Patient-Reported Outcome Consortium, Critical Path Institute, 1730 E River Road, Tucson, AZ, 85718-5893, USA,
Qual Life Res. 2014 Feb;23(1):229-37. doi: 10.1007/s11136-013-0454-1. Epub 2013 Jun 14.
The objective of this study was to evaluate the measurement equivalence of an interactive voice response system (IVRS) version and the original paper-based version of the EORTC QLQ-C30.
The QLQ-C30 is a cancer-specific, health-related quality of life questionnaire consisting of nine multi-item scales (physical, role, emotional, cognitive and social functioning, fatigue, nausea/vomiting, pain, and quality of life) and six single item measures (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial problems). This study utilized a crossover design with subjects randomly assigned to one of two assessment orders: (1) paper then IVRS or (2) IVRS then paper. Equivalence between the two administration modes was established by comparing the 95% lower confidence interval (CI) of the intraclass correlation coefficients (ICCs) for each scale, with a critical value of 0.70.
The ICCs for the nine multi-item scales were all above 0.79, ranging from 0.791 to 0.899 (ICC 95% lower CI range 0.726-0.865) and significantly different from our threshold reliability of 0.70. The ICCs for the six single items ranged from 0.689 to 0.896 (ICC 95% lower CI range 0.611-0.888). Two of the items, insomnia and appetite loss, were not statistically different from 0.70. When considered together, the per-protocol analysis results support the equivalence of the paper and IVRS versions of the QLQ-C30 for 13 of the 15 scores.
This analysis provides evidence that the scores obtained from the IVRS version of the QLQ-C30 are equivalent to those obtained with the original paper version except for the insomnia and appetite loss items.
本研究旨在评估交互式语音应答系统（IVRS）版本与原始纸质版 EORTC QLQ-C30 的测量等效性。
QLQ-C30 是一种癌症特异性的健康相关生活质量问卷，由 9 个多项目量表（身体、角色、情感、认知和社会功能、疲劳、恶心/呕吐、疼痛和生活质量）和 6 个单项测量组成（呼吸困难、失眠、食欲减退、便秘、腹泻和经济问题）。本研究采用交叉设计，将受试者随机分配到两种评估顺序之一：（1）纸质版然后 IVRS 版，或（2）IVRS 版然后纸质版。通过比较每个量表的组内相关系数（ICC）的 95%置信区间（CI）的下限，建立两种管理模式之间的等效性，临界值为 0.70。
九个多项目量表的 ICC 均高于 0.79，范围从 0.791 到 0.899（ICC 95%置信区间下限范围为 0.726-0.865），与我们的 0.70 可靠性阈值显著不同。六个单项项目的 ICC 范围从 0.689 到 0.896（ICC 95%置信区间下限范围为 0.611-0.888）。其中两个项目，失眠和食欲减退，与 0.70 没有统计学差异。当综合考虑时，方案分析结果支持纸质版和 IVRS 版 QLQ-C30 的 13 个评分中的 12 个等效。
本分析提供了证据表明，除了失眠和食欲减退项目外，从 IVRS 版 QLQ-C30 获得的分数与原始纸质版的分数等效。
