Using GRADE methodology for the development of public health guidelines for the prevention and treatment of HIV and other STIs among men who have sex with men and transgender people

BackgroundThe World Health Organization (WHO) Department of HIV/AIDS led the development of public health guidelines for delivering an evidence-based, essential package of interventions for the prevention and treatment of HIV and other sexually transmitted infections (STIs) among men who have sex with men (MSM) and transgender people in the health sector in low- and middle-income countries. The objective of this paper is to review the methodological challenges faced and solutions applied during the development of the guidelines.MethodsThe development of the guidelines followed the WHO guideline development process, which utilizes the GRADE approach. We identified, categorized and labeled the challenges identified in the guidelines development process and described the solutions through an interactive process of in-person and electronic communication.ResultsWe describe how we dealt with the following challenges: (1) heterogeneous and complex interventions; (2) paucity of trial data; (3) selecting outcomes of interest; (4) using indirect evidence; (5) integrating values and preferences; (6) considering resource use; (7) addressing social and legal barriers; (8) wording of recommendations; and (9) developing global guidelines.ConclusionWe were able to successfully apply the GRADE approach for developing recommendations for public health interventions. Applying the general principles of the approach while carefully considering specific challenges can enhance both the process and the outcome of guideline development.

[1]  N. Black.  Why we need observational studies to evaluate the effectiveness of health care , 1996, BMJ.

[2]  P. Sandercock,et al.  Framework for design and evaluation of complex interventions to improve health , 2000, BMJ : British Medical Journal.

[3]  Allan Donner,et al.  Design and Analysis of Cluster Randomization Trials in Health Research , 2001 .

[4]  G. Guyatt,et al.  Grading evidence and recommendations , 2001 .

[5]  Anne M Johnson,et al.  A cognitive behavioural intervention to reduce sexually transmitted infections among gay men: randomised trial , 2001, BMJ : British Medical Journal.

[6]  M. Frommer,et al.  Criteria for evaluating evidence on public health interventions , 2002, Journal of epidemiology and community health.

[7]  Andrew D Oxman,et al.  Letters, numbers, symbols and words: how to communicate grades of evidence and recommendations. , 2003, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[8]  J. Bryce,et al.  Evidence-based public health: moving beyond randomized trials. , 2004, American journal of public health.

[9]  L. Gramling,et al.  Stigma: a health barrier for women with HIV/AIDS. , 2004, The Journal of the Association of Nurses in AIDS Care : JANAC.

[10]  S Michie,et al.  Words matter: increasing the implementation of clinical guidelines , 2005, Quality and Safety in Health Care.

[11]  E. Anyanwu,et al.  AIDS-related stigma in sub-Saharan Africa: its contexts and potential intervention strategies. , 2005, AIDS & public policy journal.

[12]  Gordon H Guyatt,et al.  Need for expertise based randomised controlled trials , 2005, BMJ : British Medical Journal.

[13]  A. Oxman,et al.  Health Research Policy and Systems BioMed Central Review Improving the use of research evidence in guideline development: 9. Grading evidence and recommendations , 2006 .

[14]  Andrew D Oxman,et al.  Improving the use of research evidence in guideline development , 2007 .

[15]  Elizabeth Allen,et al.  Process evaluation in randomised controlled trials of complex interventions , 2006, BMJ : British Medical Journal.

[16]  Elie A Akl,et al.  Symbols were superior to numbers for presenting strength of recommendations to health care consumers: a randomized trial. , 2007, Journal of clinical epidemiology.

[17]  S. Kegeles,et al.  “They see you as a different thing”: the experiences of men who have sex with men with healthcare workers in South African township communities , 2008, Sexually Transmitted Infections.

[18]  Gordon H Guyatt,et al.  GrADe : what is “ quality of evidence ” and why is it important to clinicians ? rATING quALITY of evIDeNCe AND STreNGTH of reCommeNDATIoNS , 2022 .

[19]  R. Beaglehole,et al.  Grading of evidence of the effectiveness of health promotion interventions , 2008, Journal of Epidemiology & Community Health.

[20]  David R. Holtgrave,et al.  Alternatives to the randomized controlled trial. , 2008, American journal of public health.

