Research Department, Providence VA Medical Center, Providence, RI, United States of America.
Health Services, Policy and Practice, Brown University, Providence, RI, United States of America.
PLoS One. 2021 Dec 28;16(12):e0261865. doi: 10.1371/journal.pone.0261865. eCollection 2021.
Recent advances in upper limb prosthetics include sensory restoration techniques and osseointegration technology that introduce additional risks, higher costs, and longer periods of rehabilitation. To inform regulatory and clinical decision making, validated patient reported outcome measures are required to understand the relative benefits of these interventions. The Patient Experience Measure (PEM) was developed to quantify psychosocial outcomes for research studies on sensory-enabled upper limb prostheses. While the PEM was responsive to changes in prosthesis experience in prior studies, its psychometric properties had not been assessed. Here, the PEM was examined for structural validity and reliability across a large sample of people with upper limb loss (n = 677). The PEM was modified and tested in three phases: initial refinement and cognitive testing, pilot testing, and field testing. Exploratory factor analysis (EFA) was used to discover the underlying factor structure of the PEM items and confirmatory factor analysis (CFA) verified the structure. Rasch partial credit modeling evaluated monotonicity, fit, and magnitude of differential item functioning by age, sex, and prosthesis use for all scales. EFA resulted in a seven-factor solution that was reduced to the following six scales after CFA: social interaction, self-efficacy, embodiment, intuitiveness, wellbeing, and self-consciousness. After removal of two items during Rasch analyses, the overall model fit was acceptable (CFI = 0.973, TLI = 0.979, RMSEA = 0.038). The social interaction, self-efficacy and embodiment scales had strong person reliability (0.81, 0.80 and 0.77), Cronbach's alpha (0.90, 0.80 and 0.71), and intraclass correlation coefficients (0.82, 0.85 and 0.74), respectively. The large sample size and use of contemporary measurement methods enabled identification of unidimensional constructs, differential item functioning by participant characteristics, and the rank ordering of the difficulty of each item in the scales. The PEM enables quantification of critical psychosocial impacts of advanced prosthetic technologies and provides a rigorous foundation for future studies of clinical and prosthetic interventions.
上肢假肢的最新进展包括感觉恢复技术和骨整合技术，这些技术带来了额外的风险、更高的成本和更长的康复期。为了为监管和临床决策提供信息，需要使用经过验证的患者报告结局测量来了解这些干预措施的相对益处。患者体验测量（PEM）是为了量化研究感觉功能上肢假肢的研究中的心理社会结果而开发的。虽然 PEM 在之前的研究中对假肢体验的变化有反应，但它的心理测量特性尚未得到评估。在这里，使用大量上肢缺失患者（n = 677）的样本对 PEM 的结构有效性和可靠性进行了检查。PEM 经过三个阶段进行了修改和测试：初步改进和认知测试、试点测试和现场测试。探索性因素分析（EFA）用于发现 PEM 项目的潜在因素结构，并通过确认性因素分析（CFA）验证结构。Rasch 部分信用建模通过年龄、性别和假体使用评估了所有量表的单调性、拟合度和差异项目功能的大小。EFA 产生了一个七因素解决方案，在 CFA 后减少到以下六个量表：社会互动、自我效能、体现、直观性、幸福感和自我意识。在 Rasch 分析中删除了两个项目后，整体模型拟合度可接受（CFI = 0.973，TLI = 0.979，RMSEA = 0.038）。社会互动、自我效能和体现量表具有很强的个体可靠性（0.81、0.80 和 0.77）、克朗巴赫的 alpha（0.90、0.80 和 0.71）和内类相关系数（0.82、0.85 和 0.74），分别。大样本量和使用现代测量方法能够识别出单一维度的结构、参与者特征的差异项目功能以及每个量表中项目难度的排序。PEM 能够量化先进假肢技术的关键心理社会影响，并为未来的临床和假肢干预研究提供严格的基础。
