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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?
PURPOSE: Longitudinal 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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282717/ https://www.ncbi.nlm.nih.gov/pubmed/24277234 http://dx.doi.org/10.1007/s11136-013-0583-6 |
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author | Anota, Amélie Hamidou, Zeinab Paget-Bailly, Sophie Chibaudel, Benoist Bascoul-Mollevi, Caroline Auquier, Pascal Westeel, Virginie Fiteni, Frederic Borg, Christophe Bonnetain, Franck |
author_facet | Anota, Amélie Hamidou, Zeinab Paget-Bailly, Sophie Chibaudel, Benoist Bascoul-Mollevi, Caroline Auquier, Pascal Westeel, Virginie Fiteni, Frederic Borg, Christophe Bonnetain, Franck |
author_sort | Anota, Amélie |
collection | PubMed |
description | PURPOSE: Longitudinal 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. METHODS: Several 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. RESULTS: In 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. CONCLUSION: Currently, 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11136-013-0583-6) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4282717 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-42827172015-01-08 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? Anota, Amélie Hamidou, Zeinab Paget-Bailly, Sophie Chibaudel, Benoist Bascoul-Mollevi, Caroline Auquier, Pascal Westeel, Virginie Fiteni, Frederic Borg, Christophe Bonnetain, Franck Qual Life Res Quantitative Methods Special Section PURPOSE: Longitudinal 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. METHODS: Several 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. RESULTS: In 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. CONCLUSION: Currently, 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s11136-013-0583-6) contains supplementary material, which is available to authorized users. Springer International Publishing 2013-11-26 2015 /pmc/articles/PMC4282717/ /pubmed/24277234 http://dx.doi.org/10.1007/s11136-013-0583-6 Text en © The Author(s) 2013 https://creativecommons.org/licenses/by/2.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. |
spellingShingle | Quantitative Methods Special Section Anota, Amélie Hamidou, Zeinab Paget-Bailly, Sophie Chibaudel, Benoist Bascoul-Mollevi, Caroline Auquier, Pascal Westeel, Virginie Fiteni, Frederic Borg, Christophe Bonnetain, Franck 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? |
title | 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? |
title_full | 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? |
title_fullStr | 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? |
title_full_unstemmed | 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? |
title_short | 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? |
title_sort | 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? |
topic | Quantitative Methods Special Section |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4282717/ https://www.ncbi.nlm.nih.gov/pubmed/24277234 http://dx.doi.org/10.1007/s11136-013-0583-6 |
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