Validity, reliability, responsiveness and interpretability of the EFAS-DK PROM: an observational cohort study of Danish speaking foot and ankle patients.

IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES

Journal of Patient-Reported Outcomes Pub Date : 2025-06-13 DOI:10.1186/s41687-025-00897-y

Mick Nielsen, Jens Kurt Johansen, Anna Kathrine Pramming, Jeannette Østergaard Penny

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Abstract

Background: This study is an external evaluation of the Patient Reported Outcome Measure (PROM) EFAS-DK developed by the European Foot and Ankle Society (EFAS). The evaluation included a test of the psychometric properties.

Methodology: From October 2019 to September 2022, 101 patients undergoing elective foot or ankle surgery completed questionnaires (EFAS-DK, SEFAS-DK, EQ-5D-5L) prior to surgery and 6 months post-surgery. A subgroup of patients completed a retest. A foot-healthy group control group was added. Testing covered construct validity with hypothesis testing, floor and ceiling effects, internal consistency (Cronbach's Alpha), test-retest reliability (ICC 2.1), effect size (ES), Standardized Response Mean (SRM), Smallest Detectable Change (SDC) and Minimal Important Change (MIC).

Results: Moderate construct validity with 59% confirmed hypothesis. High content validity, no floor ceiling effects. Cronbach's alpha 0.88, ICC 0.93. ES and SRM were both 1.06. SDC 4 and MIC 6. Control group score changes was insignificant.

Conclusion: EFAS-DK is a valid, reliable, and responsive foot and ankle PROM score. EFAS-DK can detect a clinically subjective relevant change score of 6 (25% of the total scale), which makes it useful for implementation in the clinic when evaluating patients undergoing foot and ankle surgery. Comparison with a control group showed results that significantly differ from the patients.

Level of evidence: IIa prospective observational analytic cohort study.

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EFAS-DK PROM的效度、信度、反应性和可解释性：一项丹麦语足部和踝关节患者的观察性队列研究。

背景：本研究是对欧洲足踝协会（EFAS）开发的患者报告结果测量（PROM） EFAS- dk的外部评估。评估包括心理测量特性的测试。方法：2019年10月至2022年9月，101例选择性足部或踝关节手术患者在手术前和术后6个月完成问卷调查（EFAS-DK、SEFAS-DK、EQ-5D-5L）。一组患者完成了重新测试。另设足健组和对照组。检验包括假设检验的结构效度、下限和上限效应、内部一致性（Cronbach’s Alpha）、重测信度（ICC 2.1）、效应大小（ES）、标准化反应平均值（SRM）、最小可检测变化（SDC）和最小重要变化（MIC）。结果：构念效度中等，假设确认度为59%。内容效度高，无地板天花板效应。Cronbach's alpha 0.88, ICC 0.93。ES和SRM均为1.06。SDC 4和MIC 6。对照组评分变化不显著。结论：EFAS-DK是一种有效、可靠、反应灵敏的足踝关节PROM评分方法。EFAS-DK可以检测到临床主观相关变化评分为6分（占总量表的25%），这使得它在临床评估接受足部和踝关节手术的患者时非常有用。与对照组比较，结果与患者有显著差异。证据水平：ia前瞻性观察分析队列研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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