Acquadro Catherine, Patrick Donald L, Eremenco Sonya, Martin Mona L, Kuliś Dagmara, Correia Helena, Conway Katrin
Mapi Research Trust, 27 rue de la Villette, 69003 Lyon, France.
2University of Washington, Seattle, WA USA.
J Patient Rep Outcomes. 2017;2(1):8. doi: 10.1186/s41687-018-0035-8. Epub 2018 Feb 21.
This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.
本文介绍了患者报告结局(PRO)指标可译性评估(TA)的新兴良好实践。ISOQOL翻译与文化适应特别兴趣小组(TCA-SIG)在参与TA的组织以及TCA-SIG成员的合作下,对几种TA方法进行了审查。这项工作使写作小组就以下良好实践达成了一致:1)用于指代可译性过程的术语;2)TA的最佳定义;3)该过程每个步骤推荐的方法;4)参与TA的人员;5)评估时间;6)TA的审查标准;7)TA过程结束时应提出的建议。在TCA-SIG成员的投入以及与该领域专家协商的基础上,这些新兴的良好实践可以指导TA在PRO开发中的未来应用。