E-ISSN 2231-3206 | ISSN 2320-4672
 

Original Research 


Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study

Anushree D, Sushma M.

Abstract
Background: A randomized controlled trial (RCT) is the most valued method for evaluating the drug safety and its efficacy. However, due to incomplete reporting, RCTs may not be a reliable source of information and can lead to false interpretation of outcome.

Aim and Objective: The aim of this study was to analyze the completeness in reporting of RCTs published in the Indian medical journals (IMJs) according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and to analyze, if there was a variation in the completeness between registered and unregistered trials.

Materials and Methods: This was a cross-sectional study conducted in the Department of Pharmacology, Bangalore Medical College and Research Institute. The clinical trials published by the IMJs between January 2020 and August 2021 were accessed online, and its full text versions published were downloaded. Completeness in reporting of the RCTs with respect to different CONSORT checklist domains was recorded. The impact of trial registration and CONSORT endorsement on the completeness of reporting RCTs according to CONSORT checklist was determined. Descriptive statistics was used to assess and summarize the data.

Results: The overall completeness of reporting was 82.4%, better than the previous years. Major areas of reporting deficiencies were in the title and abstract, result, and registration domains. Registered trials reported better than unregistered.

Conclusions: Endorsement of CONSORT in the journal had no difference in reporting. Although the quality of reporting RCTs in the IMJs has improved, it remains unsatisfactory. Completeness of trial reporting could be improvised by strict implementation of CONSORT guidelines.

Key words: Consolidated Standards of Reporting Trials 2010; Indian Medical Journals; Quality of Reporting; Randomized Controlled Trials


 
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Pubmed Style

D A, M S. Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study. Natl J Physiol Pharm Pharmacol. 2022; 12(12): 2126-2130. doi:10.5455/njppp.2022.12.04177202210052022


Web Style

D A, M S. Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study. https://www.njppp.com/?mno=17112 [Access: February 02, 2023]. doi:10.5455/njppp.2022.12.04177202210052022


AMA (American Medical Association) Style

D A, M S. Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study. Natl J Physiol Pharm Pharmacol. 2022; 12(12): 2126-2130. doi:10.5455/njppp.2022.12.04177202210052022



Vancouver/ICMJE Style

D A, M S. Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study. Natl J Physiol Pharm Pharmacol. (2022), [cited February 02, 2023]; 12(12): 2126-2130. doi:10.5455/njppp.2022.12.04177202210052022



Harvard Style

D, A. & M, . S. (2022) Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study. Natl J Physiol Pharm Pharmacol, 12 (12), 2126-2130. doi:10.5455/njppp.2022.12.04177202210052022



Turabian Style

D, Anushree, and Sushma M. 2022. Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study. National Journal of Physiology, Pharmacy and Pharmacology, 12 (12), 2126-2130. doi:10.5455/njppp.2022.12.04177202210052022



Chicago Style

D, Anushree, and Sushma M. "Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study." National Journal of Physiology, Pharmacy and Pharmacology 12 (2022), 2126-2130. doi:10.5455/njppp.2022.12.04177202210052022



MLA (The Modern Language Association) Style

D, Anushree, and Sushma M. "Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study." National Journal of Physiology, Pharmacy and Pharmacology 12.12 (2022), 2126-2130. Print. doi:10.5455/njppp.2022.12.04177202210052022



APA (American Psychological Association) Style

D, A. & M, . S. (2022) Assessment of the quality of randomized controlled trials published in Indian Medical Journals from 2020 to 2021: A cross-sectional study. National Journal of Physiology, Pharmacy and Pharmacology, 12 (12), 2126-2130. doi:10.5455/njppp.2022.12.04177202210052022