Yorkshire Centre for

Health Informatics
LEEDS INSTITUTE OF HEALTH SCIENCES

Overcoming barriers to the use of patient data for Research

and Development between the National Health Service and
Higher Education

A Briefing Paper for the UK Faculty of Health Informatics

March 2009

Charles Thackrah Building

101 Clarendon Road
Leeds, United Kingdom
LS2 9LJ
Tel. +44 (0) 113 343 4961
www.ychi.leeds.ac.uk
ychi@leeds.ac.uk
 Overcoming barriers to the use of patient data for Research and
Development between the National Health Service and Higher Education

In this briefing paper and accompanying presentation we discuss the key issues, risks and
opportunities associated with the sharing of patient data for Research and Development (R&D)
between Higher Education and the National Health Service (NHS), identify lessons that could be
learned from countries outside of the UK, present a series of practical ideas and recommendations on
how to better facilitate the use of information and data for health research between Universities
involved in clinical education and research and the NHS, and discuss throughout how the UK Faculty
of Health Informatics could best support the implementation of these recommendations in the future.

1. Introduction

In 2005, the UK government committed to develop the research capability of NHS Information
Technology (IT) systems in order to facilitate the recruitment of patients to clinical trials and to gather
data to support work on the population’s health, and effectiveness of health interventions. This
included promoting the Secondary Uses Service (SUS) which is an example of a source of
comprehensive data enabling a range of reporting and analysis. In support of this development, the
National Institute for Health Research Clinical Research Network Coordinating Centre (NIHR CRN
CC) (formerly the UK Clinical Research Collaboration [UKCRC]) and Wellcome Trust carried out
paper-based research simulations and made recommendations1 on the technical, regulatory and
governance issues surrounding the use of electronic patient records for research and health benefit.
The NHS Connecting for Health Research Capability Programme (RCP)2 was established to carry
these recommendations forward alongside the Office for Strategic Coordination of Health Research
(OSCHR) E-Health Records Research Board3 who act primarily as an external reference group for
RCP and in addition “provide strategic oversight of e-health records research in the UK”. E-health

1
UK Clinical Research Collaboration and Wellcome Trust (2007) “Use of Electronic Patient Records for
Research and Health Benefit” available at: http://www.wellcome.ac.uk/About-
us/Publications/Reports/Biomedical-science/WTX039411.htm

2
NHS Connecting for Health Research Capability Programme available at:
http://www.connectingforhealth.nhs.uk/systemsandservices/research

3
OSCHR E-Health Records Research Board available at: http://www.nihr.ac.uk/about/Pages/about_oschr.aspx

1
records research is being stimulated by the Wellcome Trust, in partnership with the Economic and
Social Research Council (ESRC), the Engineering and Physical Sciences Research Council (EPSRC)
and the Medical Research Council (MRC) with for instance their current research call4.

2. Organisation of Clinical Research in the UK

The UK has a strong history in clinical research, however, there is a common understanding that the
costs of research are high and as a society we are duty-bound to maximise the return on research
investment Hence efforts are being made to streamline the research process. These include the
emergence of an NHS research strategy5, the pulling together of all government funded applied NHS
and social service research under the National Institute for Health Research (NIHR) and the attempted
alignment of the academic, NHS and industry agendas. Government-funded basic research is
delivered through research councils such as the Medical Research Council (MRC), Economic and
Social Research Council (ESRC), the Engineering and Physical Sciences Research Council (EPSRC).
In addition charities such as the Wellcome Trust and Nuffield Foundation support both basic and
applied health research.

The UK Clinical Research Network comprises of a number of Clinical Research Networks (CRNs).
Clinical Research Networks in England have been established to support work in the areas of cancer,
dementias and neurodegenerative diseases, diabetes, medicines for children, mental health, primary
care and stroke. Each CRN consists of a number of Local Research Networks that coordinate and
facilitate the conduct of clinical research within a specific geographical area of England. Each
Network, with the exception of the Primary Care Research Network, is overseen by a national
Coordinating Centre. A major function of each of the CRNs is to increase involvement and
recruitment into clinical trials. For example the National Cancer Research Network (NCRN) in
England has 33 cancer research networks across England, closely aligned to cancer service networks,
which are currently conducting around 400 clinical trails. Alongside these networks there are disease

