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Perspect Clin Res. 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.

Author information

1
Department of Clinical Pharmacology, SRM MCH and RC, Kattankulathur, Kancheepuram, Chennai, Tamil Nadu, India.

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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