Information Mode-Dependent Success Rates of Obtaining German Medical Informatics Initiative-Compliant Broad Consent in the Emergency Department: Single-Center Prospective Observational Study
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View abstract on PubMed
Summary
This summary is machine-generated.Obtaining broad consent (BC) for research in emergency departments (EDs) is feasible. Face-to-face consent, especially for inpatients, yields higher success rates than telephone approaches, which show increased dropout.
Area Of Science
- Medical Informatics
- Clinical Research
- Patient Engagement
Background
- Broad consent (BC) is a national strategy in Germany for research using routinely collected data.
- Emergency departments (EDs) offer opportunities to enroll diverse patient populations.
- Obtaining BC in EDs faces regulatory and ethical challenges but can expand data availability.
Purpose Of The Study
- Evaluate the success rate of obtaining BC using different consenting approaches in a tertiary ED.
- Explore factors influencing consent and dropout rates.
Main Methods
- Prospective observational study in a German tertiary ED (Sept-Dec 2022).
- Patients were informed via direct ED approach, inpatient ward, or post-discharge telephone call.
- Primary outcome: BC success rate within 30 days; secondary outcomes: factors influencing consent/dropout.
Main Results
- 151 eligible patients; 45% consented, 15.9% refused, 39.1% dropped out.
- Highest consent rate (85.2%) for face-to-face inpatient approach; lowest dropout (7.1%) for direct ED approach.
- Longer interaction time improved consent (P=.03); female sex increased dropout (P=.02).
Conclusions
- BC is feasible in EDs, enabling representative patient inclusion.
- Discharge from ED and female sex negatively impacted consent rates.
- Tailored consent strategies and dedicated staff are crucial for effective BC delivery.
Keywords:
Europe Germany biomedical biomedical research broad consent data analysis data science delivery of health care digital health emergency emergency medical services health care delivery informed consent inpatient stay inpatients logistic regression analysis medical informatics prospective observational study routinely collected health data secondary data analysis
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