Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients
Neuro-Oncology, vol. 23, pp. 1327–1336
Abstract
BACKGROUND: Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients. METHODS: Clinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (>0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence. RESULTS: A total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and -4 to -14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and -4 to -16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10). CONCLUSIONS: MIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials.
Authors 15
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Leiden University Medical Center · Medisch Centrum Haaglanden · Stichting Haaglanden Medisch Centrum
Affiliation as printed
Department of Neurology, Haaglanden Medical Center, The Hague, the Netherlands
Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands
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European Organisation for Research and Treatment of Cancer · European Organisation for Research and Treatment of Cancer
Affiliation as printed
European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium
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European Organisation for Research and Treatment of Cancer · European Organisation for Research and Treatment of Cancer
Affiliation as printed
European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium
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Amsterdam University Medical Centers · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Neurology & Brain Tumor Center, Amsterdam University Medical Centers, location VU University Medical Center, Amsterdam, the Netherlands
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Leiden University Medical Center · Medisch Centrum Haaglanden · Stichting Haaglanden Medisch Centrum
Affiliation as printed
Department of Neurology, Haaglanden Medical Center, The Hague, the Netherlands
Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands
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University of Leeds · St James's University Hospital
Affiliation as printed
Faculty of Medicine and Health, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
Leeds Institute of Medical Research at St James’s, St James’s University Hospital, Leeds, UK
Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK
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University of Copenhagen · Frederiksberg Hospital · St James's University Hospital · Bispebjerg Hospital
Affiliation as printed
Departments of Public Health and Palliative Medicine, University of Copenhagen and Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Leeds Institute of Medical Research at St James’s, St James’s University Hospital, Leeds, UK
Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK
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Affiliation as printed
Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands
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Affiliation as printed
Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA
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St James's University Hospital
Affiliation as printed
Leeds Institute of Medical Research at St James’s, St James’s University Hospital, Leeds, UK
Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK
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Adelphi Group (United Kingdom)
Affiliation as printed
Adelphi Values, Bollington, Cheshire, UK
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Cancer Center Amsterdam · University of Amsterdam
Affiliation as printed
Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam University Medical Centers, location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
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Affiliation as printed
Faculty of Science, School of Psychology, University of Sydney, Sydney, NSW, Australia
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Otto-von-Guericke-Universität Magdeburg
Affiliation as printed
Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany
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European Organisation for Research and Treatment of Cancer · European Organisation for Research and Treatment of Cancer
Affiliation as printed
European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium
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