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Evaluation of a DIC Broad Consent Cohort
Marvin O Kampf1, Hans-Ulrich Prokosch2, Christian Gulden2
1Medical Center for Information and Communication Technology, Universitätsklinikum Erlangen, Erlangen, Germany.
Studies in Health Technology and Informatics
|May 17, 2025
Summary
Comparing hospital and broad consent patient cohorts revealed demographic and clinical biases. Researchers should consider federated data analysis to mitigate these biases when broad consent is not universally obtained.
Area of Science:
- Medical Informatics
- Health Services Research
- Clinical Data Analysis
Background:
- Electronic health records (EHRs) are valuable for research but require patient consent.
- Obtaining broad consent (BC) for research data use can introduce patient selection biases.
- Understanding these biases is crucial for accurate clinical data analysis.
Purpose of the Study:
- To compare the representativity of a broad consent (BC) cohort against a hospital (HOSP) cohort.
- To identify demographic and clinical differences between patients with and without broad consent.
- To inform best practices for clinical data analysis in research settings.
Main Methods:
- Retrospective observational study at a single academic medical center.
- Analysis of pseudonymized demographic and clinical data (ICD-10 diagnoses).
- Comparison of a large hospital cohort (n=98,564) with a smaller broad consent cohort (n=1,678) from March 2021 to December 2023.
Main Results:
- Significant biases in clinical and demographic characteristics were observed in the broad consent cohort compared to the hospital cohort.
- The stepwise implementation of consent obtainment processes contributes to these observed biases.
- The broad consent cohort is not fully representative of the overall hospital patient population.
Conclusions:
- The broad consent process introduces selection biases, impacting the representativity of research cohorts.
- Researchers should be aware of these biases when utilizing broad consent data.
- Federated data analysis approaches are recommended to overcome limitations associated with centralized broad consent models.
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