Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

Bobb, Morgan R.; Heukelom, Paul Van; Faine, Brett; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory K.; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

doi:10.1111/acem.12966

Cited by 35 publications

(51 citation statements)

References 20 publications

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“…The quality of the included studies varied widely. Among the randomized controlled trials, only 3 studies [ 25 - 27 ] received a quality score of 3. Quality scores of 2 and 1 were provided to 1 study [ 28 ] and 6 studies [ 29 - 34 ], respectively.…”

Section: Resultsmentioning

confidence: 99%

“…In some studies [ 28 , 33 , 34 , 39 , 44 - 46 , 48 , 55 , 60 , 62 ], the majority of participants had a high level of education. It should also be noted that a number of studies [ 27 , 29 , 51 ] assessing comprehension did not report the education level of their participants. Therefore, there might be additional barriers for less educated participants to achieving an adequate level of understanding.…”

Section: Discussionmentioning

confidence: 99%

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Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Sutter¹,

Zaçe²,

Boccia³

et al. 2020

J Med Internet Res

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Background Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. Objective We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. Methods We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. Results A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. Conclusions Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. Trial Registration PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Sutter¹,

Zaçe²,

Boccia³

et al. 2020

J Med Internet Res

View full text Add to dashboard Cite

show abstract

“…Such capabilities can take the form of telemedicine, where researchers connect remotely but in real time with prospective participants, or manifest in online or mail-based strategies. One recent randomized trial has shown that telemedicine is not inferior to a face-to-face informed consent process, in terms of patient-reported understanding [ 10 ]. And in a recent worldwide online survey ( N = 12,427), 60% of respondents reported the use of some form of technology in their clinical studies, most commonly taking the form of text messaging (18%), use of a tablet for informed consent (17%), use of a smartphone app (10%), and use of wearable devices (8%) [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial

Baca-Motes

Edwards

Waalen

et al. 2019

Contemporary Clinical Trials Communications

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ObjectivesThe advent of large databases, wearable technology, and novel communications methods has the potential to expand the pool of candidate research participants and offer them the flexibility and convenience of participating in remote research. However, reports of their effectiveness are sparse. We assessed the use of various forms of outreach within a nationwide randomized clinical trial being conducted entirely by remote means.MethodsCandidate participants at possibly higher risk for atrial fibrillation were identified by means of a large insurance claims database and invited to participate in the study by their insurance provider. Enrolled participants were randomly assigned to one of two groups testing a wearable sensor device for detection of the arrhythmia.ResultsOver 10 months, the various outreach methods used resulted in enrollment of 2659 participants meeting eligibility criteria. Starting with a baseline enrollment rate of 0.8% in response to an email invitation, the recruitment campaign was iteratively optimized to ultimately include website changes and the use of a five-step outreach process (three short, personalized emails and two direct mailers) that highlighted the appeal of new technology used in the study, resulting in an enrollment rate of 9.4%. Messaging that highlighted access to new technology outperformed both appeals to altruism and appeals that highlighted accessing personal health information.ConclusionsTargeted outreach, enrollment, and management of large remote clinical trials is feasible and can be improved with an iterative approach, although more work is needed to learn how to best recruit and retain potential research participants.Trial registrationClinicaltrials.govNCT02506244. Registered 23 July 2015.

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“…In a recent study, researchers found noninferior informed consent using telemedicine for remote study enrollment; understanding of consent and accrual rates of participation were similar between face-to-face and telemedicine groups. 11 …”

Section: Discussionmentioning

confidence: 99%

Enrollment Challenges in Critical Care Nursing Research

Sole¹,

Middleton²,

Deaton³

et al. 2017

Am J Crit Care

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Background Enrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers. Objective To describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment. Methods Two years’ worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients’ sex, race, and ethnicity. Results Target enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients (P=.02). Conclusions Unavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.

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Telemedicine Provides Noninferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

Cited by 35 publications

References 20 publications

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review

Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial

Enrollment Challenges in Critical Care Nursing Research

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