Protocol for the conceptualization and evaluation of a screening-tool for fitness-to-drive assessment in older people with cognitive impairment.

Introduction: Due to aging and health status people may be subjected to a decrease of cognitive ability and subsequently also a decline of driving safety. On the other hand there is a lack of valid and economically applicable instruments to assess driving performance.
Objective: The study is designed to develop a valid screening-tool for fitness-to-drive assessment in older people with cognitive impairment externally validated on the basis of on-road driving performance.
Methods: In a single-centre, non-randomized cross-sectional trial cognitive functioning and on-road-driving-behavior of older drivers will be assessed. Forty participants with cognitive impairment of different etiology and 40 healthy controls will undergo an extensive neuropsychological assessment. Additionally, an on-road driving assessment for external validation of fitness to drive will be carried out. Primary outcome measures will be performance in attention, executive functions and visuospatial tasks that will be validated with respect to performance on the on-road-driving-test. Secondary outcome measures will be sociodemographic, clinical- and driving characteristics to systematically examine their influence on the prediction of driving behavior.
Discussion: In clinical practice counselling patients with respect to driving safety is of great relevance. Thus, having valid, reliable, time economical and easily interpretable screening-tools on hand to counsel patients is of great relevance for practitioners.
Ethics and Dissemination: Ethics approval was obtained from the Ethics Committee at the Ludwig-Maximilians-University Munich. The trial results will be disseminated through peer-reviewed publications and various conferences.
Trial Registration: 18-640. Trial registration: German Clinical Trials Register. Registration number: DRKS00023549.
Competing Interests: Brieber and Herle work at the Schuhfried GmbH, who funded the present study. The other authors declare that the research will be conducted in absence of any commercial or financial relationships that could be interpreted as a potential conflict of interest.