Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types
European Journal of Cancer, vol. 188, pp. 171–182
Abstract
INTRODUCTION: Early guidelines for minimally important differences (MIDs) for the EORTC QLQ-C30 proposed ≥10 points change as clinically meaningful for all scales. Increasing evidence that MIDs can vary by scale, direction of change, cancer type and estimation method has raised doubt about a single global standard. This paper identifies MID patterns for interpreting group-level change in EORTC QLQ-C30 scores across nine cancer types. METHODS: Data were obtained from 21 published EORTC Phase III trials that enroled 13,015 patients across nine cancer types (brain, colorectal, advanced breast, head/neck, lung, mesothelioma, melanoma, ovarian, and prostate). Anchor-based MIDs for within-group change and between-group differences in change over time were obtained via mean change method and linear regression, respectively. Separate MIDs were estimated for improvements and deteriorations. Distribution-based estimates were derived and compared with anchor-based MIDs. RESULTS: Anchor-based MIDs mostly ranged from 5 to 10 points. Differences in MIDs for improvement vs deterioration, for both within-group and between-group, were mostly within a 2-points range. Larger differences between within-group and between-group MIDs were observed for several scales in ovarian, lung and head/neck cancer. Most anchor-based MIDs ranged between 0.3 SD and 0.5 SD distribution-based estimates. CONCLUSIONS: Our results reinforce recent claims that no single MID can be applied to all EORTC QLQ-C30 scales and disease settings. MIDs varied by scale, improvement/deterioration, within/between comparisons and by cancer type. Researchers applying commonly used rules of thumb must be aware of the risk of dismissing changes that are clinically meaningful or underpowering analyses when smaller MIDs apply.
Authors 20
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Jammbe Z. Musoro corresponding
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. Electronic address: jammbe.musoro@eortc.org
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 UMC Location University of Amsterdam · Cancer Center Amsterdam
Affiliation as printed
Amsterdam UMC Location University of Amsterdam, Medical Psychology, Amsterdam, The Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, The Netherlands
Amsterdam UMC Location University of Amsterdam, Medical Psychology, Amsterdam, The Netherlands
Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, The Netherlands
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Affiliation as printed
Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden
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University of Copenhagen · Bispebjerg Hospital
Affiliation as printed
Department of Public Health, University of Copenhagen, and Bispebjerg Hospital, Copenhagen, Denmark
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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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Adelphi Group (United Kingdom)
Affiliation as printed
Adelphi Values, Bollington, Cheshire, UK
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University of Leeds · Leeds Teaching Hospitals NHS Trust · St James's University Hospital
Affiliation as printed
Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, UK; Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, St James's University Hospital, Leeds, UK
Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, St James's University Hospital, Leeds, UK
Leeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, UK
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Leiden University Medical Center · Medisch Centrum Haaglanden · Stichting Haaglanden Medisch Centrum
Affiliation as printed
Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands
Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands
Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands
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Affiliation as printed
Medical University Graz, Graz, Austria
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Johannes Gutenberg University Mainz · University Medical Center of the Johannes Gutenberg University Mainz
Affiliation as printed
Institute of Medical Biostatistics, Epidemiology and Informatics, Division of Epidemiology and Health Services Research, University Medical Centre Mainz, Germany; University Cancer Centre Mainz, Germany
Institute of Medical Biostatistics, Epidemiology and Informatics, Division of Epidemiology and Health Services Research, University Medical Centre Mainz, Germany
University Cancer Centre Mainz, Germany
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The Maria Sklodowska-Curie National Research Institute of Oncology
Affiliation as printed
Departmenf of Breast Cancer and Reconstructive Surgery, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland
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Affiliation as printed
Innsbruck Institute of Patient-centered Outcome Research (IIPCOR), Innsbruck, Austria
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Affiliation as printed
School of Health Sciences, University of Southampton, Southampton, UK
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University Medical Center Utrecht · Princess Máxima Center · Technical University of Munich · Ludwig-Maximilians-Universität München
Affiliation as printed
Princess Máxima Center, Utrecht and University Medical Center Utrecht, The Netherlands; Comprehensive Cancer Center Munich, Technical University Munich & Ludwig Maximiliaan University, Munich, Germany
Comprehensive Cancer Center Munich, Technical University Munich & Ludwig Maximiliaan University, Munich, Germany
Princess Máxima Center, Utrecht and University Medical Center Utrecht, The Netherlands
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University Hospital Regensburg · University of Regensburg
Affiliation as printed
Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany
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Amsterdam University Medical Centers · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam University Medical Centers, location VU University Medical Center, Department of Neurology Brain Tumor 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, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands
Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands
Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands
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Affiliation as printed
University of Sydney, Faculty of Science, School of Psychology, Sydney, NSW, Australia
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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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