a eIC: electronic informed consent.
b F2F IC: face-to-face informed consent.
c Reference group.
d SAP: systolic arterial blood pressure.
e HbA 1c : glycated hemoglobin.
f HDL: high-density lipoprotein.
g LDL: low-density lipoprotein.
h CRP: c-reactive protein.
i eGFR CKD-EPI: estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration equation.
Within each cohort, we assessed whether there were differences in characteristics between the response categories (ie, full consent vs nonresponse). In the eIC cohort, the nonresponse group was significantly younger than the full consent group ( Table 2 ). Other than that, the clinical characteristics of the full consent group were similar to those of the nonresponse group.
More differences were found between the response categories of the face-to-face IC cohort. Adjusted for age and sex, patients in the full consent group had higher hemoglobin, but lower HbA 1c and c-reactive protein values than the nonresponse group ( Table 3 ).
Variable | Full consent (n=415) | Nonresponse (n=443) | value | |
Age (years), median (IQR) | 60.0 (48.0-70.0) | 56.0 (28.0-72.0) | .0002 | |
Male | 237 (57.1) | 222 (50.1) | — | |
Female | 178 (42.9) | 221 (49.9) | .0420 | |
BMI (kg/m ), mean (SD) | 26.6 (5.2) | 26.0 (4.9) | .3673 | |
SAP (mm Hg), mean (SD) | 132.1 (19.4) | 130.4 (19.6) | .4168 | |
Hemoglobin (mmol/L), mean (SD) | 8.5 (1.4) | 8.4 (1.3) | .2397 | |
HbA (mmol/mol), median (IQR) | 37.5 (34.0-44.0) | 37.5 (34.0-40.2) | .1940 | |
Cholesterol (mmol/L), mean (SD) | 4.8 (1.2) | 4.6 (1.5) | .2852 | |
HDL -cholesterol (mmol/L), mean (SD) | 1.3 (0.4) | 1.2 (0.5) | .3371 | |
LDL -cholesterol (mmol/L), mean (SD) | 2.7 (1.1) | 2.6 (0.9) | .9304 | |
Triglycerides (mmol/L), median (IQR) | 1.7 (1.1-2.6) | 1.4 (1.1-2.0) | .4167 | |
CRP (mg/L), median (IQR) | 2.0 (0.5-10.0) | 3.0 (0.5-12.0) | .5922 | |
Creatinine (µmol/L), median (IQR) | 76.0 (64.2-94.0) | 79.0 (64.0-100.5) | .0897 | |
eGFR CKD-EPI (mL/min/1.73 m ), mean (SD) | 83.3 (23.1) | 82.0 (30.7) | .1103 |
a Reference group.
b SAP: systolic arterial blood pressure.
c HbA 1c : glycated hemoglobin.
d HDL: high-density lipoprotein.
e LDL: low-density lipoprotein.
f CRP: c-reactive protein.
g eGFR CKD-EPI: estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration equation.
Variable | Full consent (n=876) | Nonresponse (n=1034) | value | |
Age, median (IQR) | 61.0 (50.0-69.0) | 61.0 (48.0-71.0) | .9461 | |
Male | 476 (54.3) | 552 (53.4) | — | |
Female | 400 (45.7) | 482 (46.6) | .7859 | |
BMI (kg/m ), mean (SD) | 26.7 (5.7) | 26.2 (5.5) | .1063 | |
SAP (mm Hg), mean (SD) | 137.6 (19.6) | 136.3 (22.0) | .1093 | |
Hemoglobin (mmol/L), mean (SD) | 8.8 (0.9) | 8.3 (1.2) | <.0001 | |
HbA (mmol/mol), median (IQR) | 37.0 (34.0-40.0) | 38.0 (34.0-42.0) | .0001 | |
Cholesterol (mmol/L), mean (SD) | 5.1 (1.3) | 5.0 (1.4) | .4493 | |
HDL -cholesterol (mmol/L), mean (SD) | 1.4 (0.4) | 1.3 (0.4) | .0898 | |
LDL -cholesterol (mmol/L), mean (SD) | 2.9 (1.1) | 2.9 (1.1) | .2754 | |
Triglycerides (mmol/L), median (IQR) | 1.6 (1.0-2.1) | 1.6 (1.0-2.4) | .0435 | |
CRP (mg/L), median (IQR) | 2.6 (1.1-8.5) | 8.1 (2.0-38.2) | <.0001 | |
Creatinine (µmol/L), median (IQR) | 74.0 (64.0-88.0) | 75.0 (63.0-92.0) | .4361 | |
eGFR CKD-EPI (mL/min/1.73 m ), mean (SD) | 84.5 (22.3) | 81.3 (29.0) | .0946 |
We repeated the regression analyses adjusted for sex and age. In these regression analyses, age was maintained continuous instead of categorized, to assess whether the categorization of age led to different results. The results were similar ( Multimedia Appendix 5 ).
