JMIR Publications

ABSTRACT

Background:

Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits, including increased enrolment and improved efficiency. Within a learning healthcare system (LHS) a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.

Objective:

We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based IC. We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure.

Methods:

All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the LHS. From November 2021 until August 2022 an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Response (i.e., consent, no consent, non-response) was assessed and compared between the eIC and face-to-face IC cohort. Clinical characteristics of consenting and non-responding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses.

Results:

2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs. 876/2254, 38.9%, respectively). Apart from a lower mean haemoglobin in the full consent group of the eIC cohort (8.5 vs. 8.8; P=.0021), characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohort. In the eIC cohort, only age differed between the full consent and the non-response group (median 60 vs. 56; P=.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (i.e., higher haemoglobin, lower HbA1c, lower CRP levels) than the non-response group.

Conclusions:

More patients provided full consent using an eIC. In addition, the study population remained broadly similar. As compared to eIC, the face-to-face IC approach seemed to result in a healthier study population (i.e., full consenting patients) than the patients without IC. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.