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Open Access 15-02-2023 | Care | ORIGINAL RESEARCH

Technical Review of Clinical Outcomes Assessments Across the Continuum of Alzheimer's Disease

Authors: Dana B. DiBenedetti, Heather Menne, Russ Paulsen, Holly B. Krasa, George Vradenburg, Meryl Comer, Leigh F. Callahan, John Winfield, Michele Potashman, Kim Heithoff, Ann Hartry, Dorothee Oberdhan, Hilary Wilson, Deborah L. Hoffman, Dan Wieberg, Ian N. Kremer, Geraldine A. Taylor, James M. Taylor, Debra Lappin, Allison D. Martin, Brett Hauber, Carla Romano

Published in: Neurology and Therapy | Issue 2/2023

Abstract

Introduction

Insight into the relationship between concepts that matter to the people affected by Alzheimer’s disease (AD) and the clinical outcome assessments (COAs) commonly used in AD clinical studies is limited. Phases 1 and 2 of the What Matters Most (WMM) study series identified and quantitatively confirmed 42 treatment-related outcomes that are important to people affected by AD.

Methods

We compared WMM concepts rated as “very important” or higher to items included in COAs used commonly in AD studies.

Results

Twenty COAs designed to assess signs, symptoms, and impacts across the spectrum of AD were selected for review. Among these 20 COAs, only 5 reflected 12 or more WMM concepts [Integrated Alzheimer's Disease Rating Scale (iADRS), Alzheimer's Disease Cooperative Study–Activities of Daily Living Inventory (ADCS-ADL), Alzheimer's Disease Cooperative Study–Activities of Daily Living Inventory–Mild Cognitive Impairment (ADCS-ADL-MCI), Alzheimer's Disease Composite Scores (ADCOMS), and Clinical Dementia Rating; Clinical Dementia Rating-Sum of Boxes (CDR/CDR-SB)]. Multiple symptoms and impacts of AD identified as important and meaningful in the WMM studies map only indirectly at best to 7 of the 20 most widely used COAs.

Conclusion

While many frequently used COAs in AD capture some concepts identified as important to AD populations and their care partners, overlap between any single measure and the concepts that matter to people affected by AD is limited. The highest singly matched COA reflects fewer than half (45%) of WMM concepts. Use of multiple COAs expands coverage of meaningful concepts. Future research should explore the content validity of AD COAs planned for AD trials based on further confirmation of the ecological validity of the WMM items. This research should inform development and use of core outcome sets that capture WMM items and selection or development of new companion tools to fully demonstrate clinically meaningful outcomes spanning WMM.

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Title: Technical Review of Clinical Outcomes Assessments Across the Continuum of Alzheimer's Disease
Authors: Dana B. DiBenedetti
Heather Menne
Russ Paulsen
Holly B. Krasa
George Vradenburg
Meryl Comer
Leigh F. Callahan
John Winfield
Michele Potashman
Kim Heithoff
Ann Hartry
Dorothee Oberdhan
Hilary Wilson
Deborah L. Hoffman
Dan Wieberg
Ian N. Kremer
Geraldine A. Taylor
James M. Taylor
Debra Lappin
Allison D. Martin
Brett Hauber
Carla Romano
Publication date: 15-02-2023
Publisher: Springer Healthcare
Keywords: Care
Alzheimer's Disease
Dementia
Alzheimer's Disease
Dementia
Mild Neurocognitive Disorder
Published in: Neurology and Therapy / Issue 2/2023
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI: https://doi.org/10.1007/s40120-023-00443-2

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Technical Review of Clinical Outcomes Assessments Across the Continuum of Alzheimer's Disease

Abstract

Introduction

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

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