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WORLD HEALTH ORGANIZATION Management of Noncommunicable Diseases

WHO INFORMAL MEETING FOR THE DEVELOPMENT OF THE METHODOLOGY FOR EVIDENCE-BASED GUIDELINES: "HYPERTENSION GUIDELINES AS A CASE STUDY" 13-14 July 2000 Geneva

WORLD HEALTH ORGANIZATION 2000


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par des auteurs cits nommment n'engagent que lesdits auteurs.

Table of Contents

TABLE OF CONTENTS...................................................................................................................................................3 BACKGROUND.................................................................................................................................................................4 TERMS OF REFERENCE OF THE MEETING ..........................................................................................................4 CONCLUSIONS AND RECOMMENDATIONS...........................................................................................................5 DEFINITION OF GUIDELINES ..................................................................................................................................................5 GENERAL ISSUES..................................................................................................................................................................5 CURRENT BEST PRACTICE.......................................................................................................................................................5 GENERAL PRINCIPLES FOR WHO GUIDELINE DEVELOPMENT .......................................................................................................6 ROLES AND RESPONSIBILITIES OF GRG AND GDG ..................................................................................................................6 SPECIFIC ISSUES RELATING TO THE 1999 WHO/ISH GUIDELINES ............................................................................................7 OTHER RECOMMENDATIONS....................................................................................................................................8 RESOURCES.........................................................................................................................................................................8 ACCESS TO DATA FOR ALL SETTINGS........................................................................................................................................8 THE COST-EFFECTIVENESS OF RECOMMENDATIONS......................................................................................................................8 FRAMING AND PRESENTATION OF GUIDELINES............................................................................................................................8 PILOT TESTING.....................................................................................................................................................................8 DISSEMINATION....................................................................................................................................................................9
GRG.....................................................................................................................................................................................10 Annex 1 ......................................................................................................................................................................11

PROGRAMME ................................................................................................................................................................11
Annex 2....................................................................................................................................................................13 WORLD HEALTH ORGANIZATION ...........................................................................................................................13

Background
One of WHOs core functions is setting, validating, monitoring and pursuing the proper implementation of norms and standards. In the performance of this mandate, WHO has been and will continue issuing guidelines in line with article 2 of its constitution. As there have been many new developments in the methodology of formulating guidelines, WHO recognises the need to review the methodology and the procedure it follows in developing its guidelines. In January this year, the Director General's cabinet reviewed the development of guidelines in WHO. As a fundamental principle, it stressed the importance of all guidelines being evidence-based. Cabinet also reiterated the need to focus on public health implications when issuing guidelines and the need to explore the ethical and practical implications of introducing considerations of resource constraints and availability into guidelines. A decision was also made by the Director General in May 1999 to review the 1999 WHO/ISH hypertension guidelines to address the comments and published views expressed by various sources on some of the recommendations made in these guidelines.

Terms of Reference of the Meeting


In view of the above and in order to apply the above mentioned principles to WHOs future work on guideline development and also to implement the decision of the Director General in relation to hypertension guidelines, it was decided to review the hypertension guidelines as a case study. This meeting was therefore summoned to provide guidance on the new methodology for guideline development particularly in relation to the evidence base of recommendations, public health considerations such as cost effectiveness, feasibility and affordability and ethical issues such as conflict of interest. In his introductory remarks, Dr D. Yach, Executive Director, Noncommunicable Diseases and Mental Health Cluster provided an outline of the strategic directions of the Cluster and emphasised the stronger focus on evidence-based approaches and the search for cost-effective community and health services interventions. He referred to the hypertension guidelines and stressed the importance of the review process being evidence-based, transparent and requiring full disclosure of possible conflicts of interest, and inclusive with active participation of experts from diverse settings. Dr Yach felt it is imperative to ensure that the guidelines apply to real health systems where the majority of people benefit from the recommendations given therein. Dr A. Alwan, Director, Management of Noncommunicable Diseases (MNC) provided the background and outlined the objectives of the meeting, which included the following: Discuss the methodology for the development of clinical guidelines Agree on the methods that will be used to identify and collect evidence Identify key questions that require review and updating in the WHO/ISH Hypertension Guidelines Prepare detailed terms of reference for the systematic literature review 4

Dr Alwan also outlined the proposed new methodology for guideline development, which was included as one of the working papers for the meeting.

