Response Shift-Adjusted Treatment Effect on Health-Related Quality of Life in a Randomized Controlled Trial of Taxane Versus S-1 for Metastatic Breast Cancer: Structural Equation Modeling.
Adult
Aged
Antineoplastic Agents
/ administration & dosage
Breast Neoplasms
/ drug therapy
Drug Combinations
Female
Humans
Latent Class Analysis
Middle Aged
Oxonic Acid
/ administration & dosage
Quality of Life
Reproducibility of Results
Surveys and Questionnaires
Taxoids
/ administration & dosage
Tegafur
/ administration & dosage
breast cancer
chemotherapy
quality of life
response shift
structural equation modeling
Journal
Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
ISSN: 1524-4733
Titre abrégé: Value Health
Pays: United States
ID NLM: 100883818
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
13
08
2019
revised:
19
12
2019
accepted:
02
02
2020
entrez:
17
6
2020
pubmed:
17
6
2020
medline:
4
9
2020
Statut:
ppublish
Résumé
We investigated the quantification of the response shift-adjusted treatment effect on quality-of-life (QOL) data in a randomized controlled trial of taxane versus S-1 for patients with metastatic breast cancer (SELECT-BC). This study was a secondary data analysis of a previously published trial. The response shift-adjusted treatment effect on health-related QOL (HRQOL) data measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was estimated using structural equation modeling techniques in addition to quantifying the "true" treatment effect. Measurement invariances in the values of the common factor loadings, intercepts, and residual variances between before treatment and at the 3-, 6-, and 12-month visits were considered the response shift effects. In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning. The observed change of -4.56 for role functioning comprised +2.26 response shifts and -6.82 "true" change. The observed change of +9.41 for emotional functioning comprised +12.43 response shifts and -1.17 "true" change. In the S-1 group, we observed positive reprioritization and negative recalibration effects for emotional functioning and positive reprioritization effects for social functioning. The observed change of +10.54 for emotional functioning comprised +10.07 response shifts and +0.47 "true" change. The observed change of +2.43 for social functioning comprised +3.50 response shifts and -1.07 "true" change. Detailed analysis of the response shift effects will improve the evaluation reliability of observed HRQOL data during clinical trials.
Identifiants
pubmed: 32540235
pii: S1098-3015(20)30129-7
doi: 10.1016/j.jval.2020.02.003
pii:
doi:
Substances chimiques
Antineoplastic Agents
0
Drug Combinations
0
Taxoids
0
S 1 (combination)
150863-82-4
Tegafur
1548R74NSZ
Oxonic Acid
5VT6420TIG
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
768-774Informations de copyright
Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.