Electronic consent in a COVID-19 vaccine implementation trial in South Africa: Participant perspectives

The novel SARS-CoV-2 coronavirus poses many unique challenges to the implementation of clinical research, particularly as it relates to the processes of informed consent. Traditional methods of in-person informed consent were no longer plausible, as face-to-face discussions may expose researchers and patients to increased risk of contracting and spreading the virus. In many circumstances the research personnel obtaining consent were considered non-essential workers, and thus did not have priority for personal protective equipment in light of national shortages.

Background Consent is a core pillar of patient care, especially for surgical procedures under anaesthesia. Some patients lack capacity to consent, and in these cases documentation of capacity assessment and a best interests decision is essential. Error rates on hand-written consent forms can be high and this can be reduced by using electronic consent forms. In a UK DGH, electronic consent was implemented in October 2022, and we look at the impact this has had on the process of consent in patients who lack capacity. Methods We examined the process required for documentation of consent in patients who lack capacity to be sent to the safeguarding team and how many they had received in the 3 years prior to electronic consent implementation. We then compared the process for the safeguarding team to be sent electronic documentation and how many they had received from October-January. Results For paper documentation to be received by the safeguarding team, a clinician would have to scan the MCA and email it to the safeguarding team. In the 3 years prior to October 2022, they had received 1 form. Currently, the safeguarding team request a weekly report from the electronic consent supplier and receive electronic copies directly. They have received 45 to date. Conclusions The implementation of electronic consent has resulted in the safeguarding team having greater insight into the number of patients who are having procedures that lack capacity. This enables them to follow up the patients and ensures better, more holistic, patient care.

BackgroundObtaining explicit consent from patients to use their remnant biological samples and deidentified clinical data for research is essential for advancing precision medicine.ObjectiveWe aimed to describe the operational implementation and scalability of an electronic universal consent process that was used to power an institutional precision health biobank across a large academic health system.MethodsThe University of California, Los Angeles, implemented the use of innovative electronic consent videos as the primary recruitment tool for precision health research. The consent videos targeted patients aged ≥18 years across ambulatory clinical laboratories, perioperative settings, and hospital settings. Each of these major areas had slightly different workflows and patient populations. Sociodemographic information, comorbidity data, health utilization data (ambulatory visits, emergency room visits, and hospital admissions), and consent decision data were collected.ResultsThe consenting approach proved scalable across 22 clinical sites (hospital and ambulatory settings). Over 40,000 participants completed the consent process at a rate of 800 to 1000 patients per week over a 2-year time period. Participants were representative of the adult University of California, Los Angeles, Health population. The opt-in rates in the perioperative (16,500/22,519, 73.3%) and ambulatory clinics (2308/3390, 68.1%) were higher than those in clinical laboratories (7506/14,235, 52.7%; P<.001). Patients with higher medical acuity were more likely to opt in. The multivariate analyses showed that African American (odds ratio [OR] 0.53, 95% CI 0.49-0.58; P<.001), Asian (OR 0.72, 95% CI 0.68-0.77; P<.001), and multiple-race populations (OR 0.73, 95% CI 0.69-0.77; P<.001) were less likely to participate than White individuals.ConclusionsThis is one of the few large-scale, electronic video–based consent implementation programs that reports a 65.5% (26,314/40,144) average overall opt-in rate across a large academic health system. This rate is higher than those previously reported for email (3.6%) and electronic biobank (50%) informed consent rates. This study demonstrates a scalable recruitment approach for population health research.

