Recently published results of the ADAPTABLE study demonstrate no difference in rates of death, hospitalization for heart attack or stroke, or bleeding in those who were assigned to high- versus low-dose aspirin (325 mg versus 81 mg). Trial participants frequently switched their dose, which may have biased the results toward the null: 41.6% of patients who were assigned to take the 325 mg dose switched to 81 mg daily dose. The study, funded by PCORI,  is the first randomized controlled trial conducted using PCORnet®, the National Patient-Centered Clinical Research Network, which involves patient representatives during all phases of the trial. It enrolled 15,076 patients with cardiovascular disease at 40 health centers across the United States.

“As interest grows for real-world evidence, the trial provides a demonstration that randomized clinical trials can leverage electronic health record data, direct-to-patient methods, and patient-reported outcomes to address important, patient-centered questions.” —Jones, et al. 2021, New England Journal of Medicine

An accompanying editorial states that this trial represents a step forward for pragmatic clinical trials, demonstrating proof-of-concept for PCORnet. The study and used electronic health record data to identify patients; low-touch recruitment strategies; and a patient portal for consent, collection of patient-reported outcomes, and follow-up.

“ADAPTABLE is a major achievement […] because it has shown a method of conducting trials efficiently and at low cost in the United States, and the method can now be adapted and used more widely. This should allow many more clinical questions to be answered, with obvious benefits to health care consumers.” —Baigent 2021, New England Journal of Medicine.

Read the plain language summary of results and learn more about the ADAPTABLE study.