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. 2019 Apr-Jun;10(2):79-83.
doi: 10.4103/picr.PICR_60_18.

The assessment of the quality of randomized controlled trials published in Indian medical journals

Luxitaa Goenka  1 , Suramya Rajendran  1 , Kalaiselvi Arumugam  1 , Jamuna Rani  1 , Melvin George  1
Affiliations

The assessment of the quality of randomized controlled trials published in Indian medical journals

Luxitaa Goenka et al. Perspect Clin Res. 2019 Apr-Jun.

Abstract

Aim: In this retrospective cross-sectional study, we sought to evaluate if the published randomized controlled trials (RCTs) reported in the year 2017 among the Indian medical journals (IMJs) complied with the Consolidated Standards of Reporting Trials (CONSORT) guidelines and identify domains where reporting could be improved.

Methods: A literature search was performed using PubMed and Google Scholar to identify all the IMJs that published RCTs in the year 2017. In the archives of the identified journals, the number of published RCTs was identified and the full text was obtained. We selected articles that stated RCT in abstract and title and that evaluated the safety and efficacy of all therapeutic and preventive interventions.

Results: A total of seven IMJs comprising of the Indian Journal of Anesthesia, Indian Journal of Dermatology, Venereology and Leprology, Indian Journal of Pharmacology, Indian Journal of Ophthalmology, Journal of Obstetrics and Gynaecology, Journal of Pharmacology and Pharmacotherapeutics, and Indian Journal of Medical and Pediatric Oncology that published a total of 84 RCTs were included. The mean compliance score of all the RCTs was 13.7 ± 2.66 (57%). Most RCTs had serious reporting deficiencies in the methodology and result sections.

Discussion: In spite of journals making it mandatory for prospective authors to comply with the CONSORT guidelines, it is intriguing that there continues to be significant lacunae in reporting RCTs adequately in most IMJs.

Conclusion: There is an urgent need to impart training to the medical community of our country in clinical research methods and reporting of RCTs.

Keywords: Compliance score; Consolidated Standards of Reporting Trials; Indian Medical Journals; Randomized Controlled Trials.

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Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
The Overall Consolidated Standards of Reporting Trials compliance score (%) obtained by each journal in the year 2017
Figure 2
Figure 2
The percentage compliance (%) in the methods section of included randomized controlled trials of all Indian medical journals in the year 2017
Figure 3
Figure 3
The percentage compliance (%) in the results section of included randomized controlled trials of all Indian medical journals in the year 2017
See this image and copyright information in PMC

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References

    1. Kabisch M, Ruckes C, Seibert-Grafe M, Blettner M. Randomized controlled trials: Part 17 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2011;108:663–8. - PMC - PubMed
    1. Manchikanti L, Hirsch JA, Smith HS. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: Part 2: Randomized controlled trials. Pain Physician. 2008;11:717–73. - PubMed
    1. Stang A. Randomized controlled trials-an indispensible part of clinical research. Dtsch Arztebl Int. 2011;108:661–2. - PMC - PubMed
    1. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8:18. - PMC - PubMed
    1. Tharyan P, George AT, Kirubakaran R, Barnabas JP. Reporting of methods was better in the clinical trials registry-India than in Indian journal publications. J Clin Epidemiol. 2013;66:10–22. - PubMed