4
Wellcome Trust (2007/8) “Electronic patient records and databases in research” available at:
http://www.wellcome.ac.uk/Funding/Biomedical-science/Grants/Other-initiatives/WTD028245.htm

5
Department of Health (2006) “Best Research for Best Health: a new national health research strategy”
available at:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4127127

2
registries which identify all cases of a particular disease in a defined population. A report6
commissioned by the Department of Health Policy Research Programme identified 250 registries in
use in England, and with an estimation of around 400 registries in total. Studies based on registers can
supplement data available from randomised studies and should be seen as an important adjunct to
rather than a replacement for them.

3. Types of Clinical Trials Research

Clinical research studies can take many forms and their design has become something of a science in
its own right. All have in common the need to answer a research question and to do so by gathering,
analysing and interpreting data. Clinical research mainly falls into two general categories:
experimental and observational. Experimental trials can also be sub-divided into two: randomised and
non-randomised. Observational studies can be either analytical or descriptive. Whether they are
observational, interventional or whether they employ quantitative or qualitative outcomes it is
necessary to guard against bias and to provide evidence of sufficient power to avoid false positive or
false negative conclusions. Issues of scale, cost, feasibility, ethics and utility have also to be factored
into the designs. In some fields, especially cancer, where the number of competing new interventions
is large recruiting sufficient subjects is becoming rate limiting and great efforts are being made to
invite all possible patients to become participants.

4. Current Uses of Data

In supporting research, patient data can be used in a number of ways. This includes being utilised in
clinical trials designed to test the safety and/or effectiveness and/or cost-effectiveness of healthcare
interventions, identifying potential participants in specific research trials to seek their consent,
providing data from routine care for analysis according to epidemiological principles, to identify
trends and unusual patters indicative of more detailed research, and providing specific datasets for
defined approved research projects. Indeed, the traditional model of clinical research has been based
around the collection of data in support of a specific research objective, which may include
developing a specific data collection process or retrospectively seeking to collect data from existing
sources. It is against this background that new approaches to harvesting routinely captured clinical
data have a potentially significant role. Each of these approaches will present specific issues but one
challenge for the Health Informatics (HI) community is to identify the generic questions and to ensure

6
John Newton & Sarah Garner (2002) “Disease Registers in England” available at:
http://www.sepho.org.uk/Download/Public/5445/1/disease_registers_in_england.pdf

3
that developments in this field remain coherent. For example, promoting standards as regards to the
way in which data is captured and represented in the databases to ensure interoperability, reusability
and greater reliability of the data in a research context.

With the growing number, scale and richness of the available clinical data sources the opportunities to
exploit these sources have increased. There are many examples of where such approaches have been
taken already, for example The General Practice Research Database (GPRD)7 is a clinical dataset
which has been running since 1987 and includes 39 million person years of research quality data from
over 460 practices. However the degree of sophistication of databases varies with many still
disconnected across disparate systems. Many are unstructured and not coded, and require manual data
entry between systems. The current question is whether, and how, the potential to support research
can be enhanced and exploited.

5. Future Uses of Data

With the development of strategic clinical databases in the NHS there is an opportunity to support
real-time collection of clinically relevant outcomes. For example, the SystmOne8 database used by
GPs in Yorkshire and the Humber holds information approaching 50% of the population (4.5 million)
in a single database instance. This database collects, in real-time, Read/SNOMED-CT coded patient
events of the type of interest to clinical researchers. These outcomes could potentially be made
available to researchers using either push (XML messages sent to research systems on suitably tagged
patients) or pull approaches (authorised database searches) which considerably improve on the current
situation. Extending this model to facilitate targeted data capture would provide other generic
benefits. For example, a suitably designed architecture could provide messaging interfaces for
accessing current patient records and relevant clinical databases which would enable the identification
of family members of index cases who are marked as carrying a high risk cancer gene, such as
BRCA1. This currently is a difficult and expensive task reliant on family history questionnaires
administered manually. A number of models of data use could be envisaged:

• Providing access for researchers to clinical systems to conduct work on the data in situ. For
example identifying patients who have consented to follow-up and allowing controlled access
to their clinical records to collect health activity data.

