Jammbe Z Musoro1, Corneel Coens1, Susanne Singer2,3, Silke Tribius4, Sjoukje F Oosting5, Mogens Groenvold6, Christian Simon7, Jean-Pascal Machiels8, Vincent Grégoire9, Galina Velikova10, Kim Cocks11,12, Mirjam A G Sprangers13, Madeleine T King14, Andrew Bottomley1. 1. European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium. 2. Division of Epidemiology and Health Services Research University Medical Centre, Institute of Medical Biostatistics, Epidemiology and Informatics, Mainz, Germany. 3. University Cancer Centre Mainz, Mainz, Germany. 4. Department of Radiation Oncology, Asklepios Hospital St. Georg, Hamburg, Germany. 5. University Medical Center Groningen, Department of Medical Oncology, University of Groningen, Groningen, The Netherlands. 6. Department of Public Health, University of Copenhagen and Bispebjerg Hospital, Copenhagen, Denmark. 7. Department of Otolaryngology, Head and Neck Surgery, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland. 8. Institut Roi Albert II, Service d'oncologie médicale, Cliniques universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale, U C Louvain, Brussels, Belgium. 9. Radiation Oncology Department, Centre Léon Bérard, Lyon, France. 10. Leeds Institute of Cancer and Pathology, University of Leeds, St James's Hospital, Leeds, UK. 11. Department of Health Sciences, University of York, York, UK. 12. Adelphi Values, Bollington, UK. 13. Department of Medical Psychology, Amsterdam University Medical Centers, Academic Medical Center, University of Amsterdam, Cancer Center, Amsterdam, The Netherlands. 14. Faculty of Science, School of Psychology, University of Sydney, Sydney, New South Wales, Australia.
Abstract
BACKGROUND: We aimed to estimate minimally important difference (MID) for interpreting group-level change over time for European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in head and neck cancer. METHODS: Data were derived retrospectively from two published EORTC trials. Clinical anchors were selected using correlation strength and clinical plausibility of the given anchor/QLQ-C30 scale pair. MIDs for within-group and between-group change were estimated via the mean change method and linear regression, respectively. Distribution-based MIDs were also examined. MIDs for two of the scales, dyspnea and nausea/vomiting, are more uncertain considering their low correlations with the anchors. RESULTS: Anchor-based MIDs could be determined for deterioration in 7 of the 14 QLQ-C30 scales assessed, and in 3 scales for improvement. MIDs varied by scale, direction of change, and anchor. Absolute MID values ranged from 5 to 15 points for within-group change and 4 to 12 for between-group change. Most MIDs were within 4 to 10 points. CONCLUSIONS: Our findings, if confirmed, will aid interpreting changes in selected QLQ-C30 scale scores over time and inform sample size calculations in future clinical trials in head and neck cancer.
BACKGROUND: We aimed to estimate minimally important difference (MID) for interpreting group-level change over time for European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in head and neck cancer. METHODS: Data were derived retrospectively from two published EORTC trials. Clinical anchors were selected using correlation strength and clinical plausibility of the given anchor/QLQ-C30 scale pair. MIDs for within-group and between-group change were estimated via the mean change method and linear regression, respectively. Distribution-based MIDs were also examined. MIDs for two of the scales, dyspnea and nausea/vomiting, are more uncertain considering their low correlations with the anchors. RESULTS: Anchor-based MIDs could be determined for deterioration in 7 of the 14 QLQ-C30 scales assessed, and in 3 scales for improvement. MIDs varied by scale, direction of change, and anchor. Absolute MID values ranged from 5 to 15 points for within-group change and 4 to 12 for between-group change. Most MIDs were within 4 to 10 points. CONCLUSIONS: Our findings, if confirmed, will aid interpreting changes in selected QLQ-C30 scale scores over time and inform sample size calculations in future clinical trials in head and neck cancer.
Authors: Oreste Gallo; Chiara Bruno; Luca Giovanni Locatello; Federica Martelli; Maria Cilona; Pietro Orlando; Giuseppe Fancello; Giandomenico Maggiore; Francesca Viberti; Pierguido Ciabatti; Simone Boccuzzi; Marco Mandalà Journal: Support Care Cancer Date: 2021-04-15 Impact factor: 3.603
Authors: Mette-Marie Dybeck; Lis Adamsen; Victor Sørensen; Christian Lillelund; Tom Møller; Christina Andersen Journal: Eur J Cancer Care (Engl) Date: 2022-05-12 Impact factor: 2.328