfamylon)
Bacitracin
Neomycin
Polymyxin B
Nystatin (Mycostatin)
Mupirocin (Bactroban)

Antimicrobial Soaks
0.5% Silver nitrate
5% Mafenide acetate
0.025% Sodium hypochlorite (Dakin solution)
0.25% Acetic acid
Synthetic Coverings
OpSite
Biobrane
Transcyte
Integra

Biologic Coverings
Xenograft (pig skin)
Allograft (homograft, cadaver skin)

Broad-spectrum antimicrobial; painless and easy to use; does not penetrate eschar; deeply may leave black tattoos
from silver ion; mild inhibition of epithelialization
Broad-spectrum antimicrobial; penetrates eschar well; may cause pain in sensate skin; wide application causes metabolic
acidosis, therefore only suitable for small areas; mild inhibition of epithelialization.
Ease of application; painless; antimicrobial spectrum not as wide as above agents
Ease of application; painless; antimicrobial spectrum not as wide
Ease of application; painless; antimicrobial spectrum not as wide
Effective in inhibiting most fungal growth; cannot be used in combination with mafenide acetate
More effective staphylococcal coverage; does not inhibit epithelialization; expensive

Effective against all microorganisms; stains contacted areas; leaches sodium from wounds; may cause methemoglobinemia
Wide antibacterial coverage; no fungal coverage; painful on application to sensate wound; wide application associated with
metabolic acidosis, and therefore generally used for small high-risk areas such as cartilage coverage in nose and ears.
Effective against almost all microbes, particularly gram-positive organisms; mildly inhibits epithelialization
Effective against most organisms, particularly gram-negative ones; mildly inhibits epithelialization

Provides a moisture barrier; inexpensive; decreased wound pain; use complicated by accumulation of transudate and exudate
requiring removal; no antimicrobial properties
Provides a wound barrier; associated with decreased pain; use complicated by accumulation of exudate risking invasive
wound infection; no antimicrobial properties
Provides a wound barrier; decreased pain; accelerated wound healing; use complicated by accumulation of exudate;
no antimicrobial properties
Provides complete wound closure and leaves a dermal equivalent; sporadic take rates; no antimicrobial properties.
Allows for coverage with a very thin skin graft with no dermis. Very expensive product

Completely closes the wound; provides some immunologic benefits; must be removed or allowed to slough
Provides all the normal functions of skin; can leave a dermal equivalent; epithelium must be removed or allowed to slough

58 Hospital and Healthcare Innovation Book 2009/2010

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permeability, mucosal necrosis and sloughing. As a result


subsequent distal airway obstruction, from atelectasis, edema and
inflammatory debris, leads to a high risk of bronchopneumonia;
the most frequent complication seen in a cohort of children with
inhalational injuries in South Africa, seen in 32% of patients19.
Other compounding factors include non-cardiogenic pulmonary
edema secondary to aggressive fluid resuscitation in burn
patients, poor lung compliance and chest wall rigidity in the setting
of trunk burns, secondary ventilatory-associated lung injury from
aggressive high tidal volume, ventilator associated pneumonia,
relative immunosuppression and the emergence of multi-drug
resistance.25
Recent recommendations to minimize respiratory complications
in burn patients have been shown to improve outcomes in high
income countries.25,26 These include using low tidal volume
ventilation with PEEP (positive end expiratory pressure) to maintain
alveolar patency and minimize baro-trauma, humidified
oxygenation and elevating the head of the bed to improve
pulmonary toilet and judicious use of antibiotics based on
bronchoalveolar lavage cultures. Other interventions and
treatments remain controversial including early tracheostomy27,
adjunct inhalational therapies (heparin or N-acetylcysteine) or
other modes of ventilation. Corticosteroids have been shown to be
harmful in this patient population28.
The final inflammatory-inflammation phase of injury (5 days and
beyond) persists until complete lung healing and burn wound
closure, during which time patients remain at risk for infectious
complications.
Most patients do not suffer from long-term respiratory
complications as a result of their lung injury, with evidence of
normal lung function seen in a study at 4 years post-injury29.
Rarely, complications such as fibrosis and tracheal stenosis have
been seen and should be managed independently of the causal
etiology.

Wound care
Wound care is a fundamental pillar in the care of the burn patient,
and an area of evolution partially responsible for improved survival
seen since the 1960s. As a result of loss of dermal integrity, the
burn wound loses its protective barrier against invasion by microorganisms and against evaporative losses. Therefore, until
complete re-epitheliazation occurs, the burn dressing serves a
number of functions: protection against micro-organism invasion,
minimizing metabolic losses, limiting the pain of exposed burn
surfaces, containing messy wound secretions, and hiding the burn
to help prevent adverse psychological responses.30 Most of the
practices used in modern burn units are based on anecdotal or
uncontrolled clinical observations. However, with the introduction
of topical antimicrobial prophylaxis, occlusive dressing, and
improved sterility as well as a goal of early wound closure, the
incidence of burn wound infections have steadily declinedV.
Burn wound care requires an experienced eye and knowledge
of the dressing options available. Surgeons often lack the time to
examine wounds as often as they should so developing expertise
in the nursing staff is important. If dressings are changed each day
by a nurse experienced in burns many problems will be averted
and if staff understand well the importance of both splinting and
early mobilization to prevent contracture functional results will
improve. The routine inspection of wounds by a knowledgeable

person is at least as important as the selection of the dressing


material itself. This is the advantage of a burn team.
Exposure Method: Leaving a burn open is a poor option but
where dressings are not possible it may be the only option. The
patients is washed daily and kept of clean dry sheets with another
sheet or mosquito net draped over a frame to reduce the pain
from air currents and to reduce contamination from the
environment. Ambient temperature control is important to maintain
normothermia. Exposure is less painful for full-thickness burns
than for partial thickness burns but has little else to recommend it.
Tubbing: Most modern burn units avoid the regular immersion
of patients in water both because they practice early excision and
grafting and because of the high risks developing resistant strains
of bacteria in the tub environment and of patient cross-infection.
That said, tubbing can be helpful to clean the wounds and gently
remove eschar as it separates. When early wound infections
develop suspect the tub! Avoid the routine immersion of infected
patients in filthy bathtubs of cold water on the basis of ignorance
and tradition.
Bland Dressings: These provide a clean, moist wound healing
environment, absorb exudates protect from contamination and
provide comfort at a fraction of the cost of antibiotic dressings.
Where antibiotic dressings are scarce bland dressings are a very
acceptable solution for burns. Expensive topical antibiotic
dressings may be reserved for infected wounds. Paraffin gauze is
widely available and can be manufactured locally. Honey and ghee
dressings were first advocated in Ayurvedic texts two thousand
years ago and remain an excellent choice for bland burn
dressings. Mix two parts honey with one part ghee (clarified butter)
and pour over a stack of gauze dressings in a tray. Cover and
store. Vegetable oil or mineral oil may be substituted for Ghee.
Gauze sheets can be applied directly to the wound in a single layer
and covered with plain dry gauze to absorb exudates, then
wrapped. Dressings should be changed at least ever second day,
or when soiled.
Antimicrobial dressing: There exist numerous topical
antimicrobial agents that are effective in delaying the onset of
invasive wound infections, but none prevent them entirely. This is
why they must be used in conjunction with a goal of early surgical
wound closure when possible. A brief review of the agents most
likely to be available to low and middle income countries will follow.
There are also alternative synthetic wound coverings and newer
silver-ionized agents that can be used; however they are often very
costly and inaccessible in low-income countries. A more detailed
review, as well as instructions for preparation, can be found in
these references.11,33
Silver sulfadiazine (SSD, Flamazine), is by far the most frequently
used agent, given its broad antimicrobial coverage, painless
application and minimal toxicity. It is better to apply the SSD to
large gauze squares and to apply these to the wound than to
attempt to cover the burn in an even coat of cream before
applying the gauze. A very loose plastic or surgical glove
containing silver sulfadiazine and gently secured with tape around
the wrists is a simple and excellent hand dressing. Splints can be
applied outside the bag and the fingers can easily be mobilized to
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reduce swelling and prevent stiffening.


There exist many other less expensive options worthy of
mention. Honey has well established antimicrobial properties, and
has demonstrated effectiveness in limited studies.34 Tannins, as
found in tea leaves, have also been shown to have antibacterial
properties and may reduce the incidence of hypertrophic
scarring.64,65 Amniotic membrane, used as a biologic wound
coverage has also been shown to be more effective than
nitrofurazone in decreasing the incidence of wound infection35, as
well as being cost-effective in reducing the length of stay and
increasing epithelialization36. Obvious caution regarding the risk of
disease transmission with the use of human tissue should be used
and comprehensive donor viral screening performed prior to widespread adoption of this technique. Another innovative way to
minimize cost yet still provide an occlusive dressing to prevent
dehydration has been demonstrated in India with the use of
Banana leaves.37 Gore et al have shown an acceptable level of
patient acceptance, in comparison to potato peels. Both options
provide wound protection and healing at a fraction of the cost of
conventional dressings.
If despite vigilance, an invasive wound infection becomes
evident on serial observations, one must consider altering the
current treatment protocol. An invasive wound infection can be
determined by clinical expertise or suggestive by wound cultures
showing >105 organism per gram or invasion seen on tissue
biopsy. Invasion of microorganism into viable tissues may lead to
progression of the burn or systemic sepsis. It should be noted that
elevated temperatures per se are not necessarily indicative of
sepsis, but are common secondary to the inflammatory
component of the burn wound process. The same organisms
have been identified in serial wound cultures in both low and
middle income countries, with Staph aureaus, Proteus, Klebsiella,
E.coli and Pseudomonas being the most common. The problem
of drug resistance is not confined to high income countries38. A
recent Nigerian study, looking at serial wound cultures, concluded
that systemic prophylactic antibiotics did not reduce invasive
infection, but may in fact select more virulent, resistant strains of
bacteria39, a notion which has gained wide spread acceptance.
We should therefore guide our antimicrobial use by evidence of
invasive infection, organism culture and sensitivities when these
are known. Prophylactic antibiotics at the time of initial admission
are not routinely advised.

Medical management
Severe burn wounds are known to induce systemic inflammatory
response syndrome (SIRS) through the release of a series of proinflammatory endotoxins, exotoxins from infectious sources or
from the wound itself. Although the exact mechanism is not well
understood, it is clear that there is a systemic response which can
lead to progressive infection, immuno-suppression, sepsis and
eventually multi-organ failure. Supportive measures are needed
early in the care of the severely burned patient to minimize the
progression and attenuate the hypermetabolic response to burn
injury.
Nutritional support
Early nutritional support is essential in burn patients, even more so
in low-middle income countries where many patients present
malnourished. Burn patients demonstrate levels of metabolism
60 Hospital and Healthcare Innovation Book 2009/2010

that can be as high as 200% normal and that are proportional to


the severity of the burn. The metabolic rate does not return to
normal until wound closure. Supporting this high metabolic rate
with diets rich in carbohydrate and protein without overfeeding
patients can decrease muscle wasting, and poor wound healing
consequences of chronic malnutrition. Early feeding also avoids
mucosal atrophy and bacterial translocation.40 This is particularly
important for intubated patients, for whom feeding is often not
initiated at presentation, increasing the risk of bacterial sepsis.
Strategies to achieve this goal include tube feeding, which should
begin within 6 hours, weekly monitoring patients weights, and the
creation of high protein high-caloric feeds from locally available
produce. The frequency of the feeds should be adjusted to the
severity of the burn (%TBSA) and the patients pre-existing
nutritional status.11
Anemia
Unfortunately the prevalence of underlying disease in burn patients
is common in low to middle income countries and may influence
treatment options. A Liberian study found that 61% of their
patients had underlying medical co-morbidities, including epilepsy,
anemia as a result of malaria, or iron deficiency and malnutrition41.
Anemia and malnutrition contribute to infectious complications in
these burn patients; however grafting was possible, albeit
delayed, in this study, with surgery being performed between 5-96
days (average 29.8 days) with reasonable graft take (mean 81%).
There is no question that the benefits of early excision must be
weighted against the risk of blood loss and physiological needs of
these specific patients. However, new understanding of the
potentially infectious complications of blood transfusion is
emerging as a result of large prospective multi-centered ICU
trials42. A recent multicentre retrospective cohort study that has
shown an associated 13% rise in infectious complications per unit
of blood transfused and an associated increased mortality rate
even when accounting for burn severity43. This study underlined
the importance of further research to establish appropriate
transfusion guidelines. Strategies should be undertaken to
minimize blood loss during surgery. Some techniques for
minimizing blood loss are discussed in the surgical management.
HIV
Another important consideration in many low-income countries is
the burn patient who is HIV positive. Until recently, little was known
regarding clinical outcomes in this specific patient population.
James et al conducted a study in a burn unit in Malawi44, showing
a 31% HIV prevalence rate in their adult burn population (34 of 112
patients) and in 3% of the pediatric burn patients (6 of 231 patients
under the age of 15). The researchers found that HIV status was
an independent risk factor for death, mostly from infectious
complications with more marked immunosuppression, as
indicated by a lower mean CD 4 count (383mm3 vs. 937 mm3 in
HIV negative patients). They found no differences in bacterial
cultures, need or outcome of skin grafting, transfusion or antibiotic
requirements or length of stay. In a case-controlled study out of
South Africa45, no differences in mortality or morbidity was found
when comparing 33 patients with and without HIV, when matched
for age, sex, burn severity and inhalational injury. Two patients with
clinical AIDS died of infectious complications leading the authors
to conclude that HIV positive patients, without the stigmata of

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AIDS should be treated in the same manner with similar outcomes


expected. Further research is needed to understand the effect of
HIV on immunosuppression in its early stages of disease.

Surgical management
After hemodynamic stabilization, a burned patients priority of
treatment shifts to burn-wound-management46. Preoperatively,
several factors can pose a challenge to surgical patient care. In
the developing world, many of the burns present late, already
infected, or the poor general health of the patients makes them
unfit for anesthesia. In addition, blood loss can be significant in
burn wound excision, especially since inflamed and infected
wounds tend to bleed more during tangential excision. Thus, burn
surgery can be dangerous in high risk patients where blood
transfusion facilities are not readily available.
The options for the surgical management of burns includes early
tangential excision and grafting for deep dermal burns and
delayed escharectomy skin grafting for full thickness skin loss47.
Tangential excision describes the sequential and layered excisions
of devitalized tissues to a vital bed, generally recognized by
punctuate bleeding. An inadequately excised wound is more likely
to become infected and is unsuitable for graft take, necessitating
further surgery.19 The use of tumescence (discussed below) is
good for decreasing blood loss from the burn site; however it
makes judgment of adequacy of excision and of hemostasis more
difficult. It can decrease blood loss to a minimal amount. Adequate
debridement must instead be determined by tissue quality, and
not by punctuate bleeding.
The exact timing for wound excision is debatable. It is often
suggested that burn wounds should be excised and grafted if they
are not expected to heal within 21 days of injury. This is especially
true for key functional and esthetic locations such as the hands
and face.19 The decision to perform extensive excisions in a single
setting versus staged procedures is dependent upon the
hemodynamic stability of the patient, the availability of resources,
and the coordination of all parties involved in the care of the
patient.19 Conservative treatment of burn wounds, with silver
sulfadiazine, followed by serial excision of the burn wound is
currently the standard of care in many burn centres throughout the
world. Burns are excised in areas of as much as 20% TBSA in one
operative setting, and performing the entire excision of the burn
wound in 10 days post-injury is the goal. All full-thickness burns
can be excised first, so that deep dermal and indeterminate depth
wounds are addressed later, preventing excision of potentially
viable tissue. Early excision and grafting is the treatment of choice
to potentially reduce scar contractures and hypopigmentation47.
The disadvantages to serial excision are that the patient needs to
return many times to the operative room, so that episodes of
bacterial translocation, bacteremia, and cardiovascular instability
are repeated. Other disadvantages include exaggerated blood
losses, prolongation of the hypermetabolic response, and
increased risk of infection and sepsis from remaining eschar in
which bacteria proliferate.
Near-total wound excision has been advocated as an alternative
to serial debridement in massive burns. In near-total excision, all
full-thickness and partial-thickness burns are excised within 24
hours of admission, and the excised wounds are covered with
autografts and skin substitutes are used if the burn exceeds the
donor-site supply. Areas of the face are normally not excised in the

first operation. Near-total burn excision has dramatically improved


survival in massive burns18. However, it has been postulated that
the surgical trauma of immediate burn wound excision, especially
given the hemodynamic instability of burn patients during the first
72 h after the injury, may aggravate the inflammatory and catabolic
responses, leading to potentially fatal postoperative
complications.18,47 It should be clear that near-total wound excision
is only meant for massive burns, and allograft/autograft/xenograft
must be available for coverage, or the wounds would only have
been converted to full thickness open wounds.
General surgical principles
The intent of burn wound operations is twofold: to remove
devitalized tissue and restore skin continuity. For this process to
take place and for the skin graft to take, four things are required:
 A viable wound bed.
 No accumulation of fluid between the graft and the wound
bed.
 No shear stresses on the wound.
 Avoidance of massive micro-organism proliferation.
Surgical debridement is performed using a Goulian blade for small
areas or those with multiple irregular contours (e.g., hand or knee)
and a Watson or Humby blade for larger areas. Inexpensive
alternatives have been proposed for harvesting and debriding
blades48. Burned tissue is excised tangentially and sequentially
until the wound has been excised down to healthy dermis, fat,
muscle, peritenon, or periosteum. The wound may then be
covered with an autograft, allograft, or synthetic skin substitute.
Graft depth should be adjusted in pediatric and geriatric
populations for their thinner reticular dermis layer. If using a
powered dermatome, it should be set at less than 10/1000th
inch. The meshing pattern used for wound closure depends on
burn surface area and donor site availability. Meshing of the skin
graft has several advantages, including expanding the square
centimeters of coverage, allowing for drainage of fluid from under
the graft, and allowing for placement of the graft over contoured
areas, such as the knee or ankle. The disadvantage of the meshed
skin graft includes a permanent weave-like appearance of the
healed scar site, and increased contraction.17
Many authors have described innovative methods for
performing skin grafting in resource-poor settings49. With minimal
financial resources, using readily available modified household or
industrial materials a surgeon is able to sharpen the Humby knife
and use a pizza cutter for meshing grafts.48, 50
Methods of optimizing hemostasis and minimizing blood losses
include meticulous attention to maintaining the patients core body
temperature (operating in a warm environment, isolating surgical
fields, warming intravenous fluids, warming humidified air circuits
for anesthesia), the use of cautery, the application of topical
epinephrine solutions or topical thrombin solutions, injecting dilute
epinephrine tumescent solution below the eschar, and the use of
topical fibrin sealants.
The use of tumescence and tourniquet in burn excision
significantly reduces intraoperative blood loss and facilitates
accurate wound excision. Epinephrine is diluted in saline to a
concentration of 1:500,000 (2mg/l) and large volumes are injected
beneath the wound to be excised. Use a concentration of
1:1,000,000 for children. The edges of the wound are scored with
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a scalpel and the burned dead skin is sliced away with a grafting
knife. Tangential excision is continued to the point where the
dermis looks healthy, clean and pearly white, fat appears shiny and
yellow with no haem staining and small visible vessels have
patency and flow. If the fat does not look healthy consider excision
down to the fascia which is possessed of a better blood supply
than the fat. Bleeding vessels are coagulated and the wound is
wrapped in adrenaline saline soaked gauze while natural
haemostasis takes place. Attention is the turned to the donor site
and a template of gauze from the excised wound is used to
measure the area of skin to be harvested. Adrenaline saline is
injected beneath the donor site till the skin is taught and blanched
then it is harvested with the humby knife or power dermatome.
The donor wound is wrapped in adrenaline saline gauze while
attention returns to the burn site. When hemostasis is satisfactory
the grafts are applied and secured in place. Local anesthetic can
also be added for small wounds, with 20ml of 1% xylocaine added
to 1 L of solution. The addition of local anesthetic to the solution
can decrease pain, reducing anesthetic agents and narcotics
during surgery but the toxicity of xylocaine exceeds that of the
adrenaline. A number of recent papers have addressed the safety
of high dose adrenaline tumescence during burn excision and are
cited here to placate anesthetic concerns. Atropine and ketamine
are poor choices for tumescent burn excision as the patient will be
tachycardic and hypertensive even before adrenaline infiltration is
begun. Excision of burns from the extremities under tourniquet
control can minimize bleeding significantly
If possible, donor sites should be chosen that are inconspicuous
and will have a good color match for the wound bed. Donor sites
may develop hypertrophic scars and should not cross joints.
Potential donor sites include the upper thigh or the buttock, which
remain hidden with normal clothing and the back, which heals well
but is technically difficult to harvest with a hand held grafting knife.
Selection of the donor site should also consider the color match of
the wounded area, which is most significant on the head and
neck. A number of types of donor site dressings are available. The
first type is a fine-mesh cotton gauze that may or may not be
impregnated. Dressings of this type include Scarlet Red and
Xeroform, which have the advantage of low cost and familiarity.
These may need to be reinforced with more gauze initially that can
be removed in 24-48 hours, and the inner layer left intact. The
adherent gauze will start lifting in 1-2 weeks as the wound reepithelializes. The edges can be trimmed off as they
spontaneously lift. An occlusive dressing such as
OpSite/tegaderm can also be used, but may require a few holes
to drain seromas.47
Loss of dermis leads to significant scarring and wound
contracture. There are a number of dermis substitutes that can be
used such as Integra and AlloDerm. These products allow the use
of a very thin partial thickness skin graft on top of the dermis.
These products require a very clean wound bed, and meticulous
cleanliness post-operatively to prevent infection. These two
options are very expensive, though, and are not mainstays of the
armamentarium of burn surgeons in the developing world.
Grafts must be held in place by sutures or staples. Some form
of dressing is required to hold grafts in place. In more mobile
locations, a bolster dressing may be placed on top of the graft. An
inner layer that can maintain moisture (petroleum jelly or mineral oil
product) should be placed before gauze. Grafts over joints will
62 Hospital and Healthcare Innovation Book 2009/2010

require casting/splinting for the time period for grafts to take,


usually 10-14 days. Dressings are left intact during the time
period.
Specific anatomic considerations
Particular anatomical regions require specific treatments. The
head and neck region is well vascularized and this is protective
against invasive infection. Excision and grafting of the face is
ideally done in full aesthetic units (Figure 5). Early excision of
eschar is not recommended in order to preserve any dermal and
epidermal structures that may survive. Once the eschar separates
in 1014 days, the underlying wound can be grafted. The color of
the skin in this area is relatively specific; therefore, autograft skin
should be obtained from donor sites above the clavicles. The
scalp is an excellent donor site for
the face21.
With regards to the breasts,
keratinocytes are often found
deep beneath the skin. These will
proliferate and facilitate wound
closure if left in place. The
coloration of the areola is also
very specific so the nipple/areolar
complex should not be excised.
The buttocks and perineum are
in a very difficult position for skin Figure 5: Anantomic subunits
of the face
grafts to take, since the dressings
applied are often soiled from
excrement, and cleaning, often shearing the grafts. It may be
necessary to leave the patient in the prone position at later
operations after application of grafts to this area while they adhere.
In extreme cases, a temporary defunctioning colostomy may be
considered until the burn wounds in the perineum are closed.
The penis and scrotum have an excellent blood supply, so they
will usually heal in a timely fashion. The skin in this region occupies
a highly important function, so, in general, excision is avoided. In
the case of a small burn to the shaft of the penis, excision and
primary closure akin to a circumcision can suffice. The scrotum is
also a very good donor site because it heals well, is relatively
hidden, and can be vastly expanded to provide a surprising
amount of donor skin.
The hands are very important in terms of function and cosmesis.
Most burns of the hand are limited to the dorsal surface as the
hand is clenched during injury. Unfortunately, sometimes the digits
sustain a second injury associated with diminished perfusion
during resuscitation. Escharotomies along the axial lines may
salvage digits during resuscitation. Grafts placed on the hands
should either be unmeshed or meshed tightly at a 1:1 ratio to
improve cosmesis. Burns through to the extensor tendons can
result in boutonniere deformities even with complete wound
closure due to sliding of tendons medial and lateral around the
proximal interphalangeal joint. Extension contractures at the
metacarpophalangeal joint are also common because the burn
and subsequent scarring are limited to the dorsal surface. For
these two reasons, consideration should be given to fixing the
digits in extension at the proximal interphalangeal joint and flexion
at the metacarpophalangeal joint by insertion of threaded
Kirschner wires which are removed after complete wound healing,
at which time the position can be maintained easily with splints21

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Burns to the palm of the hand should be treated conservatively


with gentle debridement, as they will often heal spontaneously
because of the depth of the skin. In the paediatric population
contractures may develop, either in the acute phase or, years later,
as the scar growth is less than that of the normal tissue.
For the feet, great care must also be taken with excision of fullthickness eschar in this area, because the extensor tendons are in
very close proximity to the skin. Autograft skin applied to this area
should be of a narrow mesh to avoid hypertrophic scarring, which
can make it difficult to fit shoes. The toes require the same
considerations as the fingers.21

Rehabilitation
The goals of the rehabilitation process are to maximize function
and appearance of the scars. This is done by trying to counteract
two main physiologic processes, scar hypertrophy and
contracture.
Hypertrophic Scarring
Hypertrophic scarring generally does not develop in burns that
require less than 2 weeks to heal. Hypertrophic scarring develops
in 33% of wounds that take less than 3 weeks to heal, but 78% of
wounds that take more than 3 weeks. It also affects skin grafts.
Hypertrophic scars are thickened, red, and raised scars which can
often be very itchy. Unlike keloids, hypertrophic scars do not
outgrow their boundaries. They will also generally remodel and
regress over time, but this may take a number of years, and
contractures may develop in the interim. Although children
generally heal quickly, they are at higher risk of hypertrophic
scarring if there is delayed healing. In addition, individuals with
darker skin pigmentation are also at greater risk of hypertrophic
scarring and keloids. Tangential excision and grafting of burns that
require greater than 3 weeks to heal can help prevent or reduce
hypertrophic scarring.
Scar compression is the mainstay of non-surgical hypertrophic
scarring prevention and management. This can be achieved with
customized compression garments, or with elastic tensor
bandages. The goal is to have pressures of approximately
25mmHg. If using tensor bandages, they must be wrapped from
distal to proximal, taking care not to cause ischemia or venous
stasis. Using tensors for compression over grafts should be
initiated after grafts are well healed, approximately 2-3 weeks after
grafting. This should continue until scar maturation, which can
take up to 1-2 years, and is gauged by when the scar is softened
and stabilized.
Scar massage can also help with breaking down of excess scar
tissue. This is often done in combination with stretching exercises
to prevent scar contractures. Scar massage should be done 2-3
times per day with a hypo-allergenic lotion or cream, or petroleum
jelly (Vaseline). Moisturizing and massaging the scars, which can
be dry due to the lack of glands in the scar tissue, may be sore at
first, but usually becomes soothing, and can help with the
itchiness of the scars. Massaging must press hard enough to
blanch the pink scars. Maturation and flattening of the scars can
take 1-2 years, particularly in children where the hypertrophic
phase may be longer. Most scars will eventually fade and lose
their pink colour over time, but the 1-2 year time frame may be
longer.
Silicone gel sheets can also be beneficial. The exact mechanism

is unknown, but they appear to help soften the scar. To reap the
benefits, they must be worn for long periods (over 20 hours a day)
to be beneficial. They can be placed under compression
garments, or simply taped on for areas not amenable to
compression. These can be washed daily and reused.
Contractures
Joint contractures are one of the most challenging aspects of burn
management, and are the main source of disability from thermal
burns. Scar contracture is due to activity of the myofibroblasts
which act to contract scars. When the scars are across joints,
particularly flexion joints, these can lead to permanent flexion
deformities. In addition, flexed positions are often positions of
comfort during the acute phase of burn management,
exacerbating the problem. To combat joint contractures,
stretching and splinting is necessary. Stretching and range of
motion exercises should be initiated from the beginning. With initial
edema, movement may be a bit difficult but should be encouraged
with daily exercises.
To combat joint contractures, stretching, careful positioning and
splinting are necessary. Necks should be hyperextended with a roll
under the shoulders. Axillae should be carefully positioned. Upper
thigh/lower abdominal burns require positioning to prevent flexion
of the hips. Stretching and range of motion exercises should be
initiated from the beginning. With initial edema, movement may be
a bit difficult, but should be encouraged with daily exercises.
Splinting
Contractures are the most debilitating residual stigma of burns,
and high-risk patients (deeper burns over flexion joint surfaces)
can easily be identified. Contractures are much easier to prevent
than to fix. Once developed, can be very difficult to manage and
correct. Elevation of the burned limb reduces edema and
facilitates early joint mobilization. Where surgical treatment is
limited by resource issues; hyperalimentation, good dressings,
splinting and aggressive stretching can still make a big difference
to patient outcomes. Equally, surgical results will improve
dramatically with good post-operative splinting and early
mobilization as soon as the grafts are solid.
Splinting should be considered when any loss of extension is
noted across elbows and knees. Hands should be splinted from
the onset.51Simple plaster slabs covered in elastic tube bandage
or stockinet make excellent volar hand splints, can be wrapped
on with tensor bandages and are re-usable till soiled. Splints are
often applied overnight, allowing for mobilization and function in
the daytime.
There are numerous splinting techniques suggested. Both static
and dynamic splints can be used. Dynamic splints may be better
for reversing any contractures, as they may gain extension, not
only maintain the gains during therapy. However, they are
significantly more costly to produce, and long-term gains have not
consistently been shown. Many local materials have been used to
produce inexpensive splints, including easily malleable aluminum
sheets.
Neck collar braces, or custom thermoplastic splints may be
used to prevent flexion contractures, and stretches should include
both extension and lateral flexion. The splint should be properly
padded to prevent pressure points. There are also alternative
splinting techniques for the neck52. Axilla contractures can be
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Innovation and clinical specialities: burns

challenging to splint, with various


materials used for airplane
splints. Because splinting in
abduction can be uncomfortable
and awkward, this is sometimes
neglected. However, the inability to
abduct the arms leads to
Figure 6: Position of safety
significant morbidity, and it severely
59
for splinting hands
limits overhead activities.53
The ankle can have contractures in both directions. Burns and
scar contractures to the dorsum are more common, which must
be combated with plantar flexion exercises and splints. However,
the Achilles tendon may also become shortened with a prolonged
planter flexion. For an ambulating patient, this is not a concern.
However, for a patient who is bed-ridden, splinting should be
initially for dorsiflexion to prevent Achilles tendon shortening.
Fingers and hands should be splinted in the position of safety
(Figure 6), with MCPs flexed and IPs extended. If there is a severe
burn over the palmer aspect of the MCP joints, the MP joints can
sometimes be splinted in extension, but it becomes very important
to ensure that daily exercises maintain good flexion of the collateral
ligaments of the MCP joint, which can tighten when in extension.
Oral burns, particularly commissure burns can lead to
complications of microstomia. These can be initially managed with
mouth exercises, and gradually increasing the amount of mouth
opening.Splints can also be fabricated to stretch the
commissures.54

Surgical release
Surgical release of burn contractures can involve local flaps for
reorientation of the scar, but often also include a skin deficit which
must be filled with a graft or flap. Skin grafts are also more prone
to contractures, and aggressive post-operative therapy much be
implemented. Repeat surgeries may be necessary. Thick (full
thickness if the area is small enough) unmeshed grafts offer less
contracture. Alternatives include artificial dermal substitutes that
will allow decreased contracture with thinner split-thickness grafts.
However, dermal substitutes such as Integra, a bovine collagen
product, are commercial produced and extremely expensive. If
skin or myocutaneous flaps are possible, they offer the advantage
of coverage with minimal contracture and need for repeat surgery.
These include both local flaps such as z-plasties and transposition
flaps, but also pedicled or free vascularized flaps. The surgeons
will require an armamentarium of possible flaps and grafts to apply
to the situation. Figure 7 gives a possible algorithm for selective
various surgical options.55 Other general principles include the
release of more proximal contractures before distal ones in limbs
with multiple levels involved, such as elbow release followed by
wrist, then fingers. Certain anatomic areas are more prone to
contractures and have specific complications.
Neck contractures
Neck flexion is often associated with webbing of the neck. There
is often a severe shortage of skin, and a significant size skin graft
may be necessary for coverage of the defect after release. Unless
very minor, or featuring a narrow band of scar, these are usually
not amenable to z-plasties. Another challenge for severe neck
contractures is difficulty with intubation. The release of the neck
may need to be done under local anesthetic to allow for neck
64 Hospital and Healthcare Innovation Book 2009/2010

Figure 7: An algorithm for the cover of burn contractures of the


extremities, after adequete release: band contracture (ROM =
normal joint rnage of motion)

extension before initiation of general anesthetic and reconstruction


of the defect. If the injury is anterior only, a good alternative for
coverage of the neck is a pedicled latissimus dorsi flap, which
would provide normal skin coverage without risk of contracture
recurrence.56
Hands
Contractures in the hands include flexion contractures of the
fingers and wrist, web space narrowing of the digits, as well as
hyperextension of the MCP joints.
Finger contractures can sometimes be released with z-plasties,
if the burn area is isolated to the central palmer aspect of each
finger. If z-plasties are used, care should be taken not to cause
excess tension with closures leading to finger ischemia. Release of
prolonged flexion contractures can also have ischemia from
overstretching of shortened neurovascular bundles. Release may
need to be staged, or stretched post-operatively with therapy.
Kirshner wires may be beneficial for the first 1-2 weeks until the
skin graft take is reasonable. They also facilitate the fabrication of
post-operative splints which are best fashioned with the K-wires
still in place. Web-space deepening is particularly important in the
first web-space. A 4-flap or 5-flap z-plasty (Figures 8&9) will allow
deepening of the webspace and increased abduction of the
thumb. A 5-flap z-plasty (also known as a double Z-plasty with VY advancement) allows for more deepening, while a 4-flap allows
for much greater lengthening. These are used primarily in the 1st
webspace. Deepening of the other webspaces is often performed
using techniques for congenital syndactyly, with a skin flaps used
to reconstruct the base of the webspace to prevent future web
creep. Skin grafts are often necessary to fill in the gaps on the
sides of the fingers.57
Axilla
Axillary scar contractures are also very common. These can at

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lengthened (such as tendons or joints), while


others may limit the release to limited stages
serial casting/splinting postoperatively. The
exposure of tendons or nerves in the scar
bed may require a flap rather than graft
coverage. Preservation of the peritenon on
the tendon/peritenon may allow for a
primary skin graft to survive. However, if the
tendon is in an area that requires significant
mobility, the skin graft may tether the tendon
leading to decreased mobility. Caution
should be also taken when putting a skin
graft on an exposed nerve, as this may lead
to complications of neuromas, or
hypersensitivity in the area.

Figure 8: 4-Flap Z-plasty63

Figure 9: 4-Flap Z-plasty63

times be treated with a large 4-flap z-plasty, similar to for the first
webspace, or multiple z-plasties or V-Y plasties.58 Alternatively,
they can sometimes also be managed with release and skin grafts.
The use of skin grafts requires post-operative splinting, often in
airplane splints to prevent recurrence. An alternative may be a
Figure-of-8 splint which also helps to hold the graft in place.59
Recurrent or very tight contractures may be amenable to local
flaps if the burn is localized to the axilla with sparing of chest or
back tissue. These include latissimus dorsi, or pectoralis
major/minor myocutaneous flaps.60

Face
Eyelid contractures can be released with
skin grafts. Patients with eyelid burns must
be followed to watch for ectropion, which
can lead to corneal abrasions. These can be
release with preferably full thickness skin
graft placement. Thin full-thickness skin can be harvested from the
pre or post-auricular region if available. Microstomia and
commissure burns can be treated initially with splinting and
stretching exercises. Customized splints can be made, preferably
with the ability to slowly expand the mouth. With severe
microstomia, a commissureplasty using mucosa to recreate
vermillion may be necessary.54 Esselman et al. has a literature
review of rehabilitation evidence in burn management.61

Conclusions

Many accomplishments have been made in burn care over the


past several decades, as illustrated below (Figure 10).31
Encouragingly, these have resulted in steady improvements in
mortality rates.
This progress has also been noted in a number of centres in
resource-poor countries where a multidisciplinary, global approach to the burn
ICU
80
patient has been embraced; from
Nutrition
prevention to rehabilitation.
70
Excision common
An excellent reference for burn surgeons
60
in resource poor countries is the Burns
Topical Rx
Penicillin
Manual, written by Dr E J van Hasselt. The
50
Burn centres
Early
excision
most recent 2008 edition should be made
Resuscitation
More antibiotics
40
available to all surgeons.
See Van Hasselt Burns Manual
Skin banks
30
Ventiilators
TPN
http://www.ptolemy.ca/members/library.
More antibiotics
20
htm. International collaboration is also
available
and
encouraged
through
10
organizations such as Interburns, the
International Network for Training Education
0
and Research in Burns, who run courses
1940
1950
1960
1970
1980
1990
such as Emergency Burn Care and other
50
Burn LA
public awareness programs, http://www.
interburns.org/index.htm
Figure 10: Advances in burn xare a schematized time line of important advances in burn
This review has demonstrated that
care ICU=intensive care unit, LA50=survival of half of patients, depending on the
percentage of total body surface area (TBSA) burned, Rx=therapy, TPN=total parenteral
specific changes in clinical practice can and
nutrition31
do improve outcomes. As medical
Burn TBSA, %

Deep structures
Release of the scar may be insufficient for chronic contractures.
Contractures may be limited by deep structures, such as joint
capsules, tendons, or nerves. Some of these may be released or

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professionals, we must not be paralyzed by the magnitude of the


task ahead. Instead we must think of each small step as a
significant improvement. With focused attention and the
application of evidence-based knowledge, we will see change
both measurable and meaningful in the treatment of burn patients.

Recommendations
The following recommendations capture the key elements of a
simple, but effective approach to better burn management tailored
to developing countries:
 Community leaders and burn surgeons must collaborate in
developing local prevention strategies as well as community
education strategies on immediate first aid steps for burn
victims and the critical importance of early transportation to the
nearest source of appropriate medical services.
 Medical personnel must be trained in resuscitation; including
aggressive fluid resuscitation, monitoring for airway
compromise, and high flow oxygen, all of which to be initiated
within the first hours in the case of a major burn. The burns
must be assessed for depth, size, need for escharotomy and
risk of inhalation injury on presentation
 Both physiotherapy, including early active and passive
movements and splinting for high risk joints and high protein,
high caloric frequent feeds should be in place as of the first
day.
 Wound care must be performed daily, with careful attention for
signs of invasive infection. Appropriate analgesia, sterile
conditions and topical antibiotics (SSD) should be used.
 Whenever possible, deep second degree burns and third
degree burns should be grafted within 10 days of the injury.
Techniques to minimize blood loss such as tumescence and
tourniquets should be standard practice.
 Systemic antibiotics should be reserved for single-dose
immediate pre-operative prophylaxis and treatment of invasive
wound sepsis, tailored if possible to wound culture results and
institutional resistance patterns.
 All practicing physicians and surgeons working in areas
without a regional burn center should receive training in skin
grafting.
 Blood transfusion should be limited to when physiologic need
exists.
 Life-long seizure prophylaxis and patient education regarding
the importance of compliance must be part of burn care
prevention in all epileptic patients. J
Acknowledgement
Reprinted with kind permission from Surgery in Africa Monthly
Review October 2008
Bimpe Ayeni, MD MPH is a fourth year Plastic Surgery resident at
McMaster University in Hamilton, Ontario. He holds a Bachelor of
Arts Degree from Yale University, a Masters in Public Health from
Columbia University, and a Doctorate in Medicine from the
University of Ottawa.

