基于患者报告结局的气滞血瘀证评价量表研制

王阶; 安宇; 何庆勇; 李赵陵; 何浩强; 陈光

doi:10.13422/j.cnki.syfjx.20183101

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基于患者报告结局的气滞血瘀证评价量表研制

冠心病病证结合诊断及疗效评价标准研究 | 更新时间：2024-01-04

- 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
- 中国实验方剂学杂志 2018年24卷第15期页码：21-27
- 作者机构：
- 作者简介：
- 基金信息：
  
  国家中医药局公益性行业项目（201207009）
- DOI：10.13422/j.cnki.syfjx.20183101
  中图分类号： R24
- 纸质出版日期：2018
- 稿件说明：
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王阶, 安宇, 何庆勇, 等. 基于患者报告结局的气滞血瘀证评价量表研制[J]. 中国实验方剂学杂志, 2018,24(15):21-27.

WANG Jie, AN Yu, HE Qing-yong, et al. Constructing Evaluation Scale for Qi Stagnation and Blood Stasis Syndrome Based on Patient Reported Outcomes[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(15): 21-27.
王阶, 安宇, 何庆勇, 等. 基于患者报告结局的气滞血瘀证评价量表研制[J]. 中国实验方剂学杂志, 2018,24(15):21-27. DOI： 10.13422/j.cnki.syfjx.20183101.

WANG Jie, AN Yu, HE Qing-yong, et al. Constructing Evaluation Scale for Qi Stagnation and Blood Stasis Syndrome Based on Patient Reported Outcomes[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(15): 21-27. DOI： 10.13422/j.cnki.syfjx.20183101.

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。

Abstract

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 non-QSBSS 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 than 0.2 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.

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