目的:按摩是非药物治疗的常用疗法,特别是在推拿(中国按摩)作为其最常见的风格,干预措施的评估和复制需要详细的报告指导.根据CONSORT(合并报告试验标准),我们的目标是开发推拿/按摩的延伸,即“推拿/按摩临床试验中报告干预措施的标准”(STRICTOTM)。\"
方法:一组专业临床医生,审判人员,方法学家,报告指南的开发者,流行病学家,统计学家,编辑通过EQUATOR(增强健康研究的质量和透明度)网络推荐的标准方法流程开发了此STRICTOTM清单,包括预期注册,文献综述,初始项目的草案,德尔福调查的三轮,共识会议,试点测试,并最终确定指导方针。
结果:七个项目的清单(即推拿/按摩理由,推拿/按摩的细节,干预方案,干预的其他组成部分,推拿/按摩提供者背景,控制或比较干预措施,和预防措施),并制定了16个子项目。还提供了每个项目的说明和示例(E&E)。
结论:工作组希望STRICTOTM,结合CONSORT声明和非药物治疗的扩展,可以提高推拿按摩临床研究的报告质量和透明度。
OBJECTIVE: Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely \"The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM).\"
METHODS: A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline.
RESULTS: A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided.
CONCLUSIONS: The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.