Myelofibrosis symptom assessment form total symptom score version 4.0: measurement properties from the MOMENTUM phase 3 study.

IF 3.3 3区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Quality of Life Research Pub Date : 2024-11-25 DOI:10.1007/s11136-024-03855-1

Christina Daskalopoulou, Boris Gorsh, Gerasimos Dumi, Samineh Deheshi, Chad Gwaltney, Jean Paty, Catherine Ellis, Jun Kawashima, Ruben Mesa

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引用次数: 0

Abstract

Purpose: The Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) comprises 7 common MF symptom items (fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, bone pain) and is the first patient-reported outcome (PRO) instrument designed to assess MF symptom burden. Given that information on the psychometric properties of this instrument has been limited, we sought to evaluate its measurement properties and validate its use in the phase 3 MOMENTUM trial.

Methods: Data were pooled to assess MFSAF item distribution, structural validity, reliability (test-retest and internal consistency), construct validity (convergent, divergent, and known-groups), and sensitivity to change. Other PRO measures included Patient Global Impression of Severity/Change (PGIS/PGIC), EORTC QLQ-C30, PROMIS Physical Function Short Form 10b, and ECOG performance status.

Results: Participants (N = 195) showed high completion rates (> 93%) across 24 weeks. Moderate to strong Spearman correlation coefficients among items were mostly observed at baseline (range, 0.289-0.772) and week 24 (range, 0.391-0.829), which supported combining items into a multi-item scale and total score. Internal consistency (Cronbach's α, 0.877 at baseline and 0.903 at week 24) and test-retest reliability (intraclass correlation coefficient, > 0.829) were satisfactory across selected time intervals. Reliability was also supported by McDonald's omega (ω) coefficient (> 0.875). MFSAF moderately correlated with PRO measures of similar content, differentiated between PGIS and ECOG groups (P < .001), and was able to detect change over time.

Conclusions: The MFSAF v4.0 is a valid tool to assess MF symptom burden, supporting its use in future trials in similar populations.

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骨髓纤维化症状评估表症状总分 4.0 版：MOMENTUM 3 期研究的测量特性。

目的：骨髓纤维化症状评估表4.0版（MFSAF v4.0）包括7个常见的骨髓纤维化症状项目（疲劳、盗汗、瘙痒、腹部不适、左肋下疼痛、早饱、骨痛），是首个旨在评估骨髓纤维化症状负担的患者报告结果（PRO）工具。鉴于有关该工具心理测量特性的信息有限，我们试图评估其测量特性，并验证其在 MOMENTUM 试验 3 期中的应用：汇总数据以评估 MFSAF 的项目分布、结构效度、可靠性（重复测试和内部一致性）、构建效度（收敛性、发散性和已知组）以及对变化的敏感性。其他PRO测量包括患者对严重程度/变化的总体印象（PGIS/PGIC）、EORTC QLQ-C30、PROMIS身体功能简表10b和ECOG表现状态：参与者（N = 195）在 24 周内的完成率很高（> 93%）。在基线（范围为 0.289-0.772）和第 24 周（范围为 0.391-0.829）时，各项目之间的斯皮尔曼相关系数大多为中度到高度相关，这支持将各项目合并为多项目量表和总分。在选定的时间间隔内，内部一致性（Cronbach's α，基线为 0.877，第 24 周为 0.903）和测试-再测可靠性（类内相关系数大于 0.829）均令人满意。麦克唐纳欧米茄（ω）系数（> 0.875）也支持可靠性。MFSAF 与内容相似的 PRO 测量值之间存在中度相关性，在 PGIS 组和 ECOG 组之间存在差异（P 结论）：MFSAF v4.0 是评估 MF 症状负担的有效工具，支持在未来类似人群的试验中使用。

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来源期刊

Quality of Life Research 医学-公共卫生、环境卫生与职业卫生

CiteScore

6.50

自引率

8.60%

发文量

224

审稿时长

3-8 weeks

期刊介绍： Quality of Life Research is an international, multidisciplinary journal devoted to the rapid communication of original research, theoretical articles and methodological reports related to the field of quality of life, in all the health sciences. The journal also offers editorials, literature, book and software reviews, correspondence and abstracts of conferences. Quality of life has become a prominent issue in biometry, philosophy, social science, clinical medicine, health services and outcomes research. The journal''s scope reflects the wide application of quality of life assessment and research in the biological and social sciences. All original work is subject to peer review for originality, scientific quality and relevance to a broad readership. This is an official journal of the International Society of Quality of Life Research.