
The ENDORISK model is a Bayesian network-based CDSS that allows oncologists to preoperatively estimate the risk of lymph node metastasis; this allows for risk stratification and the avoidance of unnecessary removal of the lymph nodes in low-risk patients, considerably improving their post-operative quality-of-life. A part of the network is shown to the right for illustration. On the basis of this network, a decision support tool (see www.endorisk.eu) can be used by gynaecologic oncologists to enter available information (test results, biomarkers, preoperative tumour grade) and estimate the probability of lymph node metastasis for this patient.
The CDSS use was tested using focus groups with professionals and interviews with patients, and currently, a prospective implementation study is initiated. Simultaneously, challenges in the implementation of ENDORISK in the clinic are being addressed: keeping the network up-to-date with new knowledge and additional patient data, and dealing with the EU regulation for clinical use of the tool. CE marking and IVDR assessment, as well as business model scenarios are currently being explored, simultaneously with the implementation trial. This makes the ENDORISK model and tool an excellent use case to explore all aspects of this ELSA lab from technological innovation (e.g., traceability of changes to the underlying model) to accountability in usage of the tool (e.g., dealing with uncertain advise) and all legal aspects relating to the certification and deployment of this model in clinical practice.