Journal of clinical epidemiology
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Review Meta Analysis
Modified intention-to-treat analysis did not bias trial results.
To investigate whether analysis of the modified intention-to-treat (mITT) population with postrandomization exclusion of patients from analysis is associated with biased estimates of treatment effect compared to the conservative intention-to-treat (ITT) population. ⋯ We found no difference in the treatment effect between randomized trials using ITT and mITT analyses populations. This suggests that the mITT approach in rheumatoid arthritis trials investigating biological or targeted interventions does not introduce bias compared to ITT.
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The goal of this study was to assess the quality of reporting of statistical methods in randomized clinical trials (RCTs), including identification of primary analyses, missing data accommodation, and multiplicity adjustment, in studies of nonpharmacologic, noninterventional pain treatments (e.g., physical therapy, cognitive behavioral therapy, acupuncture, and massage). ⋯ This review identified deficiencies in the reporting of primary analyses and methods to adjust for multiplicity and accommodate missing data in articles disseminating results of nonpharmacologic, noninterventional trials. Investigators should be encouraged to indicate whether their analyses were prespecified and to clearly and completely report statistical methods in clinical trial publications to maximize the interpretability of trial results.
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To investigate adverse event (AE) reporting practices in a systematic review of randomized controlled trials for persistent depressive disorder (PDD). ⋯ There is a strong need to improve the current practice of assessing, analyzing, and reporting AEs, especially for psychotherapeutic studies.
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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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The promotion of health equity, the absence of avoidable and unfair differences in health outcomes, is a global imperative. Systematic reviews are an important source of evidence for health decision makers but have been found to lack assessments of the intervention effects on health equity. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) is a 27-item checklist intended to improve transparency and reporting of systematic reviews. We developed an equity extension for PRISMA (PRISMA-E 2012) to help systematic reviewers identify, extract, and synthesize evidence on equity in systematic reviews. ⋯ This explanation and elaboration document is intended to accompany the PRISMA-E 2012 statement and the PRISMA statement to improve understanding of the reporting guideline for users. The PRISMA-E 2012 reporting guideline is intended to improve transparency and completeness of reporting of equity-focused systematic reviews. Improved reporting can lead to better judgment of applicability by policy makers which may result in more appropriate policies and programs and may contribute to reductions in health inequities.