66 Hospital and Healthcare Innovation Book 2009/2010

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21.
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25.
Godwin, Y.W., SH, Major burns in CapeTown: a modified burns score for patient triage. Burns,
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Innovation and clinical specialities: burns

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Bell, M. and M. Duncan, The Cutting Edge of Plastic Surgery: How to Sharpen Your Humby
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Bell, M., M. Duncan, and S. Shanhrokhi Ebrahimipour, Successful Skin Grafting in Developing
Countries. Tropical Doctor, 2000. 30(3): p. 149-51.
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Richard, R. and R.S. Ward, Splinting Strategies and Controversies. Journal of Burn Care &
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Manigandan, C., et al., A multi-purpose, self-adjustable aeroplane splint for the aplinting of
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Germann, G. and K. Philipp, The Burned Hand, in Greens Operative Hand Surgery, D.e.a.
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Hashem, F.K. and Z.A. Khayal, Oral Burn Contractures in Children. Annals of Plastic Surgery,
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Hudson, D. and A. Renshaw, An algorithm for the release of burn contractures of the
extremities. Burns, 2006. 32: p. 663-8.
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Wilson, I.F., et al., Latissimus Dorsi Myocutaneous Flap Reconstruction of Neck and Axillary
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63.
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Gulgonen, A. and K. Ozer, The correction of post-burn contractures of the second through
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65.
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66.
Obaidullah, H. Ullah, and M. Aslam, Figure-of-8 sling for prevention of recurrent axillary
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Hospital and Healthcare Innovation Book 2009/2010 67

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Cardiovascular risk factor trends


and options for reducing future
coronary heart disease mortality in
the United States of America
ARTICLE BY SIMON CAPEWELL
Division of Public Health, University of Liverpool, England
EARL S FORD
Division of Adult and Community Health, Centers for Disease Control and Prevention, Atlanta, GA, USA
JANET B CROFT
Division for Heart Disease and Stroke Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA
JULIA A CRITCHLEY
Institute of Health and Society, Newcastle University, England
KURT J GREENLUND
Division for Heart Disease and Stroke Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA
DARWIN R LABARTHE
Division for Heart Disease and Stroke Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA

One of the objectives of the Healthy People 2010 initiative in the United States of America (USA) is achievement of a 20% reduction
in age-adjusted coronary heart disease (CHD) mortality rates. We examined the potential for changes in cardiovascular risk factors
to achieve that target using a previously validated, comprehensive CHD mortality model. This model integrates information on
trends in all the major cardiovascular risk factors, stratified by age and sex. The potential reductions in CHD mortality within the
projected population of the USA aged 25 to 84 years in 2010 (198 million) from base year 2000 were calculated for three
contrasting scenarios. In the first scenario, if age-adjusted CHD mortality rates observed in 2000 remained unchanged, some 388
470 CHD deaths would occur in 2010. Continuation of recent risk factor trends should result in approximately 19 000 fewer coronary
deaths (some 51 000 fewer deaths attributable to improvements in total cholesterol and mens blood pressure, decreased smoking
and increased physical activity, minus approximately 32 000 additional deaths attributable to adverse trends in obesity, diabetes
and womens blood pressure). In the second scenario, success in reaching all the Healthy People 2010 risk factor targets would
achieve approximately 188 000 fewer deaths. In the third, additional reductions in risk factors to the levels already seen in the lowrisk stratum could potentially prevent approximately 372 000 deaths. Achievement of the Healthy People 2010 targets could almost
halve predicted CHD deaths. Additional reductions in major risk factors could prevent or postpone substantially more CHD deaths.

oronary heart disease (CHD) accounted for over 450 000


deaths in the United States of America (USA) in 2004.1,2
The burden of CHD is enormous, affecting more than 13
million people and generating direct health-care costs exceeding
US$ 150 billion annually.1,2 Since the late 1970s, age-adjusted
CHD mortality rates have been halved in most industrialized
countries including the USA. However, between 1990 and 2000
this decrease diminished, with clear flattening in younger age
groups.1,2 Many adults in the USA still demonstrate high levels of
risk for cardiovascular disease. Total cholesterol levels exceed 200
mg/dl among more than 100 million adults, approximately 70
million have or are being treated for high blood pressure (a systolic
blood pressure 140 mmHg or diastolic blood pressure 90
mmHg) and over 50 million people still smoke.24
The Healthy People 2010 (HP2010) initiative promoted by the
government of the USA contains targets for heart disease and
stroke that explicitly address risk factor prevention, detection and
management, along with prevention of recurrent events. HP2010
objectives include a 20% reduction in age-adjusted CHD mortality

68 Hospital and Healthcare Innovation Book 2009/2010

rates (from 203 per 100 000 population in 1998 to 162 per 100
000 in 2010).3 They also include specific targets for reducing
cholesterol (to 199 mg/dl), smoking (to 12%), hypertension (to
16%), diabetes (to 6%), obesity (to 15%) and inactivity (to 20%).3
Inactivity was measured in the Behavioral Risk Factor Surveillance
System of the United States Centers for Disease Control and
Prevention as the proportion of adults engaging in no physical
activity.5 If those targets are achieved, what reduction in CHD
mortality might actually result?
Large meta-analyses and cohort studies have consistently
demonstrated substantial reductions in CHD deaths related to
decreases in each of the major cardiovascular risk factors among
individuals covered by the studies.68 However, it is difficult to
attribute a decline in the mortality rate for an entire population
either to specific risk factor changes or to more effective medical
interventions because favourable trends in both often have
occurred simultaneously.9,10 Furthermore, risk factor improvements
such as lower blood pressure or cholesterol may be achieved
through medications, lifestyle changes or a combination.1,2,810

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Innovation in clinical specialities: cardiovascular disease

Table 1: Major risk factors a in coronary heart disease mortality

Risk factor

2544

Age groups (years)


4554
5564
6574

7584

-0.036
-0.046

-0.035
-0.046

-0.032
-0.035

-0.027
-0.032

-0.021
-0.026

0.900
-1.2942

0.650
-0.8238

0.450
-0.5245

0.333
-0.3719

0.317
-0.3512

1.04
0.0363

1.03
0.0297

1.02
0.0165

Systolic blood pressure


Men (log hazard ratio per 1 mmHg)
Women (log hazard ratio per 1 mmHg)
Total cholesterol 6
Men & women: mortality reduction per 1
mmol/l (38.6 mg/dl) change in total cholesterol
Log coefficient
Body mass index (BMI) 8
Age-specific relative risks per 1 kg/m2
cMen & women: log coefficients
a

1.01
0.0132

1.01
0.0099

Used as input for the IMPACT model for the United States of America

trends in the major population


risk factors (smoking, high
systolic
blood
pressure,
Men
Women
elevated total cholesterol,
65 years
> 65 years
55 years
>55 years
obesity, diabetes and physical
Smoking
333 (280395) b
252 (215296) 449 (311647) 214 (135339)
inactivity) and from medical
b
Exercise
102 (083125)
079 (066096) 074 (049110) 075 (046122)
b
and surgical treatments given
193 (158237) 353 (249501) 259 (178378)
Diabetes
266 (204346)
to CHD patients.10,17,26 The
27
Source: INTERHEART study
model employs regression
a
Used as input for the IMPACT model for the United States of America
coefficients produced by large
b
Odds ratios for relative effect of ri sk factors with 99% confidence intervals
meta-analyses and cohort
studies.6-8 Each coefficient
A variety of CHD policy models have been developed to
quantifies the independent (log linear) relationship between the
estimate the relative contributions and hence the population
absolute change in a specific cardiovascular risk factor, such as
impact of medical and public-health interventions. Good models
high systolic blood pressure or total cholesterol, and the
are able to integrate and simultaneously consider large amounts of
consequent change in population mortality rates from CHD (Table
data on patient numbers, treatments and population risk factor
1).6-8 For each risk factor, the subsequent reduction in deaths in
911
trends. The CHD Policy Model developed in the USA was used
2010 from base year 2000 could then be estimated as the product
of three variables:
successfully to examined trends in that country between 1980 and
Number fewer deaths = number of CHD deaths observed in
19909 and later demonstrated the potential advantages of a
2000 the risk factor reduction the specific regression
population-based approach to prevention,12 consistent with
coefficient exponentiated.10,22,23
European studies.13-15
Capewell et al. have subsequently developed, refined and
applied the IMPACT model in a variety of populations.10,16-19
All the coefficients and relative risk values were obtained from
multivariate logistic regression analyses and were assumed to be
Approximately 44% of the substantial CHD mortality decline in the
independent, having been adjusted for potential confounding from
USA between 1980 and 2000 was attributable to changes in
the other major risk factors. The total deaths prevented could
major risk factors and 47% to specific cardiological treatments,10
therefore be summed. Independent regression coefficients were
similar to findings in other industrialized countries.16,17,19,20 Three
not available for smoking, diabetes and physical inactivity. An
earlier analyses suggested that further modest reductions in major
alternative methodology was therefore used, which involved
risk factors could halve CHD deaths in the United Kingdom of
population-attributable risk fractions9,21,22 calculated for the
Great Britain and Northern Ireland.15,2123 To determine whether
similar gains may be possible for the population of the USA, or
INTERHEART study, a large, international multivariate analysis that
whether they would be negated by recent dramatic rises in obesity
included data from the USA27 (Table 2).
and diabetes, we used the previously calibrated IMPACT model10
The original 19802000 IMPACT model10 was extended to 2010
using United States Census Bureau population projections and
for the USA to estimate the number of CHD deaths that could
mortality data for men and women aged 2584 years. The number
potentially be prevented or postponed in 2010, compared with the
of CHD deaths (ICD-10: I20-I25) expected in 2010 was then
number in 2000. The model was applied to three contrasting
calculated under three contrasting risk factor scenarios.
scenarios, the most optimistic of which assumed that the
prevalence of risk factors in the entire population reaches the
levels already reported in its low-risk stratum.24,25
Risk factor scenarios
The first scenario assumed that recent risk factor trends would
continue to 2010. Using data from the Third National Health and
Methods
Nutrition Examination Survey (NHANES) 19881994, NHANES
The IMPACT model aims to explain changes in CHD mortality
1999 2002, and the Behavioral Risk Factor Surveillance System
rates in a population. It quantifies the contribution from temporal
Table 2: Relative risksa of smoking, diabetes and physical inactivity for coronary heart disease mortality

Hospital and Healthcare Innovation Book 2009/2010 69

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Innovation in clinical specialities: cardiovascular disease

Table3:3.Risk
Risk
factorlevels
levelsinin2000
2000base
baseyear
yearand
andprojections
projectionsto
to 2010
2010under
underthree
three scenarios
scenarios of
of cardiovascular
change,
Table
factor
cardiovascularrisk
riskfactor
factor
change,
United
UnitedStates
Statesof
of America
America
Scenario

Smoking prevalence
(%)

NHANES III (19881994)

Total cholesterol
a
(mg/dl) (mmol/l)

Systolic blood
pressure (mmHg)

Body mass index


(kg/m2)

Diabetes
prevalence (%)

Prevalence of
physical
b
activity (%)
Men
Women

Men

Women

Men

Women

Men

Women

Men

Women

Men

Women

31.6

24.7

206 (5.32)

210 (5.42)

123.5

119.6

26.87

26.73

9.0

8.9

70.4

68.0

207 (5.35)

124.4

123.9

27.86

28.51

11.7

9.5

75.1

70.5

In 2010, assuming recent trends continue

22.6

18.7

204 (5.28)

204 (5.28)

125.3

128.5

29.18

30.16

15.2

10.1

80.8

74.1

In 2010, assuming Healthy People


targets are achieved

12.0

12.0

199 (5.15)

199 (5.15)

119.4

118.9c

25.00d

26.00d

6.0e

6.0e

80

80

176 (4.54)

179
(4.64)

115.7

114.7

25.50

23.60

0.0

0.0

100

100

In 2010, assuming all in low-risk


stratum

NHANES, National Health and Nutrition Examination Survey


a

Cholesterol conversion factor mg/dl to mmol/l = 38.67


Any leisure time activity
c
Assuming a 5 mmHg decrease from 2000
b

d
e

Assuming that obesity prevalence falls to 15%


Total diabetes (diagnosed and undiagnosed), equivalent to HP2010 target of 25 per 1000 population diagnosed cases

Table 4: Observeda and projected coronary heart disease mortality rates and deaths in the United States of America in 2000 and 2010

Population
in 2010
(thousands)
Men
2534
years
3544
years
4554
years
5564
years
6574
years
7584
years
Total
men
Women
2534
years
3544
years
4554
years
5564
years
6574
years
7584
years
Total
women
Total
men &
women
a

CHD
mortality
rates per
100 000
observed
in 2000

Annual
change in
CHD
mortality
rates
19972002
(%)

CHD
mortality
rates per
100 000
expected in
2010 if
trends
continue

21 105

3.50

- 0.52%

3.32

20 552

25.78

- 0.52%

24.43

22 064

103.52

- 2.70%

17 438

290.20

9 797

Number of
CHD
deaths in
2010 if
recent
trends
continue

Number of
CHD deaths
in 2010 if
2000 rates
unchanged

Expected
decrease in
number of
CHD deaths
in 2010
compared
with 2000

Decrease in
CHD deaths
in 2010
compared
with 2000
(%)

739

- 39

-5.2%

5 022

5 298

- 277

-5.2%

75.59

16 679

22 841

- 6 163

-27.0%

- 4.14%

170.10

29 663

50 607

- 20 944

-41.4%

705.19

- 4.03%

420.76

41 222

69 088

- 27 866

-40.3%

5 272

1736.85

3.20%

1180.98

62 265

91 573

- 29 307

-32.0%

96 229

236.00

-1.97%

161.65

240 145

-84 595

-35.2%

20 541

1.17

+2.16%

1.42

292

240

+52

+21.6%

20 568

7.63

+2.16%

9.28

1 909

1 569

+339

+21.6%

22 763

29.93

- 1.56%
- 4.15%

25.25

5 749

6 813

- 1 065
- 8 591

-15.6%
-41.5%

18 747

110.39

64.57

12 104

20 696

11 473

340.32

- 3.69%

214.61

24 621

39 044

- 14 423

-36.9%

7 578

1055.16

- 3.14%

723.60

54 838

79 964

- 25 127

-31.4%

10 1670

146.90

-1.12%

97.88

99 515

148 325

-48 815

-32.9%

19 7900

190.00

-1.5%

142.15

25 5060

388 470

-133 410

-34.3%

Source: American Heart Association 1

70 Hospital and Healthcare Innovation Book 2009/2010

700

155 550

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(19882002),3,4 linear projections were made from 19881994


through 19992002 to the countrys population in 2010 of recent
trends in total cholesterol (mg/dl), smoking (%), systolic blood
pressure (mmHg), body mass index (BMI) (kg/m2), all diabetes (%)
and any leisure-time physical activity (%), all stratified by age and
sex10,22,23 (Table 3).
The second scenario assumed risk factor levels equal to the
substantial but feasible reductions defined in the HP2010
objectives.3 In the absence of specific HP2010 targets for BMI,
total diabetes and systolic blood pressure, we assumed that: (i)
the 15% obesity target would equate to a population mean BMI of
25 kg/m2 for men and 26 kg/m2 for women; (ii) the 25 per 1000
population clinically diagnosed diabetes prevalence target would
equate to a total (diagnosed and undiagnosed) type 1 and type 2
diabetes prevalence of 6%; and (iii) the 16% hypertension
prevalence target would equate to a population mean systolic
blood pressure of 119 mmHg, representing a 5 mmHg reduction
from 2000 levels (Table 3).
In the third scenario, mean population risk factors were
assumed to reach levels already observed in the healthiest
stratum of cohorts in the USA, as defined by Stamler et al.24 and
Daviglus et al.25 Levels for specific risk factors were as follows: (i)
no smoking among men or women; (ii) 175.6 mg/dl (4.54 mmol/l)
total cholesterol for men and 179.6 mg/dl (4.64 mmol/l) for
women; (iii) a mean systolic blood pressure of 115.7 mmHg for
men and 114.7 mmHg for women, representing a 10mmHg
reduction from 2000 levels; (iv) a BMI of 25.5 kg/m2 for men and
23.6 kg/m2 for women; (v) zero prevalence of diabetes among
both men and women.24,25 Physical activity was not specifically

considered by in these studies,24,25 so we defined the level in the


lowest risk stratum as 100%, with everyone undertaking some
leisure-time physical activity. (Table 3). To preserve the focus on
risk factor changes, we assumed that the proportion of the
population receiving medical and surgical treatments for CHD
would remain constant.
Sensitivity analysis
Because of the uncertainties surrounding some of the estimates,
a multi-way sensitivity analysis was performed using the analysis
of extremes method.28 Minimum and maximum estimates of
deaths prevented or postponed were generated using minimum
and maximum plausible values for the main parameters: 95%
confidence intervals when available; otherwise, the best value
20%.10,22,23,28 The Supplementary Appendix (available at:
http://content.nejm.org/cgi/data/356/23/2388/DC1/1) provides
worked examples of the calculations used in the model plus
further details on the methods and data sources used.10

Results
Trends and estimates
Approximately 388 000 CHD deaths among people aged 2584
years would be expected in 2010 if the same age-specific death
rates recorded in 2000 (the base year) were also observed in
2010. This number would represent 15% more than the 338 000
deaths observed in 2000, reflecting population aging
compounded by an increase in population size (Table 4).
Between 1997 and 2002, the overall annual declines observed
in CHD mortality rates were 2% for men and 1% for women.

base-year
following
changes
in specificheart
risk factors
Table
5: Estimated
reduction
in coronary
disease mortality in the United States of America in 2010 compared with the 2000
base-year following changes in specific risk factors
Risk factor changes

Smoking prevalence in 2000


If recent trends continue to 2010
If HP2010 targets are achieved
If all in low-risk stratum
Total cholesterol in 2000
If recent trends continue to 2010
If HP 2010 targets are achieved
If all in low-risk stratum
Population systolic blood pressure in 2000
If recent trends continue to 2010
If HP2010 targets are achieved
If all in low-risk stratum
Body mass index (BMI) in 2000
If recent upward trends continue to 2010
If HP2010 targets are achieved
If all in low-risk stratum
Diabetes in 2000
If recent upward trends continue to 2010
If HP2010 targets are achieved
If all in low-risk stratum
Physical activity in 2000
If recent trends continue to 2010
If HP2010 targets are achieved
If all in low-risk stratum
If recent downward trends continue (smoking,
cholesterol, physical inactivity male BP)
If recent upward trends continue (female BP, obesity,
diabetes)
Net effect if recent trends continue
If HP2010 targets are achieved
If all in low-risk stratum
If only smoking, cholesterol and BP match low-risk
stratum
If only BMI, diabetes and physical activity match low-risk
stratum

Absolute values

MenBest
estimate

Fewer (additional) CHD deaths in 2010 with


a
risk factor changes

Men
27.3%
22.6%
12.0%
0%
205.0
204.2
199.0
175.6
124.4
125.3
119.4
115.7
27.86
29.18
25.00
25.50
11.7%
15.2%
6.0%
0%
75.1%
80.8%
80%
100%
n/a

Women
21.9%
18.7%
12.0%
0%
206.9
204.3
199.0
179.6
123.9
128.5
118.9
114.7
28.51
30.16
26.00
23.60
9.5%
10.1%
6.0%
0%
70.5%
74.1%
80%
100%
n/a

Best estimate

n/a
n/a
n/a
n/a
n/a
n/a

WomenBest
estimate

Minimum

Maximum

-10 000
-26 000
-60 000

-8 000
-21 000
-48 000

-12 000
-32 000
-72 000

- 7 000
- 18 000
- 42 000

-3 000
-8 000
-18000

-28 000
-40 000
-103 000

-17 000
-24 000
-70 000

-41 000
-59 000
-160 000

- 15 000
- 17 000
- 68 000

-14 000
-24 000
-35 000

(+2 000)
-48 000
-83 000

(+1 000)
-39 000
-75 000

(+4 000)
-58 000
-108 000

- 6 000
- 28 000
- 54 000

(+8 000)
-20 000
-29 000

(+8 000)
-17 000
-21 000

(+5 000)
-10 000
-12 000

(+11 000)
-24 000
-27 000

(+5 000)
- 12 000
- 10 000

(+3 000)
-5 000
-10 000

(+16 000)
-44 000
-72 000

(+5 000)
-26 000
-49 000

(+22 000)
-66 000
-100 000

(+11 000)
- 24 000
- 38 000

(+5 000)
-20 000
-34 000

-7 000
-12 000
-34 000
-51 000

-6 000
-10 000
-27 000
-29 000

-9 000
-14 000
-40 000
-57 000

- 4 000
- 6 000
- 18 000
- 32 000

-2 000
-6 000
-16 000
19 000

n/a

(+32 000)

(+10 000)

(+32 000)

(+16 000)

(+16 000)

n/a
n/a
n/a
n/a

-19 000
-188 000
-372 000
-246 000

-10 000
-129 000
-281 000
-194 000

-25 000
-252 000
-507 000
-339 000

- 16 000
-105 000
- 230 000
- 164 000

-3 000
-83 000
-142 000
-82 000

n/a

-126 000

-87 000

-167 000

- 66 000

-60 000

HP2010, Health People 2010; BP, systolic blood pressure

Hospital and Healthcare Innovation Book 2009/2010 71

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Innovation in clinical specialities: cardiovascular disease

Table
6: 6.
Reductions
in coronary
heart
disease
mortality
achievable
in in
thethe
United
States
of of
America
in 2010
compared
withwith
20002000
Table
Reductions
in coronary
heart
disease
mortality
achievable
United
States
America
in 2010
compared

Age groups(years)

2534

3544

4554

5564

6574

7584

Totals

Scenario
If recent trends continue
If HP2010 targets are achieved
If all achieved low-risk stratum values
If recent trends continue
If HP2010 targets are achieved
If all achieved low-risk stratum values
If recent trends continue
If HP2010 targets are achieved
If all achieved low-risk stratum values
If recent trends continue
If HP2010 targets are achieved
If all achieved low-risk stratum values
If recent trends continue
If HP2010 targets are achieved
If all achieved low-risk stratum values
If recent trends continue
If HP2010 targets are achieved
If all achieved low-risk stratum values
If recent trends continue
If HP2010 targets are achieved
If all achieved low-risk stratum
values

Total
(+355a)
300
2 000b
(+2 000)
4 000
12 000
(+2 000)
20 000
46 000
1 000
44 000
89 000
9 000
52 000
106 000
12 000
62 000
120 000
19 000
188 000

Men
Women
(+55)
(+305)
225
75
1 000
1 000
(+380)
(+1 000)
3 000
2 000
4 000
8 000
(+2 000)
(+115)
16 000
5 000
35 000
11 005
2 000
-1 000
27 000
16 000
31 000
57 000
10 000
(+1 000)
25 000
28 000
62 000
44 000
5 000
7 000
37 000
25 000
67 000
53 000
16 000
3 000
105 000
83 000

372 000

230 000

142 000

HP2010, Healthy People 2010


a
b

Additional deaths shown as a positive value: e.g. (+355)


Number of deaths from coronary heart disease rounded to nearest 1000 on this and subsequent rows

However, declines were minimal among men younger than 45


years of age, and increases were seen among women in that age
group. Three of the six major risk factors declined between 1988
and 2002, while obesity and diabetes increased. Systolic blood
pressure rates rose among women and fluctuated among men.
Assuming continuation of the same trends, the overall result would
be approximately 19 000 fewer deaths in 2010 than in 2000
(minimum estimate 10 000 and maximum estimate 25 000). This
represents some 51 000 fewer deaths because of improvements
in total cholesterol and mens blood pressure, less smoking and
increased physical activity, minus approximately 32 000 additional
deaths attributable to adverse trends in obesity, diabetes and
womens blood pressure (Table 5).
Approximately 188 000 fewer CHD deaths than in 2000
(minimum 129 000, maximum 252 000) could be achieved by
reaching the specific reductions in cardiovascular risk factors
called for in HP2010: (i) approximately 40 000 fewer deaths if
population mean cholesterol levels declined to 199 mg/dl (5.15
mmol/l) among both men and women; (ii) approximately 26 000
fewer deaths if the smoking prevalence fell to 12% among both
men and women; (iii) approximately 48 000 fewer deaths,
assuming a decrease in mean systolic blood pressure to 119.4
mmHg among men and 118.9 mmHg among women
(representing a 5 mmHg reduction in all age groups); (iv)
approximately 12 000 fewer deaths, assuming an increase in
physical activity rates (to 80% among both men and women); (v)
approximately 17 000 fewer deaths, assuming a substantial
decrease in BMI to 25.0 kg/m2 for men and 26.0 kg/m2 for women;
(vi) approximately 44 000 fewer deaths, assuming a substantial
decrease in total diabetes prevalence to 6% among both men and
women. If the ideal scenario were achieved, with mean population
72 Hospital and Healthcare Innovation Book 2009/2010

cardiovascular risk factors reduced substantially to levels already


observed in the healthiest stratum of cohorts,24,25 approximately
372 000 CHD deaths (minimum 281 000, maximum 507 000)
could be prevented or postponed (Figure 1). The 372 000 fewer
deaths would be distributed as follows: (i) approximately 103 000
fewer deaths if population mean cholesterol levels declined to
175.6 mg/dl (4.54 mmol/l) among men and 179.6 mg/dl (4.64
mmol/l) among women; (ii) approximately 60 000 fewer deaths if
smoking prevalence fell to zero; (iii) approximately 83 000 fewer
deaths, assuming a 10 mmHg decrease in mean systolic blood
pressure to 115.7 mmHg for men and114.7 mmHg for women; (iv)
approximately 34 000 fewer deaths if all men and women were
physically active; (v) approximately 21 000 fewer deaths, assuming
a decrease in BMI to 25.5 in men and 23.6 in women; (vi)
approximately 72 000 fewer deaths, assuming a zero prevalence
of diabetes (Table 5).
Estimated mortality benefits
Under the scenario in which current trends continued,
approximately 16 000 fewer deaths would occur among men and
3000 among women. In the two more optimistic scenarios, men
would consistently benefit more than women, gaining 54% of the
182 000 fewer deaths under the HP2010 reductions scenario and
62% of the 372 000 fewer deaths if low-risk stratum levels are
assumed (Table 5). Gains would predominantly occur among men
aged 4584 years and among women aged 6584 years (Figure
2). Of the 372 000 fewer deaths in the most optimistic scenario,
252 000 (68%) would represent premature deaths avoided, that is,
deaths among those under 75 years of age (Table 6). Extensive
sensitivity analyses examined the impact of higher and lower
values for model parameters.28 Changing the values influenced the

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rising steeply. Furthermore, population aging will increase the


numbers of CHD deaths in that country and elsewhere.30 There is
no room for complacency. Continuation of recent risk factor trends
should result in approximately 20 000 fewer coronary deaths in
2010 than in 2000. This reflects some 50 000 fewer deaths
expected from improvements in total cholesterol, smoking, physical
activity and male blood pressure, but more than half of the gain is
negated by approximately 30 000 additional deaths attributable to
Discussion
increases in rates of obesity and diabetes, plus systolic blood
Success in achieving the HP2010 targets could almost halve
pressure increases among women. Increasing treatments could
predicted CHD deaths in 2010, or indeed in 2015. Our findings are
not compensate for these worsening risk factors. In 2000, barely
reassuringly consistent with earlier studies in the England,23
40% of eligible patients received appropriate therapies.10 Even
Scotland22 and the USA12. In the United Kingdom, a modest
reduction in mean population cholesterol level from 225 mg/dl to
raising this proportion to an optimistic 50% would only postpone
200 mg/dl could reduce CHD deaths by approximately half.14,15,24 In
approximately 60 000 additional deaths in 2010.31
contrast, a rather optimistic 25% reduction in the prevalence of
Successfully achieving the specific risk factor reductions
obesity would probably prevent just 2% of CHD deaths.15,24 A
proposed in the HP2010 targets could prevent or postpone
approximately 190 000 CHD deaths. This would potentially halve
corresponding 25% reduction in the prevalence of inactivity might
the mortality burden seen in 2000. The HP2010 objectives for
prevent 1% of CHD deaths.15,29
cholesterol and physical activity remain potentially attainable.
Although CHD death rates have been falling in the USA for four
However, attaining the targets for obesity, diabetes and female
decades, they are now plateauing in young men and women.2
blood pressure appear more challenging because of the need to
Recent declines in total cholesterol have been modest, blood
actually reverse recent adverse trends.3 Successfully reducing
pressure is now rising among women and obesity and diabetes are
population risk factor levels to those already seen in
the healthiest (lowrisk) stratum could result in
approximately 370 000 fewer CHD deaths among
people aged 2584 years. This figure would represent
a 96% decrease compared to the 2000 baseline of
388 0001,3 and is somewhat larger than the 85%
reduction predicted by other studies.24,25 Although
15885
probably an overestimate, the results for this third
20 000
8105
2190
0
scenario show an aspirational ideal to highlight
-6810
-10 020
-20 000
potential future gains. However, the low-risk stratum
-12 010
-17 430
-26 270
-20 535
-40 000 -28 300
-33 670
-33 540
in the population of the USA remains frustratingly
-43 900
-48 635
-60 000
-60 135
small, even when defined only by smoking, blood
-80 000
-71 860
-82 520
pressure and cholesterol: 6% in the 1970s32 and,
-100 000
-103 080
IF
Current
trends
continue
to
2010
-120 000
even now, only 7.5% among whites and 4% among
-140 000
IF Healthy People 2010 targets
African Americans.33
-160 000
-180 000

lA
ct
iv

ab

Di

BM

ys

Ph

ete

ic a

in

ok

Sm

Sy

Ch

ol

s to

es

lic

te

ro

BP

ity

number of deaths postponed or prevented but did not alter the


relative contribution of each risk factor (Table 5, columns 5 and 6).
Thus, regardless of whether best, minimum or maximum
estimates were considered, the most substantial contributions
came from the changes in cholesterol, blood pressure and
smoking (Table 5).

IF USA Low Risk stratum

Achieving risk factor reductions

1525

355-300

-5000

-1525

75
-84

65
-74

55
-64

45
-54

35
-44

25
-34

Figure 1: Estimated reductions in coronary heart disease mortality in the United


Although fashionable, screening and treating high-risk
of America
in 2010 under
three different
scenarios
. States
2. Estimated
reductions
in coronary
heart disease
mortality in the United State individuals would necessitate medicating 15% to

2235
-1450

-4190
-12 175

-8775

-11 840

-20815

-45 000
-45 770

-43 615
-52 300
-61 790

-85 000
-88 500

-125 000

IF Current trends continue to 2010


IF Healthy People 2010 targets
IF USA Low Risk stratum

-106 295
-119 705

Figure 2: Estimated reductions in coronary heart disease mortality in the United


States of America in 2010 by age group under three different scenarios

25% of all adults.34,35 Furthermore, the key goal is not


intervention but sustained risk factor reductions.35 The
whole population approach described by Rose13
appears both more effective and cost-effective.1315
Similar conclusions have been reported previously in
Dutch, Finnish and American cohorts.12,35
Lowering cholesterol should therefore remain a
priority in the USA, as it offers a potentially powerful
1% mortality reduction for every 1 mg/dl decrease in
total cholesterol.6 Large cholesterol declines have
already been achieved by comprehensive national
policies elsewhere (-20% in Finland18 and -15% in
Mauritius36). In contrast, in the USA between 1988
and 2004 total cholesterol fell barely 3% in adults
(from 206 to 201 mg/dl).37 Furthermore, these levels
remain well above the optimal, prompting recent
national dietary policies to further reduce total
cholesterol levels.2,3,38
Hospital and Healthcare Innovation Book 2009/2010 73

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Smoking prevalence remains above 20% overall in the USA and


is even higher in certain groups. This represents substantial room
for improvement. Success in reducing tobacco use requires two
comprehensive strategies: preventing young people from starting
to smoke, and promoting cessation among smokers.39 Examples
of successful efforts include intensive antismoking programmes in
California (USA);40 advertising bans in Finland, Iceland and Norway;
and smoke-free environments legislation in Ireland, Italy, Scotland
and New York City in the USA.41 It is encouraging that many more
states in the USA are now passing laws requiring smoke-free
environments.41 The recent blood pressure trends in women are
alarming. This is a powerful risk factor; every 1 mmHg reduction in
systolic blood pressure could prevent approximately 10 000 CHD
deaths each year in the population of the USA.7 Furthermore,
population blood pressure has been decreasing in most
industrialized countries in recent decades, reflecting dietary trends
rather than use of medications.4244 The American Public Health
Association has called on industry to reduce the salt content of
processed food over the next decade, which could contribute to
meeting the dietary guidelines for daily sodium intake of less than
2300 mg.44,45
Our analysis suggested that the current adverse trends in the
USA increases in obesity and diabetes rates and blood pressure
in women will probably cause approximately 30 000 additional
CHD deaths in 2010. Obese individuals with pre-diabetes can
benefit from a combination of diet, exercise advice and
behavioural therapy,46 but prevention is preferable. Yet todays
obesogenic environment is reinforced by powerful commercial,
political, economic and social factors,47 and thus reversing these
trends will require substantial efforts and appears daunting.2,3,32
Recent increases in physical activity in the USA are encouraging,
echoing trends in Canada, Finland and elsewhere.5,18,48 Although
engaging in adequate physical activity confers many health
benefits, our analyses found that the potential reductions in CHD
mortality appeared modest in the USA, as elsewhere.15,23
Interventions promoting activity among individuals seldom show
long-term sustainability.48 However, physical activity in populations
may be increased by 4% to 9% through multiple interventions.23,49

The IMPACT model


Our current analyses used the validated IMPACT model for the
USA.10 Recent high-quality data from NHANES and other large
national studies reflected many events in a very large population.
The model is comprehensive and transparent; it uses recent,
reliable and reasonably precise age-specific regression coefficients
from substantial meta-analyses6,7 and relative risk values obtained
from the large INTERHEART study.27 Every key assumption is
addressed and justified in the Supplementary Appendix (available
at: http://content.nejm.org/cgi/data/356/23/2388/DC1/1). All
models are simplifications of reality, with clear limitations. First, this
model considered only mortality, not morbidity. However, our
estimates of fewer deaths can easily be translated into a 12-fold
increase in life-years gained.50 Second, the model only explained
91% of the mortality decrease, leaving 9% unexplained. Third,
several assumptions were necessary, for instance, that any delay
in mortality reduction (lag time) would be relatively unimportant
over a 10-year scenario.10,17,23
However, extending the projections from 20002010 to
20002015 would generate very similar results. Although all
74 Hospital and Healthcare Innovation Book 2009/2010

coefficients were independent, coming from multivariate logistic


regression analyses,6,7,27 some may not have been fully adjusted
and thus residual confounding may remain, along with some
imprecision.10 Furthermore, the population-attributable risk
approach may have slightly overestimated the contributions of
diabetes, smoking and physical activity. Some net overestimation
of benefits is thus possible, particularly for the ideal scenario.
Conversely, underestimation was also possible because the model
assumed similar change across the population.
Larger reductions among older, more motivated individuals with
higher mortality rates might generate greater benefits. Model
development and comparisons with other models may be useful,
along with consideration of novel risk factors, such as high levels
of C-reactive protein.2,3,51 It may also be useful for future studies to
address economic and ethnic analyses and seek to validate the
model using 2010 data when it becomes available. However, our
rigorous sensitivity analyses were reassuring and suggested that
the key findings are unlikely to change substantially.10,17,23 Moreover,
even crude estimates are potentially valuable for planners and
policy-makers. In conclusion, implementing evidence-based
policies to better control tobacco use and achieve healthier diets
could potentially halve future CHD deaths in the United States of
America. J
Acknowledgements
We thank Wayne H Giles, Umed A Ajani and Thomas E Kottke for
helpful comments on the original model. Funding: This study was
supported by investigator salaries only Higher Education Funding
Council for England (SC, JAC) and United States Centers for
Disease Control and Prevention (ESF, JBC, KJG, DRL). Competing
interests: None declared.
Originally published in Bulletin of the World Health Organization;
Article DOI: 10.2471/BLT.08.057885
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World Health Organization; Type: Policy and Practice Article DOI: 10.2471/BLT.08.057885
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The breast service psychosocial


model of care project
ARTICLE BY LAUREN K WILLIAMS PhD
Research Fellow, Clinical Research Department, Melbourne IVF and The Royal Womens Hospital, East Melbourne, Victoria, Australia
G BRUCE MANN MB BS, PhD, FRACS
Professor, University of Melbourne, and Director of The Breast Service, Royal Melbourne Hospital and Royal Womens Hospital,
Parkville, Victoria, Australia

Objective: It has been consistently demonstrated that many women with breast disease will experience psychosocial
distress at some stage along the patient journey. Psychosocial care has recently gained more prominence and is
increasingly recognised as an important aspect of care offered to patients with breast cancer. The purpose of this project
was to develop a model that improved the way psychosocial services were provided to patients. The aim of this paper is to
describe the process in developing this psychosocial model of care for patients with breast disease.
Methods: Using in-depth semi-structured interviews with a sample of patients and staff, we examined psychosocial
concerns experienced by breast patients and the factors associated with the effective assessment and delivery of
psychosocial care. The project was approved by the Royal Womens hospital ethics secretariat as a quality assurance
project.
Results: An inductive analysis of staff responses indicated that a standardised screening and referral pathway was needed
in a context of well defined staff roles and a multidisciplinary team environment. An inductive analysis of patient responses
indicated that psychosocial concerns were common, but varied, and a tailored approach to the provision of psychosocial
care was warranted.
Discussion: In line with these findings, a standardised assessment and referral pathway was developed for The Breast
Service that may be extended for use in other clinical settings and tumour streams.

ver 12 000 women are diagnosed with breast cancer in


Australia each year.1 Unsurprisingly, psychosocial distress
plays a significant role in the journey experienced by
women diagnosed with this disease. Many of the common
psychosocial concerns of women with breast cancer include body
image disruption, sexual dysfunction, treatment-related anxieties,
depression, marital/partner communication and relationship
difficulties, and existential concerns regarding mortality.2-4 Although
many women will encounter and manage some degree of
psychosocial distress following diagnosis, it is estimated that as
many as 30% of women will experience episodes of persistent
psychosocial distress that will interfere with their ability to cope
with cancer treatment and life in general.2,4
Psychosocial interventions such as support from a nurse/breast
care nurse, exercise, telephone counselling, computer/online
support, psychological and psychiatric care and social supports
have all been found to improve the psychosocial status of women
diagnosed with breast cancer.5-7 As a result, the clinical practice
guidelines from the National Health and Medical Research Council

76 Hospital and Healthcare Innovation Book 2009/2010

of Australia for the psychosocial care of adults with cancer3


highlight the need for further research regarding strategies to
improve the detection of psychological difficulties in people with
cancer and optimal methods for psychosocial referral and
practice strategies to improve uptake. Enhanced knowledge
about the best way to detect and respond to patients
psychosocial needs is vital in empowering and equipping health
professionals with the necessary skills and resources to help
patients with the range of psychosocial issues that arise along the
breast cancer treatment continuum.

Setting
Recently, the Royal Womens Hospital and Royal Melbourne
Hospital breast services merged to form The Breast Service in an
attempt to connect existing resources and provide a more
comprehensive breast cancer service. Strategies to detect and
respond to patients psychosocial needs were identified as a key
priority area for The Breast Service. Before the merging of
services, psychosocial care coordination differed between sites

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Box 1: Issues with the psychological screening tool identified by staff and patients

Issues identified by The Breast Service staff


Staff not accessing the completed supportive care tool (SCT) in patients medical file
More specialised tools needed for specific areas of concern
Not specific to breast cancer/some questions not relevant
Only used once. Supplement testing/brief version needed at different stages of the disease
Some questions not included to screen for identified psychosocial concern (eg, body image)
Absence of criteria for referral (eg, if patient answers yes to certain questions what is the process for referral? Criteria needed to
facilitate consistency between clinicians)
Questions regarding patient strengths to use for possible referral/support
Section needed for patient comments
Dichotomous responses (eg, yes/no) create limitations
Area needed to record referral details/outcome. Possibly useful to combine details from referral form to SCT. Expansion of referral
options
Unclear psychometric validity
Does not assess all risk factors
Issues identified by The Breast Service patients
Include questions that ask women whether they wanted to be linked in with a group
Tailor SCT to patients individual situation given that some questions are not relevant
Administer the SCT later given that concerns are greater after surgery (it is generally administered at preadmission clinic [PAC])
Administer the SCT twice, rather than once at PAC. Some experience concerns at later stages than before surgery and others
dont recognise their issues until later stages of the disease
Include body image questions

and was largely managed by the breast care nurses. Previous


research has highlighted that a range of health professionals is
optimal in assessing and managing the psychosocial needs of
women diagnosed with breast cancer and to support breast care
nurses who, in some cases, are not trained in making
psychosocial assessments and referrals for patients. Furthermore,
before the merging of services, the screening tool used to detect
psychosocial concerns (entitled supportive care tool [SCT]) was an
amalgamation of items from instruments utilised in other health
care settings. Before the development of the current project, the
SCT had not been evaluated since it was implemented into The
Breast Service. A psychosocial working group and steering
committee was developed to address challenges and
opportunities arising from the merging of the two services, and
involved clinicians from the departments of psychology, psychiatry,
medicine, nursing, social work, pastoral care, womens services
and music therapy. A consumer representative was included and
a project worker appointed to coordinate and execute the project
objectives.

Objectives
The aim of the psychosocial model of care project was to develop
a standardised way of screening for psychosocial distress and
referring patients to the most appropriate clinician(s) and supports.
The first objective of the project was to provide a reflection of the
strengths and weaknesses of the current model of psychosocial
care from relevant clinicians and to generate ideas on the most
effective way to merge and coordinate existing services. The
second objective was to provide a reflection from consumers
regarding their psychosocial needs, the level of psychosocial
support they received and their perceptions and opinions on the
structure and delivery of the current psychosocial model of care

from The Breast Service.

Consultation with health professionals


Methods
A total of nineteen staff members who had (or wanted to have) a
role in the screening, assessment and treatment of patients were
interviewed by the project worker. Staff were recruited from social
work, pastoral care, psychology, psychiatry, medicine, nursing and
community support services (eg, BreaCan). A semi-structured
interview guide was developed which focussed on (a) the method
for screening and referring patients, (b) the role of different staff in
providing psychosocial care, and (c) issues, barriers or concerns
with the provision of psychosocial care. Data were analysed
qualitatively using inductive thematic analysis. The project was
approved by the Royal Womens hospital ethics secretariat as a
quality assurance project.
Results
It was found that the existing method of screening for
psychosocial needs of patients with breast cancer relied heavily on
the breast care nurses. Completion of a screening tool by patients
at the time of initial diagnosis and surgical treatment was viewed
as beneficial for identifying and recording psychosocial concerns,
however the screening process relied on breast care nurses to
administer the tool, evaluate the results and generate referrals at
their discretion. In addition, The Breast Service staff identified
several issues with the SCT (Box 1). Although the role of breast
care nurses in screening psychosocial needs was viewed by most
as valuable, it was commonly agreed that psychosocial
assessment from additional health professionals would enhance
the validity of the screening procedure. In addition, it was
suggested that periodic rescreening was required to identify those
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with particular psychosocial needs that emerge subsequent to


initial diagnosis and surgery.

Consultations with patients attending The Breast Service


The second step of the project was to consult patients about their
psychosocial concerns and supports they received from The
Breast Service staff.
Methods
A total of thirteen women diagnosed with breast cancer attending
The Breast Service participated in either a focus group or
individual interview. The age of participants ranged from 33 to 87
years and four women were from non-English speaking
backgrounds. A semi-structured interview guide which contained
open-ended questions that assessed patients psychosocial
concerns and their experience with The Breast Service
(psychosocial screening and referral procedures) was developed.
Patients were recruited from a list of all patients that had
attended/were attending The Breast Service for the last 6 months.
Interviews were conducted at The Royal Womens Hospital in a
private room and were later transcribed to facilitate coding and
analysis. Data were analysed qualitatively using inductive thematic
analysis.
Results
The most commonly reported psychological concerns were
anxiety and depression. Anxiety was reportedly heightened at
diagnosis, between appointments while waiting for results, before
chemotherapy and in social situations for those with visual signs of
cancer, such as hair loss. Patients reported feeling depressed
during treatment, particularly those patients having chemotherapy.
Other reported psychosocial concerns included body image
concerns, relationship issues with their partners, family and
friends, and concerns with mortality, survival and recurrence. Eight
of 13 women interviewed (61.5%) had completed the screening
tool, with most reporting no issues or distress in answering the
questions. Specific comments are shown in Box 1. Psychosocial
support accessed by patients varied. Some women reported
accessing counsellors, psychologists and social workers. These
services were offered through The Royal Melbourne Hospital or
privately. Other women reported that they felt comfortable
knowing that these supports were available, however were not
ready or did not feel they would be able to assist them with their
concerns. These women relied on community, family, peer and
individual supports. Some women felt uneasy or awkward about
attending group settings with strangers and would prefer
alternative supports such as email, telephone or a casual
unstructured group setting. These results suggest the individuality
of womens support needs and the need for a wide range or
services that can address different concerns at different stages of
the disease.

