Evidence map›Paper›PMID 33594474›Full record

SynthesisEuropean journal of nuclear medicine and molecular imaging2021

Outcomes of clinical utility in amyloid-PET studies: state of art and future perspectives.

Matteo Cotta Ramusino, Giulia Perini, Daniele Altomare, Paola Barbarino, Wendy Weidner, Gabriella Salvini Porro, Frederik Barkhof, Gil D Rabinovici, Wiesje M van der Flier, Giovanni B Frisoni and 3 more

Abstract readSystematic Review
In one paragraph

Synthesis in European journal of nuclear medicine and molecular imaging, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
–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

22 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Why should academia care about the Target Product Profile?Journal of translational medicine · 2024
    Article
  12. Incremental value of amyloid PET in a tertiary memory clinic setting in China.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Article
  13. Clinical outcomes up to 9 years after [Alzheimer's research & therapy · 2023
    Article
  14. Article
  15. Lower Cerebrospinal Fluid Amyloid-βJournal of Alzheimer's disease reports · 2023
    Article
  16. Review
  17. The Role of Amyloid PET in Imaging Neurodegenerative Disorders: A Review.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022
    Review
  18. Article
  19. Review
  20. 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

13 authors.

Matteo Cotta RamusinoUnit of General Neurology, IRCCS Mondino Foundation, Pavia, Italy.ORCID http://orcid.org/0000-0003-3090-9648
Giulia PeriniUnit of General Neurology, IRCCS Mondino Foundation, Pavia, Italy.
Daniele AltomareLaboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.
Paola BarbarinoAlzheimer's Disease International, London, UK.
Wendy WeidnerAlzheimer's Disease International, London, UK.
Gabriella Salvini PorroAlzheimer Italia Federation, Milan, Italy.
Frederik BarkhofDepartment of Radiology and Nuclear Medicine, Amsterdam University Medical Centre, Amsterdam, NL, the Netherlands.
Gil D RabinoviciDepartments of Neurology, Radiology and Biomedical Imaging, University of California, San Francisco, CA, USA.
Wiesje M van der FlierDepartment of Neurology, Amsterdam Neuroscience, Alzheimer Center Amsterdam, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Giovanni B FrisoniLaboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland.
Valentina GaribottoNIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.
Stefan TeipelDepartment of Psychosomatic Medicine, University of Rostock, Rostock, Germany.
Marina BoccardiLate Translational Dementia Research Group, German Center for Neurodegenerative Diseases (DZNE), Rostock-Greifswald site, Rostock, Germany. Marina.Boccardi@dzne.de.

Funding

Innovative Medicines Initiative 2 Joint Undertaking 115952Swiss National Science Foundation 320030_169876
6 · The paper itself

Abstract

purposeTo review how outcomes of clinical utility are operationalized in current amyloid-PET validation studies, to prepare for formal assessment of clinical utility of amyloid-PET-based diagnosis.

methodsSystematic review of amyloid-PET research studies published up to April 2020 that included outcomes of clinical utility. We extracted and analyzed (a) outcome categories, (b) their definition, and (c) their methods of assessment.

resultsThirty-two studies were eligible. (a) Outcome categories were clinician-centered (found in 25/32 studies, 78%), patient-/caregiver-centered (in 9/32 studies, 28%), and health economics-centered (5/32, 16%). (b) Definition: Outcomes were mainly defined by clinical researchers; only the ABIDE study expressly included stakeholders in group discussions. Clinician-centered outcomes mainly consisted of incremental diagnostic value (25/32, 78%) and change in patient management (17/32, 53%); patient-/caregiver-centered outcomes considered distress after amyloid-pet-based diagnosis disclosure (8/32, 25%), including quantified burden of procedure for patients' outcomes (n = 8) (1/8, 12.5%), impact of disclosure of results (6/8, 75%), and psychological implications of biomarker-based diagnosis (75%); and health economics outcomes focused on costs to achieve a high-confidence etiological diagnosis (5/32, 16%) and impact on quality of life (1/32, 3%). (c) Assessment: all outcome categories were operationalized inconsistently across studies, employing 26 different tools without formal rationale for selection.

conclusionCurrent studies validating amyloid-PET already assessed outcomes for clinical utility, although non-clinician-based outcomes were inconsistent. A wider participation of stakeholders may help produce a more thorough and systematic definition and assessment of outcomes of clinical utility and help collect evidence informing decisions on reimbursement of amyloid-PET.

Indexed as

Alzheimer DiseaseAmyloidosisAmyloidHumansPositron-Emission TomographyQuality of LifeAmyloidAlzheimer’s diseaseAmyloid-PETClinical utilityDiagnostic biomarkersOutcomeSystematic review

Identifiers

PMID33594474
PMCPMC8175294

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.