Don’t calculate post-hoc power using observed estimate of effect size | Statistical Modeling, Causal Inference, and Social Science

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Herz und Mund und Tat und Leben, BWV 147: X. Choral, Jesu bleibet meine Freude

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Data-Sharing Statements Requested from Clinical Trials by Public, Environmental, and Occupational Health Journals: Cross-Sectional Study

Background: Data sharing plays a crucial role in health informatics, contributing to improving health information systems, enhancing operational efficiency, informing policy and decision-making, and advancing public health surveillance including disease tracking. Sharing individual participant data in public, environmental, and occupational health trials can help improve public trust and support by enhancing transparent reporting and reproducibility of research findings. The International Committee of Medical Journal Editors (ICMJE) requires all papers to include a data-sharing statement. However, it is unclear whether journals in the field of public, environmental, and occupational health adhere to this requirement. Objective: This study aims to investigate whether public, environmental, and occupational health journals requested data-sharing statements from clinical trials submitted for publication. Methods: In this bibliometric survey of “Public, Environmental, and Occupational Health” journals, defined by the Journal Citation Reports (as of June 2023), we included 202 journals with clinical trial reports published between 2019 and 2022. The primary outcome was a journal request for a data-sharing statement, as identified in the paper submission instructions. Multivariable logistic regression analysis was conducted to evaluate the relationship between journal characteristics and journal requests for data-sharing statements, with results presented as odds ratios (ORs) and corresponding 95% CIs. We also investigated whether the journals included a data-sharing statement in their published trial reports. Results: Among the 202 public, environmental, and occupational health journals included, there were 68 (33.7%) journals that did not request data-sharing statements. Factors significantly associated with journal requests for data-sharing statements included open access status (OR 0.43, 95% CI 0.19-0.97), high journal impact factor (OR 2.31, 95% CI 1.15-4.78), endorsement of Consolidated Standards of Reporting Trials (OR 2.43, 95% CI 1.25-4.79), and publication in the United Kingdom (OR 7.18, 95% CI 2.61-23.4). Among the 134 journals requesting data-sharing statements, 26.9% (36/134) did not have statements in their published trial reports. Conclusions: Over one-third of the public, environmental, and occupational health journals did not request data-sharing statements in clinical trial reports. Among those journals that requested data-sharing statements in their submission guidance pages, more than one quarter published trial reports with no data-sharing statements. These results revealed an inadequate practice of requesting data-sharing statements by public, environmental, and occupational health journals, requiring more effort at the journal level to implement ICJME recommendations on data-sharing statements.

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Comparisons against baseline within randomised groups are often used and can be highly misleading - Trials

Background In randomised trials, rather than comparing randomised groups directly some researchers carry out a significance test comparing a baseline with a final measurement separately in each group. Methods We give several examples where this has been done. We use simulation to demonstrate that the procedure is invalid and also show this algebraically. Results This approach is biased and invalid, producing conclusions which are, potentially, highly misleading. The actual alpha level of this procedure can be as high as 0.50 for two groups and 0.75 for three. Conclusions Randomised groups should be compared directly by two-sample methods and separate tests against baseline are highly misleading.