基于患者报告结局的气滞血瘀证评价量表研制  

Constructing Evaluation Scale for Qi Stagnation and Blood Stasis Syndrome Based on Patient Reported Outcomes

作　　者：王阶[1] 安宇[1,2] 何庆勇 李赵陵[1] 何浩强 陈光[1,3] WANG Jie;AN Yu;HE Qing-yong;LI Zhao-ling;HE Hao-qiang;CHEN Guang(Guang＇anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China;Traditional Chinese Medical Hospital of Huangdao District, Qingdao 266500, China;Beijing University of Chinese Medicine, Beijing 100029, China)

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]青岛市黄岛区中医医院,山东青岛266500 [3]北京中医药大学,北京100029

出　　处：《中国实验方剂学杂志》2018年第15期21-28,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家中医药局公益性行业项目(201207009)

摘　　要：目的：研制气滞血瘀证基于患者报告的临床结局评价量表。方法：参照国际量表制定原则并结合中医理论形成理论框架;通过102篇气滞血瘀证相关文献分析与209例病例回顾,经14名专家讨论,形成量表条目池;通过小样本预调查和访谈,形成气滞血瘀证患者报告结局（PRO）初选量表;通过338例气滞血瘀证患者临床调查,运用离散趋势法、因子分析法等7种统计学方法和专家咨询法对条目进行筛选和修订,形成气滞血瘀证PRO终选量表;通过213例气滞血瘀证患者及100例非气滞血瘀证患者临床调查,对量表可行性、信度、效度、区分度等进行临床验证。结果：形成气滞血瘀证基于患者报告的临床结局评价量表,包涵37个条目,其中生理领域22个,心理领域9个,独立化领域1个,社会领域5个。该量表的信度分析发现克朗巴哈α系数0.716,分半信度0.666。效度分析发现64.70%的变量能被因子分析法提取的公因子解释,Spearman相关系数除独立性领域外均〉0.2,区分度分析发现总量表和各领域独立样本t检验P均〈0.01。结论：气滞血瘀证基于患者报告的临床结局评价量表具有较好的信度、效度和区分度,可用于气滞血瘀证患者的疗效评价使用。Objective： To construct the patient reported outcome（PRO） scale for Qi stagnation and blood stasis syndrome（QSBSS）. Method： According to the international principle of scale construction and traditional Chinese medicine theory, the theoretic framework of this scale was build. Through analyzing 102 references pertaining to the QSBSS,retrospectively reviewing 209 cases and discussion of 14 experts,the item pool of this scale was formed. The primary PRO scale was shaped by survey and interview of participants with a small sample size. The eventual PRO scale was constructed after the survey of 338 QSBSS participants by the 7 analysis methods,partly including item distribution,tendency of dispersion,factor analysis,and was revised in the light of experts suggestion. The PRO scale was also evaluated by clinical study of 213 QSBSS participants and 100 nonQSBSS participants from the perspective of feasibility, reliability, validity and discrimination degree. Result：Evaluation scale for QSBSS based on PROs was eventually build with 37 items,mainly including 22 physiology items,9 psychology items,1 independent item and 5 community items. The reliability analysis showed that the Cronbach α coefficient was 0. 716, half reliability was 0. 666. Validity analysis showed that 64. 70% of the variables could be interpreted by the common factor,and the Spearman coefficient of association was larger than0. 2 except the independent item,and P value was smaller than 0. 01 in terms of t test for the whole scale and separate fields of the scale. Conclusion： Evaluation scale for QSBSS based on PROs embraces high level of reliability,validity and discrimination degree, which can be used for the evaluation for the efficacy and effectiveness of QSBSS patients.

关 键 词：气滞血瘀证 证候 疗效评价 患者报告结局 量表 统计学方法 专家咨询法 

分 类 号：R22[医药卫生—中医基础理论] G304[医药卫生—中医学]