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Translation of Patient-Reported Outcome (PRO) Measures

Raoul Breugelmans
International Medical Communications Center
Tokyo Medical University

21 November 2007


A patient-reported outcome (PRO) measure is a questionnaire used in a clinical trial or a clinical setting which was designed to obtain responses directly from the patient. The most commonly used PRO questionnaires assess symptoms, functioning, or (health-related) quality of life (QoL). PRO questionnaires must meet certain standards to be considered relevant, reliable and valid. To make sure that these requirements are met, PRO questionnaires must be developed using appropriate methodology and tested thoroughly. The majority of PRO measures are developed in English, and translated into other languages when needed. To make sure that the same requirements are met in the translated versions, the translation must be done according to a very rigorous methodology, often referred to as linguistic validation.
After a short introduction to PRO measures, how they are developed and how they are used, an overview was presented of the linguistic validation process, which typically consists of the following 6 steps.
  1. Forward translation
  2. Back translation
  3. Clinician review
  4. Pilot testing on patients
  5. Harmonization of all language versions
    (in projects involving multiple target languages)
  6. Proofreading

In a mini-workshop, the participants were divided into groups of three to do a mock forward translation step. They were given a fictitious 2-item English questionnaire, which they were asked to first translate into Japanese individually. They were then asked to compare their individual translations in their groups, and to produce a single Japanese translation based on the individual versions. We then discussed some of the problems encountered and how they were solved in different groups.

Finally, concrete examples of various types of difficulties related to language and cultural differences commonly encountered when translating questionnaires from English into Japanese were discussed.


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