Published Mar 2005
Citation
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 Translation and Cultural Adaptation. Value Health. 2005;8(2):94-104.
Abstract
In 1999, ISPOR formed the Quality of Life Special Interest
group (QoL-SIG)—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. This
process resulted in the development of Translation and
Cultural Adaptation of Patient Reported Outcomes
Measures—Principles of Good Practice (PGP), a report on
current methods, and an appraisal of their strengths and
weaknesses. 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. Through this review, a consensus
emerged on a broad approach, along with a detailed critique
of the strengths and weaknesses of the differing
methodologies. The results of this review are set out
as “Translation and Cultural Adaptation of Patient
Reported Outcomes Measures—Principles of Good Practice”
and are reported in this document.
Keywords: cultural adaptation, good practice, guidelines,
linguistic validation, patient reported outcomes measures,
translation.
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