7
General Practice Research Database available at: http://www.gprd.com/

8
TPP SystmOne available at: http://www.tpp-uk.com/

4
 • Transferring data sets from NHS systems to research systems in bulk with or without
anonymisation. For example exporting large collections of data from specific sub-populations
to allow epidemiology analysis of interventions and outcomes, such as trends in epileptic
control with different drug regimens.

• Harvesting individual data items off clinical systems in support of research, e.g. blood
pressure readings or drug prescriptions for a particular research cohort, which could be
retrospective.

• Providing access to data on patients whose samples have been stored in “bio-banks” against
which new diagnostics are being tested. This has the potential to shorten the time to
implementation of new tests since the discriminating power can potentially be identified on
retrospectively collected clinical data rather than waiting to amass prospective information.
This model has worked successfully in many areas such as antenatal screening where
outcomes are known at short intervals. It is much more problematic for conditions with longer
prodromal lead times.

6. What Are The Issues?

The focus of routine data collection in the NHS is to support clinical care and operational
management of patients. Unless specifically engaged, providers do not have time to collect additional
data. From a research perspective this can mean that such data collected will be of lower quality than
that collected by research staff because of lack of incentives and motivation, lack of time, and
interruptions. However, paradoxically, because the data for patient care is likely to be used to provide
safe and effective care what is collected maybe more accurate and, from some points of view, of
higher quality. Thus if one wished to measure some health impacts across a cohort the clinical
database might hold a better validated set than a specifically designed study set collected ‘off-line’. It
might also be available at lower cost. Clinical databases however will not answer all questions,
particularly prospective ones. Unless data collection procedures can be injected into the clinical
pathway to ensure that data is routinely collected on a regular basis it is unlikely that specific
questions can be prospectively researched. However, the examples of data collection for Quality
Outcomes Framework (QOF) where General Practitioners (GPs) are incentivised to collect items
about their patients do show that practise can be influenced at a macro scale. If a sufficiently serious
question needed to be addressed one could envisage the injection of a data collection process on a
widespread basis to generated large datasets very rapidly. The NIHR CRNCC report of research

5
simulations 9 highlighted four models of research similar to some of the examples above where it was
felt benefit could be identified (See Appendix A). One challenge for the HI community is to study
those simulations and to consider the implications they raise and what measures would be needed to
bring them into realistic and routine use.

Clinical researchers struggle to obtain relevant clinical outcomes for prospective cohort studies,
clinical trials and pharmaco-surveillance following the introduction of new therapies and therapeutic
strategies. The paradigm adopted is to create independent research databases and for these to be
administered in isolation from real-time clinical systems by a pool of research administrators.
Longitudinal clinical data is traditionally collected in the setting of a research clinic or postal
questionnaire, which is both labour-intensive and expensive. For the single outcome of death it is
possible to register research subjects with the Office of National Statistics (ONS) and to receive death
notifications automatically, on the same basis as such notifications are now made to NPfIT Patient
Administration Systems (PAS). For intermediate outcomes other than death (e.g. heart attack in
patients in secondary prevention trials) such notifications are not possible at present even though in
many ways such outcomes have high relevance.

Similarly, researchers find it difficult to assess baseline health needs against which to design
intervention studies especially where multiple agencies are involved in care exemplified by work in
assistive technology and disability. Here routine clinical outcome data (e.g. Hospital Episode
Statistics [HES]) is too coarse to enable fine-grained analysis or management. ‘Stroke’, a commonly
collected major outcome, in itself does not predict disability and may point to a fully recovered
episode. Matching electronic assistive technology to ’the independence needs’ of a client requires
detailed assessments of their disease progression, as well as current physical, sensory and cognitive
impairment. Using intelligent algorithms which integrate information from the patient records has the
potential to support a whole-system approach to address posture, mobility, well-being, lifestyle
choices and emotional and mental needs of each individual. For record linkage to work effectively
robust data identification methods will be needed. One is aware that the use of NHS number is far
from universal in NHS systems and most likely used to a minimal degree in research databases.
Promoting its use by researchers must be an early step.

