基于CONSORT声明和STRICTA清单的中英文针刺随机对照试验报告质量评价

Evaluation of the report quality of Chinese and English randomized controlled trials of acupuncture based on CONSORT statement and STRICTA checklist

目的:基于CONSORT声明和STRICTA清单评价中英文针刺随机对照试验(RCT)的报告质量。方法:计算机检索PubMed等7个数据库中中英文针刺RCT,检索时间为2015年1月1日至2019年12月31日,并采用CONSORT2010声明和STRICTA清单对纳入RCT进行报告质量评价。结果:共纳入中文文献506篇,英文文献76篇。在CONSORT声明的评估中,中文针刺RCT报告率<50%的条目占全部条目的78.38%,试验背景和试验理由、试验设计、结局指标、样本量等25个条目的报告率均<10%;英文针刺RCT报告率<50%的条目占全部条目的35.14%。报告率<10%的条目有5个。中英文文献在试验背景和试验理由、描述试验设计等15个条目的报告率差异超过50%。中英文文献的STRICTA清单各条目的报告率都相对较高,中文针刺RCT中,报告率<50%的条目占全部条目的29.41%,为针刺治疗的理由、进针深度等;英文针刺RCT报告率<50%的仅有2个条目,分别为针刺治疗的理由及治疗场所和相关信息。中文针刺RCT在留针时间、治疗单元的频数和持续时间、针刺组附加干预的细节、治疗场所和相关信息及精确描述对照或对照措施这5个条目上的报告率均高于英文针刺RCT。结论:中文针刺RCT的报告质量亟待提高,应采取相应措施进一步规范针刺临床研究的书写与报告。

Objective To evaluate the report quality of Chinese and English randomized controlled trials(RCTs)of acupuncture based on the CONSORT statement and STRICTA checklist.Methods The Chinese and English RCTs of acupuncture published from January 1,2015 to December 31,2019 were searched in 7 databases including PubMed.The report quality of the included RCTs was evaluated with the CONSORT 2010 statement and STRICTA checklist.Results A total of 506 Chinese RCTs and 76 English RCTs were included.According to the CONSORT statement,in Chinese RCTs,the items with report rate less than 50% accounted for 78.38% of all items,and the report rate of 25 items,such as background and reason,study design,outcome index,and sample size,was less than 10%.In English RCTs,the items with report rate less than 50% accounted for 35.14% of all items,and 5 items had a report rate of less than 10%.The difference of the report rate of 15 items,such as background,reason and study design,was more than 50% between Chinese and English RCTs.The report rate of all items of STRICTA checklist was relatively high in both Chinese and English RCTs.In Chinese RCTs,the items with report rate less than 50% accounted for 29.41% of all items,which included acupuncture rationale and depth of insertion.In English RCTs,only two items had a report rate less than 50%,which were acupuncture rationale,setting and context of treatment.The report rate of five items,including needle retention time,frequency and duration of treatment sessions,details of other interventions administered to the acupuncture group,setting and context of treatment,and precise description of the control or comparator in Chinese RCTs,were higher than in English RCTs.Conclusion The report quality of Chinese acupuncture RCT needs to be improved urgently,and corresponding measures should be taken to further standardize the writing and reporting of acupuncture clinical research.