Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, AZ, USA.
Patient. 2012;5(1):21-6. doi: 10.2165/11595840-000000000-00000.
BACKGROUND: Electronic data capture technologies, such as interactive voice response (IVR) systems, are emerging as important alternatives for collecting patient-reported outcome data. OBJECTIVE: The objective of this study was to assess the test-retest reliability of an IVR version of the EQ-5D. METHODS: Outpatient cancer clinic patients (n = 127) were asked to complete the IVR-based EQ-5D twice, 2 days apart. The analyses tested for mean differences (paired t-test) and test-retest reliability (intraclass correlation coefficient [ICC]) to assess measurement stability over time. Equivalence of the means was established if the 95% confidence interval (CI) was within the minimally important difference (MID) interval; namely -0.035 to 0.035 for the EQ-5D index and -3.0 to 3.0 for the visual analog scale (i.e. EQ VAS). Adequacy of the ICC was established by testing whether it differed from a value of 0.70. RESULTS: Both administrations were completed per protocol by 114 subjects (EQ-5D index) and 110 subjects (EQ VAS). For the EQ-5D index, the means (SD) of the first and second administrations were 0.871 (0.14) and 0.871 (0.15), respectively. The 95% CI of the mean difference was -0.013, 0.013, within the equivalence interval. The ICC was 0.876 (95% lower bound of 0.826) and was significantly different from 0.70. The EQ VAS means (SD) were 81.3 (17.5) and 80.8 (17.5), respectively. The 95% CI of the mean difference was -0.598, 1.617, within the equivalence interval. The EQ VAS ICC was 0.944 (95% lower bound of 0.919) and was significantly greater than 0.70. CONCLUSION: This analysis provides substantial evidence that the scores obtained from the IVR version of the EQ-5D are reliable upon repeated administrations.
背景:电子数据采集技术(如交互式语音应答(IVR)系统)正逐渐成为收集患者报告结局数据的重要替代方法。
目的:本研究旨在评估 IVR 版 EQ-5D 的重测信度。
方法:127 名门诊癌症患者(n=127)被要求在两天内完成两次 IVR 版 EQ-5D。分析测试了均值差异(配对 t 检验)和重测信度(组内相关系数[ICC]),以评估随时间推移的测量稳定性。如果 95%置信区间(CI)在最小重要差异(MID)区间内(即 EQ-5D 指数为 -0.035 至 0.035,视觉模拟量表[EQ VAS]为 -3.0 至 3.0),则认为均值等效;即 EQ-5D 指数为 -0.035 至 0.035,视觉模拟量表(EQ VAS)为 -3.0 至 3.0。通过测试 ICC 是否与 0.70 不同来确定 ICC 是否充足。
结果:114 名受试者(EQ-5D 指数)和 110 名受试者(EQ VAS)均按方案完成了两次评估。EQ-5D 指数的第一次和第二次测量的平均值(SD)分别为 0.871(0.14)和 0.871(0.15)。均值差异的 95%CI 为 -0.013,0.013,在等效区间内。ICC 为 0.876(95%置信区间的下限为 0.826),显著高于 0.70。EQ VAS 的平均值(SD)分别为 81.3(17.5)和 80.8(17.5)。均值差异的 95%CI 为 -0.598,1.617,在等效区间内。EQ VAS 的 ICC 为 0.944(95%置信区间的下限为 0.919),显著高于 0.70。
结论:本分析提供了充分的证据表明,从 IVR 版 EQ-5D 获得的分数在重复测量时是可靠的。
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