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Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma
- Source :
- Health and Quality of Life Outcomes, Vol 8, Iss 1, p 79 (2010), Health and Quality of Life Outcomes
- Publication Year :
- 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.
- Subjects :
- Gerontology
Adult
Male
medicine.medical_specialty
Longitudinal study
Psychometrics
lcsh:Computer applications to medicine. Medical informatics
Interviews as Topic
Quality of life
Internal medicine
Surveys and Questionnaires
medicine
Health Status Indicators
Humans
Longitudinal Studies
Multiple myeloma
Aged
Retrospective Studies
Aged, 80 and over
Analysis of Variance
business.industry
Norway
Research
Public Health, Environmental and Occupational Health
Reproducibility of Results
Retrospective cohort study
General Medicine
Middle Aged
Reference Standards
medicine.disease
humanities
Clinical trial
Quality of Life
lcsh:R858-859.7
Female
Analysis of variance
business
Multiple Myeloma
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Health and Quality of Life Outcomes, Vol 8, Iss 1, p 79 (2010), Health and Quality of Life Outcomes
- Accession number :
- edsair.doi.dedup.....fc736b02e0f4449b52a86b4f41b7997a