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.

Methodology for the adolopment of recommendations for the treatment of rheumatoid arthritis in the Kingdom of Saudi Arabia.

BACKGROUND: Currently, there are no guidelines for the treatment of rheumatoid arthritis (RA) tailored to the context of the Kingdom of Saudi Arabia (KSA). Adaptation of guidelines accounts for contextual factors and becomes more efficient than de novo guideline development when relevant, good quality, and up-to-date guidelines are available. The objective of this study is to describe the methodology used for the adolopment of the 2021 American College of Rheumatology (ACR) guidelines for the treatment of RA in the KSA. METHODS: We followed the 'Grading of Recommendations Assessment, Development and Evaluation' (GRADE)-ADOLOPMENT methodology. The adolopment KSA panel included relevant stakeholders and leading contributors to the original guidelines. We developed a list of five adaptation-relevant prioritization criteria that the panelists applied to the original recommendations. We updated the original evidence profiles with newly published studies identified by the panelists. We constructed Evidence to Decision (EtD) tables including contextual information from the KSA setting. We used the PanelVoice function of GRADEPro Guideline Development Tool (GDT) to obtain the panel's judgments on the EtD criteria ahead of the panel meeting. Following the meeting, we used the PANELVIEW instrument to obtain the panel's evaluation of the process. RESULTS: The KSA panel prioritized five recommendations, for which one evidence profile required updating. Out of five adoloped recommendations, two were modified in terms of direction, and one was modified in terms of certainty of the evidence. Criteria driving the modifications in direction were valuation of outcomes, balance of effects, cost, and acceptability. The mean score on the 7-point scale items of the PANELVIEW instrument had an average of 6.47 (SD = 0.18) across all items. CONCLUSION: The GRADE-ADOLOPMENT methodology proved to be efficient. The panel assessed the process and outcome positively. Engagement of stakeholders proved to be important for the success of this project.

Protocol for the development of guidance for collaborator and partner engagement in health care evidence syntheses.

BACKGROUND: Involving collaborators and partners in research may increase relevance and uptake, while reducing health and social inequities. Collaborators and partners include people and groups interested in health research: health care providers, patients and caregivers, payers of health research, payers of health services, publishers, policymakers, researchers, product makers, program managers, and the public. Evidence syntheses inform decisions about health care services, treatments, and practice, which ultimately affect health outcomes. Our objectives are to: A. Identify, map, and synthesize qualitative and quantitative findings related to engagement in evidence syntheses B. Explore how engagement in evidence synthesis promotes health equity C. Develop equity-oriented guidance on methods for conducting, evaluating, and reporting engagement in evidence syntheses METHODS: Our diverse, international team will develop guidance for engagement with collaborators and partners throughout multiple sequential steps using an integrated knowledge translation approach: 1. Reviews. We will co-produce 1 scoping review, 3 systematic reviews and 1 evidence map focusing on (a) methods, (b) barriers and facilitators, (c) conflict of interest considerations, (d) impacts, and (e) equity considerations of engagement in evidence synthesis. 2. Methods study, interviews, and survey. We will contextualise the findings of step 1 by assessing a sample of evidence syntheses reporting on engagement with collaborators and partners and through conducting interviews with collaborators and partners who have been involved in producing evidence syntheses. We will use these findings to develop draft guidance checklists and will assess agreement with each item through an international survey. 3. CONSENSUS: The guidance checklists will be co-produced and finalised at a consensus meeting with collaborators and partners. 4. DISSEMINATION: We will develop a dissemination plan with our collaborators and partners and work collaboratively to improve adoption of our guidance by key organizations. CONCLUSION: Our international team will develop guidance for collaborator and partner engagement in health care evidence syntheses. Incorporating partnership values and expectations may result in better uptake, potentially reducing health inequities.

Conflict of interest and funding in health communication on social media: a systematic review.

