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国内外推拿手法治疗肩周炎随机对照试验(Randomized Controlled Trial,RCT)研究的报告质量.方法:使用计算机检索中国知网、万方数据知识服务平台、维普中文科技期刊全文数据库、中国生物医学文献服务系统(SinoMed)、OVID数据库、PubMed,根据其纳排标准进行剔除、筛选、确定文献,采用NoteExpress 3.2文献管理器进行文献题录管理,最终将纳入的文献运用CONSORT声明2010、偏倚风险评估工具分别由2位评价人员独立进行评估,并根据评价结果进行统计学分析.结果:最终纳入中文文献共22篇,无外文文献.根据CONSORT声明2010条目结果可看出,文章所纳入文献报告质量不足之处主要体现在以下方面:题目及摘要的报告率为0.00%、背景和目的报告率约为31.81%、描述样本量的文献为0.00%、阐述具体随机方法约占32.00%、盲法报告率为0.00%、基线资料完整约占95.00%、对文章局限性进行报告的文献约占4.54%.另外根据偏倚风险评价结果,评价为低风险、不清楚及高风险的分别占18.18%、67.53%及14.29%.结论:目前推拿治疗肩周炎RCT的研究报告质量普遍较低,今后应注意严格按照CONSORT声明要求,进一步完善临床试验设计,开展标准化报告.
A study on the reporting quality of randomized controlled trials on massage therapy in the treatment of scapulohumeral periarthritis based on CONSORT statement
Objective:The Standard Statement of Clinical Trial Reporting(CONSORT)2010 and bias risk assessment tool were used to evaluate the reporting quality of domestic and international randomized controlled trials(RCTS)on massage therapy in the treatment of scapulohumeral periarthritis.Methods:After searching CNKI,Wanfang Data,VIP,SinoMed,OVID database and PubMed,studies were excluded,screened and identified according to the inclusion and exclusion criteria,and the bibliothems were managed by NoteExpress 3.2 literature manager.Finally,the included literature were independently evaluated by two reviewers using CONSORT statement 2010 and bias risk assessment tool,and statistical analysis was conducted according to the evaluation results.Results:A total of 22 Chinese articles were included,and no foreign language articles were included.According to the items of CON SORT statement 2010,the deficiencies in the reporting quality of the studies included in this study were mainly reflected in the following aspects:The reporting rate of title and abstract was 0.00%,the reporting rate of background and objective was 31.81%,the reporting rate of literature describing sample size was 0.00%,the specific randomized method was 32.00%,the blind method was 0.00%,the complete baseline data was 95.00%,and the limitations of the article was 4.54%.In addition,according to the results of risk of bias assessment,the percentages of low risk,uncertain risk and high risk were 18.18%,67.53%and 14.29%,respectively.Conclusion:At present,the quality of randomized controlled trials on massage therapy in the treatment of scapulohumeral periarthritis is generally low.In the future,attention should be paid to further improve clinical trial design and carry out standardized reports in strict accordance with the requirements of CONSORT statement.