|Developing HIV/AIDS Treatment Guidelines (UNAIDS, 1999, 43 p.)|
|How to use this booklet|
|Part 1: Appraisal and validation of existing guidelines|
|Applying the guideline assessment tool and reporting the results|
|Part 2: Developing valid HIV/AIDS guidelines|
|Steps in developing HIV/AIDS treatment guidelines|
|1. Target groups and type of guideline|
|2. Stakeholder mapping exercise|
|3. Setting up a guideline development committee|
|4. Role of the committee members|
|5. Guideline scope|
|6. Identifying and applying scientific evidence|
|7. Methods of establishing consensus|
|8. Deriving recommendations|
|9. Drafting guidelines|
|10. Involving external reviewers|
|11. Disseminating and implementing guidelines|
|12. Workplan for guideline development|
|13. Budgeting for guideline development|
|14. Public policy implications of HIV/AIDS treatment guidelines|
|Appendix: Guideline appraisal tools|
1. Managing drug supply: the selection, procurement, distribution and use of pharmaceuticals, 2nd ed. WHO Action Programme on Essential Drugs, Geneva, and Management Sciences for Health (Kumarian Press), West Hartford, Connecticut, 1997, 11:13-14.
This chapter examines the development of treatment guidelines, essential drugs lists and formulary manuals. Insight into the development process and the important factors that need to be considered in making this process successful are given. Practical examples of the development of guidelines and their success or failure are given from different parts of the world. The guideline development process advocated is useful and effective as shown by the examples of the success of the process, however, there is very little guidance given about evidence-based guideline development.
2. Grimshaw JM, Russell IT. Achieving health gain through clinical practice guidelines I: Developing scientifically valid guidelines. Quality in health care, 1994, 2:243-248.
There is considerable uncertainty about the effectiveness of clinical management guidelines and how to introduce them into clinical practice. Interest in their role in encouraging good practice and generating health gains is discussed. A systematic review of 59 rigorous evaluations of clinical management guidelines identified improvements in the process of care in 55 studies and suggested that guidelines can change clinical practice when they were appropriately developed, disseminated, and implemented.
3. Grimshaw JM, Russell IT. Achieving health gain through clinical practice guidelines II: Developing scientifically valid guidelines. Quality in health care, 1994, 3:45-52.
A systematic review of 59 published rigorous evaluations of clinical management guidelines covering a wide range of clinical activities shows that all but four detected statistically significant improvements in the process of medical care. Two of the 11 that measured the outcome of care reported statistically significant improvements in outcome. It was concluded that guidelines improve clinical practice and achieve health gains when introduced in the context of rigorous evaluations. This evidence-based approach to the development of guidelines is comprehensive and produces valid guidelines but is time consuming and can be costly.
4. Putnam RW, Curry L. Impact of patient care appraisal on physician behaviour in the office setting. Canadian medical association journal, 1985, 132:1025-1029.
The effect of patient care appraisal on physicians' management of patients' problems was assessed. Sixteen family physicians were involved. Eight in the experimental group helped in the selection of two of the five disease conditions to be audited and in the generation of optimum criteria of care for two of the conditions. It was concluded that patient care appraisal is an effective tool in continuing medical education that leads to improvement in the quality of care, provided the process focuses on essential criteria of care. Patient care appraisal is an implementation strategy that is easily introduced as part of patient care but requires a system of monitoring to be effective.
5. Guidelines for the clinical management of HIV infection in adults and children. CAREC, PAHO, WHO. Port of Spain, Trinidad and Tobago, West Indies, 1994.
Guidelines for the clinical management of HIV infection in children and adults in the Caribbean are elaborated in one document. The form of the guideline is algorithms with annotations based on the WHO model of HIV clinical management guidelines. The process of development was through an expert committee and a consensus workshop. A multidisciplinary approach to their development was used. Documentation of the process undertaken in identifying the scientific evidence before and during the workshop is lacking but the overall comprehensiveness of the guideline is evidence of the quality of discussion and the variety of participants in the meeting.
6. Adapting WHO guidelines for the clinical management of HIV infection to country needs. Geneva, World Health Organization, 1994 (unpublished document WHO/GPA/TCO/HCS/94.8 available on request from UNAIDS, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland).
These guidelines are to assist countries in adapting the WHO guidelines for the clinical management of HIV infection in adults and children to country needs. The methodology advocated involves organizing national or programme-based workshops using the nominal group technique. A step-by-step outline is given of the key activities to successfully conduct this. A coordinator is to be appointed to organize the meeting and an expert in the nominal group process is to be appointed to lead the discussions in the meeting. The outcome of the meeting is then used to develop country-specific HIV clinical management guidelines. These guidelines, however, do not emphasize the identification and statement of the strength of evidence upon which recommendations are based.