OBJECTIVES: To synthesise the available evidence on the reporting of conflicts of interest (COI) by individuals posting health messages on social media, and on the reporting of funding sources of studies cited in health messages on social media. DATA SOURCES: MEDLINE (OVID) (2005-March 2022), Embase (2005-March 2022) and Google Scholar (2005-August 2022), supplemented with a review of reference lists and forward citation tracking. DESIGN: Reviewers selected eligible studies and abstracted data in duplicate and independently. We appraised the quality of the included studies using the Mixed Methods Appraisal Tool. We summarised the results in both narrative and tabular formats. We followed the PRISMA 2020 checklist for reporting our study. RESULTS: Of a total of 16 645 retrieved citations, we included 17 eligible studies. The frequency of reporting of conflicts of interest varied between 0% and 60%, but it was mostly low. In addition, a significant proportion, ranging between 15% and 80%, of healthcare professionals using social media have financial relationships with industry. However, three studies assessed the proportion of conflicts of interest of physicians identified through Open Payment Database but not reported by the authors. It was found that 98.7-100% of these relationships with industry are not reported when communicating health-related information. Also, two studies showed that there is evidence of a potential association between COI and the content of posting. No data was found on the reporting of funding sources of studies cited in health messages on social media. CONCLUSIONS: While a significant proportion of healthcare professionals using social media have financial relationships with industry, lack of reporting on COI and undisclosed COI are common. We did not find studies on the reporting of funding sources of studies cited in health messages on social media. TRIAL REGISTRATION: dx.doi.org/10.17504/protocols.io.5jyl8jj4rg2w/v1.

Equity issues rarely addressed in the development of COVID-19 formal recommendations and good practice statements: a cross-sectional study.

BACKGROUND AND OBJECTIVE: To identify COVID-19 actionable statements (e.g., recommendations) focused on specific disadvantaged populations in the living map of COVID-19 recommendations (eCOVIDRecMap) and describe how health equity was assessed in the development of the formal recommendations. METHODS: We employed the place of residence, race or ethnicity or culture, occupation, gender or sex, religion, education, socio-economic status, and social capital-Plus framework to identify statements focused on specific disadvantaged populations. We assessed health equity considerations in the evidence to decision frameworks (EtD) of formal recommendations for certainty of evidence and impact on health equity criteria according to the Grading of Recommendations, Assessment, Development, and Evaluations criteria. RESULTS: We identified 16% (124/758) formal recommendations and 24% (186/819) good practice statements (GPS) that were focused on specific disadvantaged populations. Formal recommendations (40%, 50/124) and GPS (25%, 47/186) most frequently focused on children. Seventy-six percent (94/124) of the recommendations were accompanied with EtDs. Over half (55%, 52/94) of those considered indirectness of the evidence for disadvantaged populations. Considerations in impact on health equity criterion most frequently involved implementation of the recommendation for disadvantaged populations (17%, 16/94). CONCLUSION: Equity issues were rarely explicitly considered in the development COVID-19 formal recommendations focused on specific disadvantaged populations. Guidance is needed to support the consideration of health equity in guideline development during health emergencies.

Conflict of interest in the peer review process: A survey of peer review reports.

OBJECTIVES: To assess the extent to which peer reviewers and journals editors address study funding and authors' conflicts of interests (COI). Also, we aimed to assess the extent to which peer reviewers and journals editors reported and commented on their own or each other's COI. STUDY DESIGN AND METHODS: We conducted a systematic survey of original studies published in open access peer reviewed journals that publish their peer review reports. Using REDCap, we collected data in duplicate and independently from journals' websites and articles' peer review reports. RESULTS: We included a sample of original studies (N = 144) and a second one of randomized clinical trials (N = 115) RCTs. In both samples, and for the majority of studies, reviewers reported absence of COI (70% and 66%), while substantive percentages of reviewers did not report on COI (28% and 30%) and only small percentages reported any COI (2% and 4%). For both samples, none of the editors whose names were publicly posted reported on COI. The percentages of peer reviewers commenting on the study funding, authors' COI, editors' COI, or their own COI ranged between 0 and 2% in either one of the two samples. 25% and 7% of editors respectively in the two samples commented on study funding, while none commented on authors' COI, peer reviewers' COI, or their own COI. The percentages of authors commenting in their response letters on the study funding, peer reviewers' COI, editors' COI, or their own COI ranged between 0 and 3% in either one of the two samples. CONCLUSION: The percentages of peer reviewers and journals editors who addressed study funding and authors' COI and were extremely low. In addition, peer reviewers and journal editors rarely reported their own COI, or commented on their own or on each other's COI.

