• Prathap Tharyan, Aneesh Thomas George, Richard Kirubakaran, and Jabez Paul Barnabas.
• South Asian Cochrane Network & Centre, Prof. BV Moses & Indian Council of Medical Research Centre for Advanced Research & Training in Evidence-Informed Healthcare, Christian Medical College, Vellore 632002, Tamil Nadu, India. prathap@cmcvellore.ac.in
• J Clin Epidemiol. 2013 Jan 1; 66 (1): 10-22.

ObjectiveWe sought to evaluate if editorial policies and the reporting quality of randomized controlled trials (RCTs) had improved since our 2004-05 survey of 151 RCTs in 65 Indian journals, and to compare reporting quality of protocols in the Clinical Trials Registry-India (CTRI).Study Design And SettingAn observational study of endorsement of Consolidated Standards for the Reporting of Trials (CONSORT) and International Committee of Medical Journal Editors (ICMJE) requirements in the instructions to authors in Indian journals, and compliance with selected requirements in all RCTs published during 2007-08 vs. our previous survey and between all RCT protocols in the CTRI on August 31, 2010 and published RCTs from both surveys.ResultsJournal policies endorsing the CONSORT statement (22/67, 33%) and ICMJE requirements (35/67, 52%) remained suboptimal, and only 4 of 13 CONSORT items were reported in more than 50% of the 145 RCTs assessed. Reporting of ethical issues had improved significantly, and that of methods addressing internal validity had not improved. Adequate methods were reported significantly more frequently in 768 protocols in the CTRI, than in the 296 published trials.ConclusionThe CTRI template facilitates the reporting of valid methods in registered trial protocols. The suboptimal compliance with CONSORT and ICMJE requirements in RCTs published in Indian journals reduces credibility in the reliability of their results.Copyright © 2013 Elsevier Inc. All rights reserved.

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