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

Brain Neoplasms Glioma Humans Quality of Life Research Design Surveys and Questionnaires
EORTC QLQ-C30 brain tumor clinical relevance health-related quality of life (HRQOL) minimally important difference (MID)

Journal

Neuro-oncology
ISSN: 1523-5866
Titre abrégé: Neuro Oncol
Pays: England
ID NLM: 100887420

Informations de publication

Date de publication:
02 08 2021
Historique:
pubmed: 19 2 2021
medline: 7 8 2021
entrez: 18 2 2021
Statut: ppublish

Résumé

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. 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. 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). 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.

Sections du résumé

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.

Identifiants

DOI: 10.1093/neuonc/noab037 PMID: 33598685 PMC: PMC8328025
pubmed: 33598685
pii: 6142946
doi: 10.1093/neuonc/noab037
pmc: PMC8328025
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1327-1336

Subventions

Organisme : EORTC Quality of Life Group
ID : 006/2014

Commentaires et corrections

Type : CommentIn

Informations de copyright

© The Author(s) 2021. Published by Oxford University Press on behalf of the Society for Neuro-Oncology.

Références

Annu Rev Public Health. 1993;14:43-68
pubmed: 8323597
J Neurooncol. 2006 Oct;80(1):27-35
pubmed: 16598415
J Clin Oncol. 2011 Jan 1;29(1):89-96
pubmed: 21098316
Cancer Chemother Pharmacol. 2017 Dec;80(6):1209-1217
pubmed: 29075855
J Clin Oncol. 1993 Mar;11(3):570-9
pubmed: 8445433
Neuro Oncol. 2015 Oct;17 Suppl 4:iv1-iv62
pubmed: 26511214
World Neurosurg. 2018 Sep;117:e172-e179
pubmed: 29886297
J Clin Epidemiol. 2008 Feb;61(2):102-9
pubmed: 18177782
J Clin Oncol. 1998 Jan;16(1):139-44
pubmed: 9440735
J Clin Oncol. 2004 Jan 1;22(1):157-65
pubmed: 14701778
JAMA Oncol. 2018 Apr 1;4(4):495-504
pubmed: 29392280
J Clin Oncol. 2007 Dec 20;25(36):5723-30
pubmed: 18089866
JNCI Cancer Spectr. 2019 Jun 04;3(3):pkz037
pubmed: 32328553
J Clin Oncol. 2013 Nov 10;31(32):4076-84
pubmed: 24101048
Neuro Oncol. 2019 Jan 14;21(Suppl 1):i32-i43
pubmed: 30649488
Lancet. 2017 Oct 7;390(10103):1645-1653
pubmed: 28801186
Qual Life Res. 1996 Feb;5(1):139-50
pubmed: 8901377
J Clin Oncol. 2015 Jul 1;33(19):2166-75
pubmed: 26014298
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Cancer. 1995 Mar 1;75(5):1151-61
pubmed: 7850714
BMJ Open. 2018 Jan 10;8(1):e019117
pubmed: 29326191
Neurosurgery. 2000 Aug;47(2):324-33; discussion 333-4
pubmed: 10942005
Acta Neurol Scand. 2013 Mar;127(3):161-9
pubmed: 22725678
Lancet Oncol. 2005 Dec;6(12):937-44
pubmed: 16321761
Qual Life Res. 1996 Dec;5(6):555-67
pubmed: 8993101
Expert Rev Pharmacoecon Outcomes Res. 2011 Apr;11(2):171-84
pubmed: 21476819
Neurooncol Pract. 2015 Mar;2(1):20-31
pubmed: 26034638
Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):285-91
pubmed: 23642624
Eur J Cancer. 2018 Nov;104:169-181
pubmed: 30359910
J Pain Symptom Manage. 2010 Feb;39(2):219-29
pubmed: 20152586
Asia Pac J Clin Oncol. 2014 Jun;10(2):109-17
pubmed: 23551530
N Engl J Med. 2007 Apr 12;356(15):1527-35
pubmed: 17429084
J Clin Epidemiol. 2020 Feb;118:1-8
pubmed: 31639445
Eur J Cancer. 2012 Jul;48(11):1713-21
pubmed: 22418017
Clin Neurol Neurosurg. 2017 Dec;163:18-23
pubmed: 29035741
Surg Neurol Int. 2013 Apr 05;4:48
pubmed: 23646258
J Clin Epidemiol. 2004 Sep;57(9):898-910
pubmed: 15504633
Med Care. 2003 May;41(5):582-92
pubmed: 12719681
Psychooncology. 2019 Aug;28(8):1654-1662
pubmed: 31141624
J Clin Oncol. 2006 Jun 20;24(18):2715-22
pubmed: 16782911
J Clin Oncol. 1995 May;13(5):1249-54
pubmed: 7738629
Ann Oncol. 2011 Sep;22(9):2107-2112
pubmed: 21324954
N Engl J Med. 2005 Mar 10;352(10):987-96
pubmed: 15758009
Eur J Cancer. 2010 Apr;46(6):1033-40
pubmed: 20181476

Auteurs

Linda Dirven (L)

Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.
Department of Neurology, Haaglanden Medical Center, The Hague, the Netherlands.
ORCID: 0000-0001-9157-9895

Jammbe Z Musoro (JZ)

European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.

Corneel Coens (C)

European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.

Jaap C Reijneveld (JC)

Department of Neurology & Brain Tumor Center, Amsterdam University Medical Centers, location VU University Medical Center, Amsterdam, the Netherlands.

Martin J B Taphoorn (MJB)

Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.
Department of Neurology, Haaglanden Medical Center, The Hague, the Netherlands.

Florien W Boele (FW)

Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.
Faculty of Medicine and Health, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Mogens Groenvold (M)

Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.
Departments of Public Health and Palliative Medicine, University of Copenhagen and Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.

Martin J van den Bent (MJ)

Brain Tumor Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.

Roger Stupp (R)

Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.

Galina Velikova (G)

Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.
ORCID: 0000-0003-1899-5942

Kim Cocks (K)

Adelphi Values, Bollington, Cheshire, UK.

Mirjam A G Sprangers (MAG)

Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam University Medical Centers, location Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

Madeleine T King (MT)

Faculty of Science, School of Psychology, University of Sydney, Sydney, NSW, Australia.
ORCID: 0000-0001-7192-2887

Hans-Henning Flechtner (HH)

Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany.

Andrew Bottomley (A)

European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.

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Classifications MeSH

questionsmedicales.fr › Maladies du système nerveux › Tumeurs du système nerveux › Tumeurs du système nerveux central › Tumeurs du cerveau › Establishing anchor-based minimally important...
questionsmedicales.fr › Tumeurs › Tumeurs par type histologique › Tumeurs du tissu nerveux › Tumeurs neuroectodermiques › Tumeurs neuroépitheliales › Gliome › Establishing anchor-based minimally important...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Establishing anchor-based minimally important...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Establishing anchor-based minimally important...
questionsmedicales.fr › Disciplines des sciences naturelles › Science › Recherche › Plan de recherche › Establishing anchor-based minimally important...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Establishing anchor-based minimally important...