Key issues for stakeholder engagement in the development of health and healthcare guidelines.

Established in 2015, the Multi-Stakeholder Engagement (MuSE) Consortium is an international network of over 120 individuals interested in stakeholder engagement in research and guidelines. The MuSE group is developing guidance for stakeholder engagement in the development of health and healthcare guideline development. The development of this guidance has included multiple meetings with stakeholders, including patients, payers/purchasers of health services, peer review editors, policymakers, program managers, providers, principal investigators, product makers, the public, and purchasers of health services and has identified a number of key issues. These include: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. In this paper, we discuss these issues and our plan to develop guidance to facilitate stakeholder engagement in all stages of the development of health and healthcare guideline development.

A group of international researchers, patient partners, and other stakeholders are working together to create a checklist for when and how to involve stakeholders in health guideline development. Health guidelines include clinical practice guidelines, which your healthcare provider uses to determine treatments for health conditions. While working on this checklist, the team identified key issues to work on, including: (1) Definitions, roles, and settings (2) Stakeholder identification and selection (3) Levels of engagement, (4) Evaluation of engagement, (5) Documentation and transparency, and (6) Conflict of interest management. This paper describes each issue and how the team plans to produce guidance papers to address them.

Proposed triggers for retiring a living systematic review.

Living systematic reviews (LSRs) are systematic reviews that are continually updated, incorporating relevant new evidence as it becomes available. LSRs are critical for decision-making in topics where the evidence continues to evolve. It is not feasible to continue to update LSRs indefinitely; however, guidance on when to retire LSRs from the living mode is not clear. We propose triggers for making such a decision. The first trigger is to retire LSRs when the evidence becomes conclusive for the outcomes that are required for decision-making. Conclusiveness of evidence is best determined based on the GRADE certainty of evidence construct, which is more comprehensive than solely relying on statistical considerations. The second trigger to retire LSRs is when the question becomes less pertinent for decision-making as determined by relevant stakeholders, including people affected by the problem, healthcare professionals, policymakers and researchers. LSRs can also be retired from a living mode when new studies are not anticipated to be published on the topic and when resources become unavailable to continue updating. We describe examples of retired LSRs and apply the proposed approach using one LSR about adjuvant tyrosine kinase inhibitors in high-risk renal cell carcinoma that we retired from a living mode and published its last update.

Ultrasound-guided arterial cannulation in the paediatric population.