We showed that by using an eIC in an LHS, patients more often provided full consent to link their data to national registries, GPs, and other hospitals compared with a face-to-face IC procedure. The clinical characteristics of patients with full consent remained largely similar after changing the IC procedure to an eIC. Except for age, we did not find any differences between the response categories of the eIC cohort, whereas in the face-to-face cohort, several differences were found. These differences potentially suggest a higher (cardiovascular) disease burden in the nonresponse group compared with the full consent group, indicative of a potentially more pronounced selection in the face-to-face approach.
A possible explanation for the differences in characteristics between the response categories in the face-to-face cohort is that patients may have been too ill or frail to attend the physical appointment with the research nurse to discuss and sign the IC form, resulting in nonresponse. The inability to attend the appointment was probably less of an issue in the eIC cohort, as patients were able to access the eIC form remotely. The finding suggests that the use of eIC results in a study population (ie, those who give full consent) that is more representative of the full target population. Our findings agree with a previous study showing that providing computer-based clinical study information leads to more willingness to participate [ 19 ], as the increased willingness to participate is consistent with the higher full consent rates found in the eIC group compared with the face-to-face IC group in our study.
Concerns have been raised about whether consent given via an eIC is truly an “informed” consent [ 8 ]. According to the principles of the Declaration of Helsinki [ 7 ], potential participants must be adequately informed about various aspects of the study, such as its purpose, sources of funding, the anticipated benefits and potential risks, and the right to refuse or withdraw consent to participate without giving a reason [ 7 ]. According to previous research, comprehension assessment is more challenging when an eIC procedure is used as there is no direct interaction between the potential participant and researcher [ 6 ]. As a result, patients might provide consent without fully understanding what they are consenting to, or, conversely, patients may be less likely to consent because of the lack of personal interaction with the researcher or clinician, especially those who were already doubtful about participating in the first place. However, our findings indicate that the latter might not have been the case in our pilot study, as we observed a higher percentage of patients with full consent in the eIC cohort compared with the face-to-face IC cohort.
Another frequently mentioned concern is that studies using an eIC procedure could become inaccessible to patients who lack the digital literacy needed to access and understand the eIC form [ 6 ]. In 2021, the Netherlands had the highest percentage (ie, 79%) of 17- to 74-year-olds with at least basic digital skills in Europe [ 20 ]. Therefore, incomprehension of the eIC due to limited digital literacy may appear less of an issue in our study. However, the percentage of persons with basic digital skills varied considerably by age, with older people being less literate [ 20 ]. A sensitivity analysis showed that the age distribution of responding patients was similar between the eIC and the face-to-face approach ( Multimedia Appendix 6 ), indicating that the eIC was not less accessible than the face-to-face IC for certain age groups. However, accessibility may be an issue for geriatric patients, who are generally older than cardiology patients and often have geriatric syndromes that sometimes affect comprehension and literacy [ 21 ]. These syndromes generally make it difficult to obtain IC from the elderly [ 21 ]. eIC could, therefore, also be seen as an opportunity. Unlike paper-based ICs, multiple formats can be used to inform the patient about the purpose of the eIC and to provide technical support, for example, by using instructional videos or audio. The use of multiple formats in IC forms for the elderly has been recommended by, among others, Barron et al [ 22 ]. Furthermore, UCC-CVRM’s eIC form is available in UMC Utrecht’s long-existing patient portal. In the portal, patients have the opportunity to, among others, ask questions to their clinician via an e-consult, which can be used if parts of the eIC are unclear [ 23 ]. Another possibility would be a hybrid format, allowing patients who prefer correspondence by regular mail to respond using a paper-based IC form. However, it is questionable whether this would be helpful and it would negate the positive aspects of the eIC highlighted in this study (eg, less pronounced selection).
