Minimally Important Differences for Interpreting ORTC QLQ-C30 Change Scores Over Time: A Synthesis Across 21 Clinical Trials Involving Nine Different Cancer Types

Autor: Jammbe Z. Musoro, Corneel Coens, Mirjam A.G. Sprangers, Yvonne Brandberg, Mogens Groenvold, Hans-Henning Flechtner, Kim Cocks, Galina Velikova, Linda Dirven, Elfriede Greimel, Susanne Singer, Katarzyna Pogoda, Eva M. Gamper, Samantha C. Sodergren, Alexander Eggermont, Michael Koller, Jaap C. Reijneveld, Martin J.B. Taphoorn, Madeleine T. King, Andrew Bottomley
Přispěvatelé: Neurology, CCA - Cancer Treatment and quality of life
Rok vydání: 2023
Předmět:
Zdroj: Musoro, J Z, Coens, C, Sprangers, M A G, Brandberg, Y, Groenvold, M, Flechtner, H-H, Cocks, K, Velikova, G, Dirven, L, Greimel, E, Singer, S, Pogoda, K, Gamper, E M, Sodergren, S C, Eggermont, A, Koller, M, Reijneveld, J C, Taphoorn, M J B, King, M T & Bottomley, A 2023, ' 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 . https://doi.org/10.1016/j.ejca.2023.04.027
European Journal of Cancer, 188, 171-182. Pergamon
Musoro, J Z, Coens, C, Sprangers, M A G, Brandberg, Y, Groenvold, M, Flechtner, H-H, Cocks, K, Velikova, G, Dirven, L, Greimel, E, Singer, S, Pogoda, K, Gamper, E M, Sodergren, S C, Eggermont, A, Koller, M, Reijneveld, J C, Taphoorn, M J B, King, M T, Bottomley, A & EORTC Melanoma, Breast, Head and Neck, Genito-urinary, Gynecological, Gastro-intestinal, Brain, Lung and Quality of Life Groups 2023, ' 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 (Oxford, England : 1990), vol. 188, pp. 171-182 . https://doi.org/10.1016/j.ejca.2023.04.027
ISSN: 0959-8049
DOI: 10.2139/ssrn.4367384
Popis: Introduction: Early guidelines for minimally important differences (MID) 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 enrolled 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.
Databáze: OpenAIRE
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