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目的:本研究旨在针对当前太极拳干预措施报告存在的问题,结合国际临床试验报告规范及其扩展版,制定出一套太极拳临床试验干预措施报告规范建议,以期能够提高太极拳临床试验的报告质量,为读者提供完整、准确和透明的报告,促进医疗决策和临床实践。方法:通过文献计量分析进行条目总结,召集研究人员讨论,咨询相关专家,研究者根据讨论结果对规范进行反复修改,最终确定报告规范建议的条目、条目说明、并列举高质量的报告范例。结果:本研究制定的太极拳临床试验干预措施报告规范建议,包括7个条目和16个亚条目。7个条目分别是:1)太极拳干预的合理性;2)太极拳学习和练习的细节;3)太极拳干预方案;4)其他干预措施;5)太极拳老师的资历;6)练习太极拳的达标要求;7)对照或者对照干预。结论:该建议条目有待召集国内外相关专家形成共识意见,并将在太极拳临床试验中加以试用。
Aims: To address the current problems of Taijiquan intervention report, this study combined with the international clinical trial report specification and its extended version to formulate a set of guidelines for clinical trial intervention report specifications, in order to improve the clinical trial of Taijiquan Report quality, provide readers with complete, accurate and transparent reports to promote medical decision-making and clinical practice. Methods: Through the bibliometric analysis of the article summary, convened researchers to discuss, consult the relevant experts, researchers based on the results of the discussion on the specification repeatedly modified to finalize the report of the proposed specification entries, entry description, and cite high-quality report paradigm. Results: The report proposed the Taijiquan clinical trials intervention report specifications, including 7 items and 16 sub-items. The seven items are: 1) the rationality of Taijiquan intervention; 2) the details of Taijiquan study and practice; 3) the Taijiquan intervention program; 4) other interventions; 5) the qualifications of Taijiquan teacher; Fist compliance requirements; 7) control or control intervention. Conclusion: The proposed entry is subject to the convening of relevant experts at home and abroad to form a consensus opinion, and will be tried in clinical trials in Tai Chi.