Breuer Jan-Philipp, Seeling Matthes, Barz Michael, Baldini Timo, Scholtz Kathrin, Spies Claudia
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Campus Charité Mitte und Campus Virchow-Klinikum, CHARITÉ-Universitätsmedizin Berlin.
Z Evid Fortbild Qual Gesundhwes. 2012;106(7):500-8. doi: 10.1016/j.zefq.2012.05.021. Epub 2012 Jul 20.
In order to be comprehensible and comparable scientific data should be reported according to a certain standard. One example is the 'STAndards for Reporting of Diagnostic Accuracy (STARD) Statement', a 25-item checklist for the appropriate conduct and reporting of diagnostic studies. Usually such scientific standards are published in English. The International Society for Pharmacoeconomics and Outcome Research (ISPOR) has developed guidelines for the translation and cultural adaptation of written medical instruments. The aim was to apply these ISPOR criteria to the German translation of the STARD Statement in order to allow for authorisation to be conferred by the original authors.
In cooperation with the original authors the STARD statement was translated according to the ISPOR steps: (1) Preparation, (2) Forward Translation, (3) Reconciliation, (4) Back Translation, (5) Back Translation Review, (6) Harmonisation, (7) Cognitive Debriefing, which evaluated comprehensiveness and linguistic style with marks from 1 (very good) to 6 (insufficient), and (8) Review of Cognitive Debriefing Results and Finalisation.
Die ISPOR criteria applied reasonably to the translation process, which required the work input and energy of four scientists and one professional translator and 177 accumulated working hours. The cognitive debriefing resulted in average grades 1.62±0.33 and 1.72±0.39 for comprehensiveness and linguistic style, respectively. Finally, the German STARD version was authorised by the original authors.
Die ISPOR guidelines seem to be a suitable means to facilitate the structured adaptation of defined criteria for the reporting of studies, such as the STARD statement, to other languages.
为了使科学数据具有可理解性和可比性，应按照一定标准进行报告。其中一个例子是“诊断准确性报告标准（STARD）声明”，这是一份包含25项内容的清单，用于规范诊断研究的恰当实施和报告。通常这类科学标准以英文发布。国际药物经济学与成果研究协会（ISPOR）制定了书面医疗工具的翻译和文化调适指南。目的是将这些ISPOR标准应用于STARD声明的德语翻译，以便获得原作者的授权。
与原作者合作，按照ISPOR的步骤对STARD声明进行翻译：（1）准备，（2）正向翻译，（3）核对，（4）反向翻译，（5）反向翻译审核，（6）协调统一，（7）认知反馈，用1（非常好）至6（不足）的分数评估全面性和语言风格，以及（8）认知反馈结果审核与定稿。
ISPOR标准合理地应用于翻译过程，这一过程需要四位科学家和一位专业翻译人员的工作投入和精力，累计工作时长177小时。认知反馈得出全面性和语言风格的平均分数分别为1.62±0.33和1.72±0.39。最终，德语版STARD获得了原作者的授权。
ISPOR指南似乎是一种合适的手段，有助于将诸如STARD声明这类研究报告的既定标准有组织地调适为其他语言。