Conclusions and recommendations


Definition of Guidelines Guidelines are defined as systematically developed, evidence-based statements to assist decisions about appropriate health interventions. General issues WHO guidelines have multiple functions that include providing guidance to practitioners in their clinical practice, providing guidance to governments for public health considerations, and providing models for developing guidelines that can be adapted for use at national and local levels. A new methodology for guideline development should be adopted that is consistent with current international standards of best practice for guideline development (see below). WHO/ISH Hypertension Guidelines will be reviewed and used to establish an approach for future WHO/ISH collaboration. Current best practice The meeting considered models of guideline development that are now being used internationally. The following key issues were identified as representing best practice: Guidelines should be developed by multidisciplinary guideline development groups There should be explicit, transparent use of systematic reviews of evidence to develop recommendations There needs to be an audit trail that documents the guideline development process (includes conflict of interest declarations at all levels of involvement) Guidelines should include cost-effectiveness considerations of key recommendations There should be consideration of population and health system issues as well as individual patient issues There needs to be a defined and explicit process for consultation and peer review of the draft guidelines Guidelines should have multiple level outputs, including versions for specialists, primary care professionals, and patients

It was agreed that this methodology is consistent with recommendations of the Cabinet and that it met the requirements for the hypertension guidelines that were outlined at the start of the meeting. It would be adopted as the standard approach for guideline development.

General principles for WHO guideline development The group considered that the following general principles for WHO guideline development might be adopted. WHO decides on the need for guidelines. There are two functional groups that are involved in guideline development. First, the WHO guideline review group (GRG) who sets standards for the methodology for guideline development and provides quality assurance that the methodology has been followed. This group is made up of internal staff members of WHO and may co-opt external advisors as it sees fit. Second, a guideline development group (GDG) is constituted for each guideline. It has the responsibility of developing the draft guideline and providing the guideline to the GRG for final approval. Roles and responsibilities of the two groups as well as further detailed steps in the process are listed below. Roles and responsibilities of GRG and GDG GRG - Sets best practice standards for methods of developing guidelines - Selects initial GDG, appoints chair - Provides initial question for the guidelines - Provides general guidance for the specific topic as required - Reviews draft guideline to ensure that it meets WHO requirements - Sends draft for additional external review as required - Organises final approval by WHO GDG - Reviews initial membership, provides advice on additional members - Reviews initial questions, expands as required, refines - Undertakes guideline development - Appoints task groups to develop draft evidence-based recommendations - Collates draft guideline for external peer review and first round consultation - Revises draft guideline as a result of peer review - Provides draft guideline to GRG for final approval

A GDG may, for logistical reasons, require an executive committee to be formed from within its membership. TASK groups are to be encouraged to seek external expert input as appropriate. Task groups would be responsible for the following: Conduct or supervise a review of the relevant literature Evaluate the literature for methodological quality and relevance to the key questions in their area of responsibility. Summarise the best available evidence. Draft recommendations taking into account the strength of the evidence, the implications for practice, and the feasibility of applying the recommendations in different contexts.

Technical support for guideline development may be provided by a number of groups that have specific expertise for example, SIGN, COCHRANE, WONCA, etc (See fig 1 for relationship between GRG, GDG, TASK groups and Technical Support Groups) Specific Issues relating to the 1999 WHO/ISH Guidelines The meeting then considered specifically the updating of the current WHO/ISH Hypertension Guidelines. It was agreed that using the accepted methodology consistent with current best practice, the following specific areas of the guidelines would be updated: Initiation of treatment according to general cardiovascular risk stratification Thresholds for initiation of treatment and blood pressure targets for treatment, with due regard to patient autonomy/choice Indications for different drug groups, including choice of first line treatment, incorporating most recent evidence Cost-effectiveness estimates for treatment alternatives in different health systems

The group noted that although population based strategies for reducing the morbidity and mortality of disease associated with high blood pressure are important, incorporating this topic into an update of the current guidelines would not be considered a priority by this group at the present time and that some of these issues such as early detection and screening will be addressed by other activities planned by the MNC Department. The need to involve ISH in the process of guideline updating was discussed at length, and a number of options were considered. A slight modification of the general model for guideline development may be considered, that takes account of the longstanding relationship between ISH and WHO. This may also be considered as a possible model for other guidelines that are developed in partnership with other organisations. For the hypertension guidelines, it includes the reconstitution of the ISH/WHO liaison committee in a manner that meets the current needs of both partners, including appropriate representation from WHO and a stronger representation from developing countries. The final membership of the GDG for hypertension will be decided after discussion with ISH. The meeting noted that the existence of the current WHO/ISH group as the technical development group for the hypertension guidelines might cease, if agreement was reached with ISH on the final composition of the GDG. It was considered extremely important that the GDG be constituted as soon as possible, and that it take account of the needs of the agreed methodology to ensure that the membership was appropriate. In addition to the stakeholders currently represented in the technical guideline development group, it was considered that there should be stronger representation from content experts, and consumers.

