February 5, 2016: Developing a Participant-Centric Consent Process for ADAPTABLE

February 5, 2016: Developing a Participant-Centric Consent Process for ADAPTABLE

Topic

Developing a Participant-Centric Consent Process for ADAPTABLE

Presenter

Laura M. Beskow, MPH, PhD, Director, Program for Empirical Bioethics at Duke School of Medicine, and Coinvestigator, ADAPTABLE Aspirin Study

Keywords

ADAPTABLE; Aspirin study; Informed consent; PCORI; Patient engagement; Patient-centered outcomes research; PCOR; PCORnet; Empirical bioethics

Key Points

  • ADAPTABLE, known as “the aspirin study,” is the first NIH Collaboratory Trial conducted through PCORnet, the National Patient-Centered Clinical Research Network.
  • ADAPTABLE compares the effectiveness and safety of 2 commonly used doses of aspirin (81mg vs 325mg) in high-risk patients with coronary artery disease.
  • An empirical process was used to develop a participant-centric informed consent form and comprehension tool.
  • One goal is to produce a web-based, electronic informed consent process, using both text and video formats, in English and Spanish.
  • The consent comprehension tool includes focused questions that promote consent understanding.

Discussion Themes

What plans are there to educate patients on transmission of identifiable information to obtain longitudinal data from health plans?

Won’t the decision process be different depending on the patient’s starting point—that is, someone not now taking aspirin versus those now taking a lower dose versus those now taking a higher dose?

It would be interesting to compare data about the levels of participant comprehension when consent is administered online compared with face-to-face or over the telephone.

For More Information

Details about ADAPTABLE and its patient-centric informed consent process are at the study’s website: http://theaspirinstudy.org/.

Tags
#InformedConsent, #ResearchEthics, #pctGR, #PCORnet
@PCTGrandRounds, @Collaboratory1, @PCORnetwork