Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma.
Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma.
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DOI：
10.1186/1477-7525-8-79
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发表时间：
2010-08-03
影响因子：
3.6
通讯作者：
Fayers PM
中科院分区：
文献类型：
--
作者：
Kvam AK;Wisløff F;Fayers PM
我们之前报道过EORTC QLQ-C30评分6- 17%的变化对于多发性骨髓瘤患者来说是重要的，因此可以认为是最小重要差异（mid）。然而，患者的内部测量标准可能随着时间的推移而改变（反应移位，RS）。在目前的工作中，我们评估了骨髓瘤患者是否经历RS，以及这是否会影响mid估计。2006年至2008年间，239名多发性骨髓瘤患者在基线（T1）和3个月后（T2）完成了EORTC QLQ-C30。在T2时，询问患者是否注意到疼痛、疲劳、身体功能和整体生活质量方面的任何变化。他们还被要求对他们在所有四个领域的基线值作出回顾性判断。我们在骨髓瘤患者中发现了明显的RS证据。然而，在声称改善和恶化的患者之间，在程度和方向上都存在差异。病情恶化的患者回顾性报告T1时疼痛、疲劳和身体功能的健康相关生活质量较好。在这些患者中，观察到经RS调整的mid增加了12个百分点。相比之下，对于声称改善的患者，我们只在总体生活质量领域发现了统计学上显著的RS证据。从测试前/测试后数据估计的MIDs对于报告在3个月内改善的患者的RS似乎是稳健的。这可能表明RS对对治疗有反应的患者的结果影响最小，并且RS可能对临床试验中出现改善的变化报告的解释没有重要影响。虽然RS的效应量很小，但恶化患者的RS可能对临床试验中报告的变化的解释有重要影响。该研究已在clinicaltrials.gov注册，标识符NCT00290095。
We previously reported that changes of 6-17 percent in the EORTC QLQ-C30 scores are regarded important by patients with multiple myeloma and thus may be considered as Minimal Important Differences (MIDs). However, patients' internal standard of measurement may have changed over time (response shift, RS). In the present work, we evaluated whether myeloma patients experience RS and if this could affect the MID-estimates. Between 2006 and 2008, 239 patients with multiple myeloma completed the EORTC QLQ-C30 at baseline (T1) and after three months (T2). At T2, patients were asked if they had noticed any change in the domains pain, fatigue, physical function and global quality of life. They were also asked to give a retrospective judgment of their baseline values on all the four domains. We found clear evidence of RS in myeloma patients. However, there were differences in both magnitude and direction between patients who stated that they improved and those who deteriorated. Deteriorating patients retrospectively reported better health-related quality of life at T1 for the domains pain, fatigue and physical function. In these patients, MIDs adjusted for RS were observed to increase up to 12 percentage points. In contrast, for patients stating that they improved, we only found evidence of statistically significant RS in the domain global quality of life. MIDs estimated from pre-test/post-test data appeared to be robust against RS in patients reporting improvement over 3-months. This could indicate that RS has a minimal impact on the results in patients who respond to treatment, and that RS may not have an important impact on interpretation of changes reported in clinical trials where an improvement occurs. Although the effect sizes of the RSs were small, RS in deteriorating patients may have an important impact on the interpretation of changes reported in clinical trials. The study is registered at clinicaltrials.gov, identifier NCT00290095.
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