TY  - JOUR
AU  - Hans, Felix Patricius
AU  - Kleinekort, Jan
AU  - Boerries, Melanie
AU  - Nieters, Alexandra
AU  - Kindle, Gerhard
AU  - Rautenberg, Micha
AU  - Bühler, Laura
AU  - Weiser, Gerda
AU  - Röttger, Michael Clemens
AU  - Neufischer, Carolin
AU  - Kühn, Matthias
AU  - Wehrle, Julius
AU  - Slagman, Anna
AU  - Fischer-Rosinsky, Antje
AU  - Eienbröker, Larissa
AU  - Hanses, Frank
AU  - Teepe, Gisbert Wilhelm
AU  - Busch, Hans-Jörg
AU  - Benning, Leo
PY  - 2024
DA  - 2024/12/17
TI  - Information Mode–Dependent Success Rates of Obtaining German Medical Informatics Initiative–Compliant Broad Consent in the Emergency Department: Single-Center Prospective Observational Study
JO  - JMIR Med Inform
SP  - e65646
VL  - 12
KW  - biomedical research
KW  - delivery of health care
KW  - informed consent
KW  - medical informatics
KW  - digital health
KW  - emergency medical services
KW  - routinely collected health data
KW  - data science
KW  - secondary data analysis
KW  - data analysis
KW  - biomedical
KW  - emergency
KW  - Germany
KW  - Europe
KW  - prospective observational study
KW  - broad consent
KW  - inpatient stay
KW  - logistic regression analysis
KW  - health care delivery
KW  - inpatients
AB  - Background: The broad consent (BC) developed by the German Medical Informatics Initiative is a pivotal national strategy for obtaining patient consent to use routinely collected data from electronic health records, insurance companies, contact information, and biomaterials for research. Emergency departments (EDs) are ideal for enrolling diverse patient populations in research activities. Despite regulatory and ethical challenges, obtaining BC from patients in ED with varying demographic, socioeconomic, and disease characteristics presents a promising opportunity to expand the availability of ED data. Objective: This study aimed to evaluate the success rate of obtaining BC through different consenting approaches in a tertiary ED and to explore factors influencing consent and dropout rates. Methods: A single-center prospective observational study was conducted in a German tertiary ED from September to December 2022. Every 30th patient was screened for eligibility. Eligible patients were informed via one of three modalities: (1) directly in the ED, (2) during their inpatient stay on the ward, or (3) via telephone after discharge. The primary outcome was the success rate of obtaining BC within 30 days of ED presentation. Secondary outcomes included analyzing potential influences on the success and dropout rates based on patient characteristics, information mode, and the interaction time required for patients to make an informed decision. Results: Of 11,842 ED visits, 419 patients were screened for BC eligibility, with 151 meeting the inclusion criteria. Of these, 68 (45%) consented to at least 1 BC module, while 24 (15.9%) refused participation. The dropout rate was 39.1% (n=59) and was highest in the telephone-based group (57/109, 52.3%) and lowest in the ED group (1/14, 7.1%). Patients informed face-to-face during their inpatient stay following the ED treatment had the highest consent rate (23/27, 85.2%), while those approached in the ED or by telephone had consent rates of 69.2% (9/13 and 36/52). Logistic regression analysis indicated that longer interaction time significantly improved consent rates (P=.03), while female sex was associated with higher dropout rates (P=.02). Age, triage category, billing details (inpatient treatment), or diagnosis did not significantly influence the primary outcome (all P>.05). Conclusions: Obtaining BC in an ED environment is feasible, enabling representative inclusion of ED populations. However, discharge from the ED and female sex negatively affected consent rates to the BC. Face-to-face interaction proved most effective, particularly for inpatients, while telephone-based approaches resulted in higher dropout rates despite comparable consent rates to direct consenting in the ED. The findings underscore the importance of tailored consent strategies and maintaining consenting staff in EDs and on the wards to enhance BC information delivery and consent processes for eligible patients. Trial Registration: German Clinical Trials Register DRKS00028753; https://drks.de/search/de/trial/DRKS00028753 
SN  - 2291-9694
UR  - https://medinform.jmir.org/2024/1/e65646
UR  - https://doi.org/10.2196/65646
DO  - 10.2196/65646
ID  - info:doi/10.2196/65646
ER  -