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Article Abstract
Objective: It is widely recognised that selective reporting clinical trial results based on their outcomes, in the forms of publication bias, outcome reporting bias, or p-hacking, has detrimental effects on the scientific literature and on evidence synthesis. This can be recognised, and perhaps ameliorated with comprehensive trial registration. However, previous investigations of clinical trial registration focussed on study-level examinations, rather than the number of trial participants, which is often more relevant to meta-analysis. Our objective was to investigate the risk of bias from selective reporting considering both trials but also the number of included participants.
Methods: We took a random sample of 50 Cochrane systematic reviews of interventions which included randomised controlled trials, forming a retrospective cohort. Focussing on the primary outcome in the systematic review we used the review, published trial information, and public trial registration documents to collect information about the reviews themselves, as well as information about 'included', 'ongoing' and studies 'awaiting classification'.
Results: In all 50 selected reviews, there were 423 'included' trials which examined the primary outcome, of which 109 (25.7%) were pre-registered. There was substantial variability in proportions of pre-registration of included trials among reviews, with a median of 16.0% (IQR 0-79.6%). Registered trials covered 60.1% of all participants, suggesting larger studies were more likely to be pre-registered. The proportion of participants in registered trials which were published was high (98.2%), but the proportion of registered trials which were published also varied substantially between reviews.
Conclusion: We found that in Cochrane reviews, there remains a low rate of pre-registration among included studies and evidence for a substantial rate of trial non-reporting of registered trials. However, pre-registered trials contributed proportionally more patients to reviews, and findings remain unpublished for only a small proportion of participants in registered trials.
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| http://dx.doi.org/10.1016/j.jclinepi.2025.111958 | DOI Listing |
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