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Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study
BACKGROUND: Internet‐based participation has the potential to enhance pragmatic and decentralized trials, where representative study populations and generalizability to clinical practice are key. We aimed to study the differences between internet and noninternet/telephone participants in a large rem...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10356087/ https://www.ncbi.nlm.nih.gov/pubmed/37345815 http://dx.doi.org/10.1161/JAHA.122.027899 |
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author | Shen, Rebecca Mulder, Hillary Wruck, Lisa Weissler, E. Hope Robertson, Holly R. Sharlow, Amber G. Kripalani, Sunil Muñoz, Daniel Effron, Mark B. Gupta, Kamal Girotra, Saket Whittle, Jeff Benziger, Catherine P. VanWormer, Jeffrey J. Polonsky, Tamar S. Rothman, Russell L. Harrington, Robert A. Hernandez, Adrian F. Jones, W. Schuyler |
author_facet | Shen, Rebecca Mulder, Hillary Wruck, Lisa Weissler, E. Hope Robertson, Holly R. Sharlow, Amber G. Kripalani, Sunil Muñoz, Daniel Effron, Mark B. Gupta, Kamal Girotra, Saket Whittle, Jeff Benziger, Catherine P. VanWormer, Jeffrey J. Polonsky, Tamar S. Rothman, Russell L. Harrington, Robert A. Hernandez, Adrian F. Jones, W. Schuyler |
author_sort | Shen, Rebecca |
collection | PubMed |
description | BACKGROUND: Internet‐based participation has the potential to enhance pragmatic and decentralized trials, where representative study populations and generalizability to clinical practice are key. We aimed to study the differences between internet and noninternet/telephone participants in a large remote, pragmatic trial. METHODS AND RESULTS: In a subanalysis of the ADAPTABLE (Aspirin Dosing: A Patient‐Centric Trial Assessing Benefits and Long‐Term Effectiveness) study, we compared internet participants with those who opted for noninternet participation. Study process measures examined included participant characteristics at consent, study medication adherence, and study retention. The clinical outcome examined was a composite of all‐cause mortality, hospitalization for myocardial infarction, or hospitalization for stroke. Noninternet participants were older (mean 69.4 versus 67.4 years), more likely to be female (38.9% versus 30.2%), more likely to be Black (27.3% versus 6.0%) or Hispanic (11.1% versus 2.0%), and had a higher number of comorbid conditions. The composite clinical outcome was more than twice as high in noninternet participants. The hazard of nonadherence to the assigned aspirin dosage was 46% higher in noninternet participants than internet participants. CONCLUSIONS: Noninternet participants differed from internet participants in notable demographic characteristics while having poorer baseline health. Over the course of ADAPTABLE, they also had worse clinical outcomes and greater likelihood of study drug nonadherence. These results suggest that trials focused on internet participation select for younger, healthier participants with a higher proportion of traditionally overrepresented patients. Allowing noninternet participation enhances diversity; however, additional steps may be needed to promote study retention and study medication adherence. REGISTRATION INFORMATION: clinicaltrials.gov. Identifier: NCT02697916. |
format | Online Article Text |
id | pubmed-10356087 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-103560872023-07-20 Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study Shen, Rebecca Mulder, Hillary Wruck, Lisa Weissler, E. Hope Robertson, Holly R. Sharlow, Amber G. Kripalani, Sunil Muñoz, Daniel Effron, Mark B. Gupta, Kamal Girotra, Saket Whittle, Jeff Benziger, Catherine P. VanWormer, Jeffrey J. Polonsky, Tamar S. Rothman, Russell L. Harrington, Robert A. Hernandez, Adrian F. Jones, W. Schuyler J Am Heart Assoc Original Research BACKGROUND: Internet‐based participation has the potential to enhance pragmatic and decentralized trials, where representative study populations and generalizability to clinical practice are key. We aimed to study the differences between internet and noninternet/telephone participants in a large remote, pragmatic trial. METHODS AND RESULTS: In a subanalysis of the ADAPTABLE (Aspirin Dosing: A Patient‐Centric Trial Assessing Benefits and Long‐Term Effectiveness) study, we compared internet participants with those who opted for noninternet participation. Study process measures examined included participant characteristics at consent, study medication adherence, and study retention. The clinical outcome examined was a composite of all‐cause mortality, hospitalization for myocardial infarction, or hospitalization for stroke. Noninternet participants were older (mean 69.4 versus 67.4 years), more likely to be female (38.9% versus 30.2%), more likely to be Black (27.3% versus 6.0%) or Hispanic (11.1% versus 2.0%), and had a higher number of comorbid conditions. The composite clinical outcome was more than twice as high in noninternet participants. The hazard of nonadherence to the assigned aspirin dosage was 46% higher in noninternet participants than internet participants. CONCLUSIONS: Noninternet participants differed from internet participants in notable demographic characteristics while having poorer baseline health. Over the course of ADAPTABLE, they also had worse clinical outcomes and greater likelihood of study drug nonadherence. These results suggest that trials focused on internet participation select for younger, healthier participants with a higher proportion of traditionally overrepresented patients. Allowing noninternet participation enhances diversity; however, additional steps may be needed to promote study retention and study medication adherence. REGISTRATION INFORMATION: clinicaltrials.gov. Identifier: NCT02697916. John Wiley and Sons Inc. 2023-06-22 /pmc/articles/PMC10356087/ /pubmed/37345815 http://dx.doi.org/10.1161/JAHA.122.027899 Text en © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Research Shen, Rebecca Mulder, Hillary Wruck, Lisa Weissler, E. Hope Robertson, Holly R. Sharlow, Amber G. Kripalani, Sunil Muñoz, Daniel Effron, Mark B. Gupta, Kamal Girotra, Saket Whittle, Jeff Benziger, Catherine P. VanWormer, Jeffrey J. Polonsky, Tamar S. Rothman, Russell L. Harrington, Robert A. Hernandez, Adrian F. Jones, W. Schuyler Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study |
title | Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study |
title_full | Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study |
title_fullStr | Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study |
title_full_unstemmed | Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study |
title_short | Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study |
title_sort | internet versus noninternet participation in a decentralized clinical trial: lessons from the adaptable study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10356087/ https://www.ncbi.nlm.nih.gov/pubmed/37345815 http://dx.doi.org/10.1161/JAHA.122.027899 |
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