Reporting Conflicts of Interest and Funding in Health Care Guidelines: The RIGHT-COI&F Checklist.

BACKGROUND: Conflicts of interest (COIs) of contributors to a guideline project and the funding of that project can influence the development of the guideline. Comprehensive reporting of information on COIs and funding is essential for the transparency and credibility of guidelines. OBJECTIVE: To develop an extension of the Reporting Items for practice Guidelines in HealThcare (RIGHT) statement for the reporting of COIs and funding in policy documents of guideline organizations and in guidelines: the RIGHT-COI&F checklist. DESIGN: The recommendations of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network were followed. The process consisted of registration of the project and setting up working groups, generation of the initial list of items, achieving consensus on the items, and formulating and testing the final checklist. SETTING: International collaboration. PARTICIPANTS: 44 experts. MEASUREMENTS: Consensus on checklist items. RESULTS: The checklist contains 27 items: 18 about the COIs of contributors and 9 about the funding of the guideline project. Of the 27 items, 16 are labeled as policy related because they address the reporting of COI and funding policies that apply across an organization's guideline projects. These items should be described ideally in the organization's policy documents, otherwise in the specific guideline. The remaining 11 items are labeled as implementation related and they address the reporting of COIs and funding of the specific guideline. LIMITATION: The RIGHT-COI&F checklist requires testing in real-life use. CONCLUSION: The RIGHT-COI&F checklist can be used to guide the reporting of COIs and funding in guideline development and to assess the completeness of reporting in published guidelines and policy documents. PRIMARY FUNDING SOURCE: The Fundamental Research Funds for the Central Universities of China.

Conducting evaluations of evidence that are transparent, timely and can lead to health-protective actions.

BACKGROUND: In February 2021, over one hundred scientists and policy experts participated in a web-based Workshop to discuss the ways that divergent evaluations of evidence and scientific uncertainties are used to delay timely protection of human health and the environment from exposures to hazardous agents. The Workshop arose from a previous workshop organized by the European Environment Agency (EEA) in 2008 and which also drew on case studies from the EEA reports on 'Late Lessons from Early Warnings' (2001, 2013). These reports documented dozens of hazardous agents including many chemicals, for which risk reduction measures were delayed for decades after scientists and others had issued early and later warnings about the harm likely to be caused by those agents. RESULTS: Workshop participants used recent case studies including Perfluorooctanoic acid (PFOA), Extremely Low Frequency - Electrical Magnetic Fields (ELF-EMF fields), glyphosate, and Bisphenol A (BPA) to explore myriad reasons for divergent outcomes of evaluations, which has led to delayed and inadequate protection of the public's health. Strategies to overcome these barriers must, therefore, at a minimum include approaches that 1) Make better use of existing data and information, 2) Ensure timeliness, 3) Increase transparency, consistency and minimize bias in evidence evaluations, and 4) Minimize the influence of financial conflicts of interest. CONCLUSION: The recommendations should enhance the production of "actionable evidence," that is, reliable evaluations of the scientific evidence to support timely actions to protect health and environments from exposures to hazardous agents. The recommendations are applicable to policy and regulatory settings at the local, state, federal and international levels.

Evidence-to-decision frameworks: a review and analysis to inform decision-making for environmental health interventions.

