Mick Nielsen, Jens Kurt Johansen, Anna Kathrine Pramming, Jeannette Østergaard Penny
{"title":"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。","authors":"Mick Nielsen, Jens Kurt Johansen, Anna Kathrine Pramming, Jeannette Østergaard Penny","doi":"10.1186/s41687-025-00897-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methodology: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Level of evidence: </strong>IIa prospective observational analytic cohort study.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"67"},"PeriodicalIF":2.9000,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12165927/pdf/","citationCount":"0","resultStr":"{\"title\":\"Validity, reliability, responsiveness and interpretability of the EFAS-DK PROM: an observational cohort study of Danish speaking foot and ankle patients.\",\"authors\":\"Mick Nielsen, Jens Kurt Johansen, Anna Kathrine Pramming, Jeannette Østergaard Penny\",\"doi\":\"10.1186/s41687-025-00897-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methodology: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Level of evidence: </strong>IIa prospective observational analytic cohort study.</p>\",\"PeriodicalId\":36660,\"journal\":{\"name\":\"Journal of Patient-Reported Outcomes\",\"volume\":\"9 1\",\"pages\":\"67\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-06-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12165927/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Patient-Reported Outcomes\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s41687-025-00897-y\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Patient-Reported Outcomes","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s41687-025-00897-y","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
Validity, reliability, responsiveness and interpretability of the EFAS-DK PROM: an observational cohort study of Danish speaking foot and ankle patients.
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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