Adaptation Process of Patient-Reported Outcomes, an eVALuation Study (APPROVALS)

GUILLEMIN Francis, MD

Status: Completed

Conditions: Chronic Disease

Treatments: Other: Cross cultural adaptation of patient reported outcomes (PRO)

Study type: Observational

Funder types: Other

Identifiers

NCT02883322

APPROVALS

Details and patient eligibility

About

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

Enrollment: 4,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

4,000 participants in 4 patient groups

Initial

Description:

Patients answering the initial translation

Treatment:

Other: Cross cultural adaptation of patient reported outcomes (PRO)

Committee-only

Description:

Patients answering the translation modified by an expert committee

Treatment:

Other: Cross cultural adaptation of patient reported outcomes (PRO)

BT-only

Description:

Patients answering the translation modified with the use of a back-translation

Treatment:

Other: Cross cultural adaptation of patient reported outcomes (PRO)

Both

Description:

Patients answering the translation modified by an expert committee with the use of a back-translation

Treatment:

Other: Cross cultural adaptation of patient reported outcomes (PRO)