Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients

Linda Dirven; Jammbe Z. Musoro; Corneel Coens; Jaap C. Reijneveld; Martin J. B. Taphoorn; Florien W. Boele; Mogens Groenvold; Martin J. van den Bent; Roger Stupp; Galina Velikova; Kim Cocks; Mirjam A. G. Sprangers; Madeleine T. King; Hans-Henning Flechtner; Andrew Bottomley

doi:https://doi.org/10.1093/neuonc/noab037

Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients

Linda Dirven, Jammbe Z. Musoro, Corneel Coens, Jaap C. Reijneveld, Martin J. B. Taphoorn, Florien W. Boele, Mogens Groenvold, Martin J. van den Bent, Roger Stupp, Galina Velikova, Kim Cocks, Mirjam A. G. Sprangers, Madeleine T. King, Hans-Henning Flechtner, Andrew Bottomley

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

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Abstract

Background: Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients. Methods: Clinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (>0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence. Results: A total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and -4 to -14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and -4 to -16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10). Conclusions: MIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials.

Original language	English
Pages (from-to)	1327-1336
Number of pages	10
Journal	Neuro-oncology
Volume	23
Issue number	8
DOIs	https://doi.org/10.1093/neuonc/noab037
Publication status	Published - 1 Aug 2021

Keywords

EORTC QLQ-C30
brain tumor
clinical relevance
health-related quality of life (HRQOL)
minimally important difference (MID)

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https://doi.org/10.1093/neuonc/noab037

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Dirven, L., Musoro, J. Z., Coens, C., Reijneveld, J. C., Taphoorn, M. J. B., Boele, F. W., Groenvold, M., van den Bent, M. J., Stupp, R., Velikova, G., Cocks, K., Sprangers, M. A. G., King, M. T., Flechtner, H.-H., & Bottomley, A. (2021). Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients. Neuro-oncology, 23(8), 1327-1336. https://doi.org/10.1093/neuonc/noab037

@article{123d259a7ba44e3db911a2481d73008c,

title = "Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients",

abstract = "Background: Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients. Methods: Clinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (>0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence. Results: A total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and -4 to -14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and -4 to -16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10). Conclusions: MIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials.",

keywords = "EORTC QLQ-C30, brain tumor, clinical relevance, health-related quality of life (HRQOL), minimally important difference (MID)",

author = "Linda Dirven and Musoro, {Jammbe Z.} and Corneel Coens and Reijneveld, {Jaap C.} and Taphoorn, {Martin J. B.} and Boele, {Florien W.} and Mogens Groenvold and {van den Bent}, {Martin J.} and Roger Stupp and Galina Velikova and Kim Cocks and Sprangers, {Mirjam A. G.} and King, {Madeleine T.} and Hans-Henning Flechtner and Andrew Bottomley",

note = "Publisher Copyright: {\textcopyright} 2021 The Author(s) 2021.",

year = "2021",

month = aug,

day = "1",

doi = "https://doi.org/10.1093/neuonc/noab037",

language = "English",

volume = "23",

pages = "1327--1336",

journal = "Neuro-oncology",

issn = "1522-8517",

publisher = "Oxford University Press",

number = "8",

}

Dirven, L, Musoro, JZ, Coens, C, Reijneveld, JC, Taphoorn, MJB, Boele, FW, Groenvold, M, van den Bent, MJ, Stupp, R, Velikova, G, Cocks, K, Sprangers, MAG, King, MT, Flechtner, H-H & Bottomley, A 2021, 'Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients', Neuro-oncology, vol. 23, no. 8, pp. 1327-1336. https://doi.org/10.1093/neuonc/noab037

TY - JOUR

T1 - Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients

AU - Dirven, Linda

AU - Musoro, Jammbe Z.

AU - Coens, Corneel

AU - Reijneveld, Jaap C.

AU - Taphoorn, Martin J. B.

AU - Boele, Florien W.

AU - Groenvold, Mogens

AU - van den Bent, Martin J.

AU - Stupp, Roger

AU - Velikova, Galina

AU - Cocks, Kim

AU - Sprangers, Mirjam A. G.

AU - King, Madeleine T.

AU - Flechtner, Hans-Henning

AU - Bottomley, Andrew

PY - 2021/8/1

Y1 - 2021/8/1

N2 - Background: Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients. Methods: Clinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (>0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence. Results: A total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and -4 to -14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and -4 to -16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10). Conclusions: MIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials.

AB - Background: Minimally important differences (MIDs) allow interpretation of the clinical relevance of health-related quality of life (HRQOL) results. This study aimed to estimate MIDs for all European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) scales for interpreting group-level results in brain tumor patients. Methods: Clinical and HRQOL data from three glioma trials were used. Clinical anchors were selected for each EORTC QLQ-C30 scale, based on correlation (>0.30) and clinical plausibility of association. Changes in both HRQOL and the anchors were calculated, and for each scale and time period, patients were categorized into one of the three clinical change groups: deteriorated by one anchor category, no change, or improved by one anchor category. Mean change method and linear regression were applied to estimate MIDs for interpreting within-group change and between-group differences in change over time, respectively. Distribution-based methods were applied to generate supportive evidence. Results: A total of 1687 patients were enrolled in the three trials. The retained anchors were performance status and eight Common Terminology Criteria for Adverse Events (CTCAE) scales. MIDs for interpreting within-group change ranged from 4 to 12 points for improvement and -4 to -14 points for deterioration. MIDs for between-group difference in change ranged from 4 to 9 for improvement and -4 to -16 for deterioration. Most anchor-based MIDs were closest to the 0.3 SD distribution-based estimates (range: 3-10). Conclusions: MIDs for the EORTC QLQ-C30 scales generally ranged between 4 and 11 points for both within-group mean change and between-group mean difference in change. These results can be used to interpret QLQ-C30 results from glioma trials.

KW - EORTC QLQ-C30

KW - brain tumor

KW - clinical relevance

KW - health-related quality of life (HRQOL)

KW - minimally important difference (MID)

UR - http://www.scopus.com/inward/record.url?scp=85112086691&partnerID=8YFLogxK

U2 - https://doi.org/10.1093/neuonc/noab037

DO - https://doi.org/10.1093/neuonc/noab037

M3 - Article

C2 - 33598685

SN - 1522-8517

VL - 23

SP - 1327

EP - 1336

JO - Neuro-oncology

JF - Neuro-oncology

IS - 8

ER -

Establishing anchor-based minimally important differences for the EORTC QLQ-C30 in glioma patients

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Keywords

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