May 6, 2022: N-of-1 Randomized Trials: CRAVE and I-STOP-AFib as Examples (Gregory Marcus, MD, MAS)

Posted on by terren.green@duke.edu

Speaker

Gregory Marcus, MD, MAS
Professor of Medicine
University of California, San Francisco

 

 

Keywords

Eureka; AFEQT; I-STOP-AFib; CRAVE; Atrial Fibrillation; PVC; PAC; alcohol; coffee

 

Key Points

  • Atrial Fibrillation (AFib) is fairly static and chronic, but recent studies have shown a reduction in AFib with weight loss in obese patients and a reduction in AFib with a reduction in alcohol consumption.
  • In an N-of-1 study each individual participant serves as their own case control. N-of-1 studies can show how a particular individual reacts to a given condition, but not all questions can be studied with n of 1 studies.
  • The I-STOP-AFib study was a randomized completely remote N-of-1 study to assesses quality of life and test for discreet triggers of AFib. Patients chose a trigger they could readily withhold or introduce, and used a mobile app, Eureka, to determine eligibility and record their consent to participate.
  • The control group tracked their trigger. The intervention group were told to expose themselves to the trigger or avoid it and track incidence of exposure. An Alivecor ECG monitor was sent to each patient to track occurrences of AFib.
  • No difference in primary outcome was found for either group, but the intervention group had a 40% reduction in days with AFib.
  • The I-STOP-AFib study showed an increased chance of AFib immediately following consumption of alcohol, and a lower risk of AFib with consumption of caffeine.
  • The CRAVE study found no evidence that caffeine consumption increases incidence of AFib.

Discussion Themes

– Patients are very interested in N-of-1 studies and enjoy participating in a study where they can learn about themselves. Explaining how the trial works can be more difficult.

– Conducting a study involving IT, apps, and wearable technology in language other than English can take considerable planning and collaboration. Not only do study documents need to be provided in additional languages, but IT support must be available in additional languages as well.

Read more about I-STOP-AFib and CRAVE.

Tags

#pctGR, @Collaboratory1