The Breast Service Model of psychosocial care


Based on the outcomes of this project, a revised model for the
assessment and delivery of psychosocial care was developed and
is currently being implemented. As highlighted in Box 2, and
consistent with the previous pathway, at the first suitable visit
(preferably soon after diagnosis), the breast care nurse uses a
screening tool to identify patients who are potentially in need of
78 Hospital and Healthcare Innovation Book 2009/2010

more extensive assessment and intervention. The new screening


tool combines a risk factor checklist,i a distress thermometer
(010 ranking of distress) and a yes/no checklist of
items/concerns; which differs from the original screening tool that
relied solely on the latter. The patient is then discussed at a newly
developed multidisciplinary psychosocial team meeting where a
referral is made if appropriate. Review of patients and subsequent
referrals also occurs in this forum. Given that some patients
reported experiencing psychological concerns such as anxiety
and depression and body image issues, referral options were
extended to include a clinical psychologist, psychiatrist and a
sexual counsellor. A music therapist is also available to assist
patients.
Unlike previously, where the screening tool was only
administered once at initial presentation, the distress thermometer
and checklist is administered again during and after definitive
treatment. Re-presentation of the same patient occurs if significant
distress or psychosocial need subsequently appears. Accurate
execution of the revised pathway is overseen by the director of
The Breast Service and staff attending the multidisciplinary
meeting. Furthermore, patient results (completed screening tool,
referrals forms, and related progress notes) are now inserted into
the patients medical file to ensure accessibility by all relevant
health professionals.

Limitations and discussion


One of the main challenges of this project was to build a team of
clinicians with adequate time and resources committed to
assisting with the project. The development of a working group,
steering committee and mutually agreed project plan was the
fundamental key to initiating this process. Staff provided the
project worker with background information, details of current
psychosocial practice and feasibility of new ideas. Another
challenge was delegating and executing tasks, both in the
development and implementation stages of the project.
Clarification was particularly needed around who is doing what
and how. These decisions are best made in the working group
meetings, using existing staff and therefore reducing the need for
additional resources. Furthermore, it proved pivotal to the
cohesion and sustainability of the working/steering group that after
each fundamental stage of the project (eg, focus groups) the
execution of the findings was communicated to all relevant staff in
an interactive forum (eg, email reports, meetings, in-services or
workshops).

Conclusion
In summary, the psychosocial model of care project has
transformed the way psychosocial care is provided to patients
attending The Breast Service. We have implemented a
standardised screening, assessment and referral process and a
multidisciplinary team to provide a service of psychosocial care to
all patients. Decisions about assessment, referrals and treatment
no longer rely solely on the breast care nurse. Instead,
collaborative recommendations are made for the patient in a forum

National Breast and Ovarian Cancer Centre and National Health and Medical
Research Council guidelines for the psychosocial care of patients with cancer
recommends assessing these risk factors to alert practitioners about certain subgroups of potentially at-risk patients.

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Box 2: The Breast Service Psychosocial model of care

Step 1 First suitable visit


Identify high risk factors.
(The revised assessment tool will
allow breast care nurses
[BCNs] to document patient
risk factors

Risk factor check-list


Is/has the patient:
Younger
Single, separated, divorced, widowed
Living alone
Children younger than 21 years
Experiencing economic adversity
A real or perceived lack of social support
Poor marital or family functioning
Had a history of psychiatric problems
Had stressful life events
Had a history of alcohol and/or substance abuse
Been diagnosed with cancer
In the advanced stages of the disease
Received a poor prognosis
Having/had treatment side effects greater than most
Experiencing lymphoedema
Experiencing chronic pain and/or having difficulties managing pain
Significantly fatigued

Step 2 Assess level of distress

Does the patient appear or is the patient highly distressed/anxious?


BCNs to distribute distress thermometer whereby patients will rank their
perceived level of distress from 0 (no distress) to 10 (extreme distress)

Step 3 Assess specific psychosocial


concerns

BCNs will distribute psychosocial checklist to patients where they can


indicate (yes/no) whether they have experienced psychosocial distress
on a range of dimensions (eg, depression, anxiety, body image, sexual health etc)

Step 4 Psychosocial Assessment/


interview with BCN. BCN requires
expands on relevant areas
identified by patient in the
screening process (distress
thermometer and checklist)
and records outcome on the
screening forms.

Patient is not
considered high risk
and is not distressed

Patient is
considered high
risk and is
distressed and
requires action
(not immediate)

Patient is considered high risk


and is distressed
urgent/immediate action

Patient completes the


distress thermometer
and checklist at next
visit or as appropriate

A referral is made
and the patient is
discussed at the
next Psychosocial
Multidisciplinary
meeting (PMDM)

Clinician pages mental health


service, social work or pastoral
care for urgent referral. A
referral is made using the
referral form and the patient is
discussed at the next PMDM

Step 5 PMDM

Step 6 Psychosocial screening may


be conducted at:
1. Notification of diagnosis
2. Post-surgery check-up
3. During chemotherapy
4. At the end of treatment
5. 12-month follow-up

Discuss patients risk factors, assessment of distress, BCN evaluation


and checklist responses. Multidisciplinary referrals are made where
applicable, referral outcomes are discussed

Go to step 2

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that can ensure adequate follow-up and execution of accurate and


targeted referrals. An evaluation of the revised process is planned.
It is envisaged that these findings could assist researchers and
clinicians with the process of developing a psychosocial
assessment and referral pathway. The psychosocial model of care
can also be adapted and utilised in other clinical settings where
psychosocial distress and morbidity is likely. The psychosocial
model of care is already being implemented in the gynaecological
service and ward nurses are being trained in administering the
screening tool. As the results from this quality assurance project
suggest, strategies for detecting and responding to the
psychosocial needs of patients is a vital and achievable
component to the provision of health care. J
Acknowledgements
This project was generously funded by Western and Central
Melbourne Integrated Cancer Service (WCMICS). The Breast
Service staff would like to thank the WCMICS for its support in
enabling the improvement of the quality of psychosocial care for
women with breast cancer. The psychosocial model of care project
team would also like to thank staff from the Royal Womens Hospital
and The Royal Melbourne Hospital who participated in the health
professionals consultation phase and women attending The
Breast Service who generously donated their time and thoughts in
the focus groups and interviews.
Competing interests
The authors declare that they have no competing interests.
Article originally appeared in Australian Health Review
(http://www.aushealthreview.com.au) and is reproduced with
permission from the Australian Healthcare Association
(www.aushealthcare.com.au)

80 Hospital and Healthcare Innovation Book 2009/2010

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brief]. Washington, DC: National Academies Press, 2004: 1-8.
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National Breast Cancer Centre and National Cancer Control Initiative. Clinical practice
guidelines for the psychosocial care of adults with cancer. Sydney: National Breast Cancer
Centre, 2003.
4.
Schou I, Ekeberg O, Sandvik L, et al. Multiple predictors of health-related quality of life in
early stage breast cancer. Data from a year follow-up study compared with the general
population. Qual Life Res 2005; 14: 1813-23.
5.
Badger T, Segrin C, Dorros SM, et al. Depression and anxiety in women with breast cancer
and their partners. Nurs Res 2007; 56: 44-53.
6.
McArdle JMC, George WD, McArdle CS, et al. Psychological support for patients undergoing
breast cancer surgery: a randomised study. BMJ 1996; 312: 813-6.
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Shaw BR, McTavish F, Hawkins R, et al. Experiences of women with breast cancer:
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Supporting cancer control for


indigenous Australians:
initiatives and challenges for
Cancer Councils
ARTICLE BY SHAOULI SHAHID MA, MSS PHD
Student
KERRI R BECKMANN MPH, BSC
Senior Research Scientist Research and Information Science, The Cancer Council South Australia
AND SANDRA C THOMPSON PHD, FAFPHM, MPH
Associate Professor Centre for International Health, Curtin University of Technology, Perth, WA

As in other developed countries, the Australian population is ageing, and cancer rates increase with age. Despite their
substantially lower life expectancy, Indigenous Australians are also experiencing concerning cancer statistics, characterised by
increasing rates, later diagnosis, higher mortality, and lower participation in screening than the non-Indigenous population.
Eighteen months after the first national Indigenous Cancer Control Forum, this environmental scan within the statebased Cancer
Councils was undertaken to map activities in service provision in Indigenous cancer control with a view to sharing the lessons
learned. The findings show that although most of the organizations had tried to work with Indigenous communities on cancer
issues, there have been difficulties in building and sustaining relationships with Indigenous organizations. Lack of having
Indigenous staff internally, few Indigenous-specific resources, and few planned, long-term commitments were some of the
major impediments. Some of these limitations can easily be overcome by building and improving regional or local partnerships,
providing cultural awareness training to internal staff, and by building the capacity of Indigenous organizations. Health
promotion projects of the Cancer Councils directed at Indigenous people could be more effectively implemented with such
considerations.
What is known about the topic? For many years cancer was not considered a high priority issue for Indigenous Australians as a
consequence of social and other health issues. Cancer incidence and death rates of Indigenous Australians have been unclear
as there has been limited epidemiological information and misclassification of Indigenous status. It is now evident that the
pattern of cancer differs for Indigenous Australians, and Indigenous people tend to be diagnosed later, have poorer
participation in treatment and a higher mortality rate for any equivalent stage of diagnosis.
What does this paper add? This paper presents a snapshot of the staffing, projects, programmes and activities of the state
Cancer Councils in early 2006 in terms of efforts to progress cancer control issues focussing on Indigenous Australians. Most
successful initiatives began by establishing a relationship and working over the longer term to sustain programme activity.
What are the implications for practitioners? Insights from the analysis of progress in the cancer field are relevant and
applicable to practitioners in other areas of health where mainstream services have a role to improve the health of Indigenous
communities.

he number of recorded cancer deaths in Australia continues


to increase, attributed in part to the increase in cancer
incidence that occurs in an ageing and an expanding
population.1,2 Until recently, cancer was seldom identified as a
priority health issue for Aboriginal and Torres Strait Islander
(hereafter Indigenous) Australians.i, 3 The immediate health and
welfare problems of Indigenous Australians across the lifecourse
are well documented,4-6 and these may have distracted attention
from the fact that cancer has become one of the major causes of

death for these people. Interest about cancer among Indigenous


populations may also be affected by their lower incidence of many
cancers and their shorter life expectancy. Moreover, cancer rates
in Indigenous Australians may under-represent the real burden
because of misclassification and under-ascertainment of
Indigenous status.7-9
Australia has two groups of Indigenous populations: Aboriginal, and Torres Strait
Islanders. In this paper, we will use the term Indigenous to refer to both Aboriginal
and Torres Strait Islander peoples.
i

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Nevertheless, available data show that Indigenous Australians


are experiencing an increasing rate for some cancers.3 For almost
all cancers, they experience later diagnosis, lower 5-year survival
and a higher mortality rate than non-Indigenous Australians.10
Indigenous women have lower participation in mammography and
Pap smear screening than non-Indigenous women.11,12 It has also
been reported that the overall response rate was significantly
lower for Indigenous people than the general population in the
Bowel Cancer Screening Pilot Program that ran between
November 2002 and June 2004 at three sites in Australia.13
Moreover, while the last two decades have seen a 30% reduction
in cancer mortality rates in Australia, there has been little impact
upon Indigenous cancer mortality.14 The need to prioritise cancer
prevention and control was recognised in the National Indigenous
and Torres Strait Islander Health Strategy 2001, where cancer was
documented as one of three major chronic diseases for
Indigenous Australians.15
The first national forum to discuss Indigenous cancer issues,
held in Darwin in August 2004, highlighted various gaps that exist
around responding appropriately to these issues. Many strategies
were proposed to improve their poorer cancer outcomes.
Increased government funding, boosting research on cancer
among Indigenous Australians by enhancing their ownership over
the data, and involving them in partnership with non-Indigenous
health professionals to ensure appropriate service design and
delivery mechanisms were a few of the significant
recommendations. At the conclusion of the forum, the peak nongovernment organizations providing advocacy for prevention and
care for cancer in Australia.
The Cancer Council Australia and its statebased affiliates,
committed to factoring Indigenous issues into their policy
development and advocacy for cancer prevention and care.14 This
paper summarises the findings of an environmental scan of current
and past programmes and practice in Indigenous cancer control
by state and territory member organizations of The Cancer Council
Australia. It was primarily undertaken to inform the deliberations of
The Cancer Council Western Australia (TCCWA) on its potential
role and contribution in improving cancer-related services for
Indigenous people in WA. Environmental scanning is a method
most commonly used in business but is quite popular in the health
care sector around the world,16-18 and is used to identify emerging
issues within the broader economic and political environment.19 It
is similar to situation analysis in which a review is undertaken of
health strategies and policies, institutional support systems,
programmes and interventions with the aim of strengthening
health reform and health systems. It differs from audits which
generally evaluate performance and are aimed at ascertaining the
validity and reliability of information as part of quality control
processes. Morrison argues that environmental scanning is a
method that enables decision makers both to understand the
external environment and the interconnections of its various
sectors and to translate this understanding into an institutions
planning and decision-making processes.20 The advantage of
environmental scanning for organisational leaders is that knowing
both the internal and external environment in which the
organisation operates is helpful in planning their future course of
action.21
The scan was undertaken to identify various Indigenous-specific
programmes and experiences of the Cancer Councils of Australia
82 Hospital and Healthcare Innovation Book 2009/2010

1215 months following the Darwin forum. This paper highlights


the key issues, learning, successes and limitations of related
initiatives that have been undertaken by the state Cancer
Councils.

Methods
Environmental scanning was agreed to be a suitable method for
learning about how a range of organizations across the sector had
approached supporting Indigenous cancer control approaches
and gathering information about successful initiatives and efforts
that had been less productive, and this approach was accepted
by a Steering Committee and approved by the Curtin Health
Research Ethics Committee.
An initial approach letter was mailed to the Chief Executive
Officers/Directors (CEOs) of all the Cancer Councils, outlining the
background to the survey. They were also requested to nominate
appropriate staff members who could be interviewed about their
organizations past or present initiatives to improve Indigenous
engagement with cancer issues and to pass the background
information about the study on to those they nominated. When the
individuals were contacted and nominated others, these additional
nominees were also interviewed if available and willing. A copy of
the letter sent to their CEO was provided to the participants
beforehand.
Semi-structured interviews, either face-to-face or by telephone,
were undertaken with the key nominated staff (Indigenous and
non-Indigenous). The interview was based upon a theme list
developed following a review of relevant literature and discussion
within the research team. The list was also discussed with
Indigenous colleagues and forwarded to a Steering Committee
established to oversee the project of which this scan was a
component. Key areas focusing on Indigenous Australians that
were considered during the interviews, included: cancer
prevention and education; cancer support services for Indigenous
health organizations; healthcare delivery (workforce/access to
healthcare services); research; advocacy/policy and human
resources and any cross-organisational initiatives. Interviews were
taped with the permission of participants, and the responses were
coded following the key themes of the interview schedule.
Thematic analysis was undertaken manually, in which the efforts
and experiences of each Cancer Council were recorded against
the major service areas.
Staff from The Cancer Councils of the Australian Capital
Territory, Tasmania, Victoria, New South Wales and the Cancer
Foundation of Queensland participated in telephone interviews.
Information was collected from staff at the Cancer Councils of
Western Australia and South Australia through face-to-face
interviews. Before submission of this article for publication, it was
circulated to the CEOs of all participating Cancer Councils, giving
them the opportunity to make additions or corrections, and
appropriately represent their organisation, and suggested
amendments were incorporated.

Findings from the scan


Most interviewees indicated that their organisation had tried to
work with Indigenous communities on cancer-related issues.
Working in partnership with Indigenous organizations was seen as
important, and perhaps more effective than establishing
Indigenous-specific positions within the organisation. However, a

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Jurisdiction

Organisational
Indigenous person employed
Position with specific Indigenous
focus
Cultural awareness training
Specific Indigenous action plan

Indigenous person on board


Indigenous representation on
working parties
Links with ACCHOs
Specific programs
Cancer awareness/health
promotion at Indigenous events
Tobacco control
Cervical screening
Breast cancer awareness
Aboriginal health worker training
Cancer support and care
Speakers
Indigenous-focussed resources
Data on Indigenous cancer
statistics

ACT

NSW

Qld

SA

Tas

Vic

WA

No

Not
current

No

No

No

Yes

No

No

No

No

Yes (0.2 FTE)*

No

Yes

No

No
No

Yes
No

Yes
Recent

No
No

No
No

Voluntary
Tobacco
Cervical
screening

No
No

No

No

No

No

No

No

No

No
Strong

Yes
No
Beginning No

No
Yes

No
No

Yes
Yes

No
Ad hoc

Yes

Yes

Yes

Yes No Yes Yes

Yes
Limited

Yes
Yes

Sustained
Funds
VAHS +

Yes

Sustained Yes

Yes
No
Limited
No

Limited
Yes

Ad hoc
Yes
Yes
For women
Yes
Yes
Limited
Beginning Yes

Ad hoc
Yes

Limited Yes
No
Yes

No
Beginning
Yes

* A non-Indigenous person spends 1 day a week on Indigenous cancer issue. ACCHOs =Aboriginal controlled community health
organisations.
Figure 1: Summary of progress in organisational and programme initiatives for indigenous cancer control by participating jurisdictional
Cancer Councils, March 2006

number of respondents noted the difficulty of building and


sustaining relationships with Indigenous health agencies because
they were under-resourced to respond and cancer is not
prioritised among many competing social and health issues. Key
findings related to Indigenous cancer control are summarised in
the Box. Further details are reported according to core functional
areas.
Education and training
Capacity building within the Indigenous health sector was
identified as a priority area, in which respondents believed Cancer
Councils could play an important supportive and advocacy role.
Some success was reported in running training programmes with
Aboriginal Health Workers (AHWs). The most promising example
was initiated by The Queensland Cancer Fund (QCF). Based upon
the priorities identified through consulting Indigenous groups and
other key stakeholders, a cancer care course was developed for
AHWs with assistance from an Indigenous advisory panel in
developing the course content. The five-day programme
introduced various aspects of cancer treatment and care, and

provided site visits to various cancer support services. Overall, it


was felt the course provided a good overview for the AHWs on the
rationale and practical aspects of cancer treatment and insight into
what patients go through during treatment. Scholarships were
provided to 14 health workers from across Queensland to attend
the first course, and this helped with the development of networks
between AHWs and cancer service providers. Indigenous
participants were generally identified through the regional officers
of the QCF and contact with Indigenous communities. The
desirability of oneto- one follow-up and support after training,
utilising regional officers, was emphasised. The QCF has also
trialled a less intensive version of education, for example, by
adapting a mainstream 2- day training programme for community
speakers around prevention and awareness of cancer for delivery
to AHWs in northern Queensland. A small number of volunteer
Indigenous speakers were trained through this programme to
increase cancer awareness in their local communities. Cancer
Councils in some other jurisdictions have also tried to arrange
training programmes with AHWs, although some reported
receiving a low level of interest from the stakeholders. TCCWA
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regularly contributes to teaching around cancer within


metropolitan-based AHW training. Others, in partnership with
Indigenous Community Controlled Health Organizations in their
areas, have begun planning to incorporate cancer awareness
into AHW training, but not all discussions have yet resulted in
established commitment. The Cancer Council Victoria (TCCV)
has, since 2001, been delivering training on cancer, screening
and cervical cancer to AHWs undertaking the Certificate 4 in
Womens and Babies health which is delivered by the Victorian
Aboriginal Community Controlled Health Organisation. The
Cancer Council New South Wales (TCCNSW) had organised
one-day training workshops for AHWs covering basic
information about cancer biology, prevention, early detection,
treatment and end of life which were jointly delivered by two
Aboriginal consultants. However, the workshops have not been
systematically and regularly conducted. The organisation now
proposed to develop a more sustainable, organised programme
with regional Aboriginal Health Services (AHSs) interested in this
approach. Implementation may occur by extending the 1-day
training workshop to 2 days, and shifting the focus to include
more practical issues related to cancer care. Lack of availability
of Indigenous-specific resources was mentioned as a barrier to
education about cancer. TCCV has supported development of
many Indigenous-friendly resources addressing smoking
cessation and cervical screening. Respondents were also aware
of resources in the process of development by other
organizations such as The Centre for Excellence in Indigenous
Tobacco Control, and felt that specific resources would be
helpful in address Indigenous needs. It was considered
important to develop educational and outreach materials that
included artwork, pictures, role models and/or stories resonating
culturally with the programmes target population. It was also
stressed that any resources produced must be appropriately
used, because in some instances, good resources remain underutilised as a result of inadequate promotion, poor distribution or
inadequate staff training in their appropriate use. Although there
was recognition that resources designed in another jurisdiction
were not always suitable and relevant elsewhere, some
respondents noted a lack of capacity within their organizations in
adapting these or developing new resources.

Education of cancer staff about indigenous people


Training and capacity building are not only necessary for AHWs
and community members. Respondents acknowledged the need
for awareness of Indigenous culture, cultural differences and
beliefs to be taught and understood among the mainstream health
service providers. The QCF runs cultural awareness training for
staff twice a year, with training provided by the Department of
Health and delivered by an Indigenous person. The TCCNSW has
been running 2-day workshops on Indigenous culture for about 5
years, and it is mandatory for all staff. TCCV have organised
cultural awareness training in 2001 and 2005, and they now plan
to deliver it annually.
Cancer prevention education
The focus within cancer prevention was strongest in the area of
tobacco control, and primarily focussed on education and support
initiatives. For instance, TCCWA provides support and advice to
Say No To Smokes, the only Aboriginaltargeted tobacco control
84 Hospital and Healthcare Innovation Book 2009/2010

project in WA. Working in collaboration with the Say No To


Smokes team, the partners have now submitted a joint funding
proposal for another project, the brainchild of an Aboriginal exsmoker, to capture and tell in their own words the success stories
of Indigenous people who have stopped smoking. The Australian
Capital Territory Cancer Council in partnership with Winnunga
Nimmitjah runs a smoking cessation programme No More Bunda
for Indigenous people that includes access to free
nicotinereplacement therapy (NRT). This programme was adapted
from a standard cessation programme and has been running for 5
years. TCCV is working in two programme areas tobacco
control and cervical screening to take on an Indigenous-specific
focus, and to train and support AHWs. TCCSA supports and plays
partnership roles with the Aboriginal Health Council of South
Australia to deliver a Quit Skills training programme to AHWs.
TCCNSW appointed an Indigenous representative on the planning
committee for a tobacco control conference and provided 12
scholarships for Indigenous people to attend. In reporting on
successful initiatives, respondents often described relatively smallscale local or regional initiatives where the kernel of the project
came out of a personal or good relationship between a Cancer
Council member and an Indigenous person working in a local
health service or in the community. Such partnerships recognised
that Indigenous Health Services are experienced in working with
Indigenous people, while the Cancer Councils have expertise
around cancer education and supporting people affected by
cancer. Building relationships and reciprocity through sharing
information and skills between organizations was valued by the
informants. A local or regional approach was seen as better able
to support the diverse needs of the Indigenous population within
each state.
Indigenous employment
Involvement of Indigenous people was acknowledged as a crucial
factor in every aspect of cancerrelated service delivery. However,
only one of the Cancer Councils (TCCV) during the project period
reported having an Indigenous staff member. While some Cancer
Councils had experience in recruiting Indigenous staff,
respondents recognised the inherent problems of appointing one
Indigenous position to provide advice across the organisation.
Based upon their observations and experience, respondents
believed that it was difficult to recruit Indigenous staff with the skills
and knowledge to hit the ground running. One respondent
proposed the merits of two or three part-time positions working
together on one project instead of one person across the whole
organisation.
Respondents were aware of the need to provide orientation,
adequate direction and support to Indigenous staff in the same
way as other staff members, but some noted that there had been
difficulties in achieving this in practice. There were risks of
Indigenous staff members feeling isolated, and either not
performing to their ability or suffering burnout. Some respondents
proposed the need to encourage Indigenous employees to
network with other Indigenous people in the health sector if there
were not other Indigenous employees within the organisation. In
the absence of Indigenous staff members, some organizations are
working with Indigenous volunteers and some with nonIndigenous staff, generally through linking with Indigenous health
service organizations.

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Policy and advocacy


The need for Indigenous people to be involved in setting the
agenda and deciding priorities was consistently recognised by the
respondents as it is in the literature. But respondents also
acknowledged that initiatives would have to fit within the Cancer
Councils scope and priorities. Cancer Council staffs are aware of
their reliance upon donors and fundraising events, and were
cautious about undertaking activities that might offend donors or
distract from their mainstream business. A number of the
informants described their organisation as white middle class,
not intended as criticism but rather as a statement of where they
were in their historical development. In some jurisdictions,
programmes for culturally and linguistically diverse populations
were also acknowledged as relatively under-developed. The
Cancer Councils generally had not adopted specific Indigenous
action plans, although they had strategic plans that addressed
social determinants of health inequalities, special needs groups
and under-served populations.
Informants generally felt that insufficient time and effort had been
put into Indigenous cancer issues within their organizations to
date. What had been undertaken was described by some as
piecemeal, just scratching the surface. There were some
criticisms that efforts had not generally been sustained over time.
For example, one respondent reported that their organisation had
been running programmes like a 1-day workshop on Quit skills to
raise awareness; promoting discussion about priorities and areas
for action to support Indigenous cancer support group; running
projects with young Indigenous women smokers to quit smoking
and so on. However, systematic efforts with follow through have
only recently begun, and are still at an early stage of development.
Some Cancer Councils have established a staff Aboriginal Health
Interest Group. At TCCV a voluntary group with representatives
from most Units was established in 2002 and meets quarterly to
discuss Indigenous issues, provide cultural awareness
opportunities and links with external Aboriginal health agencies.
The group enables increased awareness of Indigenous needs and
information goes back to Units to address.
Cancer support services
Cancer support services provide support across a range of needs
to people during their cancer journey, from counselling newly
diagnosed cancer patients, their families and friends, to providing
emotional and practical support, advice, accommodation and
assistance with palliative care. None of the Cancer Councils
reported that Indigenous people were truly represented in their
client groups. However, TCCSA had supported the establishment
of an independent Indigenous Womens Cancer Action Group that
provides support to other women with cancer.
Underlying issues for inclusion of Indigenous people in cancer
care and support emerged during the interviews. With regard to
accommodation facilities, some informants reported there had
been tensions related to large families visiting and staying, mess,
dirtiness and noise. It was widely reported that many staff felt ill
equipped to deal with the cultural differences of Indigenous
patients, and some staff were uncomfortable in dealing with
Indigenous families. They did not understand the values and
customs of Indigenous people, while language difficulties further
impeded communication. Often there was no access to
interpreters when the person spoke an Aboriginal language as

their first and usual language. There were also issues with some
Indigenous clients not wanting to be alone in private rooms,
preferring being at floor level rather than bed height, having
different dietary preferences and their preferred foods being
unavailable. Despite challenges in communication, staff often
understood the desire of rural patients to return home to die, but
it generally had required dedicated effort and substantial cost to
achieve this. A number of informants spoke of the importance of
improving the quality of data around Indigenous cancer and
needs. Good information serves as the impetus for setting
priorities and directing resources, giving individuals a rationale for
further work with a minority population. Baseline data for
monitoring progress was seen as vital for people in the field.

Discussion
Cancer Councils in Australia have been highly effective nongovernment organizations with considerable expertise on all
aspects of cancer control. As a result of their strategic approach,
they are effective advocates around cancer screening, treatment
and support services. As key players in cancer control, they
contribute through education, training, research, advocacy and
cancer support service functions, all of which are necessary
components of achieving improved cancerrelated outcomes for
Indigenous Australians. Cancer Council staff acknowledged the
limitations of their organizations in addressing Indigenous cancer
issues and their own deficiencies in understanding Indigenous
culture and hence the right way to do things. But their
willingness and enthusiasm to work with these communities was
apparent in the organisation and participation at the 2004
Indigenous Cancer Control Forum in Darwin, and this was
followed by new initiatives within many of the Cancer Councils.
These initiatives include planning for a state-based Indigenous
Cancer Forum in South Australia (held in September 2006),
training of AHWs, cultural safety training for non-Indigenous
cancer support staff, and working in collaboration with local and
regional Indigenous health organizations.
Limitations identified in the environmental scan which impeded
progress on Indigenous cancer issues were the lack of dedicated
staff time for Indigenous issues, lack of Indigenous staff, limited
commitment of significant resources on a sustained basis, and
lack of Indigenous input into policy and programmes. There were
no Indigenous Board members, and where an Indigenous person
had been appointed as a staff member, often many demands were
made upon them. Some were uncomfortable working in a
mainstream organisation without Indigenous colleagues providing
peer-support. While it was recognised as desirable to have
Indigenous staff members working within the organizations,
respondents appreciated the practical challenges of this, and that
an Indigenous person per se was not a panacea. Most
organizations therefore opted to develop linkages with Indigenous
health organizations, and in some instances such projects had
been sustained over a number of years, with resources committed
over that time period. The linkage approach sometimes proved
frustrating as it often relied upon individual relationships and
required that the Indigenous organisation have both capacity and
commitment to the partnership. Informants recognised the
necessity to build capacity around cancer within the Indigenous
health sector. Considerable activity, not all of which had yet come
to fruition, had been initiated at planning and service levels
Hospital and Healthcare Innovation Book 2009/2010 85

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subsequent to the Darwin forum, and the project funded by


TCCWA, of which this scan is a component, exemplifies the
interest in how Indigenous cancer control might be progressed. An
intensive week of training with ongoing opportunities for
networking and relevant professional development seems a
particularly useful approach to increasing Indigenous capacity
around cancer issues. Activities and projects catalysed by small
seed project funding and initiated regionally or locally within
established networks, were often cited as successes. However,
such successes had not generally been translated into sustained
activity or programmes. Participants consistently recognised the
importance of long-term and well planned programmes with
dedicated resources. Practitioners involved in health promotion
with Indigenous clients advocated the use of nonpreachy
methods, that is, approaches that appeal to an individuals
concern for the health and wellbeing of their family and the
community rather than harms to their own health. Thus, messages
around tobacco control might focus initially upon harm reduction
by preventing passive exposure of family members to tobacco
smoke.
Cancer Councils provide support services for people with
cancer that recognise the social, spiritual, emotional, and physical
supports of cancer patients and their family members. However,
most were aware of their own organisational limitations in
understanding and capacity, particularly around Indigenous culture
and values. Although there has been very limited exploration in
Australia of what cancer means to Indigenous Australians, those
interviewed recognised that Western psychosocial and support
models might not be appropriate for Indigenous clients. This deficit
in understanding made service providers feel that they lacked the
knowledge and confidence in supporting Indigenous clients well.
Staffs were keen to better appreciate Indigenous peoples sociocultural understanding of cancer and to use this knowledge in their
practice in cancer service delivery. Many would welcome
Indigenous cultural awareness training but wanted specific
information around cancer beliefs, not just information about the
historical context of Indigenous health. Although Cancer Councils
have a well developed network of volunteers to help support
people with cancer, training of existing staff and volunteers to
support Indigenous people is needed. It may be helpful to provide
Indigenous mentors for non-Indigenous staff who are
inexperienced in working with Indigenous people. Recruitment
and support for Indigenous volunteers and cancer survivors to
assist in cancer advocacy work is in place in SA and Queensland,
but not in other jurisdictions. One-to-one support services appear
to be underutilised currently, and Indigenous-specific cancer
survivor support resources using testimonials or story-telling may
be helpful. An issue regularly raised within Indigenous cancer
contexts was the use of traditional healers and traditional
medicines,22 although these issues were generally not mentioned
by the informants interviewed. Support programmes that integrate
cultural components (traditional medicine, selected ceremonies)
may be acceptable and effective means of supporting Indigenous
people to engage in cancer treatment.
There are many similarities between the cancer issues
experienced by Indigenous Australians and those of indigenous
people in other developed countries. It is beyond the scope of this
paper to discuss in detail the experience in cancer control and
support strategies in indigenous populations in countries such as
86 Hospital and Healthcare Innovation Book 2009/2010

Canada, New Zealand and the United States. However, the


authors have undertaken a comprehensive literature review of
these populations and key lessons from international experience
are: acknowledgement of past treatment and the impact of
colonisation; acknowledgement of the cultural diversity of
Aboriginal people; recognition of the impact of the structural
causes of inequality; need to enable Indigenous ownership,
participation, partnership and control, with Indigenous
representation at all levels of decision making; and support for
community-based and community-driven interventions. There
have also been efforts to develop culturally appropriate resources
and servicebased programmes, promoting Indigenous healing
approaches concurrently with Western medical treatment. The
reader is recommended to read further about these
approaches23,28 which were generally Indigenous community-led
and government supported.
While there has been a lack of Australian government leadership
in this area, Cancer Councils can play both an effective practical
and advocacy role at the local, state and national level to ensure
Indigenous issues in cancer control are more effectively
incorporated and heeded. Respondents recognised that this
should be done hand-in-hand in partnership with Indigenous
communities, and leadership is needed from The Cancer Council
Australia to ensure that there is steady national progress with
lessons shared across jurisdictions. The need for Cancer Councils
to adopt a respectful approach that invests in learning and
understanding about Indigenous issues, and the reciprocal
benefits that might derive from such partnerships in enhancing
Indigenous cancer control are recognised in the words of one
informant:
The Darwin Forum was like... the Cancer Council people trying
to learn from Aboriginal people... and if we maintain that theme all
the way through our state-based work or national work, we will do
ok... because we have developed lots of respect in taking that
approach... J
Acknowledgements
This project was funded by the Cancer Council of Western Australia
(TCCWA). An Aboriginal Working Group had been established for
the project by TCCWA to assist and guide the reviewers. The
funding agency did not have any other involvement in the study
design, data collection, analysis and interpretation other than
participating in the study. The reviewers sent the draft of this article
to all Cancer Councils and asked for their comments and feedback.
Reprint acknowledgement
Article originally appeared in Australian Health Review
(http://www.aushealthreview.com.au) and is reproduced with
permission from the Australian Healthcare Association
(www.aushealthcare.com.au)

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2005 Oct 23-26; BC Cancer Agency, 2005.
26.
Burhansstipanov L, Gilbert PHA, LaMarca K, Krebs LU. An innovative path to improving
cancer care in Indian country. Public Health Rep 2001; 116 (September-October): 424-33.
27.
Burhansstipanov L. Cancer: a growing problem among American Indians and Alaska
Natives. In: Dixon M, Roubideaux Y, editors. Promises to keep: public health policy for
American Indians and Alaska Natives in the 21st century. Washington, DC: The American
Public Health Association, 2001.
28.
Ministry of Health. DHB toolkit: cancer control to reduce the incidence and impact of cancer.
Wellington: Ministry of Health, 2001.
2.

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Company Profile: Shimadzu Europa GmbH

Technology of the 21st Century


Pioneers in Diagnostic Imaging:
Reliability and advanced technology
add value and increase safe diagnosis
ARTICLE BY SHIMADZU EUROPA GMBH

As a pioneer in medical technology since 1896 after recording the first X-ray images in Japan, Shimadzu
develops, manufactures and distributes a broad range of diagnostic systems in almost all areas of clinical
applications Digital Subtraction Angiography (DSA), cardiovascular systems, digital radiography &
fluoroscopy systems and general radiography equipment.

Directly digitalized X-ray data merge economic with


diagnostic benefits

C-arm systems, radiography and fluoroscopy as well as


projection radiography

Safire is one of the most recent developments in X-ray technology


and is the worlds first large-field flat-panel X-ray detector with
direct conversion. X-rays are converted directly into electrical
signals using amorphous selenium without the need for indirect
light conversion. The result is an outstanding image quality, free of
any influence of scattering with an unparalleled ability for detail
discrimination. With its dynamic detector system which can
acquire 30 images per second, safire offers a wide range of new
and revolutionary applications in radiology, fluoroscopy and
cardiology, such as tomosynthesis, dual-energy subtraction and
slot-radiography. The 23 x 23 cm (9-inch-square) or 43 x 43 cm
(17-inch-square) safire FPD can be used for both still images and
fluoroscopy. Shimadzus safire FPDs are integrated in cardio
systems as well as fluoroscopic equipment and bucky rooms.
Introducing the safire direct-conversion FPD to the medical
sector enables digitizing of all X-ray related diagnostic imaging. It
allows faster diagnosis, improved diagnostic capabilities and
accelerated remote medical diagnostics. The current image
amplifier technology, inferior in image quality and dose efficiency,
is expected to soon become obsolete.

Under the BRANSIST name Shimadzu offers floor- or ceilingmounted as well as biplane C-arm systems with integrated safire
FPDs (22 x 22 cm or 43 x 43 cm). In addition to the brilliant image
quality, the BRANSIST system enables real-time operation at a
rotation speed of up to 60 per second.
The SONIALVISION safire X-ray multifunctional instrument can
be used, for instance, to create three-dimensional images of
patients standing upright during prostheses check-ups.
SONIALVISION safire has a low access of 47 cm and a capacity
of up to 318 kg for use in bariatrics.
RADspeed safire, the digital high-end product of the RADspeed

Safire is one of the most


recent developments in
X-ray technology and is
the worlds first largefield flat-panel X-ray
detector with direct
conversion

88 Hospital and Healthcare Innovation Book 2009/2010

Figure 1: BRANSIST VC17 delivers 3D reconstructable CT-like


images thanks to ultra-fast C-arm sequences (cone beam CT)

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family, combines high patient throughput with optimal


convenience for users as well as patients and, at the same time,
delivers brilliant image quality. RADspeed safire acquires clear
images of difficult-to-diagnose findings such as round lesions that
are often obscured by ribs.

Award-winning mobile X-ray technology


In 2009, Shimadzu introduced the MobileArt Evolution series, the
next generation mobile X-ray systems of the award-winning
MobileArt series. This family of systems offers efficiency as well as
user and patient friendliness together with high-quality images.
The premium version can be extended to a fully digital unit
applying FPD.
The new mobile fully digital MobileDaRt Evolution system covers
the entire radiological spectrum. Based on its high-performance
flat-panel detector of 35 x 43 cm, an optimal image quality can be
guaranteed under the most difficult conditions, for example in
trauma and intensive care medicine or on patient wards. With the
integrated touch-screen monitor an image can already be
processed within 3 seconds after exposure. In this way, the
MobileDaRt Evolution closes the work-flow gap in fully digitally
equipped clinics, as the critical intensive care or trauma images
are already available within a few seconds after creation on the
PACS diagnostic workstations.

Patented technology for angiographic applications


Using novel technologies and equipment, the company paved the
way for new applications and diagnostic tools, for example Realtime Smooth Mask DSA. The patented RSM-DSA technology
enables subtraction angiography, where the mask and filler images
are acquired almost simultaneously and subtracted in real-time.
Finding the right diagnosis becomes much easier and more
precise while reducing the enormous technical effort, time and
cost required for modern angiography applications.

Figure 2: The MobileDaRt Evolution stands for mobile state-ofthe-art technology.

Each customer benefits from each customer


Shimadzus research and development is led by a simple yet
central mission: to offer the best possible diagnostics with the
highest patient- and user friendliness. Shimadzus medical
technology is applied on all continents. The feedback from
Shimadzus customers is integrated directly in the development of
new systems. In this way, each of Shimadzus customers benefits
from globally acquired knowledge.
Shimadzus technology is further complemented by proximity to
its customers: Shimadzu has an extensive sales and service
network all over Europe.
Shimadzu Europa GmbH
Albert-Hahn-Str. 6-10
47269 Duisburg, Germany
Phone: +49 (0) 203-76 87-0
Fax: +49 (0) 203-76 87 680
E-mail: medical@shimadzu.eu
www.shimadzu.eu

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Breast Cancer a review for


African surgeons
ARTICLE BY ADISA ADEYINKA CHARLES MD, FWACS, FICS
Director, Residency Training Program, Abia State University Teaching Hospital, Aba, Nigeria
ALEXANDRA M EASSON MSC, MD, FRCSC, FACS
Assistant Professor, Department of Surgery, General Surgery and Surgical Oncology, Mount Sinai Hospital and Princess
Margaret Hospital, 610 University Avenue Toronto, Ontario, Canada

Breast Cancer constitutes a major public health issue globally. In Africa, it is the commonest malignancy affecting women
and the incidence rates appear to be rising. While mortality rates are declining in the developed world as a result of early
diagnosis, screening, and improved cancer treatment programmes, the converse is true in the developing world.
Breast cancer and its treatment constitute a great physical, psychosocial and economic challenge in resource limited
societies as found in Africa. The hallmarks of the disease in Africa are clinically advanced disease, lack of adequate
infrastructure for diagnosis, screening and treatment, preponderance of younger pre-menopausal patients.
This Review is meant to provide practical guidance for the surgeon working in the developing world.

here is an international/geographical variation in the


incidence of Breast Cancer. Incidence rates are higher in the
developed countries than in the developing countries and
Japan. Incidence rates are also higher in urban areas than in the
rural areas.
In Africa, Breast Cancer has overtaken cervical cancer as the
commonest malignancy affecting women and the incidence rates
appear to be rising.3,4 In Nigeria for example, incidence rate has
increased from 13.815.3 per 100,000 in the 1980s, to 33.6 per
100,000 in 1992 and 116 per 100,000 in 2001.5 These increases
in incidence are due to changes in the demography, socioeconomic parameters, epidemiologic risk factors, better reporting
and awareness of the disease. While mortality rates are declining
in the developed world (Americas, Australia and Western Europe)
as a result of early diagnosis, screening, and improved cancer
treatment programmes, the converse is true in the developing
world as well as in eastern and central Europe.6-8
Breast cancer and its treatment constitute a great physical,
psychosocial and economic challenge in resource limited societies
as found in Africa. The hallmarks of the disease in Africa are
patients presenting at advanced stage, lack of adequate
mammography screening programmes, preponderance of
younger pre-menopausal patients, and a high morbidity and
mortality.3,6
This Review is meant to provide practical guidance for the
surgeon working in the developing world. We have relied on the
Chapter on Breast Cancer by Bland et al in Schwartzs Principles
of Surgery, 8th Edition.9
Material which is of interest but not immediately applicable has
been placed in smaller print. In the Recommendations we have
followed the principles developed in the Breast Health Global
Initiative.10-12

History
Breast cancer is one of the oldest known forms of malignancies.
90 Hospital and Healthcare Innovation Book 2009/2010

The earliest known documentation on breast cancer was the


Smith Surgical Papyrus (3000-2500 B.C.) written in Africa (Egypt).
It described 8 cases of tumors or ulcers of the breast that were
treated by cauterization, with a tool called the fire drill. The
writing says about the disease, There is no treatment. At least
one of the described cases is male. There were few other historical
references to breast cancer until the first century when Celsus
recognized the relevance of operations for early breast cancer.
In the second century, Galen inscribed his classical clinical
observation: We have often seen in the breast a tumor exactly
resembling the animal the crab. Just as the crab has legs on both
sides of his body, so in this disease the veins extending out from
the unnatural growth take the shape of a crab's legs. We have
often cured this disease in its early stages, but after it has reached
a large size, no one has cured it. In all operations we attempt to
excise the tumor in a circle where it borders on the healthy
tissue.13
Halsted and Meyer reported their operations for the local
treatment of breast cancer in 1894. Both Halsted and Meyer
advocated complete dissection of axillary lymph node levels I to III
and removal of pectoral muscle along with the breast. By
demonstrating locoregional control rates after radical resection
and providing the first opportunity for cure, these surgeons
established radical mastectomy as state-of-the-art treatment in
the early part of the 20th century. Later in the century, there was a
transition from the Halsted radical mastectomy to the modified
radical mastectomy (MRM) as the surgical procedure most
frequently used for breast cancer. This procedure maintained the
en bloc dissection of the breast and lymph nodes, but left the
pectoralis major muscle intact.
The recognition in the 1950s that breast cancer was often a
systemic disease at presentation shifted the management of
primary breast cancer away from a purely surgical approach to a
multidisciplinary one that uses systemic therapy, surgery and
radiation. As a result surgery for breast cancer may now be

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Table 1: Early detection amd access to care

LEVEL OF RESOURCE
Basic

DETECTION METHOD (S)


Breast health awareness (education + self examination)
Clinical breast examination (clinical education)

EVALUATION GOAL
Baseline assessment and repeated survey

Limited

Targeted outreach/education encouraging CBE for at-risk group


Diagnostic ultrasound + diagnostic mammography

Downstaging of eymptomatic disease

Enhanced

Diagnostic mammography
Opportunitic mamographic screening

Opportunities screening of asymptomatic patients

Maximal

Population-based mammographic screening


Other imaging technologies as appropriate:
high-risk group, unique imaging challenge

Population-based screening of asymptomatic patient

managed with more conservative and less locally ablative


procedures such as lumpectomy. The past three decades has
witnessed an enormous growth in the knowledge and
understanding of the basic science of the disease especially the
genetic and molecular basis of the disease.

