Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types
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Minimally important differences for interpreting EORTC QLQ-C30 change scores over time : A synthesis across 21 clinical trials involving nine different cancer types. / Musoro, Jammbe Z; Coens, Corneel; Sprangers, Mirjam A G; Brandberg, Yvonne; Groenvold, Mogens; Flechtner, Hans-Henning; Cocks, Kim; Velikova, Galina; Dirven, Linda; Greimel, Elfriede; Singer, Susanne; Pogoda, Katarzyna; Gamper, Eva M; Sodergren, Samantha C; Eggermont, Alexander; Koller, Michael; Reijneveld, Jaap C; Taphoorn, Martin J B; King, Madeleine T; Bottomley, Andrew; EORTC Melanoma, Breast, Head and Neck, Genito-urinary, Gynecological, Gastro-intestinal, Brain, Lung and Quality of Life Groups.
In: European journal of cancer (Oxford, England : 1990), Vol. 188, 2023, p. 171-182.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Minimally important differences for interpreting EORTC QLQ-C30 change scores over time
T2 - A synthesis across 21 clinical trials involving nine different cancer types
AU - Musoro, Jammbe Z
AU - Coens, Corneel
AU - Sprangers, Mirjam A G
AU - Brandberg, Yvonne
AU - Groenvold, Mogens
AU - Flechtner, Hans-Henning
AU - Cocks, Kim
AU - Velikova, Galina
AU - Dirven, Linda
AU - Greimel, Elfriede
AU - Singer, Susanne
AU - Pogoda, Katarzyna
AU - Gamper, Eva M
AU - Sodergren, Samantha C
AU - Eggermont, Alexander
AU - Koller, Michael
AU - Reijneveld, Jaap C
AU - Taphoorn, Martin J B
AU - King, Madeleine T
AU - Bottomley, Andrew
AU - EORTC Melanoma, Breast, Head and Neck, Genito-urinary, Gynecological, Gastro-intestinal, Brain, Lung and Quality of Life Groups
N1 - Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
U2 - 10.1016/j.ejca.2023.04.027
DO - 10.1016/j.ejca.2023.04.027
M3 - Journal article
C2 - 37257278
VL - 188
SP - 171
EP - 182
JO - European Journal of Cancer, Supplement
JF - European Journal of Cancer, Supplement
SN - 0959-8049
ER -
ID: 347895276