Journal of clinical epidemiology
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Review
Appropriate statistical methods were infrequently used in cluster-randomized crossover trials.
To assess the design and statistical methods used in cluster-randomized crossover (CRXO) trials. ⋯ There is a need for improved application of appropriate analysis and sample size methods, and reporting, in CRXO trials.
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To summarize the current gaps in human immunodeficiency virus (HIV) research evidence, describe the adequacy of reporting "implications for research," and map the number of studies that inform reviews with the prevalence of HIV for each country. ⋯ Knowledge gaps were identified for research in younger participants, over longer periods, using more pragmatic interventions, conducted in resource-limited settings and incorporating economic evaluations. Implications for research are not always reported according to the EPICOT+ format. Not all countries with a high prevalence of HIV are contributing sufficiently to HIV research.
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To identify a simplified factor structure for the PROQOL-human immunodeficiency virus (HIV) questionnaire to improve the measurement of the health-related quality of life (HRQL) of HIV-positive patients in clinical care and research settings. ⋯ The simplified factor structure and scoring scheme for PROQOL-HIV will allow clinicians to monitor with greater reliability the HRQL of patients in clinical care and research settings.
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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.