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. 2021 Feb 10;2021(2):CD010945. doi: 10.1002/14651858.CD010945.pub2

Montine 2001.

Study characteristics
Patient Sampling Participants with probable AD and dementias other than AD, who were under care at Oregon Health Science University or Vandebilt University Medical Center, were recruited. Age‐matched non‐demented controls were also recruited.
Separate data were available for the performance of biomarkers in distinguishing between AD and non‐AD dementia. We did not include data on performance of the index test to discriminate AD participants from controls.
Sampling process and exclusion criteria not reported.
Patient characteristics and setting The sample considered in the review comprises of 27 participants, 19 AD and 8 non‐AD dementia (1 DLB; 3 NPH; 3 primary progressive aphasia; 1 hippocampal sclerosis). Ten controls were also recruited in the primary study. Most patients were evaluated by neuroimaging biomarkers. There was no significant difference in age or education level among the study groups. Duration of dementia was not significantly different between patients with probable Alzheimer disease or other dementias
Sex: Not reported
Age (SD) (y): 65.3±8.7 for AD; 66.6±4.4 for non‐AD
MMSE: 24 (19 to 27) for AD; 28 (25 to 29) for non‐AD
Duration of disease (y): 4.2±0.7 for AD; 4.2±0.7 for non‐AD
Sources of recruitment: patients under care of the Oregon Health Science University or Vandebilt University Medical Center, Nashville, USA. Not reported whether inpatients or outpatients.
Index tests Patients gave CSF samples. The samples were collected in polypropylene tubes, centrifuged, aliquoted, and stored at ‐80°C and analysed.
Abeta42 was measured using Athena Diagnostics (Worcester, Mass).
Threshold: 1125 pg/ml; prespecified using the published cut‐off (Fig 1, p512)
Were the index test results reported without knowledge of the reference standard? [Not reported]
Target condition and reference standard(s) Target condition: Alzheimer's disease dementia (differential diagnosis of AD from non‐AD dementia)
Reference standards: NINCDS‐ADRDA criteria for AD.
Clinical diagnosis of non‐AD dementia was established according to 'best clinical judgement'. No further details reported.
Clinical diagnosis was established prior the results of the index test
Flow and timing The interval between established clinical diagnosis and CSF sample collection was not reported. However, it appears that CSF samples were collected short after establishing the clinical diagnosis and following informed consent
Sample included in the analysis: 19 AD; 8 non‐AD (1 DLB; 3 NPH; 3 primary progressive aphasia; 1 hippocampal sclerosis)
AD vs non‐AD (n=27)
TP=19; FP=6; FN=0; TN=2 (Fig 1A and Fig 2, p512)
Sensitivity=100%; Specificity=25% (Calculated in RevMan5)
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? No    
Did the study avoid inappropriate exclusions? Unclear    
Could the selection of patients have introduced bias?   High risk  
Are there concerns that the included patients and setting do not match the review question?     Low concern
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? Yes    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Low risk  
Are there concerns that the target condition as defined by the reference standard does not match the question?     Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Low risk