Evaluation of a DIC Broad Consent Cohort

Evaluation of a DIC Broad Consent Cohort

Observational Study

Marvin O Kampf, Hans-Ulrich Prokosch, Christian Gulden, Detlef Kraska, Thomas Ganslandt, Susanne A Seuchter

Studies in Health Technology and Informatics, 15 May 2025

Abstract

This single-center retrospective observational study accesses potential differences between adult patients who were admitted to the University Hospital Erlangen between March 2021 and December 2023 (hospital cohort) and adult patients who have given consent to use their documented data for research purposes (broad consent cohort). Demographic and clinical data (ICD-10 diagnoses) were extracted from the university hospitalt’s FHIR research data repository and analyzed in pseudonymized form. The two cohorts comprise 98,564 and 1,678 patients respectively and were compared concerning representativity of the BC cohort. The results suggest that the ongoing stepwise rollout of the consent obtainment process creates biases in clinical and demographic characteristics. For as long as these biases persist, we suggest researchers to prefer federated over centralized approaches to data analysis, where broad consent is not required and the analyses can be based on the total hospital cohort.