4.1. WHO guideline development process
WHO uses the GRADE approach (Grading of Recommendations Assessment, Development and Evaluation) for the development and review of recommendations (49). The initial steps entail identifying key topics, formulating the Population, Intervention, Comparison and Outcomes (PICO) questions, scoping the literature to identify whether evidence reviews exist or recent evidence can be obtained, developing a comprehensive search strategy and identifying and retrieving relevant evidence, including evidence concerning both benefits and harms (50).
Outcome frameworks are developed to ensure that outcomes are selected in a transparent and comprehensive manner and prior to reviewing the evidence. Each framework describes all possible pathways, starting with the intervention, going through the intermediate outcomes and leading to the important outcomes.
The first step of the GRADE approach is to rate the quality of evidence for each PICO question by outcome (51). This step entails consideration of study limitations, inconsistency, indirectness, imprecision and other limitations (50). The quality of the evidence is then graded as high, moderate, low or very low. A standardized table, the GRADE evidence table, presents the quantitative summary of the evidence and the assessment of its quality.
The second step of the GRADE approach is to move from “evidence to recommendation” for each of the PICO questions. This includes consideration of the quality of evidence, the balance of benefits and harms, community values and preferences and resource use. These factors affect both the recommendation's direction (for or against) and its strength (strong or conditional). Decision tables summarize these factors.
4.2. Viral hepatitis guideline development process
The WHO Department of HIV/AIDS led the development of these guidelines with the oversight of the WHO Guideline Review Committee. In 2010 a scoping exercise was carried out to review the literature and identify key programmatic issues related to viral hepatitis transmission among PWID (52). A subsequent expert consultation with civil society representatives and the Cochrane Collaboration Drug and Alcohol Review Group was held in September 2010 to formulate the PICO questions. Three systematic reviews were later conducted to address these questions using the GRADE methodology. A series of semi-structured interviews with service providers and PWID was carried out in late 2011 to obtain their perspectives, values and preferences on the draft recommendations for prevention of viral hepatitis in PWID.
A technical consultation was held in Geneva, Switzerland, in February 2012 to reach consensus on the recommendations on prevention, surveillance and HIV management in patients with viral hepatitis-HIV co-infection.*
The expert panel included public health professionals, clinicians, academics, programme managers, implementers, civil society representatives and a GRADE methodologist. Appropriate geographical and gender representation was considered. The three systematic reviews on prevention in PWID were presented and discussed. The multidisciplinary expert panel assessed the evidence, risks and benefits, and values and preferences for each recommendation. The expert panel determined the direction of the recommendations and strength of the evidence. Consensus was reached for all decisions. By consensus, one of the original PICO questions, “Should motivational interviewing versus no motivational interviewing be used in people who inject drugs?”, was dropped.
The expert panel noted the general low quality of evidence and the need for further research in the area of HBV and HCV prevention among PWID. Consequently, the expert panel developed a series of research questions that should be addressed in the future.
A draft version of the guidance was circulated among the expert panel members and external peer reviewers for feedback. The coordinators of the process incorporated comments from internal and external peer reviewers to finalize the guidelines.
A revision of these guidelines is planned for 2016, before which plans will be developed for quality evaluation of these guidelines, their usefulness and their impact. Recommendations from the forthcoming guidance on the surveillance of viral hepatitis will be incorporated into the quality evaluation. Complete details of the systematic reviews and all annexes are available online at http://www.who.int/hiv/pub/guidelines/hepatitis_annex/en/.
The process details for the surveillance and treatment components of the meeting are separate from this document and will be publishedelsewhere at a later date.
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Guidance on Prevention of Viral Hepatitis B and C Among People Who Inject Drugs. Geneva: World Health Organization; 2012 Jul. 4, METHODOLOGY.