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 remo...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-07-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.122.027899 |
| _version_ | 1797337886479089664 |
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| author | Rebecca Shen Hillary Mulder Lisa Wruck E. Hope Weissler Holly R. Robertson Amber G. Sharlow Sunil Kripalani Daniel Muñoz Mark B. Effron Kamal Gupta Saket Girotra Jeff Whittle Catherine P. Benziger Jeffrey J. VanWormer Tamar S. Polonsky Russell L. Rothman Robert A. Harrington Adrian F. Hernandez W. Schuyler Jones |
| author_facet | Rebecca Shen Hillary Mulder Lisa Wruck E. Hope Weissler Holly R. Robertson Amber G. Sharlow Sunil Kripalani Daniel Muñoz Mark B. Effron Kamal Gupta Saket Girotra Jeff Whittle Catherine P. Benziger Jeffrey J. VanWormer Tamar S. Polonsky Russell L. Rothman Robert A. Harrington Adrian F. Hernandez W. Schuyler Jones |
| author_sort | Rebecca Shen |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-08T09:23:06Z |
| format | Article |
| id | doaj.art-864ec099ff514660bda1747465604b4e |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-03-08T09:23:06Z |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-864ec099ff514660bda1747465604b4e2024-01-31T11:31:17ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802023-07-01121310.1161/JAHA.122.027899Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE StudyRebecca Shen0Hillary Mulder1Lisa Wruck2E. Hope Weissler3Holly R. Robertson4Amber G. Sharlow5Sunil Kripalani6Daniel Muñoz7Mark B. Effron8Kamal Gupta9Saket Girotra10Jeff Whittle11Catherine P. Benziger12Jeffrey J. VanWormer13Tamar S. Polonsky14Russell L. Rothman15Robert A. Harrington16Adrian F. Hernandez17W. Schuyler Jones18Duke University School of Medicine Durham NC USADuke Clinical Research Institute Durham NC USADuke Clinical Research Institute Durham NC USADivision of Vascular and Endovascular Surgery Duke University School of Medicine Durham NC USADuke Clinical Research Institute Durham NC USADuke Clinical Research Institute Durham NC USAVanderbilt University Medical Center Nashville TN USAVanderbilt University Medical Center Nashville TN USAUniversity of Queensland‐Ochsner Clinical School New Orleans LA USAUniversity of Kansas Medical Center Kansas City KA USAUniversity of Iowa Iowa City IA USAMedical College of Wisconsin Milwaukee WI USAEssentia Health Heart and Vascular Center Duluth MN USAMarshfield Clinic Research Institute Marshfield WI USAUniversity of Chicago Medicine Chicago IL USAVanderbilt University Medical Center Nashville TN USAStanford University School of Medicine Stanford CA USADuke Clinical Research Institute Durham NC USADuke Clinical Research Institute Durham NC USABackground 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.https://www.ahajournals.org/doi/10.1161/JAHA.122.027899cardiovascular diseaseclinical trial methodologyinternet follow‐uppragmatic trials |
| spellingShingle | Rebecca Shen Hillary Mulder Lisa Wruck E. Hope Weissler Holly R. Robertson Amber G. Sharlow Sunil Kripalani Daniel Muñoz Mark B. Effron Kamal Gupta Saket Girotra Jeff Whittle Catherine P. Benziger Jeffrey J. VanWormer Tamar S. Polonsky Russell L. Rothman Robert A. Harrington Adrian F. Hernandez W. Schuyler Jones Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease cardiovascular disease clinical trial methodology internet follow‐up pragmatic trials |
| 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 | cardiovascular disease clinical trial methodology internet follow‐up pragmatic trials |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.122.027899 |
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