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.

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.

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.

Post-mastectomy Radiation Therapy in Triple-Negative Breast Cancer Patients: Analysis of the BEATRICE Trial.

PURPOSE: Post-mastectomy radiation therapy (PMRT) improves locoregional control and overall survival in patients with breast cancer. With the evolution of systemic therapy, the benefit of PMRT in patients with triple-negative disease requires further evaluation. PATIENTS AND METHODS: BEATRICE is a phase III randomized clinical trial that examined the efficacy of bevacizumab in patients with triple-negative breast cancer (TNBC). The current study is a retrospective analysis of data on patients enrolled and treated with mastectomy and systemic therapy. The primary endpoint was determining the effect of PMRT on locoregional recurrence rates (LRR). Hazard ratios were estimated using Cox regression, and LRR curves were generated by the Kaplan-Meier method. RESULTS: In total, 940 patients were included in our analysis, of whom 359 (38.2%) received PMRT while 581 (61.8%) did not. At median follow-up of 5 years, no significant difference in LRR was noted between the PMRT and no PMRT groups in node-negative patients (HR = 1.09). Patients with N1 disease had 5-year LRR-free survival of 96% for PMRT versus 91% for no PMRT (HR = 0.46). Most N2 patients received PMRT and had 5-year LRR-free survival of 76%. CONCLUSION: PMRT benefit in TNBC patients treated with modern systemic therapy is lower than historical reports. Delivery of PMRT in patients with N1 disease enrolled in the BEATRICE trial was not shown to improve local control. As this might be due to patient selection for PMRT, future randomized controlled trials are required to assess the role of PMRT in this patient population.

COVID-19 transmission during swimming-related activities: a rapid systematic review.

BACKGROUND: There are uncertainties about mitigating strategies for swimming-related activities in the context of the COVID-19 pandemic. There is an opportunity to learn from the experience of previous re-openings to better plan the future one. Our objectives are to systematically review the evidence on (1) the association between engaging in swimming-related activities and COVID-19 transmission; and (2) the effects of strategies for preventing COVID-19 transmission during swimming-related activities. METHODS: We conducted a rapid systematic review. We searched in the L·OVE (Living OVerview of Evidence) platform for COVID-19. The searches covered the period from the inception date of each database until April 19, 2021. We included non-randomized studies for the review on association of COVID-19 transmission and swimming-related activities. We included guidance documents reporting on the strategies for prevention of COVID-19 transmission during swimming-related activities. We also included studies on the efficacy and safety of the strategies. Teams of two reviewers independently assessed article eligibility. For the guidance documents, a single reviewer assessed the eligibility and a second reviewer verified the judgement. Teams of two reviewers extracted data independently. We summarized the findings of included studies narratively. We synthesized information from guidance documents according to the identified topics and subtopics, and presented them in tabular and narrative formats. RESULTS: We identified three studies providing very low certainty evidence for the association between engaging in swimming-related activities and COVID-19 transmission. The analysis of 50 eligible guidance documents identified 11 topics: ensuring social distancing, ensuring personal hygiene, using personal protective equipment, eating and drinking, maintaining the pool, managing frequently touched surfaces, ventilation of indoor spaces, screening and management of sickness, delivering first aid, raising awareness, and vaccination. One study assessing the efficacy of strategies to prevent COVID-19 transmission did not find an association between compliance with precautionary restrictions and COVID-19 transmission. CONCLUSIONS: There are major gaps in the research evidence of relevance to swimming-related activities in the context of the COVID-19 pandemic. However, the synthesis of the identified strategies from guidance documents can inform public health management strategies for swimming-related activities, particularly in future re-opening plans.

Tobacco Research in the Eastern Mediterranean Region: A Scoping Review of Published Studies from Seven Countries.

While surveillance on a global scale has been showing a decline in tobacco smoking in the past decade, rates in the Eastern Mediterranean Region (EMR) remained stable with some countries showing rising trends. This study aimed to analyze the landscape of tobacco research in the EMR, present data on publication trends, and identify research gaps and opportunities to guide future tobacco research in the region. We conducted a scoping review of tobacco research in seven countries from January 2000 to December 2013. Three hundred and forty eight studies were identified, the majority of which were published in international journals and in English language. There was an increase in publications over time, with a significant positive linear trend (p = 0.03). Descriptive cross-sectional and case-control studies were the most common study designs (67.0%), and only 8% were longitudinal studies. Papers that reported, in part or solely, on waterpipe tobacco smoking (WTS) constituted 25.6% of the total publication pool. Tobacco consumption was treated as an exposure variable in half of the papers and mostly in relation to cancer and cardiovascular diseases, as an outcome measure in 37.7%, and as a confounding variable in 14.7% of the papers. Studies that examined associations of tobacco with other behaviors (5.3%) were lacking. The scarcity of high-evidence tobacco research in the EMR, together with the relatively deficient data on WTS and associations with other factors warrant the need for discussions on research priority setting and guidance on funding allocations in the region.

Ventilation Techniques and Risk for Transmission of Coronavirus Disease, Including COVID-19: A Living Systematic Review of Multiple Streams of Evidence.

