Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia

Laura C Hanson; Antonia V Bennett; Mattias Jonsson; Amy Kelley; Christine Ritchie; Debra Saliba; Joan Teno; Sheryl Zimmerman

doi:10.1111/jgs.16619

Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia

J Am Geriatr Soc. 2020 Jul;68 Suppl 2(Suppl 2):S55-S61. doi: 10.1111/jgs.16619.

Authors

Laura C Hanson^{1

2}, Antonia V Bennett^{3

4}, Mattias Jonsson⁴, Amy Kelley⁵, Christine Ritchie⁶, Debra Saliba^{7

8

9}, Joan Teno¹⁰, Sheryl Zimmerman^{2

11}

Affiliations

¹ Division of Geriatric Medicine and Center for Aging and Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
² Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
³ Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁴ Patient Reported Outcomes Core, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁵ Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁶ Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
⁷ Borun Center, University of California, Los Angeles, Los Angeles, California, USA.
⁸ Los Angeles VA Geriatric Research Education and Clinical Center, Los Angeles, California, USA.
⁹ RAND, Santa Monica, California, USA.
¹⁰ Division of General Internal Medicine and Geriatrics, Oregon Health Sciences University, Portland, Oregon, USA.
¹¹ Schools of Social Work and Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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-Reported 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.

Keywords: Alzheimer's disease; dementia; patient-reported outcomes; pragmatic trial.

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Caregivers
Dementia / therapy*
Humans
National Institute on Aging (U.S.)
Patient Reported Outcome Measures*
Pragmatic Clinical Trials as Topic*
United States

Grants and funding

U54 AG063546/AG/NIA NIH HHS/United States