The WHO/ISH Liaison Committee may take on the role of the executive committee for the GDG. (see fig 2 for proposed structure)

Other Recommendations
The following issues were discussed, in relation to both the hypertension guidelines and guidelines in general. Resources Guideline development is an expensive, resource intensive and time-consuming process. It is essential that appropriate resources are made available. In the past, guideline development groups have in some cases sought their resources as was possible in the individual circumstances, from a variety of sources. This practice may not be consistent with WHO policy and regulations. Any funds needed for guideline development have to be sought in a manner that is consistent with WHO regulations. Access to data for all settings If WHO guidelines are to be based on evidence that can be applied in all health care systems, there is a need for a system to be developed that provides access to data from a wide range of sources, including in particular, studies from developing countries. The cost-effectiveness of recommendations The precise approach to updating the hypertension guidelines will be developed after the meeting between WHO and ISH in August. However, it was agreed that WHO should start to develop an approach that could be used to determine the cost effectiveness of the possible alternatives for the management of hypertension, in consultation with appropriate external experts as required. Framing and presentation of guidelines It was considered that there is some evidence that suggest that guideline need to be presented differently for different target groups and that standards for presentation may need to be developed and tested.

Pilot testing The need for pilot testing of guidelines was discussed.

Dissemination Options for dissemination of guidelines were discussed, both in general terms and in relation to the hypertension guidelines. The possibilities included dissemination via the WWW, via medical journals, via ministries of health and through professional organisations. It was considered that all strategies that might enhance guideline utilisation should be adopted.

Figure 1 - General guideline development GDG Content Methods Practitioners Stakeholders Consumers WHO Task Groups

WHO

External expert input

Technical Support

Figure 2 - Hypertension Guidelines WHO WHO/ISH Task Groups GDG Independent peer review

GRG

External expert input

Technical support

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Annex 1 WORLD HEALTH ORGANIZATION Management of Noncommunicable Diseases

AN INFORMAL MEETING FOR THE DEVELOPMENT OF THE METHODOLOGY FOR EVIDENCE-BASED GUIDELINES: "HYPERTENSION GUIDELINES AS A CASE STUDY" Geneva, 13-14 July 2000 Location : M Building Room M-605 Programme

Thursday 13 July, 2000 09.00 - 09.15 09.15 - 09.45 09.45 - 10.00 10.00 - 10.30 10.30 10.45 10.45 - 11.15 11.15 11.45 11.45 - 12.30 12.30 - 13.30 13.30 - 14.00 Registration Opening remarks : Dr D. Yach, Executive Director NMH Introduction of participants Background and objectives - Dr A. Alwan Experience and methodologies in developing evidence-based guidelines Prof. J. Petrie and Mr R. Harbour Coffee break Discussion Public Health and Cost considerations of guidelines Dr S. Hill and Dr Tessa Tan-Torres Discussion Lunch break Declaration of interest for WHO experts

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14.00 - 14.30

Hypertension guidelines as a case study: an outline on the development and content of the 1999 WHO/ISH guidelines on hypertension and discussion Prof. John Chalmers Discussion Proposed methodology Dr A. Alwan Coffee break Discussion

14.30 - 15.00 15.00 - 15.30 15.30 - 16.00 16.00 17.00 Friday, 14 July 2000 09.00 - 10.00 10. 00 - 11.00

Conclusions on the methodology to be followed for revision of Hypertension Guidelines Discussion and conclusions on specific issues requiring review in 1999 WHO/ISH Hypertension Guidelines, terms of reference for systematic review of literature, and on drafting of recommendations Coffee break A plan of action: next steps on literature review, drafting of guidelines, circulation for peer review.

11.00 - 11.30 11.30 - 12.30

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Annex 2 WORLD HEALTH ORGANIZATION Management of Noncommunicable Diseases

