Use of Real-World FHIR Data Combined with Context-Sensitive Decision Modeling to Guide Sentinel Biopsy in Melanoma

Background: To support clinical decision-making at the point of care, the "best next step" based on Standard Operating Procedures (SOPs) and actual accurate patient data must be provided. To do this, textual SOPs have to be transformed into operable clinical algorithms and linked to the data of the patient being treated. For this linkage, we need to know exactly which data are needed by clinicians at a certain decision point and whether these data are available. These data might be identical to the data used within the SOP or might integrate a broader view. To address these concerns, we examined if the data used by the SOP is also complete from the point of view of physicians for contextual decision-making. Methods: We selected a cohort of 67 patients with stage III melanoma who had undergone adjuvant treatment and mainly had an indication for a sentinel biopsy. First, we performed a step-by-step simulation of the patient treatment along our clinical algorithm, which is based on a hospital-specific SOP, to validate the algorithm with the given Fast Healthcare Interoperability Resources (FHIR)-based data of our cohort. Second, we presented three different decision situations within our algorithm to 10 dermatooncologists, focusing on the concrete patient data used at this decision point. The results were conducted, analyzed, and compared with those of the pure algorithmic simulation. Results: The treatment paths of patients with melanoma could be retrospectively simulated along the clinical algorithm using data from the patients' electronic health records. The subsequent evaluation by dermatooncologists showed that the data used at the three decision points had a completeness between 84.6% and 100.0% compared with the data used by the SOP. At one decision point, data on "patient age (at primary diagnosis)" and "date of first diagnosis" were missing. Conclusions: The data needed for our decision points are available in the FHIR-based dataset. Furthermore, the data used at decision points by the SOP and hence the clinical algorithm are nearly complete compared with the data required by physicians in clinical practice. This is an important precondition for further research focusing on presenting decision points within a treatment process integrated with the patient data needed.