The predominant coding standard in primary care throughout the NHS is Read, though this is
strategically moving to SNOMED-CT. However this is only one relevant code standard and many

9
UK Clinical Research Collaboration (2007) “UKCRC Advisory Group for Connecting for Health: The Report
of the Research Simulations” available at: http://www.ukcrc.org/publications/reports.aspx

6
other codes and data recording conventions (e.g. units of measure, drugs, etc) are used within the
clinical record. Though some research data is coded in the majority of instances such data will be
recorded using idiosyncratic codes. Achieving alignment between the NHS and research
representations of data will be a challenge. However, much data in the clinical record is likely to be
recorded as free text. In part this is because it provides a richer narrative of a patient’s clinical
problem and partly because that systems in current use lack sophistication. Whatever the case,
technologies to extract codified information from free text should be of great benefit.

Although the benefits seem apparent, and are well documented, the power of modern information
technology to gain insights from large databases of population data has yet to be fully realised. In part
this is due to public concerns, and media sensationalism, over the confidentiality and security of data.
Further analyses are documented in a Wellcome Trust funded report10 on public perspectives on
research governance, a working group report11 on secondary uses of patient information, and a
consultation on the wider use of patient information12 supported by the Data Sharing Review13. Whilst
the public are aware of the principle and potential values of research, many conceded that their
awareness of issues surrounding such research was low. Implications for research included
researchers needing to pro-actively engage with participants’ desire for more transparency about, and
active involvement in, the research process including data access and scope, models of consent and re-
enforcement of database security and their potential future or other uses. However, we intend to
venture from such concerns, as they have already been investigated in great depth, and adopt a more
positive approach illustrated with working examples from other countries and the UK of the
successful uses of patient data for research and development.

10
Wellcome Trust (2007) “Public Attitudes to Research Governance: A qualitative study in a deliberative
context” available at: http://www.wellcome.ac.uk/About-us/Publications/Reports/Public-
engagement/WTX038446.htm

11
Connecting for Health (2007) “Report of the Care Record Development Board Working Group on the
Secondary Uses of Patient Information” available at: http://www.connectingforhealth.nhs.uk/crdb/workstreams/

12
Connecting for Health (2008) “Consultation on the wider use of patient information” available at:
http://www.connectingforhealth.nhs.uk/systemsandservices/research/consultation

13
Ministry of Justice (2008) “Data Sharing Review” available at:
http://www.justice.gov.uk/reviews/datasharing-intro.htm

7
7. What Are The Benefits And Opportunities?

Although most healthcare practitioners and institutions in the United States are not yet ready to
implement electronic medical record (EMR) systems there are many pioneers and innovators who
have overcome enormous obstacles to informing research goals with clinical practice data14. The
Mayo Clinic, that conducts more than 4,000 clinical trials per year, is working alongside IBM
applying super-computing technology to uncover correlations in clinical data. Kaiser Permanente has
automated records for its 8.4 million members and created both a transactional system for patient care
and a data warehouse with extracted data for use by researchers. The Indiana Health Service (IHS)
and Veterans Health Administration (VA) also provide data repositories for supporting research and
population analyses, improving data quality and security, and facilitating patient access to data and
health information.

European-level collaboration, as well as global partnerships, are helping establish reference

frameworks of best practices and mistakes, organisational, ethical, and economic aspects of re-use of
electronic patient data. For example the Biobanking and Biomolecular Resources Research
Infrastructure (BBMRI) has over 200 organisations in 24 EU Member States jointly planning an EU
infrastructure to deliver secure access to biological resources required for health-related research and
development intended to improve the prevention, diagnosis and treatment of disease and to promote
the health of the citizens of Europe15. The year 2007 marked the beginning of the European
Commission’s seventh framework programme with a large increase in funding (63%) and the creation
of a European Research Council (Mladovsky, Mossialos & McKee, 2008). Despite the allocation of
€6bn in the health research budget, little has been done to promote equitable access to the data whose
collection it will finance. Ethical and regulatory problems combined with the technical barriers of
interoperability of computing systems, make sharing health research data more complex than other
types of research data, where individual records should ideally be available to make data meaningful.
However, there are examples of countries (including the UK) where great progress has been made.

