Tharyan Prathap, Premkumar Titus Samson, Mathew Vivek, Barnabas Jabez Paul
Professor B V Moses and ICMR Advance Centre for Research and Training in Evidence-Informed Health Care, Christian Medical College, Vellore 632002, Tamil Nadu, India.
Natl Med J India. 2008 Mar-Apr;21(2):62-8.
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.
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.
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.
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.
许多国际期刊要求随机对照试验的作者遵守《报告试验的统一标准》（CONSORT）声明中所述的报告标准以及国际医学期刊编辑委员会（ICMJE）发布的要求。我们调查了印度医学期刊采用这些国际标准的程度。
为了识别发表随机对照试验的印度医学期刊，我们对国家信息中心（印度医学文献中心）、开放获取期刊数据库、国立医学图书馆、世界卫生组织东南亚区域医学索引以及谷歌的网站进行了电子搜索。我们分析了它们给作者的关于认可CONSORT声明和ICMJE关于随机对照试验报告要求的说明。然后我们识别了在2004年和2005年期间这些期刊上发表的所有随机对照试验，并根据选定的CONSORT项目和ICMJE要求对它们进行评估，并用雅达量表对它们进行评分。
在所选的65种期刊中，38种（58.5%）在给作者的说明中提到了ICMJE要求，但只有20种（31%）特别要求作者按照CONSORT声明提交稿件。在2004 - 2005年期间发表的151项随机对照试验中，在超过50%的试验报告中报告了13项选定CONSORT项目中的仅4项（30.8%）。反映内部有效性的项目报告不佳。综合医学期刊的雅达评分显著高于专科期刊（平均差异0.46；95%可信区间：0.15 - 0.78；p = 0.005），并且2005年发表的试验高于2004年发表的试验（平均差异0.48；95%可信区间：0.18 - 0.79；p = 0.002）。三分之一的报告中伦理问题报告不佳，超过四分之三的报告未声明资金来源和利益冲突。报告的充分性与认可CONSORT声明或ICMJE要求均无关。
印度出版的医学期刊应采用国际认可的临床试验报告规范，并与作者、审稿人和机构审查委员会合作，以提高试验的实施、报告和推论有效性的标准。
