中医个体化疗效评价系统的构建思路与方法

Theory and methods on the development of traditional Chinese medicine individual assessment system

中医个体化诊疗的特色评价是中医药生存与发展的瓶颈。现有传统评价方法难以同时体现辨证论治的整体全面性和个体化,且个体化评价难以同时兼顾标准统一性。本研究以整体观和个体化特征为框架(评价特征和要求),着眼分析中医个体化疗效评价的主体(谁来评价),构建中医个体化疗效评价的评价思路和测量方法(怎么评价与评价什么)。“医患共同决策”是中医个体化疗效评价的主体,在“医患共同决策”指导下探索性分析条目库“全面性”和目标成就评量法(GAS)“个体化”的优势与不足,扬长避短发挥各自优势,提出标准化GAS概念并构建中医个体化疗效评价系统。标准化GAS要求以全面、单维度、高测量性能的结局域条目库为结局指标评价清单(体现整体全面性和个体化),以核心结局指标集指导患者赋权评价指标,并应用最小重要临床差异值(MICD)明确预期结局的评价标准(个体化与评价标准统一),“标准化”贯穿中医个体化疗效评价的全过程,整个评价过程是“医患共同决策”理念和循证标准化内容的高度整合,充分体现中医个体化疗效评价的整体观、个体化和标准化。

The characteristic assessment of traditional Chinese medicine(TCM)individualized diagnosis and treatment is the bottleneck of TCM development.The existing traditional assessment methods are difficult to reflect the overall comprehensiveness and individuation of syndrome differentiation,and the individuation assessment is difficult to take into account the criteria and standards.Based on the framework of holistic view and individualized characteristics(assessment characteristics and requirements),this study focuses on the analysis of the subject of TCM individualized efficacy assessment(who evaluate),and constructs the assessment ideas and measurement methods of TCM individualized efficacy assessment(how and what to evaluate).The patient-physician decision-making is the main body of the individual assessment of TCM.Under the guidance of the patient-physician decision-making,the advantages and disadvantages of the item bank and the Goal attainment scale(GAS)for individual assesment are explored and analyzed.The concept of standardized GAS is put forward and the individualized assessment system of TCM efficacy will be constructed.Standardized GAS requires a comprehensive,single-dimensional and high-performance local item database as the assessment list of outcome indicators(reflecting overall comprehensiveness and individuation),the core outcome indicator set to guide patients to assign weights to assessment indicators,and the application of most important clinical difference(MICD)to define the assessment criteria for expected outcome(individualization and unification of assessment criteria).Standardization runs through the whole process of TCM individualized curative effect assessment.The whole assessment process is the highly integration of the concept of'doctor-patient joint decision'and the content of evidence-based standardization,which fully embodies the holistic view,individuation and standardization of TCM individualized curative effect assessment.