A database for oncological research and quality assurance: implementation and first experiences with the University Clinical Cancer Registry Regensburg.

Legal requirements, certification specifications, as well as the demand for real world data on cancer research and treatment led to the decision to establish the University Clinical Cancer Registry Regensburg. The first organizational step in the implementation process of this oncological data registry was the evaluation and acquisition of suitable tumor documentation and database software. For this purpose, an evaluation matrix comprising required database software criteria was designed and consented by a multidisciplinary group of experts. Next, a yearly report of the Institute for Cancer Center Certification (OnkoZert 2019) was considered to identify database software already in use. The identified systems were rated according to the established criteria matrix and other relevant aspects. Onkostar was the system considered most suited for building up an oncological data repository. In the second step, the central IT department implemented Onkostar on-premise and migrated digitally available data after an adaptation and verification process. In parallel, a uniformed process for handling emerging oncological research questions was established. For research requirements, a data analysis concept was established comprising a proposal for data extraction, procedural instructions, and statistical training materials. In the final step, the implemented software and the process for handling research requirements in practice were evaluated by using two exemplary use cases with the focus on clinic-wide analyses and currently relevant scientific topics. A 2-month test phase conducted by various user groups showed a preference for Onkostar tumor documentation software from IT-Choice, mainly because of its adjustability to support research and treatment. Newly added and migrated data can be used for certification and research purposes. This software also provides support in current tumor documentation by displaying the course of cancer disease for individual patients over time. Such oncological data registries can be a powerful tool for legally required cancer registration, the certification of medical centers, as well as for additional oncological research. Tumor databases can be helpful in projects on cancer treatment and scientific aims. The experiences made at the University Hospital Regensburg may be used as a guidance for implementing clinical databases in similar settings with interdisciplinary responsibilities.

Systematic development of a patient-reported ONCOlogical-ROUTinE-Screening (ONCO-ROUTES) procedure at the University Cancer Center Regensburg.

PURPOSE: The evaluation of treatment success and progression in oncology patient-reported outcomes (PROs) is playing an increasingly important role. Meanwhile, PROs are a component of the certification requirements of the German Cancer Society for oncology centers. PROs are used to provide supportive therapy. There is currently no instrument that fully covers the requirements. At the University Hospital Regensburg (UKR), a digital ONCOlogical-ROUTinE-Screening (ONCO-ROUTES) procedure was developed in order to assess the need for supportive therapy in a standardized way and to provide patients with supportive interventions tailored to their needs. METHODS: On the basis of current requirements and guidelines, the development of ONCO-ROUTES was supported by experts in focus groups and interviews, and digitalization was carried out in connection with the IT infrastructure. RESULTS: A Needs-based, Quality-of-life (QoL) and Symptoms Screening (NQS2) tool already established in the routine at the UKR was further developed into ONCO-ROUTES, which is made up of the domains therapy phase, nutrition, tobacco use, alcohol use, quality of life, general condition/functional status, physical activity, psychooncology, social services, and further support needs. By linking the digitized questionnaire to the hospital information system, the results are available for immediate use in routine operations and thus for the referral of patients for further supportive therapy. CONCLUSION: The digital PRO application ONCO-ROUTES is designed to involve patients in monitoring additional supportive needs and thus, improves supportive interdisciplinary treatment.