Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications

• Published in: Journal of clinical epidemiology 2013, Vol.66 (1), p.10-22
• Main Authors: Tharyan, Prathap, George, Aneesh Thomas, Kirubakaran, Richard, Barnabas, Jabez Paul
• Format: Article
• Language: English
• Subjects: Bias; Clinical trials; Conflict of Interest; Conformity; CONSORT statement; Data Collection; Editorial Policies; Epidemiology; Ethics, Research; Humans; ICMJE; Identification; India; Internal Medicine; Medical libraries; Observational studies; Periodicals as Topic - standards; Prospective trials registration; Randomized Controlled Trials as Topic - methods; Randomized Controlled Trials as Topic - standards; Randomized trials; Registries - standards; Research design; Research Support as Topic
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/j.jclinepi.2011.11.011

Abstract Objective We 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 Setting An 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. Results Journal 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. Conclusion The 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.