Guideline Development At WHO Courtesy of Susan L. Norris, MD MPH MSc Guidelines Review Committee Secretariat 10 October 2016

Outline What is a WHO guideline? Guideline development processes at WHO Principles underlying WHO guidelines Role of Guideline Development Group Rules of procedure: consensus

What is a WHO guideline? “A WHO guideline is any document, whatever its title, that contains WHO recommendations about health interventions, whether they be clinical, public health or policy interventions.”  ”A recommendation provides information about what policy-makers, health-care providers or patients should do. It implies a choice between different interventions that have an impact on health and that have ramifications for the use of resources.” "Guidelines are recommendations intended to assist providers and recipients of health care and other stakeholders to make informed decisions. Recommendations may relate to clinical interventions, public health activities, or government policies." WHO 2003, 2007 Any document containing recommendations about health interventions (treatment,diagnosis, policy) Name of document not relevant Health information products that are not guidelines are: Standards for manufacturing health technologies or standard operating procedures for organisations `how to` documents – eg how to implement a service, how to set up a research project

Types of guidelines at WHO Standard Full systematic review and guideline development process 6 months to 2 years Compiled or consolidated Include GRC-approved recommendations Rapid advice guidelines Compressed and abbreviated process, potential for bias 1 to 3 months Interim Standard or rapid advice guideline processes; Often narrow scope Anticipate short shelf-life: follow with standard guideline

Oxman et al, Lancet 2007;369:1883-9

Oxman et al. Lancet 2007 “Findings: Systematic review and concise summaries of findings are rarely used for developing recommendations. Instead processes usually rely heavily on experts in a particular specialty, rather than representatives of those who will have to live with the recommendations or on experts in particular methodological areas.”

WHO Guidelines Review Committee Established in 2007 to develop and implement procedures to ensure that WHO guidelines are: consistent with internationally accepted best practices appropriately based on evidence. transparent Members from headquarters and all 6 regions 5 external members Decisions are made by consensus

Principles for WHO Guidelines Well-defined scope and target audience Broad and representative guideline development group Disclosure and management of all secondary interests (COI) A priori development of key question for systematic reviews Systematic and comprehensive evidence retrieval, synthesis Quality assessment of the body of evidence for each question Formulation of recommendations based on the evidence and other explicit considerations. Adherence to WHO reporting standards Usable document: relevant, applicable, user-friendly Include a plan for implementation and updating

FINAL GUIDELINES: Top reasons for non-approval Evidence to recommendations Inadequate explanation for determination of strength of recommendations Disclosures of interest and funder DOI not presented in sufficient detail Document presentation Executive summary, copy editing, technical editing, organization, layout Within these categories, some of the major issues were…

Guideline development at WHO 1 Scope the guideline 2 Set up GDG and External Review Group 3 DOI and manage conflicts of interest 4 Formulate questions (PICO) and Choose relevant outcomes GRC approval of guideline development proposal 5 Evidence retrieval, assessment, synthesis (systematic review(s)) GRADE - evidence profile(s) 6 Formulate recommendations: GRADE Include explicit consideration of: Benefits and harms Values and preferences Resource use GRC approval of final guideline 7 Disseminate, implement (a 8 Evaluate impact 9 Plan for updating 11

WHO Guidelines… Must meet the highest quality standards for evidence-based guidelines Must be based on high-quality systematic reviews of all relevant evidence Use GRADE, which provides an explicit approach to: Assessing the quality of the evidence across studies and outcomes Translating evidence to recommendations Incorporate multiple processes to minimize bias and optimize usability Must incorporate transparency in all judgments and decision making processes Updating: when

Knowledge gaps Identifying gaps in the evidence is an important aspect of systematic reviews and guideline development Guideline Development Groups are in an ideal position to define an agenda for future research Especially important when evidence is sparse Want to mention one other important issue: Although we will not have time to formally work on and prioritize a research agenda, we should all keep this in mind over the next 2 days, as future research will be an important section of the final guideline document.

Rules of Procedure: Group decision making WHO recommendations should be based on consensus Defined as general agreement among the decision makers Minor disagreements can be addressed in the Remarks Section of the guideline Co-chairs to work with the Secretariat to find solutions If consensus cannot be reached, voting Simple majority, anonymous or hand-raising at Chair’s discretion (observers and secretariat do not vote) Tied vote within the GDG: 2 co-chairs to identify a solution or break the tie by consensus between 2 of them Voting is discouraged, consensus is strongly preferred

Rules of Procedure: Group decision making Every effort should be made to try to achieve consensus!

Role of Guideline Development Group provide input into the scope of the guideline; assist the steering group in developing the key questions in PICO format; choose and rank priority outcomes that will guide the evidence reviews; examine the GRADE evidence profiles or other assessments of the quality of the evidence used to inform the recommendations and provide input; interpret the evidence and formulate recommendations taking into account benefits, harms, values and preferences, feasibility, equity, acceptability, resource requirements and other factors, as appropriate; and review and approve the final guideline document before submission to the GRC.

Composition of Guideline Development Group relevant technical experts; end-users, such as programme managers and health professionals, who will adopt, adapt, and implement the guideline representatives of groups most affected by the recommendations in the guideline, such as service users and representatives of disadvantaged groups; experts in assessing evidence and developing guidelines informed by evidence; other technical experts as required. Complete DOI; COI assessed and managed by WHO staff Participate as individuals; do not represent institutions

Role of meeting attendees Meeting Observers Technical consultants: provide information, opinions, guidance, provide comments only upon request Do not participate in deliberations on the recommendations No DOI needed May represent an institution or group WHO Steering Group and other WHO staff Prepare initial planning proposal Support development of recommendations by the GDG Draft the guideline document Are subject to WHO Staff Regulations for COI and confidentiality

Role of meeting attendees Guideline methodologist Helps to develop recommendations informed by evidence using a transparent and explicit process Provides technical expertise on systematic review and guideline development methods Completes DOI; generally has no COI Other technical experts: Systematic Review Team Presents the review; provides technical expertise on review methods

Rules of Procedure: Confidentiality CONFIDENTIALITY UNDERTAKING  The World Health Organization (WHO), acting through its Department of ………………, has access to certain information relating to ……………., which information WHO considers to be proprietary to itself or to parties collaborating with it (hereinafter referred to as "the Information"). All meeting attendees who are external to WHO should have signed this agreement: observers, consultants, GDG members

Questions? ? http://www.who.int/kms/handbook_2nd_ed.pdf