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
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
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DOI：
10.1111/j.1524-4733.2005.04054.x
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发表时间：
2005-03-01
期刊：
影响因子：
4.5
通讯作者：
Erikson, P
中科院分区：
文献类型：
--
作者：
Wild, D;Grove, A;Erikson, P
1999年，ISPOR成立了生活质量特别兴趣小组（QoL-SIG）-翻译和文化适应小组（TCA小组），以促进讨论并制定患者报告结局（PRO）指标的翻译和文化适应的指南和标准。在确定目前的方法和已公布的准则普遍缺乏一致性之后，TCA小组认为有必要制定一个综合所有已公布方法的整体观点。这一过程导致了翻译和文化适应的发展，患者报告的结果措施-良好实践原则（PGP），对当前方法的报告，并评估其优缺点。TCA小组审查了来自当前实践的证据，审查了文献和现有指南，并考虑了制药行业，监管机构和更广泛的结果研究界面临的问题。每种翻译和文化适应方法都从原理、组成部分、关键参与者以及与每种方法和步骤相关的潜在利益和风险方面进行了系统的考虑。这次审查的结果在技术合作评估小组内部进行了讨论和质疑，并与整个成果研究界进行了磋商。通过这次审查，就广泛的方法达成了共识，同时沿着对不同方法的优缺点进行了详细的批评。该审查的结果被列为“患者报告结局指标的翻译和文化适应-良好实践原则”，并在本文件中报告。
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.