Department of Haematology, Oslo University Hospital, Ullevaal Faculty of Medicine, University of Oslo, Oslo, Norway.
Eur J Haematol. 2011 Oct;87(4):330-7. doi: 10.1111/j.1600-0609.2011.01665.x. Epub 2011 Jul 26.
The aims of this study were to (i) compare the responsiveness of the EORTC QLQ-C30 cancer-specific questionnaire and the generic questionnaires EQ-5D and 15D used for economic evaluation of healthcare interventions and (ii) determine the minimal important differences (MIDs) in these questionnaires. The MID is the smallest change in a quality-of-life score considered important to patients.
Between 2006 and 2008, 239 patients with multiple myeloma completed the questionnaires at inclusion (T1) and after 3 months (T2). At T2, patients were asked whether they had noticed any change in their quality of life. Responsiveness and MIDs were determined by mean score changes (T2-T1) for patients who, in the interview, stated they had improved, deteriorated, or were unchanged. Responsiveness was also assessed using standardized response means. Wilcoxon tests for pair differences were used to evaluate the statistical significance of the changes.
Patients who improved had significantly (P < 0.01) higher scores at T2 in all three questionnaires. Patients who deteriorated reported lower scores at T2; however, for the 15D, the differences in score were not statistically significant. The MIDs for the QLQ-C30, EQ-5D, and 15D were 8, 0.08, and 0.03 in patients who improved and 12, 0.10 and 0.02 in patients who deteriorated, respectively.
All three questionnaires showed an acceptable responsiveness in patients who improved. However, the 15D did not respond optimally in patients who deteriorate and cannot be recommended for use in patients with myeloma.
本研究旨在:(i) 比较 EORTC QLQ-C30 癌症特异性问卷与用于医疗保健干预经济评估的通用问卷 EQ-5D 和 15D 的反应能力,以及 (ii) 确定这些问卷的最小重要差异 (MID)。MID 是患者认为重要的生活质量评分的最小变化。
在 2006 年至 2008 年期间,239 名多发性骨髓瘤患者在纳入时 (T1) 和 3 个月后 (T2) 完成了问卷。在 T2 时,患者被问及他们是否注意到生活质量有任何变化。通过在访谈中表示有所改善、恶化或保持不变的患者的平均评分变化 (T2-T1) 来确定反应能力和 MID。还使用标准化反应均值来评估反应能力。使用 Wilcoxon 检验对差值进行配对差异的统计显著性评估。
在所有三个问卷中,报告改善的患者在 T2 的得分明显更高 (P < 0.01)。报告恶化的患者在 T2 的得分较低;然而,对于 15D,评分的差异无统计学意义。在有所改善的患者中,QLQ-C30、EQ-5D 和 15D 的 MID 分别为 8、0.08 和 0.03,在恶化的患者中,分别为 12、0.10 和 0.02。
在有所改善的患者中,所有三个问卷都表现出可接受的反应能力。然而,15D 在恶化的患者中反应不佳,不建议用于骨髓瘤患者。