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Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study

Longitudinal clinical studies traditionally require in-person study visits which are well documented to pose barriers to participation and contribute challenges to enrolling representative samples. Remote trial models may reduce barriers to research engagement, improve retention, and reach a more re...

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Autores principales: Naz-McLean, Sarah, Kim, Andy, Zimmer, Andrew, Laibinis, Hannah, Lapan, Jen, Tyman, Paul, Hung, Jessica, Kelly, Christina, Nagireddy, Himaja, Narayanan-Pandit, Surya, McCarthy, Margaret, Ratnaparkhi, Saee, Rutherford, Henry, Patel, Rajesh, Dryden-Peterson, Scott, Hung, Deborah T., Woolley, Ann E., Cosimi, Lisa A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9165767/
https://www.ncbi.nlm.nih.gov/pubmed/35657813
http://dx.doi.org/10.1371/journal.pone.0269127
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author Naz-McLean, Sarah
Kim, Andy
Zimmer, Andrew
Laibinis, Hannah
Lapan, Jen
Tyman, Paul
Hung, Jessica
Kelly, Christina
Nagireddy, Himaja
Narayanan-Pandit, Surya
McCarthy, Margaret
Ratnaparkhi, Saee
Rutherford, Henry
Patel, Rajesh
Dryden-Peterson, Scott
Hung, Deborah T.
Woolley, Ann E.
Cosimi, Lisa A.
author_facet Naz-McLean, Sarah
Kim, Andy
Zimmer, Andrew
Laibinis, Hannah
Lapan, Jen
Tyman, Paul
Hung, Jessica
Kelly, Christina
Nagireddy, Himaja
Narayanan-Pandit, Surya
McCarthy, Margaret
Ratnaparkhi, Saee
Rutherford, Henry
Patel, Rajesh
Dryden-Peterson, Scott
Hung, Deborah T.
Woolley, Ann E.
Cosimi, Lisa A.
author_sort Naz-McLean, Sarah
collection PubMed
description Longitudinal clinical studies traditionally require in-person study visits which are well documented to pose barriers to participation and contribute challenges to enrolling representative samples. Remote trial models may reduce barriers to research engagement, improve retention, and reach a more representative cohort. As remote trials become more common following the COVID-19 pandemic, a critical evaluation of this approach is imperative to optimize this paradigm shift in research. The TestBoston study was launched to understand prevalence and risk factors for COVID-19 infection in the greater Boston area through a fully remote home-testing model. Participants (adults, within 45 miles of Boston, MA) were recruited remotely from patient registries at Brigham and Women’s Hospital and the general public. Participants were provided with monthly and “on-demand” at-home SARS-CoV-2 RT-PCR and antibody testing using nasal swab and dried blood spot self-collection kits and electronic surveys to assess symptoms and risk factors for COVID-19 via an online dashboard. Between October 2020 and January 2021, we enrolled 10,289 participants reflective of Massachusetts census data. Mean age was 47 years (range 18–93), 5855 (56.9%) were assigned female sex at birth, 7181(69.8%) reported being White non-Hispanic, 952 (9.3%) Hispanic/Latinx, 925 (9.0%) Black, 889 (8.6%) Asian, and 342 (3.3%) other and/or more than one race. Lower initial enrollment among Black and Hispanic/Latinx individuals required an adaptive approach to recruitment, leveraging connections to the medical system, coupled with community partnerships to ensure a representative cohort. Longitudinal retention was higher among participants who were White non-Hispanic, older, working remotely, and with lower socioeconomic vulnerability. Implementation highlighted key differences in remote trial models as participants independently navigate study milestones, requiring a dedicated participant support team and robust technology platforms, to reduce barriers to enrollment, promote retention, and ensure scientific rigor and data quality. Remote clinical trial models offer tremendous potential to engage representative cohorts, scale biomedical research, and promote accessibility by reducing barriers common in traditional trial design. Barriers and burdens within remote trials may be experienced disproportionately across demographic groups. To maximize engagement and retention, researchers should prioritize intensive participant support, investment in technologic infrastructure and an adaptive approach to maximize engagement and retention.