Anatomy of the breast


The breast is a modified sweat gland and therefore ectodermal in
origin. It is present in all mammals and becomes particularly
prominent in females as the hallmark of pubertal development. It
lies cushioned in adipose tissue between the subcutaneous fat
layer and the superficial pectoral fascia. It extends from the clavicle
above to the upper border of the rectus sheath below and from the
midline to the posterior axillary line. It overlies the second to the
sixth ribs, the pectoralis major, serratus anterior and the upper part
of the rectus sheath. The area covered is wider than the visible
protuberant breast. An axillary extension of the breast (axillary tail
of Spence) always exists and its size is proportional to the total
volume of the main breast mass. The innervation of the breast is
derived from the anterior branches of the intercostal nerves 2
through 6 with the nipple receiving its innervation from the 4th
intercostal nerve. The major blood supply, in order of importance,
are the internal mammary branches, the lateral thoracic, and the
thoracodorsal perforating vessels from the pectoral branch of the
throacoacrominal branch of the axillary artery, and small
intercostals branches. The venous and lymphatic drainage parallel
the blood supply.
The glandular tissue consists mainly of epithelium, fibrous
stroma, and fat. The breast is organized into roughly 20 lobular
units made up of terminal ducts surrounded by fat and fibrous
tissues and efferent ductules. These terminal ducts coalesce and
drain towards the areola forming the 15-20 ducts of the nipple
areolar complex.
The lymphatic drainage is primarily to the axillary nodes (75%),
divided into three levels by the Pectoralis minor muscle (level I
nodes lie lateral, level II nodes behind and level III nodes medial to
the muscle). Usually, but with some exceptions, lymphatic
drainage is progressive through these levels. Drainage also occurs
to the internal mammary chain of lymph nodes which lie in the
intercostal spaces, the supraclavicular nodes, the opposite breast
and axilla, and to the liver via the rectus abdominis muscle.

Epidemiologic risk factors/etiology


The precise etiology of breast cancer is largely unknown, but

several risk factors have been identified. Table 1 lists the known
risk factors.14
The risk factors include:
 Age: The incidence of breast cancer increases with age and is
rare before the age of 20 years. The breast cancer incidence in
Caucasians is highest at age 50-59, after menopause,
dropping after age 70. In Africa and African-Americans the
peak age incidence is about one decade less, so that the
majority of the patients are pre- menopausal. While numerous
theories have been proposed to explain this difference,
including age at menarche, time of first delivery, parity, sociodemographic factors, body mass index, and underlying genetic
difference, none are completely satisfactory and more research
is needed in this area.3-5;15-17
 Sex: Breast Cancer is 100 times more common in women
than in men with male breast cancer accounting for <1% of all
breast cancer cases in the United States and 0.1% of cancer
mortality in men18-20. However in Africa this situation may be
different as from 5-15% of breast cancer in Uganda and
Zambia may occur in males.18;21-24
 Geographic variation: A wide difference in age adjusted
incidence and mortality for breast cancer exists between
different countries (up to five fold). Figure 1 shows the
difference which may be explained by environmental and
genetic factors.25-28
 Hormone/pregnancy related factors: The role of estrogen
in the causation of breast cancer has been extensively studied
and the general opinion is that estrogen is the primary
stimulant for breast epithelial proliferation. Factors that increase
exposure to high or prolonged level of estrogen are therefore
associated with an increased risk of developing breast
cancer29-33. These include early menarche, late menopause, use
of contraceptives and exogenous estrogen, nulliparity and
increased age at first term pregnancy. Induced abortion and
spontaneous abortion do not increase the risk. Prolonged
lactation and breast feeding reduce the risk. As the living
standard and healthcare facilities in Africa improve, it is
probable that age at menarche will decrease while that of
menopause increases. The demands for education and a
career may increase the number of women who delay
childbearing, have fewer children, use contraceptives and
breast feed for a shorter time. These will likely impact on the
increase in the incidence of breast cancer as African countries
meet the minimum development goals.
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 Previous breast disease: Individuals who have a prior


history of invasive carcinoma or ductal carcinoma in situ have
a 0.5%-1% per year risk of developing a new invasive breast
carcinoma. Women with atypical ductal or lobular hyperplasia
have a four to five times higher risk of developing breast
cancer. Proliferative lesions without atypia, such as moderate
hyperplasia and sclerosing adenosis, are associated with a
slightly increased risk (1.5-2%). Other common nonproliferative changes such as palpable cysts, fibroadenomas
and duct papillomas are not associated with a significantly
increased risk.34
 Enviromental Exposures: Exposure to ionizing irradiation
increases the risk of developing breast cancer. Excess breast
cancer has been observed in patients given multiple
fluoroscopies, radiotherapy for ankylosing spondylitis, Hodgkins
disease, or enlargement of the thymus gland and in survivors of
the atomic bombings, painters of radium watch faces and X-ray
technicians28. Environmental exposures to organic chlorines and
other environmental/synthetic estrogens like cosmetics and
phytoestrogens found in food have also been postulated to
increase the risk, but so far there are no conclusive evidence
linking organic chlorines to breast cancer.31;35;36

Lifestyle risks
Anthropometric indices and physical activity: Height, obesity and
high body mass index are risk factors especially in post
menopausal women. In pre-menopausal women, obesity and high
body mass index has an insignificant but inverse relationship to
breast cancer risk that is reduced by physical activity.37-39
Diet, alcohol and smoking: alcohol and diets rich in fat especially
saturated fat raises the risk while smoking does not appear to
affect the risk.40-42

Family history and genetics


A family history of breast cancer increases a woman's risk of
developing the disease. A woman is considered to be at increased
risk if the family member is a first degree relation with early age of
onset (< age 50), if both breasts are involved, or if she has multiple
primary cancers (such as breast and ovarian cancer). Women with
one, two, and three or more first-degree affected relatives have an
increased breast cancer risk when compared with women who do
not have an affected relative (risk ratios 1.8, 2.9 and 3.9,
respectively)43 Such women are recommended to begin breast
cancer screening at an age 10 years younger than the age at
which the affected relative was diagnosed.
Hereditary breast cancer caused by an underlying inherited
gene mutation accounts for a small proportion (5-10%) of all
breast cancers. The majority is accounted for by 2 germline
mutations BRCA-1 (50%) and BRCA-2 (32%), which are inherited
in an autosomal dominant fashion with varying penetrance. These
tumor suppressor genes are important in the processing of DNA
damage and preservation of genomic integrity. BRCA-1 is located
on chromosome 17q while BRCA-2 is located on chromosome
13q.44 They are most commonly found in the European Ashkenazi
Jewish population and their descendants, accounting for their
relatively high prevalence in the developed world. In Europe and
North America, BRCA1 is found in 0.1% of the general population,
compared with 20% in the Ashkenazi Jewish population and is
found in 3% of the unselected breast cancer population and in
92 Hospital and Healthcare Innovation Book 2009/2010

70% of women with inherited early-onset breast cancer.9 Up to 5087% of women carrying a mutated BRCA1 gene develop breast
cancer during their lifetime. Risks for ovarian and prostate cancers
are also increased in carriers of this mutation. BRCA2 mutations
are identified in 10-20% of families at high risk for breast and
ovarian cancers and in only 2.7% of women with early-onset
breast cancer. The lifetime risk of developing breast cancer in
female carriers is 25-30%. BRCA2 is also a risk factor for male
breast cancer; male carriers have a lifetime risk of 6% for
developing the cancer. BRCA2 mutations are associated with
other types of cancers, such as prostate, pancreatic, fallopian
tube, bladder, non-Hodgkin lymphoma, and basal cell carcinoma.
Risk management strategies for BRCA-1 and BRCA-2 carriers
include:
 prophylactic mastectomy and reconstruction;
 prophylactic oophorectomy and hormone replacement
therapy;
 intensive surveillance for breast and ovarian cancer; and
 chemoprevention using Tamoxifen or raloxifene (postmenopausal women)
In contrast, less is known about genetic mutations as a cause of
breast cancer in the non-Caucasian population. Studies that have
been done of African-Americans, whose genetic history includes
Caucasians, have identified BRCA-1 and -2 mutations but of a
different pattern.17,45,46 In native Africans, a wide range of BRCA-1
and BRCA-2 mutations and sequence variations have been found
which are unique. This suggests that there may be significant
differences in the genetics of hereditary breast cancer in Africa.
A screening of 206 black South African women with breast
cancer revealed 3 common BRCA1 mutations: 185delAG in exon
2, 4184del4 in exon 11, and 5382insC in exon 2022. A second
study of the coding regions of BRCA1 and BRCA2 genes from 70
Nigerian patients diagnosed with breast cancer before the age of
40 years revealed 2 novel BRCA1 truncating mutations, Q1090X
and 1742insG; four BRCA1 missense variations; one BRCA2
truncating mutation, 3034del4, previously unreported in anyone of
African descent; and 20 nontruncating variants were detected in
BRCA2.45 BRCA1 and BRCA2 mutations and sequence
variations are potentially significant in cases of early-onset breast
cancer within Africa. However, only a small portion of the
mutations were protein truncating, fewer than those observed
among white women47
Other rare genetic changes that account for predisposition to
breast cancer include Li Fraumeni syndrome (TP53 gene mutation),
Cowdens syndrome, Peutz-Jeghers and Muir-Torre syndromes,
Ataxia Telangiectasia syndrome (caused by the ATM gene).48-51 New
breast cancer susceptibility genes are being reported and they
include the CHEK2 or CHK2 gene, cytochrome P450 genes
(CYP1A1, CYP2D6, CYP19), glutathione S-transferase family
(GSTM1, GSTP1), alcohol and one-carbon metabolism genes
(ADH1C and MTHFR), DNA repair genes (XRCC1, XRCC3,
ERCC4/XPF) and genes encoding cell signaling molecules (PR, ER,
TNFalpha or HSP70). All these factors contribute to a better
understanding of breast cancer risk but the degree of penetrance
of these genes are far less than the BRCA1 and BRCA2 genes43,51

Risk assessment
Several statistical models are currently in use in North America to

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predict the risk of breast cancer, based on the above risk factors
identified in the American Caucasian population. The universal
applicability of these models can not, however be taken for
granted as the data on which they rely on were generated from
predominantly American Caucasian population and have not been
tested for African women43,52,53
The most prominent statistical models are the Gail and the
Claus models. Gail and colleagues developed the most frequently
used model, which incorporates age at menarche, the number of
breast biopsies, age at first live birth, and the number of firstdegree relatives with breast cancer. It predicts the cumulative risk
of breast cancer according to decade of life. To calculate breast
cancer risk with the Gail model, a woman's risk factors are
translated into an overall risk score by multiplying her relative risks
from several categories. This risk score is then compared to an
adjusted population risk of breast cancer to determine a womans
individual risk. A software programme incorporating the Gail
model is available from the National Cancer Institute at
http://bcra.nci.nih.gov/brc.
Claus and colleagues, using data from the Cancer and Steroid
Hormone Study, a case-control study of breast cancer, developed
the other frequently used risk-assessment model, which is based
on assumptions about the prevalence of high-penetrance breast
cancer susceptibility genes. Compared with the Gail model, the
Claus model incorporates more information about family history,
but excludes other risk factors. The Claus model provides
individual estimates of breast cancer risk according to decade of
life based on knowledge of first- and second-degree relatives with
breast cancer and their age at diagnosis. Risk factors that are
less-consistently associated with breast cancer (diet, use of oral
contraceptives, lactation), or are rare in the general population
(radiation exposure), are not included in either the Gail or Claus
risk-assessment models.54

Pathology
Breast cancers are derived from the epithelial cells that line the
terminal duct lobular unit. Cancer cells that remain within the
basement membrane of the elements of the terminal duct lobular
unit and the draining duct are classified as in situ or non-invasive.
An invasive breast cancer is one in which there is dissemination of
cancer cells outside the basement membrane of the ducts and
lobules into the surrounding adjacent normal tissue.
Classification of Primary Breast Cancer
Noninvasive Epithelial Cancers
 Lobular Carcinoma in situ (LCIS).
 Ductal Carcinoma in situ (DCIS) or intraductal carcinoma:
Papillary, cribriform, solid and comedo types
Invasive Epithelial Cancers (percentage of total)
 Invasive lobular carcinoma (10-15).
 Invasive ductal carcinoma.
 Invasive ductal carcinoma, (NOS) Not Otherwise Specified
(50-70).
 Tubular carcinoma (2-3).
 Mucinous or colloid carcinoma (2-3).
 Medullary carcinoma (5).
 Invasive cribriform (1-3).
 Invasive papillary (1-2).

 Adenoid cystic carcinoma (1).


 Metaplastic carcinoma (1).
 Pagets disease (<1).
Mixed Connective and Epithelial Tumors
 Phylloides tumors, benign and malignant.
 Carcinosarcoma.
 Angiosarcoma.
Pagets disease of the breast is a rare manifestation of breast
cancer characterized by neoplastic cells in the epidermis of the
nipple areolar complex. It most commonly presents with eczema
of the areola, bleeding, ulceration, and itching of the nipple. The
diagnosis is often delayed because of the rare nature of the
condition and confusion with other dermatologic conditions.
Because of this, it is recommended that any ulcerated or irritated
lesion on the nipple areolar complex undergo a punch biopsy
under local anesthesia. There is an associated cancer elsewhere
in the breast in up to 80% of cases.
LCIS originates from the terminal duct lobular units and only
develops in the female breast. It is 12 times more frequent in white
women than in African American women. Invasive breast cancer
subsequently may develop in 25 to 35% of women with LCIS over
their lifetime, and may develop in either breast, regardless of which
breast harbored the initial focus of LCIS
DCIS: predominantly seen in the female breast, it accounts for
5% of male breast cancers. The risk for invasive breast cancer is
increased nearly fivefold in women with DCIS. The invasive
cancers are observed in the ipsilateral breast, usually in the same
quadrant as the DCIS that was originally detected, suggesting that
DCIS is an anatomic precursor of invasive ductal carcinoma.
Tumor grade
The degree of differentiation of the tumor can be graded by these
parameters: tubule formation, nuclear pleomorphism, and
frequency of mitoses. These are scored from 1 to 3. For example,
a tumor with many tubules (the cells are more differentiated, closer
to normal breast tissue and therefore less aggressive) would score
1 whereas a tumor with no tubules would score 3. These values
are combined and converted into three groups: grade I (score 35), grade II (scores 6 and 7), and grade III (scores 8 and 9). This
derived histological grade often known as the Bloom and
Richardson grade or the Scarff, Bloom, and Richardson grade
after the originators of this system is an important predictor of
both disease free and overall survival. (See Prognosis)
Staging
Staging of Cancer is an attempt to define characteristics that
would reliably define tumors based on the extent of the disease. It
is useful for choosing treatment options, selection of patients and
comparing the outcome of treatment and clinical trials and for
prognosticating. In Africa, where over 70% of breast cancer
patients present late, staging of breast cancer patients can
provide revealing epidemiological information about opportunities
for improving breast cancer screening and management.
The first staging method for Breast Cancer was proposed by
Steinthal, a German Physician in 1904, and since then staging
method has been evolving, with the TNM (Tumor, Node,
Metastasis) method being universally adopted by the UICC (The
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International Union Against Cancer) and the American Joint


Committee on Cancer (AJCC). Tables 2 and 3 show the latest
TNM staging for Breast Cancer (AJCC classification (6th edition or
revision)55, which incorporates both clinical information and
changes related to the growing use of new technology (e.g.,
sentinel lymph node biopsy, immunohistochemical staining,
reverse transcriptase-polymerase chain reaction). Patients with
bilateral or multicentric breast cancer are staged according to the
size of the largest tumor.

Diagnosis
Examination
Early breast cancer causes no symptoms and is usually painless.
The commonest symptom is a painless lump in the breast.
Examination of the breast should be done in such a way to show
respect for the privacy and comfort of the patient. A systematic
approach to breast examination is important. Initial examination
should start with the patient in an upright position with careful
visual inspection of masses, skin and nipple changes, and
asymmetries. Palpation should be done to include all the breast
quadrants, the nipple-areola complex, the axillary tail and the
axilla. Simple maneuvers like stretching the arms high above the
head, tensing the pectoralis muscles may help accentuate
asymmetries and dimpling.
Other less frequent presenting signs and symptoms of breast
cancer include (1) breast enlargement or asymmetry; (2) nipple
changes, retraction, or discharge, including Pagets disease; (3)
ulceration or erythema of the skin of the breast including
inflammatory carcinoma; (4) an axillary mass; and (5) systemic
symptoms such as fatigue, cough, ascites or new musculoskeletal
discomfort.
Imaging
Mammography, Ductography, Ultrasonography, MRI are imaging

techniques useful in the screening and diagnosis of breast cancer.


Mammography is the most useful test to differentiate between
benign and malignant lesions and is the one that is recommended
for breast cancer screening. Specific mammography features that
suggest a diagnosis of a breast cancer include a solid mass with
or without stellate features, asymmetric thickening of breast
tissues, and clustered microcalcifications Mammography may also
be used to guide interventional procedures, including needle
localization and needle biopsy.
Xeromammography techniques are identical to those of
mammography with the exception that the image is recorded on a
xerography plate, which provides a positive rather than a negative
image Details of the entire breast and the soft tissues of the chest
wall may be recorded with one exposure.
Ductography and ductoscopy
Mammary ductoscopy (MD) is a newly developed endoscopic
technique that allows direct visualization and biopsy examination
of the mammary ductal epithelium where most cancers originate.
When combined with ductal lavage and cytology , it may reveal
early carcinoma.56-59 The primary indication for ductography is
nipple discharge, particularly when the fluid contains blood.
Radiopaque contrast media is injected into one or more of the
major ducts and mammography is performed. Intraductal
papillomas are seen as small filling defects surrounded by contrast
media. Cancers may appear as irregular masses or as multiple
intraluminal filling defects.
Ultrasonography is an important method of resolving equivocal
mammography findings, defining cystic masses, and demonstrating
the echogenic qualities of specific solid abnormalities.
Ultrasonography is used to guide fine-needle aspiration biopsy,
core-needle biopsy, and needle localization of breast lesions. It is
highly reproducible and has a high patient acceptance rate, but
does not reliably detect lesions that are 1 cm or less in diameter

Table 2: Diagnosis and pathology

LEVEL OF RESOURCE CLINICAL


Basic
History
Physical examination
Clinical breast examination
Surgical biopsy
Fine-needle aspiration

Limited

Core needle biopsy


Image-guided sampling
(ultrasonographic+mammographic)

PATHOLOGY
Interpretation of biopsies

IMAGING AND LABORATORY TESTS

Cytology or pathology report


describe tumor size,
lymph node staue,
hiatologic type, tumor grade
Determination and reporting
of ER and PR statue
Determination and reporting
of margin satue

Diagnostic breast ultrassound+


diagnostic mammography
Plain chest mammography
Liver ultrasound
Blood chemistry profile/CBC

Enhanced

Preoperative needle localization under


mammographic or ultrasound guidance

On-site cytopathologist

Diagnostic mammography
Bone scan

Maximal

Stereotactic biopsy
Sentinal node biopsy

HER2/new statue
IHC ataining of aentinel nodes
for cytokeratin to detect
micrometastaes

CT scanning, PET
MIBI scan, breast MRI

CBC, coomplete bloodcount; CT, computed tomography; ER, estrogen recaptor; IHC, immunohistochemistry; MIBI, 99mto-sastamibi; MRI, magnetic resonance imaging;
PET, positron emission tomography; PR, progerterone receptor

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Table 3: Treatment and allocation of resources: stage I breast Cancer

Level of resource
Basic

LOCAL-REGIONAL TREATMENT
Surgery
Modified radical mastectomy

Limited

Breast-conserving theraphy*

SYSTEMIC TREATMENT (ADJUVANT)


Chemotherphy
Endocrine therphy
Ovarian ablation
Tamoxifen

Radiation therphy

Breast-conserving whole-breast
irradiation as part of breast-conserving
therapy

Classical CMF**

Postmasectomy irradiation of the chest


wall and regional nodes for high-risk cases

AC, EC or FAC**

Enhanced

Maximal

Taxanes

Sentinal node biopsy


Reconstructive surgery

Aromatase inhibitors
LH-RH agonists

Growth factors
Dose-dense chemotherapy

* Breast-conserving therapy requires mamography and reporting of margin status.


** Requires blood chemistry profile and complete blodd count (CBC) testing
AC, doxonubian and cyclosphamida; CMF, cyclophamide, methotrexate, and 5- fluorourcil; EC, epirubicin and cyclophosphamide; FAC, 5 - fluorourcil doxonubicin, and cyclophosphamide;
LH+RG, lutelnizing hormone-releasing hormone

and when used alone is a poor screening test.60,61


Magnetic Resonance Imaging is a non invasive, non radiating
imaging technique. In the process of evaluating MRI as a means
of characterizing mammography abnormalities, additional breast
lesions have been detected. However, in the circumstance of both
a negative mammogram and a negative physical examination, the
probability of a breast cancer being diagnosed by MRI is extremely
low. There is current interest in using MRI to screen the breasts of
high-risk women and of women with a newly diagnosed breast
cancer. In the first case, women with a strong family history of
breast cancer or who carry known genetic mutations require
screening at an early age, but mammography evaluation is limited

because of the increased breast density in younger women. In the


second case, a study of MRI of the contralateral breast in women
with a known breast cancer showed a contralateral breast cancer
in 5.7% of these women.62-64
Plain X-rays and Bone Scan are useful in the detection and
diagnosis of metastasis especially to the bones.
MRI, PET, CT Scans and bone scans are not readily available in
most centers in the developing world, and when available, the cost
of these procedures makes them virtually unrealistic for many of
the patients. Ultrasonography and X-rays are however readily
available and many patients will end up with these minimal
investigations and the standard history and physical examination.

Table 4: Treatment and allocation of resources: stage II breast Cancer

Level of resource
Basic

LOCAL-REGIONAL TREATMENT
Surgery
Modified radical mastectomy

Limited

Breast-conserving theraphy***

SYSTEMIC TREATMENT (ADJUVANT)


Chemotherphy
Endocrine therphy
Classical CMF**
Ovarian therapy
AC, EC or FAC**
Tamoxifen

Radiation therphy
*

Breast-conserving whole-breast
irradiation as part of breast-conserving
therapy
Postmasectomy irradiation of the chest
wall and regional nodes for high-risk cases

Enhanced

Maximal

AC, EC or FAC**

Taxanes

Sentinal node biopsy


Reconstructive surgery

Aromatase inhibitors
LH-RH agonists

Growth factors
Dose-dense chemotherapy

* Chest wall and regional lymph node irradiation substantially decrease the risk of postmastectomy local recurrance, if available it should be used as a basic level resource
** Requires blood chemistry profile and complete blodd count (CBC) testing
*** Breast-conserving therapy requires mamography and reporting of margin status.
AC, doxonubian and cyclosphamida; CMF, cyclophamide, methotrexate, and 5- fluorourcil; EC, epirubicin and cyclophosphamide; FAC, 5 - fluorourcil doxonubicin, and cyclophosphamide;
LH+RG, lutelnizing hormone-releasing hormone

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Biopsy
Pathologic diagnosis of a breast lesion can be achieved using a
number of biopsy techniques. With a larger biopsy sample, greater
accuracy and more information are obtained, but this is at the
expense of increased invasiveness. Ideally, needle biopsies should
be performed after imaging to help prevent distortions of imaging
due to hematoma. The various needle biopsy techniques can be
divided into two groups:
 1. Fine needle aspiration will provide cytology which will allow
a diagnosis of malignant cells but will not differentiate between
in situ or invasive disease.
 2. Tissue biopsy for histology which include Tru cut biopsy,
Biopty cut, Mammotome. These relatively larger tissue samples
will allow the diagnosis of invasive versus in situ cancer.
Table 4 compares the accuracy of needle biopsy techniques.
Open Biopsy (Excision or Incision biopsy) The ultimate diagnostic
biopsy is open biopsy of a lesion, normally performed under
general or local anesthetic. Open excisional biopsy should be
reserved for lesions for which some doubt remains regarding
diagnosis after less invasive assessment or for benign lesions that
the patient wants removed. A wide clearance of the lesion is usually
not the goal in diagnostic biopsies, thus avoiding unnecessary
distortion of the breast. It is also useful for excision of
mammographic lesions when percutaneous biopsy has failed or is
equivocal. Where frozen section is available, open excisional biopsy
may be performed at the same time the as definitive breast cancer
surgery. Incisional biopsy is used only in cases where the lesion is
very large and a percutaneous biopsy has been unsuccessful.

Screening
Annual screening mammography has been demonstrated to
reduce breast cancer mortality among women older than 50 years
by 20 39%. The benefit in younger women is not yet established.
For Caucasian women aged 4049, the results of RCTs are
consistent in showing no benefits at 57 years after entry, a
marginal benefit at 1012 years, and unknown benefit thereafter.
This is primarily because when used as a screening tool, the
detection rate per screened individual is lower because of denser
breasts and an overall lower incidence. The controversy over the
effectiveness of screening mammography among younger women
(i.e., 4049 years) has led to varying recommendations about its
use for this age group. In patients with high risk factors a yearly
mammography assessment from the age of 40 years is
advisable.65-67 Considering the younger demographic pattern of
Breast Cancer in Africa, it is not clear what role screening
mammography should have in Africa.
Other methods of early breast cancer screening like Self Breast
Examination and Clinical Breast Examination have not been
demonstrated to improve mortality in patients; rather SBE has
resulted in more breast biopsies due to false positive results, more
physician visits and apprehension in patients68. It is pertinent to
state that most of the studies that evaluated the role of SBE and
CBE have been done in developed societies where cancers are
small at diagnosis and this may not be relevant in Africa where the
majority of patients present late. Incorporation of Breast
Awareness programmes and health education into the Primary
Health Care of African countries may very well be a useful option
to allow for a diagnosis at an earlier stage. Cultural attitudes play
96 Hospital and Healthcare Innovation Book 2009/2010

important roles in the acceptance of screening programmes.69

Treatment
Treatment strategy will depend on the stage of the disease.
In situ breast cancer (DCIS and LCIS)
LCIS: Observation alone with or without tamoxifen is the preferred
option for women diagnosed with LCIS because their risk of
developing invasive carcinoma is relatively low (approximately 21%
over 15 years) and is equal in both breast..70 Follow-up of patients
with LCIS includes physical examinations every 6 to 12 months for
5 years and then annually. Annual diagnostic mammography is
recommended in patients being followed with clinical observation.
DCIS: Treatment options for DCIS are mastectomy, breastconserving surgery (BCS) plus radiotherapy or BCS alone. The
goal of treatment for DCIS is to reduce local recurrence, because
50% of the time that DCIS recurs it recurs as an invasive cancer.
Factors that may modify treatment are:
 the grade of the lesion, with higher-grade lesions more likely to
recur in a short time;
 the youth of the patient, with many more years at risk for
recurrence and
 the size of the lesion.
For years the traditional surgical management of DCIS was
mastectomy, with or without axillary dissection. Breast
conservation technique and irradiation is now a preferred
alternative where local breast radiation is available. Only small, low
grade DCIS that has been excised with a large margin may be
considered for BCS alone. Axillary lymph node staging is
discouraged in women with apparent pure DCIS. However, a small
proportion of patients with apparent pure DCIS will be found to
have invasive cancer at the time of their definitive surgical
procedure which will require a further axillary dissection.71 Addition
of Tamoxifen reduces the risk of developing contralateral breast
cancer.72,73. Follow-up of women with DCIS includes a physical
examination every 6 months for 5 years and then annually, as well
as yearly diagnostic mammography.
Early breast cancer (stages I and II or T1-3N0-1 M0):
Staging for metastatic disease is standard for most patients
diagnosed with early breast cancer and include a chest X-ray,
bone scan and ultrasound of the abdomen. If negative, treatment
intent is curative, and involve modalities that fight the cancer
locally (surgery and radiation) and systemically (chemotherapy and
endocrine therapy).
Loco-regional treatment:
Local treatment requires the treatment of the entire breast and the
axillary lymph nodes with surgery, radiation, or a combination of
both. Surgery can be breast conservation therapy (BCT) and
axillary staging (SLNB or axillary dissection) or simple or total
mastectomy with axillary staging (modified radical mastectomy).
The surgical procedure for the excision of the breast in BCT
goes by several names (Partial mastectomy, tylectomy, segmental
resection, quadrantectomy or lumpectomy).
The goal of breast-conserving surgery is to minimize the risk of
local recurrence while leaving the patient with a cosmetically
acceptable breast. The selection of BCT versus mastectomy
depends on the size of the tumor relative to the rest of the breast

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and the availability of radiation. BCT and breast radiation together


offers equivalent survival to total mastectomy provided the BCT
removes the entire tumor with negative margins. Generally a tumor
less that 1/4 of the breast is amenable to BCT; anything much
larger will result in significant breast distortion after surgery and
radiation. The procedure can be done safely with local anesthesia
and sedation unless axillary dissection is part of the procedure. A
curvilinear incision lying parallel to the nipple-areola complex is
made in the skin overlying the breast cancer. Radial scars are
avoided because of poor cosmetic results. Skin encompassing any
prior biopsy site is excised, but skin excision is not otherwise
necessary. The breast cancer is removed with an envelope of
normal-appearing breast tissue. Meticulous hemostasis is
important because a large hematoma distorts the appearance of
the breast and makes re-excision and follow-up more difficult.
The excised specimen is orientated for the pathologist using
sutures, clips, or dyes. Additional margins (superior, inferior,
medial, lateral, superficial, and deep) can be taken from the
surgical bed to confirm complete excision of the tumor. These six
margins are marked with titanic clips as this may help the
Radiotherapist in planning the boost. In addition, it helps the
surgeon to do an adequate re-resection if the margins are not free
of cancer cells at definitive paraffin-embedded histology sections.
Attempts to re-approximate the cavity in the breast should be
avoided, because this will usually distort the breast contour, which
may not be apparent when the patient is supine on the operating
table. Similarly, drains are not used. Allowing the cavity to fill with
serum and fibrin maintains contour in the early postoperative
period and helps to avoid deformity. The procedure is completed
with two-layer closure of the deep dermis and the subcuticular
layer, and a light dressing is used.
There is no firm consensus on the extent of the excision or
margins required. The main benefit of BCT is preservation of body
image for the woman, which greatly improves her quality of life.
Several randomized controlled trials have shown that BCT and
radiation has a similar survival advantage as mastectomy as there
were no significant differences in the two groups in disease-free
survival, distant-disease-free survival, or overall survival and even
in loco regional control.74-80
Contraindications to breast conservation therapy (BCT) can be
divided into absolute or relative. Absolute contraindications
include lack of mammography facilities to ensure all tumors have
been removed, adequate pathology facilities to ensure tumor- free
resection margins and/or lack of radiotherapy facilities.10,11 Other
contraindications include pregnancy (first or second trimester
because of the risk of radiotherapy to the fetus), patients
preference, diffuse suspicious calcifications, inflammatory breast
carcinoma, previous radiation to the region, and inability to achieve
negative margins particularly with extensive intraductal carcinoma
(EIC). Relative contraindications also include two or more gross
tumors (multicentric disease) in different quadrants, tumor greater
than 5 cm initially or after neoadjuvant chemotherapy, large tumorbreast ratio for cosmesis, and collagen vascular disease.74
In Africa, many of the factors above make the practice of BCT
difficult and these include lack of adequate diagnostic oncology
services like mammography and surgical pathology, lack of
adequate therapeutic oncology services like radiotherapy,
advanced stage disease and poor follow up culture.5 Thus the
majority of the patients with early breast cancer in Africa should

still undergo total mastectomy and axillary clearance.


In a total or simple mastectomy, the patient is placed in the
supine position with the ipsilateral arm extended horizontally.
General anesthesia is used. The incision is in the form of an ellipse
is designed to include the skin overlying the tumor or biopsy scar
and the nippleareola complex. Superior and inferior skin flaps are
then raised. The plane between the subcutaneous tissue and
breast tissue is not always obvious and is most easily identified at
the medial superior flap; it is therefore easiest to begin here. The
skin flaps must be thin, to ensure that all the breast tissue is
removed, and yet enough subcutaneous fat to ensure adequate
blood supply to the skin. Superiorly the dissection must include
the tail of Spence laterally. Inferiorly, the dissection ends at the
inframammary fold. The entire breast, the skin ellipse, nippleareola complex are then dissected off the pectoralis fascia. The
procedure is completed with an en bloc excision of the axillary
lymph nodes level I and II (see description below). The
mastectomy site and axillary nodal basin are then irrigated with
saline solution, and meticulous hemostasis is achieved. The
wound is closed with a closed suction drainage bottle fixed to a
catheter brought out through a separate stab incision.
Modified radical mastectomy can be done alone or in
association with breast reconstruction. Reconstruction, using
implants or myocutaneous flaps, provides many women with an
enhanced body image and self-esteem, and better psychosocial
adjustment, but it does not impact on the probability of disease
recurrence or survival.81,82 One method becoming widely used is
the skin-sparing mastectomy (SSM) that conserves an extensive
section of skin, as well as the more recent skin and nipple-sparing
mastectomy that preserves the nipple-areolar complex.83-85 SSM is
clearly contraindicated in patients with direct involvement of the
skin by the underlying tumor. Nicotine, previous radiotherapy,
diabetes and obesity increase the risk of skin envelope ischemia,
skin necrosis and infection.
However, the additional cost of reconstruction is an issue
especially in resource poor countries.
Treatment of the axilla
Axillary lymph node dissection (ALND)
The status of axillary and internal mammary lymph nodes is the
most significant prognostic factor for survival in patients with
breast cancer. In breast cancer, the status of axillary and internal
mammary lymph nodes is the most significant prognostic factor
for survival. The axillary nodal basin has been the main target in
lymphatic staging in breast cancer because over 75% of the
lymphatic flow from the breast is directed to the ipsilateral axilla.
Axillary clearance (ALND) has been the gold standard in axillary
staging in breast cancer, providing valuable information about the
planning of adjuvant therapy, prognosis and an excellent regional
disease control as well. Removal of 10 or more nodes as assessed
by the pathologist provides accurate information about the axillary
nodal status of the patient.
The most accepted surgical axillary clearance procedure is a
level I and II axillary dissection, detecting 98.5% of cases with
positive axillary nodes.86 Either at the time of mastectomy, or
through a separate incision (if BCT), the lateral border of pectoralis
major muscle is identified. The clavipectoral fascia, extending
laterally from the edge of this muscle, is divided parallel to the
edge of the muscle to allow entry into the axilla. The superior
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border of the dissection is the lower border of the axillary vein;


dissection above the vein runs the risk of damage to the brachial
plexus. The nerves to latissimus dorsi (thoracodorsal) and to
serratus (long thoracic) are identified and are the posterior border
of the dissection. The lateral border is the floor of the axilla,
consisting of skin and subcutaneous tissue. Retraction of the
pectoralis minor muscle medially allows for the removal of level II
nodes. All the fatty tissue within these borders is removed. The
sensory intercostal brachial nerve runs through the axilla and may
or may not be preserved.
Sentinel node biopsy
Although long considered the standard management of the axilla for
breast cancer, ANLD is associated with significant arm morbidity
(20-25% risk of lymphedema) and risk of damage to the axillary vein,
nerve to the latissimus dorsi and serratus anterior and hypoesthesia
of the arm and the thorax. For these reasons, other less invasive but
accurate methods have been sought for axillary staging in breast
cancer, especially in the developed world, where three-quarters of
patients present with early node negative disease. Clinical
examination of the axilla and available diagnostic imaging
techniques like US, CT and PDG-PET are manifestly inaccurate for
axillary staging.
Less invasive than ALND, sentinel lymph node biopsy (SLNB) is
now accepted as an alternative to routine ALND for the detection
of occult lymph node metastases in patients with clinically nodenegative breast cancer.87,88 SNLD is based on the observation that
specific areas of the breast drain by way of afferent lymphatics to
a specific sentinel node. This node can be detected by injecting
vital blue dye (isosulfan blue dye, methylene blue or patent blue V
dye) or a radioactive suspension (Tc99m radioisotope labeled
colloids). The route of injections include intra parenchymal (peritumorally), intradermal or subareolar.88,89. The use of vital dye is
resource efficient (cheaper and less time consuming) and safer,
but may miss non axillary sites and also carries the risk of
anaphylactic reactions while radioactive agents are more
expensive, carries the risk of exposure to staff, and requires that
the hospital have a nuclear medicine department.
There are five principal aims for the excision and
histopathological analysis of the SN:
 minimally invasive assessment of the nodal status;
 selection of patients with positive SNs for elective lymph node
dissection (ELND) or adjuvant therapy;
 prevention of lymph node dissection and associated morbidity
in SN negative patients;
 detection of aberrant or alternative lymphatic drainage;
 improvement of sensitivity of histopathological detection of
lymph node metastasis.90
Further surgery of the axillary nodes now depends on the results
of the sentinel lymph-node biopsy if negative, ALND is avoided.
While SLNB is becoming widely used in the developed world as a
method to assess the axilla, ALND remains the recommended
management for treatment in any hospital that does not have
access to a nuclear medicine department or a dedicated breast
pathologist able to use specialized immunohistochemistry markers.
Radiotherapy in early breast cancer
The aim of radiotherapy to the whole breast after BCT is to
98 Hospital and Healthcare Innovation Book 2009/2010

establish local control. Numerous studies have shown reductions


in local recurrences from 12-35% to 2-10% at 5-10 years. This
compares to local recurrence rates after mastectomy of 5%.(91) In
most developed countries, the current standard of care for
patients with early-stage breast cancer consists of breastconserving surgery, followed by 56 weeks postoperative
radiotherapy used on the whole breast. Probabilities of adequate
local control rates and good cosmetic results are high with the use
of conventional fractionation. Patients who cannot receive
radiation are treated with mastectomy. Some recent papers
suggest a small survival advantage which was rather offset by the
long term toxicity from radiotherapy resulting in deaths from
vascular and cardiac injuries.92
Some data support the effectiveness of an additional dose
applied to the tumor bed (i.e., boost irradiation) to reduce local
recurrence. However, delivery of the boosting dose raises the rate
of morbidity, which reduces cosmetic outcome.
Recent advances in radiotherapy includes partial breast
irradiation using various techniques such as such as low or highdose rate brachytherapy (interstitially or with an intracavitary
balloon), conformal external-beam irradiation (including intensity
modulated radiotherapy), and intraoperative radiotherapy (Electron
Intra Operative Therapy-ELIOT).93,94
Most reports of partial breast irradiation have provided results
much the same as those achieved with conventional external
beam, even though some caution is needed until the safety and
efficacy of such irradiation have been shown in appropriate
patients and analysis of long-term treatment outcomes.95-97
Systemic treatment
More than half the women with operable breast cancer who
receive only locoregional treatment die from metastatic disease.
This indicates that breast cancer is a systemic disease and that
the micrometastatic process can occur early even independently
from lymphatic spread.76,98 The way to improve survival is to give
these women systemic medical treatment, including endocrine
therapy, chemotherapy, or targeted therapy with trastuzumab
along with surgery/radiotherapy.
Systemic treatment may be given after (adjuvant) or before
(neoadjuvant, primary, or preoperative) locoregional treatment.
Adjuvant treatment has been shown to be effective in randomized
clinical trials, whereas the evaluation of neoadjuvant systemic
therapy is ongoing.
It is important to realize, especially in the African context, that any
systemic therapy including hormonal therapies, will at least
temporarily interrupt child bearing. The current recommendations of
at least 5 years of Tamoxifen after diagnosis will significantly impact
on the ability of a woman to bear many children. Chemotherapy will
cause most women to stop menstruating and permanent premature
menopause is common. These recommendations listed below,
based on the culture of the developed world, may not be
acceptable or applicable to African women.
The choice of systemic adjuvant therapy in early breast cancer
will depend on the following factors; estrogen (ER)/progesterone
(PR) receptor status, menopausal status and over-expression of
HER2. It will also depend significantly on the risk of recurrence and
therefore the potential benefit of the treatment. Any systemic
therapy carries with it a risk of toxicity, and can be quite expensive.
A woman at high risk of recurrence will benefit significantly from

