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

Santangelo 2017.

Study characteristics
Patient Sampling 326 patients were included: 165 patients with AD, 34 with NPH, 43 with FTD, 22 with LBD, 19 with PSP/CBS, 11 with VaD.
Sample procedure not reported.
We did not include data on performance of the index test to discriminate AD participants from controls or AD participants from patients with PSP/CBS.
Exclusion criteria: reported.
Patient characteristics and setting Age at diagnosis and disease duration and education:Reported
Sex: 64 males and 101 females for AD; 6 males and 5 females for VD, 26 males and 17 females for FTD, 14 males and 8 females for DLB, 23 males and 11 females for NPH
Sources of recruitment: A sample who were admitted to the Memory Centre of IRCCS‐San Raffaele Hospital, Milan, Italy between December 2008 and July 2015.
Index tests Patients gave CSF samples. The samples were collected in polypropylene tubes and stored at ‐80°C and analysed.
Abeta42 was measured using enzyme‐linked immunosorbent assays, obtained from Innogenetics NV, Gent, Belgium.
Threshold: 500 pg/ml; pre‐specified,
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.
Flow and timing The interval between established clinical diagnosis and CSF sample collection was not reported. Patients underwent lumbar puncture at the baseline visit.
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? Yes    
Could the selection of patients have introduced bias?   Low 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? Unclear    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Unclear 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? Unclear    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   Unclear risk