Consenting in the time of the COVID-19 pandemic

Many health systems use electronic consent (eConsent) for surgery, but few have used surgical consent functionality in the patient portal (PP). Incorporating the PP into the consent process could potentially improve efficiency by letting patients independently review and sign their eConsent before the day of surgery. To evaluate the association of eConsent delivery via the PP with operational efficiency and patient engagement. This mixed-methods study consisted of a retrospective quantitative analysis (February 8 to August 8, 2023) and a qualitative analysis of semistructured patient interviews (December 1, 2023, to January 31, 2024) of adult surgical patients in a health system that implemented surgical eConsent. Statistical analysis was performed between September 1, 2023, and June 6, 2024. Patient demographics, efficiency metrics (first-start case delays), and PP access logs were analyzed from electronic health records. Qualitative outcomes included thematic analysis from semistructured patient interviews. In the PP-eligible cohort of 7672 unique patients, 8478 surgical eConsents were generated (median [IQR] age, 58 [43-70] years; 4611 [54.4%] women), of which 5318 (62.7%) were signed on hospital iPads and 3160 (37.3%) through the PP. For all adult patients who signed an eConsent using the PP, patients waited a median (IQR) of 105 (17-528) minutes to view their eConsent after it was electronically pushed to their PP. eConsents signed on the same day of surgery were associated with more first-start delays (odds ratio, 1.59; 95% CI, 1.37-1.83; P < .001). Themes that emerged from patient interviews included having a favorable experience with the PP, openness to eConsent, skimming the consent form, and the importance of the discussion with the surgeon. These findings suggest that eConsent incorporating PP functionality may reduce surgical delays and staff burden by allowing patients to review and sign before the day of surgery. Most patients spent minimal time engaging with their consent form, emphasizing the importance of surgeon-patient trust and an informed consent discussion. Additional studies are needed to understand patient perceptions of eConsent, PP, and barriers to increased uptake.

IntroductionPatient consent for surgery is a vital part of the surgical pathway from both a patient safety and medicolegal point of view. Improvement in documenting the full consent process in the electronic patient record (EPR), alongside the standard completion of the paper consent form in a surgical emergency unit (SEU), to comply with the Montgomery ruling of informed consent, has become of paramount importance. The aim of this project was to improve the documentation of the full consent process by creating an electronic template that was easy for the consenting clinician to use and provided a robust record of the bespoke consent process for the individual patient.MethodsIn July 2020, clinicians in the SEU were asked to begin documenting the patient's consent process in the EPR. The number of documented electronic consent processes (ECPs) of patients who underwent emergency general surgery during a two-week period was then captured between October and November 2020. The second cycle involved creating a single consent template, allowing the ECP to be easily documented in one template for all the common emergency surgery operations. All clinicians who were responsible for surgical consenting were asked to use the electronic template as part of the consent process. The rate of electronic consent was recorded over a second two-week period, six months later, in May 2021.ResultsFrom the first cycle, 78 patients were identified as undergoing emergency surgery, of which 13% (N=10) had an electronic entry regarding the consent process fully documented and personalised to the patient. From the second cycle, 64 patients were identified. The rate of documented ECPs increased to 77% (N=49).ConclusionThis project has successfully improved the electronic demonstration of a consent process, bespoke to the individual, in accordance with the Montgomery ruling, by implementing an easy-to-use template on EPR. This is a significant step towards full digital consent in the future.

Digital technologies create opportunities for improving consenting processes in cancer care and research. Yet, little is known about the prevalence of electronic consenting, or e-consent, at US cancer care institutions. We surveyed institutions in the National Comprehensive Cancer Network about their capabilities for clinical, research, and administrative e-consents; technologies used; telemedicine consents; multilingual support; evaluations; and opportunities and challenges in moving from paper-based to electronic processes. Responses were summarized across responding institutions. Twenty-five institutions completed the survey (81% response rate). Respondents were from all census regions and included freestanding and matrix cancer centers. Twenty (80%) had e-consent capabilities, with variability in the extent of adoption: One (5%) had implemented e-consent for all clinical, research, and administrative needs while 19 (95%) had a mix of paper and electronic consenting. Among those with e-consent capabilities, the majority (14 of 20, 70%) were using features embedded in their electronic health record. Most had a combination of paper and e-consenting for clinical purposes (18, 72%). About two-thirds relied entirely on paper for research consents (16, 64%) but had at least some electronic processes for administrative consents (15, 60%). Obstacles to e-consenting included challenges with procuring or maintaining hardware, content management, workflow integration, and digital literacy of patients. Successes included positive user experiences, workflow improvements, and better record-keeping. Only two of 20 (10%) respondents with e-consent capabilities had evaluated the impact of automating consent processes. E-consent was prevalent in our sample, with 80% of institutions reporting at least some capabilities. Further progress is needed for the benefits of e-consenting to be realized broadly.

