基于临床试验报告统一标准声明评价推拿治疗失眠随机对照试验报告质量的研究

Reporting quality assessment of randomized controlled trials of treating insomnia by massage therapy based on CONSORT Statement

目的:采用临床试验报告统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明2010版及偏倚风险评价工具评估推拿治疗失眠的随机对照试验(Randomized Controlled Trial,RCT)的报告质量。方法:采用计算机及手动检索方式,检索中国知识资源总库、万方数据知识服务平台、中文科技期刊数据库、中国生物医学文献数据库(Sino Med)、Pubmed、Embase、Cochrane library等7个中英文数据库中有关推拿治疗失眠的RCT研究,将检索时间设定为2011年12月31日―2021年12月31日,由两位评价人员独立筛选文献后,采用CONSORT声明、Cochrane偏倚风险评估工具来评价报告质量。结果:18篇中文RCT文献最终被纳入,偏倚风险评价结果显示,本次研究评定为高风险、不确定及低风险的百分数分别为19.05%、65.08%及15.87%;根据CONSORT声明2010版,本研究所纳入的文献所有条目平均报告率为48.20%;在干预措施、背景、目的及受试者方面报告详细,报告百分数均大于90.00%,但在随机方法、盲法、样本量估算及试验注册等方面存在较大的缺陷,其报告百分数仅为0.00%、0.00%、5.60%及0.00%。结论:目前推拿治疗失眠临床RCT报告总体质量不高,提升空间较大,研究人员今后需认真按照CONSORT声明来规范推拿治疗失眠RCT的设计和报告,从而更好地指导临床治疗,提高疗效。

Objective:To evaluate the reporting quality of randomized controlled trial(RCT)of treating insomnia by massage therapy based on the CONSORT Statement 2010 and risk of bias assessment tool.Methods:Computer and manual retrieval methods were used to search seven Chinese and English databases Chinese National Knowledge Infrastructure(CNKI),Wanfang Data,Chinese Science and Technology Journal Database(VIP),China Biomedical Literature Database(SinoMed),Pubmed,Embase,and the Cochrane library on the RCT of massage therapy for insomnia.The retrieval period was set from December 31,2011 to December 31,2021.Two reviewers independently screened the literature.CONSORT Statement and Cochrane bias risk assessment tool were used to evaluate report quality.Results:Eighteen Chinese RCT studies were finally included.The results of bias risk assessment showed that the percentages of high risk,uncertain risk and low risk were 19.05%,65.08%and 15.87%,respectively.According to CONSORT Statement 2010,the average reporting rate of all articles included in this study was 48.20%.In terms of intervention measures,background,purposes and subjects,the report was detailed,and the report percentage was more than 90.00%.However,there were significant defects in random-ized methods,blinding methods,sample size estimation and experimental registration,and the report percentage was only 0.00%,0.00%,5.60%and 0.00%,respectively.Conclusion:At present,the overall reporting quality of the clinical randomized controlled trial reports of treating insomnia by massage therapy is not high,and there is a lot of room for improvement.Researchers should carefully standardize the design and report of clinical trials of massage therapy for insomnia in the future according to the CONSORT Statement,so as to better guide clinical treatment and improve the efficacy.