如何设计高质量的针灸临床试验——基于证据的共识。
How to design high quality acupuncture trials-a consensus informed by evidence.
机构信息
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.
CEBIM (Center for Evidence-Based Integrative Medicine)-Clarity Collaboration, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
出版信息
BMJ. 2022 Mar 30;376:e067476. doi: 10.1136/bmj-2021-067476.
Abstract
An international panel including patients, clinicians, researchers, acupuncture and surgery trialists, statisticians, and experts in clinical epidemiology and methodology have developed new guidance for randomised controlled trials in acupuncture. It addresses the most prevalent and critical concerns of current acupuncture trials and will help funding agencies, trial registers, and journal editors to evaluate the relevance, importance, and quality of submitted trial proposals and completed trials
摘要
一个国际小组，包括患者、临床医生、研究人员、针灸和手术试验人员、统计人员以及临床流行病学和方法学方面的专家，为针灸的随机对照试验制定了新的指南。该指南解决了当前针灸试验中最普遍和最关键的问题，并将帮助资助机构、试验登记处和期刊编辑评估提交的试验提案和已完成试验的相关性、重要性和质量。
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BMJ Open. 2022 Aug 29;12(8):e060237. doi: 10.1136/bmjopen-2021-060237.
2
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