BACKGROUND: Mechanical ventilation is used to treat respiratory failure in coronavirus disease 2019 (COVID-19). PURPOSE: To review multiple streams of evidence regarding the benefits and harms of ventilation techniques for coronavirus infections, including that causing COVID-19. DATA SOURCES: 21 standard, World Health Organization-specific and COVID-19-specific databases, without language restrictions, until 1 May 2020. STUDY SELECTION: Studies of any design and language comparing different oxygenation approaches in patients with coronavirus infections, including severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), or with hypoxemic respiratory failure. Animal, mechanistic, laboratory, and preclinical evidence was gathered regarding aerosol dispersion of coronavirus. Studies evaluating risk for virus transmission to health care workers from aerosol-generating procedures (AGPs) were included. DATA EXTRACTION: Independent and duplicate screening, data abstraction, and risk-of-bias assessment (GRADE for certainty of evidence and AMSTAR 2 for included systematic reviews). DATA SYNTHESIS: 123 studies were eligible (45 on COVID-19, 70 on SARS, 8 on MERS), but only 5 studies (1 on COVID-19, 3 on SARS, 1 on MERS) adjusted for important confounders. A study in hospitalized patients with COVID-19 reported slightly higher mortality with noninvasive ventilation (NIV) than with invasive mechanical ventilation (IMV), but 2 opposing studies, 1 in patients with MERS and 1 in patients with SARS, suggest a reduction in mortality with NIV (very-low-certainty evidence). Two studies in patients with SARS report a reduction in mortality with NIV compared with no mechanical ventilation (low-certainty evidence). Two systematic reviews suggest a large reduction in mortality with NIV compared with conventional oxygen therapy. Other included studies suggest increased odds of transmission from AGPs. LIMITATION: Direct studies in COVID-19 are limited and poorly reported. CONCLUSION: Indirect and low-certainty evidence suggests that use of NIV, similar to IMV, probably reduces mortality but may increase the risk for transmission of COVID-19 to health care workers. PRIMARY FUNDING SOURCE: World Health Organization. (PROSPERO: CRD42020178187).

Non-communicable diseases research output in the Eastern Mediterranean region: an overview of systematic reviews.

BACKGROUND: Rates of non-communicable diseases (NCDs) are rapidly rising in the Eastern Mediterranean Region (EMR). Systematic reviews satisfy the demand from practitioners and policy makers for prompt comprehensive evidence. The aim of this study is to review trends in NCD systematic reviews research output and quality by time and place, describe design and focus, and examine gaps in knowledge produced. METHODS: Using the Montori et al. systematic reviews filter, MeSH and keywords were applied to search Medline Ovid, Cochrane Central and Epistemonikos for publications from 1996 until 2015 in the 22 countries of the EMR. The 'Measurement Tool to Assess Systematic Reviews', AMSTAR, was used to assess the methodological quality of the papers. RESULTS: Our search yielded 2439 papers for abstract and title screening, and 89 papers for full text screening. A total of 39 (43.8%) studies included meta-analysis. Most of the papers were judged as being of low AMSTAR quality (83.2%), and only one paper was judged as being of high AMSTAR quality. Whilst annual number of papers increased over the years, the growth was mainly attributed to an increase in low-quality publications approaching in 2015 over four times the number of medium-quality publications. Reviews were significantly more likely to be characterized by higher AMSTAR scores (±SD) when meta-analysis was performed compared to when meta-analysis was not performed (3.4 ± 1.5 vs 2.6 ± 2.0; p-value = 0.034); and when critical appraisal of the included studies was conducted (4.3 ± 2.3 vs 2.5 ± 1.5; p-value = 0.004). Most of the reviews focused on cancer and diabetes as an outcome (25.8% and 24.7%, respectively), and on smoking, dietary habits and physical activity as exposures (15.7%, 12.4%, 9.0%, respectively). There was a blatant deficit in reviews examining associations between behaviors and physiologic factors, notably metabolic conditions. CONCLUSIONS: Systematic reviews research in the EMR region are overwhelmingly of low quality, with gaps in the literature for studies on cardiovascular disease and on associations between behavioral factors and intermediary physiologic parameters. This study raises awareness of the need for high-quality evidence guided by locally driven research agenda responsive to emerging needs in countries of the EMR.

Financial relationships between patient and consumer representatives and the health industry: A systematic review.

BACKGROUND: Patients and consumers are increasingly engaged in health policymaking, research and drug regulation. Having financial relationships with the health industry creates situations of conflicts of interest (COI) and might compromise their meaningful and unbiased participation. OBJECTIVE: To synthesize available evidence on the financial relationships between the health industry and patient and consumer representatives and their organizations. METHODS: We systematically searched MEDLINE and EMBASE. We selected studies and abstracted data in duplicate and independently. We reported on outcomes related to financial relationships of individuals with, and/or funding of organizations by the health industry. RESULTS: We identified a total of 14 510 unique citations, of which 24 reports of 23 studies were eligible. Three studies (13%) addressed the financial relationship of patient and consumer representatives with the health industry. Of these, two examined the proportion of public speakers in drug regulatory processes who have financial relationships; the proportions in the two studies were 25% and 19% respectively. Twenty studies (87%) addressed funding of patient and consumer organizations. The median proportion of organizations that reported funding from the health industry was 62% (IQR: 34%-69%) in questionnaire surveys, and 75% (IQR: 58%-85%) in surveys of their websites. Among organizations for which there was evidence of industry funding, a median proportion of 29% (IQR: 27%-44%) acknowledged on their websites receiving that funding. CONCLUSION: Financial relationships between the health industry and patient and consumer representatives and their organizations are common and may not be disclosed. Stricter regulation on disclosure and management is needed.

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.

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.

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.

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.

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.

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.

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.

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.