Editorial policy and the reporting of randomized controlled trials: a survey of instructions for authors and assessment of trial reports in Indian medical journals (2004-05).

BACKGROUND: Many international journals require authors of randomized controlled trials to adhere to standards of reporting described in the statement of the Consolidated Standards of Reporting Trials (CONSORT) and the requirements issued by the International Committee of Medical Journal Editors (ICMJE). We examined the extent to which these international standards have been adopted by Indian medical journals. METHODS: To identify Indian medical journals that publish randomized controlled trials, we did electronic searches of the websites of the National Informatics Centre (Indian Medlars Centre), Database of Open Access Journals, National Library of Medicine, WHO's Index Medicus for the South-East Asian region and Google. We analysed their instructions to authors for endorsement of the CONSORT statement and the ICMJE requirements for reporting of randomized controlled trials. We then identified all randomized controlled trials published in these journals during 2004 and 2005 and assessed them against selected CONSORT items and ICMJE requirements, and scored them on the Jadad scale. RESULTS: Of the 65 journals selected, 38 (58.5%) mentioned the ICMJE requirements in their instructions for authors but only 20 (31%) specifically required authors to submit manuscripts in accordance with the CONSORT statement. Of 151 randomized controlled trials published during 2004-05, only 4 of 13 (30.8%) selected CONSORT items were reported in > 50% of trial reports. Items reflecting internal validity were poorly reported. Jadad scores were significantly higher for general medical journals compared with specialty journals (mean difference 0.46; 95% CI: 0.15-0.78; p = 0.005) and in trials published in 2005 over those published in 2004 (mean difference 0.48; 95% CI: 0.18-0.79; p = 0.002). Ethical issues were poorly reported in one-third of reports, and sources of funding and conflicts of interest were not declared in over three-fourths. Adequacy of reporting was not related to endorsing either the CONSORT statement or the ICMJE requirements. CONCLUSION: Medical journals published in India should adopt internationally recognized norms for reporting clinical trials and work with authors, reviewers and institutional review boards to improve the standards of conduct, reporting and validity of inferences of trials.