BACKGROUND: In arterial line cannulation in children and adolescents, traditional methods of locating the artery include palpation and Doppler auditory assistance. It is unclear whether ultrasound guidance is superior to these methods. This is an update of a review originally published in 2016. OBJECTIVES: To evaluate the benefits and harms of ultrasound guidance compared with traditional techniques (palpation, Doppler auditory assistance) for assisting arterial line placement at all potential sites in children and adolescents. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and Web of Science from inception to 30 October 2022. We also searched four trials registers for ongoing trials, and we checked the reference lists of included studies and relevant reviews for other potentially eligible trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing ultrasound guidance versus other techniques (palpation or Doppler auditory assistance) to guide arterial line cannulation in children and adolescents (aged under 18 years). We planned to include quasi-RCTs and cluster-RCTs. For RCTs with both adult and paediatric populations, we planned to include only the paediatric population data. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the risk of bias of included trials and extracted data. We used standard Cochrane meta-analytical procedures, and we applied the GRADE method to assess the certainty of evidence. MAIN RESULTS: We included nine RCTs reporting 748 arterial cannulations in children and adolescents (under 18 years of age) undergoing different surgical procedures. Eight RCTs compared ultrasound with palpation, and one compared ultrasound with Doppler auditory assistance. Five studies reported the incidence of haematomas. Seven involved radial artery cannulation and two involved femoral artery cannulation. The people performing arterial cannulation were physicians with different levels of experience. The risk of bias varied across studies, with some studies lacking details of allocation concealment. It was not possible to blind practitioners in any case; this adds a performance bias that is inherent to the type of intervention studied in our review. Compared to traditional methods, ultrasound guidance probably causes a large increase in first-attempt success rates (risk ratio (RR) 2.01, 95% confidence interval (CI) 1.64 to 2.46; 8 RCTs, 708 participants; moderate-certainty evidence) and probably causes a large reduction in the risk of complications such as haematoma formation (RR 0.26, 95% CI 0.14 to 0.47; 5 RCTs, 420 participants; moderate-certainty evidence). No studies reported data about ischaemic damage. Ultrasound guidance probably improves success rates within two attempts (RR 1.78, 95% CI 1.25 to 2.51; 2 RCTs, 134 participants; moderate-certainty evidence) and overall rate of successful cannulation (RR 1.32, 95% CI 1.10 to 1.59; 6 RCTs, 374 participants; moderate-certainty evidence). In addition, ultrasound guidance probably reduces the number of attempts to successful cannulation (mean difference (MD) -0.99 attempts, 95% CI -1.15 to -0.83; 5 RCTs, 368 participants; moderate-certainty evidence) and duration of the cannulation procedure (MD -98.77 seconds, 95% CI -150.02 to -47.52, 5 RCTs, 402 participants; moderate-certainty evidence). More studies are needed to confirm whether the improvement in first-attempt success rates is more pronounced in neonates and younger children compared to older children and adolescents. AUTHORS' CONCLUSIONS: We identified moderate-certainty evidence that ultrasound guidance for arterial cannulation compared with palpation or Doppler auditory assistance improves first-attempt success rate, second-attempt success rate and overall success rate. We also found moderate-certainty evidence that ultrasound guidance reduces the incidence of complications, the number of attempts to successful cannulation and the duration of the cannulation procedure.

Conceptualizing the reporting of living systematic reviews.

OBJECTIVES: As part of an effort to develop an extension of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 statement for living systematic reviews (LSRs), we discuss conceptual issues relevant to the reporting of LSRs and highlight a few challenges. METHODS: Discussion of conceptual issues based on a scoping review of the literature and discussions among authors. RESULTS: We first briefly describe aspects of the LSR production process relevant to reporting. The production cycles differ by whether the literature surveillance identifies new evidence and whether newly identified evidence is judged to be consequential. This impacts the timing, content, and format of LSR versions. Second, we discuss four types of information that are specific to the reporting of LSRs: justification for adopting the living mode, LSR specific methods, changes between LSR versions, and LSR updating status. We also discuss the challenge of conveying changes between versions to the reader. Third, we describe two commonly used reporting formats of LSRs: full and partial reports. Although partial reports are easier to produce and publish, they lead to the scattering of information across different versions. Full reports ensure the completeness of reporting. We discuss the implications for the extension of the PRISMA 2020 statement for LSRs. CONCLUSION: We argue that a dynamic publication platform would facilitate complete and timely reporting of LSRs.

Risk of thromboembolic events in non-hospitalized COVID-19 patients: A systematic review.

