Abstract
Good quality medical research generally requires not only an expertise in the chosen medical field of interest but also a sound knowledge of statistical methodology. The number of medical research articles which have been published in Indian medical journals has increased quite substantially in the past decade. The aim of this study was to collate all evidence on study design quality and statistical analyses used in selected leading Indian medical journals. Ten (10) leading Indian medical journals were selected based on impact factors and all original research articles published in 2003 (N = 588) and 2013 (N = 774) were categorized and reviewed. A validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation of the articles. Main outcomes considered in the present study were – study design types and their frequencies, error/defects proportion in study design, statistical analyses, and implementation of CONSORT checklist in RCT (randomized clinical trials). From 2003 to 2013: The proportion of erroneous statistical analyses did not decrease (χ2=0.592, Φ=0.027, p=0.4418), 25% (80/320) in 2003 compared to 22.6% (111/490) in 2013. Compared with 2003, significant improvement was seen in 2013; the proportion of papers using statistical tests increased significantly (χ2=26.96, Φ=0.16, p<0.0001) from 42.5% (250/588) to 56.7 % (439/774). The overall proportion of errors in study design decreased significantly (χ2=16.783, Φ=0.12 p<0.0001), 41.3% (243/588) compared to 30.6% (237/774). In 2013, randomized clinical trials designs has remained very low (7.3%, 43/588) with majority showing some errors (41 papers, 95.3%). Majority of the published studies were retrospective in nature both in 2003 [79.1% (465/588)] and in 2013 [78.2% (605/774)]. Major decreases in error proportions were observed in both results presentation (χ2=24.477, Φ=0.17, p<0.0001), 82.2% (263/320) compared to 66.3% (325/490) and interpretation (χ2=25.616, Φ=0.173, p<0.0001), 32.5% (104/320) compared to 17.1% (84/490), though some serious ones were still present. Indian medical research seems to have made no major progress regarding using correct statistical analyses, but error/defects in study designs have decreased significantly. Randomized clinical trials are quite rarely published and have high proportion of methodological problems.
Highlights
Good quality medical research generally requires an expertise in the chosen medical field of interest and a sound knowledge of statistical methodology
As the current checklist used in the study is derived from Consolidated Standards of Reporting Trials (CONSORT), the proportion of errors in randomized clinical trials have decreased significantly (χ2 = 7.892, F = 0.31, p = 0.0065), 95.3% (41/43) in 2003 compared to 73.1% (30/41) in 2013, though only small number of randomized clinical trials we published as compared to retrospective studies
Even in 2013, after 10 years’ of steady progress, randomized clinical trials published in Indian medical journals remained quite low
Summary
Good quality medical research generally requires an expertise in the chosen medical field of interest and a sound knowledge of statistical methodology. From 1970s, Altman et al [13,14,15,16,17] have continued to study errors/defects in several aspects of study design and statistical methodologies used in medical journals. Afterwards, a series of publication guidelines have been proposed, including CONSORT and STROBE statements [18,19,20,21,22,23,24]. These guidelines have in general led to some improvement in the quality of publications in clinical research worldwide
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
