Patient-reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis.
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Clinical Trials as Topic
Disease Management
Health Care Surveys
Humans
Leukemia, Myeloid, Acute
/ diagnosis
Myelodysplastic Syndromes
/ diagnosis
Outcome and Process Assessment, Health Care
Patient Reported Outcome Measures
Practice Guidelines as Topic
Quality of Life
acute myeloid leukemia
myelodysplastic syndromes
quality of life
Journal
European journal of haematology
ISSN: 1600-0609
Titre abrégé: Eur J Haematol
Pays: England
ID NLM: 8703985
Informations de publication
Date de publication:
May 2020
May 2020
Historique:
received:
20
12
2019
accepted:
20
01
2020
pubmed:
28
1
2020
medline:
20
1
2021
entrez:
28
1
2020
Statut:
ppublish
Résumé
This study aims to describe the use of patient-reported outcome measures (PROMs) in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) studies and the PROMs landscape. A comprehensive literature review was performed in Medline/Embase (since 2000) and ClinicalTrials.gov (since 2013) to identify PROMs used in MDS and AML clinical studies. Additionally, PROMs included in approved drug labels since 2000 were reviewed. Overall, 112 different PROMs were used in 168 published MDS studies and 152 PROMs were used in 172 AML studies. From ClinicalTrials.gov, 16 different PROMs were used in 22 ongoing registered studies in MDS, and 24 were reported in 41 AML studies. The most frequently used PROMs were cancer-specific (eg, EORTC QLQ-C30, FACT-An) or generic (SF-36, EQ-5D) instruments, whereas MDS- and AML-specific instruments (eg, QUALMS and QOL-E in MDS; FACT-Leu and EORTC QLQ-Leu in AML) were used in a minority of studies. Two EMA-approved drugs for MDS included PROMs in their label. EORTC QLQ-C30 is by far the most frequently used cancer-specific PROM in both MDS and AML studies. This research indicated an underuse of AML/MDS-specific PROMs for these two indications in clinical studies and labeling claims. However, AML/MDS-specific instruments in development might be considered in future studies.
Identifiants
pubmed: 31985078
doi: 10.1111/ejh.13389
pmc: PMC7217037
doi:
Types de publication
Journal Article
Meta-Analysis
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
476-487Subventions
Organisme : Celgene, a wholly-owned subsidiary of Bristol-Myers Squibb
Informations de copyright
© 2020 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.
Références
Lancet Haematol. 2018 Sep;5(9):e379-e380
pubmed: 30072145
Blood Cancer J. 2016 Jul 01;6(7):e441
pubmed: 27367478
Oral Oncol. 2012 Oct;48(10):923-937
pubmed: 22525604
Haematologica. 2016 Jun;101(6):781-8
pubmed: 26944474
Value Health. 2018 Jun;21(6):742-747
pubmed: 29909880
Value Health. 2012 May;15(3):443-8
pubmed: 22583454
J Clin Oncol. 1993 Mar;11(3):570-9
pubmed: 8445433
Bone Marrow Transplant. 1997 Feb;19(4):357-68
pubmed: 9051246
Am Health Drug Benefits. 2013 Jul;6(5):264-74
pubmed: 24991362
Blood. 2013 Oct 24;122(17):2943-64
pubmed: 23980065
Value Health. 2012 Dec;15(8):1051-8
pubmed: 23244807
Cancer. 2000 Oct 1;89(7):1634-46
pubmed: 11013380
Leuk Res. 2008 May;32(5):691-8
pubmed: 18054795
Cancer. 2006 Apr 15;106(8):1794-803
pubmed: 16532500
J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
pubmed: 8433390
Perspect Clin Res. 2011 Oct;2(4):137-44
pubmed: 22145124
Crit Rev Oncol Hematol. 2017 Feb;110:20-34
pubmed: 28109402
Cancer. 2009 Jul 1;115(13):2903-11
pubmed: 19452536
J Clin Med. 2016 Mar 05;5(3):
pubmed: 26959069
Health Econ Rev. 2013 May 16;3(1):15
pubmed: 23680096
J Geriatr Oncol. 2015 Jul;6(4):288-98
pubmed: 26073533
Dialogues Clin Neurosci. 2014 Jun;16(2):137-45
pubmed: 25152653
BMJ. 2009 Jul 21;339:b2535
pubmed: 19622551
Blood. 2013 May 23;121(21):4287-94
pubmed: 23550038
Haematologica. 2007 Dec;92(12):1596-8
pubmed: 18055981
Breast Cancer (Auckl). 2016 Jul 14;10:93-102
pubmed: 27441001
Clin Cancer Res. 2016 Apr 1;22(7):1553-8
pubmed: 26758559
Curr Hematol Malig Rep. 2015 Sep;10(3):272-81
pubmed: 26134527
Patient Relat Outcome Meas. 2018 Nov 01;9:353-367
pubmed: 30464666
Semin Hematol. 1997 Jul;34(3 Suppl 2):13-9
pubmed: 9253779
Lancet Oncol. 2015 Nov;16(15):1506-1514
pubmed: 26404501
Eur J Haematol. 2020 May;104(5):476-487
pubmed: 31985078
J Geriatr Oncol. 2019 May;10(3):497-503
pubmed: 30241779
Cancer. 2018 Jan 1;124(1):145-152
pubmed: 28881384
Value Health. 2019 Feb;22(2):203-209
pubmed: 30711065
Leukemia. 2018 Jun;32(6):1380-1392
pubmed: 29572506