Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
National Institute of Public Health, University of Southern Denmark, Odense, Denmark.
Qual Life Res. 2019 May;28(5):1245-1253. doi: 10.1007/s11136-018-02098-1. Epub 2019 Jan 4.
Patient-reported health-related quality of life is a complementary healthcare outcome and important when assessing treatment efficacy. Using COSMIN methodological recommendations, this study evaluates the validity and reliability of a core heart disease-specific health-related quality of life questionnaire, the HeartQoL questionnaire (Danish version) in a sample of patients following heart valve surgery.
This project involved a cross-sectional validity study and a test-retest reliability study.
Eligible patients completed the HeartQoL, the SF-36 health survey questionnaire, and the Hospital Anxiety and Depression Scale following heart valve surgery. Construct validity was tested using a priori hypotheses. Internal consistency reliability was assessed with Cronbach's alpha. An independent sample of patients participated in the test-retest study and reproducibility was determined with relative [intra-class correlation coefficient (ICC)] and absolute reliability [standard error of measurement (SEM) and smallest detectable change (SDC)].
Internal consistency was high with Cronbach's alpha ≥ 0.87. ICC was 0.86-0.92. SEM ranged from 0.17 to 0.26 points and SDC ranged from 0.5 to 0.7 points. Construct validity was confirmed with 87% of all a priori hypotheses for predicted variables.
The HeartQoL questionnaire demonstrates acceptable construct validity, internal consistency, and test-retest reproducibility in patients following heart valve surgery. Future studies should focus on assessing the responsiveness of the HeartQoL questionnaire over time and following heart valve surgery.
患者报告的健康相关生活质量是一种补充性的医疗保健结果，在评估治疗效果时非常重要。本研究采用 COSMIN 方法学建议，在心脏瓣膜手术后的患者样本中评估了核心心脏病特异性健康相关生活质量问卷 HeartQoL 问卷（丹麦语版）的有效性和可靠性。
本项目涉及一项横断面有效性研究和一项测试-重测可靠性研究。
符合条件的患者在心脏瓣膜手术后完成了 HeartQoL、SF-36 健康调查问卷和医院焦虑和抑郁量表。结构有效性通过先验假设进行测试。内部一致性可靠性用 Cronbach's alpha 评估。另一组独立的患者参与了测试-重测研究，通过相对 [组内相关系数 (ICC)] 和绝对可靠性 [测量误差 (SEM) 和最小可检测变化 (SDC)] 来确定可重复性。
Cronbach's alpha 值≥0.87，内部一致性较高。ICC 为 0.86-0.92。SEM 范围为 0.17 至 0.26 分，SDC 范围为 0.5 至 0.7 分。87%的预测变量的先验假设得到了结构有效性的验证。
HeartQoL 问卷在心脏瓣膜手术后的患者中具有可接受的结构有效性、内部一致性和测试-重测可重复性。未来的研究应重点评估 HeartQoL 问卷随时间推移和心脏瓣膜手术后的反应能力。