An analysis of the study participant and study coordinator experience utilizing an electronic consent (eConsent) in REDCap

A qualitative analysis of study participant and study partner experiences with the consent process: Assessments guiding the development of an electronic consent (ECONSENT)

As of April 19, 2021, South Africa has recorded 1.56 million COVID-19 cases and almost 54,000 deaths - more than any other country on the African continent. The country has begun the national rollout of the Johnson &amp; Johnson (J&amp;J) COVID-19 vaccine, with over 292 thousand doses administered it aims to achieve herd immunity by vaccinating at least 67 percent of its population (around 40 million people) by the end of 2021. The government suspended its initial rollout of the AstraZeneca (AZ) vaccine due to concerns over its effectiveness, particularly against the new B.1.351 variant, which accounts for 90% of the infections in South Africa. The J&amp;J vaccine was put on temporary hold in April due to concerns about rare clotting disorders. Although data show that expected acceptance of COVID-19 vaccines is relatively high, the suspension of two vaccines in South Africa, where fear of infection is decreasing, will likely influence public reactions. Understanding how individuals and population groups perceive and make sense of COVID-19 vaccines is critical to inform the design and implementation of risk communication and community engagement (RCCE) strategies, and guide interventions aiming to promote and sustain acceptance of COVID-19 vaccines, while encouraging compliance with other COVID-19 preventive measures. This review syntheses community perceptions of COVID-19 vaccines in South Africa to inform RCCE strategies and policies and provides examples of successful practice. It draws on multiple secondary data sources: scientific literature, qualitative and quantitative studies, grey literature, and mainstream and social media. The review was supported by consultation with four local expert key informants from different fields. It is part of the Social Science in Humanitarian Action Platform (SSHAP) series on social science considerations relating to COVID-19 vaccines. It was written for SSHAP by Tamara Roldan de Jong and Anthrologica on request of the UNICEF South Africa Country Office. Contributions were made from the RCCE Collective Service East and Southern Africa (ESAR) Region. The brief is the responsibility of SSHAP.

Our institution participated in the Oncology Care Model, which required us to include many of the 13 elements of the National Academy of Medicine (NAM) care plan into care pathways for our patients. We optimized our existing chemotherapy consent process to meet this need and maximized completion. Our multidisciplinary committee developed a three-phase Plan-Do-Study-Act process in our breast cancer clinic: (1) update and educate providers on our paper chemotherapy form with multiple components of the NAM care plan including prognosis and treatment effects on quality of life; (2) piloted an electronic chemotherapy consent form to decrease the administrative burden; and (3) autopopulated fields within the electronic consent. We assessed feedback after cycle 1 and created a Pareto chart. The outcome measure was percent completion of chemotherapy consent documents. Baseline monthly random chart audit of 40 patients revealed 20% of paper chemotherapy consent forms were completed in their entirety among patients. When we re-educated clinicians about the new paper consent containing the NAM elements, compliance rose to nearly 30%. A Pareto chart confirmed that content redundancy and wordiness were leading to under-completion. After creating and piloting the electronic consent, compliance increased to 90%. Finally, autopopulation with drop-down selections increased and sustained completion to 100%. Incorporating regulatory requirements into an existing workflow using Plan-Do-Study-Act methodology can reduce administrative burden on clinicians. Additional use of innovative technology can further increase clinician compliance with regulatory requirements while delivering high-value quality care to patients with cancer.

Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information and to address data quality concerns. This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as the effects of eConsent on the time patients took to perform the consenting process ("cycle time") and on-site workload in comparison with traditional paper-based consenting. The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Ovid Embase and Ovid MEDLINE were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of the studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as having "high" validity if comprehensive assessments were performed using established instruments. Overall, 37 publications describing 35 studies (13,281 participants) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20/35, 57% of the studies; 10 with "high" validity), acceptability (8/35, 23% of the studies; 1 with "high" validity), and usability (5/35, 14% of the studies; 1 with "high" validity) reported significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. None of the studies reported better results with paper than with eConsent. Among the "high" validity studies, 6 studies on comprehension reported significantly better understanding of at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than with paper (P<.05 for all). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with the content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent. This systematic review showed that compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes.

