J Maringwa1, C Quinten2, M King3, J Ringash4, D Osoba5, C Coens2, F Martinelli2, B B Reeve6, C Gotay7, E Greimel8, H Flechtner9, C S Cleeland10, J Schmucker-Von Koch11, J Weis12, M J Van Den Bent13, R Stupp14, M J Taphoorn15, A Bottomley2. 1. Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium. Electronic address: john.maringwa@eortc.be. 2. Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium. 3. Psycho-oncology Co-operative Research Group, University of Sydney, Sydney, Australia. 4. Department of Radiation Oncology, The Princess Margaret Hospital, University of Toronto, Toronto. 5. Quality of Life Consulting, West Vancouver, Canada. 6. Department of Health Policy and Management, Gillings School of Global Public Health, University of North Caroline at Chapel Hill, Chapel Hill, USA. 7. Department of Health Care and Epidemiology, School of Population and Public Health, University of British Columbia, Vancouver, Canada. 8. Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria. 9. Department of Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany. 10. Department of Symptom Research, University of Texas, Houston, USA. 11. Medical Ethics, University of Regensburg, Regensburg. 12. Department of Rehabilitation Psychology, Tumor Biology Center, University of Freiburg, Freiburg, Germany. 13. AZ Rotterdam-Daniel Den Hoed Kliniek, Rotterdam, The Netherlands. 14. Department of Neurosurgery, Multidisciplinary Center for Oncology, University Hospital CHUV, Lausanne, Switzerland. 15. Department of Neurology, Medical Center Haaglanden, The Hague, Netherlands.
Abstract
BACKGROUND: We aimed to determine the smallest changes in health-related quality of life (HRQoL) scores in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 and the Brain Cancer Module (QLQ-BN20), which could be considered as clinically meaningful in brain cancer patients. MATERIALS AND METHODS:World Health Organisation performance status (PS) and mini-mental state examination (MMSE) were used as clinical anchors appropriate to related subscales to determine the minimal clinically important differences (MCIDs) in HRQoL change scores (range 0-100) in the QLQ-C30 and QLQ-BN20. A threshold of 0.2 standard deviation (SD) (small effect) was used to exclude anchor-based MCID estimates considered too small to inform interpretation. RESULTS: Based on PS, our findings support the following integer estimates of the MCID for improvement and deterioration, respectively: physical (6, 9), role (14, 12), and cognitive functioning (8, 8); global health status (7, 4*), fatigue (12, 9), and motor dysfunction (4*, 5). Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7). Estimates with asterisks were <0.2 SD and were excluded from our MCID range of 5-14. CONCLUSION: These estimates can help clinicians evaluate changes in HRQoL over time, assess the value of a health care intervention and can be useful in determining sample sizes in designing future clinical trials.
RCT Entities:
BACKGROUND: We aimed to determine the smallest changes in health-related quality of life (HRQoL) scores in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 and the Brain Cancer Module (QLQ-BN20), which could be considered as clinically meaningful in brain cancerpatients. MATERIALS AND METHODS: World Health Organisation performance status (PS) and mini-mental state examination (MMSE) were used as clinical anchors appropriate to related subscales to determine the minimal clinically important differences (MCIDs) in HRQoL change scores (range 0-100) in the QLQ-C30 and QLQ-BN20. A threshold of 0.2 standard deviation (SD) (small effect) was used to exclude anchor-based MCID estimates considered too small to inform interpretation. RESULTS: Based on PS, our findings support the following integer estimates of the MCID for improvement and deterioration, respectively: physical (6, 9), role (14, 12), and cognitive functioning (8, 8); global health status (7, 4*), fatigue (12, 9), and motor dysfunction (4*, 5). Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7). Estimates with asterisks were <0.2 SD and were excluded from our MCID range of 5-14. CONCLUSION: These estimates can help clinicians evaluate changes in HRQoL over time, assess the value of a health care intervention and can be useful in determining sample sizes in designing future clinical trials.
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