Directorate of Prosthetics, Orthotics and Podiatry, Centre for Health, Sport and Rehabilitation Sciences Research Brian Blatchford Building, University of Salford, Greater Manchester, UK.
J Clin Epidemiol. 2012 Apr;65(4):413-22. doi: 10.1016/j.jclinepi.2011.11.005.
To develop an idiographic and nomothetic patient-reported outcome measure (PROM) for the assessment and evaluation of patients with feet affected by rheumatoid arthritis (RA).
The development of the Salford Rheumatoid Arthritis Foot Evaluation (SAFE) Instrument PROM was divided into four stages: establishment of the PROM's conceptual basis and content generation, following a descriptive phenomenological study; clinimetric instrument development; instrument pretesting, involving expert reviews and cognitive interviews; and demonstration of instrument measurement properties, including convergent validity and test-retest reliability of the nomothetic scale.
A total of 123 items were initially generated for the SAFE, with 25 of them clinimetrically selected for nomothetic scale (SAFE-Part A) and 80 items initially included in the idiographic scale (SAFE-Part B). The pretesting strategy proved effective for improving and refining the SAFE, with the final draft consisting of 19 items in Part A and 42 items in Part B. The SAFE-Part A has strong evidence for convergent validity and test-retest reliability.
The SAFE features a nomothetic and idiographic assessment strategy that, with further development, will prove to be a valuable tool for clinicians involved in managing the foot health problems associated with RA.
开发一种针对类风湿关节炎（RA）足部受累患者评估和评价的特定和通论患者报告结局测量（PROM）。
萨福德类风湿关节炎足部评估（SAFE）工具 PROM 的开发分为四个阶段：基于描述性现象学研究建立 PROM 的概念基础和内容生成；计量学工具开发；仪器预测试，包括专家审查和认知访谈；以及仪器测量特性的证明，包括通论量表的收敛效度和重测信度。
最初为 SAFE 生成了总共 123 项内容，其中 25 项具有计量学选择用于通论量表（SAFE-Part A），80 项最初包含在特定量表中（SAFE-Part B）。预测试策略证明对改进和完善 SAFE 是有效的，最终草案由 A 部分的 19 项和 B 部分的 42 项组成。SAFE-Part A 具有较强的收敛效度和重测信度证据。
SAFE 具有通论和特定评估策略，随着进一步发展，它将成为管理与 RA 相关的足部健康问题的临床医生的宝贵工具。
