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

The citation for this report is:
Wild D, Grove A, Martin M, et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translating adaptation.
Value Health 2005;2:94-104.

Chair: Diane Wild MSc, Oxford Outcomes, Oxford, UK

Leadership Team:
Alyson Grove, MSc, Oxford Outcomes Ltd., Oxford, UK
Mona Martin, MPA, Health Research Associates, Seattle, WA, USA
Sonya Eremenco, MA, CORE, Evanston, IL, USA
Sandra McElroy, BA, Pfizer Inc., Kalamazoo, MI, USA
Aneesa Verjee-Lorenz, MSc, Oxford Outcomes Ltd., Oxford, UK
Pennifer Erikson, PhD, Pennsylvania State University, State College, PA, USA

Background:
In 1999, ISPOR formed the Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create guidelines and standards for the translation and cultural adaptation of patient-reported outcome (PRO) measures.  After identifying a general lack of consistency in current methods and published guidelines, the TCA group saw a need to develop a holistic perspective that synthesized the full spectrum of published methods. 

The TCA Group undertook a review of evidence from current practice, a review of the literature and existing guidelines, and consideration of the issues facing the pharmaceutical industry, regulators, and the broader outcomes research community. Each approach to translation and cultural adaptation was considered systematically in terms of rationale, components, key actors, and the potential benefits and risks associated with each approach and step. The results of this review were subjected to discussion and challenge within the TCA group, as well as consultation with the outcomes research community at large.

The main problems initially identified by the TCA group were:

1. Lack of consistency in terminology.

2. Lack of consistency in methodology.

3. The scope of future guidance. In particular should it prescribe language-specific methodology or translation methods for specific types of PRO instruments (e.g., symptom checklists, diaries, and components of case report forms)?

4. The extent to which any new guidance should be prescriptive or descriptive, i.e., whether it should describe the way in which the process can be undertaken or should it set out criteria, standards, or requirements that must be met.

5. The target audience for the new guidance needs to be defined in order to determine how results should be presented.  It was determined early on that each particular type of “language to language” translation process (e.g., English to German, or French to Russian) should be dealt with separately from “same language adaptations” (e.g., adapting a Spanish for Spain translation for use in Argentina, or English for the United States being adapted for use in South Africa).