WHO informal meeting review of hypertension guidelines by nikeborome

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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
This document is not a formal publication of the World Health              Ce document n'est pas une publication officielle de
Organization (WHO), and all rights are reserved by the Organization.       l'Organisation mondiale de la Santé (OMS) et tous les
The document may, however, be freely reviewed, abstracted,                 droits y afférents sont réservés par l'Organisation. S'il
reproduced and translated, in part or in whole, but not for sale nor for   peut être commenté, résumé, reproduit ou traduit,
use in conjunction with commercial purposes.                               partiellement ou en totalité, il ne saurait cependant l'être
                                                                           pour la vente ou à des fins commerciales.
The views expressed in documents by named authors are solely the           Les opinions exprimées dans les documents par des
responsibility of those authors.                                           auteurs cités nommément n'engagent que lesdits auteurs.
                                                                          Table of Contents




TABLE OF CONTENTS ........................................................................................................................................................1

BACKGROUND ......................................................................................................................................................................2

TERMS OF REFERENCE OF THE MEETING .................................................................................................................2

CONCLUSIONS AND RECOMMENDATIONS .................................................................................................................3
    DEFINITION OF GUIDELINES ...................................................................................................................................................3

    GENERAL ISSUES ....................................................................................................................................................................3

    CURRENT BEST PRACTICE ......................................................................................................................................................3

    GENERAL PRINCIPLES FOR WHO GUIDELINE DEVELOPMENT .................................................................................................4

    ROLES AND RESPONSIBILITIES OF GRG AND GDG ................................................................................................................4

    SPECIFIC ISSUES RELATING TO THE 1999 WHO/ISH GUIDELINES .........................................................................................5



OTHER RECOMMENDATIONS .........................................................................................................................................6
    RESOURCES............................................................................................................................................................................6

    ACCESS TO DATA FOR ALL SETTINGS .....................................................................................................................................6

    THE COST-EFFECTIVENESS OF RECOMMENDATIONS ...............................................................................................................6

    FRAMING AND PRESENTATION OF GUIDELINES .......................................................................................................................6

    PILOT TESTING .......................................................................................................................................................................6

    DISSEMINATION .....................................................................................................................................................................7

            Annex 1 Agenda .............................................................................................................................................................................9
            Annex 2 List of Participants.......................................................................................................................................................... 11




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Background

One of WHO‟s 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 WHO‟s 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


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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.




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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                                            GDG
- Sets “best practice” standards for methods   - Reviews initial membership, provides
of developing guidelines                       advice on additional members
- Selects initial GDG, appoints chair          - Reviews initial questions, expands as
- Provides initial question for the            required, refines
guidelines                                     - Undertakes guideline development
- Provides general guidance for the specific   - Appoints task groups to develop draft
topic as required                              evidence-based recommendations
- Reviews draft guideline to ensure that it    - Collates draft guideline for external peer
meets WHO requirements                         review and first round consultation
- Sends draft for additional external review   - Revises draft guideline as a result of peer
as required                                    review
- Organises final approval by WHO              - 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.




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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.




                                                                                                     5
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.


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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.




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               Figure 1 - General guideline development


WHO                  GDG             Task
                                     Groups
                                                    External expert input
                     Content
                     Methods
GRG                  Practitioners
                     Stakeholders
                     Consumers
                     WHO



                      Technical Support




                  Figure 2 - Hypertension Guidelines

 WHO                                   WHO/ISH


                                              Task Groups     External expert input
      GRG

                                       GDG


 Independent
 peer review


                                       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          Registration

09.15 - 09.45          Opening remarks : Dr D. Yach, Executive Director NMH
                       Introduction of participants

09.45 - 10.00          Background and objectives - Dr A. Alwan

10.00 - 10.30          Experience and methodologies in developing evidence-based guidelines –
                       Prof. J. Petrie and Mr R. Harbour

10.30 – 10.45          Coffee break

10.45 - 11.15          Discussion

11.15 – 11.45          Public Health and Cost considerations of guidelines
                       Dr S. Hill and Dr Tessa Tan-Torres

11.45 - 12.30          Discussion

12.30 - 13.30          Lunch break

13.30 - 14.00          Declaration of interest for WHO experts




                                                                                                9
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

14.30 - 15.00          Discussion

15.00 - 15.30          Proposed methodology
                       Dr A. Alwan

15.30 - 16.00          Coffee break

16.00 – 17.00          Discussion


Friday, 14 July 2000

09.00 - 10.00          Conclusions on the methodology to be followed for revision of Hypertension
                       Guidelines

10. 00 - 11.00         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

11.00 - 11.30          Coffee break

11.30 - 12.30          A plan of action: next steps on literature review, drafting of guidelines,
                       circulation for peer review.




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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

Dr Susanne Hill, The University of Newcastle, Faculty of Medicine and Health Sciences,
Discipline of Clinical Pharmacology, University Drive, Callaghan NSW 2308, Australia


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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

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


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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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