Journal of clinical epidemiology
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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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The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group has developed GRADE evidence profiles (EP) and summary of findings (SoF) tables to present evidence summaries in systematic reviews, clinical guidelines, and health technology assessments. Explanatory notes are used to explain choices and judgments in these summaries, for example, on rating of the quality of evidence. ⋯ We found that by and large explanations were informative but detected several areas for improvement (e.g., source of baseline risk and judgments on imprecision). Guidance about explanatory footnotes and comments will be provided in the last article in this series.
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An increasing number of organizations worldwide are using new and improved standards for developing trustworthy clinical guidelines. One of such approaches, developed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group, offers systematic and transparent guidance in moving from evidence to recommendations. The GRADE strategy concentrates on four factors: the balance between benefits and harms, the certainty of the evidence, values and preferences, and resource considerations. ⋯ Weak recommendations are appropriate when there is a close balance between desirable and undesirable consequences of alternative management strategies, uncertainty regarding the effects of the alternatives, uncertainty or variability in patients' values and preferences, or questionable cost-effectiveness. Weak recommendations usually require accessing the underlying evidence and a shared decision-making approach. Clinicians using GRADE recommendations should understand the meaning of the strength of the recommendation, be able to critically appraise the recommendation, and apply trustworthy recommendations according to their strength.
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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.