World Health Organization Guideline Development Research Articles

Contextual factors and G6PD diagnostic testing: a scoping review and evidence and gap map

BackgroundTesting for glucose-6-phosphate dehydrogenase (G6PD) deficiency is an important consideration regarding treatment for malaria. G6PD deficiency may lead to haemolytic anaemia during malaria treatment and, therefore, determining G6PD deficiency in malaria treatment strategies is extremely important.MethodsThis report presents the results of a scoping review and evidence and gap map for consideration by the Guideline Development Group for G6PD near patient tests to support radical cure of Plasmodium vivax. This scoping review has investigated common diagnostic tests for G6PD deficiency and important contextual and additional factors for decision-making. These factors include six of the considerations recommended by the World Health Organization (WHO) handbook for guideline development as important to determining the direction and strength of a recommendation, and included ‘acceptability’, ‘feasibility,’ ‘equity,’ ‘valuation of outcomes,’ ‘gender’ and ‘human rights’. The aim of this scoping review is to inform the direction of future systematic reviews and evidence syntheses, which can then better inform the development of WHO recommendations regarding the use of G6PD deficiency testing as part of malaria treatment strategies.ResultsA comprehensive search was performed, including published, peer-reviewed literature for any article, of any study design and methodology that investigated G6PD diagnostic tests and the factors of ‘acceptability’, ‘feasibility,’ ‘equity,’ ‘valuation of outcomes,’ ‘gender’ and ‘human rights’. There were 1152 studies identified from the search, of which 14 were determined to be eligible for inclusion into this review. The studies contained data from over 21 unique countries that had considered G6PD diagnostic testing as part of a malaria treatment strategy. The relationship between contextual and additional factors, diagnostic tests for G6PD deficiency and study methodology is presented in an overall evidence and gap, which showed that majority of the evidence was for the contextual factors for diagnostic tests, and the ‘Standard G6PD (SD Biosensor)’ test.ConclusionsThis scoping review has produced a dynamic evidence and gap map that is reactive to emerging evidence within the field of G6PD diagnostic testing. The evidence and gap map has provided a comprehensive depiction of all the available literature that address the contextual and additional factors important for decision-making, regarding specific G6PD diagnostic tests. The majority of data available investigating the contextual factors of interest relates to quantitative G6PD diagnostic tests. While a formal qualitative synthesis of this data as part of a systematic review is possible, the data may be too heterogenous for this to be appropriate. These results can now be used to inform future direction of WHO Guideline Development Groups for G6PD near patient tests to support radical cure of P. vivax malaria.

International standard of Traditional Chinese Medicine Techniques: Traditional Chinese Medicine guidelines for acute primary headache (2022).

To summarize the evidence from Traditional Chinese Medicine (TCM) practice in the treatment of acute primary headache and provide clinical practice guidance. The guidelines were developed in accordance with the World Health Organization guideline development manual. After the establishment of steering committee, panel and the registration and protocol formulation, the evidence on TCM for acute primary headache from published guidelines, clinical evidence, and expert experience and consensus were collected. The grading of recommendations assessment, development and evaluation method was used to grade the evidence and make the recommendations. Based on the available evidence, the guidelines recommended three TCM herbal decoctions, six Chinese patent medicines, and two kinds of external application of Chinese herbal medicines. Diagnostic recommendations based on the expert experience and consensus were also included in the guidelines. TCM diagnosis and treatment of decoction, Chinese patent medicine and external application for treating acute primary headache were recommended. We hope these guidelines will be helpful in standardize the TCM acute treatment of primary headache.

Protocol for the development of the Expert consensus on sedation and analgesia for neurocritical care patients (2023)

To further standardize the sedation and analgesia treatment for neurocritical care patients, the National Center for Healthcare Quality Management in Neurological Diseases and Chinese Society of Critical Care Medicine organized national experts in this fields to form Working group of the Expert consensus on sedation and analgesia for neurocritical care patients in order to update the Expert consensus on sedation and analgesia for patients with severe brain injury (2013) based on evidence-based medicine. This update aims to provide scientific guidance for the clinical diagnosis and treatment of neurocritical care patients. The working group followed the definition of clinical practice guidelines by the Institution of Medicine (IOM) and the World Health Organization guidelines development handbook and Guidelines for the formulation/revision of clinical guidelines in China (2022) to register and draft the Expert consensus on sedation and analgesia for neurocritical care patients. The working group will strictly adhere to the consensus development process to formulate and publish the Expert consensus on sedation and analgesia for neurocritical care patients (2023). This protocol primarily introduces the development methodology and process of the Expert consensus on sedation and analgesia for neurocritical care patients (2023), including the purpose of the update, the target population, the composition of the consensus development working group, the presentation and collection of clinical questions, evidence evaluation and summarization, and the generation of recommended opinions. This will make the consensus development process more standardized and transparent.

