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. 2017 Nov 22;2017(11):CD012216. doi: 10.1002/14651858.CD012216.pub2

Kawas 2013.

Study characteristics
Patient sampling
  • The participants were 90 years old or older. They were participants of a longitudinal, population‐based study (90+ Study) and were invited to participate at this study.

  • The participants had normal cognition or with either cognitive or functional impairment resulting from cognition not severe enough to meet DSM‐IV diagnostic criteria and they were classified as cognitively impaired not demented (CIND) and they agreed to postmortem brain donation.

  • There were 5 MCI at time of performing the test planned as evaluable for efficacy participants.

  • No further details of patient sampling and recruitment were reported.

Patient characteristics and setting
  • 5 MCI participants diagnosed as CIND, three were considered as Aβ (+) and two were considered as Aβ (‐).

  • The characteristics data of the participants included 13 participants: five of them were MCI participants and eight were normal controls; the mean age was 94.1 (range 90 to 99), for those considered as Aβ (+) the mean age was 94.4 (range 93 to 96) and 94.1 (range 90 to 99) years old for those with Aβ (‐).


Nine of the participants were women, two of them were Aβ (+), and two of four men were Aβ (+) at baseline.
APOE ϵ4 carrier: not reported
MMSE: the mean MMSE was 28 (range 24 to 30); for those considered as in the Aβ (+) group, the mean was 26.5 (range 24 to 29) and 28 (range 25 to 30) for those in the Aβ (‐) group.
Years of education: seven participants were reported having studied after high school: two of them were Aβ (+) and five were Aβ (‐); for those six having studied at high school or with less education, two were Aβ (+) and four were Aβ (‐), respectively.
  • Sources of referral: not reported

  • Setting: participants lived at home as well as in institutions in the United States of America.

Index tests
  • Participants were imaged using clinical PET and PET/computed tomographic scanners.

  • Time between the 18F‐florbetapir injection and PET acquisition: fifty minutes after injection and, a 10‐min emission scan was obtained.

  • 18F‐florbetapir administration mCi (MBq) dose: 10 mCi (370 MBq)

  • Images were acquired with a 128 x 128 matrix (zoom x 2) and were reconstructed using iterative or row action maximization likelihood algorithms.

  • Semiquantitative visual rating:


After a training session, three nuclear medicine physicians with no access to clinical information, independently rated each PET image for amyloid burden based on successive levels of florbetapir retention from from 0 (no amyloid) to 4 (high levels of cortical amyloid). The median of the three visual scores was used to dichotomize participants into Aβ (‐) (score, 0 to 1 point) and Aβ (+) (score, 2 to 4 points).
Target condition and reference standard(s)
  • Target condition: any form of dementia

  • Reference standard: DSM‐IV criteria for dementia (APA 1994)

Flow and timing
  • Duration of follow‐up (median): 1.5 years (all participants, including those as control normals)

  • Number included in analysis: 5 participants; three 18F‐florbetapir (+) and two 18F‐florbetapir (‐)

  • Progression from MCI to any form of dementia:

    • 18F‐florbetapir (+): 2 MCI converted to any form of dementia and 1 MCI not converted to any form of dementia; 18F‐florbetapir (‐): 1 MCI converted to any form of dementia and 1 MCI not converted to any form of dementia; TP = 2; FP = 1; FN = 1; TN = 1

    • Loss to follow‐up: none

  • Partial financial support from the manufacturer of 18F‐florbetapir tracer and three authors were employees

Comparative  
Notes  
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Unclear    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Unclear    
    Unclear Low
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
If a threshold was used, was it pre‐specified? Yes    
Was the PET scan interpretation done by a trained reader physician? Yes    
Was there a clear definition of a positive result? Unclear    
    Low Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Yes    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
    Unclear Unclear
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
Was the study free of commercial funding? No    
    High