Since July 2022, eICs have been permitted in the Netherlands when certain conditions are met [ 24 ]. A total of 6 conditions are described in the guideline written by the Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek) and the Dutch Association of Medical Research Ethics Committees (Nederlandse Vereniging voor Medisch-Ethische toetsingscommissies) [ 25 ]. The most important conditions are (1) eIC must be appropriate for the study, meaning that the study is associated with low potential risk and burden for the patient, (2) the eIC process must be sufficiently reliable and confidential, guaranteed by an electronic system that is compliant to the Dutch General Data Protection Regulation (UAVG in Dutch) and ensures the validity of the electronic signatures, and (3) the eIC procedure must be described in the study protocol [ 24 , 25 ]. The implementation of an eIC seems appropriate in the case of the UCC-CVRM, as no potential risk or burden for the patient is involved. Furthermore, in the eIC of the UCC-CVRM, data security, identity verification, and the validity of the electronic signature are ensured by the Dutch digital ID, an identification method for accessing web-based services [ 26 ]. Regarding the third condition, an amendment to the UCC-CVRM approach, including the eIC, was submitted and approved by the Research Ethics Committee.
Based on the results of our study, the use of eIC to obtain IC might be a sustainable and adequate way to enable researchers to link with national registries, GPs, and other hospitals. The use of the eIC seemed to have resulted in a population with consent that is more similar to the target population compared with the face-to-face IC, which is of great importance in an LHS. Results from the LHS would be more generalizable to the target population, namely to all patients at higher cardiovascular risk. Yet, one may argue whether ≈50% response to both the electronic and face-to-face IC for an LHS approach is sufficient. In addition, it should be noted that the extractability of CVRM indicators from structured fields in the EHR was much lower in the eIC cohort compared with the face-to-face IC cohort. Groenhof et al [ 13 ] showed that the former, protocolized, face-to-face UCC-CVRM approach led to more systematic registration of the cardiovascular risk profile in the EHR, which had a positive effect on CVRM guideline adherence in consenting patients, compared with the situation before UCC-CVRM was introduced [ 13 ]. The substantial missingness in the eIC cohort of our study may suggest that these improvements are at risk when the approach is automated, as deviations from the initial protocol are made, potentially leading to suboptimal CVRM in clinical care.
Exploring the views and experiences of patients could help to further improve the eIC form. Therefore, we recommend further qualitative research into the accessibility and understandability of eICs used for similar purposes and in similar settings as the UCC-CVRM LHS from a patient’s perspective.
To the best of our knowledge, we are among the first to investigate the differences in clinical patient characteristics between response categories of an eIC compared with those of a traditional face-to-face IC, specifically in the context of a cardiovascular LHS in a large sample of patients. Our uniqueness, however, limits the ability to compare our findings to the literature, as most research on eIC has focused on user perspectives, experiences, and the ethical considerations of eICs. For example, Chen et al [ 5 ] showed that in most included studies, participants had a better understanding of the information when using an eIC compared with a traditional paper-based face-to-face IC, while others found no difference [ 5 ]. Nevertheless, they [ 5 ] and others [ 2 , 6 , 27 ] indicated that face-to-face interaction should remain part of the IC process, especially for more complex and higher-risk studies. However, as the UCC-CVRM LHS is not a complex or high-risk study, the face-to-face interaction may be less necessary. Furthermore, the nonresponders in the eIC cohort may not be fully comparable to the nonresponders in the face-to-face IC cohort because, in the eIC cohort, patients received the eIC after their appointment at the cardiology outpatient clinic, whereas in the face-to-face IC cohort, cardiology patients were identified as eligible and received information about the UCC-CVRM LHS prior to their appointment. This means that patients who, for example, canceled their appointment at the last minute would still be included in the face-to-face cohort as nonresponders. It may be that patients who did not attend their appointment at all had different characteristics to those who attended but did not respond to the eIC, potentially affecting the validity of the comparisons made. Finally, the eIC form was piloted in the patient population of the cardiology outpatient clinic only. Although our results indicated that there were only minor differences (ie, hemoglobin) between patients providing full consent using the eIC compared with the face-to-face IC, it remains to be seen whether this would still be the case after implementation of the eIC in other clinical departments.
