太极拳临床试验干预措施报告规范的建议

Proposed reporting of Tai Chi intervention in clinical trials

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。

Objective： The objectives of this study are to propose a reporting standard of Tat Chi intervention in clinical studies, based on the organization and experience of STRICTA and CONSORT and its expansion,in order to improve the reporting quality of Tat Chi intervention in clinical trials to facilitate the clinical decision - making and clinical practice. Methods ： We developed the proposed reporting standard by summarizing items from the review, consulting experts, organizing group discussions, standard revision and consensus meeting. At last, the reporting items, explanation and examples were determined by the research team. Results：The proposed reporting standard of Tat Chi intervention in clinical trials includes 7 items and 16 sub -items. The 7 items are as follows：Tat Chi rationale ,details of learning and practicing, treatment regimen, other components of treatment, instructor background, requirements, and control or comparator interventions. Conclusion：Consensus are needed to be reached by relevant experts and scholars at home and abroad to improve the proposed reporting standard, and its feasibility should be tested in further clinical trials of Tat Chi intervention.