In a milestone moment for PCORnet®, the National Patient-Centered Clinical Research Network, the ADAPTABLE study team today shared results in a late-breaking clinical trials session during the 70th annual American College of Cardiology Scientific Session. The results, which were simultaneously published in the New England Journal of Medicine, establish PCORnet as a powerful resource for successfully conducting novel pragmatic clinical trials. They also provide important insights into optimal aspirin dosing and set a blueprint for the future of pragmatic research.
“As the first randomized controlled study using PCORnet, ADAPTABLE has been closely watched by researchers who are interested in the potential of large-scale, pragmatic, patient-centered trials to deliver fast, high-quality answers,” said ADAPTABLE Principal Investigator Schuyler Jones. “Today’s results leave no doubt that the novel research framework supported by PCORnet is not only possible, but necessary for the future of clinical research.”
ADAPTABLE compared two doses of aspirin (81 mg vs. 325 mg) to determine which dose was the safest and most effective for preventing a heart attack, stroke, or death in people diagnosed with existing cardiovascular disease. Ultimately, investigators found no significant difference in either protective effects or risk for bleeding between the two doses. However, the group taking the higher dose switched doses more frequently (41.6 percent of participants taking 325 mg switched doses, as compared to 7 percent who switched from the 81 mg group). Participants in the higher dose group were also more likely to discontinue aspirin completely (11 percent discontinued in the 325 mg group, as compared to 7 percent in the 81 mg group).
Inspiring a new research paradigm
While these answers are helpful for people with heart disease and providers, perhaps even more meaningful is the pragmatic and patient-inspired framework their work established. PCORnet is at the center of that framework, enabling access to data from participants’ everyday health care encounters via a distributed research network model. In collaboration with 40 health centers, one health plan, and numerous patient partners from PCORnet, the ADAPTABLE study team enrolled over 15,000 people to participate in the study.
Via PCORnet, the team leveraged electronic health records (EHRs) to identify those potential participants, and then followed up with traditional outreach such as phone calls, letters, emails, and conversations in the clinic. Data from PCORnet-accessible EHRs, patient-reported outcomes, insurance, and Medicare claims data were used to capture primary endpoints for the study where possible in lieu of in-person visits, minimizing participant burden.
ADAPTABLE patient partners, known as Adaptors, worked alongside researchers in all aspects of the trial, from helping to design the protocol, consent form, study portal, and study materials through the current dissemination of results. “By representing and sharing the patient voice at every touchpoint of the study, the Adaptors asked researchers to think about how research could be done differently,” said Greg Merritt, an ADAPTABLE patient partner. “I think if patients have more opportunities to share their lived experiences, we can shape the future of research.”
“Traditional research methods are often slow and cumbersome, so when we launched ADAPTABLE our strategy was to use PCORnet to pave a new pathway by enthusiastically embracing novel strategies that make research participation easier,” said Jones. “Since that time, the pandemic has only intensified the urgency for better, faster methods to address common clinical decisions. With the successful completion of ADAPTABLE, we now have a blueprint to meet that need.”
For more information on ADAPTABLE’s results, visit the website to read a summary of results and watch a Town Hall where Adaptors lead a discussion about ADAPTABLE results and lessons learned.