Some believe that Denmark has gathered more data on its citizens than any other country (Frank,
2000) and is one of the most successful applications of data-driven research and development. The

14
FasterCures (2005) “Think Research: Using Electronic Medical Records to Bridge Patient Care and
Research” available at:
http://www.fastercures.org/index.cfm/OurPrograms/ThinkResearch/Electronic_Health_Records

15
The Biobanking and Biomolecular Resources Research Infrastructure available at: http://www.bbmri.eu/

8
Danish government manages nearly 200 public databases, some since the 1930s. Denmark’s Civil
Registration System (CRS) assigns to all Danish citizens a health insurance card with a unique
personal identification number. This number is recorded at all hospital admissions and is also used to
register all births, deaths, migrations to and from foreign countries, and domestic address changes
(Olesen et al., 2009). The use of this number creates huge opportunities for conducting large-scale
cohort studies such as investigations into cellular phone use and cancer (Johansen et al. 2001) and
measles, mumps, and rubella vaccination and autism (Madsen et al. 2002). For added confidentiality,
all studies must be approved by the Danish Data Protection Agency, which requires adherence to a
number of data storage rules to avoid disclosure of personal data (Olesen et al, 2009).

In the UK collaborations between the NHS and Higher Education (HE) institutions are already
underway in early adopter sites as part of The NHS-HE Connectivity Project16. The project’s
objective is to achieve “good interoperability between NHS and HE networks that enable secure
anytime, anywhere access by medical, nursing and allied profession students, clinical teachers and
researchers”. In England and Scotland collaboration is between NHS Connecting for Health in
England, NHS National Services Scotland Information Systems Group and JANET (UK), and in
Wales this is run by the Public Sector Broadband Aggregation (PBSA) network. N3 is the broadband
network for the NHS in England and Scotland and used to form the N3 JANET Gateway. On a local
level there are instances of linkage between NHS systems and research databases, for example,
between the St James’s Institute of Oncology and the University of Leeds.

8. Practical Ideas and Recommendations

There is not one solution to these issues. The research field is complex and the emerging technology
is still relatively immature. What is apparent is that the awareness of the new pan-sector possibilities
of researchers and IT staff whether in academe, the NHS or industry are limited by their previous
organisationally bounded experience. A major challenge is to create a common awareness of the
potential whilst at the same time increasing insight into the technical, legal and organisational
challenges. It is important also to dispel many of the myths surrounding the supposed limitations
created by strong information governance and to promote a mature debate about the protection of the
rights of the individual and the need to harvest data for the common good.

16
JANET “The NHS-HE Connectivity Project” available at: http://www.nhs-he.org.uk/

9
As an early UK investment in the process, the Wellcome Trust has funded a small project to define
the training needs of practitioners in the field and to build a core training package17. The project
recognises that systems in the two environments, the NHS and in research, have been built with very
different objectives, have widely divergent data models, governance frameworks, and utilise different
technical standards. This is reflected in the employment backgrounds of many of the staff involved
and apart from levels of informatics experience and skills; their knowledge of the different
environments is limited. As a first step in defining the training needs the project has surveyed 266
such users and has confirmed the poor understanding of concepts such as SNOMED-CT and HL7 in
the research community. Furthermore, it has revealed that a large proportion of people developing and
using systems are self-taught and appear to have limited understanding of basic informatics concepts
such as normalisation of data tables. The same is true of a large number of key concepts including
anonymisation and pseudonymisation and a programme of widespread education will be essential.

It is also clear that beyond the HI community much confusion exists about the risks and benefits of
allowing access to data for research purposes. The public is rightly concerned about unauthorised
access to sensitive data and its potential misuse hence there is a need to develop very robust
governance processes for research access to data backed up by an effective public education
programme. Whether this is by the establishment of new processes or reinforcement and evolution of
current procedures is an obvious target for early research. For some research the necessity for
identifiable linkage will be essential and the HI community may have to work hard to increase
awareness of the relative benefits of such access and lend credibility to the fact that such access can
be achieved without compromise to patients in other ways.

What Needs To Be Done?

Several strands of intervention need to be initiated across all levels of seniority, and form both local
and national priorities. The Faculty could take a major role in all of these, including:

1. Educating and challenging the executive leaders to influence policy and increase
representation at senior-level.

• Champion cross-representation on Higher Education/NHS bodies – e.g. Trust IT,

University IT Boards.

