Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia
June 26, 2020
Authors: Laura C. Hanson, MD, MPH, Antonia V. Bennett, PhD, Mattias Jonsson, Amy Kelley, MD, MSHS, Christine Ritchie, MD, MSPH, Debra Saliba, MD, MPH, Joan Teno, MD, MS, and Sheryl Zimmerman, PhD
Core/Team: Patient and Caregiver Relevant Outcomes Core
Abstract: Outcome measures for embedded pragmatic clinical trials (ePCTs) should reflect the lived experience of people living with dementia (PLWD) and their caregivers, yet patient and caregiver-reported outcomes (PCROs) are rarely available in large clinical and administrative data sources. Although pragmatic methods may lead to use of existing administrative data rather than new data collected directly from PLWD, interventions are truly impactful only when they change outcomes prioritized by PLWD and their caregivers. The Patient- and Caregiver Relevant Outcomes Core (PCRO Core) of the IMbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory aims to promote optimal use of outcomes relevant to PLWD and their caregivers in pragmatic trials. The PCRO Core will address key scientific challenges limiting outcome measurement, such as gaps in existing measures, methodologic constraints, and burdensome data capture. PCRO Core investigators will create a searchable library of AD/AD-related dementias (ADRD) clinical outcome measures, including measures in existing data sources with potential for AD/ADRD ePCTs, and will support best practices in measure development, including pragmatic adaptation of PCROs. Working together with other Cores and Teams within the IMPACT Collaboratory, the PCRO Core will support investigators to select from existing outcome measures, and to innovate in methods for measurement and data capture. In the future, the work of the IMPACT Collaboratory may galvanize broader embedded use of outcomes that matter to PLWD and their care partners in large health systems. J Am Geriatr Soc 68:S55-S61, 2020.
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Keywords: dementia; Alzheimer’s disease; patient reported outcomes; pragmatic trial
About this Special Issue: The Journal of the American Geriatrics Society (JAGS) has published a special issue (Volume 68, S2) focused solely on the National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory and the activities and progress it has made since the September 2019 announcement.
The special issue, published online June 26, includes an introductory article describing the mission and vision of the IMPACT Collaboratory and articles from each of the 10 IMPACT cores and teams describing how they are working to achieve that mission. The introductory article authors are the two IMPACT principal investigators, Susan Mitchell, MD, MPH and Vincent Mor, PhD, as well as the two executive directors, Ellen McCarthy, PhD, MPH, and Jill Harrison, PhD.