Article type
Year
Abstract
Background: Adherence to international requirements for reporting of Randomized Controlled Clinical Trials (RCT) could ensure better quality of conduct, reporting, and inclusion of these trials in systematic reviews. Endorsement of the uniform requirements for submission of manuscripts of the International Committee of Medical Journal Editors (ICMJE) and the CONSORT statement by editors of Indian medical journals and their impact on the reporting of randomized trials published in Indian medical journals is uncertain.
Methods: We surveyed the instructions to authors of Indian medical and surgical journals for endorsement of the CONSORT statement and the ICMJE requirements regarding reporting of randomized controlled trials. Trial reports published in 2004 and 2005 in these journals were reliably evaluated using selected items from the CONSORT check-list and rated 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 (30.8%) required authors to submit manuscripts in accordance with the CONSORT statement. Of 151 RCTS published in 2004-2005, only 4/13 (30.8%) of selected CONSORT items were reported in > 50% of trial reports. Jadad scores were significantly higher in general compared to specialty journals (mean difference 0.46; 95% CI 0.15 to 0.78; p = 0.005) and in trials published in 2005 over those published in 2004 (mean difference 0.48; 95% CI 0.18 to 0.79; p = 0.002). Adequacy of reporting was not related to stated editorial policy of endorsing CONSORT or the ICMJE requirements.
Conclusions: Considerable deficiencies exist in the reporting of RCTs in Indian medical journals. Authors, reviewers, editors and institutional review boards need to work together to improve standards of conduct, reporting and validity of inferences of trials published in Indian journals so that these trials contribute more meaningfully to systematic reviews of interventions relevant to the region. Efforts are underway to strengthen the functioning of the Indian Association of Medical Journal Editors as an essential initial step in this direction.
Methods: We surveyed the instructions to authors of Indian medical and surgical journals for endorsement of the CONSORT statement and the ICMJE requirements regarding reporting of randomized controlled trials. Trial reports published in 2004 and 2005 in these journals were reliably evaluated using selected items from the CONSORT check-list and rated 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 (30.8%) required authors to submit manuscripts in accordance with the CONSORT statement. Of 151 RCTS published in 2004-2005, only 4/13 (30.8%) of selected CONSORT items were reported in > 50% of trial reports. Jadad scores were significantly higher in general compared to specialty journals (mean difference 0.46; 95% CI 0.15 to 0.78; p = 0.005) and in trials published in 2005 over those published in 2004 (mean difference 0.48; 95% CI 0.18 to 0.79; p = 0.002). Adequacy of reporting was not related to stated editorial policy of endorsing CONSORT or the ICMJE requirements.
Conclusions: Considerable deficiencies exist in the reporting of RCTs in Indian medical journals. Authors, reviewers, editors and institutional review boards need to work together to improve standards of conduct, reporting and validity of inferences of trials published in Indian journals so that these trials contribute more meaningfully to systematic reviews of interventions relevant to the region. Efforts are underway to strengthen the functioning of the Indian Association of Medical Journal Editors as an essential initial step in this direction.