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Figure 1: Advanced breast cancer

treatment while for a woman at low risk the benefit will be small yet
she will be exposed to the same toxicity. For example, a 20%
reduction with chemotherapy for a patient with a baseline 50% risk
of recurrence will result in an absolute reduction to 10% (from 50%
to 40%) where as a woman with a 10% recurrence risk reduces
her risk of recurrence to 8%, only a 2 % absolute reduction. Some
women would not choose chemotherapy for a 2% risk reduction
and others might. The decision to take systemic therapy therefore
is therefore very much dependent on the woman and her
understanding of these risks.99
Adjuvant endocrine therapy is effective in ER and/ or PR positive
tumors. The most commonly used endocrine therapy is the
Selective Estrogen Receptor Modulator (SERM) Tamoxifen, used
in premenopausal women. Other SERM agents like Toremifene
and Raloxifene are equally effective. There is strong evidence to
support the superiority of a 5 year Tamoxifen therapy over shorter
durations. Tamoxifen in addition helps to maintain bone mineral
density in post menopausal women and reduces the risk of
developing cancer in the contralateral breast. The side effects of
Tamoxifen include hot flashes, risk of thrombo-embolic disease,
endometrial carcinoma and cataracts.
For post-menopausal women, third generation selective
aromatase inhibitors have been shown in recent trials to be more
effective than Tamoxifen and have become the standard of care.
Examples include non steroidal type (anastrozole and letrozole)
and the steroidal type exemestane. Patients using aromatase
inhibitors have less gynecological symptoms such as endometrial
cancer, vaginal bleeding, and vaginal discharges. Fewer
cerebrovascular events and venous thromboembolic events were
also observed with patients receiving aromatase inhibitors.
However, musculoskeletal effects (arthritis, arthralgia, and/or
myalgia) and bone toxicity (bone fractures) are associated with
aromatase inhibitors.
The combination of endocrine therapy and cytotoxic
chemotherapy provides benefits greater than the benefits from
either therapy alone. They are therefore usually offered sequentially,
with chemotherapy given right after surgery, local radiation therapy
is then given, and endocrine therapy commenced. Premenopausal
women are given Tamoxifen for five years. The optimal duration of
the aromatase inhibitors has not yet been determined and
postmenopausal women remain on them indefinitely.
Ovarian ablation (e.g., surgical oophorectomy or radiation
ablation) or suppression (e.g., use of the gonadotropin- releasing
hormone or luteinizing hormone-releasing hormone analogues) is
another effective way to reduce estrogen in premenopausal
women. It can be used as an adjuvant treatment alone or to
induce menopause in very high risk premenopausal women to
allow the use of adjuvant aromatase inhibitors.
Chemotherapy
Chemotherapy has been shown to substantially improve the long-

term, relapse-free, and overall survival in both premenopausal and


postmenopausal women up to age 70 years with lymph nodepositive and lymph node-negative disease irrespective of the
hormone receptor status.
The administration of polychemotherapy (two or more agents) is
superior to the administration of single agents. Four to six courses
of treatment (36 months) appear to provide optimal benefit, with
the administration of additional courses adding to toxicity without
substantially improving overall outcome. Popular regimes include
CMF (cyclophosphamide, methotrexate,fluorouracil), CAF, AC,
FEC. Anthracycline based adjuvant therapy (with doxorubicin or
epirubicin) result in a small (4-5%) but statistically significant
improvement in survival compared with non-anthracyclinecontaining regimens.100.
Trials using accelerated or dose dense chemotherapy (two
weekly interval instead of the standard three weeks) with
granulocyte colony stimulating factor (GCSF) support to overcome
the risk of neutropenic sepsis has been demonstrated to improve
both disease free survival and overall survival with fewer
neutropenic crises.
Trials using high dose chemotherapy with haemopoietic stem
cell rescue on the other hand showed high morbidity and no
benefit from this approach.
Around 20% of breast cancers over express HER2, and this is
associated with an adverse prognosis. Trastuzumab is a
humanised monoclonal antibody directed against the external
domain of the receptor with clinical activity as a single agent
inpatients whose cancers over express HER2.
Trastuzumab in combination with Taxanes and other drugs have
shown considerable improvement in metastastic breast cancer. Its
role in the adjuvant setting in early breast cancer has been so
successful in HER2 positive breast cancer showing significant DFS
and OS. Unfortunately, the cost implication is a drawback to its
use in countries with limited resources.
Bisphosphonates are drugs that inhibit osteoclast mediated
bone resorption induced by tumors. Some adjuvant trials indicate
that two years of oral clodronate reduces the incidence of bone
metastases. One trial showed a small, but significant,
improvement in overall survival. Further trials are underway with
clodronate and the newer, more potent bisphosphonate
zoledronate to define their long term effectiveness.
They are very useful in patients taking Aromatase inhibitors
because of the risk of bone loss and fractures.
Advanced Breast Cancer (Stages III and IV):
This includes Locally Advanced Breast Cancer (LABC),
metastastic cancer and recurrent cancer. (see Figure 1)
LABC
LABC refers to Stage III tumors according to the TNM staging.
Locally advanced breast cancer (LABC) accounts for at least half
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of all breast cancers in countries with limited resources and has a


poor prognosis12. Locally advanced tumors include tumours that
present with palpable lymph node metastases, ulcerations, tumors
greater than 5 cm etc.
A subtype of LABC that deserves some further discussion is
Inflammatory Breast Cancer (IBC). Inflammatory breast cancer is a
rare but aggressive subtype of breast cancer, which historically
was considered uniformly fatal. Clinically, inflammatory breast
cancer is characterized by the rapid onset of breast warmth,
erythema, and edema (peau dorange) often without a welldefined mass.
Along with extensive breast involvement, women with
inflammatory carcinoma often have early involvement of the axillary
lymph nodes. In general, women with inflammatory breast cancer
present at a younger age are more likely to have metastatic
disease at diagnosis, and have shorter survival than women with
non-inflammatory breast cancer.101-103 The management of LABC
requires a combined modality treatment approach involving
surgery, radiotherapy and systemic therapy.
Radiotherapy in LABC
Radiotherapy after MRM or mastectomy to the chest wall or axilla
is restricted to patients with high risk of recurrence. These include
tumors larger than 5 cm in maximum diameter and those with
four or more involved axillary lymph nodes, those with positive
surgical margins on resection, and those with involvement of the
skin or underlying chest wall.12 It can also be a very effective local
modality in controlling or shrinking tumors that are not amenable
to surgical therapy.
Preoperative and locoregional treatment
The initial management should be neoadjuvant chemotherapy
with Doxorubicin- or Epirubicin-based or Paclitaxel- or Docetaxel
based chemotherapy. Patients with HER2 positive tumors should
be considered for preoperative chemotherapy incorporating
Trastuzumab.
The advantages of neoadjuvant therapy include down staging of
the tumor, improving operability of tumors and increasing the
chances of BCT.
For patients that respond to neoadjuvant chemotherapy, the
following options are recommended71,104-108 modified radical
mastectomy, radiotherapy to the chest wall and supraclavicular
nodes (plus internal mammary nodes if involved) with or without
delayed breast reconstruction. In those women with LABC who do
not have access to neoadjuvant chemotherapy because of
economic constraints or radiotherapy, mastectomy with node
dissection, when feasible, may still be considered in an attempt to
achieve local-regional control.12 The second option is BCT with
surgical axillary staging, radiotherapy to the breast, supraclavicular
nodes (plus internal mammary nodes if involved).
However, for patients who fail to respond to preoperative
chemotherapy, recommended treatment is to consider additional
systemic chemotherapy and/or preoperative radiation.
Adjuvant treatment
Chemotherapy should contain an anthracycline. Acceptable
regimens are 6 cycles of 5 Fluorouracil, Doxorubicin,
Cyclophosphamide (FAC) or Cyclophosphamide, Epirubicin,
5Fluorouracil (CEF). Sequential addition of Taxanes has also
100 Hospital and Healthcare Innovation Book 2009/2010

proven very effective.


Tamoxifen for 5 years should be recommended to pre- and
postmenopausal women whose tumours are hormone responsive.
Aromatase inhibitors like Letrozole, Anastozole and Examestane
can be used in post menopausal patients.
Surgical oophorectomy causing ovarian ablation is a very
effective therapy in the treatment of locally advanced and
metastatic ER positive breast cancer in premenopausal women.
This therapy is one that would be very feasibly applied in Africa
provided that it was acceptable to the woman.
Metastastic and recurrent cancer
The standard evaluation procedure for this group of patients
includes history and clinical examination, full blood count, liver
function test, platelet count , chest X-ray, limited skeletal survey
especially of any long or weight bearing bones that are painful,
biopsy of recurrence, evaluation of hormone receptor status,
ultrasound of the abdomen or CT where available.
Others include bone scans, MRI, PET, and determination of
HER2 status of the tumor. These are however tall orders in
countries with limited resources and where there are no medical
insurances to cover the cost of these investigations. Pragmatism
is required in this setting.
Treatment of local recurrence
Local recurrence can occur in two settings; post BCT or MRM.
Post MRM local recurrence should undergo local resection of
the recurrence where feasible without unnecessarily endangering
the lives of the patients. In addition, radiotherapy of the involved
area should be done if the chest wall was not previously irradiated
or if it could be done safely.
Post BCT patients should undergo a total mastectomy.
Systemic therapy for local recurrence could be adjuvant
chemotherapy or endocrine therapy as in LABC.
Addition of Hyperthermia to radiotherapy has been shown in
some trials to cause a statistically significant increase in local
tumor response and greater duration of local control. This is
however technically demanding and resource intensive.
Systemic disease
Systemic recurrence and metastatic cancers are incurable, so the
goals of therapy are to prolong survival, improve quality of life with
minimal morbidity or toxicity from the therapy.
Minimally toxic endocrine therapy is therefore preferred to the
use of cytotoxic therapy whenever indicated. Endocrine therapies
are indicated in women with hormone receptor status, bone or
soft tissue disease only and those with limited asymptomatic
visceral disease. For post menopausal women, the choice is
between Tamoxifen and aromatase inhibitors, with aromatase
inhibitors having a slight edge especially in those who have taken
anti-estrogen previously.
For premenopausal women who are anti-estrogen nave, antiestrogen with or without LHRH agonist is the preferred choice.
Oophorectomy is an excellent cheap alternative where drugs are
not available.
Since the majority of African women with breast cancer are
hormone receptor negative, few will benefit from endocrine
therapy, chemotherapy will be the option in most cases.
Premenopausal patients who have taken anti-estrogen

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previously have a choice of either surgical or radiotherapeutic


oophorectomy or luteinizing hormone-releasing hormone (LHRH)
agonists with or without an antiestrogen.
Endocrine therapies in postmenopausal women include
selective, nonsteroidal aromatase inhibitors (anastrozole and
letrozole); steroidal aromatase inhibitors (exemestane); pure
antiestrogens (fulvestrant); progestin (megestrol acetate);
androgens (fluoxymesterone); and high-dose estrogen (ethinyl
estradiol). In premenopausal women, therapies include LHRH
agonists (goserelin and luprolide); surgical or radiotherapeutic
oophorectomy; progestin (megestrol acetate); androgens
(fluoxymesterone); and high-dose estrogen (ethinyl estradiol).
Chemotherapy is the best option in women with estrogen and
progesterone receptor-negative tumors, symptomatic visceral
metastasis, or endocrine therapy refractory disease.
The higher rates of objective response and longer time to
progression of combination chemotherapy are at the expense of
increased toxicity with little survival benefit.
Therefore, there is no significant advantage of combination
chemotherapy over sequential single agents.
Preferred first-line chemotherapies include sequential single
agents or combination chemotherapy. Among preferred first-line
single agents, are doxorubicin, epirubicin, pegylated liposomal
doxorubicin, paclitaxel, docetaxel, capecitabine, vinorelbine (all
category 2A), and gemcitabine (category 2B). Among preferred
first-line combination regimens are cyclophosphamide,
doxorubicin, and fluorouracil (FAC/CAF); fluorouracil, epirubicin,
cyclophosphamide (FEC); doxorubicin, cyclophosphamide (AC);
epirubicin, cyclophosphamide (EC); doxorubicin in combination
with either docetaxel or paclitaxel (AT); cyclophosphamide,
methotrexate, fluorouracil (CMF); docetaxel, capecitabine;
gemcitabine, paclitaxel.
Patients with tumors that are HER2-positive may derive benefit
from treatment with trastuzumab as a single agent or in
combination with selected chemotherapeutic agents. 27% of
patients treated with a combination of Trastuzumab and
doxorubicin/cyclophosphamide chemotherapy develop significant
cardiac dysfunction making this regime unsafe and unpopular.71
Treatment of complications
In Africa, a good number of women present with fungating/
ulcerating masses and many of them are so ill that they can not
undergo surgery or radiotherapy immediately. The following are
some useful supportive measures:
 Dressing of the wound with honey and metronidazole
cleanses and remove the odor. This measure in addition to the
use of neoadjuvant chemotherapy has largely reduced the
need for toilet mastectomy.
 Clean malignant ulcers are prone to secondary hemorrhage;
topical formalin is effective in this setting.
 Pain is another significant problem and this may be due to the
disease, therapy or depression. Optimal pain management is
very crucial to improving the quality of life. If pain occurs, there
should be prompt oral administration of drugs in the following
order: non-opioids (aspirin and paracetamol); then, as
necessary, mild opioids (codeine); then strong opioids such as
morphine, until the patient is free of pain. To calm fears and
anxiety, additional drugs adjuvants should be used. To
maintain freedom from pain, drugs should be given by the

clock, that is every 3-6 hours, rather than on demand This


three-step approach (see figure 2) of administering the right
drug in the right dose at the right time is inexpensive and 8090% effective. Surgical intervention on appropriate nerves may
provide further pain relief if drugs are not wholly effective.109
 Anemia as a result of the disease or chemotherapy is often
under treated and underestimated in patients. It has a negative
impact on quality of life and survival. It will require blood
transfusion in some women. The introduction of recombinant
human erythropoietin (epoetin) has provided an effective and
convenient treatment of anemia without the risks of blood
transfusion. Epoetin is also effective for the prevention of
anemia and reduction of transfusion requirements in patients
with a high risk of developing anemia during chemotherapy.110-112
 Lymphedema of the arm is a very distressing complication
which may occur as a result of the disease itself or as a result
of surgery or radiotherapy in the treatment of breast cancer.
Treatment options include compression treatments (using
compression bandage or garments and pneumatic
compression devices), therapeutic exercises and
pharmacotherapy (antibiotics, flavonoids, hyaluronidase, and
selenium). Diuretics have not been found useful.113,114
 Respiratory distress in advanced breast cancer may be as a
result of pleural effusion or deposits in the lungs. Closed
thoracostomy tube drainage with pleurodesis using
Tetracycline or Bleomycin is an effective treatment. Lung
metastasis can be treated with steroids inhalers, bronchodilators,
diuretics, anxiolytics, chest physiotherapy and oxygen.5
 Neurological complications include cerebral metastases,
spinal, leptomeningeal, cranial and peripheral nerve
metastases.115 Treatment includes steroids,
radiotherapy and surgery for localized metastases.
Younger women with breast cancer are more prone to physical
and psychological distress which makes them have poorer quality
of life outcomes. These arise as a result of the disease and the
complications of treatment. Gonadal toxicity leading to irregular
menses, amenorrhea and premature menopause is especially
disturbing for African patients, the majority of whom are in their
reproductive age group. Other problems like Alopecia, fertility
problems and the cost of treatment may severely affect
relationship especially among young couples. In this context, a
multi disciplinary approach is important which will involve
psychologists, social welfare/support groups and various
advocacy groups where survivors of breast cancer can share their
experiences and support one another.116-120

Prognosis
Natural history
The natural history of breast cancer in 250 untreated women
revealed the following statistics; Median survival of untreated breast
cancer was 2.7 years after initial diagnosis. The 5- and 10-year
survival rates were 18.0 and 3.6%, respectively. Only 0.8% survived
for 15 years or longer. Autopsy data confirmed that 95% of these
women died of breast cancer, while the remaining 5% died of other
causes. Almost 75% of the women developed ulceration of the
breast during the course of the disease. The longest surviving
patient died in the nineteenth year after diagnosis.121
With modern treatment, the 5-year survival rate for stage I
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Table 5: Microscopic criteria for grading of invasive carcinoma

Level of resource
Basic

LOCAL-REGIONAL TREATMENT
Surgery
Modified radical mastectomy

Limited

Radiation therphy

SYSTEMIC TREATMENT (ADJUVANT)


Chemotherphy
Endocrine therphy
Neoadjuvant AC,
Ovarian therapy
FAC or classical CMF*
Tamoxifen

Postmasectomy irradiation of the chest


wall and regional nodes

Enhanced

Breast-conserving theraphy**

Maximal

Reconstructive surgery

Breast-conserving whole-breast irradiation

Tamoxifen

Aromatese inhibitors
LH-RH agonists

Growth factors
Dose-dense chemotherapy

*Requires blood chemistry profile and complete blodd count (CBC) testing
** Breast-conserving therapy requires mamography and reporting of margin status.
AC, doxonubian and cyclosphamida; CMF, cyclophamide, methotrexate, and 5- fluorourcil; EC, epirubicin and cyclophosphamide; FAC, 5 - fluorourcil doxonubicin, and cyclophosphamide;
LH+RG, lutelnizing hormone-releasing hormone

patients is 94%; for stage IIa patients, 85%; and for stage IIb
patients, 70%, while for stage IIIa patients the 5-year survival rate
is 52%; for stage IIIb patients, 48%; and for stage IV patients, 18%.
Prognostic Iindicators:
Tumor size
Prognosis deteriorates with increasing tumor size, which is an
independent predictor of survival in node-negative patients and
correlates with the incidence of nodal metastases.
Staging
The status of the axillary lymph nodes is one of the most useful
prognostic indicators for breast cancer, with average 10-year
survival rates of 60-70% for node-negative patients, dropping to
20-30% in node-positive patients.
Histopathology
 Histologic type
Carcinoma in situ, because it is a preinvasive condition, is
curable if completely removed, although 16% of patients with
carcinoma in situ develop invasive recurrence after local
excision of ductal carcinoma in situ, usually high grade.
Similarly, 18% of patients develop invasive recurrence after
lobular carcinoma in situ excision.
Well-differentiated invasive cancers have a relatively good
prognosis if they are tubular, mucinous, cribriform, or
secretory.
Medullary carcinoma is probably of intermediate prognosis, but
different studies have used different criteria for its definition.
Invasive ductal and invasive lobular carcinomas have a less
favorable prognosis but are influenced heavily by other factors.
 Cytologic grade
Cytologic grade is the best predictor of disease prognosis in
carcinoma in situ but is dependent on the grading system
used, such as the Van Nuys classification (high-grade, lowgrade comedo, low-grade noncomedo).
The grading of invasive carcinoma is also important as a
prognostic indicator, with higher grades indicating a worse
prognosis. Microscopic criteria for grading are shown in
Table 5.
102 Hospital and Healthcare Innovation Book 2009/2010

 Lymphovascular: Lymphatic invasion, vascular invasion,


microvessel quantification, and lymphoplasmacytic infiltration
are associated with a worse prognosis.
 Hormone receptor status: With the aid of gene expression
studies using DNA microarrays and immunohistochemistry,
several distinct biologic breast cancer subtypes have been
identified. These subtypes differ markedly in prognosis and in
the number of potential therapeutic targets they express.
The intrinsic subtypes include 2 main subtypes of estrogen
receptor (ER)negative tumors (basal-likeand human epidermal
growth factor receptor-2 positive/ER- [HER2_/ER-] subtype) and
at least 2 types of ER+ tumors (luminal A and luminal B). The basal
like subtype carries poor biologic (worse grade) and clinical
prognostic indicators like positive axillary nodes.
This subtype was found to be more prevalent in pre-menopausal
African-American women compared to post menopausal AfricanAmerican women and other races.122 This finding may be one of the
reasons why African-American women with breast cancer have
high grade, late stage tumor and with poor prognosis and poor
survival outcome.
The similar clinical outcome of native African women with breast
cancer may tempt one to extrapolate these findings seen in
African-American women. To lend credence to this fact, the few
studies on hormone receptor status of breast cancer in native
African women show that the majority of them are Estrogen or
Progesterone negative123-125.
There are also several other provocative parallels between
African-American and native African breast cancer patients which
include a younger age distribution and a greater prevalence of high
grade, estrogen-receptor-negative disease among breast cancer
patients in the Ghanaian and Nigerian populations of western
Africa similar to the patterns of breast cancer reported among
African-American women. Western African populations served as
the source for most of the slave trade to colonial North America,
and therefore share a common ancestry with present-generation
African Americans. These parallels suggest the possible
contribution of founder effects.16
However, further research needs to be done in this area before
reaching any conclusion is reached as the African-Americans are

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Table 6: Treatment and allocation of resources: Metastatic (stage IV) and recurrent breast Cancer

Level of resource
Basic

LOCAL-REGIONAL TREATMENT
Surgery
Radiation therphy
Total mastectomy for
ipeilateral breast tumor recurrance*

Limited

Pallative radiation therapy

Enhanced

Maximal

Reconstructive surgery

Chemotherphy

SYSTEMIC TREATMENT (ADJUVANT)


Endocrine therphy
Supportive and pallative ther
Ovarian ablation
Nonopioid and opioid
Tamoxifen
analgesics

Classical CMF**
Anthracycline montherapy
or in combination**

Taxanes
Capecitabine
Trastzumab

Aromatese inhibitors

Growth factors
Vinorebine
Gemcitabine
Carboplatin

Fulvestrant

Biophosphonates

* Required resources are the same as those modified radical masectomy


** Requires blood chemistry profile and complete blood count (CBC) testing. CMF, cyclophosphamides, methotrexate and 5-fluorouracil

a heterogeneous group with mixed genetic heritage consisting of


Hispanics, Caucasians and Africans. In addition other
socioeconomic factors and environmental factors may contribute
to the clinical outcome seen.126,127
 Immunohistochemistry
The most widely used tests are for the estrogen receptors (ER)
and progesterone receptors (PR). Immunohistochemistry
analysis of heat-treated paraffin sections has largely
superseded the enzyme-linked immunosorbent assay (ELISA)
ligand-binding assay. ER- and PR-positive status (ie, >10 fmol
on ELISA; >15 H-score on immunohistochemistry) predict
improved response to endocrine treatment, time to relapse,
and overall survival.
Immunohistochemical positivity for c-erb-B2 and p53 is
associated with a worse prognosis.
HER-2 status: The human epidermal growth factor receptor-2
(HER-2/neu) is a well-characterized biomarker in the biology of
breast carcinoma that has had immediate impact on clinical
medicine. The positive status of HER-2/neu is associated with
a younger age and several adverse prognostic factors, i.e.,
advanced stage, absence of estrogen and progesterone
receptors, metastasis to axillary lymph nodes, and high
nuclear grade. In addition, women diagnosed with
positiveHER-2/neu breast carcinoma generally have relative
resistance to anthracycline-based chemotherapy, tamoxifen
therapy, and have shorter disease-free and overall survival.128
Other prognostic indicators
Advances, in the knowledge of the molecular mechanisms that
influence normal and aberrant cell growth, have led to the
identification of an increasing number of surrogate biomarkers,
which have been correlated with prognosis or used as predictors
of response to specific treatments. These novel prognostic
markers can be classified as follows:
 Oncogene products
Bcl-2
p53
HER-2/neu

Cyclin D1
Nm23
 Proteases
uPA
Cathepsin D
Tenascin C
 Markers of proliferation - Ki-67
HER-2/neu identifies patients with a poor prognosis. These
patients are likely to respond to treatment with trastuzumab
(Herceptin).
Tumors positive for Ki-67 have a high metastatic potential and
warrant the possible use of early aggressive therapy.
uPA and cathepsin D identify poor prognosis node-negative
tumors. In these cases, chemotherapy can be offered.
The use of gene expression profiling to detect breast carcinoma
has already shown that the differential expression of specific genes
is a more powerful prognostic indicator than traditional
determinants such as tumor size and lymph node status. These
molecular assays are awaiting clinical validation.

Prevention
Screening as currently practiced can reduce mortality but not
incidence, and then only in a particular age group. Advances in
treatment have produced significant but modest survival benefits.
A better appreciation of factors important in the etiology of breast
cancer would raise the possibility of disease prevention. Currently,
prevention strategies fall into two groups: chemoprevention and
surgical prophylaxis.
Chemoprevention is defined as the systemic use of natural or
synthetic chemical agents to reverse or suppress the progression
of a premalignant lesion to an invasive carcinoma129. Tamoxifen is
currently the only agent that has been approved clinically for use
in women with high risk of developing cancer. Raloxifene,
selenium, retinoids, aromatase inhibitors and cyclo-oxygenase 2
inhibitors require further clinical investigation before adoption in
this context.
Surgical prophylaxis: by either a bilateral mastectomy or
oophorectomy, is another avenue of prevention. Some studies
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Table 7: Healthcare systems and public policy

LEVEL OF RESOURCE SERVICE


Basic
Primary care service
Surgical services
Pathology services
Oncology services
Nursing services
Pallative services

FACILITIES
Health facility
Operating facility
Pathology laboratory
Pharmcay
Outpatient care facility

RECORD KEEPING
Individual medical records and servvice-based patient registartion

Linked

Imaging facility
Radiation theraphy
Clinical information systems
Health system network

Facility-based medical records and centrilized patient registration

Imaging services
Radiation oncology services
Peer support services
Early detection programme

Local cancer registry

Enhanced

Opportunistic screening programme Centralized referal cancer centre(s) Facility-based follow-up registry
Cancer follow-up
Rehabilitation services
Population based cancer registry Regional Cancer registry

Maximal

Population based
screening programme
Individual psychological care

Sarellite (non-centralized
or regional) Cancer centre

have demonstrated that women with definite BRCA1 or BRCA2


mutation may have an overall reduction in their breast cancer risk
profile after such operation.130
Dietary intervention If specific dietary factors are found to be
associated with an increased risk of breast cancer dietary
intervention will be possible. However, reduction of dietary intake
of such a factor in whole communities may well be difficult to
achieve without major social and cultural changes. Dietary fat
reduction and exercise decrease the circulating serum oestradiol
level, but whether this in turn leads to a reduction in the incidence
of breast carcinoma has not been determined conclusively.131

National Cancer registry

 the stage of the breast cancer.


A detailed guideline on the management of breast cancer in
pregnancy can be found in the NCCN Clinical Practice Guidelines
in Oncology Breast cancer V.1.2007 at www.nccn.org.
Early studies have indicated that the prognosis of breast cancer
in pregnancy is very poor; however, more recent studies with more
careful consideration of age and the stage of the disease show no
significant differences. Evidence is lacking that termination of
pregnancy changes the outcome of breast cancer. Pregnancy
after breast cancer does not alter the outcome of treatment. The
ideal interval between treatment for breast cancer and subsequent
pregnancy is unknown.132

Breast cancer and pregnancy


Pregnancy associated breast cancer is defined as breast cancer
diagnosed during pregnancy or lactation or one year post partum.
Breast cancer and pregnancy can be classified into three main
situations; these are (a) breast cancer that is detected during the
evolution of pregnancy, (b) breast cancer that is detected during
lactation or postpartum, and (c) pregnancy in patients who have
had a previous breast cancer. Cancer complicates approximately
1 per 1000 pregnancies and accounts for one-third of maternal
deaths during gestation. The prevalence of breast cancer during
pregnancy is increasing due to delayed onset of childbearing.
Breast cancer is diagnosed in approximately 1 in 3000
pregnancies. The incidence ranges from 0.76% to 3.8% of breast
cancer cases. The median age of pregnant women affected with
breast cancer is 33 years. In a recent review in Nigeria, 12% of the
patients with Breast Cancer were pregnant or lactating and 74%
were premenopausal , making it the most frequently occurring
malignancy during pregnancy, along with cancer of the uterine
cervix.(5) Treatment decisions for breast cancer patients during
pregnancy become most difficult because not only the mother but
also the fetus is involved. The final advice should be based upon
the following considerations:
 the parents decision whether or not to continue with the
pregnancy,
 the period of pregnancy when the breast cancer is
diagnosed, and
104 Hospital and Healthcare Innovation Book 2009/2010

Breast cancer in males


Male breast cancer is an uncommon disease although the
incidence has increased over the past 25 years. Less than 1% of
all breast cancer patients are male. Rates of male breast cancer
vary widely between countries: in Uganda and Zambia the annual
incidence rates are 5% and 15%, respectively of all breast cancer
cases. These relatively high rates have been attributed to endemic
infectious diseases causing liver damage, leading to
hyperestrogenism. By contrast, the annual incidence of male
breast cancer in Japan is less than five per million, in parallel with
the lower than average incidence of female breast cancer in that
country. Jewish men are the only racial group with a higher than
average incidence (23/100 000 per year), irrespective of living in
Israel or the USA.133 Risk factors for Breast Cancer include Genetic
(BRCA2, Klinefelters syndrome), Lifestyle (Obesity, Alcohol,
Estrogen intake), Work (High ambient temperature, Exhaust
emissions), and Disease (Testicular damage, Liver damage,
Radiotherapy to chest) The predominant histological type of
disease is invasive ductal, which forms more than 90% of all male
breast tumors.
Much rarer tumour types include invasive papillomas and
medullary lesions. Lobular carcinoma of the male breast has been
reported not only in men with Klinefelters syndrome, but also in
genotypically normal men with no previous history of oestrogen
exposure or gynaecomastia. In large studies of male breast cancer,

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oestrogen receptor positivity has been reported in more than 90%


of tumours, with 9296% being progesterone-receptor positive.
Some studies suggested that breast cancer has a worse
prognosis in men than in women, but if age- matched and stagematched breast cancer is compared, there is no difference
between the sexes18;134;135
Future trends and controversies
 Diagnosis and early detection Several new technologies,
apart from mammography are being evaluated to improve the
early detection of breast cancer. These include non ionizing
imaging techniques like Ultrasonography and MRI. Other
imaging tools being evaluated include scintimammography,
positron emission tomography, magnetic resonance
spectroscopy, optical imaging, thermo-acoustic computed
tomography, microwave imaging, Hall effect imaging etc.
 Molecular targets and new drugs HER-2 Pertuzumab
(also known as 2C4, Omnitarg) is a new recombinant
humanised monoclonal antibody that also binds the
extracellular portion of HER2, which causes steric hindrance
and impairs receptor dimerisation. Ongoing phase-I testing
has shown activity in patients with breast cancer that is either
HER2-negative and trastuzumab-refractory HER2-positive.
 Tyrosine kinase, cyclines, and proteosoma Most tyrosinekinase inhibitors are in preclinical investigations and only a few
have been tested in patients with advanced breast cancer.
Gefitinib is an inhibitor of the tyrosine kinase of human
epidermalgrowth-factor receptor (HER1) and has shown some
antitumour activity in preclinical studies and a phase II trial of
patients heavily pretreated for metastatic breast cancer.
 Insulin-like growth factor (IGF) IGF is an interesting
therapeutic target in breast cancer because its ligands and
receptors are often overexpressed and are implicated in
proliferation, transformation, and metastasis. The IGF system
includes ligands IGF-I and IGF-II, receptors IGF-IR and IGF-IIR,
and six known IGF-binding proteins. These binding proteins
are promising targets for the manipulation of endocrine
responsiveness and resistance to Trastuzumab.
 Angiogenesis Bevacizumab is a recombinant, humanised
monoclonal antibody to vascular endothelial growth factor that
has shown some efficacy when used alone in phase II clinical
trials. Several anti-angiogenic drugs have been tested for
efficacy, including thalidomide, endostatin, angiostatin,
SU6668, SU11248, and cyclo-oxygenase 2 (COX-2) inhibitors.
COX-2 also improves the efficacy of
 Receptors as targets for radionuclides Efficacy of targeted
therapy depends on the biologically relevant quality and
quantity of the specific compound. This treatment needs to
reach the target efficiently and accurately and exert a selective
therapeutic effect. The development of biomarkers to assess
in-vivo responses and the ability to use such biomarkers as
targets for specific radionuclide treatment represent great
challenges in cancer medicine.
In situ ablation
In situ ablation of the primary tumour has been suggested as an
alternative to surgery. There are preliminary reports on methods
using cryosurgery, or coagulating with heat, delivered by a laser
fiberoptic technique .

Who will perform breast surgery?


Within the next decade the number of patients undergoing axillary
surgery will diminish as a result of improved staging by sentinel
node biopsy. A greater part of the patients will have only breast
resection, and these operations can be performed as day-case
surgery, even under local anaesthesia. The surgical challenges
during the next decade will be immediate breast reconstruction
and various oncoplastic procedures. Therefore breast surgery will
increasingly be performed by plastic surgeons. General surgeons
will not be so interested in carrying out all the other rather
undemanding breast procedures.136
Controversies
 Relevance.
 The place of post mastectomy radiotherapy in early breast
cancer especially in women with T1 ,T2 and one to three
positive lymph nodes.
 Sequencing of post mastectomy radiotherapy and breast
reconstruction.137
 The impact of mammographic screening in reduction of
mortality in breast cancer.

Conclusion
Management of breast cancer is a major challenge in resource
limited countries.
Efforts should be geared towards early diagnosis, prompt and
standardized treatment to reduce the burden of advanced disease
in African women, majority of who are worse hit in the most
productive part of their life time.
Our knowledge about breast cancer is evolving, but is still
limited with respect to its etiology and biology, and with respect to
its features in individual countries and cultures.
Further research is needed to understand the role of genetics
and environment in the etiology of breast cancer in Africa.

Recommnedations
In high-resource countries, evidence-based guidelines outlining
optimal approaches to early detection, diagnosis, and treatment of
breast cancer have been defined and disseminated. These
guidelines unfortunately are not applicable in countries with
resource constraints as they are not economically feasible or
culturally appropriate.
The following recommendations might be considered appropriate
in the resource-poor countries of Africa. Following the Breast Health
Global Initiative we have stratified the recommendations into Basic,
Limited, Enhanced and Maximal.10-12,138
Definition of stratification terms
 Basic level Core resources or fundamental services
absolutely necessary for any breast healthcare system to
function. By definition, a healthcare system lacking any basiclevel resource would be unable to provide breast cancer care
to its patient population. Basic-level services are typically
applied in a single clinical interaction.
 Limited level Second-tier resources or services that
produce major improvements in outcome, such as increased
survival, but which are attainable with limited financial means
and modest infrastructure. Limited-level services may involve
single or multiple clinical interactions.
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 Enhanced level Third-tier resources or services that are


optional but important. Enhanced-level resources may produce
minor improvements in outcome but increase the number and
quality of therapeutic options and patient choice.
 Maximal level High-level resources or services that may be
used in some high-resource countries, but nonetheless should
be considered lower priority than those in the basic, limited, or
enhanced categories on the basis of cost or impracticality for
limited-resource environments. In order to be useful, maximallevel resources typically depend on the existence and
functionality of all lower-level resources.
Our own recommendations include:
 Early Detection and Diagnosis: Possible less resourceintensive methods for earlier diagnosis of breast cancer like
education in breast awareness, training in breast selfexamination (BSE), regular clinical breast examination (CBE) by
experienced personnel and diagnostic ultrasound may be the
option in resource limited countries as mammography
screening may be resource intensive.69
 To improve breast pathological capacity and services in Africa,
the following approaches may be explored; including training
pathologists, establishing pathology services in centralized
facilities, and organizing international pathology services. In
particular it is important that estrogen and progesterone
receptor status of tumors be identified.
 As staging is crucial to treatment decisions and prognosis, a
thorough clinical evaluation after the diagnosis of breast cancer
to check for clinically obvious indications of metastases to the
lymph nodes and other areas is crucial. In addition, tests to
assess the presence of metastases to the lungs, liver, and
bone provide valuable information, if available. Hormone
receptor testing of pathology specimens should be part of the
pathology services
 More training for surgeons in BCT and Sentinel node biopsy. J
Acknowledgements
Recommendations are presented in tabular form and are
reproduced with permission from the BHGI.
References

Reprinted with kind permission from Surgery in Africa Monthly


Review February 2007
Charles A Adisa, MBBS, FWACS, FACS- Dr Adisa is Professor of
Surgery at the Abia State University(ABSU) and a honorary
Consultant Surgeon to the Abia State University Teaching Hospital
(ABSUTH) . He joined the division of surgery at ABSU in 1995
where he served as the Chief of Surgery and the pioneer director
of the residency training programme. He is currently the Head of
the surgical oncology division in ABSUTH and the evolving
minimally invasive surgical unit. His basic science research
focuses on the role of pro inflammatory macrophages in breast
cancer. His clinical interest is in surgical oncology especially
breast, colorectal and prostatic cancers. He received his medical
degree from the University of Ibadan, Nigeria with a distinction in
Anatomy. He completed his general surgery residency at the
University College Hospital, Ibadan and the University of Nigeria
Teaching Hospital, Enugu, Nigeria. He was the best graduate in
Surgery at the Fellowship examination of the West African College
of Surgeons in 1995 with the award of the distinguished Jide Ajayi
gold medal in Surgery.He was the American Colllege of Surgeons
Guest Scholar in 2007 and the recipient of the American Society
of Clinical Oncology International Development and Educational
Award (IDEA) in 2008. He is an active member of several
professional associations including the west African college of
surgeons where he serves as an examiner, ASCO, AAS,
AUA,ACS and several others.
Dr Adisas first faculty position was as a Lecturer I (Assistant
Professor) at the College of Medicine and Health Sciences, Abia
State University in 1995. He is currently the Dean of Clinical
Medicine at the Abia State University and the Chief Medical
Director of Maranatha Specialist Hospital. Abia State University
Teaching Hospital is the apex medical institution in Abia State
South East Nigeria and caters for a population of over 5 million
people from Abia state and the neighboring states. She was the
second state funded teaching hospital in Nigeria to commence
undergraduate medical education.

Breast Journal 2006;12(s1):S3-S15.


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May;16(5):817-24.
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comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of
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111.

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Responding to challenges
in physical therapy
ARTICLE BY CATHERINE SYKES PT, MSC
professional policy consultant, World Confederation for Physical Therapy
BRENDA MYERS BScPT, MHSA
Secretary General, World Confederation for Physical Therapy
MARILYN MOFFAT PT, DPT, PhD, FAPTA, CSCS
President, World Confederation for Physical Therapy
TRACY BURY MSc Grad Dip Phys MCSP
professional policy consultant, World Confederation for Physical Therapy

This paper describes a range of contemporary challenges affecting the physical therapy profession and its
practice around the world, and the way the profession is responding to them.

hysical therapists (called physiotherapists in some


countries) provide services to individuals and populations to
develop, maintain and restore maximum movement,
functional ability and quality of life throughout the lifespan. Their
practice encompasses the spheres of promotion, prevention,
treatment/intervention, habilitation and rehabilitation. Their work
includes incorporating the aspects of physical, psychological,
emotional, and social wellbeing into their practice. The practice of
physical therapy includes treatments/interventions for
patients/clients with a multiplicity of diseases, disorders and
conditions of the musculoskeletal, neuromuscular, cardiovascular/
pulmonary, integumentary, genito-urinary, endocrine, and
immunological systems. Working with patients/clients, other
health professionals, families, caregivers, and communities,
physical therapists examine movement potential and establish
mutually agreed upon goals, using knowledge and skills unique to
them.
Physical therapists practise in a wide variety of settings: not only
in hospitals and other acute care settings but also in the
community, out-patient clinics, private practices, rehabilitation
centres, schools, work places, recreational facilities and public
places. As governments seek to reduce healthcare budgets,
services are moved from the expensive hospital environment to
more community-based service delivery settings. Physical
therapists have responded to the increasingly diverse service
delivery system in flexible, responsive and unique ways that are
reflective of local needs and resources.
As the international voice of the profession, the World
Confederation for Physical Therapy (WCPT) is instrumental in
leading the profession, providing strong communication on behalf
of its member organisations. WCPT is the international body
founded in 1951 to represent the global interests of physical
therapists and their patients/clients. It represents 101 member
organisations and more than 300 000 physical therapists

worldwide, providing the sole international voice for the profession.

Evolution of the profession of physical therapy


Physical therapy firmly established itself in the 20th century. Its
growth was triggered by the large numbers of people injured
particularly in World War I and and by the raging polio epidemics
leaving untold numbers of children and adults with paralysis.
Educated at the highest levels, physical therapists now deliver
services as autonomous practitioners.

Professional challenges
Physical therapy now faces a number of new challenges around
the world, which are being addressed by the World Confederation
for Physical Therapy (WCPT).
These include the growth of lifestyle-related diseases, such as
arthritis, cardiovascular disease, diabetes and asthma; new
technologies such as robotics; increasingly complex service
delivery systems; the supply of physical therapists to meet service

Figure 1: A physiotherapist working on a young child

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Innovation and clinical specialities: physical therapy

delivery requirements; and public access to physical therapy


services.
The World Confederation for Physical Therapy is addressing this
range of challenges through its policies, programmes and
advocacy.

Lifestyle related diseases


Chronic and lifestyle related diseases are the primary causes of
death and disability in many countries, including those with low
and middle incomes. Physical therapists are increasingly
undertaking a primary care role, specifically in relation to the
prevention and management of those lifestyle diseases that are
associated with low levels of physical activity. As experts in
movement and exercise and with a thorough knowledge of
anatomy, physiology and the effects of pathology on all systems,
physical therapists are the ideal professionals to promote, guide,
prescribe and manage exercise activities. Exercise promotes wellbeing and fitness. It is a powerful intervention for strength, power,
endurance, flexibility, balance, relaxation, recreation and the
remediation of functional limitations. There is evidence of the cost
benefits that this intervention can bring:
 One study showed statistically significant decreases in body
mass index (BMI) over time in an intervention group of people
with intellectual disabilities compared with a non-intervention
group (Chapman et al 2009).
 A home-based programme of strength and balance retraining
exercises, individually prescribed by a physical therapist, was
effective in reducing falls and injuries in women aged 80 years
and older. The benefit, for those who keep exercising,
continued over a 2-year period (Campbell et al 1999). The
reduction in healthcare costs per individual for treating fallrelated injuries was 1.85 times higher than the cost of
implementing a fall prevention programme (Hektoen et al
2009).
A range of policies and resources has been developed by WCPT
for use by member organisations to support of the role of physical
therapists in this area.

