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

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.

Translation and cultural adaptation of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale into Arabic for use with patients with diabetes in Libya

“…The translation process followed the Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcome Measures [21] using the following steps:Preparation: Four bilingual translators who were fluent in Arabic and English were selected. Three translators were clinicians and one translator was a university academic.…”

Systematic review of tools to measure outcomes for young children with autism spectrum disorder

“…Language and cultural issues can affect how tools perform. 282 Therefore, the review does not provide information on how robust a tool may be if translated for use in the UK with a child whose home language is not English. The review has not commented on how appropriate some North American tools may be (or the changes which may be required) for use in the UK.…”

Evaluating self-reported pressure ulcer prevention measures in persons with spinal cord injury using the revised Skin Management Needs Assessment Checklist: reliability study

“…The guidelines regarding cross-cultural adaptations recommended to conduct an acceptability study on the translated questionnaire, among a sample group of patients. 11,12 In our case, the acceptability study was deemed extremely useful, as it yielded several changes taken into account by the Coordination Committee and submitted to medical experts for content validity. Cross-cultural adaptations were made, the experts wanted to highlight the importance of the area 'preventing PUs' by adding seven items, representing the prevention measures taught in France.…”

“…The translation methodology followed the good practices translation guidelines for self-reported measures. 11,12 The backtranslation technique is described below.…”