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

August 25, 2016 updated by: GUILLEMIN Francis, MD

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Initial
Patients answering the initial translation
Other: Cross cultural adaptation of patient reported outcomes (PRO)
Process used to adapt a questionnaire from one cultural setting to another
Committee-only
Patients answering the translation modified by an expert committee
Other: Cross cultural adaptation of patient reported outcomes (PRO)
Process used to adapt a questionnaire from one cultural setting to another
BT-only
Patients answering the translation modified with the use of a back-translation
Other: Cross cultural adaptation of patient reported outcomes (PRO)
Process used to adapt a questionnaire from one cultural setting to another
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)
Process used to adapt a questionnaire from one cultural setting to another

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
heiQ questionnaire
Time Frame: baseline
Face/content validity, reliability, structural validity
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GUILLEMIN Francis, MD

Collaborators

Societe Francaise de Rhumatologie
Région Lorraine

Investigators

  • Study Director: Francis Guillemin, MD, PHD, Inserm, CHRU Nancy, Université de Lorraine, CIC 1433 Épidémiologie Clinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPROVALS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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