Assessment of Reporting Quality of Drug-Related Randomized Controlled Trials Conducted in India and Published in MEDLINE-Indexed Indian Journals Over a Decade: A Systematic Review.

Abstract

Poorly published trials may result in biased and erroneous healthcare decisions. We conducted this systematic review to evaluate the reporting quality of drug-related randomized controlled trials (RCTs) conducted in India and published in MEDLINE-indexed Indian journals over a decade (between January 1, 2011, and December 31, 2020), as per the Consolidated Standards of Reporting Trials (CONSORT) Checklist 2010. An extensive literature search was conducted using the terms "Randomized controlled trial AND India." The full-length papers were extracted for RCTs related to drugs. Two independent investigators assessed each article against the checklist containing 37 criteria. Each article was scored 1 or 0 against each criterion which was finally summed up and evaluated. None of the articles fulfilled all 37 criteria. A compliance rate of >75% was seen in only 15.5% of articles. More than 75% of articles fulfilled a minimum of 16 criteria. Major checklist points observed to be deficient were "important changes to methods after trial commencement" (7%), "interim analysis and stopping guidelines" (7%), and "description of similarity of interventions while blinding" (4%). There remains ample room for improvement regarding research methodology and manuscript preparation in India. Moreover, journals should stringently implement the CONSORT Checklist 2010 to enhance the standard and quality of publications.