Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

Chronic Disease Clinical Trial

— APPROVALS  

Official title:

Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883322
• Other study ID #: APPROVALS
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: August 25, 2016
• Start date: December 2010

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (other 18 years)

• Able to read, understand and answer the adapted questionnaire

• Having a medical condition targeted by the questionnaire

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Other:
• Cross cultural adaptation of patient reported outcomes (PRO)
Process used to adapt a questionnaire from one cultural setting to another

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
GUILLEMIN Francis, MD	Région Lorraine, Société Française de Rhumatologie

References & Publications (2)

Epstein J, Osborne RH, Elsworth GR, Beaton DE, Guillemin F. Cross-cultural adaptation of the Health Education Impact Questionnaire: experimental study showed expert committee, not back-translation, added value. J Clin Epidemiol. 2015 Apr;68(4):360-9. doi: — View Citation

Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol. 2015 Apr;68(4):435-41. doi: 10.1016/j.jclinepi.2014.11.021. Epub 2014 Dec 17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heiQ questionnaire	Face/content validity, reliability, structural validity	baseline	No