Minimally Important Differences for Interpreting EORTC QLQ-C30 Scores in Patients With Advanced Breast Cancer.


Journal

JNCI cancer spectrum
ISSN: 2515-5091
Titre abrégé: JNCI Cancer Spectr
Pays: England
ID NLM: 101721827

Informations de publication

Date de publication:
Sep 2019
Historique:
received: 05 03 2019
revised: 24 04 2019
accepted: 20 05 2019
entrez: 25 4 2020
pubmed: 25 4 2020
medline: 25 4 2020
Statut: epublish

Résumé

We aimed to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in patients with advanced breast cancer. Data were derived from two published EORTC trials. Clinical anchors (eg, performance status [PS]) were selected using correlation strength and clinical plausibility of their association with a particular QLQ-C30 scale. Three change status groups were formed: deteriorated by one anchor category, improved by one anchor category, and no change. Patients with greater anchor changes were excluded. The mean change method was used to estimate MIDs for within-group change, and linear regression was used to estimate MIDs for between-group differences in change over time. For a given QLQ-C30 scale, MID estimates from multiple anchors were triangulated to a single value via a correlation-based weighted average. MIDs varied by QLQ-C30 scale, direction (improvement vs deterioration), and anchor. MIDs for within-group change ranged from 5 to 14 points (improvement) and -14 to -4 points (deterioration), and MIDs for between-group change over time ranged from 4 to 11 points and from -18 to -4 points. Correlation-weighted MIDs for most QLQ-C30 scales ranged from 4 to 10 points in absolute values. Our findings aid interpretation of changes in EORTC QLQ-C30 scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in advanced breast cancer.

Sections du résumé

BACKGROUND BACKGROUND
We aimed to estimate the minimally important difference (MID) for interpreting group-level change over time, both within a group and between groups, for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scores in patients with advanced breast cancer.
METHODS METHODS
Data were derived from two published EORTC trials. Clinical anchors (eg, performance status [PS]) were selected using correlation strength and clinical plausibility of their association with a particular QLQ-C30 scale. Three change status groups were formed: deteriorated by one anchor category, improved by one anchor category, and no change. Patients with greater anchor changes were excluded. The mean change method was used to estimate MIDs for within-group change, and linear regression was used to estimate MIDs for between-group differences in change over time. For a given QLQ-C30 scale, MID estimates from multiple anchors were triangulated to a single value via a correlation-based weighted average.
RESULTS RESULTS
MIDs varied by QLQ-C30 scale, direction (improvement vs deterioration), and anchor. MIDs for within-group change ranged from 5 to 14 points (improvement) and -14 to -4 points (deterioration), and MIDs for between-group change over time ranged from 4 to 11 points and from -18 to -4 points. Correlation-weighted MIDs for most QLQ-C30 scales ranged from 4 to 10 points in absolute values.
CONCLUSIONS CONCLUSIONS
Our findings aid interpretation of changes in EORTC QLQ-C30 scores over time, both within and between groups, and for performing more accurate sample size calculations for clinical trials in advanced breast cancer.

Identifiants

pubmed: 32328553
doi: 10.1093/jncics/pkz037
pii: pkz037
pmc: PMC7050000
doi:

Types de publication

Journal Article

Langues

eng

Pagination

pkz037

Informations de copyright

© The Author(s) 2019. Published by Oxford University Press.

Références

Annu Rev Public Health. 1993;14:43-68
pubmed: 8323597
Support Care Cancer. 2011 Nov;19(11):1753-60
pubmed: 20886240
J Clin Oncol. 2011 Jan 1;29(1):89-96
pubmed: 21098316
Health Qual Life Outcomes. 2018 Dec 11;16(1):228
pubmed: 30537955
BMJ Open. 2018 Jan 10;8(1):e019117
pubmed: 29326191
Eur J Cancer. 2005 Aug;41(12):1697-709
pubmed: 16043345
Eur J Cancer. 2012 Jul;48(11):1713-21
pubmed: 22418017
Cancer. 2007 Jul 1;110(1):196-202
pubmed: 17546575
J Clin Oncol. 1995 May;13(5):1249-54
pubmed: 7738629
J Clin Epidemiol. 2008 Feb;61(2):102-9
pubmed: 18177782
J Clin Oncol. 1998 Jan;16(1):139-44
pubmed: 9440735
Qual Life Res. 1996 Dec;5(6):555-67
pubmed: 8993101
Eur J Cancer. 2008 Sep;44(13):1793-8
pubmed: 18599286
JAMA Oncol. 2017 Aug 1;3(8):1043-1050
pubmed: 28208174
Eur J Cancer. 2018 Nov;104:169-181
pubmed: 30359910
Ann Oncol. 2011 Sep;22(9):2107-12
pubmed: 21324954
Health Serv Res. 2005 Apr;40(2):593-7
pubmed: 15762909
J Clin Oncol. 2003 Mar 1;21(5):843-50
pubmed: 12610183
J Clin Oncol. 2002 Jul 15;20(14):3114-21
pubmed: 12118025

Auteurs

Jammbe Z Musoro (JZ)

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

Corneel Coens (C)

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

Frederic Fiteni (F)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Department of Medical Oncology, University Hospital of Nîmes, France.
Institut de Recherche en Cancérologie de Montpellier, France.
University of Montpellier, France.

Pogoda Katarzyna (P)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland.

Fatima Cardoso (F)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Breast Unit, Champalimaud Clinical Centre, Champalimaud Foundation, Lisbon, Portugal.

Nicola S Russell (NS)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Netherlands Cancer Institute, Amsterdam, The Netherlands.

Madeleine T King (MT)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
University of Sydney, Faculty of Science, School of Psychology, Sydney, NSW, Australia.

Kim Cocks (K)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Department of Health Sciences, University of York, York, UK.
Adelphi Values, Bollington, Cheshire, UK.

Mirjam Ag Sprangers (MA)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Department of Medical Psychology, Amsterdam University Medical Centers, Academic Medical Center, University of Amsterdam, Cancer Center Amsterdam, The Netherlands.

Mogens Groenvold (M)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Department of Public Health, University of Copenhagen, and Bispebjerg Hospital, Copenhagen, Denmark.

Galina Velikova (G)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Leeds Institute of Cancer and Pathology, University of Leeds, St James's Hospital, Leeds, UK.

Hans-Henning Flechtner (HH)

European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany.

Andrew Bottomley (A)

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

Classifications MeSH