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

Perani 2016.

Study characteristics
Patient Sampling 86 early dementia patients were recruited.
Patients were referred to the memory clinics of the San Raffaele Hospital (Milan, Italy). They underwent clinical evaluation.
Separate data were available for the performance of the biomarkers in distinguishing AD from MCI. We did not include data on performance of the index test to discriminate AD participants from MCI.
Exclusion criteria: reported
Patient characteristics and setting The sample considered in the review comprises of 75 patients with dementia: 47 AD, 14 FTLD and 14 DLB. All patients underwent clinical assessment.
Sex: 26 males and 21 females for AD; 8 males and 6 females for FTLD; 11 males and 3 females for DLB
Age (SD) (y): 66±6.8 for AD; 65± 7.3 for FTLD; 72± 6 for DLB
Disease duration (y): 39 ± 24 for AD; 32±19 for FTLD; 42±22 for mixed dementia
Index tests Patients gave CSF samples. The samples were 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? [Yes]
Target condition and reference standard(s) Target condition: Alzheimer's disease dementia (1. differential diagnosis of AD from FTLD and DLB; 2. differential diagnosis of AD from FTLD only)
Reference standards: NINCDS‐ADRDA criteria for Alzheimer's disease dementia
McKeith criteria for DLB and Rascovsky et al., 2013 for FTLD.
Flow and timing All biomarker data were collected within 3 months from the baseline clinical 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? Yes    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Unclear risk  
Are there concerns that the included patients and setting do not match the review question?     Unclear
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Unclear    
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?     Unclear
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Were all patients included in the analysis? No    
Could the patient flow have introduced bias?   Unclear risk