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德国自我报告的足踝评分(SEFAS)在足踝手术患者中的信度、效度及反应度

Reliability, validity and responsiveness of the German self-reported foot and ankle score (SEFAS) in patients with foot or ankle surgery.

作者信息

Arbab Dariusch, Kuhlmann Katharina, Schnurr Christoph, Bouillon Bertil, Lüring Christian, König Dietmar

机构信息

Department of Orthopedic Surgery, Klinikum Dortmund, Member Faculty of Health Witten/Herdecke University, Beurhausstraße 40, 44137, Dortmund, Germany.

Medical University Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany.

出版信息

BMC Musculoskelet Disord. 2017 Oct 10;18(1):409. doi: 10.1186/s12891-017-1772-1.

DOI:10.1186/s12891-017-1772-1
PMID:29017475
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5634858/
Abstract

BACKGROUND

Patient-reported outcome measures are a critical tool in evaluating the efficacy of orthopedic procedures and are increasingly used in clinical trials to assess outcomes of health care. The intention of this study was to develop and culturally adapt a German version of the Self-reported Foot and Ankle Score (SEFAS) and to evaluate reliability, validity and responsiveness.

METHODS

According to Cross Cultural Adaptation of Self-Reported Measure guidelines forward and backward translation has been performed. The German SEFAS was investigated in 177 consecutive patients. 177 Patients completed the German SEFAS, Foot and Ankle Outcome Score (FAOS), Short-Form 36 and numeric scales for pain and disability (NRS) before and 118 patients 6 months after foot or ankle surgery. Test-Retest reliability, internal consistency, floor and ceiling effects, construct validity and minimal important change were analyzed.

RESULTS

The German SEFAS demonstrated excellent test-retest reliability with ICC values of 0.97. Cronbach's alpha (α) value of 0.89 demonstrated strong internal consistency. No floor or ceiling effects were observed for the German version of the SEFAS. As hypothesized SEFAS correlated strongly with FAOS and SF-36 domains. It showed moderate (ES/SRM > 0.5) responsiveness between preoperative assessment and postoperative follow-up.

CONCLUSION

The German version of the SEFAS demonstrated good psychometric properties. It proofed to be a valid and reliable instrument for use in foot and ankle patients.

TRIAL REGISTRATION

DRKS00007585.

摘要

背景

患者报告的结局指标是评估骨科手术疗效的关键工具,并且在临床试验中越来越多地用于评估医疗保健的结局。本研究的目的是开发并在文化上改编德语版的自我报告足踝评分(SEFAS),并评估其信度、效度和反应度。

方法

根据自我报告测量的跨文化改编指南进行了正向和反向翻译。对177例连续患者进行了德语版SEFAS的研究。177例患者在足踝手术前完成了德语版SEFAS、足踝结局评分(FAOS)、简短健康调查问卷36项(Short-Form 36)以及疼痛和残疾数字量表(NRS),118例患者在足踝手术后6个月完成了上述评估。分析了重测信度、内部一致性、地板效应和天花板效应、结构效度以及最小有意义变化。

结果

德语版SEFAS显示出出色的重测信度,组内相关系数(ICC)值为0.97。克朗巴赫α系数(α)值为0.89,显示出很强的内部一致性。德语版SEFAS未观察到地板效应或天花板效应。正如所假设的,SEFAS与FAOS和SF-36各领域密切相关。术前评估与术后随访之间显示出中度(效应量/标准化反应均值>0.5)反应度。

结论

德语版SEFAS显示出良好的心理测量学特性。它被证明是用于足踝疾病患者的有效且可靠的工具。

试验注册

DRKS00007585

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Foot Ankle Surg. 2016 Mar;22(1):59-70. doi: 10.1016/j.fas.2015.09.004. Epub 2015 Oct 9.
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Arch Orthop Trauma Surg. 2014 Jul;134(7):897-901. doi: 10.1007/s00402-014-1994-8. Epub 2014 Apr 19.
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Minimally important change was estimated for the Manchester-Oxford Foot Questionnaire after foot/ankle surgery.在足/踝关节手术后,对曼彻斯特-牛津足部问卷的最小重要变化进行了评估。
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