The risk of thromboembolism in non-hospitalized COVID-19 patients remains uncertain and was assessed in this review to better weigh benefits vs. risks of prophylactic anticoagulation in this population. A search was performed through three databases: Medline, Embase, and Cochrane Library until 2022. Self-controlled case series, case-control and cohort studies were included, and findings summarized narratively. Meta-analyses for risk of thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI) between COVID-19 and non-COVID-19 non-hospitalized patients were conducted. Frequency, incidence rate ratio (IRR), and risk ratio (RR) of stroke were used to assess risk in non-hospitalized COVID-19 patients considering the lack of studies to conduct a meta-analysis. Ten studies met inclusion criteria characterized by adult non-hospitalized COVID-19 patients. Risk of bias was relatively low. Risk of DVT (RR: 1.98 with 95% CI: 1.03-3.83) and PE (OR: 6.72 with 95% CI: 4.81-9.39 and RR: 4.44 with 95% CI: 1.98-9.99) increased in non-hospitalized COVID-19 patients compared to controls. Risk of MI (OR: 1.91 with 95% CI: 0.89-4.09) is possibly increased in non-hospitalized COVID-19 patients with moderate certainty when compared to controls. A trend in favor of stroke was documented in the first week following infection. Our meta-analyses support the increase in risk of DVT and PE, and likely increase of MI, in non-hospitalized COVID-19 patients. The risk of stroke appears significant in the first week following infection but drops to insignificance two weeks later. More studies are needed to establish evidence-based recommendations for prophylactic anticoagulation therapy in non-hospitalized COVID-19 patients.

Good or best practice statements: proposal for the operationalisation and implementation of GRADE guidance.

An evidence-based approach is considered the gold standard for health decision-making. Sometimes, a guideline panel might judge the certainty that the desirable effects of an intervention clearly outweigh its undesirable effects as high, but the body of supportive evidence is indirect. In such cases, the application of the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach for grading the strength of recommendations is inappropriate. Instead, the GRADE Working Group has recommended developing ungraded best or good practice statement (GPS) and developed guidance under which circumsances they would be appropriate.Through an evaluation of COVID-1- related recommendations on the eCOVID Recommendation Map (COVID-19.recmap.org), we found that recommendations qualifying a GPS were widespread. However, guideline developers failed to label them as GPS or transparently report justifications for their development. We identified ways to improve and facilitate the operationalisation and implementation of the GRADE guidance for GPS.Herein, we propose a structured process for the development of GPSs that includes applying a sequential order for the GRADE guidance for developing GPS. This operationalisation considers relevant evidence-to-decision criteria when assessing the net consequences of implementing the statement, and reporting information supporting judgments for each criterion. We also propose a standardised table to facilitate the identification of GPS and reporting of their development. This operationalised guidance, if endorsed by guideline developers, may palliate some of the shortcomings identified. Our proposal may also inform future updates of the GRADE guidance for GPS.

Recommendations for the treatment of rheumatoid arthritis in Saudi Arabia: adolopment of the 2021 American College of Rheumatology guidelines.

BACKGROUND: The 2021 American College of Rheumatology (ACR) rheumatoid arthritis (RA) guideline considers the specific context of the United States which differs from that of Saudi Arabia in many aspects that may impact recommendations. The objective of this project was to adapt a set of prioritized recommendations from the 2021 ACR guideline for the treatment of rheumatoid arthritis RA for the context of Saudi Arabia, by the Saudi Society for Rheumatology (SSR). METHODS: The process followed the GRADE-ADOLOPMENT methodology, and the reporting adhered to the RIGHT-Ad@pt checklist. Working groups included a coordination group and a 19-member panel representing different stakeholder groups. The Evidence to Decision (EtD) tables included evidence on health effects from the source guideline and contextual information from the Saudi setting. RESULTS: The panel prioritized and adapted five recommendations from the source guideline. The process led to modifying two out of the five prioritized recommendations, all listed here. In naive patients with low disease activity, methotrexate (MTX) is conditionally recommended over sulfasalazine (SSZ) (modified direction); hydroxychloroquine (HCQ) is conditionally recommended over SSZ (unmodified). Initiation of csDMARDs with short-term glucocorticoids is conditionally recommended over csDMARDs alone in naive patients with moderate to high disease activity (modified direction). Switch to subcutaneous MTX is conditionally recommended over addition/switch to alternative DMARD(s) in patients taking oral MTX who are not at target (unmodified). Discontinuation of MTX is conditionally recommended over gradual discontinuation of the bDMARD or tsDMARD for patients taking MTX plus a bDMARD or tsDMARD who wish to discontinue a DMARD (unmodified). CONCLUSION: Rheumatologists practicing in Saudi Arabia can use the adoloped recommendations generated by this project while adopting the rest of the recommendations from the 2021 ACR guidelines.

