JMIR Publications

ABSTRACT

Background:

The Broad Consent (BC) by the German Medical Informatics Initiative (MII) was developed to serve as a national blueprint for consenting patients for the use of routinely collected medical-, insurance- and contact data and biomaterials for research purposes, ensuring compliance with European General Data Protection Regulation (GDPR). Emergency departments (EDs) are characterized by a broad and unselected patient population that provides the opportunity to include patients from different demographic and socioeconomic groups as well as from different disease groups. While also posing regulatory and ethical challenges, obtaining BC in an ED environment presents a promising opportunity to increase the availability of ED data for research.

Objective:

This study aimed to evaluate the success rate of obtaining BC through different consenting approaches in a tertiary ED. The study also explored 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. Patients were randomly selected (every 30th patient) and screened for eligibility to be informed about BC. Eligible patients were informed through one of three modalities: (a) directly in the ED, (b) during inpatient stay on the ward, or (c) via telephone after discharge. The primary outcome was the success rate of obtaining BC within 30 days of ED presentation. Secondary outcomes included analysis of potential influences on the success- and dropout rate concerning patient characteristics, information mode, and the interaction time applied for the information.

Results:

Out of 11,842 ED visits in the study period, 419 patients were randomly screened for BC eligibility, with 151 meeting the inclusion criteria. Of these, 68 patients (45.0 %) consented to at least one BC module, while 24 (15.9 %) refused participation. The overall dropout rate was 39.1 %, with the highest dropout occurring in the telephone-based group (52.3 %) and lowest in the ED group (7.1 %). Patients who were informed face-to-face during the inpatient stay following their ED treatment had the highest consent rate (85.2 %), while those approached in the ED or by telephone consented in 69.2 %. Logistic regression analysis indicated that longer interaction time was significantly associated with higher consent rates, whereas female gender was associated with increased dropout rates. No significant differences were found between consenting and non-consenting groups concerning age, triage category, billing details (inpatient treatment), or diagnosis distribution.

Conclusions:

Obtaining BC in an ED environment is feasible, and showed representative inclusion of the ED-population. However, discharge from the ED and female gender negatively influenced the odds of obtaining consent to the BC. Face-to-face interaction significantly improves consent rates and seems to be the most promising approach for consenting inpatients. Telephone-based approaches, conversely, resulted in higher dropout rates but equal consent rates as the direct consenting in the ED. The study highlights the need for tailored consent strategies, indicating a benefit to maintain staff in EDs and on wards to provide information on BC and obtain consent from eligible patients. Clinical Trial: German Trials Registry DRKS00028753, DRKS00030054