AN INFORMAL MEETING FOR THE DEVELOPMENT OF THE METHODOLOGY FOR EVIDENCE-BASED GUIDELINES: "HYPERTENSION GUIDELINES AS A CASE STUDY" Geneva, 13-14 July 2000 List of Participants Dr O.O. Akinkugbe, Emeritus Professor of Medicine, Department of Medicine, University of Ibadan, Ibadan, Nigeria Tel: +234 2 231 7717 Fax: +234 2 231 8502 Email: akin.ooihc@errands.skannet.com Dr John Chalmers, Professor and Chairman of Research, Northern Sidney Area Health Service, Level 4, Vidin House, Royal North Shore Hospital, St. Leonards, NSW 2065, Australia Tel: 61 2 9926 6178 Fax: 61-2 9926 6179 Email: jchalmers@med.usyd.edu.au Ms Lise Declerck, International Council of Nurses, Place Jean-Marteau 3, 1201 Geneva Switzerland Tel: 908 01 00 Fax: 908 01 01 Email:bosson@uni2a.unige.ch Dr Azhar Masood A. Faruqui, Professor and Director, National Institute of Cardiovascular Diseases, Rafiqui (H.J.)Shaheed Road, Karachi 75510, Pakistan Tel: 92-21 920 1286 Fax: 92-21 920 1287 Email: nicvd@khi.comsats.net.pk Mr Robin T. Harbour, Information Manager, Scottish Intercollegiate Guidelines Network (SIGN), Royal College of Physicians, 9 Queen Street, Edinburgh EHE 1JQ, United Kingdom Tel: 44-131 247 3667 Fax: 44-131 225 1769 Email: r.harbour@rcpe.ac.uk Dr Irene Hetlevik, Specialist and Associate Professor in General Practice, Norwegian University of Science and Technology, Department of Community and General Practice, MTFS, 7489 Trondheim, Norway Tel: 47-73 59 75 73 Fax:47-73 59 87 89 Email: irene.hetlevik@medisin.ntnu.no

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Dr Susanne Hill, The University of Newcastle, Faculty of Medicine and Health Sciences, Discipline of Clinical Pharmacology, University Drive, Callaghan NSW 2308, Australia Tel: 61-2 49 21 1856 Fax: 61-2 4960 2088 Email: hillsu@mail.newcastle.edu.au Dr Shanthi Mendis, Professor of Medicine, Department of Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka Tel: 94-8 388 315/260 Fax: 94-8 388 948 Email: shanthi@med.pdn.ac.lk Dr James Petrie, Professor and President, Royal College of Physicians of Edinburgh, 9 Queen Street, Edinburgh, EH2 1JQ, United Kingdom Tel: 44-131 225 7324 Fax: 44-131 225 1769 Email: j.c.petrie@abdn.ac.uk

Ms Annick Rieker, International Council of Nurses, Place Jean-Marteau 3, 1201 Geneva Switzerland Tel: 41-22 908 01 00 Fax: 41-22 908 01 01 Email:bosson@uni2a.unige.ch Dr Thomas Strasser, World Hypertension League, Liaison Officer, 20, avenue du Bouchet, 1209 Geneva, Switzerland Tel: 41-22 734 9289 Fax: 41-22 734 9289 WHO Secretariat Dr Derek Yach, Executive Director, Noncommunicable Diseases and Mental Health, World Health Organization, 1211 Geneva 27, Switzerland Tel: 41-22 791 2736 Fax: 41- 22 791 4755 Email: yachd@who.int Dr Ala Din Alwan, Director, Management of Noncommunicable Diseases, World Health Organization, 1211 Geneva 27, Switzerland Tel: 41-22 791 4619 Fax: 41- 22 791 4259 Email: alwana@who.int Ms Judy Canny, Management of Noncommunicable Diseases, World Health Organization, 1211 Geneva 27, Switzerland Tel: 41-22 791 4619 Fax: 41- 22 791 4259 Email: cannyj@who.int Dr Max de Courten, Management of Noncommunicable Diseases, World Health Organization, 1211 Geneva 27, Switzerland Tel: 41-22 791 3441 Fax: 41- 22 791 4259 Email: decourtenm@who.int Dr David Evans, Coordinator, Effectiveness, Quality, Costs, Gender and Ethics, Evidence for Health Policy, World Health Organization, 1211 Geneva 27, Switzerland Tel: 41-22 791 3768 Fax: 41-22 791 4328 Email:evansd@who.int

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Dr Hans Hogerzeil, Coordinator, Policy Access and Rational Use, Essential Drugs and Medicines Policy, World Health Organization, 1211 Geneva 27, Switzerland Tel: 41-22 791 35 28 Fax: 41-22 791 4167 Email: hogerzeilh@who.int Dr Porfirio Nordet, Cardiovascular Diseases, Management of Noncommunicable Diseases, World Health Organization, 1211 Geneva 27, Switzerland Tel: 41-22 791 3459 Fax: 41- 22 791 4151 Email: nordetp@who.int Dr Tessa Tan-Torres Edejer, Effectiveness, Quality, Costs, Gender and Ethics, Evidence for Health Policy,World Health Organization, 1211 Geneva 27, Switzerland Tel: 41-22 7913497 Fax: 41-22 791 4328 Email: tantorrest@who.int

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