Evidence map›Paper›PMID 36790638›Full record

ArticleNeurology and therapy2023

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

Dana B DiBenedetti, Heather Menne, Russ Paulsen, Holly B Krasa, George Vradenburg, Meryl Comer, Leigh F Callahan, John Winfield, Michele Potashman, Kim Heithoff and 12 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Trial
  2. Review
  3. Priorities of people living with Alzheimer's and care partners: What Matters Most?Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Observational
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. How donanemab data address the coverage with evidence development questions.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Review
  11. Article
  12. Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Dana B DiBenedettiDepartment of Patient-Centered Outcomes Assessment, RTI Health Solutions, 3040 Cornwallis Road, PO Box 12194, Research Triangle Park, NC, 27709-2194, USA. ddibenedetti@rti.org.
Heather MenneRTI International, Research Triangle Park, NC, USA.
Russ PaulsenUsAgainstAlzheimer's, Washington, DC, USA.
Holly B KrasaBlue Persimmon Group LLC, Washington, DC, USA.
George VradenburgUsAgainstAlzheimer's, Washington, DC, USA.
Meryl ComerUsAgainstAlzheimer's, Washington, DC, USA.
Leigh F CallahanUniversity of North Carolina, Chapel Hill, NC, USA.
John Winfield *University of North Carolina, Chapel Hill, NC, USA.
Michele PotashmanBiogen, Cambridge, MA, USA.
Kim HeithoffBiogen, Cambridge, MA, USA.
Ann HartryLundbeck LLC, Deerfield, IL, USA.
Dorothee OberdhanOtsuka Pharmaceutical Development & Commercialization Inc., Rockville, MD, USA.
Hilary WilsonBoehringer Ingelheim, Burlington, ON, Canada.
Deborah L HoffmanTakeda Pharmaceuticals, Cambridge, MA, USA.
Dan WiebergHome Instead Inc., Omaha, NE, USA.
Ian N KremerLEAD Coalition (Leaders Engaged On Alzheimer's Disease), Washington, DC, USA.
Geraldine A TaylorLiving with AD, Co-Founder of Memory Advocate Peers (MAP), New York, NY, USA.
James M TaylorCare Partner, CEO of Memory Advocates Peers (MAP), New York, NY, 10023, USA.
Debra LappinFaegre Drinker Consulting, Washington, DC, USA.
Allison D MartinFaegre Drinker Consulting, Washington, DC, USA.
Brett HauberPfizer, New York, NY, USA.
Carla RomanoDepartment of Patient-Centered Outcomes Assessment, RTI Health Solutions, 3040 Cornwallis Road, PO Box 12194, Research Triangle Park, NC, 27709-2194, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInsight 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.

methodsWe compared WMM concepts rated as "very important" or higher to items included in COAs used commonly in AD studies.

resultsTwenty 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.

conclusionWhile 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.

Indexed as

Alzheimer’s diseaseCaregiverCare partnerClinically meaningfulClinical outcome assessmentOutcomesPatientValue

Identifiers

PMID36790638
PMCPMC10043075

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.