Information Mode-Dependent Success Rates of Obtaining German Medical Informatics Initiative-Compliant Broad Consent...

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.