PRO Task Force: Translation & Linguistic Validation of an Application

Chair: Diane Wild MSc Director, Oxford Outcomes

Leadership Team:
Lee Yee Chong BSc, Researcher, Applied Health Psychology Uxbridge, UK
Lawrence J Cohen, PharmD, BCPP, FASHP, FCCP, Professor of Pharmacotherapy Washington State University College of Pharmacy Assistant Director for Psychopharmacology Research and Training WIMIRT (Washington Institute for Mental Illness Research and Training), Spokane, WA USA
Sonya Eremenco MA, Director, Translation and Formatting Services Center on Outcomes, Research, and Education (CORE) Evanston Northwestern Healthcare, Evanston, IL USA
Mary Gawlicki, MBA President, Corporate Translations, Inc., East Hartford, CT USA
Asha Hareendran, MA, PhD, Director – Team Leader, Global Outcomes Research, Pfizer Ltd., Sandwich, UK
Caroline Houchin, MA, Translation and Linguistic Validation Coordinator, Oxford Outcomes, Oxford, UK
Mona L. Martin RN, MPA, Executive Director, Health Research Associates, Inc, Seattle, WA USA
Isabelle Mear MA, Managing Director, Director of Linguistic Validation Department, Mapi Research Institute, Lyon, France
Robyn Von Maltzahn MSc, Associate Outcomes Researcher, Oxford Outcomes, Oxford, UK
Ingela Wiklund PhD, Professor, Director, Patient Reported Outcomes, Global Health Outcomes, GlaxoSmithKline, Uxbridge, Middlesex, UK

Background:
With the increasing internationalization of clinical trial programs, the need to translate and adapt PRO instruments for use in other than the source language has grown rapidly and continues to develop with the increasing involvement of new countries such as India and China in clinical trials. Most instruments are developed in English speaking countries, and therefore, need to be translated and adapted for use in other countries.

Full adaptation requires that the scaling and psychometric properties of the new language are also assessed. Comparability of language version is dependent on both conceptual equivalence and construct value equivalence, i.e. even if the translation is accurate, the target culture may place a different value on what is measured. This is particularly important to assess in multi-center clinical trials where data is pooled. There is also the issue of the reliability and validity of translations done using different methodologies.

In February 2006, the U.S. Food and Drug Administration issued a draft version of Guidance for Industry titled “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.”

Draft FDA Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Draft Guidance

In Chapter IV: Evaluating PRO Instruments, Part D: Modification of an Existing Instrument, Section 4 addresses Changed Culture or Language of Application:

An instrument developed in one language or culture is adapted or translated for use in another language or culture. The FDA recommends that sponsors provide evidence that the methods and results of the translation process were adequate to ensure that the validity of the responses is not affected. Some examples include the following:

PRO instruments are developed initially in one language, culture, or ethnic group and are used subsequently in another
PRO instruments developed and validated outside the United States are applied to the U.S. population

Sponsors should consider whether generally accepted standards for translation and cultural adaptation have been used to support the validity of data from a translated / adapted PRO instrument, including but not restricted to the following:

The background and experience of the persons involved in the translation/adaptation
The translation/adaptation methodology used
The harmonization of different versions
The evidence that measurement properties for translated versions are comparable.

The methodology for the process of translation and linguistic validation has been developing over the past decade, but the supporting evidence indicating the best methods and good research practices is still a work in progress/in development.

It is this task force’s goal to build on the published paper below with recommendations for good research practices for adapting and translating PRO measures.

Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation published in Value in Health, Vol. 8, Issue 2, 2005 pp 95-104. http://www.ispor.org/workpaper/research_practices/PROTranslation_Adaptation.pdf

Task Force Actions

Identify adaptation / translation methods currently in use
Determine the strengths and weaknesses of each method, including the measurement properties of translated versions and acceptability of pooling data in multi-language trials
Make recommendations regarding the use of adaptation / translation methods
Develop the recommendations into good research practices for adapting or translating an instrument from one language/culture to another.
Identify mechanisms by which these good research practices can be incorporated in the development and assessment of health technology (drugs, medical devices, et al)

Task Forces Index