7. United States Department of Health and Human Services. Evaluation and management of early HIV infection. United States Agency for Health Care Policy and Research (AHCPR), 1994, Publication No 94-0572, 13. (Available at http://www.cdcnac.org)
These are guidelines for the management of early HIV infection developed by the United States Department of Health and Human Services. In the guideline preparation, scientific evidence was identified and recommendations developed with a grading of the strength of evidence. The guideline document has a section explaining the procedures used in developing the document. A review was conducted first by a team of 45 outside peer reviewers including clinicians, AIDS directors, social workers, counsellors, health educators and clinical researchers. A consumer guideline was also developed and reviewed by 25 consumers, 16 providers and 100 HIV-positive individuals and their families before being disseminated. The procedures used were sufficiently comprehensive and rigorous to ensure the validity of the document.
8. Criteria for appraising clinical guidelines for national use. Scottish Intercollegiate Guidelines Network. Centre for Medical Education, University of Dundee 1995. (Available at http://www.pc.47.cee.hw.ac.uk/sign/home/html)
Generic criteria for assessing the validity of clinical practice guidelines are provided focusing on the guideline development process, group selection and the key disciplines required for the appraisal. The identification, synthesis of evidence and linking of this to recommendations is discussed. The role of content and format of guidelines in assessing validity is also discussed. A tool for appraising guidelines is presented including the reporting format. This booklet sets out a clear and practical format for conducting a rapid appraisal of guidelines. The appraisal results also make evident which aspects of the guideline need improvement to ensure the development of a valid product.
9. Eisenberg JM. Sociologic influences on decision-making by clinicians. Annals of internal medicine, 1997, 90:957-964.
Recent articles on clinical decision-making have proposed sophisticated quantitative methods for improving the physician s clinical judgement. Actual clinical decisions, however, are influenced by interactions between the clinician, the patient and the social cultural milieu as well as biomedical considerations. This paper explores four types of sociological factors that influence the clinician s judgement, the characteristics of the patient; the characteristics of the clinician; the clinician s interaction with his profession and the health-care system; and the clinician s relationship with the patient. Assessing the impact of non-clinical aspects of decision-making is important to ensure successful application of clinical guidelines.
10. Essential drugs list for Zimbabwe. Ministry of Health and Child Welfare, Zimbabwe, Causeway, Harare, Zimbabwe. 1994:95-117.
This guideline document includes an outline of biomedical principles for HIV/AIDS clinical care including prevention, control and counselling. Zimbabwe-specific clinical information and local knowledge are included. A proper consideration of the full spectrum of clinical manifestations is given. The treatment sections discuss the drugs, dosage, side-effects, availability and costs in the form of algorithms, flow charts and narrative. There are good cross-references to other sources elsewhere in the book.
11. Standard treatment guidelines, Ministry of Health, Malawi, Capital Printing Press, Lilongwe, Malawi, 1993:40-54.
This guideline is for all health-care workers who prescribe for all patient groups at all hospital levels. HIV counselling and testing are not covered. Clinical problems are considered and a proper consideration of the full spectrum of clinical manifestations and treatment (drugs, dosage, side-effects) is given as narrative. No algorithms or flow charts are included. Good cross-references to other sources are included elsewhere in the book and in the Malawi HIV management guidelines.
12. Mulrow CD. Systematic review: rationale for systematic reviews. British medical journal, 1994, 309:597-599.
Health care providers, researchers and policy makers are inundated with unmanageable amounts of information; they need systematic reviews to integrate existing information effectively and to provide data for rational decision-making. Systematic reviews establish whether scientific findings are consistent and can be generalized across population settings and treatment variations. The methodologies proposed are intensive and appropriate for evidence-based guideline development.
13. Series on the systematic review of clinical literature to ensure its validity and acceptability for use as evidence in the development of clinical guidelines. British medical journal, 1994, 309:597-599, 648-651, 719-721, 789-791, 1007-1010, 1286-1291, 1351-1355.
A comprehensive review of the methodologies and approaches used to identify and synthesize relevant and valid data from scientific studies. Different authors give their views including comments on the controversial issues in using the different approaches. Recommendations and suggestions for future action and research are also given.
14. Fourteen years with an essential drugs list: Zimbabwe experience. Essential drugs monitor. Geneva, World Health Organization, 1995, 19:17-18.
