Italian Translation of the Michigan Hand Outcomes Questionnaire

Hand Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04527588
• Other study ID #: Michigan2020.USZ
• Status: Withdrawn
• Start date: December 1, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: December 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hand Fracture
• Hand Injuries
• Hand Injury Wrist
• Hand Osteoarthritis
• Hand Sprain
• Wounds and Injuries
• Wrist Arthritis
• Wrist Fracture
• Wrist Injuries

Intervention

Other:
• Questionaire Michigan
Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. The Michigan Hand Questionnaire is one of the most important.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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