Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02883322

Acronym

APPROVALS

Enrollment

4000

Registered

2016-08-30

Start date

2010-12-31

Completion date

Unknown

Last updated

2016-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

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

Interventions

OTHERCross cultural adaptation of patient reported outcomes (PRO)

Process used to adapt a questionnaire from one cultural setting to another

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
heiQ questionnaire	baseline	Face/content validity, reliability, structural validity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026