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.
ABSTRACT
BACKGROUND: The reporting quality of economic research could benefit from enhanced quality assurance procedures. At present, there are small numbers of health economic researches being conducted with Indian context or setting. There is not much clarity about the reporting quality of health economic researches being conducted with Indian context or setting. OBJECTIVE: The primary objective is to of this study was to appraise the quality of reporting of health economic evaluations conducted in the Indian setting and published between January 2014 and December 2018. MATERIALS AND METHODS: This was a retrospective, cross-sectional, descriptive analysis. The MEDLINE in PubMed, Google Scholar, and Science Direct were systematically searched to search for economic evaluations. The consolidated health economic evaluation reporting standards statement checklist was utilized to assess the quality of reporting of the included studies. For grading the quality of the included health economic assessments, the Quality of Health Evaluation Studies (QHES) instrument was used. RESULTS: Thirty studies fulfilled the inclusion criteria and were included in the study. The mean QHES score was 80.26 (standard deviation = 8.06). Twenty-five (83.33%, 95% confidence interval [CI]: 0.66-0.92) of the article mentioned perspective of the study. Twenty-nine (96.66%, 95% CI: 0.83-0.99) of the article described the effects of uncertainty for all input parameters. Twenty (66.66%, 95% CI: 0.48-0.80) of the article reported all funding sources. CONCLUSIONS: Overall, the quality of reporting of the included health economic studies was good, which reemphasizes their usefulness in supporting the decision-making procedure about better medicine. The finding of this study will be a small step toward ensuring robust and high-quality health economics data in India.
