Guideline Development At WHO Susan L. Norris, MD MPH MSc Guidelines Review Committee Secretariat September 24, 2015 1
Questions Who has ever used a clinical practice guideline? Who regularly uses clinical practice guidelines? Who has produced a systematic review? Who has participated in developing a clinical practice guideline? Who is interested in participating in developing a guideline? 2
Presentation outline What are? Guideline development processes at WHO Role of the WHO Guidelines Review Committee Steps involved in producing a WHO guideline Quality of 3
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. 4
Target audience: global; primarily low- and middle-income countries, low resource settings Broad range of topics: Disease- or program-focused: TB, malaria, HIV, diabetes, etc. E.g., Consolidated guidelines on HIV testing services Health systems: e.g., Operational guidance on systematic screening for active TB Health technology: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children Health workforce: Optimizing health worker roles for maternal and newborn health Policy: Country pharmaceutical pricing 5
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approved by the Guidelines Review Committee available at http://www.who.int/publications/guidelines/en/ 7
Why is there a standard process for guideline development at WHO? 8
Oxman et al, Lancet 2007;369:1883-9 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. 10
WHO response Established the Guidelines Review Committee (GRC) Revised the WHO Handbook for Guidelines Development Developed standards for Process for development and approval Reporting of evidence and recommendations 11
WHO Guidelines Review Committee Established in 2007 to develop and implement procedures to ensure that are: consistent with internationally accepted best practices appropriately based on evidence transparent Members from headquarters and all 6 regions 5 external members 12
Guideline development at WHO 1 2 Scope the guideline Set up Guideline Development 3 4 5 7 8 9 6 Manage conflicts of interest Formulate questions (PICO) and Choose relevant outcomes Evidence retrieval, assessment, synthesis (systematic review(s)) GRADE - evidence profile(s) Formulate recommendations: GRADE Include explicit consideration of: Benefits and harms Values and preferences Resource use Disseminate, implement (a Evaluate impact Plan for updating GRC approval of guideline development proposal GRC approval of final guideline
GRADE: Grades of Recommendation Assessment, Development and Evaluation Aim: to develop a common, transparent and sensible system for grading the quality of evidence and the strength of recommendations (over 100 systems) International group of guideline developers, methodologists, and clinicians from around the world (>100 contributors) since 2000 International group: ACCP, AHRQ, Australian NMRC, BMJ Clinical Evidence, CC, CDC, NICE, Oxford CEBM, SIGN, UpToDate, USPSTF, WHO 15
GRADE: Grades of Recommendation Assessment, Development and Evaluation Involves two fundamental determinations: Quality of the evidence: reflects the extent of our confidence that the estimates of an effect are adequate to support a particular decision or recommendation. Strength of recommendation: reflects the extent to which we can, across the range of patients for whom the recommendations are intended, be confident that desirable effects of a management strategy outweigh undesirable effects. 16
Required elements of WHO Guidelines Well-defined scope and target audience Broad and representative guideline development group Disclosure and management of conflicts of interest A priori development of key questions 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 17
Burda et al. 2014* 18 Quality of is improving Examined the quality of all published, GRC-approved guidelines (2007-2012) using AGREE-II (validated assessment tool) recommended (some with modification): 116/124 scored well on scope and purpose, clarity of presentation scored less well on rigor of development, stakeholder engagement, transparency of conflict of interest, and implementation guidance 77% based on an evidence review; 49% used GRADE All quality domains improved from 2007 to 2012 *Public Health; 2014;128:444-74
Does WHO issue too many strong recommendations based on low quality evidence? Alexander et al. 2014* Examined approved by the GRC 2007 to 2012: n=116 37% assessed the quality of the body of evidence using GRADE Of 456 recommendations, 63.4% were strong 55.5% of these strong recommendations were based on low quality evidence Conclusion: WHO may be issuing too many strong recommendations when there is uncertainty about the balance of benefits and harms. Need to explore why this is occurring. *Journal of Clinical Epidemiology 2014 19
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 20