To conclude, our findings suggest that using an eIC may lead to a better representation of the target population by consenting patients. This increases the generalizability of results from studies using the data collected within the LHS from consenting patients.
The Utrecht Cardiovascular Cohort-Cardiovascular Risk Management (UCC-CVRM) is primarily financed by the University Medical Center (UMC) Utrecht (contact information of UCC-CVRM is [email protected]). AGMZ was supported by a grant from the European Union’s Horizon 2020 research and innovation program (grant agreement number 101017331; ODIN). MJH and RvdG were supported by the ZonMw, ETHMIRE project (grant agreement number 91217027). The funding sources were not involved in the design of the study, the analysis and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. Members of the UCC-CVRM study group were the following: GJ de Borst, Department of Vascular Surgery; ML Bots (chair), Julius Center for Health Sciences and Primary Care; M Hollander, Julius Center for Health Sciences and Primary Care; MH Emmelot, Department of Geriatrics; PA de Jong, Department of Radiology; AT Lely, Department of Obstetrics/Gynecology; HM Nathoe, Department of Cardiology; IE Hoefer, Central Diagnostic Laboratory; NP van der Kaaij, Department of Cardiothoracic Surgery; YM Ruigrok, Department of Neurology; and MC Verhaar, Department of Nephrology and Hypertension, FLJ Visseren, Department of Vascular Medicine, University Medical Center Utrecht and Utrecht University.
AGMZ, HMN, WWvS, MLB, SH, and RWMV contributed to the conceptualization of the project. AGMZ, RWMV, SH, WWvS, and MLB contributed to the methodology of the project. AGMZ analyzed the data and drafted the manuscript. AGMZ, MJH, RvdG, HMN, WWvS, MLB, SH, and RWMV contributed substantially to the interpretation of the data. The final manuscript was critically reviewed and edited by all authors. Approval of the final manuscript was obtained by all authors.
None declared.
The electronic informed consent form as presented in the patient portal of the UMC (University Medical Center) Utrecht (translated from Dutch to English).
Missingness per variable in count and percentage, by cohort and informed consent response strata.
Yield (ie, response to the informed consent invitation), by type of informed consent. eIC: electronic informed consent; GP: general practitioner.
Differences between patients who did not respond, by cohort, adjusted for age and sex.
Results of the sensitivity analysis in which age is treated as a continuous variable instead of categorical variable.
Age distribution of patients who completed the informed consent form, stratified by cohort.
cardiovascular risk management |
electronic health record |
electronic informed consent |
general practitioner |
glycated hemoglobin |
informed consent |
learning health care system |
Strengthening the Reporting of Observational Studies in Epidemiology |
Utrecht Cardiovascular Cohort-Cardiovascular Risk Management |
University Medical Center |
Edited by A Mavragani; submitted 29.11.23; peer-reviewed by CMJ Wong, H Kondylakis; comments to author 28.02.24; revised version received 15.04.24; accepted 10.05.24; published 11.07.24.
©Anna G M Zondag, Marieke J Hollestelle, Rieke van der Graaf, Hendrik M Nathoe, Wouter W van Solinge, Michiel L Bots, Robin W M Vernooij, Saskia Haitjema, UCC-CVRM study group. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 11.07.2024.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research (ISSN 1438-8871), is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.
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Background: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.
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