Department of Public Health, Shihezi University School of Medicine, Shihezi, Xinjiang, China.
Department of Obstetrics and Gynaecology, The First Affiliated Hospital of Shihezi University School of Medicine, Shihezi, Xinjiang, China.
Health Qual Life Outcomes. 2020 Oct 2;18(1):324. doi: 10.1186/s12955-020-01578-8.
With the widespread clinical application of the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L), whether the questionnaire scores are responsive to changes in patients' health and how much changes in questionnaire scores represent patients' real health changes require consideration. Consequently, we assessed responsiveness and estimated the minimal clinically important difference (MCID) of the EQ-5D-5L in surgically treated patients with cervical intraepithelial neoplasia (CIN) to determine the relationship between MCID and minimal detectable change (MDC).
We conducted a longitudinal, observational study. Participants were patients with CIN from the gynecology inpatient department of a grade-A tertiary hospital in Shihezi, Xinjiang, China. Participants completed the EQ-5D-5L and the Global Rating of Change Questionnaire (GRCQ) at baseline and one month post-surgery. The Wilcoxon signed-rank test was used to compare EQ-5D-5L scores pre- and post-treatment. We calculated the effect size (ES) and the standardized response mean (SRM) to quantitatively assess responsiveness. Distribution-based, anchor-based, and instrument-defined methods were used to estimate MCID. MCID to MDC ratios at individual- and group-levels were also calculated.
Fifty patients with CIN completed the follow-up investigation (mean age 44.76 ± 8.72 years; mean follow-up time 32.28 ± 1.43 days). The index value and EQ visual analogue scale (EQ VAS) of the EQ-5D-5L improved by 0.025 and 6.92 (all p < 0.05) at follow-up as compared to baseline respectively. The ES and the SRM of the index value were 0.47 and 0.42 respectively, indicating small responsiveness; while the ES and the SRM of EQ VAS were 0.50 and 0.49 respectively, indicating small to moderate responsiveness. The average (range) of MCIDs for index value and EQ VAS were 0.039 (0.023-0.064) and 5.35 (3.12-6.99) respectively. These values can only be used to determine whether patients have experienced clinically meaningful health improvements at the group level.
The EQ-5D-5L has only small to moderate responsiveness in post-surgical patients with CIN, and the MCIDs developed in this study can be used for group-level health assessment. However, further study is needed concerning health changes at the individual level.
随着欧洲五维健康量表（EQ-5D-5L）五级版本在临床上的广泛应用，问卷评分是否能对患者健康变化做出反应，以及问卷评分变化多少才能代表患者真实的健康变化，这些问题都需要考虑。因此，我们评估了手术治疗的宫颈上皮内瘤变（CIN）患者的 EQ-5D-5L 的反应性，并估计了最小临床重要差异（MCID），以确定 MCID 与最小可检测变化（MDC）之间的关系。
我们进行了一项纵向观察性研究。参与者为来自中国新疆石河子市一家甲级三级医院妇科住院部的 CIN 患者。参与者在基线和手术后一个月时完成了 EQ-5D-5L 和全球变化量表（GRCQ）的评估。采用 Wilcoxon 符号秩检验比较治疗前后的 EQ-5D-5L 评分。我们使用效应量（ES）和标准化反应均值（SRM）来定量评估反应性。使用基于分布、基于锚定和基于工具的方法来估计 MCID。还计算了个体和群体水平的 MCID 与 MDC 的比值。
50 名 CIN 患者完成了随访调查（平均年龄 44.76±8.72 岁；平均随访时间 32.28±1.43 天）。与基线相比，EQ-5D-5L 的指标值和 EQ 视觉模拟量表（EQ VAS）分别提高了 0.025 和 6.92（均 p<0.05）。指标值的 ES 和 SRM 分别为 0.47 和 0.42，表明反应较小；而 EQ VAS 的 ES 和 SRM 分别为 0.50 和 0.49，表明反应为小到中度。指标值和 EQ VAS 的平均（范围）MCID 分别为 0.039（0.023-0.064）和 5.35（3.12-6.99）。这些值只能用于确定患者在群体水平上是否经历了有临床意义的健康改善。
在手术治疗的 CIN 患者中，EQ-5D-5L 仅具有小到中度的反应性，本研究中开发的 MCID 可用于群体健康评估。然而，仍需要进一步研究个体层面的健康变化。
