ElVisML: A little less conversation. Experiences with the Electrophysiology of Vision Markup Language in clinical routine and in a multi‐center trial.

Purpose The International Society for Electrophysiology of Vision (ISCEV) started a process of standardization in electrophysiology of vision to increase comparability of recordings. Standardization is important, especially in clinical trials. However, there is no standard for encoding electrophysiological data of vision. Recently, we proposed such a standard, called Electrophysiology of Vision Markup Language (ElVisML). Here we give an overview of our experiences in the application of ElVisML in clinical routine and in a multi‐center clinical trial. Methods The University Eye Hospital Tuebingen runs three Espion (Diagnosys Ltd) systems, all connected to a central database, which is integrated into a hospital information system (HIS). ERG recordings are added to patients electronic health records (EHR) as ElVisML file. The software system of the STZ eyetrial ERG reading center uses ElVisML as a native format for the electronic exchange of ERG recordings between stakeholders of the reading process. Results Integrated into a HIS, ElVisML allows for a network‐wide access to ERG recordings and long‐term archiving. Compliance to regulatory requirements of the reading center are successfully implemented in a multi‐center study (2 sites, 20 patients, 4 examinations) using ElVisML: An audit trail is realized by revisions of ElVisML files, conformance checks are automatically enforced during each step of the workflow using data included in ElVisML. Conclusion Open standards like ElVisML help to ensure quality, validity, and integrity of ERG recordings, provide manufacturer independent access, and long‐term archiving in a future‐proof format in clinical routing as well as in reading centers. Commercial interest [ABSTRACT FROM AUTHOR]