Ophthabase: a generic extensible patient registry system

Purpose To allow analyses on large amounts of patient datasets as well as to assemble populations of patients for clinical trials it is of great importance to have a robust and easily accessible patient registry system. Problems regarding technological and organisational aspects are usually reappearing among such systems. To enhance reusability we are pursuing a generic approach for our system, using a standardized model as a basis for free specifications of data definitions. Methods The system is a Web application based on the Java. The model containing the data definitions is based on the CDISC Operational Data Model (ODM), a common standard for interchange of clinical data. The ODM‐file is parsed at compile‐time to generate the persistence layer, as well as templates for the Web‐masks, reports, search‐forms and interfaces. The application includes reusable aspects, e.g. auditing mechanisms, user management and input validation. Results The generic system was successfully used in Tuebingen to construct a concrete patient registry called Ophthabase. Although created for ophthalmology, the generic concept allows creation of almost any kind of patient registry. The patient registry can easily be modified by editing the ODM‐file. The generated system is less error‐prone during system development, since data modelling is separated from technological concerns. Conclusion The generic concept will be extended in the future to further augment the patient registry systems, e.g. by adding sophisticated search routines, analytic functionality or optional pedigrees. Multi‐centre data interchange will be possible based on Web Services using a mediator‐server able to match ODM‐models of different patient registries. The ODM‐file can also be used to configure clinical trial systems.