Page 112 - 2022-22-中国全科医学

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and item response theory may achieve complementary advantages，which may be a theoretical basis and methodological support
for the development or revision of instruments. Objective To develop a modified ESQ-COPD（mESQ-COPD） based on the
combination of disease and syndrome，and to evaluate its psychometric properties. Methods 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. Results 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. Conclusion 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.
【Key words】 Pulmonary disease，chronic obstructive；Patient satisfaction；Treatment outcome；Classical test
theory；Item response theory

慢 性 阻 塞 性 肺 疾 病（chronic obstructive pulmonary 太大，各参数指标之间的配套性较差等 ［11］ 。项目反应
disease，COPD）是一种常见的、以持续呼吸症状和气 理论则是针对经典测量理论局限性提出来的一种现代测
流受限为特征的、可以预防和治疗的疾病，严重危害 量理论，具有项目参数的跨群体不变性、潜在特质量表
公众健康 ［1］ 。美国成人 COPD 患病率为 12% ［2］ ，我国 的可选择性、参数设计的科学性、信息函数概念的引进
40 岁以上人群 COPD 患病率达 13.7% ［3］ ，COPD 位居 与信息函数的可加性等特点，已被广泛用于测评工具条
我国主要死因第 3 位 ［4］ 。近年来，国内外 COPD 临床 目的筛选 ［11］ 。联合应用两种测量理论可实现优势互补，
试验取得较大进展，而疗效指标的选择、测量和比较是 为研制 / 修订测评工具提供理论基础与方法学支撑。因
评价各种干预措施临床疗效的关键。根据来源不同，疗 此，本研究遵循国际量表研制规范，结合以往研究经验，
效指标可分为生物标记物和临床结局评估 ［5］ 。患者报 联合应用经典测量理论和项目反应理论对 ESQ-COPD
告结局作为临床结局评估方法之一，是从患者自身的角 进行修订，形成病证结合 ESQ-COPD 修订版（mESQ-
度报告患者的健康状态和治疗结果，其中疗效满意度是 COPD），并评价其测量学特性，以期为 COPD 临床疗
其独特组成部分 ［6］ 。课题组曾基于经典测量理论研制 效评价提供新的有效工具。
了由 18 个条目组成的病证结合 COPD 患者疗效满意度 1 对象与方法
问卷（Effectiveness Satisfaction Questionnaire for COPD， 1.1 成立 ESQ-COPD 修订小组 参照国际量表研制规
ESQ-COPD），包括工作生活能力、临床症状、治疗效 范，成立 ESQ-COPD 修订小组，负责概念框架、条目
果、治疗方便和总体疗效 5 个领域，为 COPD 临床疗效 管理和数据管理等工作。此外，成立由量表学、呼吸病
评价提供了有效工具 ［7-10］ 。经典测量理论具有数学模 学（中医、西医和中西医结合）和卫生统计学等多个领
型简单等优点，是应用最广泛的测量理论，主要用于条 域专家组成的专家委员会，负责为本研究提供技术指导。
目筛选和测评工具评价。随着测量实践不断深入，经典 1.2 预设问卷特征，规范概念和术语 预设问卷类型
测量理论局限性日益显现，表现在信度估计精度不高， 及目的、适用对象、条目形式、反应尺度、回忆周期、
误差指标笼统、单一，各种参数的估计对样本的依赖性 条目数量及顺序、计分规则和管理方式等，见表 1。规