Perspectives in Clinical Research (Jan 2022)
The critical appraisal of randomized controlled trials published in an Indian journal to assess the quality of reporting: A retrospective, cross-sectional study
Abstract
Background: Although randomized controlled trials (RCTs) are the highest levels of evidence, they might not necessarily be of good quality. Hence, RCTs should always be appraised critically. Critical appraisal is the corroboration of evidence by methodically studying its validity, reliability, and applicability. Objective: The primary objective of this study was to do a critical appraisal of the RCTs published in Indian Journal of Pharmacology (IJP) from 2011 to 2016. The secondary objective was to scrutinize how adequately the published RCTs adhere to the Consolidated Standards of Reporting Trials (CONSORT) declaration. Materials and Methods: The present study included all RCTs published as full-text articles in IJP from January 2011 to December 2016. The identified RCTs were critically appraised using the critical appraisal checklist based on CONSORT 2010 guidelines and its extensions. Results: According to this analysis, 75% (95% confidence interval [CI]: 0.56–0.87) of the articles had given details about the sample size calculation. Nearly 89.29% (95% CI: 0.72–0.96) of the articles described the method for generating random allocation sequence, but only 35.71% (95% CI: 0.20–0.54) of the articles described allocation concealment method. Almost 35.71% (95% CI: 0.20–0.54) of the trials reported results as per the principle of the intention to treat (ITT). Nearly 21.43% (95% CI: 0.10–0.39) of the studies reported CIs in the present study. Conclusion: Allocation concealment method, analysis of the data based on the ITT principle, and reporting CIs were found to be underreported in this study. There should be more emphasis on reporting of allocation concealment, ITT analysis, and CI.
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