Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

NCT02883322 | Completed

• 1 other identifier: APPROVALS
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (1)

• heiQ questionnaire

  Face/content validity, reliability, structural validity

  baseline

Study Arms (4)

Initial

Patients answering the initial translation

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

Committee-only

Patients answering the translation modified by an expert committee

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

BT-only

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

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

Both

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

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

Interventions

Cross cultural adaptation of patient reported outcomes (PRO) OTHER

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

BT-only; Both; Committee-only; Initial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a chronic condition, susceptible to answer the adapted questionnaire

You may qualify if:

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

Sponsors & Collaborators

• GUILLEMIN Francis, MD: lead
• Societe Francaise de Rhumatologie: collaborator
• Région Lorraine: collaborator

Related Publications (2)

• 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.

  PMID: 25698408 BACKGROUND

• 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: 10.1016/j.jclinepi.2013.07.013. Epub 2013 Sep 29.

  PMID: 24084448 RESULT

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis Guillemin, MD, PHD

  Inserm, CHRU Nancy, Université de Lorraine, CIC 1433 Épidémiologie Clinique

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Médecin coordinateur de module

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 30, 2016
• Study Start: December 1, 2010
• Primary Completion: September 1, 2012
• Last Updated: August 30, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share