6629Plymouth Marjon University, Plymouth, UK.
Faculty of Health, 6633University of Plymouth, Plymouth, UK.
Chron Respir Dis. 2021 Jan-Dec;18:14799731211043530. doi: 10.1177/14799731211043530.
BackgroundThe sensitivity of patient-reported outcomes (PROs) to detect the effects of treatment change depends on the match between the change in items of the PRO and the change that takes place in a sample of people. The aim of this study is to compare the sensitivity of different PROs in detecting changes following the initiation of biologic treatment in asthma. Patients starting a biologic treatment as part of clinical care completed the Asthma Control Questionnaire (ACQ-6), the Severe Asthma Questionnaire (SAQ and SAQ-global scores) and the EQ5D (EQ-5D-5L and EQ5D-VAS) at baseline. They completed the ACQ-6, SAQ, SAQ-global and a retrospective global rating of change (GRoC) scale at weeks 4, 8 and 16 and completed the EQ-5D-5L and EQ5D-VAS at week 16. The SAQ-global and EQ5D-VAS differ but both are single item 100-point questions. Sensitivity was measured by Cohen's D effect size at each of the three time points. 110 patients were recruited. Depending on the time of assessment, effect size varied between 0.45 and 0.64 for the SAQ, between 0.50 and 0.77 for the SAQ-global; between 0.45 and 0.69 for ACQ-6; between 0.91 and 1.22 for GRoC; 0.32 for EQ-5D-5L and 0.49 for EQ5D-VAS. The sensitivity to change of a questionnaire varies with the time of measurement. The three asthma-specific prospective measures (SAQ, SAQ-global and ACQ-6) have similar sensitivity to change. The single-item EQ5D-VAS was less sensitive than the asthma specific measures and less sensitive than the single-item SAQ-global. The EQ-5D-5L was least sensitive.
患者报告结局（PROs）的敏感性（即检测治疗效果改变的能力）取决于 PRO 项目改变与人群中发生的改变之间的匹配程度。本研究旨在比较不同 PRO 在检测哮喘患者开始生物治疗后变化时的敏感性。
患者在临床护理中开始生物治疗时，填写哮喘控制问卷（ACQ-6）、严重哮喘问卷（SAQ 和 SAQ-global 评分）和 EQ5D（EQ-5D-5L 和 EQ5D-VAS）。他们在第 4、8 和 16 周时分别填写 ACQ-6、SAQ、SAQ-global 和回顾性总体变化评分（GRoC）量表，在第 16 周时填写 EQ-5D-5L 和 EQ5D-VAS。SAQ-global 和 EQ5D-VAS 不同，但都是 100 分的单项问题。在每个时间点，敏感性通过 Cohen's D 效应大小进行测量。
共招募了 110 名患者。根据评估时间的不同，SAQ 的效应大小在 0.45 至 0.64 之间，SAQ-global 的效应大小在 0.50 至 0.77 之间，ACQ-6 的效应大小在 0.45 至 0.69 之间，GRoC 的效应大小在 0.91 至 1.22 之间，EQ-5D-5L 的效应大小在 0.32 之间，EQ5D-VAS 的效应大小在 0.49 之间。
问卷对变化的敏感性随测量时间而变化。三种哮喘特异性前瞻性量表（SAQ、SAQ-global 和 ACQ-6）对变化的敏感性相似。单项 EQ5D-VAS 比哮喘特异性量表敏感性差，比单项 SAQ-global 敏感性差。EQ-5D-5L 的敏感性最低。