The lessons learnt in developing the Essential drugs list for Zimbabwe (EDLIZ) are discussed, from inclusion of material, to reviews by expert groups and health workers at all levels. The importance given to distribution and training is emphasized. Further revision and incorporation of new information over the years has enhanced its use among all health care prescribers in the public sector resulting in 94% of drugs prescribed being generic.
15. Forshaw JC. Production of national drug and therapeutic information materials: The Malawi approach to developing standard treatment guidelines. Geneva, World Health Organization, 1994 (unpublished document WHO/DAP/94.14, available on request from UNAIDS, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland).
A practical and detailed account of the stages involved in the development of the first two editions of the Malawi standard treatment guidelines. This includes sections on the rationale for developing the guidelines, the preparations required before starting, issues in the formulation of the content of the guideline, and problems to anticipate in the printing, publication, distribution and use of the guidelines.
16. The United States Public Health Service and the Infectious Diseases Society of America (USPHS/IDSA) Guidelines for the prevention of opportunistic infection in persons infected with HIV. 1997, 3:S299-350.
A detailed guideline for the prevention and treatment of opportunistic infections. Each opportunistic infection is described in detail and the recommended treatments for each is given. Features of interest that are included are:
- details of how the recommendations were developed from evidence and the criteria used to grade them,
- recommendations concerning each opportunistic disease are made by different panels,
- a bibliography of all the sources of evidence used is given at the end of each chapter,
- the qualifications and addresses of all the participating specialists are given,
- the recommendations have a consistent format and presentation.
17. World Health Organization press release No 27, 4 March 1997. Additional material available on WHO's Internet web site (http://www.who.ch).
The Reproductive Health Library s (RHL) main aim is to promote evidence-based care in the area of reproductive health by making available to health workers the most reliable and up-to-date medical information. This is being provided electronically on 3.5 inch diskettes so that the large volumes of data can be made available at low cost. RHL operates under the windows TM operating system and it requires no special knowledge of computers. Subscription is free to health workers in developing countries. Others can access the reviews through a paid subscription to The Cochrane Library. (Available from http://www.cochrane.dk./revabastr/ccabout.html)
18. Recommendations of the First International Conference on Improving Use of Medicines (ICIUM), Chiang Mai, Thailand, April 1-4, 1997. (Available from http://www.who-int/dap-icium/summary.html)
The objectives of the Conference were to synthesize the evidence for success of different strategies to improve use of medicines in developing countries, to develop policy guidelines for implementing proven strategies, and to identify important directions for future research. International teams of authors presented six critical reviews of experience from developing countries on improving pharmaceutical practice by health professionals, improving community drug use, and assessing economic and policy interventions on the use of drugs.
19. Guidelines for clinical practice: from development to use. National Academy Press, Washington DC, 1992.
This is a comprehensive review of the work of the Agency for Health Care Policy and Research. It outlines the criteria recommended for the development of clinical practice guidelines and the criteria used to appraise clinical practice guidelines. Numerous examples of practice guidelines are given in the appendix. A tool for the purpose of appraisal is provided including various examples of how guidelines are developed. This is a useful guide for persons interested in understanding the rationale for the development of practice guidelines and the use of appraisal tools.
20. Woolf SH. Practice guidelines-a new reality in medicine. II Methods of developing guidelines. Archives of internal medicine,1992, 152:946-975.
Four methods of guideline development are compared: informal consensus, formal consensus, evidence-based and explicit guideline development. Evidence-based development linking scientific evidence to recommendations is described and its benefits in developing valid guidelines outlined. Steps in the guideline development process are also given in detail.
21. Guidelines for the clinical management of HIV in adults. Geneva, World Health Organization, 1991 (unpublished document WHO/GPA/IDS/HCS/91.6 available on request from UNAIDS, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland).
The guidelines are to assist health care workers in the diagnosis and management of HIV infection in adults at the primary, secondary and tertiary levels of the health care system. They were developed by a group of international clinical experts working in the field of HIV using a nominal group process. The guidelines are presented in the form of algorithms with annotations on the common signs and symptoms of HIV disease. The notable features of the guidelines are:
- the guidelines are well written and have a clear layout,
- all the common symptoms in HIV infection and the required treatment are covered adequately,
- the guidelines have formed the basis for the development of many national guidelines. However,
- concepts of comprehensive care and referral systems are not included,
- topics related to terminal care, counselling, pain relief and nutrition were not included in this edition,
- the source and grading of the scientific evidence used in the recommendations are not clearly indicated.
22. Guidelines for the clinical management of HIV in children. Geneva, World Health Organization, 1993 (unpublished document WHO/GPA/IDS/HCS/93.3 available on request from UNAIDS, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland).
