Bonomi A E, Cella D F, Hahn E A, Bjordal K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R
University of Washington, School of Public Health and Community Medicine, Seattle, USA.
Qual Life Res. 1996 Jun;5(3):309-20. doi: 10.1007/BF00433915.
There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29-49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.
在国际肿瘤学临床试验中,需要具备多语言、跨文化效度的生活质量(QOL)评估工具来评估QOL终点。因此,我们启动了将癌症治疗功能评估(FACT)生活质量测量系统(第3版)翻译成以下语言的工作:荷兰语、法语、德语、意大利语、挪威语和瑞典语。在这个项目之前,FACT测量系统有英语、西班牙语和加拿大法语版本。FACT是一种自我报告工具,用于测量多维QOL。FACT(第3版)评估系统使用了由一个通用核心(29个李克特式项目)和众多子量表(每个子量表9 - 20个项目)组成的29 - 49个项目的汇编,这些子量表反映了与不同疾病、症状复合体和治疗相关的症状。FACT - G(通用版本)和18个可用的癌症相关子量表中的8个通过反复向前 - 向后翻译的顺序进行了翻译。在21名双语健康专业人员随后进行审查之后,所有接近最终的语言版本在原产国对总共95名患者进行了预测试。现有结果表明,以母语使用者为主时,总体理解度良好。FACT的等效外语版本将允许对来自不同文化背景的人群进行QOL评估。