The Effectiveness Satisfaction Questionnaire for COPD (ESQ-COPD) previously developed by us based on classical test theory has proven to have some limitations. The combination use of classical test theory and item response theory may achieve complementary advantages, which may be a theoretical basis and methodological support for the development or revision of instruments.

To develop a modified ESQ-COPD (mESQ-COPD) based on the combination of disease and syndrome, and to evaluate its psychometric properties.

By predefining basic characteristics of the instrument, normalizing the essential concepts and terminologies, revising the conceptual framework, generating an item pool, and reviewing the items, the draft of the mESQ-COPD was developed by our revision group. Then the draft was improved to be a mESQ-COPD by screening items based on the results of a pretest conducted during October 2017 to February 2018 with a convenience sample of 265 stable COPD patients from the respiratory clinic of 10 grade A tertiary hospitals in China, in combination with item screening using the classical test theory and item response theory. After that, the psychometric properties of the mESQ-COPD were tested using an onsite investigation carried out in a convenience sample of 365 stable COPD patients from the respiratory clinic of six grade A tertiary hospitals in China from November 2018 to February 2019.

The final mESQ-COPD includes four domains (clinical symptoms, capabilities for work and life, ability of environmental adaptation, and therapeutic effect) and 19 items. The Cronbach's α of the questionnaire was 0.949, and that of the four domains was 0.943, 0.869, 0.829, and 0.767, respectively. The correlation coefficient between the domain of clinical symptoms, capabilities for work and life, ability of environmental adaptation, or therapeutic effect and its component items ranged from 0.667 to 0.798, 0.855 to 0.882, 0.795 to 0.907, or 0.857 to 0.934, respectively. Confirmatory factor analysis showed that the comparative fit index, incremental fit index, non-normed fit index, standardized root mean square residual, and root mean square error of approximation measuring the construct validity of the mESQ-COPD were 0.94, 0.94, 0.93, 0.07, and 0.16, respectively. The correlation coefficients of the mESQ-COPD and its domains with COPD assessment test ranged from 0.371 to 0.538, while those of the mESQ-COPD and its domains with the modified Medical Research Council scale ranged from 0.329 to 0.564. The differences in the total score and domain scores of the mESQ-COPD between mild/moderate and severe/extremely severe COPD patients were both statistically significant (P<0.01). The acceptance rate of the mESQ-COPD was 99.5%, and the completion rate was 99.2%, with a mean completion time of (6.13±4.59) min.

The 19-item mESQ-COPD (consists of four domains: clinical symptoms, ability of work and life, capability for environmental adaptation, and therapeutic effect) has good reliability, validity, and applicability, which could be used to support the efficacy evaluation in COPD.

基于经典测量理论研制的病证结合慢性阻塞性肺疾病患者疗效满意度问卷（ESQ-COPD）尚存在局限性，而联合应用经典测量理论和项目反应理论可实现优势互补，为研制/修订测评工具提供理论基础与方法学支撑。

研制病证结合ESQ-COPD修订版（mESQ-COPD），并进行测量学特性评价。

通过成立ESQ-慢性阻塞性肺疾病（COPD）修订小组、预设问卷基本特征、规范基本概念和术语、修订概念框架、建立条目池和评阅条目等环节，形成mESQ-COPD草表；2017年10月至2018年2月，采用方便抽样法选取全国10家三级甲等医院呼吸科门诊收治的COPD稳定期患者265例进行预调查，联合应用经典测量理论和项目反应理论分析与筛选条目，形成mESQ-COPD；2018年11月至2019年2月，采用方便抽样法选取全国6家三级甲等医院呼吸科门诊收治的COPD稳定期患者365例进行现场调查，评价mESQ-COPD测量学特性。

最终形成的mESQ-COPD包括4个领域（临床症状、工作生活能力、环境适应能力和治疗效果）、19个条目。mESQ-COPD的Cronbach's α系数为0.949，临床症状、工作生活能力、环境适应能力和治疗效果4个领域的Cronbach's α系数分别为0.943、0.869、0.829、0.767；条目与所在领域相关系数分别为0.667~0.798、0.855~0.882、0.795~0.907、0.857~0.934；验证性因子分析结果显示，比较拟合指数、增量拟合指数均为0.94、非规范拟合指数为0.93，标准化残差均方根为0.07，近似误差均方根为0.16；mESQ-COPD及各领域与COPD评估测试的相关系数为0.371~0.538，与改良版医学研究委员会呼吸困难量表（mMRC）的相关系数为0.329~0.564；肺功能1、2级与肺功能3、4级患者mESQ-COPD及各领域得分比较，差异有统计学意义（P<0.01）；问卷接受率为99.5%，完成率为99.2%，平均完成时间为（6.13±4.59）min。

mESQ-COPD由19个条目组成，包括临床症状、工作生活能力、环境适应能力和治疗效果4个领域，具有良好的信度、效度和临床可行性，为COPD疗效评价提供了有效工具。