AimsTo examine the relationship between self-reported level of workplace support (WS) and various mental health outcomes in HCPs and non-HCPs at different time-points during the COVID-19 pandemic, and to examine whether improved WS is associated with improved mental health outcomes over time. Lastly, to identify what support healthcare professionals (HCPs) perceive to be most helpful.MethodsCohort survey study at baseline (July-September 2020) and follow-up (approximately four months later).SettingHCPs working in primary or secondary care, from UK and other countries, and non-HCP controls from primarily London-based universities.Participants1574 HCPs and 147 non-HCPs (academic and research staff at London-based universities). The inclusion criteria for the study were: 1) aged 18 or older, 2) electronic consent given, and 3) identified as HCP or non-healthcare academic staff or self-declared non-HCPs.Main outcome measuresPresence of generalized anxiety disorder (assessed using the GAD-7), clinical insomnia (ISI), major depressive disorder (PHQ-9), well-being (SWEMWBS), and burnout (emotional exhaustion and depersonalization; EEDP2Q). Qualitative data exploring what support HCPs perceive as most useful was gathered using free-text inputs.ResultsAt baseline and follow-up, consistently, compared to those who felt unsupported, those who felt supported had significantly reduced risk (odds) of generalized anxiety disorder (baseline: 59% [95% CI of OR, 0.29 to 0.57], follow-up: 41% [0.38 to 0.92]), clinical insomnia (51% [0.34 to 0.69], 66% [0.20 to 0.55]), major depressive disorder (58% [0.31 to 0.58], 54% [0.31 to 0.74]), emotional exhaustion (65% [0.26 to 0.46], 61% [0.27 to 0.56]) and depersonalization (58% [0.28 to 0.61], 68% [0.21 to 0.50]).At follow-up, self-reported improved WS (vs. baseline) was associated with significantly improved GAD-7 (adjusted difference. −1.73 [-2.54 to −0.91]), ISI (-0.96 [-1.88 to −0.04]), PHQ−9 (-1.32 [-2.16 to −0.49]), SWEMWBS (0.97 [0.37 to 1.57]) and EEDP2Q (burnout) (-1.30 [-1.82 to −0.79]) scores, independent of baseline level of support.Five themes were identified constituting WS: ‘managerial support’ was the largest sub-theme.ConclusionA consistent association was observed between level of WS and the mental health of HCPs and non-HCPs. Improved WS was associated with improved mental health scores over a four-month period during the pandemic.

RATIONALE: Research in intensive care units (ICUs) is essential to improving care for critically ill patients; however, patients are often unable to consent for themselves. Surrogates are often required to participate in the informed consent process for critical care research, though how to best engage surrogates in this process remains unclear. This study seeks to identify best practices for conducting surrogate consent for critical care research. METHODS: We conducted a mixed-methods study including quantitative surveys with open-ended questions, focus groups, and semi-structured interviews with principal investigators (PIs), research coordinators (RCs), surrogate decision makers who had been approached about a critical care research clinical trial, and when possible, the patient who had been critically ill. RESULTS: In total, 230 individuals (105 RC, 90 PI, 27 surrogates, 8 patients) completed surveys, and 61 participated in focus groups or interviews. In both surveys and focus groups/interviews, participants across all groups believed that RCs (as opposed to PIs) should conduct the consent process, as RCs are not considered to be authority figures and have fewer perceived conflicts of interest that could influence surrogates decision-making. Surrogates appreciated it when research staff waited until an optimal time to initiate contact and were given physical space and a defined period to consider their decision before follow up with them. When compared to PI/RCs, surrogates and/or patients attributed more importance to seeing the research team as an additional resource in explaining the progress of the patient's care and were appreciated having additional team members whom they perceived as advocating for adherence to clinical protocols for their loved ones (p&amp;lt;0.0001 and p=0.0016). Compared to PI/RCs, surrogates thought the written consent was more important and were less concerned with its length, (p=0.001 and p&amp;lt;0.0001). In general, all participants felt that phone and electronic consent was less effective than in-person consent, though these modalities could facilitate the process for distant surrogates. Consent timing, respect for surrogate decision-making autonomy, and clear communication of the patient's presumed wishes were additional significant themes. CONCLUSIONS: Our study highlights the need for better guidance for carrying out the surrogate consent process in ICU research and identifies several themes that could serve to develop recommendations including designating trained RCs as primary facilitators, improving consent timing and setting, and for implementing accessible consent documentation. This study supports developing standardized training and guidelines for the surrogate informed consent process that could be consistently applied by ethics review boards in reviewing consent processes for clinical care research.

The quest for more COVID-19 vaccinations in Africa