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Health and Quality of Life Outcomes

, 8:79

First Online: 03 August 2010Received: 27 March 2010Accepted: 03 August 2010

Abstract

BackgroundWe 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.

MethodsBetween 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.

ResultsWe 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.

ConclusionsMIDs 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.

Trial registrationThe study is registered at clinicaltrials.gov, identifier NCT00290095.

Electronic supplementary materialThe online version of this article doi:10.1186-1477-7525-8-79 contains supplementary material, which is available to authorized users.

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Autor: Ann K Kvam - Finn Wisløff - Peter M Fayers

Fuente: https://link.springer.com/



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