Stakeholders' views and perspectives on treatments of visceral leishmaniasis and their outcomes in HIV-coinfected patients in East Africa and South-East Asia: A mixed methods study.

BACKGROUND: In visceral leishmaniasis (VL) patients coinfected with human immunodeficiency virus (HIV), combination therapy (liposomal amphotericin B infusion and oral miltefosine) is being considered as an alternative to liposomal amphotericin B monotherapy. We aimed to assess the views of stakeholders in relation to these treatment options. METHODOLOGY: In a mixed methods study, we surveyed and interviewed patients, government functionaries, programme managers, health service providers, nongovernmental organizations, researchers, and World Health Organization (WHO) personnel. We used the Evidence to Decision (EtD) framework for data collection planning and analysis. Constructs of interest included valuation of outcomes, impact on equity, feasibility and acceptability of the treatment options, implementation considerations, monitoring and evaluation, and research priorities. PRINCIPAL FINDINGS/CONCLUSION: Mortality and non-serious adverse events were rated as "critical" by respectively the highest (61%) and lowest percentages (47%) of survey participants. Participants viewed clinical cure as essential for patients to regain productivity. Non-patient stakeholders emphasized the importance of "sustained" clinical cure. For most survey participants, combination therapy, compared with monotherapy, would increase health equity (40%), and be more acceptable (79%) and feasible (57%). Interviews revealed that combination therapy was more feasible and acceptable than monotherapy when associated with a shorter duration of hospitalization. The findings of the interviews provided insight into those of the survey. When choosing between alternative options, providers should consider the outcomes that matter to patients as well as the impact on equity, feasibility, and acceptability of the options.

A Framework for the Development of Living Practice Guidelines in Health Care.

BACKGROUND: Living practice guidelines are increasingly being used to ensure that recommendations are responsive to rapidly emerging evidence. OBJECTIVE: To develop a framework that characterizes the processes of development of living practice guidelines in health care. DESIGN: First, 3 background reviews were conducted: a scoping review of methods papers, a review of handbooks of guideline-producing organizations, and an analytic review of selected living practice guidelines. Second, the core team drafted the first version of the framework. Finally, the core team refined the framework through an online survey and online discussions with a multidisciplinary international group of stakeholders. SETTING: International. PARTICIPANTS: Multidisciplinary group of 51 persons who have experience with guidelines. MEASUREMENTS: Not applicable. RESULTS: A major principle of the framework is that the unit of update in a living guideline is the individual recommendation. In addition to providing definitions, the framework addresses several processes. The planning process should address the organization's adoption of the living methodology as well as each specific guideline project. The production process consists of initiation, maintenance, and retirement phases. The reporting should cover the evidence surveillance time stamp, the outcome of reassessment of the body of evidence (when applicable), and the outcome of revisiting a recommendation (when applicable). The dissemination process may necessitate the use of different venues, including one for formal publication. LIMITATION: This study does not provide detailed or practical guidance for how the described concepts would be best implemented. CONCLUSION: The framework will help guideline developers in planning, producing, reporting, and disseminating living guideline projects. It will also help research methodologists study the processes of living guidelines. PRIMARY FUNDING SOURCE: None.

A framework is proposed for defining, categorizing, and assessing conflicts of interest in health research.