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spelling pubmed-91657672022-06-05 Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study Naz-McLean, Sarah Kim, Andy Zimmer, Andrew Laibinis, Hannah Lapan, Jen Tyman, Paul Hung, Jessica Kelly, Christina Nagireddy, Himaja Narayanan-Pandit, Surya McCarthy, Margaret Ratnaparkhi, Saee Rutherford, Henry Patel, Rajesh Dryden-Peterson, Scott Hung, Deborah T. Woolley, Ann E. Cosimi, Lisa A. PLoS One Research Article Longitudinal clinical studies traditionally require in-person study visits which are well documented to pose barriers to participation and contribute challenges to enrolling representative samples. Remote trial models may reduce barriers to research engagement, improve retention, and reach a more representative cohort. As remote trials become more common following the COVID-19 pandemic, a critical evaluation of this approach is imperative to optimize this paradigm shift in research. The TestBoston study was launched to understand prevalence and risk factors for COVID-19 infection in the greater Boston area through a fully remote home-testing model. Participants (adults, within 45 miles of Boston, MA) were recruited remotely from patient registries at Brigham and Women’s Hospital and the general public. Participants were provided with monthly and “on-demand” at-home SARS-CoV-2 RT-PCR and antibody testing using nasal swab and dried blood spot self-collection kits and electronic surveys to assess symptoms and risk factors for COVID-19 via an online dashboard. Between October 2020 and January 2021, we enrolled 10,289 participants reflective of Massachusetts census data. Mean age was 47 years (range 18–93), 5855 (56.9%) were assigned female sex at birth, 7181(69.8%) reported being White non-Hispanic, 952 (9.3%) Hispanic/Latinx, 925 (9.0%) Black, 889 (8.6%) Asian, and 342 (3.3%) other and/or more than one race. Lower initial enrollment among Black and Hispanic/Latinx individuals required an adaptive approach to recruitment, leveraging connections to the medical system, coupled with community partnerships to ensure a representative cohort. Longitudinal retention was higher among participants who were White non-Hispanic, older, working remotely, and with lower socioeconomic vulnerability. Implementation highlighted key differences in remote trial models as participants independently navigate study milestones, requiring a dedicated participant support team and robust technology platforms, to reduce barriers to enrollment, promote retention, and ensure scientific rigor and data quality. Remote clinical trial models offer tremendous potential to engage representative cohorts, scale biomedical research, and promote accessibility by reducing barriers common in traditional trial design. Barriers and burdens within remote trials may be experienced disproportionately across demographic groups. To maximize engagement and retention, researchers should prioritize intensive participant support, investment in technologic infrastructure and an adaptive approach to maximize engagement and retention. Public Library of Science 2022-06-03 /pmc/articles/PMC9165767/ /pubmed/35657813 http://dx.doi.org/10.1371/journal.pone.0269127 Text en © 2022 Naz-McLean et al 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 author and source are credited.
spellingShingle Research Article
Naz-McLean, Sarah
Kim, Andy
Zimmer, Andrew
Laibinis, Hannah
Lapan, Jen
Tyman, Paul
Hung, Jessica
Kelly, Christina
Nagireddy, Himaja
Narayanan-Pandit, Surya
McCarthy, Margaret
Ratnaparkhi, Saee
Rutherford, Henry
Patel, Rajesh
Dryden-Peterson, Scott
Hung, Deborah T.
Woolley, Ann E.
Cosimi, Lisa A.
Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study
title Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study
title_full Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study
title_fullStr Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study
title_full_unstemmed Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study
title_short Feasibility and lessons learned on remote trial implementation from TestBoston, a fully remote, longitudinal, large-scale COVID-19 surveillance study
title_sort feasibility and lessons learned on remote trial implementation from testboston, a fully remote, longitudinal, large-scale covid-19 surveillance study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9165767/
https://www.ncbi.nlm.nih.gov/pubmed/35657813
http://dx.doi.org/10.1371/journal.pone.0269127
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