17
University of Leeds (2008/9) “Training and education for the developers of databases in research and clinical
practice” available at: http://www.ychi.leeds.ac.uk/eprresearch

10
 • Ensure Health Informatics involvement in research ethics committees.

2. Educating middle-ranking research leaders and influencing the design of grant forms.

• Educate NHS IT managers, Caldicott Guardians, Trust leads for R&D, and
Information Governance leads in research needs.

• Establish Health Informatics involvement in local Research Design Services.

3. Promoting engagement between suppliers and designers.

• Include R&D needs in the procurement cycle, for example adding additional fields to
NHS datasets with research use in mind.

• Establish data access requirement for research on all clinical systems.

• Pressurising for the use of a single identifier within the care environment.

4. Increasing the Health Informatics capacity in the NHS workforce.

• Influence recruitment policy to ensure potential staff have the requisite Health
Informatics awareness and skills.

• Include “Research” in Key Skills Framework for NHS IT staff.

5. Building Health Informatics into teaching and research programmes in Health and Computer
Science.

• Embed Health Informatics in the undergraduate curriculum.

• Promote intercalated medical degrees in Health Informatics and Computing.

• Support health related undergraduate projects in Computer Science.

In addition there are a number of practical activities which would cut across these strands to which the
Faculty could make a very positive contribution.

11
 • Promote guidance resources such as the Information Governance Toolkit18 and
Research Capability Programme19, as well as publications by the Wellcome Trust and
UK Clinical Research Collaboration, which are not being fully utilised across
research environments.

• Support a programme of master classes for senior opinion leaders.

• Support a funded CPD programme for health, research and industry professionals.

• Promote Health Informatics within Medical and Computer Science Teaching and
Training courses in Higher Education.

9. Conclusions

The secondary uses of clinical data are already widespread amongst Higher Education institutions and
the NHS. Many resources contain personally identifiable or potentially identifiable data amidst,
justified or otherwise, concerns of consent, privacy and security. Potential benefits gained through
exploitation of such data are recognised amongst local innovation centres but are not reproduced
across national boundaries. Apart from consensus on privacy, policy and security, transparent policies
and practices, and public awareness of trust (Barrett et al. 2006; Davies & Collins, 2006; Safran et al.
2007) there must also be campaigns to improve the capacity and capability of NHS and research staff
on the effective use of clinical data for research.

Acknowledgements

This paper was written by Mark Hawker, Dr Susan Clamp, and Dr Rick Jones. We are grateful to the
many respondents for their contributions.

The Yorkshire Centre for Health Informatics is a leading international centre for health informatics
expertise, collaboration and research. Our mission is to improve heath care practice through high
quality research and evidence based education and training. The centre brings together partners from

18
Connecting for Health (2009) “Information Governance Toolkit” available at:
https://www.igt.connectingforhealth.nhs.uk/

19
Connecting for Health (2009) “Research Capability Programme” available at:
http://www.connectingforhealth.nhs.uk/systemsandservices/research

12
the University, NHS and Industry to help meet the challenges in handling health information. Our
objectives are to develop knowledge through multidisciplinary research; develop ‘best practice’ and
quality assurance within health informatics processes; disseminate ‘best practice’ through education
and training; facilitate knowledge transfer by bridging the gap between health informatics researchers,
healthcare providers and health IT industries.

References

Barrett, G., Cassell, J.A., Peacock, J.L. & Coleman, M.P. (2006) National survey of British public’s
views on use of identifiable medical data by the National Cancer Registry, British Medical Journal,
332, 1068-72.

Davies, C. & Collins, R. (2006) Balancing potential risks and benefits of using confidential data,
British Medical Journal, 333, 349-351.

Frank, L. (2000) Epidemiology: When an Entire Country Is a Cohort, Science, 287 (5462), 2398-9.

Johansen, C., Boice, J.D., McLaughlin, J.K. & Olsen, J.H. (2001) Cellular Telephones and Cancer – a
Nationwide Cohort Study in Denmark, Journal of the National Cancer Institute, 93 (3), 203-7.

Madsen, K.M., Hviid, A., Vestergaard, M., Schendel, D., Wohlfahrt, J., Thorsen, P., Olsen, J. &
Melbye, M. (2002) A Population-Based Study of Measles, Mumps, and Rubella Vaccination and
Autism, The New England Journal of Medicine, 347, 1477-82.