OBJECTIVE: We propose an operational definition of conflicts of interest (COI), a framework for categorizing interests, and an approach to assessing whether an interest qualifies as a COI. STUDY DESIGN AND SETTING: We reviewed the literature and conducted methodological studies to inform the development of a draft framework for classifying interests. RESULTS: We developed the following operational definition: "a conflict of interest exists when a past, current, or expected interest creates a significant risk of inappropriately influencing an individual's judgment, decision, or action when carrying out a specific duty". Interest refers to a benefit (e.g., money received from industry) or to an attribute of the individual (e.g., having specific religious beliefs). The proposed framework includes seven types of interests relating to individuals (direct financial benefit, benefit through professional status, intellectual, and personal) or their institution (direct financial benefit to the institution, benefit through increasing services provided by the institution, and nonfinancial). When assessing whether an interest qualifies as a COI, one could consider its relevance, nature (e.g., cash vs. educational support), magnitude, and recency. CONCLUSION: The proposed operational definition and categorization framework may help journals, guideline organizations, professional societies, and healthcare institutions enhance transparency in health research.

Reporting of funding and conflicts of interest improved from preprints to peer-reviewed publications of biomedical research.

BACKGROUND AND OBJECTIVES: To assess changes in the reporting of funding and conflicts of interest (COI) in biomedical research between preprint server publications and their corresponding versions in peer-reviewed journals. METHODS: We selected preprint servers publishing exclusively biomedical research. From these, we screened articles by order of publication date and identified 200 preprints first published in 2020 with subsequent versions in peer-reviewed journals. We judged eligibility and extracted data about authorship, funding, and COI in duplicate and independently. We performed descriptive statistics. RESULTS: A quarter of the studies added at least one author to the peer-reviewed version. Most studies reported funding in both versions (87%), and a quarter of these added at least one funder to the peer-reviewed version. Eighteen studies (9%) reported funding only in the peer-reviewed version. A majority of studies reported COI in both versions (69%) and 5% of these had authors reporting more COI in the peer-reviewed version. A minority of studies (23%) reported COI only in the peer-reviewed version. None of the studies justified any changes in authorship, funding, or COI. CONCLUSION: Reporting of funding and COI improved in peer-reviewed versions. However, substantive percentages of studies added authors, funders, and COI disclosures in their peer-reviewed versions.

Which actionable statements qualify as good practice statements In Covid-19 guidelines? A systematic appraisal.

OBJECTIVES: To evaluate the development and quality of actionable statements that qualify as good practice statements (GPS) reported in COVID-19 guidelines. DESIGN AND SETTING: Systematic review . We searched MEDLINE, MedSci, China National Knowledge Infrastructure (CNKI), databases of Grading of Recommendations Assessment, Development and Evaluation (GRADE) Guidelines, NICE, WHO and Guidelines International Network (GIN) from March 2020 to September 2021. We included original or adapted recommendations addressing any COVID-19 topic. MAIN OUTCOME MEASURES: We used GRADE Working Group criteria for assessing the appropriateness of issuing a GPS: (1) clear and actionable; (2) rationale necessitating the message for healthcare practice; (3) practicality of systematically searching for evidence; (4) likely net positive consequences from implementing the GPS and (5) clear link to the indirect evidence. We assessed guideline quality using the Appraisal of Guidelines for Research and Evaluation II tool. RESULTS: 253 guidelines from 44 professional societies issued 3726 actionable statements. We classified 2375 (64%) as GPS; of which 27 (1%) were labelled as GPS by guideline developers. 5 (19%) were labelled as GPS by their authors but did not meet GPS criteria. Of the 2375 GPS, 85% were clear and actionable; 59% provided a rationale necessitating the message for healthcare practice, 24% reported the net positive consequences from implementing the GPS. Systematic collection of evidence was deemed impractical for 13% of the GPS, and 39% explained the chain of indirect evidence supporting GPS development. 173/2375 (7.3%) statements explicitly satisfied all five criteria. The guidelines' overall quality was poor regardless of the appropriateness of GPS development and labelling. CONCLUSIONS: Statements that qualify as GPS are common in COVID-19 guidelines but are characterised by unclear designation and development processes, and methodological weaknesses.