[Status and perspectives of registry-based studies in German ophthalmology]. / Stand und Perspektiven registerbasierter Studien in der deutschen Augenheilkunde.

ABSTRACT

BACKGROUND AND OBJECTIVE: Registry studies provide insights into real-life diagnostic and treatment data outside of clinical trials. Registry studies are interesting for quality management and explorative analyses can lead to the identification of possible risk or prognostically relevant factors and generate hypotheses. There are currently relatively few active registry studies in German ophthalmology. The aim of this survey was to collate the different infrastructure and in particular the potential hurdles in the establishment and performance of registry studies in German ophthalmology departments. METHODS: An online questionnaire collected data on participation in registry studies in German ophthalmology departments between September and December 2018. The survey was addressed to all hospital management and medical staff involved in registry studies in German ophthalmology. RESULTS: Out of 45 participants 18 were head of the department, the remaining 27 were consultants (15), medical specialists (2) and residents (10). According to the department head an average of 2.5 (2.0-3.5) employees per clinic participate in 2.0 (1.7-3.0) registry studies. The amount of reimbursement recommended by the hospital management differed significantly from the amount suggested by the staff (0.0 (0; 75) € (0-100) vs. 100.0 (50.0; 150.0) €; p = 0.0012). The most frequent hurdles to conducting a registry study were bureaucracy and limited human resources. Half of the surveyed centers profited from a separate study center and good clinical practice (GCP) courses for employees involved in studies were mandatory. A quarter of these centers received support from an IT department and/or a statistician. CONCLUSION: Registry studies are an important instrument in ophthalmology research and their importance is increasing in Germany. An agreement on national standards would make the establishment of further registry studies easier.