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

Bibl 2006.

Study characteristics
Patient Sampling Prospective investigation of participants with probable AD, probable DLB and non‐demented disease controls from initially consecutively referred sample to a laboratory for neurochemical evaluation.
Separate data were available for the performance of biomarkers in distinguishing between AD from DLB. We did not include data on performance of the index test to discriminate AD participants from controls.
Exclusion criteria: not reported. Exclusion criteria were only reported for the control group.
Patient characteristics and setting The sample considered in the review comprised of 43 participants, 18 AD and 25 DLB. CSF was collected from hospitalised DLB patients from a clinic specialising in the diagnosis and treatment of Parkinson's disease. CSF of AD patients came from a memory clinic. The mean age and the mean MMSE score did not significantly differ between AD and DLB participants.
Sex: 5 males and 13 females for AD; 21 males and 4 females for DLB
Age mean (SD) (y): 69.7 ± 10.6 for AD; 72.0 ± 7.5 for DLB
Disease duration (y): not reported
Sources of recruitment: AD patients from the memory clinic, University of Goettingen; DLB patients: inpatients from a Paracelsus‐Elena Klinic, Kassel; Germany
Index tests Patients gave CSF samples. The samples were collected in polypropylene tubes, centrifuged, aliquoted, and stored at ‐80°C and analysed (within 2 days).
Abeta42 was measured using enzyme‐linked immunosorbent assays, obtained from Innogenetics NV, Gent, Belgium.
Threshold: 475pg/ml, not prespecified; determined by ROC analysis.
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 (differential diagnosis of AD from DLB)
Reference standards: NINCDS‐ADRDA and DSM‐IV criteria for AD.
Clinical diagnosis of DLB was based on McKeith and DSM‐IV criteria.
Diagnosis was established by a psychiatrist and a neurologist (blinded to biomarker results) thorough anamnesis, clinical examination, results of neuropsychological assessment, clinical records of the patients and the best clinical judgement.
Flow and timing The interval between established clinical diagnosis and blood sample collection was not reported.However, it appears that CSF samples were collected short after establishing the clinical diagnosis of AD and DLB.
At baseline: 18 AD; 25 DLB
Sample included in the analysis: 18 AD; 23 DLB
AD vs DLB (n=41)
Disease+: 18; Disease: 23
Sensitivity=50%; Specificity=96% (Calculated in Revman5)
TP=9; FP=1; FN=9; TN=22 (calculated in RevMan5)
Missing data: CSF Abeta42 sample was unavailable from 2 DLB participants (p1772)
Comparative  
Notes Author contacted: there is some discrepancy between our findings and findings data reported in the Table 2, p1775. No reply.
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? No    
Could the patient flow have introduced bias?   Unclear risk