Estimation of the Minimal Important Difference and Validation of Foot and Ankle Instruments

Study Overview
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Brief Summary
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The present study investigates the minimal important change and validity of foot and ankle measures.

Detailed Description
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Patients who are waiting for foot and ankle surgery are recruited from four large referral centers (Peijas Hospital, Seinäjoki Central Hospital, Central Finland Central Hospital, Oulu University Hospital). Participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. Both pen-and-paper and electronic options for completing the questionnaire set are provided. The data obtained from the Foot and ankle outcome score (FAOS), European foot and ankle society (EFAS) score, modified Lower extremity functional scale (LEFS), Visual analog scale foot and ankle (VAS-FA), Manchester Oxford foot and ankle (MOxFA) questionnaire, and the Foot and ankle ability measure (FAAM) are analyzed using the Rasch Measurement Theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle PRO instruments.

Official Title
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Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments

Conditions
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Foot Diseases, Ankle Disease

Intervention / Treatment
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* Procedure: Foot or ankle surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full understanding of Finnish language Undergoing foot or ankle surgery At least 18 years old Exclusion Criteria: Unbalanced mental disorder such as schizophrenia or depression Age under 18 Does not understand Finnish Undergoing operation other than foot or ankle

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Foot or ankle surgery|Surgery for foot or ankle|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal important difference | Change from baseline scores at 6 months | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability | Change from 6 months scores at 6.5 months | 6 months, 6.5 months | 
| General health question | Change from baseline scores at 6 months | Baseline, 6 months | 
| General health question | Change from baseline scores at 6 months | 6 months, 6.5 months | 
| Global assessment scale | Change from baseline scores at 6 months | 6 months | 
| Validity | Baseline scores | Baseline | 
| Validity | 6 months scores | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foot, Ankle, Finnish, Validation, FAOS, EFAS, LEFS, FAAM, VAS-FA, MOxFA