Mladovsky, P., Mossialos, E. & McKee, M. (2008) Improving access to research data in Europe,
British Medical Journal, 336, 287-8.

Olesen, A.V., Parner, E.T., Mortensen, P.B., Sørensen, H.T. & Olsen, J. (2009) Prenatal Risk Factors
for Cutaneous Malignant Melanoma: Follow-up of 2,594,783 Danes Born from 1950 to 2002, Cancer
Epidemiology, Biomakers and Prevention, 18 (1), 155-61.

Safran, C., Bloomrosen, M., Hammond, E., Labkoff, S., Markel-Fox, S., Tang, P.C. & Detmer, D.E.
(2007) Toward a National Framework for the Secondary Use of Health Data: An American Medical
Informatics Association White Paper, Journal of the American Medical Informatics Association, 14
(1), 1-9.

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Appendix A: Report of Research Simulations (Executive Summary)

14
 EXECUTIVE SUMMARY
The UK can significantly enhance its clinical research
capability by using, strictly within the bounds of
patient confidentiality, the electronic patient data
that the UK’s National Programmes for IT in the NHS
have the potential to allow. This will have enormous
benefits for all types of clinical, public health and
health services research and for many aspects of
patient care.
The UK Clinical Research Collaboration’s (UKCRC)
Research & Development Advisory Group to
Connecting for Health therefore commissioned a
series of simulations in October 2006 to provide
the Department of Health Directorate of Research
and Development, and NHS Connecting for Health
(NHS CfH), with detailed specifications for a range of
possible research applications. The objective was to:
 Inform future development of the NHS Care
Records Service (NHS CRS)
 Highlight technical, regulatory and governance
issues
 Inform plans for any further simulations and full
pilots to test the capacity of the infrastructure,
using real patient data with appropriate
safeguards when this becomes feasible.
Four simulations were commissioned, based on a
range of clinical research applications. These were:
interventional clinical trials; surveillance; prospective
tracking of an identified cohort; and observational
epidemiological research. Detailed reports and key
findings were presented to the Advisory Group in
February 2007 and form part of this report.
The simulation leads worked as a team over this
period and there was strong consensus in relation
to both the high level and more detailed messages
UKCRC R&D Advisory Group to Connecting for Health
emerging from their work. They have identified a
number of key data, regulatory and governance issues
that need to be addressed for future development:
 Clinical services and research share the same
mission of improving patient care and patient
safety: research is integral to patient benefit
 Research makes a very important contribution to
assessing the completeness and quality of data
used for clinical care and health services
 Leadership is needed to create the sustainable
and governance infrastructure required to exploit
the research opportunities afforded by routine
patient and other data
 Solutions should be addressed from a UK-wide
perspective and build on the extensive experience
with record linkage already in place
 Much of this research involves information
about groups of patients rather than individuals
and hence requires anonymised rather than
identifiable data. However there will be occasions
where data needs to be linkable (possibly by
an ‘honest broker’) and comprehensive at the
individual patient level in order to have maximum
value and to allow quality and completeness to
be validated
 Where data are required at individual patient
level, such data access will need to be to
pseudonymised data. Where identifiers need to
retained, appropriate consent must be gained as
part of enabling access to those data
 Existing UK strengths in the use of routine
and other patient data for research will be
significantly enhanced by the mandated use of a
unique identifier (for example NHS number) in all
6
 key NHS records and activities and by ensuring
that new and existing data sets are person-based
 The data made available must cover the whole
population, be up-to-date, and be retrospective
over a number of years to give a rich historical
picture of patients’ health and care. They must
also be accurate and based on high-quality input
 Further work to confirm the detailed requirements
for data, which have been spelled out in each
of the individual simulation reports, will need to
be finalised. Much of the same data required for
purposes such as safety monitoring and clinical
trial research is of interest for public health and
NHS management activity including monitoring
service delivery. So there is a high degree of
commonality in the data needs
 The breadth of data needed for the potential
research applications explored in the simulations
supports the concept of a data switchboard, with
potential to link NHS Care Record data widely
to other data sources. Thus future strategic
developments should be based on this premise,
rather than that of a single data warehouse
 A federated structure of data sources rather than
a single data warehouse would also provide an
effective infrastructure with optimal governance
systems in place. This could be an honest broker
with responsibility for removing identifiers,
linkage of data and data quality checks