Multidisciplinary Guidelines for the Rational Use of Topical Non-Steroidal Anti-Inflammatory Drugs for Musculoskeletal Pain (2022)

(1) Background: Topical non-steroidal anti-inflammatory drugs (NSAIDs) are one of the primary drugs for treating musculoskeletal pain. However, there are currently no evidence-based recommendations about drug selection, drug administration, drug interactions, and use in special populations or other pharmacology-related content of such medications. To this end, the Chinese Pharmaceutical Association Hospital Pharmacy Professional Committee developed multidisciplinary guidelines on using topical NSAIDs to treat musculoskeletal pain. (2) Methods: The guidelines development process followed the World Health Organization guideline development handbook, the GRADE methodology, and the statement of Reporting Items for Practice Guidelines in Healthcare. The guideline panel used the Delphi method to identify six clinical questions to be addressed in the guidelines. An independent systematic review team conducted a systematic search and integration of evidence. (3) Results: Based on the balance between the benefits and harms of an intervention, the quality of the evidence, patient preferences and values, and resource utilization, the guideline panel developed 11 recommendations and nine expert consensuses on using topical NSAIDs to treat acute and chronic musculoskeletal pain. (4) Conclusions: Based on the effectiveness and overall safety of topical NSAIDs, we recommend patients with musculoskeletal pain use topical NSAIDs and suggest high-risk patients use topical NSAIDs, such as those with other diseases or receiving other concurrent treatments. The evidenced-based guidelines on topical NSAIDs for musculoskeletal pain incorporated a pharmacist perspective. The guidelines have the potential to facilitate the rational use of topical NSAIDs. The guideline panel will monitor the relevant evidence and update the recommendations accordingly.

Global health-care interventions for preterm and low birthweight infants.

Journal of Paediatrics and Child HealthVolume 58, Issue 9 p. 1702-1703 Heads UpFree Access Global health-care interventions for preterm and low birthweight infants First published: 25 August 2022 https://doi.org/10.1111/jpc.16191 edited by Craig Mellis (craig.mellis@sydney.edu.au) AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat In December 2020, a World Health Organization guideline development group expert meeting identified 24 research questions (framed as PICO: population, intervention, comparator and outcomes) for global health-care interventions for preterm and low birthweight (LBW) infants. Two researchers looked for systematic reviews in the last 3 years which addressed these research questions.1 The researchers found nine systematic reviews. Eight reviews of 121 studies and 25 465 preterm or LBW infants published in the last 36 months ‘fully’ addressed 8 of the 24 research questions (continuous positive airways pressure (CPAP) any, CPAP early, CPAP prophylactic), donor human milk, emollients, formula milk, multicomponent fortifier and probiotics. All eight of these systematic reviews received a ‘high’ AMSTAR quality rating. However, one systematic review (mother's own milk) found no trials. There was no systematic review in the last 3 years of 15 research questions (early initiation, responsive feeding, advancement, exclusive breastfeeding duration, kangaroo mother care, iron, zinc, vitamin D, vitamin A, calcium and phosphorus, multiple micronutrients, CPAP pressure source, methyl xanthines, family involvement and family support). The authors concluded that while they found high-quality systematic reviews of almost a third of their research, they found gaps in thermal care, feeding and family support interventions. Reference 1Edmond K, Strobel N. Evidence for global health care interventions for preterm or low birth weight infants: An overview of systematic reviews. Pediatrics 2022; 150(S1): e2022057092C. Reviewer: David Isaacs, david.isaacs@health.nsw.gov.au, Children's Hospital at Westmead, Sydney, New South Wales, Australia. Volume58, Issue9September 2022Pages 1702-1703 ReferencesRelatedInformation

Evidence for Global Health Care Interventions for Preterm or Low Birth Weight Infants: An Overview of Systematic Reviews.

