体现中医药干预特色的结局指标集的构建

Establishment of Traditional Chinese Medicine Specific Outcome Sets

基于患者或其疾病状态的核心结局指标集(Pa-COS)的概念,提出从体现中医药干预特点出发,构建体现中医药干预特色的结局指标集(TCM-SOS)。TCM-SOS是反映中医药某一类干预(如针刺、推拿、中药等)特色的结局指标集。从方法论角度,Pa-COS与TCM-SOS的关系体现共性与个性的辩证观,Pa-COS强调特定健康状态下结局指标的共性特征,而TCM-SOS突出某类干预措施对特定健康状态下的特异性效果。研究方法上,前者强调结局指标对特定健康状态的重要性、可行性,后者强调结局指标反映措施干预后效果的特异性、显著性。以慢性腰背痛为例,阐述如何根据"反映干预措施特点"的研究目标,采用混合研究方法构建TCM-SOS的研究方法、流程及结果,从而建立一个以人群状态核心结局指标集为核心模块和能体现中医药干预特色为特异模块的模型。该模型既可以满足最小报告结局指标的要求,又可以体现中医药干预特点结局指标的诉求。

With reference to the concept of participants-related core outcome sets(Pa-COS), this paper brought out new hypothesis that traditional Chinese medicine specific outcome sets(TCM-SOS) should be established based on the characteristics of TCM treatment. TCM-SOS was identified to the effective and safety outcomes related to the specific intervention that were categorized into the non-core outcomes sets, which described the feature about the treatment intervention such as acupuncture, Tuina, and herbal formulae. From the perspective of methodology, the relationship between Pa-COS and TCM-SOS belongs to the dialectical view of commonness and individuality. Pa-COS emphasizes the commonness of outcome indicators in a specific health state, while TCM-SOS highlights the specific effect of certain interventions on a specific health state. In terms of research methods, the former emphasizes the importance and feasibility of outcome indicators for specific health status, while the latter lays emphasis on the specificity and significance of outcomes to reflect the effects of intervention. Taking chronic low back pain as an example, this paper described the research method, process and results of constructing TCM-SOS by using a mixed method research with the goal of "reflecting the characteristics of interventions". To meet the requirements of the minimum reporting of outcome indicators and to address the characteristics of TCM interventions, a new system of outcomes sets should be established and introduced, of which the COS was regarded as the core model for population health condition, while the TCM-SOS as the specific model for TCM intervention feature.