Developing and testing a patient-reported outcome measure for patients with sleep disturbances using EQ-5D and condition-specific bolt-ons: a mixed method study.

IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Ai-Ping Chua, Aureliano Paolo Finch, Shaffinaz Abd Rahman, Mary Anne Relimbo Dela Cruz, Emelita Naval Montaniel, Kaayathiri Ravichandran, Nan Luo
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引用次数: 0

Abstract

Objectives: The EQ-5D-5L may not adequately capture the health-related quality of life in patients with sleep disturbances. We examined the psychometric properties of a hybrid PROM comprising a module of four sleep-related bolt-ons and EQ-5D-5L.

Methods: We employed a sequential exploratory mixed method by first qualitatively testing the face validity of "sleep", "cognition", "tiredness" and "relationship" and refining these bolt-ons through in-depth interviews with 23 patients and clinicians. We then quantitatively assessed their performance by administering the four bolt-ons, appended to EQ-5D-5L, and three condition-specific patient-reported outcome measures (cPROMs) during two clinical visits of patients with respiratory-related sleep disorders. We compared ceiling effects and construct validity of EQ-5D-5L with and without the bolt-ons by testing a priori hypotheses about the cPROMs and polysomnographic characteristics via correlation and areas under the curves (AUC) analyses, respectively. We examined their responsiveness among "treated/improved" participants using standardized response means (SRM) and AUC analysis, and reliability among "untreated/no change" participants using intra-class correlation coefficient (ICC) or Cohen's Kappa (k).

Results: 110 participants (mean [SD] age: 47[13]) were recruited and 90 returned for their review assessments (mean [SD] interval: 2.2 [2.1] months). The bolt-ons led to a reduction of 42.7% in ceiling effects. The bolt-ons were better correlated with cPROMs and exhibited higher discriminatory power and responsiveness, with comparable reliability to EQ-5D-5L. A combined module of the four bolt-ons provided better results than individual bolt-ons.

Conclusions: A "hybrid" PROM of sleep bolt-ons module added to EQ-5D-5L improved its psychometric properties among patients with sleep disturbances.

使用EQ-5D和条件特异性栓接开发和测试患者报告的睡眠障碍患者结果测量:一项混合方法研究。
目的:EQ-5D-5L可能不能充分反映睡眠障碍患者的健康相关生活质量。我们研究了由四个睡眠相关螺栓和EQ-5D-5L模块组成的混合PROM的心理测量特性。方法:采用序贯探索性混合方法,首先对“睡眠”、“认知”、“疲劳”和“关系”四个选项的面部效度进行定性检验,并通过对23名患者和临床医生的深度访谈对这些选项进行细化。然后,我们在两次呼吸相关睡眠障碍患者的临床就诊期间,通过给他们四种附加在EQ-5D-5L上的栓接物和三种特定病情的患者报告结果测量(cPROMs),定量评估了他们的表现。我们通过相关分析和曲线下面积(AUC)分析分别检验了cPROMs和多导睡眠图特征的先验假设,比较了有和没有螺栓连接的EQ-5D-5L的天花板效应和结构效度。我们使用标准化反应方法(SRM)和AUC分析检验了“治疗/改善”参与者的反应性,并使用类内相关系数(ICC)或Cohen’s Kappa (k)检验了“未治疗/无改变”参与者的信度。结果:招募了110名参与者(平均[SD]年龄:47岁),并返回90名参与者进行回顾评估(平均[SD]间隔:2.2[2.1]个月)。螺栓连接导致天花板效应降低42.7%。bolt-ons与cprom的相关性更好,具有更高的分辨能力和响应性,可靠性与EQ-5D-5L相当。四个螺栓的组合模块提供了比单独螺栓更好的结果。结论:在EQ-5D-5L中加入一种“混合型”睡眠栓接模块,改善了EQ-5D-5L在睡眠障碍患者中的心理测量特性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Quality of Life Research
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.
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