Estimation of minimally important differences and responder definitions for EORTC QLQ-MY20 scores in multiple myeloma patients.

EORTC QLQ-MY20 interpretation guidelines meaningful change minimally important difference mixed methods multiple myeloma qualitative interviews quality of life responder definition

Journal

European journal of haematology
ISSN: 1600-0609
Titre abrégé: Eur J Haematol
Pays: England
ID NLM: 8703985

Informations de publication

Date de publication:
Nov 2019
Historique:
received: 23 05 2019
revised: 14 08 2019
accepted: 15 08 2019
pubmed: 25 8 2019
medline: 15 2 2020
entrez: 25 8 2019
Statut: ppublish

Résumé

Thresholds for the minimally important difference (MID) or responder definition (RD) in health-related quality-of-life (HRQoL) scores are required to interpret the impact of an intervention or change in the trajectory of the condition which is meaningful to patients. This study aimed to establish MID and RD for the European Organisation for Research and Treatment of Cancer Quality of Life Multiple Myeloma questionnaire (EORTC QLQ-MY20). A novel mixed-methods approach was applied by utilizing both existing clinical trial data and prospective patient interviews. Anchor-based, distribution-based, and qualitative-based estimates of meaningful change were triangulated to form recommended RDs for each scale of the EORTC QLQ-MY20. Anchor-based MIDs were summarized using weighted correlation. Recommended MIDs were as follows: Disease Symptoms (DS 10 points), Side Effects of Treatment (SE 10 points), Body Image (BI 13 points), and Future Perspective (FP 9 points). Recommended RDs were as follows: DS (16 improvement; 11 worsening), SE (6 improvement; 9 worsening), BI (33 improvement; 33 worsening), and FP (11 improvement; 11 worsening). The study generated estimates of the MID and RD for each scale of the EORTC QLQ-MY20. Published estimates will enable investigators and clinicians to adopt these as standard for interpretation and for hypothesis testing. Consequently, analyses from trials of different interventions can be more comparable.

Identifiants

pubmed: 31444815
doi: 10.1111/ejh.13316
pmc: PMC6852250
doi:

Types de publication

Clinical Trial Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

500-509

Subventions

Organisme : Amgen

Informations de copyright

© 2019 The Authors. European Journal of Haematology Published by John Wiley & Sons Ltd.

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Auteurs

Kate Sully (K)

Adelphi Values, Cheshire, UK.

Andrew Trigg (A)

Adelphi Values, Cheshire, UK.

Nicola Bonner (N)

Adelphi Values, Cheshire, UK.

Alejandro Moreno-Koehler (A)

Adelphi Values, Cheshire, UK.

Claire Trennery (C)

Adelphi Values, Cheshire, UK.

Nina Shah (N)

Amgen Inc, Thousand Oaks, CA, USA.
University of California, San Francisco, CA, USA.

Emre Yucel (E)

Amgen Inc, Thousand Oaks, CA, USA.

Sumeet Panjabi (S)

Amgen Inc, Thousand Oaks, CA, USA.

Kim Cocks (K)

Adelphi Values, Cheshire, UK.

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Classifications MeSH