针刺临床试验中假针刺对照报告指南与清单(SHARE)  

Sham acupuncture reporting guidelines and a checklist in clinical trials

作　　者：刘晓玉 马培宏 刘志顺[3] 郭义[4] 周科华 卞兆祥[6] 孙承颐 刘婷兰 熊芝怡 谢依璇 陆盈 劳力行 何丽云[9] 刘保延[10] 刘存志[1] 闫世艳 SHARE工作组 LIU Xiaoyu;MA Peihong;LIU Zhishun;GUO Yi;ZHOU Kehua;BIAN Zhaoxiang;SUN Chengyi;LIU Tinglan;XIONG Zhiyi;XIE Yixuan;LU Ying;LAO Lixing;HE Liyun;LIU Baoyan;LIU Cunzhi;YAN Shiyan;SHARE Workgroup(Acupuncture and Moxibustion Department,Beijing University of Chinese Medicine,Beijing 100105,P.R.China;School of Medical Technology,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,P.R.China;Department of Acupuncture and Moxibustion,Guang’an Men Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,P.R.China;School of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,P.R.China;Department of Hospital Medicine,ThedaCare Regional Medical Center,Wisconsin 54911,USA;Department of Chinese Medicine Development,Hong Kong Baptist University,Hong Kong 999077,P.R.China;Department of Biomedical Data Science,Stanford University School of Medicine,California 94305,USA;Virginia University of Integrative Medicine,Virginia 22182,USA;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,P.R.China;China Academy of Chinese Medical Sciences,Beijing 100700,P.R.China;不详)

机构地区：[1]北京中医药大学针灸推拿学院,北京100105 [2]天津中医药大学医学技术学院,天津301617 [3]中国中医科学院广安门医院,北京100053 [4]天津中医药大学中医学院,天津301617 [5]美国ThedaCare地区医疗中心医学部,美国威斯康星54911 [6]中国香港浸会大学中医药学院,中国香港999077 [7]美国斯坦福大学医学院,美国加利福尼亚94305 [8]美国弗吉尼亚整合医学大学,美国弗吉尼亚22182 [9]中国中医科学院中医临床基础医学研究所,北京100700 [10]中国中医科学院,北京100700 [11]不详

出　　处：《中国循证医学杂志》2024年第7期745-750,共6页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金资助项目(编号:82174234)。

摘　　要：目的假针刺对照是针刺临床试验中常用的评价针刺特异性效应的对照方式。然而由于缺乏相应的报告规范,目前针刺临床试验中假针刺对照的报告质量较差。为规范假针刺对照的报告,提高其报告质量,项目组制订了针刺临床试验中假针刺对照报告指南与清单(sham acupuncture reporting guidelines and a checklist in clinical trials,SHARE)。方法研制过程包括四个部分:通过文献研究形成假针刺对照报告初始条目;开展两轮德尔菲调查评价假针刺对照报告初始条目的报告必要性;召开两次专家共识会议进一步讨论、共识德尔菲调查的结果,确定假针刺对照报告清单;最后,进行清单预测试以评价假针刺对照报告清单的可操作性与实用性,形成假针刺对照报告清单。结果SHARE清单包括10个方面,19个报告条目,主要从假针刺对照细节要素和相关背景因素等方面对假针刺对照提出了规范化报告要求。结论SHARE指南是专门针对假针刺对照的报告指南,为全面、清晰地报告假针刺对照提供了明确的指导。Objective Sham acupuncture control is a commonly employed method to assess the specific effects of acupuncture in clinical trials.However,due to the absence of specific reporting standards,the reporting quality of sham acupuncture in these trials is low.In order to standardize the reporting of sham acupuncture and improve the reporting quality of sham acupuncture,our project team has developed SHam Acupuncture REporting guidelines and a checklist in clinical trials(SHARE).Methods The development process included four parts:we conducted literature research to form initial items of sham acupuncture reporting;two rounds of Delphi surveys were carried out to evaluate the reporting necessity of these initial items;two expert consensus meetings were held to further discuss and agree upon the Delphi results and approve the SHARE checklist;a pilot testing was conducted to assess the feasibility and practicality of the list and make necessary revisions to generate the final SHARE checklist.Results The SHARE checklist consisted of 10 categories with 19 items.The requirements for reporting sham acupuncture primarily focused on sham acupuncture detailed information as well as relevant background factors.Conclusion The SHARE serves as specialized reporting guidelines for sham acupuncture that offers clear guidance on comprehensive and concise reporting of sham acupuncture.

关 键 词：假针刺 针刺 临床试验 报告指南 指南 报告清单 

分 类 号：R246[医药卫生—针灸推拿学]