Twenty-four research questions (framed as population, intervention, comparator, and outcomes) for global health care interventions for preterm and low birth weight (LBW) infants were identified at a World Health Organization guideline development group expert meeting in December 2020. To describe which systematic reviews had addressed these research questions in the last 3 years. Medline (Ovid); the Cochrane Database of Systematic Reviews; the Cochrane Database of Systematic Review Protocols; and the PROSPERO International prospective register of systematic reviews databases from January 1, 2019 to December 31, 2021 were used.Randomized controlled trials or observational studies. Two reviewers independently extracted data. We found 9 systematic reviews. Eight reviews of 121 studies and 25 465 preterm or LBW infants published in the last 36 months "fully" addressed 8 of our 24 research questions (donor human milk, multicomponent fortifier, formula milk, probiotics, emollients, continuous positive airways pressure [CPAP] any, CPAP early, CPAP prophylactic); and 1 systematic review found no trials (mother's own milk). All received a "high" AMSTAR quality rating. Fifteen research questions (kangaroo mother care, early initiation, responsive feeding, advancement, exclusive breastfeeding duration, iron, zinc, vitamin D, vitamin A, calcium and phosphorous, multiple micronutrients, CPAP pressure source, methyl xanthines, family involvement, and family support) had no systematic review. Limitations include that we restricted our search to those interventions identified as a priority at a World Health Organization scoping meeting. Other interventions that may be of importance to preterm or LBW infants were not able to be considered. Almost a third of our research questions were addressed by high quality systematic reviews. We found gaps in thermal care, feeding, and familysupport interventions, which need to be addressed.

Prevention and management of physical health conditions in adults with severe mental disorders: WHO recommendations

BackgroundPeople with severe mental disorders (SMD) experience premature mortality mostly from preventable physical causes. The World Health Organization (WHO) have recently produced guidelines on the prevention and management of physical health conditions in SMD. This paper presents the evidence which led to the recommendations presented in the guidelines.MethodsThe work followed the methodological principles for WHO guideline development. Systematic reviews in relation to the treatment of seven key priority physical health conditions and associated risk factors in persons with SMD were systematically sourced. The quality of this evidence was assessed, and compiled into evidence profiles. Existing guidelines and treatment recommendations were also considered. Based on this information, specific recommendations were developed on the prevention and management of physical health conditions and their risk factors amongst people with SMD.ResultsNineteen recommendations were made in relation to the seven key priority physical health conditions and risk factors, alongside best practice statements for each condition. A mixture of conditional and strong recommendations were made, the quality of evidence underpinning these was generally low or very low. This is owing to the dearth of direct evidence relating to people living with SMD and comorbidities.ConclusionsThis paper presents evidence-based recommendations to prevent and manage physical health conditions in people with SMD. The recommendations are designed to inform policy makers, healthcare providers as well as other stakeholders about what they can do to improve the management of physical health conditions in adults with SMD and support the promotion of individual health behaviors to reduce the risk factors for these conditions. If implemented, these recommendations can improve the care that people with SMD receive for their physical health conditions in an equitable and person-centered manner, so that in future in relation to premature mortality ‘no-one is left behind’.

Practice guideline for patients with osteoporosis

In recent years, osteoporosis (OP) has become one of the main diseases affecting the health of middle-aged and elderly people in China, and the prevalence of OP has increased significantly. The clinical diagnosis and treatment guidelines for this disease are also constantly updated. The overall principles speciallyemphasise that doctors and patients need to work together to negotiate the details of the diagnosis and treatment guidelines, in order to improve the OP clinical diagnosis and treatment rate. Therefore, patients' knowledge of the disease, understanding of clinical guidelines, and cooperation with doctors to implement diagnosis and treatment plans are very important. In this study, from the most concerned issues of the patients, we established the OP patient practice guideline working group. 14 recommendations, as the OP patient practice guidelines, are proposed in accordance with the relevant principles of the "World Health Organization guidelines development manual" and the international normative process.

Advancing the WHO-INTEGRATE Framework as a Tool for Evidence-Informed, Deliberative Decision-Making Processes: Exploring the Views of Developers and Users of WHO Guidelines.

