Measuring change in health-related quality of life: the impact of different analytical methods on the interpretation of treatment effects in glioma patients

Marijke B. Coomans; Martin J. B. Taphoorn; Neil K. Aaronson; Brigitta G. Baumert; Martin van den Bent; Andrew Bottomley; Alba A. Brandes; Olivier Chinot; Corneel Coens; Thierry Gorlia; Ulrich Herrlinger; Florence Keime-Guibert; Annika Malmstrom; Francesca Martinelli; Roger Stupp; Andrea Talacchi; Michael Weller; Wolfgang Wick; Jaap C. Reijneveld; Linda Dirven; EORTC Quality of Life Group; EORTC Brain Tumor Group

doi:10.1093/nop/npaa033

Measuring change in health-related quality of life: the impact of different analytical methods on the interpretation of treatment effects in glioma patients

Marijke B. Coomans^*, Martin J. B. Taphoorn, Neil K. Aaronson, Brigitta G. Baumert, Martin van den Bent, Andrew Bottomley, Alba A. Brandes, Olivier Chinot, Corneel Coens, Thierry Gorlia, Ulrich Herrlinger, Florence Keime-Guibert, Annika Malmstrom, Francesca Martinelli, Roger Stupp, Andrea Talacchi, Michael Weller, Wolfgang Wick, Jaap C. Reijneveld, Linda DirvenEORTC Quality of Life Group, EORTC Brain Tumor Group

^*Corresponding author for this work

GROW - Innovative Cancer Diagnostics & Therapy

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background. Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions.

Methods. HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project). Change in HRQoL scores, measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN20 questionnaires, was analyzed in 3 ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms, (2) at the patient level per scale/item, calculating the percentage of patients that deteriorated, improved, or remained stable per scale/item, and (3) at the individual patient level, combining all scales/items.

Results. Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level, only the item "hair loss" showed a significant and clinically relevant change (ie, >= 10 points) over time, whereas change scores on the other scales/items were statistically significant only (all P

Conclusions. Different analytical methods of changes in HRQoL result in distinct conclusions of treatment effects, all of which may be relevant for informing clinical decision making.

Original language	English
Pages (from-to)	668-675
Number of pages	8
Journal	Neuro-Oncology Practice
Volume	7
Issue number	6
DOIs	https://doi.org/10.1093/nop/npaa033
Publication status	Published - Dec 2020

Keywords

brain tumor
patient-reported outcome
quality of life
questionnaire
BEVACIZUMAB
VALIDATION

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Cite this

Coomans, M. B., Taphoorn, M. J. B., Aaronson, N. K., Baumert, B. G., van den Bent, M., Bottomley, A., Brandes, A. A., Chinot, O., Coens, C., Gorlia, T., Herrlinger, U., Keime-Guibert, F., Malmstrom, A., Martinelli, F., Stupp, R., Talacchi, A., Weller, M., Wick, W., Reijneveld, J. C., ... EORTC Brain Tumor Group (2020). Measuring change in health-related quality of life: the impact of different analytical methods on the interpretation of treatment effects in glioma patients. Neuro-Oncology Practice, 7(6), 668-675. https://doi.org/10.1093/nop/npaa033

@article{2dfa6979bcca4d74aea6f756bad5fd80,

title = "Measuring change in health-related quality of life: the impact of different analytical methods on the interpretation of treatment effects in glioma patients",

abstract = "Background. Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions.Methods. HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project). Change in HRQoL scores, measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN20 questionnaires, was analyzed in 3 ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms, (2) at the patient level per scale/item, calculating the percentage of patients that deteriorated, improved, or remained stable per scale/item, and (3) at the individual patient level, combining all scales/items.Results. Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level, only the item {"}hair loss{"} showed a significant and clinically relevant change (ie, >= 10 points) over time, whereas change scores on the other scales/items were statistically significant only (all PConclusions. Different analytical methods of changes in HRQoL result in distinct conclusions of treatment effects, all of which may be relevant for informing clinical decision making.",

keywords = "brain tumor, patient-reported outcome, quality of life, questionnaire, BEVACIZUMAB, VALIDATION",

author = "Coomans, {Marijke B.} and Taphoorn, {Martin J. B.} and Aaronson, {Neil K.} and Baumert, {Brigitta G.} and {van den Bent}, Martin and Andrew Bottomley and Brandes, {Alba A.} and Olivier Chinot and Corneel Coens and Thierry Gorlia and Ulrich Herrlinger and Florence Keime-Guibert and Annika Malmstrom and Francesca Martinelli and Roger Stupp and Andrea Talacchi and Michael Weller and Wolfgang Wick and Reijneveld, {Jaap C.} and Linda Dirven and {EORTC Quality of Life Group} and {EORTC Brain Tumor Group}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Neuro-Oncology and the European Association of Neuro-Oncology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com",

