Editorial policy and the reporting of randomized controlled trials in Indian medical journals in 2004–2005 versus 2007–2008

Article type
Authors
George A, Kirubakaran R, Barnabas J, Yamuna B, Raj M
Abstract
Background: Editorial requirements for submission of reports of randomized controlled trials (RCTs) in Indian medical journals in 2005 and the quality of reporting of RCTs in 2004 and 2005 were suboptimal (National Medical Journal of India 2008; 21:62-8). Objectives: To assess changes in editorial policy in 2008 for manuscript submission and the quality of reporting of RCTs published in 65 Indian medical journals in 2007 and 2008 since the previous report. Methods: We evaluated the instructions to authors of 65 Indian medical journals that were part of our earlier survey for endorsement of the CONSORT statement and the ICMJE requirements for reporting of RCTs. We analyzed reports of all RCTs published in these journals in 2007 and 2008 against 13 selected CONSORT items and the ICMJE requirements and compared adequacy of reporting with the reports in 2004 and 2005. Results: No improvements were noted in the instructions for authors regarding ICMJE requirements (2005: 38/65, 59%; 2008: 37/65, 57%) or for CONSORT (2005: 20/65, 31%; 2008: 22/65, 33%). Of 151 RCTs in 2004 and 2005, and 145 RCTs in 2007 and 2008, only 4/13 (31%) of selected CONSORT items were reported in > 50% of trial reports. Reporting was better in 2007-2008 for some Items reflecting internal validity (random sequence generation: 57/151 (38%) in 2004-2005 versus 79/145 (54%); OR 2.0; 95% CI 1.2 to 3.1), no different (allocation concealment: 24/151 (16%) versus 30/145 (21%); OR 1.4; 95% CI 0.8 to 2.5) or worse (blinding: 96/151 (61%) versus 67/145 (46%); OR 0.5; 95% CI 0.3 to 0.8). Ethical issues, funding sources and conflicts of interest were poorly reported in roughly a third of reports in both time periods. Conclusions: Editorial policies on reporting of RCTs and the peer review process in Indian medical journals require urgent revision if reports of trials are to provide reliable and transparent results.