Tackling regulatory and governance issues
successfully will be key to ensuring appropriate
access and use of the data for research purposes.
 Ensuring patient confidentiality is critical. Data
governance must be robust and at the same time
capable of facilitating research
7 UKCRC R&D Advisory Group to Connecting for Health
 Although for some research applications fully
anonymised data will suffice, for many research
applications pseudonymised data is required
to enable linking of data sets or elimination of
duplicate records. However, for other research
purposes it will be important for patients to
be contactable in an appropriate manner.
Appropriate approaches to consent will need to
be built into access mechanisms for information
which might be capable of being linked to a
specific patient
 In order to satisfy regulatory requirements for
purposes such as pharmacovigilance and for
clinical trials research, there are specific data
quality and access requirements that need to be
addressed
The dual role of the honest broker in ensuring patient
data confidentiality and security as well as scientific
integrity of data delivered to the research community
will be key to engendering trust amongst patient,
clinical professional and research communities.
The potential benefits for research will be lost unless
these issues can be addressed.
It is critical that the needs of research be formally
prioritised so that both individual healthcare and
public health can reap the full benefits of this NHS
resource. The recommendations are summarised
below.
 Key recommendations of the
UKCRC simulations
Quick Wins
Recommendation 1: Mandate a common patient
identifier
To enable linkage of sources of data at patient level
a unique patient identifier will be required: use of
the NHS Number should be mandated in all key NHS
records and activities, including laboratory records.
Recommendation 2: Communicate the relevance of
research to healthcare
There should be formal recognition that research is a
core, not secondary, component of the development
of the NHS Care Records Service as it benefits
patients directly. Objectives, strategy and resources
need to be committed or endorsed at the highest
level of NHS Connecting for Health and reflected in
its literature including website content.
Short Term Deliverables
Recommendation 3: Federate existing databases
A federated structure of data sources is required
for research. A high-level strategy to support such
an infrastructure needs to be developed together
with a roadmap for its delivery. This strategy should
ensure that the data made available cover the whole
population, are up-to-date, person-based and of high
quality, and extend back over a number of years to
give a rich historical picture of a patients’ health and
care.
Recommendation 4: Improve data quality
Data quality is of paramount importance both in
the clinical setting and for research. Data should be
accurate (relying on high quality input) and based
on a set of standards for recording and processing
data. Ongoing processes will need to be developed to
improve data completeness and quality which could
involve development of incentives.
Recommendation 5: Initiate governance discussions
Tackling regulatory and governance issues
successfully will be key to ensuring appropriate
access and use of the data for research purposes.
Data governance must be robust and at the same
UKCRC R&D Advisory Group to Connecting for Health
time capable of facilitating research.
Recommendation 6: Engage key stakeholders
It is essential to engage professional audiences
who are key to implementation, particularly for
the enhancement of data quality and improving
data access. Patient safety is of importance to
all audiences and should be at the forefront
when communicating the value of research. A
communication strategy regarding the joint benefits
of using patient data for research and clinical care
needs to be developed. The responsibility for this
development and those in recommendation 5 above
will be with the Care Record Development Board
and may subsequently transfer to the National
Information Governance Board upon its formation.
UK-Wide Strategy: Next Steps
In informing plans for next steps, the outcomes of
the simulations suggest that more extensive data
are required to enable research than those currently
available through the Secondary Uses Service.
We recommend that an approach that relies on a
federated system of databases should be based on a
UK-wide strategy.
This will require:
 Initiation of pilots to link datasets, on the basis of
existing successful examples within the UK;
 Definition of methods of access to the different
sources housing the data. This should include
access to detailed patient-level data from primary
care, pathology services, disease registers and
key private sector services;
 Future development which learns from, and build
upon, existing skills, knowledge, databases and
systems that have been developed in the UK over
many years;
 Adoption of a UK-wide approach: not only
are there examples of good practice beyond
England that can be built upon, but the future
development should ensure compatibility across
the UK;
 An organisation capable of managing the
specification and delivery of the required
infrastructure and providing the linkage and
definition of research support services.
8