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Group name EquipeCTCS
Item Type Journal Article
Title Longitudinal analysis of health-related quality of life in cancer clinical trials: methods and interpretation of results
Creator Bascoul-Mollevi et al.
Author Caroline Bascoul-Mollevi
Author Antoine Barbieri
Author Céline Bourgier
Author Thierry Conroy
Author Bruno Chauffert
Author Mohamed Hebbar
Author William Jacot
Author Beata Juzyna
Author Sophie Gourgou
Author Franck Bonnetain
Author Célia Touraine
Author Amélie Anota
Abstract PURPOSE: Health-related quality of life (HRQoL) is assessed by self-administered questionnaires throughout the care process. Classically, two longitudinal statistical approaches were mainly used to study HRQoL: linear mixed models (LMM) or time-to-event models for time to deterioration/time until definitive deterioration (TTD/TUDD). Recently, an alternative strategy based on generalized linear mixed models for categorical data has also been proposed: the longitudinal partial credit model (LPCM). The objective of this article is to evaluate these methods and to propose recommendations to standardize longitudinal analysis of HRQoL data in cancer clinical trials. METHODS: The three methods are first described and compared through statistical, methodological, and practical arguments, then applied on real HRQoL data from clinical cancer trials or published prospective databases. In total, seven French studies from a collaborating group were selected with longitudinal collection of QLQ-C30. Longitudinal analyses were performed with the three approaches using SAS, Stata and R software. RESULTS: We observed concordant results between LMM and LPCM. However, discordant results were observed when we considered the TTD/TUDD approach compared to the two previous methods. According to methodological and practical arguments discussed, the approaches seem to provide additional information and complementary interpretations. LMM and LPCM are the most powerful methods on simulated data, while the TTD/TUDD approach gives more clinically understandable results. Finally, for single-item scales, LPCM is more appropriate. CONCLUSION: These results pledge for the recommendation to use of both the LMM and TTD/TUDD longitudinal methods, except for single-item scales, establishing them as the consensual methods for publications reporting HRQoL.
Publication Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation
Volume 30
Issue 1
Pages 91-103
Date 2021-01
Journal Abbr Qual Life Res
Language eng
DOI 10.1007/s11136-020-02605-3
ISSN 1573-2649
Short Title Longitudinal analysis of health-related quality of life in cancer clinical trials
Library Catalog PubMed
Extra PMID: 32809099
Tags clinic, Clinical trial, Female, Humans, Longitudinal Studies, Male, Neoplasms, Quality of Life, Surveys and Questionnaires, Time to deterioration
Date Added 2023/11/14 - 15:21:47
Date Modified 2023/11/14 - 15:44:59
Notes and Attachments PubMed entry (Attachment)


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