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首页> 外文期刊>European Journal of Haematology >Patient‐reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis
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Patient‐reported outcome measures in studies of myelodysplastic syndromes and acute myeloid leukemia: Literature review and landscape analysis

机译：患者报告的骨髓增生综合征和急性髓性白血病研究的结果措施：文献综述与景观分析

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Abstract Objectives 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. Methods 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. Results 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. Conclusions 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.
机译：摘要目标本研究旨在描述患者报告的霉菌综合征（MDS）和急性髓性白血病（AML）研究和PROMS景观的使用患者报告的结果措施（PROM）。方法在Medline / Embase（自2000年以来）和ClinicalTrials.gov（自2013年以来）进行综合文献综述，以确定MDS和AML临床研究中使用的PROM。此外，审查了2000年以来批准的药物标签中包含的PROM。结果总体而言，112名不同的PROM在168名发表的MDS研究中使用了152个奖励，用于172个AML研究。来自ClinicalTrials.gov，22种不同的PROM在MDS的持续注册研究中使用，41个AML研究中报告了24项。最常用的舞会是癌症特异性的（例如，EORTC QLQ-C30，事实-An-a）或通用（SF-36，EQ-5D）仪器，而MDS-和AML特定仪器（例如，QUARMM和QOL-E在MDS中; AML中的事实 - LEU和EORTC QLQ-LEU）用于少数研究。两个EMA批准的MDS药物包括标签中的舞会。 EORTC QLQ-C30是迄今为止MDS和AML研究中最常用的癌症特异性舞会。结论这项研究表明，对于临床研究和标签索赔的这两种适应症，对AML / MDS特异性裁决的缺乏缺乏。但是，在未来的研究中可能会考虑开发的AML / MDS特定文书。

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