TY - JOUR
T1 - Internet Versus Noninternet Participation in a Decentralized Clinical Trial
T2 - Lessons From the ADAPTABLE Study
AU - Shen, Rebecca
AU - Mulder, Hillary
AU - Wruck, Lisa
AU - Weissler, E. Hope
AU - Robertson, Holly R.
AU - Sharlow, Amber G.
AU - Kripalani, Sunil
AU - Muñoz, Daniel
AU - Effron, Mark B.
AU - Gupta, Kamal
AU - Girotra, Saket
AU - Whittle, Jeff
AU - Benziger, Catherine P.
AU - Vanwormer, Jeffrey J.
AU - Polonsky, Tamar S.
AU - Rothman, Russell L.
AU - Harrington, Robert A.
AU - Hernandez, Adrian F.
AU - Jones, W. Schuyler
N1 - Publisher Copyright:
© 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
PY - 2023/7/4
Y1 - 2023/7/4
N2 - BACKGROUND: Internet-based participation has the potential to enhance pragmatic and decentralized trials, where representa-tive 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 reten-tion. 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 nonadher-ence 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.
AB - BACKGROUND: Internet-based participation has the potential to enhance pragmatic and decentralized trials, where representa-tive 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 reten-tion. 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 nonadher-ence 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.
KW - cardiovascular disease
KW - clinical trial methodology
KW - internet follow-up
KW - pragmatic trials
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U2 - 10.1161/JAHA.122.027899
DO - 10.1161/JAHA.122.027899
M3 - Article
C2 - 37345815
AN - SCOPUS:85164238350
SN - 2047-9980
VL - 12
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 13
M1 - e027899
ER -