[A standardised German translation of the STAndards for Reporting of Diagnostic accuracy studies (STARD statement)*: Methodological aspects]. / Eine standardisierte Übersetzung der STAndards for Reporting of Diagnostic accuracy studies (STARD Statement) in Deutsch: Methodische Aspekte.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.