Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

Completed

• Conditions: Chronic Disease

• Registration Number: NCT02883322
• Lead Sponsor: GUILLEMIN Francis, MD

Brief Summary

Objectives: To identify the respective contributions of back-translations and of the expert committee in the process of cultural adaptation of patient reported outcome with an experimental design in the adaptation process :

Four translations of a questionnaire will be produced:

* A simple translation by two translators, who serves as the basis for the three other translations

* A translation made with the use of a back-translation.

* A translation with review by an expert committee.

* A translation the use of a back-translation and review by an expert committee.

Properties of each translation will be analyzed and compared

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2012-09
• Status Verified: 2016-08
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-25
• Last Update Submitted: 2016-08-25
• Study First Posted: 2016-08-30
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Adult (other 18 years)
• Able to read, understand and answer the adapted questionnaire
• Having a medical condition targeted by the questionnaire

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
heiQ questionnaire	baseline	Face/content validity, reliability, structural validity