Background: Decision-making on matters of public health and health policy is a deeply value-laden process. The World Health Organization (WHO)-INTEGRATE framework was proposed as a new evidence-to-decision (EtD) framework to support guideline development from a complexity perspective, notably in relation to public health and health system interventions, and with a foundation in WHO norms and values. This study was conducted as part of the development of the framework to assess its comprehensiveness and usefulness for public health and health policy decision-making. Methods: We conducted a qualitative study comprising nine key informant interviews (KIIs) with experts involved in WHO guideline development and four focus group discussions (FGDs) with a total of forty health decision-makers from Brazil, Germany, Nepal and Uganda. Transcripts were analyzed using MAXQDA12 and qualitative content analysis. Results: Most key informants and participants in the FGDs appreciated the framework for its relevance to real-world decision-making on four widely differing health topics. They praised its broad perspective and comprehensiveness with respect to new or expanded criteria, notably regarding societal implications, equity considerations, and acceptability. Some guideline developers questioned the value of the framework beyond current practice and were concerned with the complexity of applying such a broad range of criteria in guideline development processes. Participants made concrete suggestions for improving the wording and definitions of criteria as well as their grouping, for covering missing aspects, and for addressing overlap between criteria.Conclusion: The framework was well-received by health decision-makers as well as the developers of WHO guidelines and appears to capture all relevant considerations discussed in four distinct real-world decision processes that took place on four different continents. Guidance is needed on how to apply the framework in guideline processes that are both transparent and participatory. A set of suggestions for improvement provides a valuable starting point for advancing the framework towards version 2.0.

Identifying research questions for HIV, tuberculosis, tuberculosis-HIV, malaria, and neglected tropical diseases through the World Health Organization guideline development process: a retrospective analysis, 2008–2018

ObjectivesWorld Health Organization (WHO) guidelines for health programmes and healthcare delivery are the foundation of its technical leadership in public health and essential to decision-making globally. A key function of guideline development is to identify areas in which further evidence is needed because filling these gaps will lead to future improvements in population health. The objective of this study was to examine the knowledge gaps and research questions for addressing those gaps generated through the WHO guideline development process, with the goal of informing future strategies for improving and strengthening the guideline development process. Study designWe did a systematic, retrospective analysis of research questions identified in the published guidelines. MethodsWe analyzed guidelines published between January 1, 2008, and December 31, 2018, by the Communicable Diseases Cluster in five disease areas: tuberculosis (TB), HIV, malaria, TB-HIV, and neglected tropical diseases (NTDs). Research questions were extracted independently by two researchers. We analyzed the distribution of research questions by disease and by topic category and did a qualitative assessment of optimum practice for research question generation during the guideline development process. ResultsA total of 48 guidelines were included: 26 on HIV, 1 on malaria, 11 on TB, 5 on TB/HIV, and 5 on NTDs. Overall, 36 (75%) guidelines encompassed a total of 360 explicit research questions; the remainder did not contain specific research questions. The number of research questions that focused on TB was 49, TB/HIV was 38, HIV was 250, and NTDs was 23. The number of research questions that focused on diagnosis was 43 (11.9%) of 360, prevention was 62 (17.2%), treatment was 103 (28.6%), good practice was 12 (3.3%), service delivery was 86 (23.8%), and other areas was 54 (15%). Research questions were often not formulated in a specific or actionable way and were hard to identify in the guideline. Examples of good practice identified by the review team involved the generation of specific and narrowly defined research questions, with accompanying recommendations for appropriate study design. ConclusionsThe WHO must strengthen its approach to identifying and presenting research questions during the guideline development process. Ensuring access to research questions is a key next step in adding value to the guideline development process.

