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OpenTrials
Completed

NCT Number: NCT02883322

Adaptation Process of Patient-Reported Outcomes, an eVALuation Study

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

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Cross cultural adaptation of patient reported outcomes (PRO)

Other

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

Primary outcomes

  1. heiQ questionnaire

    Time frame: baseline

    Face/content validity, reliability, structural validity

Sponsors and collaborators

Lead sponsor

GUILLEMIN Francis, MD

Other

Collaborators

  • Région Lorraine
  • Societe Francaise de Rhumatologie

Registry information

Acronym: APPROVALS

Important dates

Study start
2010
Primary completion
2012
First posted
Aug 30, 2016
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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