BACKGROUND: Evidence-to-decision (EtD) frameworks provide a structured and transparent approach for groups of experts to use when formulating recommendations or making decisions. While extensively used for clinical and public health recommendations, EtD frameworks are not in widespread use in environmental health. This review sought to identify, compare and contrast key EtD frameworks for decisions on interventions used in clinical medicine, public health or environmental health. This information can be used to develop an EtD framework suitable for formulating recommendations for interventions in environmental health. METHODS: We identified a convenience sample of EtD frameworks used by a range of organizations. We searched Medline for systematic reviews of frameworks. We summarized the decision criteria in the selected frameworks and reviews in a qualitative manner. FINDINGS: Fourteen organizations provided 18 EtD frameworks; most frameworks focused on clinical medicine or public health interventions; four focused on environmental health and three on economic considerations. Harms of interventions were examined in all frameworks and benefits in all but one. Other criteria included certainty of the body of evidence (15 frameworks), resource considerations (15), feasibility (13), equity (12), values (11), acceptability (11), and human rights (2). There was variation in how specific criteria were defined. The five identified systematic reviews reported a similar spectrum of EtD criteria. INTERPRETATION: The EtD frameworks examined encompassed similar criteria, with tailoring to specific audience needs. Existing frameworks are a useful starting point for development of one tailored to decision-making in environmental health. FUNDER: JPB Foundation.

Using RIGHT (Reporting Items for Practice Guidelines in Healthcare) to evaluate the reporting quality of WHO guidelines.

BACKGROUND: Without adequate reporting of research, valuable time and resources are wasted. In the same vein, adequate reporting of practice guidelines to optimise patient care is equally important. Our study examines the quality of reporting of published WHO guidelines, over time, using the RIGHT (Reporting Items for Practice Guidelines in HealThcare) reporting checklist. METHODS: We examined English-language guidelines approved by the WHO Guidelines Review Committee from inception of the committee in 2007 until 31 December 2017. Pairs of independent, trained reviewers assessed the reporting quality of these guidelines. Descriptive data were summarised with frequencies and percentages. RESULTS: We included 182 eligible guidelines. Overall, 25 out of the 34 RIGHT items were reported in 75% or more of the WHO guidelines. The reporting rates improved over time. Further, 90% of the guidelines reported document type in the title. The identification of evidence, the rationale for recommendations and the review process were reported in more than 80% of guidelines. The certainty of the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system was assessed in 81% of the guidelines assessed. While 82% of guidelines reported funding sources, only 25% mentioned the role of funders. CONCLUSIONS: WHO guidelines provide adequate reporting of many of the RIGHT items and reporting has improved over time. WHO guidelines compare favourably to guidelines produced by other organisations. However, reporting can be further improved in a number of areas.

Evidence-based guidelines for supportive care of patients with Ebola virus disease.

The 2013-16 Ebola virus disease outbreak in west Africa was associated with unprecedented challenges in the provision of care to patients with Ebola virus disease, including absence of pre-existing isolation and treatment facilities, patients' reluctance to present for medical care, and limitations in the provision of supportive medical care. Case fatality rates in west Africa were initially greater than 70%, but decreased with improvements in supportive care. To inform optimal care in a future outbreak of Ebola virus disease, we employed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to develop evidence-based guidelines for the delivery of supportive care to patients admitted to Ebola treatment units. Key recommendations include administration of oral and, as necessary, intravenous hydration; systematic monitoring of vital signs and volume status; availability of key biochemical testing; adequate staffing ratios; and availability of analgesics, including opioids, for pain relief.

Medicines for Treatment Intensification in Type 2 Diabetes and Type of Insulin in Type 1 and Type 2 Diabetes in Low-Resource Settings: Synopsis of the World Health Organization Guidelines on Second- and Third-Line Medicines and Type of Insulin for the Control of Blood Glucose Levels in Nonpregnant Adults With Diabetes Mellitus.

