Italian Translation of the Michigan Hand Outcomes Questionnaire

Italian Translation and Cross-cultural Adaptation of the Michigan Hand Outcomes Questionnaire

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.

Study Overview

• Status: Withdrawn
• Conditions: Hand Osteoarthritis; Wrist Injuries; Wrist Fracture; Hand Injury Wrist; Wrist Arthritis; Hand Fracture; Hand Sprain
• Intervention / Treatment: Other: Questionaire Michigan

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Native Italian speaking patients followed by the Hand Therapy of the University Hospital Zürich and the Handtherapy Fairplay center of Bologna, IT, with a pathology of the hand/s and or wrist/s.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validity	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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability	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]).	3 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Study Director: Maurizio Calcagni, MD, University Hospital, Zürich

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: August 22, 2020
• First Submitted That Met QC Criteria: August 22, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Arm Injuries; Wounds and Injuries; Fractures, Bone; Wrist Injuries; Hand Injuries
• Other Study ID Numbers: Michigan2020.USZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No