Italian Translation of the Michigan Hand Outcomes Questionnaire

Withdrawn

• Conditions: Wrist Fracture; Wrist Injuries; Wrist Arthritis; Hand Fracture; Hand Injury Wrist; Hand Osteoarthritis; Hand Sprain

• Registration Number: NCT04527588
• Lead Sponsor: University of Zurich

Brief Summary

Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian.

Detailed Description

Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. Some of the most used Questionnaires, unfortunately, are not available in Italian. This poses a problem when evaluating Italian speaking patients. Our aim is to develop a culturally adapted Italian version of the Michigan Hand Questionnaire. There is no risk involved for the patients, as the task of the recruited patients is to answer a survey (online and in clinics).

Study Timeline

• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-22
• Study First Posted: 2020-08-26
• Status Verified: 2021-12
• Study Start: 2021-12-01
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age > 18 years
• native Italian speakers
• wrist/hand pathology
• trauma (fractures, tendon injuries, etc.)
• chronic pathology, the pathology has been present for at least 1 month (tenosynovitis, chronic arthrosis pain, rheumatic hand or wrist disorders)
• in case of hand/wrist surgery: at least 4 weeks have elapsed since surgery to avoid that the patient could not perform certain actions evaluated by the scale, for example lifting a pan or shopping bags, due to normal post-operative precautions.
• full possession of mental capacity

Exclusion Criteria

• age < 18 years
• non-native Italian speakers of Italian, thus also excluding second generation Swiss Italians ("secundo")
• mental incapacity
• upper limb in cast/locked by splint (criterion in Chung's article 98) at the time of the evaluation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validity	3 months	Validity will be assessed as structural validity, i.e., "the degree to which the scores of the Health-Related Patient Reported Outcome (HR-PRO) are an adequate reflection of the dimensionality of the construct to be measured" (Mokkink et al., 2010).

Secondary Outcome Measures

Name	Time	Method
Reliability	3 months	Reliability will be assessed as internal consistency (i.e., "the degree of the interrelatedness among the items" \[Mokkink et al., 2010\]), test-retest reliability (i.e., "the proportion of the total variance in the measurements which is due to 'true' differences between patients" \[Mokkink et al., 2010\]), and measurement error (i.e., "the systematic and random error of a patient's score that is not attributed to true changes in the construct to be measured" \[Mokkink et al., 2010\]).