Description: The World Health Organization developed these guidelines to provide guidance on selection of medicines for treatment intensification in type 2 diabetes and on use of insulin (human or analogue) in type 1 and 2 diabetes. The target audience includes clinicians, policymakers, national diabetes program managers, and medicine procurement officers. The target population is adults with type 1 or 2 diabetes in low-resource settings in low- or high-income countries. The guidelines also apply to disadvantaged populations in high-income countries. Methods: The recommendations were formulated by a 12-member guideline development group and are based on high-quality systematic reviews identified via a search of several bibliographic databases from 1 January 2007 to 1 March 2017. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to assess the quality of the evidence and the strength of the recommendations. The guideline was peer-reviewed by 6 external reviewers. Recommendation 1: Give a sulfonylurea to patients with type 2 diabetes who do not achieve glycemic control with metformin alone or who have contraindications to metformin (strong recommendation, moderate-quality evidence). Recommendation 2: Introduce human insulin treatment to patients with type 2 diabetes who do not achieve glycemic control with metformin and/or a sulfonylurea (strong recommendation, very-low-quality evidence). Recommendation 3: If insulin is unsuitable, a dipeptidyl peptidase-4 (DPP-4) inhibitor, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, or a thiazolidinedione (TZD) may be added (weak recommendation, very-low-quality evidence). Recommendation 4: Use human insulin to manage blood glucose in adults with type 1 diabetes and in adults with type 2 diabetes for whom insulin is indicated (strong recommendation, low-quality evidence). Recommendation 5: Consider long-acting insulin analogues to manage blood glucose in adults with type 1 or type 2 diabetes who have frequent severe hypoglycemia with human insulin (weak recommendation, moderate-quality evidence for severe hypoglycemia).

A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement.

The quality of reporting practice guidelines is often poor, and there is no widely accepted guidance or standards for such reporting in health care. The international RIGHT (Reporting Items for practice Guidelines in HealThcare) Working Group was established to address this gap. The group followed an existing framework for developing guidelines for health research reporting and the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach. It developed a checklist and an explanation and elaboration statement. The RIGHT checklist includes 22 items that are considered essential for good reporting of practice guidelines: basic information (items 1 to 4), background (items 5 to 9), evidence (items 10 to 12), recommendations (items 13 to 15), review and quality assurance (items 16 and 17), funding and declaration and management of interests (items 18 and 19), and other information (items 20 to 22). The RIGHT checklist can assist developers in reporting guidelines, support journal editors and peer reviewers when considering guideline reports, and help health care practitioners understand and implement a guideline.

Common issues raised during the quality assurance process of WHO guidelines: a cross-sectional study.

BACKGROUND: In 2007, WHO established the Guidelines Review Committee (GRC) to ensure that WHO guidelines adhere to the highest international standards. The GRC reviews guideline proposals and final guidelines. The objectives of this study were to examine the rates of and reasons for conditional approval and non-approval of documents submitted for the first time to the GRC, and calculate the time intervals and numbers of submissions to achieve approval for documents conditionally approved or not approved at first submission. METHODS: All initial submissions to the GRC between 2014 and 2017 were examined. Data were extracted from the GRC's records of written comments and discussions. RESULTS: Of a total of 85 proposals and 88 final guidelines, 32 (37.6%) proposals and 37 (42.0%) final guidelines were conditionally approved, and 15 (17.6%) proposals and 28 (31.8%) final guidelines were not. For both conditionally approved and not approved proposals, the most frequent reasons were suboptimal composition or inadequate description of the guideline contributor groups (in all proposals), followed by inadequate formulation of key questions (in 90.6% of conditionally approved proposals and all not approved proposals). For both conditionally approved and not approved final guidelines, the most frequent reasons were problems with recommendations (in all final guidelines), followed by inappropriate methods for evidence retrieval or an inadequate description thereof (in all conditionally approved final guidelines and 75.0% of not approved final guidelines). The median time to achieve approval was 2 months for proposals and 1-2 months for final guidelines. The median number of submissions was 2 for proposals and 2-2.5 for final guidelines. CONCLUSION: The GRC implements a rigorous quality assurance process and identifies problems with a significant percentage of initial submissions. WHO needs to continuously evaluate its guideline development processes to inform effective quality improvement measures and optimise the quality of its guidelines.

Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise.