New technologies
Technology has been developing apace in recent years and,
physical therapists with their educational background in the
physical, biological, biomechanical, and kinesiological sciences
can engage readily with these new technologies.
Technology for delivering services
Physical therapists have been using electronic channels, such as
the telephone and the internet, to augment their service provision
to patients and clients and to help to reduce the costs of service
delivery. For example, a 12-week home-based tele-rehabilitation
programme delivered to people with multiple sclerosis resulted in
improved functional outcomes. The individualised exercise
programmes devised during a face-to-face consultation with a
physical therapist were monitored by online video conferencing.
Advantages of this form of delivery included the ability to monitor
performance, make progressions and address questions and
complications promptly. Tele-rehabilitation was well accepted by
the programme recipients and cost effective for providers
(Finkelstein et al 2008).
110 Hospital and Healthcare Innovation Book 2009/2010

Web-based physical therapy advice is another means of


providing prompt, cost-efficient access to physical therapy
services, especially for those in remote areas. Simultaneous
management of many people and access 24 hours a day are
advantages of this form of self-management. The majority of users
of this sort of low cost service were satisfied with the advice they
received, did not require further health services and completely
self-managed their condition (see: www.physioadvice.scot.nhs.uk).
Technology as treatments/interventions
As well as affecting how physical therapy is delivered, many new
technologies have influenced treatments and interventions.
Physical therapists are involved in the rapidly expanding field of
exoskeletons and their varied uses, including gait training during
post-stroke recovery and helping patients with neurological
disorders. Robotic systems that augment physical therapy have
shown improvements in the level and speed of recovery of
functional performance of individuals with hemiplegic upperextremity impairments. New biofeedback mechanisms such as
myoelectric signals enable the user to control prosthetic limbs
(Moffat 2004).
The Guidelines for Physical Therapist Professional Entry Level
Education (WCPT 2007) ensure that physical therapists education
constantly evolves to keep pace with new developments.
Technology for evidence and communication
Electronic health records (EHR) are the future for recording and
monitoring health care provision, not only at the individual level,
but also by aggregation of anonymised data for administrative
reporting and statistics. The challenge is to ensure that functional
status information is included in EHR in a way that is consistent
and reliable across service settings such that the value of physical
therapy can be demonstrated and communicated. For example,
current administrative records use the International Classification
of Diseases to describe the health condition (e.g. M06.0
Seronegative rheumatoid arthritis); however this does not describe
whether the upper limbs or lower limbs are affected, whether the
person can care for herself/himself and get around, or the sorts of
equipment that they need to remain independent. Functional
status information complements information about the disease
and can be used to describe how the person lives with rheumatoid
arthritis. To this end the WCPT has endorsed the International
Classification of Functioning, Disability and Health (WHO 2001)
with the aim that it be used as the framework for describing the
functional status of individuals as part of physical therapy practice.
WCPT also promotes the use of the classification for evidencing
the efficacy of physical therapy practice. High quality, reliable data
collected in daily practice can be used to make comparisons
between services, identify service training needs, highlight where
research is needed, support evidence-based policies, and help
identify the best balance of human resources for the health
system.
Many of these new developments are showcased at the WCPT
Congress; an event conducted every four years, which brings
together more than 3000 physical therapists from across the
world.

Education
WCPT recognises that there is diversity in the social, economic,

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Innovation and clinical specialities: physical therapy

cultural, and political environments in which physical therapist


education is conducted. Professional education equips physical
therapists with the appropriate knowledge and skills to practise in
a variety of settings, as well as promoting the value of practising in
these settings. Internationally, the qualification to enter the physical
therapy profession ranges from diploma to professional doctoral
degree.
With todays level of physical therapist education, the research
base for physical therapy has been expanded, supporting
evidence-based practice. WCPT supports its member
organisations as they develop new education programmes and
revise existing programmes. It has done this by developing
documents outlining the curriculum for entry level physical therapy
education (WCPT 2007a), standards for physical therapy practice
(WCPT 2007b) and guidelines for accreditation of physical therapy
programmes (WCPT in preparation).
Sufficient education programmes with qualified faculty
particularly in low resource countries, is an impediment to ensuring
adequate supply of physical therapists in these countries. WCPT
uses its network to raise awareness of the need to recruit faculty
members to work with local faculty in underserved areas on the
development and sustainability of programmes.
Resources for continuing education and development are a
challenge for the profession. One key way to foster retention is to
offer opportunities for physical therapists to continue postprofessional education studies even as they continue working in
rural areas. WCPTs focus on this issue through online courses,
courses on DVDs and other initiatives will help to meet these
education needs particularly where populations are least well
served.

other health care providers (general practitioners and secondary


referrals to hospitals). More people can be treated successfully at
a lower cost to the health system and to the greater satisfaction of
all involved (Holdsworth et al 2007).
WCPT supports professions mutually recognising each others
skills and collaborative working methods which optimise the
outcomes for their clients/patients.
Regulatory environments that permit direct access and
appropriate scope of practice enable physical therapists to offer a
greater range of skills, thus increasing their ability to practice
independently. In doing so they can relieve pressure on other
professionals, such as physicians, enhance services to areas
poorly served by other health care providers and improve the
patient/client experience and outcomes.

Regulation of the profession


Regulation provides the right to practise physical therapy by the
appropriately qualified individuals under the appropriate legislative
framework. The purpose of regulation is to protect the public from
incompetent, unqualified or unethical practitioners. The form of
regulation varies across jurisdictions, but generally involves
registration of those appropriately qualified to practise, protection
of professional title, a system of accreditation and standards of
practice and a process whereby those failing to meet ethical or
practice standards can be removed from the register.
WCPT encourages open and fair regulatory systems and works
to reduce restrictive practices. In assisting member organisations
and potential new members, WCPT has developed a range of
position papers and policies on various aspects of the profession
to provide information to governments, international nongovernmental organisations, the media and the public.

Physical therapy service delivery


Underserved areas
In addressing the challenges of attracting physical therapists to
underserved areas, WCPT has supported its member
organisations by working alongside other health professional
organisations and the Global Health Workforce Alliance (see:
http://www.who.int/workforcealliance/en/) to produce the first
guidelines on incentives for health professionals as part of the
Positive Practice Environments campaign.
The community based rehabilitation (CBR) movement and other
grass roots level health services have been well supported by
physical therapists. In many instances physical therapists have
taken the lead in developing and running such services.
Collaborative practice
Physical therapists are active members of multi-professional
teams, working in partnership with other health professionals to
deliver services as equal partners. WCPT believes it is fundamental
to professional autonomy that individual physical therapists should
exercise their professional judgement as long as it is within the
physical therapist's knowledge and competence. So it follows that
their professional decisions cannot be controlled or compromised
by persons from other professions (WCPT 2007c).
In a growing number of countries, physical therapy has first
contact/direct access status: in other words, a referral from
another practitioner is not required, legally or ethically, before
physical therapy services are provided. When physical therapists
see patients without a referral, they can relieve the pressure on

Conclusion
Many of the contemporary issues for physical therapy are
interdependent. Where there is high quality professional education
in accredited education programmes and a regulatory
environment that supports autonomous practice, direct access to
physical therapy services and respectful and collaborative
relationships amongst health care providers, there are excellent
opportunities for enhancing the delivery of physical therapy
services to all that need them. J
References
Campbell AJ, Robertson MC, Gardner MM, Norton RN and Buchner DM (1999) Falls prevention
over 2 years: a randomized controlled trial in women 80 years and older Age and Ageing
28:6,513-518.
Chapman M, Craven M, Chadwick D (2005) Fighting Fit? An evaluation of health practitioner
input to improve healthy living and reduce obesity for adults with learning disabilities in
Journal of Intellectual Disabilities, 9(2), 131-144.
Hektoen LF, Aas E, Lurs H (2009) Cost-effectiveness in fall prevention for older women.
Scandinavian Journal of Public Health, 37:6,584-589.
Holdsworth L, Webster V, McFadyen A. (2007). What are the costs to NHS Scotland of self
referral to physiotherapy?: Results of a national trial. Physiotherapy 93: 3-11.
Moffat M (2004). Braving new worlds: To conquer, to endure. Physical Therapy 84:1056-1086.
World Confederation for Physical Therapy (2007a) Guidelines for physical therapist
professional entry level education. Accessed 24 August 2009
http://www.wcpt.org/node/29550.
World Confederation for Physical Therapy (2007b) Standards of Physical Therapy Practice.
Accessed 24 August 2009 http://www.wcpt.org/node/29447.

Hospital and Healthcare Innovation Book 2009/2010 111

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Population based surgery in low


and middle income countries
ARTICLE BY DAVID A SPIEGEL MD, AND RICHARD GOSSELIN MD, MPH
Division of Orthopaedic Surgery, Childrens Hospital of Philadelphia, University of Pennsylvania School of Medicine,
& University of California at Berkeley School of Public Health
ADAM KUSHNER MD, MPH
Department of Surgery, Columbia University
AND STEPHEN BICKLER MD
Division of Pediatric Surgery, University of California at San Diego

The burden of surgical diseases is large and is increasing, and there are enormous gaps in access to surgery
between high and low income countries. Surgical services may be cost effective at the district level in LMICs,
and providing access to essential surgery should be viewed as primary prevention of death and disability.
The integration of essential surgical services into health systems, within the context of primary healthcare
reforms, will surely improve population health.

he worlds burden of surgical diseases is increasing, and


considerable morbidity and mortality may be averted by
providing access to safe and timely surgical care for injuries,
acute abdominal conditions, complications of pregnancy, and
many other diagnoses.1-12 Injuries, especially due to road traffic
crashes, have been recognized as emerging global public health
concern.1,2,7-9,11-17 For each death, many more individuals are left
with a permanent disability. Although more than 230 million
surgical procedures are estimated to be performed in the world
each year, there are enormous gaps in access to surgical services
both between and within countries18. Only 3.5% of major surgical
procedures are performed in countries ranked in the lowest third
in per capita health expenditure18. Surgery has been neglected as
a population-based health strategy in low and middle income
countries (LMICs), despite evidence to suggest that surgical
conditions account for approximately 11% of the worlds disease
burden1 and basic surgical services may be cost effective even at
the district level in LMICs19-22.
The question is not whether universal access to essential
surgical (including orthopaedics and anaesthesia) services would
improve population-based health care in LMICs, but rather how
this may be achieved. There has been a resurgence of interest in
primary health care23 as a means to strengthen health systems,
and integration of essential surgery and anaesthesia within the
context of primary healthcare reforms will undoubtedly improve
population health. While recognizing that modern surgical services
are usually available at a limited number of tertiary facilities in
LMICs, there is a great need to provide access for the majority of
the population, who reside in rural communities and are serviced
by a district hospital or equivalent. This process will require a
multidisciplinary, multisectoral effort, under the leadership of
governments and their ministries of health.

Barriers to the delivery of surgical and anaesthetic services


Barriers to the delivery of safe and timely surgery and anaesthesia
include deficiencies in capacity (infrastructure, physical resources,
112 Hospital and Healthcare Innovation Book 2009/2010

human resources) and quality (training and experience of


caregivers). While recognizing the positive contributions from nongovernmental organizations and others in delivering surgical
services, these vertical initiatives have often contributed to
fragmentation within the health system, and may also foster
complacency among health planners leading to inadequate
resource allocation. In addition, the misperception that surgery is
a high cost treatment benefitting only a limited segment of the
population must be reversed if adequate resources are to be made
available to support a functional district level surgical service.
While considerable attention has been directed to addressing
the global human resource crisis, there has been little mention of
deficiencies in capacity of the health system to deliver surgical
services, especially at the district level in LMICs24,25. Providing the
capacity for facilities based services, including anaesthesia and
surgery, is obviously more complex than many other health
services such as immunizations, family planning, etc. Using the
WHOs surgical situational analysis questionnaire, significant
deficiencies in capacity in Sierra Leone were identified, including
shortages of water, electricity, supplies, and trained health
workers24. Patients often had to purchase medical supplies prior to
receiving treatment24. Kushner et al studied 132 district health
facilities in 8 LMICs, and also identified significant shortfalls in
infrastructure, physical resources, and in the procedures
performed25. While incision and drainage of abscesses was
performed at 73%, only 44% could perform a caeserian section.
Only 33% of facilities treated open fractures, and 43% managed
cases of osteomyelitis. Only 13% would treat a clubfoot.
The capacity to deliver orthopaedic surgery is even more
challenging, given the plethora of technological advancements
from high income countries, which are resource intensive and
costly. While attempting to transfer these technologies is
unrealistic at the population level, we suggest that the majority of
essential orthopaedic surgical procedures may be carried out at
the district hospital, relying upon time honored methods of
treatment and only the most basic equipment/implants, for

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example the closed management of fractures and dislocations,


skeletal traction for fractures, irrigation and debridement for open
fractures and infections (osteomyelitis, septic arthritis),
amputations, and manipulation and casting for clubfoot. The
challenge lies in teaching safe and reliable methods that have often
been displaced by higher cost technologies, while maintaining
similar outcomes. Another consideration is whether some of these
technological advances may be adapted through low cost
production and dissemination in LMICs26-40. The SIGN
intramedullary nailing system for femur and tibia fractures is one
example, although the implants are currently exported free of
charge to low income countries, rather than being produced
locally41. However, surgical complications from nailing fractures
that were before successfully treated conservatively by traction or
other means will need to be monitored. Another example of a low
cost, transferable technology is the Ponseti method for clubfoot
care, which relies upon serial casting followed by a minor surgical
procedure (heelcord release) and then a long-term splinting42-45.
While the method was developed in a high-income country (USA),
excellent results have been achieved in several LMICs, even in
patients up to 6 years of age42. The treatment may be delivered by
nonmedical personnel, for example by orthopaedic clinical officers
in Malawi or physiotherapists in Nepal42-44.
Establishing and maintaining adequate capacity at the facilities
level must begin with a situational analysis of all district level health
facilities, to obtain a baseline and inform health planners as to
which improvements are required. Furthermore, a mechanism for
monitoring of capacity would be invaluable to ministries of health,
and would contribute to strengthening each health information
system. An example is the Service Availability Mapping (SAM)
technology developed by the World Health Organization
(WHO)46,48. Both district level and facilities based questionnaires are
utilized, and health workers enter information into personal digital
assistants (PDAs), and also record the location with a global
positioning system device (GPS). The data is then processed
(digital maps, graphs, etc.) and can be disseminated to help
inform decision making and the development of health care
policies. Mapping has been carried out in Tanzania48, Uganda,
Albania, Rwanda, Kenya, and Zambia. Recently, a surgical
questionnaire has been incorporated into this methodology, and a
pilot project has been initiated in Mongolia in collaboration with the
WHO and the ministry of health. Monitoring the capacity to deliver
facilities based health services such as surgery will enhance the
delivery of services. There is also the need to define the unmet
need for surgical services at the population level, which will require
community based surveys. This additional information will help
prioritize services, and guide local allocation of resources.
Once the capacity to provide basic orthopaedic and surgical
services is available, trained health workers must be available to
deliver the services. While only 10% of the worlds burden of
disease is found in the Americas, this region has 37% of the global
health work force and accounts for 50% of the worlds health
spending49. In stark contrast, Sub Saharan Africa must utilize 3%
of the worlds health work force to tackle 24% of the global
disease burden, and accounts for less than 1% of the worlds
health spending49. Brain drain has been an enormous problem,
with workers migrating both between and within (rural to urban)
countries49-57. There is a critical shortage of health workers in 57
countries worldwide (36 in Africa)49. Common problems impacting

health worker satisfaction include a lack of materials, inadequate


salary, inadequate training or lack of supportive supervision, poor
working conditions, inadequate living conditions, and inadequate
professional recognition50. Other factors may include better
opportunities in the private sector, with non-governmental
organizations, and in other countries. A nationwide survey in
Uganda demonstrated that less than 50% of health workers were
satisfied, and more than 50% of physicians would prefer to
emmigrate51. A mixture of both financial and non-financial
incentives must be provided in order to retain health workers.
There will never be enough surgeons to staff even the tertiary
facilities in LMICs, let alone primary health care facilities, for
decades to come. A recent report from Sierra Leone documented
only 10 trained surgeons for a population of 5.3 million25. Any
approach to human resources must strongly consider task shifting
as a means to provide the necessary number of surgical
caregivers, at least over the short term58-75. While there remains
some controversy regarding the use of non-physician clinicians,
especially for surgery, these health workers may be found in at
least 25 of 47 Sub Saharan African countries58. While the training
is shorter and less costly than for physicians (and is based on the
local disease burden), the curriculum and scope of practice have
not been standardized. Non-physician caregivers perform
selected surgical services in Ethiopia, Angola, Ghana, Kenya,
Mozambique, Tanzania, Malawi, and Uganda. Several reports
have suggested that alternate cadres of health worker can safely
and successfully perform caesarian section, as evidenced in
Mozambique, Malawi and Tanzania61-64. Orthopaedic services have
been shiften to non-surgeons effectively in Uganda and Malawi6567
. Malawi has nine orthopaedic surgeons for a population of
approximately 27 million, and Orthopaedic Clinical Officers (OCO)
provide all of the district hospital level orthopaedic services for the
country, under remote supervision from the few orthopaedic
surgeons65,66. A diploma is offered after eighteen months of
training, and core competencies include the treatment of
musculoskeletal infections, burns, clubfoot, fractures and
dislocations, and amputations66. Of 117 caregivers trained in this
programme, only 11% have retired or relocated66. Uganda also
utilizes 200 orthopaedic officers, as only 23 orthopaedic surgeons
are available for a population of 28 million67. Another approach is
the training of a rural surgeon; a pilot project has been initiated
in India, and medical school graduates enroll in a 3 year training
programme which focuses on competency in a finite number of
common surgical procedures drawn from all of the surgical
subspecialties, adapted to the local disease burden74,75. These
individuals are typically recruited from a rural environment, and
plan to practice in a rural environment. Further study will be
required to evaluate the utility of this approach.

Integration of surgical services in primary healthcare


reforms
The most recent World Health Report23 focuses on how primary
health care reforms may strengthen health systems and provide
universal access to quality health services. Within this scheme, the
primary care team serves to coordinate the delivery of health
services, directly interfacing with communities and individuals.
Despite the emphasis on primary care and preventive medicine,
and the suggestion that hospital based services should be
reduced, surgical care is recognized as an important component
Hospital and Healthcare Innovation Book 2009/2010 113

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Innovation and clinical specialities: surgery

of the health system23.


We feel that essential surgical care should be viewed as
primary prevention of death and disability, and that the integration
of surgical services at the district level in LMICs will strengthen
population based health care. How can we reduce maternal
mortality if access to caesarian section cannot be provided, or
improve childhood survival without better care for the injured?
Examples include not only the capacity to perform selected
procedures such as cesaerean section, laparotomy, repair of a
strangulated hernia, irrigation and debridement, or conservative
management for fractures/dislocations, but also the ability to care
for surgical diseases which might not require a procedure, such as
closed head injury or blunt abdominal trauma. The vision of a
comprehensive, horizontal approach must be emphasized, as
illustrated by the WHOs Emergency and Essential Surgical Care
project (EESC)4,6,76-79, a diverse educational programme which has
been introduced in 33 countries. In addition, the Global Initiative
for Emergency and Essential Surgical Care (GIEESC) was
launched in 2005, and represents the first coordinated effort to
address global disparities in surgical care79.
Integrating surgery and anaesthesia at the district level within
the context of primary health care reforms will require commitment
from multiple stakeholders, including governments and their
ministries of health, funding agencies, non-governmental
organizations, academic institutions, organizations outside the
health sector, as well as community leaders and individual.
Adequate resources must be allocated to upgrade and maintain
capacity of the district health system (including surgery and
anaesthesia), and mechanisms to train and retain health workers
must be developed. Strengthening the deliver of essential surgical
services will improve the capacity to deliver other hospital based
services, enhance population based health care, and contribute to
achieving the Millennium Development Goals. J
Dr David Spiegel attended Duke University for college, medical
school, and his orthopaedic surgical residency. He then completed
both a research and a clinical fellowship in pediatric orthopaedics
at the Children's Hospital of Philadelphia. He works as a pediatric
orthopaedic surgeon at the Childrens Hospital of Philadelphia, and
is an Assistant Professor at the University of Pennsylvania School
of Medicine. He serves as a Consultant in Orthopaedics and
Rehabilitation at the Hospital & Rehabilitation Centre for Disabled
Children in Banepa, Nepal. He currently serves as Chairman of the
Committee on Childrens Orthopaedics in Underdeveloped Regions
of the Pediatric Orthopaedic Society of North America, and has
been on the Board of Orthopaedics Overseas, Global-HELP, and
the Ponseti International Association. He has received the
President's Call to Service Award (2006), from the Presidents
Council on Service and Civic Participation, for 4000 hours of
community service. He has also received the Golden Apple Award
by Health Volunteers Overseas (2009). He has served as a
consultant to the World Health Organization, and is on the steering
committee for the Global Initiative for Emergency and Essential
Surgical Care (GIEESC).

114 Hospital and Healthcare Innovation Book 2009/2010

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professional shortages in Sub-Saharan Africa by 2015. Health Affairs 2009;28:w849-862.
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Chilopora G, Pereira C, Kamwendo F, Chimbiri A, et al. Postoperative outcome of caesarean
sections and other major obstetric surgery by clinical officers and medical officers in
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Joint Surg [Br] 2005;87:10-11.
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Mkandawire N, Ngulube C, Lavy C. Orthopaedic clinical officer program in Malawi: a model
for providing orthopaedic care. Clin Orthop Relat Res. 2008;466:2385-2391.
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Naddumba EK. Musculoskeletal trauma services in Uganda. Clin Orthop Rel Res
2008;466:2317-2322.
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Huicho L, Scherpbier RW, Nkawane AM, Victora CG, et al. How much does quality of child
care vary between health workers with differing durations of training? An observational
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69.
Kruk M, Pereira C, Vaz F, Bergstrom S, et al. Economic evaluation of surgically trained
assistant medical officers in performing major obstetric surgery in Mozambique. BJOG

2007;114:1253-1260.
Garrido PI. Training of medical assistants in Mozambique for surgery in rural settings. S Afr J
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Laloe V. Training programme for general practitioners in emergency surgery and obstetrics in
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Rennie JA. The training of GPs in emergency surgery in Ethiopia. Trauma Q 1999;14:335338.
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Vaz F, Bergstrom S, da Luz Vaz M, et al. Training medical assistants for surgery. Bull WHO
1999;77:688-691.
74.
Jena TK, Agarwal AK. Surgical training-distance education. A training tool for rural surgeons.
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75.
Tongaonkar RR. Scope and Limitations of Rural Surgery. Indian J Surg 2003;65:24-29.
76.
Cherian MN, Noel L, Buyanjargal Y, et al. Essential emergency surgical procedures in
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77.
Integrated Management of Emergency and Essential Surgical Care. World Health Organization
(www.who.int/surgery/publications/imeesc). (Accessed 12/15/08)
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Hospital and Healthcare Innovation Book 2009/2010 115

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Innovation in patient care

120

Surgical Site Infections (SSIs), antimicrobial agents,


universal precautions and post-exposure prophylaxis
Jonathan Samuel and Wakisa Mulwafu

127

Have we created an alternative MSD risk from a


reliance on hoisting solutions? An academic review of
patient handling research
M Fray

Hospital and Healthcare Innovation Book 2009/2010 117

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Company Profile: Wipak Medical

Wipak Medical Steriking specialized


packaging for hospital sterilization
ARTICLE BY WIPAK

Wipak manufactures specialized packaging for hospital sterilization, including


sterilization packaging materials, sterilization monitoring products and sealing
equipment and accessory products for sterile supplies.

STERIKING CLEAN PEEL, MULTI-X FILMS


Steriking Clean Peel range of see-through packaging, thanks to a
unique Multi-X film, provides for a reliable processing and safe
presentation of a packed item. In the modern multilayer film
technology, featured in the Steriking Multi-X films, it is possible to
produce steam sterilizable plastic films that resist high
temperatures but have high tensile strength. These films facilitate
strong sealing properties against medical papers, preventing
possible packaging bursting failure. The low incidence of bursting
and tearing minimizes resterilization load and costs.
The two major sources of packaging failure are bursting during
sterilization and/or film tear or paper shear when opening a
package. Bursting of a pack can be caused e.g. by inadequate
seal strength. The cause for tearing and shearing can be a low
internal tensile strength of the film or paper. When exposed to heat
upon sealing and sterilization processes, most plastic materials
crystallize. This crystallization makes the material more brittle, thus
reducing the tensile strength of the film.

Figure 2: Sterilization packs

STERILIZATION PACKS
A well-designed and correctly used sterilization pack provides for
effective sterilization and safe handling and storage of all items
until the moment they are used. A pack must remain sealed
against bacteria and facilitate aseptic presentation of the
packaged product. The Steriking sterilization packaging are
developed and designed to ensure optimal reliability of use in
hospitals and other health care institutions. The sterile state of
medical device, which is achieved through sterilization, is
maintained with the help of an appropriate packaging. The design,
materials and manufacture of the packaging materials have to be
compatible with the medical device to be packed, the handling
processes of the medical device, the sterilization method to be
used, the labelling systems and distribution and storage
conditions as well.

SEE-THROUGH PEEL POUCHES AND ROLLS


Figure 1: STERIKING CLEAN PEEL, MULTI-X FILMS

118 Hospital and Healthcare Innovation Book 2009/2010

The Steriking Clean Peel range of see-through packaging is a

118-119 Company Profile- WIPAK:2009 IHF ref 5

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Company Profile: Wipak Medical

fast and easy to pack an item into a pouch and to close it by a


heat sealer. The final pack creates an packed item.

AN UNIQUE CONTROL SHEET FOR SEAL QUALITY TEST


Where medical devices are packed for sterilization the user is
responsible for assuring the performance of the final closing seal
of a package. Steriking Seal Control is designed for operational
qualification of the sealing process. The critical paremeters of a
sealing process are temperature, time and pressure. Under the
new standard ISO 11607-2: 2006 the following qualities of the seal
should be controlled: intact seal for a specified width, channels or
open seals, punctures or tears and material delaminating or
splitting. The Seal Control sheet accurately simulates see-through
peel packages and provides users a practical tool for validation
and documentation processes. It is exclusive designed and
patented by Wipak.

A COMPREHENSIVE RANGE OF PRODUCTS

Figure 3: The Steriking Clean Peel range

safe and convenient choice of a packaging material for hospital


use. These are made of a medical grade paper that is heat sealed
to a plastics film and are available as ready made pouches or
tubing fit for the large variety of items in hospitals. The standard
range is suitable for sterilization in steam and gas processes. The
identification of packed instruments is easy because of the
transparent plastic film. Thanks to the coloured film, it is possible
to visually control the seal integrity.
The see-through packaging is a time saving concept in use. It is

The Steriking range of products offers a comprehensive selection


of items to meet the needs of Operating Rooms and Sterile Supply
service units in hospitals. The main groups of products are
pouches, bags and rolls, paper and non woven sheets, chemical
indicators, sealing machines and other accessory equipment.
Wipak manufactures packaging materials for food and medical
applications. Widely respected in the research and pioneering
development of new technologically advanced products, the
Wipak philosophy is aimed to help achieve a safer and more
environment friendly world. The quality system in accordance with
ISO 9001 and the clean-room production facilities are Wipak
Medicals guarantee of the safety and reliability of its Steriking
products. We care that you pack safely.
Wipak Medical
Steriking Healthcare Products
Wipak Oy, PO Box 45, FI - 15561 Nastola, Finland
Tel: +358 20 510 311
Fax: +358 20 510 3333
Email: steriking@wipak.com
Websites: www.wipak.com/medical www.steriking.fi
Contact: Anne Lehtovuori anne.lehtovuori@wipak.com

Figure 4: The Steriking range

Hospital and Healthcare Innovation Book 2009/2010 119

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Innovations in patient care: infection control

Surgical Site Infections (SSIs),


antimicrobial agents, universal
precautions and post-exposure
prophylaxis
ARTICLE BY JONATHAN SAMUEL,
University of North Carolina, School of Medicine, Chapel Hill, North Carolina
WAKISA MULWAFU, (PICTURED)
Queen Elizabeth Central Hospital, Blantyre, Malawi

SSIs represent a major cause of morbidity in surgical patients, affecting only around 2% of patients with
clean cases, but upwards of 15-20% of patients undergoing contaminated cases. This article sets out to
show the best ways of dealing with surgical site infections and makes specific recommendations for the
best ways of treating SSIs.

wound is defined by the Center for Disease Control (CDC)


as an interruption or break in the continuity of the external
surface of the body or the surface of an internal organ,
caused by surgical or other forms of injury or trauma. A surgical
site infection (SSI) is clinically defined as presence of pain at a
surgically created wound, which is accompanied by erythema,
induration and local tenderness or presence of purulent discharge
at wound site1. SSIs are not a modern phenomenon. As early as
14-37AD there is documentary evidence that Cornelius Celsus (a
Roman physician) described the four principal signs of
inflammation and used antiseptic solutions. Another Roman
physician, Claudius Galen (130-200 AD) had such an influence on
the management of wounds that he is still thought of by many
today as the father of surgery.
Surgeons encounter wound infections in two major ways:
patients present with an infection that requires surgical treatment,
like drainage of an abscess; or infection complicates a surgical
procedure, e.g. SSI. This problem was almost universal prior to the
development of aseptic surgery in the last century but, in spite of
our more sophisticated understanding of the nature of infection
and an arsenal of antimicrobial agents, SSI still remains a major
surgical problem today.
SSIs have a significant impact on patients, increasing length of
hospital stay, contributing to overuse of hospital stay, contributing
to an overuse of antibiotics and increased associated costs, and
contributing to increased mortality2.
SSIs are common, comprising about 12% of all hospital-

120 Hospital and Healthcare Innovation Book 2009/2010

acquired infections. The rate of infection varies depending on the


type of surgery undertaken. Especially high rates are associated
with contaminated surgery, such as colorectal surgery or delayed
surgery to traumatic wounds.

Aetiology of SSIs
SSIs are caused by the deposition and multiplication of
microorganisms in the surgical site of a susceptible host. There are
a number of ways microorganisms colonize and cause infection,
including: a) direct contact either from another patient, transfer
from surgical equipment or the hands of the hospital staff; b)
airborne dispersal surrounding air contaminated with microorganisms that deposit onto the wound; and c) self-contamination
(also known as endogenous infection) physical migration of the
patients own normal flora which are present on the skin, mucous
membranes or gastrointestinal tract to the surgical site. Most
surgical infection is due to bacterial and, more rarely, fungal
infection. Viruses, such as human immunodeficiency virus (HIV)
and the hepatitis B and C viruses are important to surgeons
because they may contract these diseases from their patients.
Due care has to be taken when managing such patients and
infection significantly alters the host response to other diseases.
The commonest organism causing SSI is Staphylococcus
aureus. Other common causative organisms include other Gramnegative aerobes, Streptococcus spp. and anaerobes. A study by
Erickson et al. in Tanzania showed that S. aureus was the most
common isolate (n=22), followed by E. coli (n=12) and Klebsiella

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Innovations in patient care: infection control

spp. (n=12)2. In another observational study in Tanzania, the overall


rate of SSI was 24% among all surgical disciplines; wound
classification associated with infection (dirty-infected wounds) had
a risk ratio of 2.8 compared to clean wounds3. Overall, 144 of the
618 patients studied developed SSIs, with the most common
isolates being S. aureus (37%), E. coli (11%), and Enterococcus
spp. (5%). Especially concerning was the isolation of one strain of
methicillin-resistant S. aureus (MRSA) and three isolates of
vancomycin-resistant Enterococcus. Of the patients with SSIs in
the study, 35% had cultures that yielded no growth or no clinically
significant organism. The authors do not specifically mention
whether anaerobic cultures were done, and no obligate anaerobes
were identified, so the high rate of negative cultures may be in part
due to failure to identify obligate anaerobes.

Risk factors associated with SSIs


The likelihood of developing an SSI is influenced by a number of
factors. These factors fall into four major groups, which are:
patient factors, anaesthetic factors, wound status, and surgeon
factors.
Patient factors
General patient characteristics that play a role in SSI include:
immunosuppression, malnutrition, endocrine & metabolic
disorders, obesity, age (young and elderly), malignant disease and
others. All these factors have their influence by lowering host
immunity to various infections.
Given the high prevalence of HIV among patients in developing
countries, the impact of HIV on surgical outcomes is a topic of
considerable interest. For example, HIV infection leads to a lower
rate of both skin graft survival (69% vs. 22%)4, and overall patient
survival among burn victims (for 21-30% burns: 100% mortality
versus 50% mortality in HIV negative patients)5. Among HIV
positive patients undergoing anorectal procedures, wound healing
is poor6,7.
A considerable body of research exists on the topic of surgical
site infections and HIV as well. In orthopaedic trauma patients, the
risk of postoperative infection is considerably higher in HIV positive
individuals (16.7% versus 5.4%)8, though in elective orthopaedic
cases with intact skin and use of implants, the rate of infection

appears similar between HIV positive and unaffected individuals9.


Open fractures in HIV positive patients managed with external
fixation are associated with a higher rate of pin site infection,
though the overall infection rate is favourable in comparison to
internal fixation10. Similar to the orthopaedic population, HIV
positive obstetric patients have a higher risk of infection;
postpartum endometritis is more common with HIV infection (24%
vs. 7%), and among those with HIV and CD4 counts below 400,
endometritis developed in 44% of patients11.
Despite the body of literature suggesting higher infection rates
among orthopaedic and obstetric patients with HIV, there does not
appear to be good evidence for or against the role of HIV in the
development of SSIs after general surgical procedures. HIV
infection does appear to be associated with infectious skin
pathology such as impetigo, folliculitis, furuncles, and carbuncles.
It is biologically plausible that this pathology would predispose HIV
infected individuals to SSIs, and such pathology should be
avoided, especially in patients undergoing clean surgical
procedures.
Anaesthetic factors
There are several peri-operative factors over which the
anaesthetist has control and which are associated with SSIs12.
Normothermia: the maintenance of peri-operative normothermia
may reduce the incidence of SSIs. The major relation between
hypothermia and increased SSI is thought to be a decrease in
subcutaneous tissue perfusion mediated by vasoconstriction.
Hyperoxia/hypoxia: high inspired oxygen in the peri-operative
period confers some benefit in reducing the incidence of SSI.
Hypoxia and shock are associated with higher rates of SSI.
Normoglycemia: it has been well established that patients with
Diabetes are at increased risk for infections, including SSI. Even in
nondiabetic patients, hyperglycemia is associated with an
increased morbidity and mortality.

Wound status
Wound characteristics which increase the risk of SSI include:
presence of foreign bodies, nonviable tissue in wound, tissue
ischemia and haematoma formation. All of these characteristics
provide a fruitful bacterial growing environment. Other factors
known to promote SSIs are a prolonged
Table 1: Classification of the risk of SSI13
preoperative hospital stay (since there is a growing
opportunity for the skin to be colonized by
WOUND CLASSIFICATION
DESCRIPTION
INFECTIVE RISK (%)
pathogens), a long operation time (as it probably
increases the extent of both tissue trauma and
Clean
Uninfected operative wound, no acute
<2
inflammation, no entry to internal organs,
contamination), and poor surgical techniques (see
and no break in aseptic technique. Hernia
below).
repair is an example.
The risk of SSI varies with the type of surgery.
Certain
types of surgery carry a higher risk of
Clean Opening to internal organ but minimal or no
<10
contamination than others and have led to the
contaminated
spillage of contents. No evidence of infection
or major break in aseptic technique.
classification of surgical wounds as clean, cleanCholecystectomy and lysis of adhesions are examples.
contaminated, contaminated, or dirty (Table 1).
Contaminated

Dirty

Opening to internal organs with inflammation


or spillage of contents. Major break in aseptic
technique. Colectomy for obstruction is an example.

15-20

Purulent inflammation present. Intraperitoneal


abscess formation Visceral perforation with.
peritonitis Perforated appendicitis is an example.

~40

Surgeon-related factors
Factors directly related to surgeon technique
include minimizing devitalisation of tissues (avoiding
factors such as tissue tension, crushing, and
parallel or tram track scars), adherence to sterile
technique, haemostasis to prevent accumulation of
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clots in the wound space and prevention of third spaces by tissue


re-approximation.

Prevention of SSIs
Prevention is always better than a cure, and thus a careful
assessment of risks related to SSIs is paramount. The goal of SSI
management is to prevent or minimise the risk through careful
planning.
The following factors or methods external to the patient are
critical to preventing SSIs: a) Theatre environment and care of
instruments; maintenance of positive pressure ventilation of
operating theatre, laminar airflow in high risk areas, and
sterilisation of surgical instruments, sutures etc. according to
guidelines, and b) Surgical team members educated in aseptic
technique; staff with infections excluded from duty and scrubbing
up followed by appropriate sterile attire.
The following section outlines the evidence regarding hair
removal, preparation of the sterile field, and wound closure
technique. Prophylactic antibiotic use is discussed in section 6.
Decisions regarding hair removal
Hair removal is commonly performed prior to surgery, yet both the
Centers for Disease Control and Prevention (CDC) and the
Norwegian Centre for Health Technology Assessment recommend
against hair removal14. The CDC recommends that, if performed,
hair removal should be done by clipping or use of a depilatory
cream, rather than by razor. A recent Cochrane Database of
Systematic Reviews identified 11 studies that met criteria for
inclusion in a meta-analysis of hair removal and infections; 3 of
these studies compared shaving with clipping and found that
shaving increased surgical site infections (relative risk 2.02, 95%
confidence interval 1.21 to 3.36). Furthermore, shaving versus
clipping leads to more skin trauma even under ideal conditions,
providing further evidence that shaving should be avoided15.
There were no studies meeting inclusion criteria that compared
clipping of hair to no hair removal. Two studies compared shaving
with no hair removal, and found that shaving increased infection
(relative risk 1.59). However there were relatively few subjects in
these two studies and hence the conclusion did not reach
statistical significance.
Evidence from within Africa supports the CDC recommendation
against hair removal. Adeleye et al. recently reported their
experience with 17 cranial procedures on black Africans, in which
all of the fields were non-shaved, and reported no serious
complications over a 2 to 6 month follow-up16.
In conclusion, if hair is to be removed at all, it should be done by
clipping and not by shaving. Furthermore, hair should not routinely
be removed except in cases where the presence of hair interferes
with the technical aspects of the surgery, which is a judgment that
is best left to the operating surgeon within the context of these
recommendations.
Preparation of the surgical field
Two factors relate to the surgical field the choice of skin
preparation, and the method of draping. In developing countries,
the choice of drapes has been limited due to cost constraints,
whereas in developed countries, sterile, adhesive iodineimpregnated drapes (commonly known as Ioban) are available.
These adhesive drapes are placed over the skin after preparation
122 Hospital and Healthcare Innovation Book 2009/2010

and application of standard side drapes. However, this practice


has demonstrated no benefit in randomized controlled trials.
Furthermore, adhesive drapes without iodine increase SSI rates
(relative risk 1.23, p=0.03)17. Thus the avoidance of adhesive
drapes as an adjunct to standard cloth drapes is best avoided.
Several methods of skin preparation are available, including
chlorhexidine, iodine, spirit, and over-the-counter soap. Bibbo et
al. compared chlorhexidine and isopropyl alcohol to povidoneiodine in a randomized of 127 patients undergoing foot surgery
and found that chlorhexidine preparation resulted in a lower rate of
culture-positive skin swabs (38% versus 79%)18. Chlorhexidine, an
antiseptic solution that has been used worldwide since the 1950s,
is a safe and effective product with broad antiseptic activity.
Chlorhexidine gluconate is a water soluble, cationic biguanide that
binds to the negatively charged bacterial cell wall, altering the
bacterial cell osmotic equilibrium and is available in a variety of
concentrations (0.5%4%) and formulations (with and without
isopropyl alcohol or ethanol). Chlorhexidine (0.05% solution) has
broad activity against gram-positive and gram negative bacteria,
facultative anaerobes and aerobes, yeasts, and some lipidenveloped viruses, including HIV. Chlorhexidine is not sporicidal19.
Meier et al., recognizing the scarcity at times of conventional
skin preparation solutions, compared the use of over-the-counter
soap followed by methylated spirit, to the use of iodine20. The
study randomized 200 patients undergoing elective inguinal hernia
repair in Nigeria. In group 1, the subjects skin was prepared by
scrubbing with soap and water, blotting with a sterile towel, and
applying spirit. In group 2, skin was prepared by scrubbing with
povidone-iodine then blotting with a sterile towel and applying
povidone-iodine paint. There was no difference in surgical site
infections between groups 1 and 2 (5.1% versus 5.9%,
respectively).
To this date, no studies have compared using soap and spirit
versus chlorhexidine. Thus the current evidence supports the use
of chlorhexidine for preparation of the surgical site. If chlorhexidine
is not available, scrubbing with soap followed by painting with
spirit (70% alcohol/30% water) appears equally efficacious as
scrubbing and painting with povidone-iodine.
Wound closure techniques and use of drains
There is little disagreement that clean wounds should be closed
primarily. However, the choice of whether to close primarily or
leave open, contaminated and clean-contaminated wounds is not
as straightforward. If a wound is not closed primarily (closed at the
time of surgery), it can be left open to heal by secondary intent, or
evaluated for closure at a later date (delayed primary closure, or
DPC). DPC of a surgical wound involves placing sterile dressing
over the wound at the conclusion of the case, and then removing
the dressing usually several days later. If the wound bed appears
clean and without devitalized tissue, the wound is then closed with
sutures.
One prospective randomized study from Tanzania found that the
rate of infection was higher when clean-contaminated or
contaminated wounds were left open, as opposed to closed
(30.2% versus 2.1%)1. It must be noted that those subjects in the
group whose wounds were left open were heterogeneous, and
included a combination of delayed primary closure (DPC) and
secondary healing techniques. Marion et al. conducted a metaanalysis of primary versus DPC in complicated appendicitis, and

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found similar results, with a lower rate of infection in those wounds


closed primarily (relative risk 0.64, 95% confidence interval 0.46 to
0.91)21.
The one exception in which DPC might be advisable is in the
management of traumatic wounds. For DPC of traumatic wounds,
the same general principles for DPC of surgical wounds apply: no
wound should be closed if grossly contaminated, and any
devitalized tissue should first be debrided. The management of
neglected or chronic wounds by DPC is more complicated. The
International Committee of the Red Cross provides a good
overview of DPC in traumatic, neglected, and contaminated
wounds22.
Decisions surrounding placement of a surgical drain is beyond
the scope of this review. However, in most cases the routine use
of surgical drains should be discouraged, as is discussed in an
excellent review by Schein23. Schein does note that select
situations may be appropriate for drain placement, including noncollapsible abscesses (rare), high prediction of fluid leakage (bile,
pancreatic juice, or urine), or drainage for a short duration of an
oozy surface. One study compared the use of post-mastectomy
drains for 4 days or 10 days, and found a significantly higher rate
of infection among those drains left in place for 10 days (9.5%
versus 2.2%)24, lending support to Scheins recommendation of a
short duration of drainage.

