Objective To develop a scale for evaluating the curative effect of traditional Chinese medicine (TCM) for liver disease under the guidance of the theory of TCM, and to improve the TCM efficacy evaluation standard system for liver disease. Methods According to the TCM theory, the concept model of the liver disease-specific scale was built in combination with the international connotation of QOL and patient-reported outcomes ( PRO). A primary clinical scale was established after item pool screening, field test, culture adaptation and clinical pre-survey by the research staff. Finally, 200 questionnaires were distributed and 198 questionnaires were reclaimed. Statistical analysis was conducted to choose the items. Results All the selected items were analyzed by the different statistical methods, including significance grading, discrete tendency ( coefficient of variation ) method, stepwise regression analysis, discriminatory analysis, Cronbach’s al pha, and principal component analysis and factor analysis. A self-reported subjective scale and a perceived objective scale were developed, including 17 self-reported subjective items and 13 objective items. Conclusion According to the TCM theory and the international connotation of QOL, the scale of assessing curative effect of TCM for liver disease is practical and repeatable. It will be worthy of further evaluation and promotion to clinical application.%目的在中医基础理论的指导下研制一套适用于中医肝病疗效评价的量表，完善中医肝病疗效评价标准体系。方法按照国际通用量表研制的程序化方法，在中医基础理论指导下，结合患者报告结局指标（patient－reported outcomes， PRO）概念内涵，建立中医肝病临床疗效评价量表的理论模型。设立研究小组，通过建立条目池、编制初选量表、语言调试、临床预调查等形成临床初步调查表。根据研究设计，共发出200份调查表，回收有效量表198份，对调查结果进行系统分析以进一步筛选条目。结果应用专家重要性评分法、离散趋势法（变异系数法）、逐步回归分析法、判别分析法、克朗巴赫系数法、主成分分析法与因子分析法等统计分析方法，对不同分析结果选中的条目进行综合考虑，最后形成了二维结构（主观部分条目17条、客观部分条目13条）的中医肝病临床疗效评价量表。结论基于中医基础理论，按照国际量表通用的程序化方式研制的中医肝病临床疗效评价量表，具有可操作性及可重复性，值得进一步考核并推广至临床应用。
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