Evidence map›Paper›PMID 37345815›Full record

Trial reportJournal of the American Heart Association2023

Internet Versus Noninternet Participation in a Decentralized Clinical Trial: Lessons From the ADAPTABLE Study.

Rebecca Shen, Hillary Mulder, Lisa Wruck, E Hope Weissler, Holly R Robertson, Amber G Sharlow, Sunil Kripalani, Daniel Muñoz, Mark B Effron, Kamal Gupta and 9 more

Registry-linked trialAbstract readPragmatic Clinical Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02697916 (Aspirin Dosing), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02697916 nacompletednot on this map

Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness

TypeinterventionalSponsorDuke UniversityRan2016 to 2020Enrolled15,076ConditionsAtherosclerotic Cardiovascular DiseaseArmsaspirin
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Rebecca ShenDuke University School of Medicine Durham NC USA.ORCID 0000-0002-3350-9853
Hillary MulderDuke Clinical Research Institute Durham NC USA.ORCID 0000-0003-4838-582X
Lisa WruckDuke Clinical Research Institute Durham NC USA.ORCID 0000-0003-1732-9067
E Hope WeisslerDivision of Vascular and Endovascular Surgery Duke University School of Medicine Durham NC USA.ORCID 0000-0002-8442-6150
Holly R RobertsonDuke Clinical Research Institute Durham NC USA.
Amber G SharlowDuke Clinical Research Institute Durham NC USA.ORCID 0000-0002-3321-1387
Sunil KripalaniVanderbilt University Medical Center Nashville TN USA.ORCID 0000-0002-4214-7129
Daniel MuñozVanderbilt University Medical Center Nashville TN USA.
Mark B EffronUniversity of Queensland-Ochsner Clinical School New Orleans LA USA.ORCID 0000-0003-4050-5030
Kamal GuptaUniversity of Kansas Medical Center Kansas City KA USA.ORCID 0000-0002-2440-9033
Saket GirotraUniversity of Iowa Iowa City IA USA.ORCID 0000-0002-4784-4513
Jeff WhittleMedical College of Wisconsin Milwaukee WI USA.ORCID 0000-0002-9544-838X
Catherine P BenzigerEssentia Health Heart and Vascular Center Duluth MN USA.ORCID 0000-0002-8992-6197
Jeffrey J VanWormerMarshfield Clinic Research Institute Marshfield WI USA.ORCID 0000-0002-8733-8703
Tamar S PolonskyUniversity of Chicago Medicine Chicago IL USA.ORCID 0000-0003-2112-9244
Russell L RothmanVanderbilt University Medical Center Nashville TN USA.ORCID 0000-0002-1506-3990
Robert A HarringtonStanford University School of Medicine Stanford CA USA.ORCID 0000-0001-5450-8676
Adrian F HernandezDuke Clinical Research Institute Durham NC USA.ORCID 0000-0003-3387-9616
W Schuyler JonesDuke Clinical Research Institute Durham NC USA.ORCID 0000-0002-7288-9596

Funding

Peripheral Artery Disease: Long-term Survival & Outcomes Study (PEARLS)R01HL166305 · NHLBI · UT SOUTHWESTERN MEDICAL CENTER · PI Saket Girotra · 2023 to 2026
$2.5M
Peripheral Artery Disease: Long-term Survival & Outcomes Study (PEARLS)R56HL158803 · NHLBI · UT SOUTHWESTERN MEDICAL CENTER · PI GIROTRA, SAKET · 2021 to 2021
$633k
NHLBI NIH HHS R01 HL166305NHLBI NIH HHS R56 HL158803
6 · The paper itself

Abstract

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.

Indexed as

Myocardial InfarctionStrokeAgedAspirinFemaleHumansInternetMaleAspirincardiovascular diseaseclinical trial methodologyinternet follow‐uppragmatic trials

Identifiers

PMID37345815
PMCPMC10356087

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.