Journal of clinical epidemiology
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Observational Study
Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles.
To assess effectiveness of legislative initiatives to stimulate public registration of trial results, we assessed adherence to protocol and results reporting, changes to registry, and publication data for randomized controlled trials (RCTs) after introduction of Food and Drug Administration Amendment Act (FDAAA). ⋯ Discrepancies remain relatively high between registered and published outcomes, particularly regarding registered omissions in publications and concomitant reporting, nature of statistical method used, and reporting of AEs. This seriously undermines transparency of clinical trials and needs immediate attention of all stakeholders in health research.
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Prediction models may facilitate risk-based management of health care conditions. In a large cluster-randomized trial, presenting calculated risks of postoperative nausea and vomiting (PONV) to physicians (assistive approach) increased risk-based management of PONV. This increase did not improve patient outcome-that is, PONV incidence. This prompted us to explore how prediction tools guide the decision-making process of physicians. ⋯ Combining probabilistic output of the model with their clinical experience may be difficult for physicians, especially when their decision-making process is mostly intuitive. Adding recommendations to predicted risks (directive approach) was considered an important step to facilitate the uptake of a prediction tool.
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To determine the predictive validity of the U.S. Evidence-based Practice Center (EPC) approach to GRADE (Grading of Recommendations Assessment, Development and Evaluation). ⋯ The limited predictive validity of the EPC approach to GRADE seems to reflect a mismatch between expected and observed changes in treatment effects as bodies of evidence advance from insufficient to high QOE.
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Evaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers. ⋯ There is support within the publicly funded UKCRC-registered CTUs for data sharing, but many perceived barriers remain. CTUs are currently using a variety of approaches and procedures for sharing data. This survey has informed further work, including development of guidance for publicly funded CTUs, to promote good practice and facilitate data sharing.