Treatment of surgical site infections


The following section outlines the diagnosis and surgical treatment
of SSIs. Use of antibiotics is discussed in section 6, and is
secondary to adequate drainage, discussed below.
Diagnostic criteria
An SSI is defined by both clinical and microbiological
examinations. The isolation of bacteria from the wound alone is
not diagnostic for an SSI without at least clinical evidence of
infection (redness, localised swelling, pain or tenderness, purulent
discharge, relative warmth to the touch). Often, SSIs are
diagnosed and treated based on a constellation of signs and
symptoms. However, samples from the wound can also be taken
for culture. Pus or, if appropriate, a tissue biopsy is preferred over
simple wound swabs. In patients where bacteraemia or sepsis is
suspected, blood cultures should also be taken.
Drainage
Never let the sun set on an abscess. This frequently quoted
surgical adage emphasizes the critical importance of timely
diagnosis and treatment of SSIs. Though some SSIs may be
limited to cellulitis, one should have a low threshold for incision and
drainage, or reopening, either a portion or all of the incision, to
drain pus if examination suggests the infection is more then
cellulitis.
Special note must also be made of necrotizing fasciitis, which
can occur as a SSI. Signs that suggest necrotizing fasciitis
include:
 wounds with early drainage of clear brown fluid (dishwater
drainage);
 wounds in which the subcutaneous fat has a dark brown
discoloration;
 wounds in which normally adherent tissue planes separate
easily;

 wounds in which subcutaneous vessel thrombosis is present.


Any of these signs or the presence of systemic toxicity, suggest
a serious infection, and immediate debridement of all infected
tissue is the mainstay of treatment. This may require debridement
of skin, subcutaneous fat, and possibly muscle. (See Surgery in
Africa, October 2005: Soft-tissue infections)

Antibiotics and SSIs


The goals of antibiotic prophylaxis are to achieve inhibitory
antibiotic levels at incision and throughout the procedure in an
effort to decrease the likelihood of developing a SSI. Antibiotics
can also play an important role in the treatment of SSIs.
Antibiotics for prophylaxis of SSIs
Animal studies have shown that antibiotic prophylaxis is most
effective in preventing post-surgical infections when administered
before the start of surgery, and pharmacokinetic data suggest
administration as near the time of incision as possible. Classen et
al., in a prospective observational study, monitored the timing of
antibiotic prophylaxis in 2847 patients in clean or clean
contaminated surgery. Using a step-wise logistic regression
model, they found that preoperative antibiotics within two hours of
incision had the lowest rate of infection as compared to antibiotics
given after incision or earlier than two hours prior25.
In addition to being given preoperatively, prophylactic antibiotics
should not be continued postoperatively. A five-month prospective
survey of surgical-site infections (SSI) conducted in the
department of general surgery at Kilimanjaro Christian Medical
Center, Tanzania by Eriksen et al., showed that 77 (19.4%) of the
397 patients studied developed SSI2. Twenty-eight (36.4%) of
these infections were apparent only after discharge from hospital.
A surprising eighty-seven percent of the patients who developed
SSI had received antibiotics, the majority having received the
antibiotics for several days. Such a practice is contrary to the
current recommendation of a single preoperative dose, and
prolonged inappropriate use of broad-spectrum antibiotics may
contribute to increased emergence of resistance.
The type of surgery (clean, clean/contaminated, contaminated,
or dirty) (see Table 1) also impacts the role of antibiotic prophylaxis.
An understanding of this classification, as well as knowledge of
recommendations for specific procedures, is invaluable in making
an appropriate choice regarding antibiotic prophylaxis. Antibiotic
administration in dirty cases is not considered prophylactic as
these cases represent treatment of infection rather than
prophylaxis.
Controversy exists regarding the use of antibiotic prophylaxis for
clean cases. When antibiotic prophylaxis is given, the agent
should target S. aureus, the most common organism causing SSIs
in clean cases; cefazolin is a good choice26. When bone is incised,
the use of prophylactic antibiotics is clearly recommended27. A
good choice in this situation, or for cardiothoracic or vascular
surgery, is cefazolin or cefuroxime (or clindamycin or vancomycin
for penicillin allergic)26. For general surgical clean cases, the
decision is less clear. A Cochrane Database of Systematic
Reviews examined the use of prophylactic antibiotics prior to
hernia surgery, and found that infection rates were lower with use
of antibiotics (2.9% versus 3.9%) but concluded that antibiotic
prophylaxis for elective inguinal hernia repair cannot be universally
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recommended because of overall low infection rates, a high


number needed to treat, and a lack of a large, randomized
controlled trial to prove efficacy28. Similarly, Osuigwe et al. studied
the use of prophylactic antibiotics for paediatric surgery in a
prospective, randomized, double-blind study of 289 children at a
teaching hospital in Nigeria29. Patients were randomly assigned to
receive either doses of ampicillin/cloxacillin (Ampliclox) with vitamin
B (Group A, treatment group), or vitamin B only (Group B, placebo
group). The doses were begun at induction and continued for five
days postoperatively. Patients were evaluated for wound infection
at postoperative day 5, and then again at postoperative day 7 to
10 during suture removal. Wound infection was defined as the
presence of erythema, induration, or discharge. Group A had a
4.3% infection rate compared to 5% in group B, a difference that
was not statistically significant.
For clean-contaminated and contaminated cases, antibiotic
prophylaxis is recommended. Colorectal surgery is the most
thoroughly studied type of procedure in this category, and as such
most recommendations are based on studies involving colorectal
surgery. The most commonly encountered organism in cleancontaminated and contaminated SSIs is still S. aureus, though
other aerobic as well as anaerobic bacteria are also culprits30. As
such, prophylaxis should be broader than that used for clean
cases. Song et al. reviewed all randomized controlled trials of
antibiotic prophylaxis in colorectal surgery31. Four of these studies
compared antibiotic regimens to no antibiotics and showed a
convincing benefit of prophylactic antibiotics (odds ratio 0.24,
95% confidence interval 0.13 to 0.43). Further analysis revealed
that the most efficacious regimens include coverage against both
aerobic and anaerobic organisms (such as a 2nd or 3rd generation
cephalosporin, or gentamicin in combination with metronidazole),
and cited certain regimens inadequate (metronidazole alone,
doxycycline alone, piperacillin alone)32. Though data from Africa is
limited, differences in efficacy between various 2nd and 3rd
generation cephalosporins appear negligible33, and choice
prophylaxis with a single-agent 2nd or 3rd generation
cephalosporin can probably be dictated by availability or cost. For
penicillin-allergic patients, clindamycin combined with gentamicin,
aztreonam, or ciprofloxacin, or metronidazole combined with
gentamicin or ciprofloxacin are adequate choices26.
Antibiotics for treatment of SSIs
Empiric treatment of an SSI after clean cases should be primarily
directed against S. aureus. Clean-contaminated, contaminated,
and dirty cases require broader empiric coverage to include both
aerobic and anaerobic bacteria. Choices of empiric therapy,
against SSIs suspected of being caused by S. aureus, such as
SSIs after clean cases, include cloxacillin or in penicillin-allergic
patients, clindamycin. For SSIs after clean-contaminated,
contaminated or dirty cases, a second- or third-generation
Cephalosporin (such as cefuroxime or ceftriaxone), metronidazole
with gentamicin, or amoxicillin/clavulanate, are all reasonable
choices that will provide aerobic and anaerobic coverage.
It is also important to take note that in many surgical operations,
patients will have previously received antibiotic prophylaxis.
Prophylaxis can affect the flora and thus the cause of any
subsequent infection. One study of antibiotic prophylaxis for
cardiac surgery compared vancomycin to cefazolin, and found
that SSIs in those receiving cefazolin were more likely to be
124 Hospital and Healthcare Innovation Book 2009/2010

Table 2: Possible regimens for post-exposure prophylaxis against


HIV40

DRUG CLASS

EXAMPLES

Two nucleotide reverse


transcriptase inhibitors
(NRTIs)

lamivudine and zidovudine (Combivir)


tenofovir and emtricitabine (Truvada)
tenofovir and lamivudine
stavudine and lamivudine

AND
One protease inhibitor (PI)

lopinavir
saquinavir
fosamprenavir
ritonavir

caused by methicillin-susceptible S. aureus compared to SSIs in


those receiving vancomycin (3.7% versus 1.3%)34. As such it is
important to determine the nature of any prior antibiotic therapy; a
prudent approach is to choose a different regimen that the one
used for prophylaxis at the time of surgery.
Lastly, it should be re-emphasized that antibiotic administration
for SSIs is secondary to the cornerstone of treatmentwhich is
adequate drainage of the infection. Additionally, if antibiotic
sensitivities are identified, it may be necessary to tailor antibiotics
to the specific strains. Many surgeons use topical agents such as
hydrogen peroxide, 2% acetic acid, or Dakins solution (0.5%
sodium hypochlorite), but evidence in support of this is scant. A
review of the evidence regarding Dakins solution, for example,
found only three small prospective studies and concluded that
there was no benefit to its use35. More important is the frequency
of dressing changes when managing SSIs; dressings should be
changed if they appear soiled or are foul-smelling, and must be
changed no less frequently than once daily. Lastly, one should not
forget to emphasize the importance of hand hygiene to the
guardian, or any others involved in the care of the patient, which
minimizes cross-contamination.

Universal precautions and post-exposure prophylaxis


Universal precautions mandate that health care providers assume
all patients carry a transmissible infectious disease (such as viral
hepatitis or HIV), and maintain precautions against contracting
such infections. The nature of personal protective equipment is
situation-dependent, and may include gloves, eye protection, a
protective gown and/or boots, or a mask. Bodily fluids, including
blood and saliva, as well as airborne particles, are considered an
exposure risk. Testing all patients to identify individuals infected
with transmissible diseases is not feasible, and thus universal
precautions are required36.
In addition to universal precautions, pre-exposure vaccination
against hepatitis B is recommended. All health care workers
potentially coming in to contact with bodily fluids should be
vaccinated against hepatitis B, which is given as a series of three
intramuscular doses. Despite the importance of hepatitis B
vaccination, many health care workers are not vaccinated due to
either not being aware of the vaccines efficacy, or being unable to
afford the series of vaccinations37.
HIV and hepatitis C pose risks to health care providers, and to
this date there are no vaccinations available for pre-exposure
prophylaxis. Therefore prevention relies solely on universal
precautions and safe practices, such as not recapping used
needles, using sharps containers appropriately, and properly

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Innovations in patient care: infection control

passing sharp instruments in theatre (by a sharps container, or


using verbal communication between the surgeon and the scrub
nurse).
To this date, there are no known cases of transmission of HIV
from a patient to a health care provider in the operating room.
However there are at least 57 documented cases of transmission
to health care providers in settings outside of the operating room38.
Hepatitis C poses a more serious risk of transmission, which is
estimated to be 2% if the patient is infected with hepatitis C, and
the health care provider as been stuck with a hollow needle39.
After unintentional exposure, the site should be copiously
washed, and consideration must be given to post-exposure
prophylaxis against HIV. If possible, the patient should be tested
for HIV. Factors influencing the choice for or against HIV post
exposure prophylaxis include the type of exposure, whether the
status of the patient is known at the time of exposure, and the
availability of post exposure prophylaxis. The overall risk of
transmission from a needle stick when the patient is HIV positive
is estimated at 0.3%; high risk occupational exposure from an HIV
positive patient is defined as a deep puncture with a hollow
needle, a needle that is visibly contaminated, large bore needle,
needle that was place directly in an artery or vein, high viral load of
the patient, or a patient with end-stage disease40. Post-exposure
prophylaxis should continue for 28 days and include both a
nucleotide reverse transcriptase inhibitor (NRTI) and a protease
inhibitor (PI); in the United Kingdom, the recommended regimen is
now Combivir (lamivudine and zidovudine, both NRTIs) with
lopinavir and ritonavir (PIs; supplied in combination as Kaletra)
(Table 2).

drain placement, or if used, such as in breast surgery, not


leaving drains in post-operatively any longer than necessary.
7. If one suspects an SSI (redness, localised swelling, pain or
tenderness, purulent discharge, relative warmth to the touch),
maintain a low threshold for opening the wound which is the
primary treatment. Antibiotics are secondary to adequate
drainage. There are a number of reasonable choices for treating
SSIs, and the choice of an agent should be dictated by culture
results when possible.
8. Surgeons should be familiar with the risks of transmission of
HIV, and the indications for and choices of post-exposure
prophylaxis. All surgeons should be vaccinated against hepatitis
B virus. J
Acknowledgement
Reprinted with kind permission from Surgery in Africa Monthly
Review November 2008
Jonathan Samuel was born and raised in Santa Barbara, California.
He completed his bachelors degree at Harvard University, and his
Medical Degree from Northwestern University. He received a
Masters Degree in Public Health from the University of Michigan,
prior to beginning his specialty training in general surgery at the
University of North Carolina. For the past two years he has worked
as a general surgeon and researcher at Kamuzu Central Hospital in
Lilongwe, Malawi, where he currently resides. At KCH he is Director
of Continuing Professional Development. He also lectures in
surgery at the Malawi College of Health Sciences. He is a candidate
member of the Association for Academic Surgery, and a resident
member of the American College of Surgeons.

Summary of recommendations
In conclusion, SSIs represent a major cause of morbidity in
surgical patients, affecting only around 2% of patients with clean
cases, but upwards of 15-20% of patients undergoing
contaminated cases.
1. To limit the chance of SSIs, one should treat any endocrine or
metabolic disorders in the patient, and optimize nutritional
status.
2. Preoperative antibiotics should be given for clean-contaminated
and contaminated cases (second or third generation
cephalosporin). For clean cases, the evidence is mixed, and if
given the best choice is a first generation cephalosporin. The
antibiotic should be given before incision, but no longer than 60
minutes before, and should not be continued for more than 24
hours postoperatively. Antibiotics for dirty cases represent
treatment of infection and thus are not considered prophylaxis.
3. Body hair need not be removed, and if the surgeon chooses to
remove hair, it should be done by use of clippers or a depilatory
agent; shaving causes an increased chance of wound infections
and must be avoided.
4. Chlorhexidine is the best skin preparation agent. Soap followed
by iodine, or 70% alcohol followed by iodone are the next best
alternatives.
5. Intraoperatively, patients should retain normothermia,
normoglycemia, and adequate perfusion and oxygenation. The
surgeon should minimize tissue devitalisation, adhere to sterile
technique, avoid hematoma formation, and close potential
spaces.
6. Evidence supports closing primarily all wounds, and avoiding

Born in Chitipa, Malawi, and a fifth born in a family of eight, Dr


Mulwafu went to Iponjola Primary School and proceeded to
Chaminade secondary school. There he was selected to do further
studies at Chancellor College in Zomba, Malawi, where he
completed two years in the faculty of bachelor of science and then
joined College of Medicine where he obtained his MBBS. From
College of Medicine, Wakisa did his internship at Queen Elizabeth
Central Hospital for two years and transferred to Kamuzu Central
Hospital where he worked as a registrar in surgery for another two
years. He specialized as an ENT surgeon at the University of Cape
Town, where he completed one year of general surgery and four
years of specialist training in ENT.

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Eriksen H, Chugulu S, Kondo S, Lingaas E. Surgical-site infections at Kilimanjaro Christian
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Have we created an alternative MSD


risk from a reliance on hoisting
solutions? An academic review of
patient handling research
ARTICLE BY AUTHOR M FRAY
Research Fellow, Healthcare Ergonomics and Patient Safety Research Unit, Department of Human Sciences, Loughborough University, UK

Many hospitals employ systems and personnel to reduce the effects of patient handling activities. Research has
found limited evidence for the benefits of patient handling interventions and poor levels of evidence for the
reduction of work-related MSDs in the healthcare setting. Historically the reduction of MSDs has been the primary
purpose of patient handling interventions but other benefits have been identified. This paper describes the range
of outcomes that have been identified in published research. Describes the type of intervention strategy that gives
best results and suggests that hospitals and healthcare providers need to consider appropriate audit systems to
collect suitable data to prove the success of their management systems.

here is clear evidence to show that the size of patients entering


healthcare is increasing in the western world.
Some systems have been developed to help reduce the risks
of managing the movement of larger people (Muir and Archer-Heese,
2009). The focus of risk reduction in patient handling has rightly been
on the reduction of lifting injuries as a priority. Given the development
of a wide range of lifting equipment to assist with the movement of
larger people the consensus is that we are in a relatively well controlled
risk position. Evidence shows the provision of hoisting equipment
reduces the risks of injury but the question raised in this review asks
whether the risks are reduced enough? Recent studies have
suggested that the push, pull and rotation forces required to move
regular and large weight patients (Marras et al, 2008, Rice et al, 2009)
exceed the much lower safe working limits for creating spinal damage
from shear force in certain circumstances. This paper challenges the
situations where current thinking would be to provide a mobile passive
lifting hoist or mechanical means to transfer a larger adult.

Literature analysis
Patient handling
A series of systematic reviews have failed to identify
musculoskeletal disorder (MSD) reduction from patient handling
interventions (Van Poppel, 2004, Bos et al, 2006, Amick et al
2006, Haslam et al, 2006, Dawson et al, 2007, Martimo et al,
2008). More inclusive reviews identify that other outcomes could
be used to show success (Hignett et al 2003, Fray and Hignett
2006, Fray and Hignett 2009). The volume of evidence for the
reduction of known risk factors is growing and the development of
multi-faceted ergonomics, equipment and education packages
are showing improvements in practice (Nelson et al 2006, Collins

et al 2004, Hignett 2003).


Systems adopted in the UK were directed by the introduction of
the Manual Handling Operations Regulations 1992 (HMSO 2004)
and the subsequent development and support of both statutory
providers and professional organisations. Though the countries of
Europe all had the same EU directive the responses have not all
been the same (Hignett et al, 2007). The North American systems
and approaches have not had the pressure of national legislation
but some state legislation has more recently been implemented
from 2006 onwards.
Risk reduction strategy
The information and guidance contained in the documents relating
to the management of health and safety in the workplace (HMSO
1992 a,b,c) stated the need for a systematic assessment of
workplace hazards, the reality of risk controls in patient handling is
different.
Research information identified that lifting people was the most
easily identified risk (Owen and Garg 1989, 1990 and 1991, Takala
and Kukkonen 1987, Zhang et al 1999, 2000 Menzel et al 2004)
and the measure for lumbar compression was critical.
Interestingly a comprehensive biomechanical study (Marras et al
1999) using the lumbar motion monitor continued the evidence
that compression values seriously exceeded the known
recommended limits and should be rectified. It also showed that
the methods for manual assistance also exceeded the safe limits
for shear(anterior-posterior and/or lateral).
The clear evidence presented related to lifting hazards, the
reactive management style of the National Health Service and the
chance of high return with simple process change lead to a large
Hospital and Healthcare Innovation Book 2009/2010 127

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Innovation in patient care: patient handling

focus on the removal of hazardous lifting and transfer tasks with a


lifting component. It has been the development of safer handling
policies in their various definitions that have lead to much
improvement in the management of patient handling risks. Proof of
the success of developing multi-faceted interventions have mostly
been recorded in studies from North America. Biomechanical and
workload reductions have been recorded in a number of studies
(Daynard et al 2001, Nelson et al, 2006, Ronald et al, 2002, Marras
et al, 1999, Engst et al, 2005,). The cost benefits of such a process
have also been recorded (Spiegel et al, 2002, Chhokar et al, 2005,
Martin et al, 2009). Patient and staff perceptions improved with use
of ceiling track systems (Alamgir et al 2009). These studies have
also measured differences between the use of mobile hoists and
ceiling track systems (Santaguida et al, 2005).
Push-pull risks
The focus of most of the biomechanical studies and workplace
studies, above, have been on the lifting component and the
resulting spinal compression loading. More specifically the
concentration is on identification and then avoidance of any very
high compression loading. This fails to address the more complex
question of physical work done represented by force over time
exposure. Daynard et al (2001) showed that when using handling
aids and mechanical lifting the cumulative effort was increased, as
the time taken was usually higher, but the peak forces were
reduced. A recent study (Fray and Hignett, 2009) that restructures
a lateral transfer task by the use of an innovative pressure reducing
device showed significant savings in physical exposure by
removing tasks and reducing the time taken to complete the
transfer. This is the cumulative loading or exposure over time
question that frequently taxes occupational injury research and
prevention literature.
Recent studies have, in addition, raised questions related to the
potential problems of the pushing and pulling associated with
healthcare tasks and in particular the use of hoists for patient
transfers. Marras et al (2009) measured the spinal loads for a
person manoeuvring a hoist across a fixed course and compared
a ceiling tracked system with a floor based system. The key
findings were that the patient weight affected the force needed with
a floor based system but not a ceiling track system and the shear
loading for the floor based system exceeded the safe working limit
for shear during push tasks. Another study (Rice et al, 2009), which
used hand held dynamometers to measure actual push pull forces
for moving hoists, concurred with the relationships of weight to
force for floor standing hoists and that floor standing hoists required
more force than ceiling track systems.
Importantly neither study investigated the forces required to
obtain an ideal sitting or lying position or the complexities and
postural loads of positioning the hoist sling. These two studies
that measure the physical requirements of the solutions to
handling issues may lead to further questions relating to some of
our known risk reduction systems. It is worthy of note that these
studies were completed with patients weighing up to 163kg and
146kg respectively to identify the hazards of larger individuals.
Population changes
Recent observations have indicated that the size of western
populations is increasing (DOH 2004, Heena 2005, Hedley et al
2004). The growth in adult prevalence is matched by the increase
128 Hospital and Healthcare Innovation Book 2009/2010

in problems with increasing size and weight of infant populations


(Stamatakis 2002, Hedley et al 2004). A systematic review (Baird
et al 2005) showed there is agreement from many studies that
childhood growth is a clear indicator for adult obesity. Given that
a Cochrane review (Summerbell et al 2005) also indicated the
general lack of success of intervention strategies for reducing
population obesity for the long term and the desired weight in
adult populations is also growing (Maynard et al 2006). Most of
the evidence indicates to the providers of healthcare that the
amount of overweight, obese and morbidly obese patients
requiring healthcare interventions will increase over the
foreseeable future. The reluctance to design environments and
systems for these types of patients will be short-sighted and
potentially hazardous for the carers delivering the hands on
treatment.
The development of products, equipment and management
systems for the reduction of patient handling risks has seen
improvements (Muir and Archer-Heese 2009, Hignett and
Chipchase, 2007). The range of beds, hoists and handling aids
allows healthcare providers access to a wider variety of physical
solutions to the transfers of larger people.
Summary of literature
The management of patient handling risks has improved over the
past 20 years. The use of education, equipment and management
systems all have made an impact on practice but any reduction in
MSD has not been proven. Recent studies have shown that the
safer methods of mobile hoists and ceiling track systems have
reduced the lifting loads on healthcare workers but there is some
doubt over the push pull requirements to use some hoists.
Evidence that handling bariatric patients is high risk has been
confirmed in one study. Randall et al (2009) showed when
bariatric patients (BMI>35kg/m2) were <10% of the workload,
handling accidents accounted for almost 30% of the recorded
staff injuries. The crossover of these areas of published research
raise questions regarding the future provision of equipment to
assist with the movement of larger and bariatric patients.

Discussion
Larger people or bariatric care
Randall et al (2009) suggest that the handling of people with BMI
over 35kg/m2 may raise the injury potential. The increased
awareness and development of bariatric handling systems
(Gallagher 2004, VISN8 2006) would agree with the increased risk.
An unpublished study in a UK hospital (OHS 2009) showed that
the perception of significant risk when moving very large patients
changed behaviour in a positive way. This creates a possible
subgroup of high risk patients that fit the description of large but
not noted as bariatric. The evidence of the growing population
indicates that this specific group will continue to be more prevalent
in the future. As familiarity with bariatric patients widens, the level
at which the highly protective behaviour is triggered may also
increase thus increasing the number of people in the larger but not
bariatric category.
Hoists as a handling solution?
Early biomechanical studies recorded high levels of spinal
compression due to lifting tasks. Hoisting or mechanical lifting has
been proven to allow these lifting risks to be avoided (Hignett

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Innovation in patient care: patient handling

example one injury that leads to 3 months


sickness absence of a mid level band 5 nurse
PHYSICAL ACTION
MOBILE HOIST
CEILING TRACK HOIST
(NHS Employees, 2009) could cost 8400 in the
direct costs of not having the nurse at work, the
Locating and collecting hoist
Manual
same again for the replacement staff to complete
Fit sling
Manual
Manual
Lift from present surface
Mechanical
Mechanical
the shift pattern. Without adding all the indirect
Move hoist to new surface
Manual
Mechanical (if in line with track position)
expenses and costs this would amount to
or
Move new surface into position
Manual
Manual
16 800.
Reposition patient (sitting or lying) Mechanical
Mechanical
The financial balance of prevention against
(if powered repositioning)
(if powered repositioning)
losses
always shows preference to the small fees
Lower to new surface
Mechanical
Mechanical
Adjust patient to best position
Mechanical
Mechanical
for prevention but full investment in prevention
(if powered repositioning)
(if powered repositioning)
solutions is rarely seen. Solutions for prevention
Remove sling
Manual
Manual
are regularly delivered at cost minimal solutions so
mobile hoists are preferred. The alternatives of
powered or two dimensional ceiling track hoist systems are price
2003). The interpretation of this research has focussed on the
comparable and might provide a better solution with a cost
removal of lifting tasks and has not evaluated the push pull levels
effective return through reduced accidents and ill health costs.
or the cumulative workload in as much detail. Warming et al
(2009) and Knibbe and Friele (1999), both used self reported logs
Future considerations
to identify the 24 hour exposure to physical loads with a good level
The provision of a vertical mechanism passive lifter has some
of reliability. These studies show that the number of care related
benefits but it is important to appreciate the cumulative effects of
tasks (e.g. re-positioning, limb movement, push, pull) add
the other assistive tasks, e.g. pushing, pulling, rolling, positioning,
significantly to the patient lifting risks of the lifting/hoisting tasks.
and transporting patients in the causation of fatigue and possible
Documented guidance to the safe use of hoists is in most UK
injury. The possible costs of increased sickness absence need to
care provider E.g. Fray et al 2001, Smith (Ed) 2005. A task analysis
be considered when supplying the mechanical solutions for
of the potential phases for hoisting show that many of the physical
handling larger adults in the healthcare environment.
tasks may not be improved by the provision of the hoist device.
This academic review raises questions that might need to be
Table 1 shows the different physical actions that may be included
considered in the future design of patient handling and healthcare
in a transfer task and whether the provision of different hoist types
solutions for the movement and positioning of larger patients:
affects the completion of the task.
 Improve the understanding of movement and positioning
When the use of hoisting systems is compared for the full range
requirements of the larger individual.
of physical tasks many components are not affected. If this
transfer is compounded by the two surfaces being a significant
 Avoid the pushing and pulling loads by having powered
distance apart then a transportation phase is also added. The
movement e.g. bed movers and powered hoist movement.
present design of hoists do not allow for the transportation of
 Consider sling sizing and sling design to minimise risks for
patients over anything other than very short distances. Design
application and removal e.g. hoistable clothing.
options for the transport of people in a sitting or lying position have
 Consider powered positioning for sitting/reclining, increased
already indicated that for large patients a powered transport
patient comfort and therapeutic benefits e.g. powered
device would be suitable (Kim et al 2009). Some technological
positioning in 3 axes.
solutions are available to assist in this movement e.g. Bed movers,
 Consider the combination of hoists with transport actions to
powered wheelchairs or trolleys and one motor driven hoist for the
reduce the in/out manoeuvres for sling application.
movement of larger patients (www.Smartlift.eu). The need to move
 Ensure compatibility between the hoisting system and the bed
people in a confined space also raises the force requirements and
mechanisms.
so powered systems may be indicated in more regular transfer
 Encourage patient handling research to examine the
tasks, e.g. bathing or toileting, with larger patients (Marras et al
cumulative load for patient handling tasks in addition to the
2009). The increase in the use of hoisting solutions for other
single high risk lifting factors.
activities, e.g. during rehabilitation, also suggests the
consideration of powered hoists as a possible requirement.
These considerations are leading the provision of healthcare
tasks towards full automation and the possible use of robots and
Financial considerations
intelligent communication to assist with care tasks. Intelligent bed
Publications that consider handling equipment options have
systems (Hill-Rom 2009) offers patient status information linked
identified the need for powered systems to assist with patient
directly to hospital networks. A recent study in the Norwegian
transport (Nelson and Fragala, 2004) but noted that the cost might
Association of Local and Regional Authorities (Nursing Times
be prohibitive for integrated powered systems e.g. trolleys.
2009) showed that carers would value the use of robots to free up
Charney (2004) and Siddarthan et al (2005) both discuss methods
carers to have more time for face to face duties. A BBC news
for calculating the direct, indirect and intangible costs of MSD
(2009) article suggests that technological advances can already
resulting from patient handling injuries and guide the calculation of
deliver a caring robot to assist with treatments, communication
a cost benefit analysis for provision of any intervention strategy.
interventions and patient movement tasks. It is time to consider
The reality of potential losses in UK healthcare is guided by the
how much more we can utilise from innovative solutions rather
NHS pay scales and the replacement fees for lost staff time. As an
than following traditional hoist design? J
Table 1: Effect of hoist provision on physical components of transfer tasks

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asia-pacific/8234463.stm. Published 2009/09/03. Accessed Sept 2009.
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pay_circular%20_AfC_%20%201_2009.pdf (Accessed Sept 2009)
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Published 1 Aug 2009. Accessed 8 Sept 2009.

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The International
Hospital Federation

Our vision is a world of healthy communities served by well


managed hospitals and health services where all individuals
reach their highest potential for health

Origins and aims


The International Hospital Federation (IHF), successor to the
International Hospital Association, established in 1929 after the first
International Hospital Congress in Atlantic City, USA, was revived
under its new title International Hospital Federation (IHF) in
1947. We are an international non-governmental organisation,
supported by members from over 100 countries. As the worldwide
body for hospitals and healthcare organizations we seek to develop
and maintain a spirit of cooperation and communication among
them, with the primary purpose of improving patient safety and
promoting health in underserved communities.

The IHF is driven by its founding ethos that it is the right of every
human being irrespective of geographical, economic, ethnic or
social condition to enjoy the best standard in quantity and quality
of health and access to hospital and health care services. By
promoting this value, IHF supports the improvement of the health of
society. The provision of health and health care to all people,
recognizes and accepts current best practice in medical standards
and patient care as well as the ethical behaviour and standards of
integrity required to govern, lead and manage health-care
organizations.

Mission, vision and activities

Membership and communications

Our vision is to become a world leader in facilitating the exchange


of knowledge and experience in health sector management, with
our main goals being:
 To improve patient care quality around the globe, through the
dissemination of evidence-based information.
 To collect, collate, publish and facilitate the exchange of
information and ideas on best practice in hospital and
healthcare management.
 To assist in the creation of environments that support
organisations in the promotion and delivery of healthcare.
 To foster international partnerships that promote interaction
among public and private hospitals and healthcare
organisations, the community and commercial entities.
 To promote and protect the dignity, safety and welfare of
patients.

Through our membership and communications activities we seek


to act as a bridge between members in order to facilitate and
support cross-fertilization of knowledge and experience in
management and leadership of health organizations. Through
these activities, we also support the creation of new national
hospital associations. Establishing strong and permanent
communication between the IHF Secretariat and members is a
priority goal.
IHF offers three categories of membership:
 Full Membership is open to any association or organizational
body deemed representative of the national healthcare
organizations, in particular but not exclusively hospitals, in a
country, a polity or a circumscribed region of the world.
 Associate Membership is open to healthcare organizations,
in particular but not exclusively hospitals, and other institutions
having a distinct relationship with the provision of healthcare,
who are not eligible for Full Membership.
 Honorary Membership is awarded to persons or
organizations who have rendered exceptional services to the
IHF.

This vision is promoted through events, publications, networking


and projects in line with our mission and values. These activities
prioritize information on leadership and management of hospitals
and health services.
132 Hospital and Healthcare Innovation Book 2009/2010

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The combined membership forms our General Assembly,


which meets every second year during the IHF Biennial World
Hospital Congress. Only Full Members have the right to vote and
elect members to the Governing Council at the General Assembly.
At present, there are some fifty two Full Members, and twenty-one
Governing Council members. The Governing Council in turn elects
from within its ranks an Executive Committee of four, namely the
President, President Designate, Immediate Past President and
Treasurer. The Executive Committee is responsible for conducting
affairs between Council meetings

Partnerships and relations with other organizations


We are in official relations with the World Health Organization. We
also have a network of international organisations with whom we
are have good working relations, which include:
 the International Council of Nurses;
 the World Medical Association;
 the Hospital Committee of the European Community;
 the World Dental Federation;
 the International Pharmaceutical Federation;
 the Global Health Workforce Alliance (GHWA);
 World Alliance for Patient Safety of the World Health
Organization (WHO)
 International Federation of Red Cross and Red Crescent
Societies (IFRC)
 Hpitaux universitaires de Genve/(University Hospitals
Geneva)
 World Confederation for Physical Therapy

forum and meeting place for


public and corporate actors.
Biennial
World
Hospital
Congress
Seoul,
S.Korea
(2007); Rio de Janeiro, Brazil
(2009); Dubai, UAE (2011)

Publications

These include:
 World Hospitals and Health Services
(WH&HS) Journal. First launched in 1929 as Nosokomeion,
and renamed World Hospitals and Health Service, is published
four times a year, featuring articles from leading international
figures, in the field of hospital and healthcare management. It
includes features such as surveys, country profiles, case
studies and advertising. The paper and electronic journal, is
Events
available to all IHF members, free of charge, or by annual
These are organized and located to enable us to be present in all
subscription to non-members.
regions of the world. Our regional events are supported by the
 International Hospital Federation Reference Book, our
Biennial World Hospital Congress. The subject focus of each of
resource for sharing ideas and information about hospital
these events is tailored to address the needs of the host region,
thereby ensuring our contribution to regional health services
management strategies, care regimens and the evaluation of
management and development. Our events also provide both a
medical equipment and treatments, among other topics. This
publication forms an integral part of our
communications strategy featuring annual
assessments of the worldwide evolution in
hospital care and facilities development.
 Building Quality in Health Care
(BQHC) journal, launched in October 2007,
is published in collaboration with The
Methodist Hospital (Texas, USA). It is
intended to fill a gap in the publishing
market on quality of health service, in that
its aim is to bridge the gap between
scientific evidence and actual practice in
healthcare. It seeks to play a critical role in
establishing global benchmarks in
organizations whose primary focus is
patient care and safety. Its mission also
IHF Full Members
IHF Associate Members
includes identification and dissemination of
practical knowledge regarding sustainable
IHF Affiliated hospital organizations in 2009
applications that would contribute to
Hospital and Healthcare Innovation Book 2009/2010 133

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FINAL.ai
Quality 4

20/10/09

09:00:58

Vol. 3 No. 1 |

lity
Building Qua
dist
rnal of Metho
The Official Jou

2009

in Health Care

l Federation
tional Hospita
and the Interna
International

A Call to Action: Ensuri


ng Global
Human Resources for Hea
lth
March 22-23, 2007
International Conference
CentreGeneva, Switzerland

Proceedings Report

CM

MY

CY

CMY

tal Federation
International Hospi le des Hpitaux
ationa
Fdration Intern acional de Hospitales
Federacin Intern

improvement in healthcare quality and safety. The circulation


for our publications is over 5000 in some 100 countries with
an estimated readership of 20 000, the key recipients being
ministers and ministries of health; national and regional hospital
associations; hospital CEOs and managers, architects,
engineers, doctors, nurses, members of hospital boards,
libraries and commercial firms in the health field.
 Ad Hoc Publications: Global Study Report The performance
of hospitals under changing socioeconomic conditions a global
study on hospital sector reform, prepared in collaboration with
the World Health Organization (WHO) involving 20 countries of
all six WHO regions. The Report analyses the performance of
hospitals under changing socioeconomic conditions and
provides a significant contribution to the WHO work on health
systems development and service delivery. Proceedings Report
(2007): A Call to Action: Ensuring Global Human Resources for
Health. This Report is a summary of the key recommendations
of the international conference, which brought together
researchers, policy-makers, educators, organization leaders
and healthcare professionals to launch a global dialogue and
agenda to improve the scaling up of workforces and health
systems structures. Language newsletters La Lettre
Hospitalire Francophone and Servicios de Salud en el Mundo,
published in partnership with our French and Argentinean
national member associations French Hospital Federation

and Camera Argentina.


 E-Newsletter: The e-newsletter is a new service provided by
the IHF secretariat, to be used as a platform for knowledge
and information sharing. The objective of this electronic news
letter is to provide an information advisory service in health
service delivery as well as to update members on IHF
activities. The e-newsletter is part of IHFs renewed
communication strategy to better serve its members and the
wider healthcare community. It provides direct access to
critical and up-to-date information on health services and
organizations. The e-newsletter is edited in-house.
Contributions of members illustrate news about the healthcare
sector in their own countries or organizations, report of events,
etc. It is expected to serve as an
interactive tool for members, to
enjoy the opportunity to express
The Internation
al Hospital Fe
themselves at an international
deration
level on topics of

Training Man
ual
on
Tuberculosis
& Multidr
Control, Treatme ug-resistant TB
nt & Prevention
for
Hospital/Clinic
/Health Facility
Managers

with support

134 Hospital and Healthcare Innovation Book 2009/2010

from Lilly

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IHF reference

interest, and disseminate their own information. The newsletter


is published five times a year. The first issue was published in
March 2009.

Activities
The diverse and various initiatives include:
 IHF Leadership Summit:
The Leadership Summit is an invitation-only event, organised by
the International Hospital Federation (IHF), for top level decision
makers on hospital issues from National Hospital Associations,
Ministries of Health and IHF Governing Council members.
Industry representatives are also invited, with whom discussions
are held on the needs and motivations of both suppliers and
consumers in a non-commercial environment.
The Summit marks the beginning of a new direction for the IHF
and for its members, as it provides an initial opportunity for the
leaders of IHFs constituent organizations to reflect together on
their individual and common goals and on the problems they
collectively confront. The inaugural event was held in Paris,
France, in May 2009. The next meeting is to be held in USA, in
June 2010.
 Development of a Training Manual for Tuberculosis (TB) and
MultiDrug Resistant-Tuberculosis (MDRTB) Control for
Hospital/ Clinic/Health Facility Managers. The target audience
of this manual are managers of hospitals, clinics and health
service facilities, to prepare them to make informed decisions
to support therapies and drugs used in the treatment of TB
and MDRTB; and to train them to implement infection control
programmes so as to protect both staff and uninfected
patients from TB transmission within healthcare facilities. This
project, which remains ongoing, is part of the Lilly MDR TB
Partnership (www.lillymdr tb.com) in which we became a
partner in 2004.
 MDR-TB Workshops:
TB Hospital Managers Training SeminarPretoria, South
Africa (2006); Beijing, China (2008); Mumbai, India (2009)
Inter-professional MDR-TB Infection Control Training
Seminars Cape Town, South Africa (2007); Rio de Janeiro,
Brazil (2009); Durban, South Africa (2009).
 First Global Forum on Human Resources for HealthGHWA,
Kampala, Uganda (2008).

