基于结局指标重要性和中医药代表性构建中医临床疗效评价指标体系

中医临床疗效评价指标体系的建立是中医药现代化研究领域的关键问题.结局指标作为疗效评价指标体系的基础单元,首先必须满足作为一种结局评判尺度的基本功能,其次才是体现中医的特色性、代表性.所谓的中医、西医的结局指标差异源于中国与国外人群对健康状态的认知等文化差异,而非中医与西医干预措施的本身.因此,西医的某些结局指标同样适用...

Construction of evaluation index system of TCM clinical efficacy based on importance of outcome assessment and representativeness of TCM treatment

It is the primary issue of modern traditional Chinese medicine(TCM) to construct the evaluation index system of TCM clinical efficacy. The outcome assessment, as basic unit in TCM evaluation index system of clinical efficacy, must meet demands of being a good scale for outcome assessment, and then can be regarded as specific and representative outcomes for TCM treatment. The true difference of outcomes between TCM and modern medicine is the cultural difference among the patients who will be assessed by such outcomes, but not treatments themselves. Therefore, many outcomes, that assess modern medicine treatment, also evaluate TCM treatment. Besides, the effect of TCM pattern differentiation is the main and TCM specific outcome, and it means the effect of all treatments that apply TCM pattern differentiation for diseases. Such effect can be collected by patient reported outcomes, clinician reported outcomes and health related quality of life scales, and be described as the outcome in TCM specific outcome sets. Apart from the former categories of outcome index in the outcome assessment system by TCM and modern medicine, we emphasize the outcome relating to importance to patients and representativeness of TCM treatment for the new categories for the system. We propose the establishment of a new system which consists of core outcome sets related to participants(Participant-related COS, Pa-COS) and specific outcome sets related to interventions(Intervention-related specific outcome sets, In-SOS), especially for TCM. The former sets focus on that the minimum set of outcomes should be reported in all trials, but the latter ones on that the outcomes representing specific treatment, eg. TCM, can be reported as primary outcome in the trials with the such treatment.