基于CONSORT和STRICTA的浮针治疗肩周炎RCT报告质量评价  

Quality Evaluation of RCT Report on Floating Needle Therapy for Shoulder Periarthritis Based on CONSORT and STRICTA

作　　者：高丽 李彬锋 王卫刚 王斌 曹星 刘智斌[3] 李聪 GAO Li;LI Binfeng;WANG Weigang;WANG Bin;CAO Xing;LIU Zhibin;LI Cong(Shaanxi Provincial Hospital of Chinese Medicine,Xi an 710003,China;Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712000,China;Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712046,China)

机构地区：[1]陕西省中医医院,陕西西安710003 [2]陕西中医药大学附属医院,陕西咸阳712000 [3]陕西中医药大学,陕西咸阳712046

出　　处：《陕西中医药大学学报》2024年第6期69-76,共8页Journal of Shaanxi University of Chinese Medicine

基　　金：陕西省科技厅重点研发计划项目(217SF-283);陕西省中医药管理局中医药科研课题(LCPT080);陕西省名老中医刘智斌工作室项目(2008)。

摘　　要：目的对浮针治疗肩周炎的临床随机对照试验进行质量评价。方法检索中国知网(CNKI)、维普中文期刊服务平台(VIP)、万方数据知识服务平台(WF)及PubMed等各大数据库中自2001年1月—2021年12月期间发表的所有文献,通过CONSORT声明、STRICTA标准及Cochrane进行质量评价。结果共纳入34篇文献。1篇可从题目直接知晓为RCT;24篇(70.59%)提及随机分组方法;无文献对研究过程中的盲法实施、样本量确定、试验注册、基金资助、操作者资历等信息进行报告;大部分文献对于受试者基线资料变化、试验存在的局限性、机体反应与对照组干预措施的合理性等细则报告不充分。结论目前发表的浮针治疗肩周炎的RCT报告质量总体较低,一定程度影响了结果可靠性。建议后续严格遵循CONSORT声明和STRICTA标准设计与实施临床试验,发表规范且高质量的RCT研究报告,提高证据体系公信力,促使科研成果更好的回馈临床治疗。Objective To evaluate the quality of a randomized controlled trial of floating needle therapy for shoulder periarthritis.Methods Retrieve all literature published in major databases such as CNKI,VIP,WF,and PubMed from January 2001 to December 2021,and evaluate their quality using CONSORT statement,STRICTA criteria,and Cochrane.Results A total of 34 articles were included.One article can be directly identified as an RCT from the title;24 articles(70.59%)mentioned the random grouping method;No literature reports on the implementation of blinding methods,sample size determination,trial registration,funding support,operator qualifications,and other information during the research process;Most of the literature lacks sufficient reporting on the changes in baseline data of subjects,limitations of the trial,and the rationality of the body s response and control group intervention measures.Conclusion The overall quality of RCT reports on floating needle therapy for RS is relatively low,which to some extent affects the reliability of the results.It is recommended to strictly follow the CONSORT statement and STRICTA standards in the design and implementation of clinical trials,publish standardized and high-quality RCT research reports,improve the credibility of the evidence system,and promote better feedback of scientific research results to clinical treatment.

关 键 词：浮针 肩周炎 CONSORT STRICTA RCT COCHRANE 质量评价 

分 类 号：R246.9[医药卫生—针灸推拿学]