 Geneva Health Forum of the Hpitaux Universitaires de


Genve (HUG) - Switzerland (2006, 2008).
 Representations:
Regular participation in conferences and workshops
organised by the WHO, to represent interests of the hospital
sector.
Regular participation in conferences and workshops
organised by the WHO, to represent interests of the hospital
sector.
 Technical Assistance Programmes:
Collaboration with the Health Strategy Committee for Kuwaiti
Health Care to articulate a long term vision for the healthcare
system in Kuwait and to propose incremental steps in
support of this vision (2008).
Mobility of Health Professionals (Mohprof), a European
Comission sponsored collaborative project, which brings
together a partnership of expert scientific institutes and
international healthcare and professional organisations to
undertake research and policy development on health
professional mobility, guidelines and recommendations
(2009).
Collaboration with the Taiwan Export Import Bank to under
take an evaluation mission for a 600-bed university hospital
project in Ouagadougou (Burkina Faso) (2009).
Collaboration with the International Association for Infant
Food Manufacturers (IFM) to develop a safe food
preparation, handling and feeding practices programme in
healthcare facilities. This will involve field missions to
hospitals/healthcare facilities in Peru and Indonesia (2009).
Collaboration with the Hamdan Bin Mohammed E-University,
Dubai, UAE, to conduct a long distance and face-to-face
accredited Senior Hospital and Health Services Managers
course (2009).
Positive Practice Environment Campaign (PPE), a five-year
partnership campaign of health professional organisations to
improve well-being, health and safety in work environments
and aid in recruitment and retention of health workers.
National PPE campaigns are planned. y

Hospital and Healthcare Innovation Book 2009/2010 135

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IHF Governing Council 20092011


THE EXECUTIVE COMMITTEE
Dr JOSE CARLOS DE SOUZA
ABRAHAO
President
CONFEDERACAO NACIONAL DE
SAUDE (CNS)
SRTVIS Quadra 701, Conjunto E
Edificio Palacio do Radio 1
Brasilia DF, CEP 70340-906
BRAZIL
Tel: +55 61 3321 0240
Fax: +55 61 3321 0250
Email: cns@cns.org.br

President-Designate
Mr THOMAS C DOLAN
Chief Executive Officer
AMERICAN COLLEGE OF
HEALTHCARE EXECUTIVES
One North Franklin Street
Suite 1700
Chicago, Illinois 60606-3491
UNITED STATES OF AMERICA
Tel: +1 312 424 9365
Fax: +1 312 424 0023
E-mail: tdolan@ache.org

Immediate Past Presidents


Dr IBRAHIM A AL ABDULHADI
Assistant Undersecretary for Health
Insurance Affairs
MINISTRY OF HEALTH
State of Kuwait
PO Box 5, PIN Code 13001
KUWAIT
Tel: +965 486 3699
Fax: +965 486 3524
E-mail: drhadi@moh.gov.kw

Mr GERARD VINCENT
Dlgu Gnral
FEDERATION HOSPITALIERE DE
FRANCE
1 bis Rue Cabanis
75014 Paris
FRANCE
Tel: +33 1 44 06 84 42 / 44
Fax: +331 44 06 84 45
E-mail: g.vincent@fhf.fr /
l.maute@fhf.fr

Dr JUAN CARLOS LINARES


Director Camara Argentina de Empresas de Salud CAES
CAMARA ARGENTINA DE EMPRESAS DE SALUD (CAES)
Tucuman 1668, 2 Piso
Buenos Aires C.P. 1050
ARGENTINA
Tel: +54 34 88 466 844 / +54 11 4372 5915 / 5762
Fax: +54 11 4372 3229
Email: linaresjcarlos@yahoo.com.ar

Dr MUKI REKSOPRODJO
President Director & CEO
RUMAH SAKIT METROPOLITAN MEDICAL CENTRE (MMCH)
JlHR Rasuna Said Kav C-21
Kuningan Jakarta Selatan 12940
INDONESIA
Tel: +6221 72791383, 72791404;
Fax: +6221 7252026
Email: mukirekso7@gmail.com

Prof HELEN LAPSLEY


Research Professor
CENTRE OF NATIONAL RESEARCH ON DISABILITY &
REHABILITATION MEDICINE
University of Queensland
3 Keston Avenue
Mosman, Sydney NSW 2088
AUSTRALIA
Tel: +612 99 692 346
Fax: +612 99 684 987
Email: cliveh@ip.net.au

Prof SHUZO YAMAMOTO


President
JAPAN HOSPITAL ASSOCIATION
13-3 Ichibancho, Chiyodaku, Tokyo
JAPAN
Tel: +813 332 650 077
Fax: +813 332 302 898
Email: ouchi@hospital.or.jp

Prof GUY DURANT


Administrateur gnral
CLINIQUES UNIVERSITAIRES SAINT-LUC
Avenue Hippocrate 10
B - 1200 Bruxelles
BELGIUM
Tel: +32 2 764 15 22
Fax: +32 2 764 15 25
Email: durant@hosp.ucl.ac.be
Dr GEORG BAUM
Chief Executive
GERMAN HOSPITAL FEDERATION
Wegelystrasse 3
10623 Berlin
GERMANY
Tel: +49 30 398 011 001
Fax:+4930 398 013 011
Email: g.baum@dkgev.de; m.schreiner@dkgev.de
Dr LAWRENCE LAI
Senior Advisor
HONG KONG HOSPITAL AUTHORITY
Room 1003, Administration Block
Queen Mary Hospital
102 Pokfulam Road
HONG KONG (SAR)
Tel: +852 2255 3253
Fax: +852 2504 2784
E-mail: laifm@ha.org.hk

Dr TAI-CHUN YOO
President
KOREAN HOSPITAL ASSOCIATION
35-1, Mapo-Dong, Mapo-Gu, Seoul
KOREA
Tel: +822 718 754 Ext 183
Fax: +822 718 7522
Email: intlaffairs@kha.org.kr
Dr ERIK KREYBERG NORMANN
President
NORWEGIAN HOSPITAL & HEALTH SERVICE ASSOCIATION
Nedre Slottsgt. 7, 0157 Oslo
NORWAY
Tel: +47 22 40 25 50
Fax: +47 22 40 55 51
Email: erik.normann@helse-sorost.no
Prof CARLOS PEREIRA ALVES
Vice Chair
ASSOCIACAO PORTUGUESA PARA O DESENVOLVIMENTO
HOSPITALAR
Av. Antnio Augusto de Aguiar, 32-4
1050-016 Lisboa
PORTUGAL
Tel: +351 21 37 83 / 66
Fax: +351 21 37 73
Email: ihf@ihf.min-saude.pt

136 Hospital and Healthcare Innovation Book 2009/2010

Dr LEKE PITAN
Former Commissioner for Health
Lagos State
House G40C, Road 2
Victoria Garden City, Lagos
NIGERIA
Tel: +234 1 775 4544 /
+234 803 7787834 /
+44 7785 764 692
Email: drlekepitan@yahoo.com

Dr THABO LEKALAKALA
Director Hospital Management
and Planning
DEPARTMENT OF HEALTH
Street Hallmark Building
231 Proes Street
001 Pretoria
SOUTH AFRICA
Tel: +27 12 312 0930
Fax: +27 12 312 3388
Email: lekala@health.gov.za
Dr DELON WU
President
TAIWAN HOSPITAL ASSOCIATION
25F, No29-5
Sec. 2, Jung jeng E. Road
Danshuei Township, Taipei County
TAIWAN
Tel: +886 22 808 3300
Fax: +886 22 808 3304
Email: hatw@hatw.org.tw
Mrs ALISON KANTARAMA
President
UGANDA NATIONAL ASSOCIATION OF HOSPITAL
ADMINISTRATORS (UNAHA)
Mulago Hospital
PO Box 7051, Kampala
UGANDA
Tel: +256 414 554 748
Fax: +256 414 532 591
Email: alisonkantarama@yahoo.com
Mr ABDUL SALAM AL-MADANI
President
INDEX HOLDING
Dubai Healthcare City
Block B, Offices 203 303
P.O.Box 13636, Dubai
UNITED ARAB EMIRATES
Tel: +97 14 362 4717
Fax: +97 14 362 4718
Email: index@emirates.net.ae
Prof STEPHEN BARNETT
Chief Executive
NHS CONFEDERATION
29, Bressenden Place
London SW1E 5DD
UNITED KINGDOM
Tel: +44 (0) 20 7074 3281
Fax: +44 (0) 844 774 4319
Email: Steve.Barnett@nhsconfed.org;
natasha.mal@nhsconfed.org

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IHF Secretariat Staff


2009/2010

Eric de Roodenbeke
Director General
Eric de Roodenbeke assumed the position of
Director General of the International Hospital
Federation in June 2008. Between July 2007 and May 2008 he was
Senior Health Specialist at the World Health Organization (WHO) for
the Global Health Workforce Alliance (GHWA) during which time he
was involved in support country action programmes to develop a
response to the HRH crisis; development of strategies for regional
networks in support of HRH development and was the focal point
for follow-up actions in Francophone countries. He was Senior
Health Specialist at the World Bank (AFTH2 & WBI) from 2004 to
2006 in which time he was Team leader (TL) for various health
intervention, educational, management and capacity building
programmes mostly in Africa. He was Director of the 700-bed
University Hospital of Tours, and Senior Officer responsible for
hospital and health financing interventions at the French Ministry of
Foreign Affairs from 2001 to 2003 and 1999 to 2001, respectively.
Between 1996 and 1998, he was Senior Officer on hospital policy
expertise at the French Ministry of Cooperation. From 1994 to 1996,
he was Deputy Director of the 870-bed University Hospital of
NANTES. 1989 to 1994, Dr de Roodenbeke was the Expert, task
team leader for a project involving construction, equipment ,
management of a 500- bed hospital in, Burkina Faso. He was
Deputy Director of Epinal- Vosges (France) General Hospital from
1984 to 1989. Dr de Roodenbeke has published widely on hospital
organisation, health systems reforms human resources and health
facility management, health policy, insurance and financing in
developed and developing countries. Dr de Roodenbeke holds a
Ph.D. in health economics - University of Paris 1, Sorbonne (France);
a Hospital Administration Diploma from ENSP Rennes (France); and
a Diploma in Public Health from the University of Nancy (France). He
speaks fluent French (native language) and English and basic Greek
and German. He is a member of various social organizations and is
affiliated to the French Health Economics Society.

Honours degree in European and Social Sciences, with a major in


French Language (University of East Anglia Norwich, UK). She is a
Christian and an active member in her local church. She speaks
fluent French, English and Ibo (mother tongue). She enjoys
international affairs, sports and has travelled widely.

Sev Lucas
Membership Manager
Sev Lucas has a Masters degree in public health in
developing countries and is a graduate of a Masters in
health economics in developing countries from the University of
Clermont Ferrand (CERDI, Center for Studies and Research on
International Development). Sev joined IHF in January 2009. She is
responsible for member liaison activities and support of designated
IHF projects. She is also in charge of development of the health
system knowledge database and in charge of the newsletter.
Sev is from Bretagne, northwestern region of France and enjoys
skiing, sailing, surfing, traveling and playing the saxophone. She
speaks fluent French, Spanish, English and she is learning
Portuguese

Dwight Moe
Dwight Moe joined the IHF in 2003 and was the
Projects and Events Manager. Born in Honolulu,
Hawaii, he lived in North America, Asia and Europe.
Dwight did his studies at the University of Minnesota
in International Relations and Chinese. He has over ten years of
experience in event planning and operations. His career has led him
around the world organising and managing travel events for major
clients in the automotive, financial and pharmaceutical industries. He
and his wife enjoy cooking, skiing and travel.
Dwight left the IHF in December 2009 to pursue further career
goals.

Sheila Anazonwu

Ccile Reynes

Programme Development and Knowledge Manager


Sheila Anazonwu, MSc, BA, is the Programme
Development and Knowledge Manager at the
International Hospital Federation. She joined the IHF in 1992 as
Personal Assistant to the Director General. Prior to joining the IHF,
Sheila worked in the private sector in development project
management and human resource training. She also worked at the
Economic Community of West African States (ECOWAS) Secretariat
in Lagos, Nigeria. She has done voluntary work for Human Rights
Watch (UK). She has a Master of Science degree in International
Relations (University of Southampton, UK) and a Bachelor of Arts

French Translator
oined the IHF in 2000 as French Translator, on a parttime basis. Since 2004 began working on a free-lance
basis.

Loly Vaswani
Spanish Translator
joined the IHF as part-time Spanish translator in 1988.
In 1990 she moved to Malaga, Spain, but continued
to work for the IHF. Since 2004 she began working on
a free-lance basis.
Hospital and Healthcare Innovation Book 2009/2010 137

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IHF Consultants
Audit & Conseil de Leman
13 Chemin du Levant, 01210 Ferney Voltaire, France
Tel: +33 (0) 450 40 75 76 +33 (0) 450 40 75 76;
Fax: +33 (0) 450 40 98 85
email: info@ac-leman.com / Contact: M. Laurent Forstmann
Haysmacintyre, Fairfax House,
15 Fulwood Place, London WC1V 6A, UK
Tel: +44 (0)20 7969 5500; F +44 (0)20 7969 5600
Email: rpierce@haysmacintyre.com / Contact: Mr. Ray Pierce
NBM-Europe.Com
373 Route du Nant, ZA de Magny, 01280 Prevessin-Mons, France
Tel: +33 (0) 450 28 07 29 +33 (0) 450 28 07 29;
Fax: +33 (0) 450 28 08 04
email: infor@nbm-europe.com / Contact: M. Olivier Bail

138 Hospital and Healthcare Innovation Book 2009/2010

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National healthcare organizations


Full members

ARGENTINA
CONFEDERACION ARGENTINA DE CLINICAS
Tucuman 1668 2do - 4 piso
1050 Buenos Aires, ARGENTINA
Tel: +54 11 4373 2315;
Fax: +54 11 4372 3229
Internet: www.caes.com.ar
CAMARA ARGENTINA DE
EMPRESAS DE SALUD
Tucuman 1668 2ndo-4 piso
1050 Buenos Aires, ARGENTINA
Tel : +54 11 4372 5915/5762
Fax: +54 11 4372 3229
Internet: www.caes.com.ar
AUSTRALIA
AUSTRALIAN HEALTHCARE ASSOCIATION
Suite 4 Level 1 99 Northbourne Avenue
2600 Turner, AUSTRALIA
Tel : +61 2 6162 0780;
Fax: +61 2 6162 0779
Internet: www.aushealthcare.com.au
AUSTRIA
Abteilung VII/3
BUNDESMINISTERIUM FR GESUNDHEIT, FAMILIE UND JUGEND
Radetzkystrae 2, A-1030 Wien
AUSTRIA
Tel: +43 1 711 00-0;
Fax +43-1 711 00-14300
Internet: www.bmgfj.gv.at
BAHRAIN
MINISTRY OF HEALTH
PO Box 12
Manama, BAHRAIN
Tel: +973 17 252755
Fax: +973 17 27 0044
Internet: www.moh.gov.bh
BELGIUM
ASSOCIATION BELGE DES HOPITAUX - ASBL
Place A. Van Gehuchten 4
1020 Brussels, BELGIUM
Tel: +322 477 3910
Fax: +322 477 3920
Internet: www.hospitals.be
SANTHEA
9 Quai au Bois de Construction
1000 Brussels, BELGIUM
Tel : +322 210 4270
Fax: +322 511 0454
Internet: www.santhea.be

FEDERATON DES ETABLISSEMENTS HOSPITALIERS ET


DASSISTANCE PRIVE A BUT NON LUCRATIF (FEHAP)
179 rue de Lourmel, 75015 PARIS
FRANCE MTROPOLITAINE
Tel: +33 1 53 98 95 08
Fax: +33 1 53 98 95 38
Internet: www.fehap.fr

COORDINATION BRUXELLOISE DES INSTITUTIONS


SOCIALES ET DE SANTE
33 Rue Cesar Franck, 1050 Brussels, BELGIUM
Tel: +322 644 0614 & 0173
Fax: +322 644 0109
Internet: www.CBI-bruxelles.be
FEDERATION DES INSTITUTIONS HOSPITALIERES DE WALLONIE
Ch. de Marche 604, 5101 Erpent, BELGIUM
Tel: +32 81 327660
Fax: +32 81 327676
Internet: www.fih-w.be
BRAZIL
CONFEDERAO NACIONAL DE SADE, HOSPITAIS,
ESTABELECIMENTOS E SERVIOS (CNS)
SRTV/S - Quadra 701, Conj. E - Ed. Palcio do Rdio I, Bl. 3, N
130 - 5 Andar. sa Sul
Braslia - DF - CEP: 70340-901, BRAZIL
Tel: +55 61 3321 0240; Fax: +55 61 3321 0250
Internet: www.cns.org.br
CANADA
CANADIAN HEALTHCARE ASSOCIATION
17 York Street, Ottawa, Ontario
CANADA K1N 9J6
Tel: +1 613-241-8005
Fax: +1 613-241-5055
Internet: www.cha.ca
COLOMBIA
ASOCIACION COLOMBIANA DE HOSPITALES
Carrera 4a No. 73 15, Bogota, COLOMBIA
Tel: +571 312 4411
Fax: +571 3121005
Internet: www.achc.org.co
CYPRUS
MINISTRY OF HEALTH
11 Byron Avenue, Nicosia, CYPRUS
Tel: +357 22 605 318
Fax: +357 222 434 203
Internet: www.moh.gov.cy
FINLAND
ASSOCIATION OF FINNISH LOCAL AUTHORITIES
Toinen Iinja 14, FI-00530 Helsinki, FINLAND
Tel: +358 9 771 1
Fax: +358 9 771 2291
Website: www.kunnat.net
FRANCE
FEDERATION HOSPITALIERE DE FRANCE
1 bis Rue Cabanis, 75014 Paris
FRANCE MTROPOLITAINE
Tel: +331 44 06 84 41
Fax: +331 4406 8445
Internet: www.fhf.fr

GERMANY
DEUTSCHE KRANKENHAUSGESELLSCHAFT
Bereich Politik Wegelystrasse 3
10623 Berlin, GERMANY
Tel: +49 30398011014
Fax: +49 30398013011
Internet: www.dkgev.de
GREECE
MINISTRY OF HEALTH AND SOCIAL SOLIDARITY
17 Aristotelous Street
10187 Athens, GREECE
Tel: +30 210 5248225
Fax: +30 210 5236023
Internet: www.mohaw.gr
HONG KONG (SPECIAL ADMINIST. REGION: CHINA)
HOSPITAL AUTHORITY
5/F Hospital Authority Building
147B Argyle Street
Kowloon, HONG KONG
(Special administ. Region: China)
Tel: +852 2805 6769
Fax: +852 2881 8058
Internet: www.ha.org.hk
HUNGARY
MAGYAR KORHAZSZO VETSEG
(Hungarian Hospital Associaton)
Ibrahim u. 19, 1125 Budapest, HUNGARY
Tel: +361 12145118 /+36 30 9967185
Fax: +361 12145159
Internet: www.korhazszovetseg.hu
INDONESIA
INDONESIAN HOSPITAL ASSOCIATION
Jl. Boulevard Artha Gading A-7A
No 28 Kelapa Gading
14350 Jakarta Utara, INDONESIA
Tel: +62214585783
Fax: +62214585783
Internet: www.pdpersi.co.id
ITALY
FEDERAZIONE ITALIANA AZIENDE SANITARIE ED OSPEDALIERE
Corso Vittorio Emanuele II 24, 186 Roma, ITALY
Tel: +39 06 6992 4145
Fax: +39 06 6780907
Internet: www.fiaso.it

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JAPAN
JAPAN HOSPITAL ASSOCIATION
13-3 Ichiban-cho Chiyoda-ku
1028414 Tokyo, JAPAN
Tel: +813 3265 0077
Fax: +813 32302898
Internet: www.hospital.or.jp
KOREA
KOREAN HOSPITAL ASSOCIATION
Mapo Hyun Dai Bldg
35-1 Mapo-dong, Mapo-gu
121-737 Seoul, KOREA
Tel: +822 718 7503
Fax: +822 7187522
Internet: www.kha.or.kr
KUWAIT
MINISTRY OF PUBLIC HEALTH
P O Box 5, 13001 Safat, KUWAIT
Tel/Fax: +965 486 3703
LEBANON
SYNDICAT DES HOPITAUX DU LIBAN
Ghazal Bldg - 7th Floor, PO Box 662-165 Adlieh
662 Beirut, LEBANON
Tel: +961 1 611011
Fax: +961 1 616772/3/4
Internet: www.syndicateofhospitals.org.lb
LUXEMBOURG
ENTENTE DES HOPITAUX LUXEMBOURGEOIS
13-15 rue Jean-Pierre Sauvage
2514 Luxembourg, LUXEMBOURG
Tel: +352 424 142
Fax: +352 425 550
Internet: www.ehl.lu
MEXICO
ASOCIACION NACIONAL DE HOSPITALES PRIVADOS
Pablo Casals 640
44670 Guadalajara Jalisco, MEXICO
Tel: +52 333 669 881
Fax: +52 333 669 882
NETHERLANDS
NVZ vereniging van ziekenhuizen
Postbus 9696, 3506 Utrecht, NETHERLANDS
Tel: +31 30 273 9451
Fax: +31 30 273 9780
Internet: www.nvz-ziekenhuizen.nl
NIGERIA
IHF NIGERIA CHAPTER: Nigerian Hospital Association
First Foundation Place
36 Opebi Road, Ikeja, Lagos, NIGERIA
Tel: +234 803 3547371
Internet: www.ihfnigeria.org
NORWAY
NORSK SYKEHUS-OG HELSETJENESTEN
Nedre Slottsgt 7, 1570 Oslo, NORWAY
Tel: +47 22 402 555;
Fax: +47 22 414 871
Internet: www.nsh.no
PERU
FEDERACIN PERUANA DE ADMINISTRADORES
DE SALUD (F.E.P.A.S)
(Peruvian Federation of Health Administrators)
PSJE, Jorge Buckley 340, DPTO 203
San Antonio Miraflores, Lima 18, PERU
Tel: +51 1 999 100 628 / 971 56406 / 910 83575
Internet: www.fepas.org.pe

PHILIPPINES
PHILIPPINE HOSPITAL ASSOCIATION
14 Kamias Road, Quezon City, PHILIPPINES
Tel: +63 2 922 7674/75
Fax: +63 2 929 2219
Internet: www.philhospitals.org
PORTUGAL
ACSS-ADMINISTRACAO CENTRAL DOS
SERVICOS DE SAUDE
Av.Antonio Augusto de Aguiar 32-4
1050-016 Lisbon, PORTUGAL
Tel: +351 21 317 974
Fax: +351 21 317 976
Internet: www.apdh.pt
PUERTO RICO
ASOCIACION DE HOSPITALES
DE PUERTO RICO
Villa Nevarez Professional Center
Suite 101- Villa Nevarez
927 San Juan PR, PUERTO RICO
Tel: +1 787 764 0290
Fax: +1 787 753 9748
Internet: www.asociacionhosppr.org
SAUDI ARABIA
MINISTRY OF HEALTH
International Health Department
11176 Riyadh, SAUDI ARABIA
Tel: +966 1 408 1233
Internet: www.moh.gov.sa/en/ (Include)
SOUTH AFRICA
DEPARTMENT OF HEALTH
231 Proes Street Hallmark Building
001 Pretoria, SOUTH AFRICA
Tel: +27 12 312 0930
Fax: +27 12 312 3388
Internet: www.doh.gov.za
SWEDEN
THE SWEDISH ASSOCIATION OF LOCAL
AUTHORITIES AND REGIONS (SALAR)
SE-118 82 Stockholm, SWEDEN
Tel: +468 452 7200
Fax: +46 8 452 7210
Internet: www.skl.se
SWITZERLAND
H+ LES HOPITAUX DE SUISSE
Lorrainestrasse 4a, 3013 Bern, SWITZERLAND
Tel: +41 31 335 1111 / 335 11 14
Fax: +41 31 335 1170
Internet: www.hplus.ch
TAIWAN
HOSPITAL ASSOCIATION OF TAIWAN
25F n 29-5 section 2 Chung Cheng East Road Damshui
Township, Taipei Hsien, TAIWAN
Tel: +886 2 2833 8829; +886 2 2808 3300 ext. 24;
Fax: +886 2 2832 3571
Internet: www.hatw.org.tw
TUNISIA
MINISTERE DE LA SANTE PUBLIQUE
Tunis 1030 TUNISIA
Tl : (216) 71 56 06 85
Fax : (216) 71 26 04 74
Internet: www.ministeres.tn/html/ministeres/sante/html
UK ENGLAND
NHS CONFEDERATION
29 Bressenden Place
London SW1E 5ER, UK ENGLAND
Tel: +44 207 074 3280/1
Fax: +44 207 074 3201
Internet: www.nhsconfed.org

140 Hospital and Healthcare Innovation Book 2009/2010

USA
AMERICAN HOSPITAL ASSOCIATION
325 Seventh Street NW
Washington DC 20004-2802, USA
Tel: +1 312 626 2363/ +1 202 638 1100
Fax: +1 202 626 2345
Internet: www.aha.org
UGANDA
UGANDA NATIONAL ASSOCIATION OF HOSPITAL
ADMINISTRATORS (UNAHA)
c/o Mulago Hospital, PO Box 7051
Kampala, UGANDA
Tel: +256 414 554 748
Fax: +256 414 532 591
UNITED ARAB EMIRATES
DEPARTMENT OF HEALTH AND
MEDICAL SERVICES
P O Box 4545, Dubai,
UNITED ARAB EMIRATES
Tel: +971 4 370 031
Fax: +971 4 374 563
Internet: www.dohms.gov.ae

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Other organizations and institutions


Associate members
BELGIUM
GHENT UNIVERSITY HOSPITAL
Kliniekgebouw 11 K12 I.A, De Pintelaan 185
9000 Gent , BELGIUM
Tel: +32 9 240 4762
Fax: +32 9 240 4860
Internet: www.uzgent.be
BENIN
Assistant Technique en appui au
RESHAOC Coopration Franaise
CNHU H.K.MAGA
01 BP 386, Cotonou, BENIN
CANADA
CENTRE HOSPITALIER MONT SINAI
5690 Cavendish Boulevard
Cote St. Luc, Quebec H4W 1S7
CANADA
Tel: +1 514 369 2222
Fax: +1 514 369 2225
Internet: ww.sinaimontreal.ca
REGINA QUAPPELLE HEALTH REGION
2180 - 23rd Avenue, Regina
Saskatchewan S4S 0A5, CANADA
Tel: +1 306 766 5279
Fax: +1 306 766 5222
Internet: www.rqhealth.ca
ST MICHAELS HOSPITAL
30 Bond Street
Toronto, Ontaria M5B 1W8, CANADA
Tel: +1 416 864 5617
Fax: +1 416 864 5669
Internet: www.stmichaelshospital.com
TRILLIUM HEALTH CENTER
100 Queensway West
L5b1Mississauga, ON
Tel: +905-848-7100
Fax: 905-848-7356
Internet: www.trilliumhealthcentre.org
CHINA
PHOENIX HOSPITAL GROUP
Beijing Jiangong Hospital
6 Rufuli, Xuanwu District, Beijing 100054
CHINA
Tel: +86 10 6352 9575
Fax: +86 10 6351 6056
Internet: www.phg.com.cn
DENMARK
DANISH INSTITUTE FOR QUALITY AND
ACCCREDITATION IN HEALTHCARE
(Institut for Kvalitet og Akkreditering i Sundhedsvsenet (IKAS))
Olof Palmes All 13, 1. th.
8200 rhus N, DENMARK
Tel: +45 87 45 00 50

HILLERD HOSPITAL
Helsevej 2, 3400 Hillerd,
DENMARK
Tel: +45 48 29 48 29
Internet: www.hillerodhospital.dk

CENTRE HOSPITALIER SAINTE ANNE


1 rue Cabanis
75014 Paris
FRANCE
Tel: +33145658000
Fax: +33145658503
Internet: www.ch-sainte-anne.fr

FINLAND
HOSPITAL DISTRICT OF HELSINKI AND UUSIMAN
PO Box 100, FI 000 HUS, FINLAND
Tel: +358 9 471 71200
Fax : +358 9 471 71206
Internet: www.hus.fi

GERMANY
LIPPISCHE NERVENKLINIK DR. SPERNAU GmbH & CO.KG
Waldstrae 2, 32105 Bad Salzuflen, GERMANY
Tel: +49 (0) 5222 188-103/ +49 (0)5222 188-0
Fax: +49 (0) 5222 188-199

KUOPIO UNIVERSITY HOSPITAL


P.O. Box 1777, FI 70211 Kuopio, FINLAND
Tel: +358 17 17 33 11 / +358 17 17 35 90
Fax : +358 17 17 35 99
Internet: www.psshp.fi

NATIONS HEALTHCAREER SCHOOL OF MANAGEMENT GmbH


Frankfurt Region Office
Else-Krner-Strae 1
61352 Bad Homburg, GERMANY
Tel: + 49 (0) 6172 608 4600
Fax: + 49 (0) 6172 608 4601
Internet: www.Nations-HealthCareer.com

OULU UNIVERSITY CENTRAL HOSPITAL


Kajaanintie 50, 90220 Oulu, FINLAND
Tel: +358 8 315 2011; Fax: +358 8315 4499
Internet: www.ppshp.fi
PIRKANMAA HOSPITAL DISTRICT
PO Box 2000, FI-33521 Tampere, FINLAND
Tel: +358 3 311 66210/ +358 50 68048 /+358 3 311 66211
Internet: www.tays.fi
TURUN YLIOPISTOLLINEN KESKUSSAIRAALA
Kiinamyllynkatu 4-8, PO Box 52
20521 Turku, FINLAND
Tel: +358 2 313 3601 / +358 2 313 0000
Fax: +358 2 313 3613
Internet: www.tyks.fi/en/
FRANCE
CENTRE HOSPITALIER D'ARRAS
Bvd Besnier BP 914
62022 Arras, FRANCE MTROPOLITAINE
Tel: +33 (0) 3 21 21 10 10
Internet: www.ch-arras.fr
CENTRE HOSPITALIER DE PERPIGNAN
20, Avenue du Languedoc
BP 49954, 66046 PERPIGNAN Cdex 9
FRANCE MTROPOLITAINE
Tel: +33 (0)4 68 61 66 33
Fax: +33 (0)4 68 61 68 33
Internet: www.ch-perpignan.fr
CLINIQUE LES SOURCES
Avenue Roses 10 C Pietruschi
06105 NICE CEDEX 2, FRANCE MTROPOLITAINE
Tel: +33 (0)4 92 15 40 00
Fax: +33 (0)4 92 15 40 11
Internet: http://www.clinique-les-sources.org

DEUTSCHER EVANGELISCHER KRANKENHAUSVERBAND


Reinhardtstrasse 18
10117 Berlin
Tel: +49 30 8019860
Fax: +49 30 80198622
Internet: www.dekv-ev.de
GREECE
PRIVATE HOSPITAL & DIAGNOSTIC CENTER
Kyanous Stavros S.A.
102 Vas. Sofias Avenue, Athens, GREECE
Tel: +30 210 746 8800
Fax: +30 210 777 4304
Internet: www.kyanousstavros.gr
INDIA
RAJAN BABU TB (R.B.T.B.) HOSPITAL
Delhi 110009, INDIA
Tel: +91 11 27433431 / +91 11 981072 1234
THE MAHARASHTRA STATE ANTI TB ASSOCIATION (MSATBA)
Kochs House, Jerbai Wadia Road
Outside Group of TB Hospitals
Sewree, Mumbai 400 015, INDIA
Tel: +91 22 2410 6583 / +91 98 69 105 521
Fax: +91 22 2410 3673
Internet: www.msatba.webs.com
INDONESIA
BETHESDA HOSPITAL
Jl. Jenderal Sudirman 70
Yogyakarta 55224, INDONESIA
Phone: +62(0) 274 586 688 /
+62 (0) 274 562 246
Fax: +62(0) 274 563 312
Internet: http://www.yakkum.or.id/bethesda/

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KENYA
THE NAIROBI HOSPITAL
PO Box 30026, Nairobi, KENYA
Tel: +254(0) 20 284 5000 / 20 284 6000 /
+254 (0) 722 204 114
Fax: +254(0) 20 272 8003 / 20 272 5237
Internet: www.nairobihospital.org
MEXICO
HOSPITAL SAN JAVIER
Av. Pablo Casals 640,
Col. Prados Providencia Esq. con Eulogio Parra
Guadalajara, 44670 Jalisco. MEXICO
Tel: +52 (33) 3640 1128 / 3669 0222
Internet: www.sanjavier.com.mx
MONGOLIA
TEGS KHUSEL HOSPITAL
49 Peace Avenue, Ulaanbaatar, MONGOLIA
Tel/Fax: +976 11 458 191
MOROCCO
ASSOCIATION MAROCAINE DES
GESTIONNAIRES HOSPITALIERS (A.M.G.H.)
7 Rue Kharoub Hay Riad, Rabat, MOROCCO
Tel: +212 53 37 71 63 96/ 661 14 40 52;
Internet: www.amgh.ma
NETHERLANDS
AMC Academisch Medisch Centrum
Meibergdreef 9, 1105 Amsterdam, NETHERLANDS
Tel: +31 20 566 2106; Fax: +31 20 691 2796
Internet: www.amc.uva.nl
ACADEMISCH ZIEKENHUIS MAASTRICHT
Postbus 5800, 6202 AZ Maastricht, NETHERLANDS
Tel: +31 43 387 65 43
Fax: +31 43 387 78 78
Internet: www.azm.nl
REVALIDATIECENTRUM RIJNDAM ADRIAANST
Postbus 23181, 3001 KD Rotterdam
NETHERLANDS
Tel: +31 181 658 571; Fax: +31 181 626 848
NIGERIA
TOTAL HEALTH TRUST
2 Marconi Road, Palmgrove Estate,
Lagos State, NIGERIA
Tel: +234 (0)1 774 7150 / +234 (0)1 804 5263
Fax: +234 (0)1 555 0508
Internet: www.totalhealthtrust.com
PAKISTAN
AGA KHAN UNIVERSITY HOSPITAL
Stadium Road, P.O. Box 3500,
Karachi 74800, PAKISTAN
Tel: +92 21 3493 0051
Fax: +92 21 3493 4294 / 3493 2095
Internet: www.aku.edu
SPAIN
HOSPITAL PLATO FUNDACIO PRIVADA
C/ Plato 21, 08006 Barcelona
SPAIN
Tel: +34 933 069 900
Internet: www.hospitalplato.com
SERVICIO DE SALUD DEL
PRINCIPADO DE ASTURIAS
Plaza del Carbayon 1, 33011 Oviedo
SPAIN
Tel: +34 98 510 6601 / +34 98 510 8500
Fax: +34 98 506 633 / +34 98 510 8511
Internet: www.asturias.es

UNIO CATALANA D'HOSPITALS


Carrer Bruc, 72 1r, 08009 Barcelona
SPAIN
Tel: +34 93 209 3699
Fax: +34 93 200 8638
Internet: www.uch.cat
SWITZERLAND
HOPITAL DU JURA
Chemin de lHpital 9, 2900 Porrentruy, SWITZERLAND
Tel: +41 32 465 65 65 ; Fax +41 32 465 69 99
Internet: www.h-ju.ch
HOPITAL UNIVERSITAIRE DE GENEVE - HUG
Hopital Cantonal Rue Micheli-du-Crest 24
1211 Geneva, SWITZERLAND
Tel: +41 22 372 6070 ; Fax: +41 22 372 6075
Internet: www.hcugh.ch
INSELSPITAL BERN
Freiburgstrasse 18
3010 Bern, SWITZERLAND
Tel: +31 632 2801 / +41 31 632 2111
Fax: +31 632 2828
Internet: www.insel.ch
INTERNATIONAL COUNCIL OF NURSES
3 Place Jean-Marteau
1201 Geneva, SWITZERLAND
Tel: +41 22908 0100; Fax: +41 22 908 0101
Internet: www.icn.ch
INTERNATIONAL ASSOCIATION OF INFANT FOOD
MANUFACTURERS
Chemin Louis Dunant 7-9
1201 Geneva, SWITZERLAND
Tel: +41 22 788 3911
Fax: +41 22 788 3912
Internet: www.ifm.net
USA
AMERICAN COLLEGE OF HEALTHCARE EXECUTIVES (ACHE)
One North Franklin Street, Suite 1700
Chicago, IL 60606-3491, USA
Tel: +1 312 424 9365
Fax: +1 312 424 0023
Internet: www.ache.org
GRIFFIN HOSPITAL - PLANETREE
130 Division Street, Derby, CT 06418, USA
Tel: +1 203 732 1365
Fax: +1 203 732 7569
Internet: www.planetree.org
ILLINOIS HOSPITAL ASSOCIATION
1151 East Warrenville Road, PO Box 3015
Naperville, Illinois 60566, USA
Tel: +1 630 276 5710 / +1 630 276 5400
Internet: www.ihatoday.org
METHODIST INTERNATIONAL
6560 Fannin ST 220, Houston,
Texas 77030, USA
Tel: +1 713 441 7500 / 441 2340
Fax: +1 713 790 6618 / 793 7097
Internet: www.methodistinternational.org
NEW JERSEY HOSPITAL ASSOCIATION
760 Alexander Road, PO Box 1
Princeton, NJ 08543-0001, USA
Tel: +1 609 275 4241 / 609 275 4000
Fax: +1 609 452 8097
Internet: www.njha.com

142 Hospital and Healthcare Innovation Book 2009/2010

UNITED ARAB EMIRATES


HAMDAN BIN MOHAMMED e-UNIVERSITY (HBM eU)
PO Box 71400, Dubai
UNITED ARAB EMIRATES
Tel: +971 4 424 1111; Fax: +971 4 439 3939
Internet: www.hbmeu.ae

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IHF reference

Honorary Members
Members elected by the General Assembly for special services rendered to the IHF or to the healthcare field in general

AUSTRALIA
R H Kronborg MBE
6 Pentland Road
3225 Point Londsdale
Victoria, AUSTRALIA
Dr Errol Pickering
13 Firestone Court
Robina Woods
The Gold Coast
4226 Queensland, AUSTRALIA
CANADA
Jean-Claude Martin
710-500 Rue de la Montagne
Montreal H3C 4T6
CANADA
FINLAND
Arvo Relander
Luuvaniementie 3 A 5
Helsinki
FINLAND
FRANCE
L Peyssard
12 Avenue Maurice Barres
13008 Marseille
FRANCE
GERMANY
Dr Klaus Proessdorf
Theodor Schwannstr. 10
50735 Koln-Riehl
GERMANY

HONG-KONG
(SPECIAL ADMINISTRATIVE REGION
CHINA)
Dr Een Kiong Yeoh
Flat 18A, Tower II, Ruby Court
55 South Bay Road
Hong-Kong
(SPECIAL ADMINISTRATIVE REGION CHINA)
MEXICO
Dr G Fajardo Ortiz
Juarez 14 Casa 11
Tlacopac San Angel
1040 Deleg Alvaro Obregon CP
MEXICO
THE NETHERLANDS
Dr Ton Krol
Postbus 2621
2002 RC Haarlem
THE NETHERLANDS
Dr Rene Peters
Weerdsingel O.Z.82 Bis
3514 Utrecht
THE NETHERLANDS
POLAND
Prof T Tolloczko
Wiejska 9/9
480 Warsaw, POLAND

PORTUGAL
Prof J M Caldeira Da Silva
Av Antonio Augusto de Aguiar 144 - 2 D
1050-021 Lisbon, PORTUGAL
SWEDEN
Prof Per-Gunnar Svensson
Fockgrand 1
260 93 TOREKOV
SWEDEN
T Thor
Koltrastvagen 39
183 51 Taby, Sweden
SWITZERLAND
Dr Franois Kohler
Talgut Zentrum 22-602
3063 Ittigen, SWITZERLAND
Ferdinand Siem TJam, MD MPH
Chemin du Ruisseau 2C
1291 Commugny VD, SWITZERLAND
Dr Andrei Issakov
4b chemin Edouard Sarasin
1218 Grand Saconnex
SWITZERLAND

Dame Gillian Morgan


Permanent Secretary
Welsh Assembly Government
Government Buildings
Cathays Park, Cardiff CF10 3NQ
Wales - UK
Sir Reginald Wilson
49 Gloucester Square
London W2 2TQ, England - UK
USA
J A McMahon
181 Montrose Drive
Durham, NC 27707
USA
Mr Scott Parker
757 S. Woodmoor Circle
Bountiful, UT 84010
USA
L W Lehr
3050 Minnesota World Trade Center
30 Seventh Street East
Saint Paul, Minnesotta 55101-490
USA

UNITED KINGDOM
D Maitland
128 Osidge Lane
London N14 5DN
England - UK

Acknowledgements
The International Hospital Federation and Pro-Brook Publishing
would like to thank all the contributors to the publication and those
involved in the production process.

Pro-Brook Publishing
Tim Probart, Publisher; Trevor Brooker, Publisher; Stephen King, Business
development; Susan Pulman, Business development; Simon Marriott, Art direction

International Hospital Federation


Sheila Anazonwu, Commissioning editor

Hospital and Healthcare Innovation Book 2009/2010 143

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IHF Corporate Member Profiles

GE Healthcare
The burden of surgical diseases is large and is increasing, and there are enormous gaps in access to surgery between high and
low income countries. Surgical services may be cost effective at the district level in LMICs, and providing access to essential
surgery should be viewed as primary prevention of death and disability. The integration of essential surgical services into
health systems, within the context of primary healthcare reforms, will surely improve population health.

Johnson Controls
JOHNSON CONTROLS uses its 125 years of experience to help healthcare organizations create comfortable, safe and sustainable
healing environments while providing measurable results. By utilizing our expertise in energy and sustainability, facilities,
building and technology infrastructure, healthcare organizations can improve their financial results, the environment of care and
their standing in the community. Johnson Controls provides design assist and construction management, funding solutions,
network integration solutions for clinical and non-clinical systems, energy management and central utility plants, operations
support and best practices, systems maintenance and facility management services. http://www.johnsoncontrols.com

Aramark
ARAMARK is a global leader in professional services, providing award-winning food services, management of facilities, assets, and
clinical technology, and uniform/career apparel to healthcare institutions and other businesses. In FORTUNE magazines 2009 list
of Worlds Most Admired Companies, ARAMARK ranks number one in its industry, consistently ranking since 1998 as one of the
top three most admired companies in its industry. ARAMARK seeks to responsibly address key issues by focusing on employee
advocacy, environmental stewardship, health and wellness, and community involvement. Headquartered in Philadelphia,
Pennsylvania (USA), ARAMARKs 255,000 employees serve clients in 22 countries. Visit www.aramark.com to learn more.

HCA International
HCA International owns six leading private hospitals in London, each with international reputations for the highest standards of
care. They are: The Wellington, the largest private hospital in the UK, The London Bridge Hospital, The Harley Street Clinic, The
Portland Hospital for Women and Children, The Lister Hospital and The Princess Grace Hospital.
HCA hospitals treat approximately 350,000 patients annually and specialise in complex medical procedures. The HCA Cancer
Network, for example, is the largest private provider of cancer care in the UK and is the best equipped outside the NHS.
In the past five years, HCA has invested over 100 million in capital expenditure including the latest diagnostic and treatment
technology. HCA International is owned by Hospital Corporation of America, the largest for-profit hospital operator in the United
States.

144 Hospital and Healthcare Innovation Book 2009/2010

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Page 2

C
Corp
orate P
Partnership
p Program

Supporting colllaboration, ideas and


d innovation
in
n global healthcare

What Is the Corporate Parttnership Program?


An opportunity offered to major corp
r orations who seek to join with IHF members to work to
improve hospital performance around the world. The Program
m is run by World Hospital
a
(WH), a company owned by the Intern
e ational Hospital Federaation (IHF) and dedicated to
supporting IHF goals through collaborative events and publicat
a ions.
The prograam is open to a limited number of corporations that are fully engaged in the global
health sector and have a good reputation as providers.

Benefitss include:
Yeaar-long access to decision makers from around the world.
Exclusive opportunity for relationship building and shari
a ng ideas and experiences
bettween corporate leaders an
a d executives in the hospital sector.
Acccess to IHF policy and advo
ocacy communications
I
  -
Advert
v ising and marketing opportunities

Corporaate Partnership Package


Please contact Sheila Anazonwu (sh
heila@ihf-fih.org ) at the IHF Secretariat for more details
and a corporate package informatio
on

How Can Health Organizations Get the Most Out of Their Data?

With a Geographic Information System.


In any modern and progressive health organization,
being able to view clinical and administrative
information in its geographic context helps
organizations make better business decisions.

GIS aids in locating scarce health care resources.

Nearly all health data today includes a field that ties it


to a specific place. A geographic information system
(GIS) is the key to bringing this data together and
seeing it in a new way. Hospitals, health systems,
managed care plans, physicians, and home health
agencies can all benefit from using a GIS.
ESRI is the world leader in GIS technology. ESRI
offers innovative software solutions that help health
organizations increase the value of the information
they manage. More than 5,000 health clients, 90
ministries of health and 350 hospitals use ESRI
software to help them make better business decisions.

Download a complimentary whitepaper


on HL7 and spatial interoperability standards
for health care delivery at www.esri.com/ihf.

Define market area by proximity to facilty.

Copyright 2009 ESRI. All rights reserved. The ESRI globe logo, ESRIThe GIS Company, ESRI, ArcMap, ArcInfo, www.esri.com, and @esri.com are trademarks, registered trademarks, or service marks of ESRI in the United States, the
European Community, or certain other jurisdictions. Other companies and products mentioned herein may be trademarks or registered trademarks of their respective trademark owners.

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