Department of Orthopedic Surgery, School of Medicine, 200 Trent Drive, Duke University, Durham, NC 27710 (USA).
Boston University School of Public Health, Health & Disability Research Institute, School of Public Health, Boston University, Boston, Massachusetts.
Phys Ther. 2018 Aug 1;98(8):715-724. doi: 10.1093/ptj/pzy049.
Pragmatic studies have gained popularity, thus emphasizing the need for patient-reported outcomes (PRO) to be integrated into electronic health records.
This study describes the development of a customized short form from the Boston University Osteoarthritis Functional Assessment PRO (BU-OA-PRO) for a specific pragmatic clinical trial.
A Functional Pain Short Form was created from an existing item bank of deidentified data in the BU-OA-PRO. Item response theory (IRT) methods were used to select items. Reliability was measured with the Cronbach alpha, then with IRT simulation methods. To examine validity, ceiling and floor effects, correlations between the short-form scores and scores from the BU-OA-PRO and the Western Ontario McMasters University Osteoarthritis Index (WOMAC) Pain and Difficulty subscales, and the area under the curve (AUC) were calculated. A minimum detectable change at 90% confidence (MDC90) was calculated based on a calibration sample.
The BU-OA-PRO was reduced from 126 items to 10 items to create the BU-OA Functional Pain Short Form (BU-OA-FPS). The Cronbach alpha indicated high internal consistency (0.91), and reliability distribution estimates were 0.96 (uniform) and 0.92 (normal). Low ceiling effects (4.57%) and floor effects (0%) were found. Moderate-to-high correlations between the BU-OA-PRO and BU-OA-FPS were found with WOMAC Pain (BU-OA-FPS = 0.67; BU-OA-PRO = 0.64) and Difficulty (BU-OA-FPS = 0.73; BU-OA-PRO = 0.69) subscales. The correlation between the BU-OA-PRO and BU-OA-FPS was 0.94. The AUC ranged from 0.80 to 0.88. The MDC90 was approximately 6 standardized points.
The BU-OA-FPS provides reliable and valid measurement of functional pain. Pragmatic studies may consider the BU-OA-FPS for use in electronic health records to capture outcomes.
实用主义研究越来越受欢迎，因此需要将患者报告的结果（PRO）纳入电子健康记录。
本研究描述了为特定实用临床试验从波士顿大学骨关节炎功能评估 PRO（BU-OA-PRO）定制简短形式的过程。
从 BU-OA-PRO 的匿名数据项目库中创建了一个功能疼痛简短形式。使用项目反应理论（IRT）方法选择项目。使用 Cronbach alpha 测量可靠性，然后使用 IRT 模拟方法。为了检查有效性、天花板和地板效应、简短形式得分与 BU-OA-PRO 和西部安大略省麦克马斯特大学骨关节炎指数（WOMAC）疼痛和困难子量表得分之间的相关性，以及曲线下面积（AUC），计算了最小可检测变化在 90%置信度（MDC90）的情况下，根据校准样本进行计算。
BU-OA-PRO 从 126 项减少到 10 项，创建了 BU-OA 功能疼痛简短形式（BU-OA-FPS）。Cronbach alpha 表明具有较高的内部一致性（0.91），可靠性分布估计值为 0.96（均匀）和 0.92（正态）。发现天花板效应（4.57%）和地板效应（0%）较低。与 WOMAC 疼痛（BU-OA-FPS=0.67；BU-OA-PRO=0.64）和困难（BU-OA-FPS=0.73；BU-OA-PRO=0.69）子量表，BU-OA-PRO 和 BU-OA-FPS 之间存在中度至高度相关性。BU-OA-PRO 和 BU-OA-FPS 之间的相关性为 0.94。AUC 范围为 0.80 至 0.88。MDC90 约为 6 个标准化点。
BU-OA-FPS 提供了功能疼痛的可靠和有效测量。实用主义研究可能会考虑在电子健康记录中使用 BU-OA-FPS 来捕捉结果。