Construction of key question list in the evidence-based guidelines for colorectal cancer screening in China

Objective: To establish the key question list for the development of evidence- based guideline in China according to the content and limitation of current evidence-based guidelines around the world. Methods: First, we introduced the evidence-based guidelines in detail which met the criteria based on World Health Organization guideline development handbook and then formulated the draft list of key questions for the development of evidence-based guidelines. At last, the Delphi method was used to determine the list of key questions in developing evidence-based guidelines of colorectal cancer screening. Results: Totally, 34 questionnaires were collected, with experts from clinical and epidemiological fields. The average experts' authority coefficient was 0.81, indicating a high degree of authority. The concentration of opinions on all items in the questionnaire was relatively high, with the full score ratio greater than 75% and the coefficient of variation less than 0.3. The list of key questions on evidence-based guidelines for colorectal cancer screening has been divided into six parts: epidemiological problems, risk classification, screening age, screening tools, implementation and selection of steering group members, which covers the issues that need to be considered in the development of evidence-based colorectal cancer screening guidelines in China. Conclusion: The key question list for evidence-based guideline development in our study can be applied to the development of evidence-based guidelines for colorectal cancer screening in the future, as well as the development of evidence-based guidelines for other cancer screening in China.

A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version)

In December 2019, a new type viral pneumonia cases occurred in Wuhan, Hubei Province; and then named “2019 novel coronavirus (2019-nCoV)” by the World Health Organization (WHO) on 12 January 2020. For it is a never been experienced respiratory disease before and with infection ability widely and quickly, it attracted the world’s attention but without treatment and control manual. For the request from frontline clinicians and public health professionals of 2019-nCoV infected pneumonia management, an evidence-based guideline urgently needs to be developed. Therefore, we drafted this guideline according to the rapid advice guidelines methodology and general rules of WHO guideline development; we also added the first-hand management data of Zhongnan Hospital of Wuhan University. This guideline includes the guideline methodology, epidemiological characteristics, disease screening and population prevention, diagnosis, treatment and control (including traditional Chinese Medicine), nosocomial infection prevention and control, and disease nursing of the 2019-nCoV. Moreover, we also provide a whole process of a successful treatment case of the severe 2019-nCoV infected pneumonia and experience and lessons of hospital rescue for 2019-nCoV infections. This rapid advice guideline is suitable for the first frontline doctors and nurses, managers of hospitals and healthcare sections, community residents, public health persons, relevant researchers, and all person who are interested in the 2019-nCoV.

Quality assessment of global guidelines on colorectal cancer screening

To systematically review and assess the quality of guidelines on colorectal cancer screening worldwide to provide guidance for the development of high-quality colorectal cancer screening guidelines in mainland China. CNKI, WanFang Data, VIP, SinoMed, PubMed, Embase, and Web of Science were systematically searched to identify guidelines on colorectal cancer screening from inception to Jun. 20th, 2018, and so were some websites and major search engines about the development of the guidelines from the existing literature (search date: Aug. 3rd, 2018). Two experienced reviewers independently examined these abstracts and then extracted information, and the Appraisal of Guidelines for Research and Evaluation II (AGREE II) were used to evaluate the methodological quality of these guidelines by four well trained reviewers. In this study, 46 guidelines published from 1994 to 2018 were finally included in our analysis from 10 countries and 5 regions, among which 5 were from mainland China. The quality of these guidelines was relatively high in domain 1 (scope and purpose) and domain 4 (clarity of presentation), and medium in domain 2 (stakeholder involvement). While in the other three domains (domain 3: rigour of development; domain 5: applicability; domain 6: editorial independence), the results were quite different among these guidelines. The quality of evidence-based guidelines (defined by the criteria based on World Health Organization guideline development handbook) was generally higher than that of the common guidelines. Existing guidelines from mainland China were not evidence-based guidelines, which were of low quality. The colorectal cancer screening guidelines all over the world are generally large in number, low in quality, different in statements, and so are the guidelines in China. There are no evidence-based guidelines in mainland China, which cannot provide effective guidance for colorectal cancer screening, so we need to pay more attention to the establishment of guidelines with high quality and high credibility for colorectal cancer screening as well as for cancer screening based on the national condition, in order to provide reasonable guidance for practice in public health and improve the health conditions in our society.

