Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
National Institute for Health and Care Research Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK.
ESC Heart Fail. 2024 Oct;11(5):3167-3179. doi: 10.1002/ehf2.14850. Epub 2024 Jun 14.
Left ventricular assist device (LVAD) recipients report symptom improvement but find adjusting to life with the LVAD challenging. These challenges are unique, and existing patient-reported outcome measures (PROMs) do not reflect their experiences. This study aimed to develop a culturally relevant quality of life PROM for use with LVAD recipients in future research, design evolutions and clinical practice.
A three-stage mixed-methods approach was used to develop a PROM: stage 1 included group concept mapping (GCM); stage 2 semi-structured qualitative interviews were conducted with 11 LVAD recipients and 10 clinicians, and a questionnaire was developed using a conceptual framework; and stage 3 used exploratory psychometric analysis of the PROM data using Rasch measurement theory. This paper presents stages 2 and 3.
The conceptual framework consisted of four key concepts, including general health, life with the LVAD, equipment and clothing and emotional impact. Statements from interviews and GCM were used to create items for the LVAD quality of life (LVAD-QoL). Cognitive interviews tested face validity and participant comprehension. Forty-nine participants were recruited from three UK transplant centres. PROM data were collected and analysed using Rasch analysis. Four items displayed misfit; dependency between item sets was the biggest issue (57/485 pairwise differences). After restructuring and dealing with item misfit, the LVAD-QoL conformed to the Rasch model, supporting the psychometric properties and quality of the LVAD-QoL.
Using a mixed-methods approach ensured the development of a robust and psychometrically sound tool for research, design evolution and clinical practice with LVAD recipients.
左心室辅助装置（LVAD）的接受者报告症状改善，但发现适应 LVAD 的生活具有挑战性。这些挑战是独特的，现有的患者报告结局测量（PROM）并不能反映他们的体验。本研究旨在开发一种与 LVAD 接受者相关的文化适应性生活质量 PROM，用于未来的研究、设计演变和临床实践。
采用三阶段混合方法学方法开发 PROM：第 1 阶段包括组概念映射（GCM）；第 2 阶段对 11 名 LVAD 接受者和 10 名临床医生进行半结构式定性访谈，并使用概念框架开发问卷；第 3 阶段使用探索性心理测量分析 PROM 数据，使用 Rasch 测量理论。本文介绍第 2 阶段和第 3 阶段。
概念框架由四个关键概念组成，包括一般健康、使用 LVAD、设备和服装以及情绪影响。访谈和 GCM 的语句用于为 LVAD 生活质量（LVAD-QoL）创建项目。认知访谈测试了表面效度和参与者的理解。从三个英国移植中心招募了 49 名参与者。使用 Rasch 分析收集和分析 PROM 数据。四项显示不匹配；项目集之间的依赖性是最大的问题（57/485 对差异）。在重新构建和处理项目不匹配后，LVAD-QoL 符合 Rasch 模型，支持 LVAD-QoL 的心理测量特性和质量。
使用混合方法学方法确保了为 LVAD 接受者的研究、设计演变和临床实践开发一种强大且具有心理测量学意义的工具。
