基于CONSORT声明评价推拿治疗膝关节骨性关节炎随机对照试验报告质量的研究

Reporting Quality Assessment of Randomized Controlled Trials on Tuina Treatment for Knee Osteoarthritis Based on CONSORT Statement

目的:采用CONSORT声明2010版及偏倚风险评估工具评估国内外推拿治疗膝关节骨性关节炎的随机对照试验(RCT)文献报告质量。方法:利用计算机检索中国知网(CNKI)、万方数据知识服务平台(WanFang Data)、维普中文科技期刊全文数据库(VIP)、Cochrane Library、OVID数据库、PubMed、Embase、Web of Science数据库,辅以手工检索的方式,年限从2010年01月01日至2021年01月31日。由两位评价者根据纳入和排除标准单独筛选文献后,运用CONSORT声明2010版及偏倚风险评估工具评估报告质量。结果:最终纳入22篇中文文献和2篇英文文献。通过偏倚风险评估工具,本研究中被评为低风险、不确定及高风险的百分数分别为44.64%、52.98%及2.38%。根据CONSORT声明2010版,中文文献所有条目平均报告率51.72%;英文文献所有条目平均报告率为75.68%。且英文文献详细叙述了其盲法的实施、随访、失访和试验注册,而中文文献在这些方面均较为欠缺。结论:目前推拿治疗膝关节骨性关节炎的随机对照试验研究报告质量总体不高,有较大提升空间,在今后的研究中应严格按照CONSORT声明进行规范化报告。

Objective:To evaluate the reporting quality of randomized controlled trials(RCTs) on tuina treatment for knee osteoarthritis based on the CONSORT Statement 2010 and Risk of Bias Assessment Tool.Methods:CNKI,Wanfang Data,VIP,Cochrane Library,OVID,PubMed,Embase and Web of Science were electronically searched by computer from January 1,2010 to January 31,2021,and supplemented by manual retrieval simultaneously.According to the inclusion and exclusion criteria of this study,two researchers firstly screened the title and abstract of literatures,and then assessed these inclusive literatures by CONSORT Statement 2010 and Risk of Bias Assessment Tool separately.Results:A total of 22 Chinese literatures and 2 English literatures were included finally.The percentage of low risk,unclear and high risk in this study were respectively 44.64%,52.98% and 2.38%.The average reporting rate in Chinese and English literatures were 51.72% and 75.68% based on all items of the CONSORT Statement 2010.The inclusive Chinese literatures had some disadvantages in the implementation of the blinding method,follow-up,loss to follow-up and trial registration.Conclusion:As a whole,the reporting quality of RCTs of tuina treatment for knee osteoarthritis is low.In the future researchers should report RCTs using the CONSORT statement.