year = "2020",

month = dec,

doi = "10.1093/nop/npaa033",

language = "English",

volume = "7",

pages = "668--675",

journal = "Neuro-Oncology Practice",

issn = "2054-2577",

publisher = "Oxford University Press",

number = "6",

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Coomans, MB, Taphoorn, MJB, Aaronson, NK, Baumert, BG, van den Bent, M, Bottomley, A, Brandes, AA, Chinot, O, Coens, C, Gorlia, T, Herrlinger, U, Keime-Guibert, F, Malmstrom, A, Martinelli, F, Stupp, R, Talacchi, A, Weller, M, Wick, W, Reijneveld, JC, Dirven, L, EORTC Quality of Life Group & EORTC Brain Tumor Group 2020, 'Measuring change in health-related quality of life: the impact of different analytical methods on the interpretation of treatment effects in glioma patients', Neuro-Oncology Practice, vol. 7, no. 6, pp. 668-675. https://doi.org/10.1093/nop/npaa033

Measuring change in health-related quality of life: the impact of different analytical methods on the interpretation of treatment effects in glioma patients. / Coomans, Marijke B.; Taphoorn, Martin J. B.; Aaronson, Neil K. et al.
In: Neuro-Oncology Practice, Vol. 7, No. 6, 12.2020, p. 668-675.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Measuring change in health-related quality of life

T2 - the impact of different analytical methods on the interpretation of treatment effects in glioma patients

AU - Coomans, Marijke B.

AU - Taphoorn, Martin J. B.

AU - Aaronson, Neil K.

AU - Baumert, Brigitta G.

AU - van den Bent, Martin

AU - Bottomley, Andrew

AU - Brandes, Alba A.

AU - Chinot, Olivier

AU - Coens, Corneel

AU - Gorlia, Thierry

AU - Herrlinger, Ulrich

AU - Keime-Guibert, Florence

AU - Malmstrom, Annika

AU - Martinelli, Francesca

AU - Stupp, Roger

AU - Talacchi, Andrea

AU - Weller, Michael

AU - Wick, Wolfgang

AU - Reijneveld, Jaap C.

AU - Dirven, Linda

AU - EORTC Quality of Life Group

AU - EORTC Brain Tumor Group

N1 - Publisher Copyright: © The Author(s) 2020. Published by Oxford University Press on behalf of the Society for Neuro-Oncology and the European Association of Neuro-Oncology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

PY - 2020/12

Y1 - 2020/12

N2 - Background. Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions.Methods. HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project). Change in HRQoL scores, measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN20 questionnaires, was analyzed in 3 ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms, (2) at the patient level per scale/item, calculating the percentage of patients that deteriorated, improved, or remained stable per scale/item, and (3) at the individual patient level, combining all scales/items.Results. Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level, only the item "hair loss" showed a significant and clinically relevant change (ie, >= 10 points) over time, whereas change scores on the other scales/items were statistically significant only (all PConclusions. Different analytical methods of changes in HRQoL result in distinct conclusions of treatment effects, all of which may be relevant for informing clinical decision making.

AB - Background. Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions.Methods. HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project). Change in HRQoL scores, measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN20 questionnaires, was analyzed in 3 ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms, (2) at the patient level per scale/item, calculating the percentage of patients that deteriorated, improved, or remained stable per scale/item, and (3) at the individual patient level, combining all scales/items.Results. Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level, only the item "hair loss" showed a significant and clinically relevant change (ie, >= 10 points) over time, whereas change scores on the other scales/items were statistically significant only (all PConclusions. Different analytical methods of changes in HRQoL result in distinct conclusions of treatment effects, all of which may be relevant for informing clinical decision making.

KW - brain tumor

KW - patient-reported outcome

KW - quality of life

KW - questionnaire

KW - BEVACIZUMAB

KW - VALIDATION

U2 - 10.1093/nop/npaa033

DO - 10.1093/nop/npaa033

M3 - Article

C2 - 33304601

SN - 2054-2577

VL - 7

SP - 668

EP - 675

JO - Neuro-Oncology Practice

JF - Neuro-Oncology Practice

IS - 6

ER -