| Autor: |
Shen R; Duke University School of Medicine Durham NC USA., Mulder H; Duke Clinical Research Institute Durham NC USA., Wruck L; Duke Clinical Research Institute Durham NC USA., Weissler EH; Division of Vascular and Endovascular Surgery Duke University School of Medicine Durham NC USA., Robertson HR; Duke Clinical Research Institute Durham NC USA., Sharlow AG; Duke Clinical Research Institute Durham NC USA., Kripalani S; Vanderbilt University Medical Center Nashville TN USA., Muñoz D; Vanderbilt University Medical Center Nashville TN USA., Effron MB; University of Queensland-Ochsner Clinical School New Orleans LA USA., Gupta K; University of Kansas Medical Center Kansas City KA USA., Girotra S; University of Iowa Iowa City IA USA., Whittle J; Medical College of Wisconsin Milwaukee WI USA., Benziger CP; Essentia Health Heart and Vascular Center Duluth MN USA., VanWormer JJ; Marshfield Clinic Research Institute Marshfield WI USA., Polonsky TS; University of Chicago Medicine Chicago IL USA., Rothman RL; Vanderbilt University Medical Center Nashville TN USA., Harrington RA; Stanford University School of Medicine Stanford CA USA., Hernandez AF; Duke Clinical Research Institute Durham NC USA., Jones WS; Duke Clinical Research Institute Durham NC USA.; Division of Cardiology Duke University Health System Durham NC USA. |
| Jazyk: |
angličtina |
| Zdroj: |
Journal of the American Heart Association [J Am Heart Assoc] 2023 Jul 04; Vol. 12 (13), pp. e027899. Date of Electronic Publication: 2023 Jun 22. |
| DOI: |
10.1161/JAHA.122.027899 |
| Abstrakt: |
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. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
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