2007-2016年《中华皮肤科杂志》随机对照临床试验文献报告质量评价  

Quality assessment of reports of clinical randomized controlled trials published in Chinese Journal of Dermatology from 2007 to 2016

作　　者：张建红[1] 刘子艳[1] 刘玉媛[1] 刘学茗 苗婷[1] 马胜男 王瑜[1] Zhang Jianhong;Liu Ziyan;Liu Yuyuan;Liu Xueming;Miao Ting;Ma Shengnan;Wang Yu(Department of Pharmacy, Tianjin Fourth Central Hospital, Tianjin 300140, China)

机构地区：[1]天津市第四中心医院药剂科,300140

出　　处：《中华皮肤科杂志》2018年第7期519-522,共4页Chinese Journal of Dermatology

摘　　要：目的 评价《中华皮肤科杂志》2007—2016年发表的随机对照临床试验（RCT）文献报告质量，为规范临床论文写作提供参考。方法 基于临床试验报告的统一标准（CONSORT）2010声明设计评价表，对《中华皮肤科杂志》2007—2016年发表的临床RCT文献进行质量评价。结果 共纳入94篇文献，其中2007—2011年45篇，2012—2016年49篇。纳入文献中，前言、讨论部分报告较规范，方法和结果部分正确报告盲法（23篇，24.47%）、样本量（0篇）、主要结局指标和次要结局指标（21篇，22.34%）、受试者流程图（0篇）、失访（32篇，34.04%）及依从性（13篇，13.83%）的文献比例较低，而纳入及排除标准、干预措施、统计学方法、随访起止时间、基线资料正确报告的比例较高，均达到80%以上。结论 《中华皮肤科杂志》发表的RCT文献大部分项目报告规范、清楚，但在报告盲法、依从性、样本量、受试者流程图等方面明显存在不足，应引起作者重视。Objective To assess the quality of reports of clinical randomized controlled trials （RCTs） published in Chinese Journal of Dermatology from 2007 to 2016, and to provide a reference for standardization of clinical paper writing. Methods Based on the consolidated standards of reporting trials （CONSORT） 2010 statement, an evaluation form was designed and used to assess the quality of the clinical RCT articles published in Chinese Journal of Dermatology from 2007 to 2016. Results A total of 94 RCT articles were enrolled, including 45 articles from 2007 to 2011, and 49 articles from 2012 to 2016. Among these articles, the writing of introduction and discussion parts was relatively standardized. In the method and result parts, the proportions of articles correctly reporting blinding （23 articles, 24.47%）, sample size （0 article）, primary and secondary outcome measures （21 articles, 22.34%）, participant flow （0 article）, loss to follow-up （32 articles, 34.04%） and compliance （13 articles, 13.83%） were low, while the proportions of those correctly reporting inclusion and exclusion criteria, intervention measures, statistical methods, starting and ending time of follow-up and baseline data were all over 80%. Conclusion Most contents of the RCT articles published in Chinese Journal of Dermatology are standardized and clear, but the reporting of blinding, compliance, sample size, participant flow and so on, is insufficient, and close attention should be paid to these items.

关 键 词：随机对照试验 研究报告 文献评价 临床试验报告的统一标准 

分 类 号：G237.5[文化科学] G353.1[医药卫生] R-05