Developing WHO rapid advice guidelines in the setting of a public health emergency

ObjectivesWe describe newly established guidance for guideline developers at the World Health Organization (WHO) on the process and procedures for developing a rapid advice guideline in the context of a public health emergency (e.g., the 2014 Ebola epidemic). Study Design and SettingWe based our approach on established rapid review methods, which were incorporated into existing WHO guideline development processes. Guidance was further informed by in-depth discussions of issues related to rapid guideline development with WHO staff (n = 6), who oversee the Organization's response to emergencies. ResultsWe discuss criteria for considering if a rapid advice guideline is appropriate and feasible and outline the roles of various contributors across the phases of development. Further, we describe the methods and steps involved in performing rapid reviews, which are more fluid and iterative than for a standard guideline process. In general, rapid advice guidelines involve a shorter timeline, narrower scope, and the use of abbreviated methods for the evidence review. ConclusionImportant differences exist between developing a standard guideline and a rapid advice guideline. However, the core principles for WHO guidelines apply to rapid advice guidelines including minimizing bias, applying transparent processes and the use of explicit methods.

Use of network meta-analysis in clinical guidelines.

The World Health Organization (WHO) has conducted two major updates to global guidance for the management of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections in 2016. (1,2) Recommendations made by WHO can have an important effect on policy and practice, particularly for low- and middle-income countries. For instance, a 2014 survey found that over three-quarters of all 158 recommendations for HIV and tuberculosis were incorporated into national guidelines. (3) Clinical guidelines are developed through multi-step processes that ensure that guidelines are feasible within the current clinical environment and that they are based on the best available evidence. For the latest HIV and HCV guidelines, WHO used network meta-analysis to inform treatment recommendations. An expansion of conventional pairwise meta-analysis, network meta-analysis includes multiple interventions within a single analysis and estimates the relative treatment effect between each two treatments compared using direct or indirect evidence. Although it is often acknowledged that having the most up-to-date evidence is critical to the development of clinical guidelines, it is equally important that the optimal analytical methods are used to appraise the evidence. We explain here why network meta-analysis lends itself to the development of clinical guidelines and why it may be used more often in this context. WHO has a history of improving the methods it uses for developing its guidelines. Following calls for greater transparency in the use of evidence for decision-making, (4) WHO adopted a process for guideline development in 2007 that included the use of the GRADE approach (grading of recommendations, assessment, development and evaluation) to support decision-making. In addition to clinical evidence, WHO guideline groups take account of factors such as patient preferences, feasibility, costs and human rights. (5) To support decision-making beyond clinical effectiveness, mathematical models have been used to appraise the cost-effectiveness and epidemiological impact of HIV testing and treatment strategies in 2013. (6) WHO guidelines are regularly revised, generally every 3-5 years, to provide up-to-date guidance on interventions to contain or reduce major public health threats. With an ever-growing number of treatment options for HIV and HCV, methods used to synthesize the evidence within the guideline development procedures should maximize the use of all evidence and generate results that can be translated into recommendations. Although the use of network meta-analysis for WHO guideline development is recent, the method is well established within national health technology assessment agencies. It has become essential to formulating recommendations on reimbursements by health care agencies around the world. The method has also recently been adopted by Cochrane, and we found that since 2015, 10% (23/230) of systematic reviews published by this organization used network meta-analysis. The method has numerous qualities that lend themselves to decision-making processes such as clinical guidelines development. In 2015, GRADE working groups published guidance on how to use GRADE in conjunction with network meta-analysis. (7) Furthermore, the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom of Great Britain and Northern Ireland has included recommendations on network meta-analysis within its clinical guidelines manual. (8) However, in 2012 only 8% of 138 NICE clinical guidelines had used network meta-analysis, (9) but the percentage is likely to be higher today. Systematic evidence appraisal, but not the network meta-analysis approach, was used to formulate recommendations in other recent, major guidelines for HIV and HCV disease. (10-12) Network meta-analysis offers several advantages to the process of developing guidelines. One advantage is the ability to make a quantitative comparison of interventions that have not been directly compared in studies. …

Senior GRADE methodologists encounter challenges as part of WHO guideline development panels: an inductive content analysis

