Fan Fang-fang, Xu Qin, Sun Qi, Zhao Sheng-jun, Wang Ping, Guo Xue-rui
Department of Pharmacy, The Affiliated Traditional Medical Hospital, Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China.
Medical Research Design and Data Analysis Center, The Affiliated Traditional Medical Hospital, Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China.
PLoS One. 2014 Jan 28;9(1):e86360. doi: 10.1371/journal.pone.0086360. eCollection 2014.
Due to language limitations, little is known about the reporting quality of randomized clinical trials (RCTs) on the treatment of coronary heart disease (CHD) with traditional Chinese medicine (TCM) in Chinese Journal of Integrated Traditional and Western Medicine (CJITWM).
In this study, we utilized the CONSORT 2010 statement to understand the reporting quality of RCTs on CHD with TCM from the CJITWM.
The China National Knowledge Infrastructure (CNKI) electronic database was searched for CJITWM RCTs on the treatment of CHD with TCM, published between January 1, 2006 and December 31, 2011. We excluded articles reported as "animal studies," "topic review," "diagnostic test," "editorials," or "others." The CONSORT checklist was applied to evaluate the reporting quality of all eligible articles by two independent authors after extensive discussion. Each item was graded as either "yes" or "no" depending on whether the authors had reported it or not.
We identified 21 articles meeting our inclusion criteria. The percentage of 11 of the 37 items was 4.8 ∼ 95.2%, 14 of the 37 items were reported in all included articles, while 12 items were not mentioned at all. The average reporting percentage for the "title and abstract" section was 52.4%, for the "introduction" section 100.0%, for the "methods" section 45.4%, for the "results" section 57.1%, for the "discussion" section 79.4%, and for the "other information" section 17.5%.
In general, the reviewed RCTs were not consistent with the CONSORT 2010 statement. Authors should adhere to the CONSORT statement in reporting RCTs; editorial departments may consider the CONSORT statement as a guideline and should instruct authors to write manuscripts, and reviewers to judge them according to CONSORT statutes.
由于语言限制,关于《中国中西医结合杂志》(CJITWM)上中医药治疗冠心病(CHD)随机临床试验(RCT)的报告质量鲜为人知。
本研究利用CONSORT 2010声明了解CJITWM上中医药治疗CHD的RCT报告质量。
检索中国知网(CNKI)电子数据库,查找2006年1月1日至2011年12月31日发表的CJITWM上中医药治疗CHD的RCT。我们排除了报告为“动物研究”“专题综述”“诊断试验”“社论”或“其他”的文章。经过广泛讨论后,由两名独立作者应用CONSORT清单评估所有符合条件文章的报告质量。根据作者是否报告,每个项目分为“是”或“否”。
我们确定了21篇符合纳入标准的文章。37项中有11项的报告率为4.8%至95.2%,37项中有14项在所有纳入文章中均有报告,而12项根本未提及。“标题和摘要”部分的平均报告率为52.4%,“引言”部分为100.0%,“方法”部分为45.4%,“结果”部分为57.1%,“讨论”部分为79.4%,“其他信息”部分为17.5%。
总体而言,所审查的RCT与CONSORT 2010声明不一致。作者在报告RCT时应遵循CONSORT声明;编辑部门可将CONSORT声明作为指南,应指导作者撰写稿件,并指导审稿人根据CONSORT规则进行评判。