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Quality of Life in Low-Risk MDS: An Undervalued Endpoint

The opinion I put forward in this paper is that attention must be paid to health-related quality of life as a study endpoint in lower-risk MDS patients. At the moment therapeutic options are limited in this population. New treatments are predominantly available in clinical studies. In announcing tri...

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Detalles Bibliográficos
Autor principal: Heyrman, Bert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9570695/
https://www.ncbi.nlm.nih.gov/pubmed/36233567
http://dx.doi.org/10.3390/jcm11195699
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author Heyrman, Bert
author_facet Heyrman, Bert
author_sort Heyrman, Bert
collection PubMed
description The opinion I put forward in this paper is that attention must be paid to health-related quality of life as a study endpoint in lower-risk MDS patients. At the moment therapeutic options are limited in this population. New treatments are predominantly available in clinical studies. In announcing trial publications and during manuscript introductions, quality of life is widely valued as a treatment goal. However, data on health-related quality of life during phase III studies are not published in the original publications, thereby undermining the importance of quality of life as a study endpoint. What seems to be forgotten is that quality of life comprises more than a study endpoint. It is the highest good of lower-risk MDS patients and should also be acknowledged as a safety aspect. Current phase II trials with new medications do not collect data on health-related quality of life, a practice that I consider unethical. In this opinion I demonstrate the current attitude towards health-related quality of life in lower risk MDS patients among leading journals and trial sponsors with several recent examples. I also argue that health-related quality of life should be the main treatment goal in this population. In the event that we shift our focus towards health-related quality of life as the main treatment goal, new treatments could come to a field where gains in overall survival have been marginal over the years.
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spelling pubmed-95706952022-10-17 Quality of Life in Low-Risk MDS: An Undervalued Endpoint Heyrman, Bert J Clin Med Opinion The opinion I put forward in this paper is that attention must be paid to health-related quality of life as a study endpoint in lower-risk MDS patients. At the moment therapeutic options are limited in this population. New treatments are predominantly available in clinical studies. In announcing trial publications and during manuscript introductions, quality of life is widely valued as a treatment goal. However, data on health-related quality of life during phase III studies are not published in the original publications, thereby undermining the importance of quality of life as a study endpoint. What seems to be forgotten is that quality of life comprises more than a study endpoint. It is the highest good of lower-risk MDS patients and should also be acknowledged as a safety aspect. Current phase II trials with new medications do not collect data on health-related quality of life, a practice that I consider unethical. In this opinion I demonstrate the current attitude towards health-related quality of life in lower risk MDS patients among leading journals and trial sponsors with several recent examples. I also argue that health-related quality of life should be the main treatment goal in this population. In the event that we shift our focus towards health-related quality of life as the main treatment goal, new treatments could come to a field where gains in overall survival have been marginal over the years. MDPI 2022-09-27 /pmc/articles/PMC9570695/ /pubmed/36233567 http://dx.doi.org/10.3390/jcm11195699 Text en © 2022 by the author. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Opinion
Heyrman, Bert
Quality of Life in Low-Risk MDS: An Undervalued Endpoint
title Quality of Life in Low-Risk MDS: An Undervalued Endpoint
title_full Quality of Life in Low-Risk MDS: An Undervalued Endpoint
title_fullStr Quality of Life in Low-Risk MDS: An Undervalued Endpoint
title_full_unstemmed Quality of Life in Low-Risk MDS: An Undervalued Endpoint
title_short Quality of Life in Low-Risk MDS: An Undervalued Endpoint
title_sort quality of life in low-risk mds: an undervalued endpoint
topic Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9570695/
https://www.ncbi.nlm.nih.gov/pubmed/36233567
http://dx.doi.org/10.3390/jcm11195699
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