Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardizationReport as inadecuate




Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization - Download this document for free, or read online. Document in PDF available to download.

Quality of Life Research

, Volume 24, Issue 1, pp 5–18

First Online: 26 November 2013Accepted: 12 November 2013DOI: 10.1007-s11136-013-0583-6

Cite this article as: Anota, A., Hamidou, Z., Paget-Bailly, S. et al. Qual Life Res 2015 24: 5. doi:10.1007-s11136-013-0583-6

Abstract

PurposeLongitudinal analysis of health-related quality of life HRQoL remains unstandardized and compromises comparison of results between trials. In oncology, despite available statistical approaches, results are poorly used to change standards of care, mainly due to lack of standardization and the ability to propose clinical meaningful results. In this context, the time to deterioration TTD has been proposed as a modality of longitudinal HRQoL analysis for cancer patients. As for tumor response and progression, we propose to develop RECIST criteria for HRQoL.

MethodsSeveral definitions of TTD are investigated in this paper. We applied this approach in early breast cancer and metastatic pancreatic cancer with a 5-point minimal clinically important difference. In breast cancer, TTD was defined as compared to the baseline score or to the best previous score. In pancreatic cancer arm 1: gemcitabine with FOLFIRI.3, arm 2: gemcitabine alone, the time until definitive deterioration TUDD was investigated with or without death as event.

ResultsIn the breast cancer study, 381 women were included. The median TTD was influenced by the choice of the reference score. In pancreatic cancer study, 98 patients were enrolled. Patients in Arm 1 presented longer TUDD than those in Arm 2 for most of HRQoL scores. Results of TUDD were slightly different according to the definition of deterioration applied.

ConclusionCurrently, the international ARCAD group supports the idea of developing RECIST for HRQoL in pancreatic and colorectal cancer with liver metastasis, with a view to using HRQoL as a co-primary endpoint along with a tumor parameter.

KeywordsHealth-related quality of life Clinical trials Oncology Longitudinal analysis Time to deterioration AbbreviationsCIConfidence interval

EORTCEuropean Organisation for Research and Treatment of Cancer

HRHazard ratio

HRQoLHealth-related quality of life

GLMMGeneral linear mixed model

IRTItem response theory

MCIDMinimal clinically important difference

OSOverall survival

RSResponse shift

SDStandard deviation

TTDTime to deterioration

TUDDTime until definitive deterioration

Electronic supplementary materialThe online version of this article doi:10.1007-s11136-013-0583-6 contains supplementary material, which is available to authorized users.

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Author: Amélie Anota - Zeinab Hamidou - Sophie Paget-Bailly - Benoist Chibaudel - Caroline Bascoul-Mollevi - Pascal Auquier - Virgi

Source: https://link.springer.com/







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