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

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 pr...

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Autores principales: Lajonchere, Clara, Naeim, Arash, Dry, Sarah, Wenger, Neil, Elashoff, David, Vangala, Sitaram, Petruse, Antonia, Ariannejad, Maryam, Magyar, Clara, Johansen, Liliana, Werre, Gabriela, Kroloff, Maxwell, Geschwind, Daniel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8701720/
https://www.ncbi.nlm.nih.gov/pubmed/34889741
http://dx.doi.org/10.2196/31121
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author Lajonchere, Clara
Naeim, Arash
Dry, Sarah
Wenger, Neil
Elashoff, David
Vangala, Sitaram
Petruse, Antonia
Ariannejad, Maryam
Magyar, Clara
Johansen, Liliana
Werre, Gabriela
Kroloff, Maxwell
Geschwind, Daniel
author_facet Lajonchere, Clara
Naeim, Arash
Dry, Sarah
Wenger, Neil
Elashoff, David
Vangala, Sitaram
Petruse, Antonia
Ariannejad, Maryam
Magyar, Clara
Johansen, Liliana
Werre, Gabriela
Kroloff, Maxwell
Geschwind, Daniel
author_sort Lajonchere, Clara
collection PubMed
description 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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spelling pubmed-87017202022-01-10 An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study Lajonchere, Clara Naeim, Arash Dry, Sarah Wenger, Neil Elashoff, David Vangala, Sitaram Petruse, Antonia Ariannejad, Maryam Magyar, Clara Johansen, Liliana Werre, Gabriela Kroloff, Maxwell Geschwind, Daniel J Med Internet Res Original Paper 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. JMIR Publications 2021-12-08 /pmc/articles/PMC8701720/ /pubmed/34889741 http://dx.doi.org/10.2196/31121 Text en ©Clara Lajonchere, Arash Naeim, Sarah Dry, Neil Wenger, David Elashoff, Sitaram Vangala, Antonia Petruse, Maryam Ariannejad, Clara Magyar, Liliana Johansen, Gabriela Werre, Maxwell Kroloff, Daniel Geschwind. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 08.12.2021. https://creativecommons.org/licenses/by/4.0/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, 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.
spellingShingle Original Paper
Lajonchere, Clara
Naeim, Arash
Dry, Sarah
Wenger, Neil
Elashoff, David
Vangala, Sitaram
Petruse, Antonia
Ariannejad, Maryam
Magyar, Clara
Johansen, Liliana
Werre, Gabriela
Kroloff, Maxwell
Geschwind, Daniel
An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study
title An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study
title_full An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study
title_fullStr An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study
title_full_unstemmed An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study
title_short An Integrated, Scalable, Electronic Video Consent Process to Power Precision Health Research: Large, Population-Based, Cohort Implementation and Scalability Study
title_sort integrated, scalable, electronic video consent process to power precision health research: large, population-based, cohort implementation and scalability study
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8701720/
https://www.ncbi.nlm.nih.gov/pubmed/34889741
http://dx.doi.org/10.2196/31121
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