The guidelines are to assist health care workers in the diagnosis and management of HIV infection in children at the primary, secondary and tertiary levels of the health care system. They were developed by a group of international clinical paediatric experts working in the field of HIV using a nominal group process. The guidelines are presented in the form of algorithms with annotations on the commonly seen signs and symptoms of HIV disease in children. The notable features are similar to those in the guideline for adults except that a section on counselling has been included.
23. Report on the sub-regional workshop on the development of HIV clinical management guidelines for the Caribbean. Geneva, World Health Organization,1992 (unpublished document GPA/IDS/HCS available on request from UNAIDS, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland).
This report describes the process of adapting the clinical management guidelines for the Caribbean region and the outcome of this process. It also describes the current HIV/AIDS care activities in the region and the reported HIV prevalence and AIDS cases.
24. Fink A et al. Consensus methods: Characteristics and guidelines for use. American journal of public health, 1984; 979-983.
Consensus methods are being used increasingly to solve problems in medicine and health. Their main purpose is to define levels of agreement on controversial subjects. Advocates suggest that, when properly employed, consensus strategies can create structured environments in which experts are given the best available information allowing solutions to problems to be more justifiable and credible than otherwise. The paper surveys several major methods, such as the Delphi nominal group and models developed by the National Institutes of Health and the guideline developer, Dr Glasser. It provides guidelines for those who want to use the techniques. Concerns raised are selection of problems, choosing members of consensus panels, specifying acceptable levels of agreement, proper use of empirical data, or obtaining professional/political support and disseminating results.
25. Chela CM. UNAIDS consultant report of the assessment of national HIV clinical management guidelines. 1996 (unpublished document).
26. Eccls M et al. Developing valid guideline methodologies from the North of England evidence-based guideline development project. Quality in health care. 1996, 5:44-50.
This describes the development of explicit evidence-based guidelines for the primary care management of asthma in adults and for stable angina. The authors present the methodological issues considered during guideline development, both for those involved in the process and for those who wish to know more about the practical details of guideline development .
27. Fergerson JH. The NIH development programme: The evolution of guidelines. International journal of technology assessment of health care. 1996, 12(3):460-474.
The United States National Institutes of Health (NIH) Consensus Development Programme (CDP) Guidelines have undergone some modification over the programme s 18-year history. They have never been published in archival form. This article reviews the evolution of the NIH CDP Guidelines and then presents the complete 1995 version.
28. Gross PA et al. Purpose of quality standards for infectious diseases. Clinical infectious diseases 1994, 18:421.
Various quality standards are discussed in relation to clinical infectious disease medicine.
29. Kalibala S. The development of the Uganda National HIV treatment guidelines for adults and children, 1996 (unpublished document).
This describes the process of developing guidelines in Uganda. The planning process and sources of encouragement are detailed. The difficulties encountered and the solutions are also elaborated. The method of pre-testing the guidelines is given.
30. Sherman CR et al. The consensus development programme: Detecting changes in medical practice following a consensus conference on the treatment of prostate cancer. International journal of technology assessment of health care. 1992, 8:33-36.
Prostate cancer treatment was reviewed by the United States National Institute of Health Consensus Development Conference in June 1987. Data from the US National Cancer Institute Surveillance, epidemiology and end results of tumour registers were analysed. This examination showed that the proportion of eligible prostate cancer patients receiving the recommended therapies did not increase at a faster rate than before. This highlights the importance of developing implementation and dissemination strategies for successful guidelines.
31. Maher D. Clinical audit in a developing country. Tropical medicine international health, 1996, 4:409-413.
The advantages are discussed of clinical audit in Malawi, a country with severe resource constraints. Measuring quality in health care raises the standard of care through decreased uncertainty in health care provision, rationalized choice and appropriate direction of limited resources.
32. Nyazema NZ. Effective use of mass communication in improving use of medicines for HIV/AIDS-related diseases: Zimbabwe experience. Proceedings of the First International Conference on Improving Use of Medicines (ICIUM), Chiang Mai, Thailand, 1997. (Available from: http://www.who.int/dap-icium/index.html)
The use of various forms of mass media to educate the public about use of anti-tuberculosis drugs has resulted in increased awareness of HIV/AIDS issues and development of plans to promote rational use of tuberculosis drugs.
33. Kalibala S. Indian doctors learn HIV/AIDS care skills. Global AIDS News, 1993, 4:14-15.
Twenty-two practising physicians from major health institutions in India were trained in counselling and clinical management. The report highlights the training methods used and the outcome. This was a successful initiative for the Indian National AIDS Control Organization (NACO). More workshops are planned along similar lines. The Christian Medical Association of India (CMAI) was a key to facilitating the workshop and has been contracted to conduct more workshops.