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BackgroundPost‐publication handling of integrity concerns in randomized clinical trials (RCTs) is a contentious matter.ObjectivesWe undertook a scoping systematic review to map the literature regarding post‐publication integrity issues in RCTs.Search Strategy and Selection CriteriaFollowing prospective registration (https://osf.io/pgxd8) we initially searched PubMed and Scopus but subsequently extended it to include the Cochrane Library, and Google Scholar databases without language, article type or publication time restriction until November 2022. Reviewers independently selected published articles covering any aspect of post‐publication research integrity concerns in RCTs.Data Collection and AnalysisThe study findings grouped within domains relating to issues concerning post‐publication integrity were extracted in duplicate, verified by a third reviewer, and then tabulated.Main ResultsThe initial search captured 3159 citations, of which 89 studies were included in the review. Cross‐sectional studies constituted the majority of included studies (n = 34, 38.2%), followed by systematic reviews (n = 10, 11.2%), methodology reviews/studies (n = 9, 10.1%) and other types of descriptive studies (n = 8, 9.0%). A total of 21 articles (23.6%) covered the domain on general issues, 25 (28.1%) in the journal's instructions and policies domain, eight (9.0%) in the editorial and peer review domain, one (1.1%) in the correspondence and complaints (post‐publication peer review) domain, 12 (13.5%) in the investigation for concerns domain, six (6.7%) in the post‐investigation decisions and sanctions domain, none in the critical appraisal guidance domain, five (5.6%) in the integrity assessment in systematic reviews domain, and 26 (29.2%) in the recommendations for future research domain. A total of 12 of the selected articles (13.5%) covered two (n = 9) or three (n = 3) different domains.ConclusionsVarious research integrity domains and issues covering post‐publication aspects of RCT integrity were captured and gaps were identified, mostly related with the necessary implications for all stakeholders to improve research transparency. There is an urgent need for a multistakeholder consensus towards creating specific statements for addressing post‐publication integrity concerns in RCTs.
BackgroundPost‐publication handling of integrity concerns in randomized clinical trials (RCTs) is a contentious matter.ObjectivesWe undertook a scoping systematic review to map the literature regarding post‐publication integrity issues in RCTs.Search Strategy and Selection CriteriaFollowing prospective registration (https://osf.io/pgxd8) we initially searched PubMed and Scopus but subsequently extended it to include the Cochrane Library, and Google Scholar databases without language, article type or publication time restriction until November 2022. Reviewers independently selected published articles covering any aspect of post‐publication research integrity concerns in RCTs.Data Collection and AnalysisThe study findings grouped within domains relating to issues concerning post‐publication integrity were extracted in duplicate, verified by a third reviewer, and then tabulated.Main ResultsThe initial search captured 3159 citations, of which 89 studies were included in the review. Cross‐sectional studies constituted the majority of included studies (n = 34, 38.2%), followed by systematic reviews (n = 10, 11.2%), methodology reviews/studies (n = 9, 10.1%) and other types of descriptive studies (n = 8, 9.0%). A total of 21 articles (23.6%) covered the domain on general issues, 25 (28.1%) in the journal's instructions and policies domain, eight (9.0%) in the editorial and peer review domain, one (1.1%) in the correspondence and complaints (post‐publication peer review) domain, 12 (13.5%) in the investigation for concerns domain, six (6.7%) in the post‐investigation decisions and sanctions domain, none in the critical appraisal guidance domain, five (5.6%) in the integrity assessment in systematic reviews domain, and 26 (29.2%) in the recommendations for future research domain. A total of 12 of the selected articles (13.5%) covered two (n = 9) or three (n = 3) different domains.ConclusionsVarious research integrity domains and issues covering post‐publication aspects of RCT integrity were captured and gaps were identified, mostly related with the necessary implications for all stakeholders to improve research transparency. There is an urgent need for a multistakeholder consensus towards creating specific statements for addressing post‐publication integrity concerns in RCTs.
Introduction: To enhance the assessment of the systematic reviews and meta-analyses performed by the Cochrane Multiple Sclerosis (MS) Group. Methods: Our study was conducted on 57 systematic reviews and meta-analyses related to MS, published by the Cochrane database until July 2023. Results: We found that the most encountered risk of bias was the low-risk domain, associated with Selective Reporting (data reporting), and followed by an unclear outcome for Allocation Concealment (selection bias). In contrast, Blinding of Participants and Personnel (performance bias) showed the highest risk of bias. Also, we concluded that up to 2015, the most prevalent risk of bias was ‘low outcome’ for Selective Reporting (data reporting). However, from 2016 till 2023, the most common risk of bias shifted to ‘low outcome’ for Random Sequence Generation (selection bias). Conclusion: Despite significant enhancements in improving the quality of studies, there is still a far way to achieve the ideal quality.
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