Abstract:

The TCM-based syndrome treatment effectiveness assessment scale could provide a basis for objectively evaluating the effectiveness of syndrome-based treatment and enrich the evaluation system of TCM treatment results. There are no unified and standardized methods for developing this kind of scale. In accordance with the international standards for developing a scale and ideas for developing a scale for assessing TCM treatment results as well as features of the TCM syndrome, and the experience of developing Syndrome Therapeutic Evaluation Scale of Chronic Obstructive Pulmonary Disease, we proposed the general process 〔including seven main parts (forming a research group, pre-designing the basic characteristics of the scale, constructing a framework and item pool, screening the items, forming a draft form of the scale, determining the weight of the items, and test of the scale) , and three key techniques (data mining technology based on association rules and latent structure analysis, item screening based on classical test theory and item response theory, and item weighting based on random forest, factor analysis, and percent weight) 〕 for developing a TCM-based syndrome treatment effectiveness assessment scale, hoping to offer guidance for other relevant studies.

Key words: Etiological factors and pathogenesis (TCM), Etiological factors symptom complex (TCM), Treatment outcome, Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease, Patient outcome assessment, Evaluation methodologies

摘要：

证候疗效评价量表可为客观评价中医证候疗效提供依据，丰富中医临床疗效评价体系。目前尚缺乏统一、规范的证候疗效评价量表研制方法。借鉴国际量表研制规范及中医量表研究思路，依据中医证候特点，基于已研制的慢性阻塞性肺疾病稳定期证候疗效评价量表（COPD-STES），初步提出中医证候疗效评价量表研制基本流程及关键技术，包括7个主要环节（成立研究小组、预设量表基本特征、构建理论框架及条目池、筛选条目、初步形成量表、确定条目权重及量表的考核）、3项关键技术（基于关联规则及隐结构分析的数据挖掘技术，基于经典测量理论与项目反应理论的条目筛选方法，基于随机森林法、因子分析法及百分权重法的条目赋权法），可为其他相关研究提供参考。

关键词: 中医病因和病机, 病因证候, 治疗结果, 慢性阻塞性肺疾病稳定期证候疗效评价量表, 病人结局评价, 评价方法