[21]  Eddy R. Segura,et al.  Epidemiology of male same-sex behaviour and associated sexual health indicators in low- and middle-income countries: 2003–2007 estimates , 2008, Sexually Transmitted Infections.

[22]  G. Guyatt,et al.  Going from evidence to recommendations , 2008, BMJ : British Medical Journal.

[23]  G. Guyatt,et al.  GRADE: an emerging consensus on rating quality of evidence and strength of recommendations , 2008, BMJ : British Medical Journal.

[24]  J. D. de Wit,et al.  Estimating Levels of HIV Testing, HIV Prevention Coverage, HIV Knowledge, and Condom Use Among Men Who Have Sex With Men (MSM) in Low-Income and Middle-Income Countries , 2009, Journal of acquired immune deficiency syndromes.

[25]  H. Jaffe,et al.  Men who have sex with men and HIV/AIDS in sub-Saharan Africa , 2009, The Lancet.

[26]  R. M. da Silva,et al.  Symbolic violence experienced by men who have sex with men in the primary health service in Fortaleza, Ceará, Brazil: negotiating identity under stigma. , 2009, AIDS patient care and STDs.

[27]  Andrew D Oxman,et al.  SUPPORT Tools for evidence-informed health Policymaking (STP) 9: Assessing the applicability of the findings of a systematic review , 2009, Health research policy and systems.

[28]  P. Sullivan,et al.  Reemergence of the HIV epidemic among men who have sex with men in North America, Western Europe, and Australia, 1996-2005. , 2009, Annals of epidemiology.

[29]  Claire Glenton,et al.  Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study , 2009, BMJ : British Medical Journal.

[30]  Andrew D Oxman,et al.  SUPPORT Tools for evidence-informed health Policymaking (STP) 10: Taking equity into consideration when assessing the findings of a systematic review , 2009, Health research policy and systems.

[31]  Michael Kelly,et al.  Evidence based public health: A review of the experience of the National Institute of Health and Clinical Excellence (NICE) of developing public health guidance in England. , 2010, Social science & medicine.

[32]  R. Detels,et al.  Evolution of Men Who Have Sex With Men Community and Experienced Stigma Among Men Who Have Sex With Men in Chengdu, China , 2010, Journal of acquired immune deficiency syndromes.

[33]  G. Rutherford,et al.  Developing WHO guidelines with pragmatic, structured, evidence-based processes: A case study , 2010, Global public health.

[34]  G. Guyatt,et al.  The GRADE approach and Bradford Hill's criteria for causation , 2010, Journal of Epidemiology & Community Health.

[35]  H. D. de Vries,et al.  High prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae infections among HIV-1 negative men who have sex with men in coastal Kenya , 2010, Sexually Transmitted Infections.

[36]  J. Csete,et al.  An inappropriate tool: criminal law and HIV in Asia , 2010, AIDS.

[37]  C. Hankins,et al.  Combination prevention: a deeper understanding of effective HIV prevention , 2010, AIDS.

[38]  P. Phanuphak,et al.  Inconsistent condom use among young men who have sex with men, male sex workers, and transgenders in Thailand. , 2010, AIDS education and prevention : official publication of the International Society for AIDS Education.

[39]  Nick Fowler,et al.  Towards Universal Access , 2010 .

[40]  Rebecca Armstrong,et al.  Using logic models to capture complexity in systematic reviews , 2011, Research synthesis methods.

[41]  G. Guyatt,et al.  GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. , 2011, Journal of clinical epidemiology.

[42]  Gordon H Guyatt,et al.  GRADE guidelines: 2. Framing the question and deciding on important outcomes. , 2011, Journal of clinical epidemiology.

[43]  Howard Balshem,et al.  GRADE guidelines: 3. Rating the quality of evidence. , 2011, Journal of clinical epidemiology.

[44]  G. Guyatt,et al.  GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk of bias). , 2011, Journal of clinical epidemiology.

[45]  J. Baeten,et al.  Combination HIV Prevention: Significance, Challenges, and Opportunities , 2011, Current HIV/AIDS reports.

[46]  Gerald Gartlehner,et al.  [GRADE guidelines: 8. Rating the quality of evidence - indirectness]. , 2012, Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen.

[47]  J. Paul.  BMC public health. , 2012, World health & population.

[48]  F. Hughes,et al.  Quality of evidence , 2013, BDJ.