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.
Sham acupuncture reporting guidelines and a checklist in clinical trials
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.
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