BACKGROUND: Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a comprehensive checklist of items linked to relevant resources and tools that guideline developers could consider, without the expectation that every guideline would address each item. METHODS: We searched data sources, including manuals of international guideline developers, literature on guidelines for guidelines (with a focus on methodology reports from international and national agencies, and professional societies) and recent articles providing systematic guidance. We reviewed these sources in duplicate, extracted items for the checklist using a sensitive approach and developed overarching topics relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions and suggestions for items to be added. RESULTS: We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers. The topics and included items cover all stages of the guideline enterprise, from the planning and formulation of guidelines, to their implementation and evaluation. The final checklist includes links to training materials as well as resources with suggested methodology for applying the items. INTERPRETATION: The checklist will serve as a resource for guideline developers. Consideration of items on the checklist will support the development, implementation and evaluation of guidelines. We will use crowdsourcing to revise the checklist and keep it up to date.

GRADE good practice statements: a time to say "good-bye"? A new typology for normative statements on interventions.

BACKGROUND: Clinical and public health guidelines include a variety of types of normative statements concerning interventions. "Recommendations" are usually the central focus, and are based on one or more systematic reviews of research evidence. Guidelines may include other types of normative statements, however, including Grading of Recommendations, Assessment, Develoment, and Evaluation (GRADE) good (or best) practice statements (GPS), which represent recommendations that guideline panels feel are important but are not appropriate for formal ratings of quality of evidence because it is sufficiently obvious that desirable effects outweigh undesirable effects. These normative statements are typically supported by a great deal of high-certainty, indirect evidence, which the authors feel would be a waste of time to examine. There are a number of conceptual and methodological issues with GRADE GPS, however, and these are manifested in guidelines, including both inappropriate overuse and underuse, and unclear interpretation and impact among end-users. This situation has arisen in part from lack of clarity in, and misunderstandings of, GRADE guidance, the lumping of many different types of normative statements under one label ("GPS"), from limitations in GRADE's approach to linked bodies of evidence, and because the appropriate basis for many normative statements about interventions is not reviews of research evidence. A new typology is needed for normative statements on interventions and policies that are not optimally based on reviews of research evidence. PROPOSED TYPOLOGY: This proposed typology differentiates normative statements about interventions by the type or nature of the most appropriate basis for the statement. The typology encompasses the range of statements encompassed by GPS, but provides a more nuanced categorization designed to assist both guideline developers and end-users. This typology encompasses two main types of normative statements about interventions (including policies): (1) statements that indicate when to use (or not) an intervention, which intervention to use, and if, when and how to use it and (2) the principles, practices, or norms that inform or underpin such interventions. These correspond to normative statements based on empirical evidence, and those based on human rights, ethics, or norms, respectively. Normative statements based on empirical evidence include: (1) recommendations based on systematic reviews of human or animal evidence on effectiveness and harms, including linked bodies of evidence; (2) normative statements based on scientific fundamentals (eg, physical/biological/chemical properties, theories, laws, or principles); and (3) implementation guidance based most commonly on experiential evidence such as case studies. Normative statements based on human rights, ethics, or norms include: (1) guiding principles, based on human rights standards and conventions and/or ethics principles; and (2) practice norms and standards, based on clinical and public health norms and/or professional standards. CONCLUSION: There are conceptual and methodological problems with GRADE GPS, leading to their misapplication, with overuse and underuse. This paper presents a proposal for a new typology for normative statements on interventions, according to the basis for the statement. This typology encompasses and replaces GPS, providing a more nuanced set of statements. Testing of this proposed approach is needed among both guideline developers and end-users.

Exploring the diverse definitions of 'evidence': a scoping review.

