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Health and Quality of Life Outcomes

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Open Access 01-12-2010 | Research

Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma

Authors: Ann K Kvam, Finn Wisløff, Peter M Fayers

Published in: Health and Quality of Life Outcomes | Issue 1/2010

Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

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.

Trial registration

The study is registered at clinicaltrials.gov, identifier NCT00290095.

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Title: Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma
Authors: Ann K Kvam
Finn Wisløff
Peter M Fayers
Publication date: 01-12-2010
Publisher: BioMed Central
Published in: Health and Quality of Life Outcomes / Issue 1/2010
Electronic ISSN: 1477-7525
DOI: https://doi.org/10.1186/1477-7525-8-79

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma

Abstract

Background

Methods

Results

Conclusions

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

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