An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine

Golembiewski, Elizabeth H.; Mainous, Arch G.; Rahmanian, Kiarash P.; Brumback, Babette; Rooks, Benjamin J.; Krieger, Janice L.; Goodman, Kenneth W.; Moseley, Ray; Harle, Christopher A.

doi:10.1370/afm.2610

Cited by 9 publications

(20 citation statements)

References 23 publications

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“…Similar concerns about data privacy and protection arose within focus group discussions in a US study on attitudes toward eIC (Simon et al, 2018). Another US study showed that subjects had a higher degree of satisfaction with informed consent and a clearer understanding of research content when using eIC that presented information about both data protection measures and the training of researchers (Golembiewski et al, 2021). The authors of this latter study speculated that presenting such information may have protected against distrust toward eIC that could have been heightened by news media coverage of data privacy issues during the study.…”

Section: Discussionmentioning

confidence: 99%

“…Evaluations in the US and UK have shown that many research participants consider eIC easier to use, more interesting, and easier to understand than paper-based consent — but also that eIC may raise concerns such as accessibility for underrepresented populations, user-friendliness, and data security (Simon et al, 2018; Skelton et al, 2020). Improved participant satisfaction with eIC is associated with trust-enhancing messages providing more background information, and interactive explanatory features (Golembiewski et al, 2021; Skelton et al, 2020). However, a 2020 scoping review showed that although experts have identified benefits to eIC versus paper-based consent, research on effective strategies for overcoming barriers to eIC adoption is still far from comprehensive (Chen et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

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Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study

Ou-yang

Hahne

et al. 2022

Journal of Empirical Research on Human Research Ethics

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This study aims to investigate the knowledge and attitudes of participants and potential participants in clinical trials toward electronic informed consent. We conducted a survey-based cross-sectional study in Hunan Province, China in March 2021. A total of 547 respondents were included in this study. All questions in an 8-item survey section assessing participants’ knowledge of electronic informed consent received correct answers from at least 70% of participants. In terms of attitude scores, most participants (86.3%) believed that electronic informed consent is more convenient than the paper-based version, and more than half (51.2%) believed that electronic informed consent could completely replace the paper-based version. Responses indicated that common concerns about electronic informed consent were its security and confidentiality, legal benefits, and implications for rights protection.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study

Ou-yang

Hahne

et al. 2022

Journal of Empirical Research on Human Research Ethics

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“…A recent review of electronic consenting suggested that this modality is well received by participants, especially if it is accessible, user-friendly, and engaging and is tailored to specific patient populations [ 25 , 26 ]. The literature also suggests that this modality improves patient-centered outcomes, such as satisfaction and understanding [ 27 ]. At UCLA Health, we have implemented the translation of the UCON video into 8 languages that are represented widely across Los Angeles County.…”

Section: Discussionmentioning

confidence: 99%

An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study

Lajonchere¹,

Naeim²,

Dry³

et al. 2021

J Med Internet Res

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Background Obtaining explicit consent from patients to use their remnant biological samples and deidentified clinical data for research is essential for advancing precision medicine. Objective We 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. Methods The 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. Results The 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. Conclusions This 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.

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“…More than half of the included studies (40/75, 53%) did not describe or report the consent model used. Broad open consent was the most explored model (11/75, 15%) [44][45][46][47][48][49][50][51][52][53][54], followed by dynamic consent (8/75, 11%) [55][56][57][58][59][60][61][62], broad controlled consent (4/75, 5%) [63][64][65][66], broad tiered/meta/menu consent (3/75, 4%) [67][68][69], and general denial consent (2/75, 3%) [70,71].…”

Section: Research Question 1: What Are Patient Preferences On Consent...mentioning

confidence: 99%

“…Frequency, n (%) Type of consent 11 (15) Broad open-existing data and PHI a do not require additional consent for use 4 (5) Broad controlled-if consent is provided, data will only be used by approved investigators 3 (4) Broad tiered, menu, or meta-consent process allows participants to select the types of research for which their PHI can be used 8 (11) Dynamic consent-consent process allows participants to set and change their consent preferences through a secure platform 2 (3) General denial-consent is required by participants on a per-use basis 7 (9) Multiple consent models reported 40 (53) Consent model not reported a PHI: personal health information.…”

Section: Table 2 Spectrum Of Consent Models Reported (N=75)mentioning

confidence: 99%

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review

Kassam¹,

Ilkina²,

Kemp³

et al. 2023

J Med Internet Res

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Background The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited. Objective This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. Methods A structured literature search was developed and deployed in 4 electronic databases—MEDLINE, IEEE Xplore, Scopus, and Web of Science—for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis. Results In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants’ willingness to share PHI (25/75, 33%) and participants’ perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. Conclusions There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.

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An Electronic Tool to Support Patient-Centered Broad Consent: A Multi-Arm Randomized Clinical Trial in Family Medicine

Cited by 9 publications

References 23 publications

Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study

Knowledge and Attitudes of Research Participants in China Toward Electronic Informed Consent in Clinical Trials: A Cross Sectional Study

An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review

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