BackgroundThe World Health Organization (WHO) classifies a substantial proportion of their recommendations as strong despite low or very low confidence (certainty) in estimates of effect. Such discordant recommendations are often inconsistent with Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance. ObjectiveTo gain the perspective of senior WHO methodology chairs regarding panels' use of GRADE, particularly regarding discordant recommendations. Data sourcesSenior active GRADE methodologists who had served on at least two WHO panels and were an author on at least one peer-reviewed published article on GRADE methodology. MethodsFive eligible methodologists participated in detailed semistructured interviews. Respondents answered questions regarding how they were viewed by other panelists and WHO leadership, and how they handled situations when panelists made discordant recommendations they felt were inappropriate. They also provided information on how the process can be improved. Interviews were recorded and transcribed, and inductive content analysis was used to derive codes, categories, and emergent themes. ResultsThree themes emerged from the interviews of five methodologists: (1) The perceived role of methodologists in the process, (2) Contributors to discordant recommendations, and (3) Strategies for improvement. Salient findings included (1) a perceived tension between methodologists and WHO panels as a result of panel members' resistance to adhering to GRADE guidance; (2) both financial and nonfinancial conflicts of interest among panel members as an explanation for discordant recommendations; and (3) the need for greater clarity of, and support for, the role of methodologists as co-chairs of panels. ConclusionsThese findings suggest that the role of the GRADE methodologist as a co-chair needs to be clarified by the WHO leadership. They further suggest the need for additional training for panelists, quality monitoring, and feedback to ensure optimal use of GRADE in guideline development at WHO.

End Users’ Views and Preferences on Prescribing and Taking Postexposure Prophylaxis for Prevention of HIV: Methods to Support World Health Organization Guideline Development

The 2014 World Health Organization guidelines for human immunodeficiency virus postexposure prophylaxis (PEP) are the first to combine recommendations for all populations and exposures. To inform the development of these guidelines, we gathered views of end users on key aspects of PEP provision. A mixed-methods approach was used to gather views from the populations for whom the guideline will be of relevance. Data gathered from an online survey, focus group discussions, and previously collected data from in-depth interviews with key populations were used to inform the development of recommendations, in particular where there is a paucity of evidence to assess the benefits and harms of an intervention. This was a successful method to gather end users' views and preferences; however, limitations exist in the generalizability and reliability of the evidence. Future guideline development processes should consider methods to include the views of end users to guide the decision-making process.

World Health Organization strong recommendations based on low-quality evidence (study quality) are frequent and often inconsistent with GRADE guidance

ObjectivesIn 2007 the World Health Organization (WHO) adopted the GRADE system for development of public health guidelines. Previously we found that many strong recommendations issued by WHO are based on evidence for which there is only low or very low confidence in the estimates of effect (discordant recommendations). GRADE guidance indicates that such discordant recommendations are rarely appropriate but suggests five paradigmatic situations in which discordant recommendations may be warranted. We sought to provide insight into the many discordant recommendations in WHO guidelines. Study Design and SettingWe examined all guidelines that used the GRADE method and were approved by the WHO Guideline Review Committee between 2007 and 2012. Teams of reviewers independently abstracted data from eligible guidelines and classified recommendations either into one of the five paradigms for appropriately-formulated discordant recommendations or into three additional categories in which discordant recommendations were inconsistent with GRADE guidance: 1) the evidence warranted moderate or high confidence (a misclassification of evidence) rather than low or very low confidence; 2) good practice statements; or 3) uncertainty in the estimates of effect would best lead to a conditional (weak) recommendation. ResultsThe 33 eligible guidelines included 160 discordant recommendations, of which 98 (61.3%) addressed drug interventions and 132 (82.5%) provided some rationale (though not entirely explicit at times) for the strong recommendation. Of 160 discordant recommendations, 25 (15.6%) were judged consistent with one of the five paradigms for appropriate recommendations; 33 (21%) were based on evidence warranting moderate or high confidence in the estimates of effect; 29 (18%) were good practice statements; and 73 (46%) warranted a conditional, rather than a strong recommendation. ConclusionWHO discordant recommendations are often inconsistent with GRADE guidance, possibly threatening the integrity of the process. Further training in GRADE methods for WHO guideline development group members may be necessary, along with further research on what motivates the formulation of such recommendations.

Correction: World Health Organization Guideline Development: An Evaluation

The affiliation of the third and fourth authors is incorrect. The correct affiliation is: 2 South African Cochrane Centre, South African Medical Research Council, Cape Town, South Africa.

P132 Quality of Guidelines Developed by the World Health Organization: Preliminary Results

BackgroundThe World Health Organization (WHO) annually publishes hundreds of guidelines. Its guideline development process, however, is often criticised even after the implementation of a Guideline Review Committee (GRC) that ensure...