OBJECTIVES: To systematically collect and analyse diverse definitions of 'evidence' in both health and social sciences, and help users to correctly use the term 'evidence' and rethink what is the definition of 'evidence' in scientific research. DESIGN: Scoping review. METHODS: Definitions of evidence in the health sciences and social sciences were included. We have excluded the definition of evidence applied in the legal field, abstracts without full text, documents not published in either Chinese or English and so on. We established a multidisciplinary working group and systematically searched five electronic databases including Medline, Web of Science, EBSCO, the Chinese Social Sciences Citation Index and the Chinese Science Citation Database from their inception to 26 February 2022. We also searched websites and reviewed the reference lists of the identified studies. Six reviewers working in pairs, independently, selected studies according to the inclusion and exclusion criteria, and extracted information. Any differences were discussed in pairs, and if there was disagreement, it was resolved via discussion or with the help of a third reviewer. Reviewers extracted document characteristics, the original content for the definitions of 'evidence', assessed definitions as either intensional or extensional, and any citations for the given definition. RESULTS: Forty-nine documents were finally included after screening, and 68 definitions were obtained. After excluding duplicates, a total of 54 different definitions of 'evidence' were identified. There were 42 intensional definitions and 12 extensional definitions. The top three definiens were 'information', 'fact' and 'research/study'. The definition of 'evidence' differed between health and social sciences. The term 'research' appeared most frequently in the definitions. CONCLUSIONS: The definition of 'evidence' has gradually attracted the attention of many scholars and decision-makers in health and social sciences. Nevertheless, there is no widely recognised and accepted definition in scientific research. Given the wide use of the term, we need to think about whether, or under what circumstances, a standardised, clear, meaningful and widely applicable definition of 'evidence' might be helpful.

CARE-radiology statement explanation and elaboration: reporting guideline for radiological case reports.

Despite the increasing number of radiological case reports, the majority lack a standardised methodology of writing and reporting. We therefore develop a reporting guideline for radiological case reports based on the CAse REport (CARE) statement. We established a multidisciplinary group of experts, comprising 40 radiologists, methodologists, journal editors and researchers, to develop a reporting guideline for radiological case reports according to the methodology recommended by the Enhancing the QUAlity and Transparency Of health Research network. The Delphi panel was requested to evaluate the significance of a list of elements for potential inclusion in a guideline for reporting mediation analyses. By reviewing the reporting guidelines and through discussion, we initially drafted 46 potential items. Following a Delphi survey and discussion, the final CARE-radiology checklist is comprised of 38 items in 16 domains. CARE-radiology is a comprehensive reporting guideline for radiological case reports developed using a rigorous methodology. We hope that compliance with CARE-radiology will help in the future to improve the completeness and quality of case reports in radiology.

Development of the Scientific, Transparent and Applicable Rankings (STAR) tool for clinical practice guidelines.

BACKGROUND: This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability. METHODS: This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability. RESULTS: STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min. CONCLUSION: The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.

Characteristics of physicians receiving large payments from pharmaceutical companies and the accuracy of their disclosures in publications: an observational study.

BACKGROUND: Financial relationships between physicians and industry are extensive and public reporting of industry payments to physicians is now occurring. Our objectives were to describe physician recipients of large total payments from these seven companies, and to examine discrepancies between these payments and conflict of interest (COI) disclosures in authors' concurrent publications. METHODS: The investigative journalism organization, ProPublica, compiled the Dollars for Docs database of payments to individuals from publically available data from seven US pharmaceutical companies during the period 2009 to 2010. We examined the cohort of 373 physicians in this database who each received USD $100,000 or more in the reporting period 2009 to 2010. RESULTS: These physicians received a total of $52,600,624 during this period (mean payment per physician $141,020). The predominant specialties were internal medicine and psychiatry. 147 of these physicians authored a total of 134 publications in the first quarter of 2011 and 77% (103) of these publications provided a COI disclosure. 69% of the 103 publications did not contain disclosures of the payment listed in the Dollars for Docs database. CONCLUSIONS: With increased public reporting of industry payments to physicians, it is apparent that large sums are being paid for services such as consulting and peer education. In over two-thirds of publications where COI disclosures were provided, the disclosures by physician authors did not include industry payments that were documented in the Dollars for Docs database.