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

Rosler 2001.

Study characteristics
Patient Sampling 170 patients were recruited: 27 patients probable AD, 24 with non‐AD dementias, 70 with various infectious, immunological, neurodegenerative, neoplastic and vascular central nervous system (CNS) diseases without cognitive impairment (OND) and 49 without CNS disease (CO). Sample procedure not reported.
Separate data were available for the performance of biomarkers in distinguishing between AD and non‐AD dementia. We did not included data on performance of the index test to discriminate AD participants from controls.
Exclusion criteria: not reported.
Patient characteristics and setting Sample included in the review comprised of 51 participants: 27 patients with probable AD according to the NINCDS‐ADRDA criteria (McKhann 1984); 11 patients had early onset and 16 patients late onset of the disease; 24 patients with non‐AD dementias: 4 Parkinson's disease with dementia, 5 vascular dementia 2 diffuse Lewy body disease, 1 progressive supranuclear palsy, 2 multisystem degeneration, 1 Pick's disease, 1 Huntington's disease and 8 normal pressure hydrocephalus.
Age: <65 years early onset AD; >65 years late onset AD; not reported for the non‐AD group
Sex: 9 males and 18 females for AD, 13 males and 11 females for non‐AD dementias
Sources of recruitment: not reported. Residual lumbar CSF samples archived for research purposes were enrolled. The study was conducted at the Ludwig Boltzman Institute of Clinical Neurobiology, Vienna, Austria.
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: 375 pg/ml; not pre‐specified, Cut‐offs were determined by ROC analysis.
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.
It was not reported whether the results of the reference standard results were interpreted without knowledge of the results of the index test.
Flow and timing The interval between established clinical diagnosis and CSF sample collection was not reported.
Sample included in the analysis: 27 AD; 24 non‐AD participants (5 VD; 4 PDD; 2 DLB, 8 NPH; 1 progressive supranuclear palsy, 2 multisystem degeneration, 1 Pick's disease, 1 Huntington's disease)
AD vs non‐AD (N=51)
Sensitivity=78%; Specificity=58% (p234)
TP=21; FP=10; FN=6; TN=14 (Calculated in RevMan; Fig 1b, p236)
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? No    
Was a case‐control design avoided? No    
Did the study avoid inappropriate exclusions? No    
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? 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?     Unclear
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Unclear    
Were all patients included in the analysis? Yes    
Could the patient flow have introduced bias?   Unclear risk