临床结局评价量表翻译和跨文化调适研究的分析和建议

Analyzing and advising on clinical outcome assessment measurements translation and cross-cultural adaptation

随着现代医学模式的转化,患者报告结局、医生报告结局、观察者报告结局和行为结局均已成为国际公认的临床结局评价指标,量表也成为其重要的评价工具,其中翻译和跨文化调适是量表的重要来源之一。但是,目前我国量表翻译指南较少,国内量表翻译在临床报告中尚未统一和规范,大多量表翻译给读者提供的信息不完整,影响了量表翻译的发展,且与临床结局评估量表翻译相关的方法仍侧重于患者报告结局量表,与其余类型的翻译建议方面存在翻译方法和流程不一致的差距。本文将通过梳理量表翻译指南,针对4种临床结局评估类型量表制定具体翻译方法及流程,以支持其翻译、跨文化适应和语言学验证的标准化方法,旨在规范患者报告结局量表、临床报告结局量表、观察者报告结局量表和行为结局量表的翻译推荐流程。

With the transformation of modern medical models,patient-reported outcomes,clinician-reported outcomes,observer-reported outcomes,and performance outcomes have become internationally recognized clinical outcome assessment indicators,and scales have also become important evaluation tools,among which translation and cross-cultural adaptation are one of the important sources of scales.However,at present,there are fewer guidelines for scale translation in China.At present,domestic scale translation has not yet been unified and standardized in clinical reporting.Most translation reports provide readers with incomplete information,which affects the development of scale translation,and the methodology related to the translation of clinical outcome assessment scales still focuses on patientreported outcome scales,which creates a gap in terms of the recommendations for the rest of the types of translations,a gap which leads to inconsistencies in the translation methodology and process.In this paper,we will develop specific translation methods and processes for each of the four current types of clinical outcome assessments by combining scale translation guidelines to support a standardized approach to translation,cross-cultural adaptation,and linguistic validation for use in standardizing the process of recommending translations of patient-reported outcome scales,clinicalreported outcome scales,observer-reported outcome scales,and behavioral outcome scales.