Balkman Geoffrey S, Stevens Phillip M, Weber Eric L, Bamer Alyssa M, Salem Rana, Fylstra Bretta L, Morgan Sara J, Hafner Brian J
Department of Rehabilitation Medicine, University of Washington, Seattle, Washington, United States of America.
Hanger Institute for Clinical Research and Education, Austin, Texas, United States of America.
PLoS One. 2025 Aug 19;20(8):e0330334. doi: 10.1371/journal.pone.0330334. eCollection 2025.
Lower limb orthoses (LLOs) are often prescribed to facilitate mobility in individuals with functional impairments. The Orthotic Patient-Reported Outcomes - Mobility (OPRO-M) is a self-report instrument developed recently to measure LLO users' perceived mobility with an orthosis. An observational, prospective, psychometric validation study was conducted to evaluate the construct validity and test-retest reliability of the OPRO-M 12- and 20-item short forms. LLO users were recruited from orthotic clinics across the United States. Participants were administered four self-report instruments (OPRO-M, Orthotic and Prosthetic Users Survey - Lower Extremity Functional Status, Lower Extremity Functional Scale, and Patient-Reported Outcomes Measurement Information System - Physical Function) and three performance-based instruments (10-meter Walk Test, Timed Up and Go Test, and Two-Minute Walk Test) during an in-person assessment. Self-report instruments were re-administered via an online survey sent to participants 7 days later. Convergent validity was assessed by comparing OPRO-M scores to those from co-administered self-report and performance-based instruments. Known groups validity was evaluated by comparing scores from patients grouped by clinician-assigned mobility level. Test-retest reliability was assessed by comparing scores from the in-person and follow-up assessments. Standard error of measurement (SEM) and smallest detectable change (SDC) were derived from test-retest reliability coefficients. A total of 104 LLO users (51% male, mean age = 53 years) completed both assessments. OPRO-M short form scores correlated strongly with those from self-report (ρ = 0.84-0.91) and performance-based (|ρ| = 0.73-0.83) instruments. OPRO-M short form scores also effectively differentiated all mobility groups except household and limited community ambulators. The OPRO-M short forms showed excellent test-retest reliability (ICC = 0.93-0.94) and low measurement error (SEM = 2.4-2.6, SDC = 5.5-6.0). These results provide sound evidence of the OPRO-M short forms' validity and reliability when used to measure mobility in LLO users. These instruments are promising, population-specific alternatives to generic surveys with psychometric performance comparable to or better than established self-report instruments.
下肢矫形器（LLOs）常用于帮助功能受损个体提高行动能力。矫形器患者报告的行动结果 - 移动性（OPRO-M）是最近开发的一种自我报告工具，用于测量使用LLOs的患者对行动能力的感知。开展了一项观察性、前瞻性的心理测量学验证研究，以评估OPRO-M 12项和20项简表的结构效度和重测信度。从美国各地的矫形器诊所招募了使用LLOs的患者。在面对面评估期间，参与者接受了四种自我报告工具（OPRO-M、矫形器和假肢使用者调查 - 下肢功能状态、下肢功能量表以及患者报告结果测量信息系统 - 身体功能）和三种基于表现的工具（10米步行测试、定时起立行走测试和两分钟步行测试）。7天后，通过向参与者发送在线调查问卷的方式重新进行自我报告工具的评估。通过将OPRO-M得分与同时使用的自我报告工具和基于表现的工具的得分进行比较来评估收敛效度。通过比较根据临床医生指定的行动能力水平分组的患者得分来评估已知群体效度。通过比较面对面评估和随访评估的得分来评估重测信度。测量标准误（SEM）和最小可检测变化（SDC）由重测信度系数得出。共有104名使用LLOs的患者（51%为男性，平均年龄 = 53岁）完成了两项评估。OPRO-M简表得分与自我报告工具（ρ = 0.84 - 0.91）和基于表现的工具（|ρ| = 0.73 - 0.83）的得分高度相关。OPRO-M简表得分还能有效区分除居家和有限社区行走者之外的所有行动能力组。OPRO-M简表显示出出色的重测信度（ICC = 0.93 - 0.94）和低测量误差（SEM = 2.4 - 2.6，SDC = 5.5 - 6.0）。这些结果为OPRO-M简表在测量使用LLOs患者的行动能力时的效度和信度提供了有力证据。这些工具是有前景的、针对特定人群的通用调查替代方案，其心理测量性能与既定的自我报告工具相当或更好。
