ADAPTABLE

ADAPTABLE Study Lauded as Top 10 Clinical Research Achievement

Posted on by Jodi Snare

ADAPTABLE, the first demonstration project of PCORnet®, the National Patient-Centered Clinical Research Network, has been named by the Clinical Research Forum as a Top 10 Clinical Research Achievement Awardee for 2022. The awards celebrate outstanding achievements and major advances in clinical research from across the U.S. Honorees were selected by a panel that considered clinical research studies published in peer-reviewed journals in 2021, with specific attention given to innovation and novelty involved in the advancement of science.

The ADAPTABLE research team, including patient partners known as Adaptors, will formally accept the achievement award on April 19 at a ceremony in Chicago, IL. The team will then present at Translational Science 2022 and meet with members of the U.S. Congress to promote the importance of funding for clinical research.

A major achievement in pragmatic study design
ADAPTABLE, which sought to determine the safest and most effective dose of aspirin for patients with existing cardiovascular disease, broke ground as the first major randomized comparative effectiveness trial conducted using the broad and rich data resources of PCORnet. The trial’s novel strategies set a blueprint for the future of pragmatic study design by integrating research within patient care and using technology to effectively alleviate site and patient burden.

The infrastructure of PCORnet was central to ADAPTABLE’s successful execution. Via the Network, the study team leveraged electronic health records (EHRs) to identify potential participants, and then followed up with traditional outreach such as phone calls, letters, emails, and conversations in clinics. Data from PCORnet-accessible EHRs, patient-reported outcomes, insurance, and Medicare claims data were used to capture primary endpoints for the study where possible. Collecting data in this way minimized the need for in-person visits and thereby reduced participant burden.

At the heart of the study’s novel design were the Adaptors, who worked alongside researchers in all aspects of the trial, including helping to design the protocol, consent form, study portal, and study materials.

Ultimately, investigators found no significant difference in either protective effects or bleeding risk between the 81 mg and 325 mg doses of aspirin. However, the patients in the group taking the lower dose were less likely to switch doses mid-study or discontinue aspirin completely.

Publication of ADAPTABLE’s results in the New England Journal of Medicine was met with praise. An accompanying editorial penned by Colin Baigent, professor of epidemiology at the Nuffield department of population health at Oxford University and director of the Medical Research Council Population Health Research Unit, called the trial “a major achievement … because it has shown a method of conducting trials efficiently and at low cost in the United States, and this 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.”

ADAPTABLE, a PCORnet® Demonstration Project, Offers a Template for Future Pragmatic Studies

Posted on by Jodi Snare

Two manuscripts recently published in peer-reviewed journals offer researchers a glimpse into the opportunities and challenges for novel pragmatic trials like Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE), a demonstration project of PCORnet®, the National Patient-Centered Clinical Research Network. The publications highlight separate, but equally important, topics of interest in pragmatic research: maximizing clinician engagement and navigating institutional review board (IRB) challenges.

ADAPTABLE, a multicenter, open-label, randomized controlled trial, is the first interventional study conducted across PCORnet. The ADAPTABLE study team is using PCORnet’s broad and rich data resources to examine high-dose versus low-dose aspirin for prevention of heart attack and stroke among patients with cardiovascular disease.

One manuscript published in Clinical Trials shares how ADAPTABLE has used new approaches to break down traditional barriers to clinician engagement, such as time limitations, insufficient research infrastructure, or lack of research training. While clinician engagement is important in all clinical research, it is particularly essential for pragmatic trials, which are conducted in real-world clinical settings and require that researchers and clinicians operate toward shared goals. The paper assesses how tactics like empowering clinician champions, periodic newsletters, and coordinated team celebrations fared in regard to their merit and utility in a pragmatic trial setting.

Novel pragmatic methods like those deployed in ADAPTABLE are intended to improve the participant experience, but unfamiliar approaches can also spark new — and justified — considerations for IRBs that can potentially make the evaluation of these studies more complex. A recent manuscript published in Trials explores unforeseen challenges the ADAPTABLE team encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination, as well as how the study team pivoted in response. It offers lessons in upfront planning to mitigate these challenges in future pragmatic research.

Together, manuscripts like these are providing the research community a valuable template for pragmatic studies, which are important to help us understand how interventions perform in the real world. Full results from ADAPTABLE are expected in May 2021. Be on the lookout for more PCORnet-enabled research in the coming months!

PCORnet® Study ADAPTABLE Inspires New Tools to Rapidly Compare Data from EHRs and Patient-Reported Data

Posted on by Jodi Snare

The ADAPTABLE study broke ground as the first major randomized comparative effectiveness trial conducted using the infrastructure of PCORnet®, the National Patient-Centered Clinical Research Network. Now, a team of researchers building on the learnings of ADAPTABLE is raising the research bar with the development of a new menu-driven query (MDQ) that enables rapid comparison between electronic health record (EHR) data and information reported directly by patients. The MDQ is part of a larger effort supported by the National Institutes of Health Collaboratory Coordinating Center to develop and test methods for integrating patient-reported data into the EHR and to streamline data for use in pragmatic clinical trials.

Development of this MDQ is important because integrating patient-reported information and EHR-derived data allows researchers to see a more complete view of patient health. Patient-reported information can offer insights into disease manifestation that are not readily available in an EHR, including the capture of outcomes that occur outside of the patient’s primary health system. The new MDQ closes that knowledge gap by allowing users to query and integrate both.

Visit the NIH Collaboratory to learn more, including user documentation for the new MDQ and a summary of its development.