Goenka Luxitaa, Rajendran Suramya, Arumugam Kalaiselvi, Rani Jamuna, George Melvin
Department of Clinical Pharmacology, SRM MCH and RC, Kattankulathur, Kancheepuram, Chennai, Tamil Nadu, India.
Perspect Clin Res. 2019 Apr-Jun;10(2):79-83. doi: 10.4103/picr.PICR_60_18.
In this retrospective cross-sectional study, we sought to evaluate if the published randomized controlled trials (RCTs) reported in the year 2017 among the Indian medical journals (IMJs) complied with the Consolidated Standards of Reporting Trials (CONSORT) guidelines and identify domains where reporting could be improved.
A literature search was performed using PubMed and Google Scholar to identify all the IMJs that published RCTs in the year 2017. In the archives of the identified journals, the number of published RCTs was identified and the full text was obtained. We selected articles that stated RCT in abstract and title and that evaluated the safety and efficacy of all therapeutic and preventive interventions.
A total of seven IMJs comprising of the Indian Journal of Anesthesia, Indian Journal of Dermatology, Venereology and Leprology, Indian Journal of Pharmacology, Indian Journal of Ophthalmology, Journal of Obstetrics and Gynaecology, Journal of Pharmacology and Pharmacotherapeutics, and Indian Journal of Medical and Pediatric Oncology that published a total of 84 RCTs were included. The mean compliance score of all the RCTs was 13.7 ± 2.66 (57%). Most RCTs had serious reporting deficiencies in the methodology and result sections.
In spite of journals making it mandatory for prospective authors to comply with the CONSORT guidelines, it is intriguing that there continues to be significant lacunae in reporting RCTs adequately in most IMJs.
There is an urgent need to impart training to the medical community of our country in clinical research methods and reporting of RCTs.
在这项回顾性横断面研究中，我们试图评估2017年印度医学期刊（IMJ）上发表的随机对照试验（RCT）是否符合《试验报告统一标准》（CONSORT）指南，并确定报告中可以改进的领域。
使用PubMed和谷歌学术进行文献检索，以识别2017年发表RCT的所有IMJ。在选定期刊的存档中，确定发表的RCT数量并获取全文。我们选择了在摘要和标题中注明RCT且评估了所有治疗和预防干预措施安全性和有效性的文章。
总共纳入了7种IMJ，包括《印度麻醉学杂志》《印度皮肤病、性病和麻风病学杂志》《印度药理学杂志》《印度眼科学杂志》《妇产科学杂志》《药理学与药物治疗学杂志》以及《印度医学与儿科肿瘤学杂志》，这些期刊共发表了84项RCT。所有RCT的平均合规分数为13.7±2.66（57%）。大多数RCT在方法和结果部分存在严重的报告缺陷。
尽管期刊要求前瞻性作者必须遵守CONSORT指南，但有趣的是，大多数IMJ在充分报告RCT方面仍然存在重大缺陷。
迫切需要对我国医学界进行临床研究方法和RCT报告方面的培训。
