Adaptation Process of Patient-Reported Outcomes, an eVALuation Study
Completed
- Conditions
- Chronic Disease
- Interventions
- Other: Cross cultural adaptation of patient reported outcomes (PRO)
- 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
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
- Arm && Interventions
Group Intervention Description Committee-only Cross cultural adaptation of patient reported outcomes (PRO) Patients answering the translation modified by an expert committee BT-only Cross cultural adaptation of patient reported outcomes (PRO) Patients answering the translation modified with the use of a back-translation Both Cross cultural adaptation of patient reported outcomes (PRO) Patients answering the translation modified by an expert committee with the use of a back-translation Initial Cross cultural adaptation of patient reported outcomes (PRO) Patients answering the initial translation
- Primary Outcome Measures
Name Time Method heiQ questionnaire baseline Face/content validity, reliability, structural validity
- Secondary Outcome Measures
Name Time Method