针灸随机对照试验现场质量控制内容探讨——基于PICOST的质量控制内容和清单设计

On-site quality control of acupuncture randomized controlled trial:design of content and checklist of quality control based on PICOST

为有效保证针灸随机对照试验的质量,形成合理的现场质量控制内容和清单,分析了针灸随机对照试验的质量影响因素,综合考虑质量控制内容的科学性和现场操作的可行性,在国家"十一五"课题"中医药防治重大疑难疾病综合治疗方案优化与临床评价共性技术和质量控制研究"现场质量控制内容和清单基础上,提出以PICOST为核心内容开展针灸随机对照试验现场质量控制,尤其要注重对干预实施者技能(I)和盲态结局评价(O)的质量控制,并形成了现场质量控制清单,供课题承担单位参考。

To effectively guarantee quality of randomized controlld trial （RCT） of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall considera- tion. Based on content and checklist of on-site quality control in National llth Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assess- ment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupunc- ture RCT should be conducted with PICOST （patient, intervention, comparison, out come, site and time） as core, especially on quality control of interveners skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.