【目的】 评估7种优秀中文临床医学期刊随机对照临床试验(RCT)摘要报告质量,为提高我国医学期刊RCT摘要报告质量提供依据。【方法】 在万方数据库中检索7种临床医学期刊近年来发表的RCT文献,根据《期刊与学术会议论文摘要中报告随机对照试验的CONSORT声明》评估摘要报告质量。【结果】 检索到RCT文献284篇,摘要条目总体报告率为41.10%50.00%,平均报告率为46.03%。《中华儿科杂志》《中华内科杂志》《中华眼科杂志》2011—2013年稿约中无摘要CONSORT要求,RCT摘要条目报告率平均为45.38%,2014—2016年稿约中有摘要CONSORT要求,摘要条目报告率平均为45.11%。摘要条目中,目的和结论报告率最高,报告率为100%,分配隐藏方法、试验注册、标题、试验设计等条目报告率较低。【结论】 我国医学期刊RCT摘要报告质量有待提高,尤其应当加强针对标题、试验设计、是否采用盲法、分析例数、试验注册等条目的报告。期刊编辑应当重视并且主动承担RCT摘要规范化的责任,保证RCT摘要的质量。
[Purposes] This paper aims to assess reporting quality of randomized controlled trial (RCT) abstracts from seven leading Chinese clinical journals and provide a basis for improving reporting quality of RCT abstracts of Chinese medical journals. [Methods] RCT abstracts published in seven clinical journals in recent years were searched in Wanfang Database. The reporting quality of RCT abstracts was assessed based on the Consolidated Standards of Reporting Trials (CONSORT) for Reporting Randomised Trials in Journal and Conference Abstracts. [Findings] Totally, 284 RCT abstracts are eligible for this study which show an overall adherence rate of 46.03% to the CONSORT checklist for abstracts. Among 7 journals, the overall adherence rate varies from 41.10% to 50.00%. The overall adherence rate is 45.38% in 45 RCT abstracts from Chinese Journal of Pediatrics, Chinese Journal of Internal Medicine, and Chinese Journal of Ophthalmology from 2011 to 2013 when the CONSORT for reporting randomised trials in abstracts is not endorsed in their instructions to authors, similar to that (45.11%) in 35 RCT abstracts from 2014 to 2016. Of these scored items, objective and conclusions are fully reported in all the abstracts, while a low adherence rate is observed for some items, including allocation concealment, trial registration, title, trial design, etc. [Conclusions] There is a need to further improve reporting quality of RCT abstracts in Chinese medical journals, and the reporting of title, trial design, blinding, and trial registration is especially required to be improved. Journal editors should shoulder the responsibility to standardize RCT abstracts and ensure their qualities.
Randomized controlled trial,
Consolidated standard of reporting trial,