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

Bousiges 2016.

Study characteristics
Patient Sampling A total of 151 patients were selected between January 2013 and January 2015.
Sampling procedure: Not reported
Separate data were available for the performance of biomarkers in distinguishing probable AD and probable DLB as well as mixed diagnosis of ADD and DLB with the other diagnostic groups. In accordance with inclusion criteria in the current review we only included data to differentiate between ADD and DLB with dementia diagnoses.
Patient characteristics and setting The sample considered in the review comprised of 51 participants, 31 ADD and 20 DLB. Diagnosis was established double‐blinded to biomarker results by clinicians and the biologist.
Sex: 12 males and 19 females for ADD; 14 males and 6 females for DLB
Age mean (SD) (y): 67.2±9.3 for ADD; 68.8±9.7 for DLB.
MMSE: 20.2±4.7 for ADD; 21±4.7 for DLB .
Disease duration (y): not reported
Sources of recruitment: The tertiary memory clinic of Strasbourg University Hospital
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 enzyme‐linked immunosorbent assays, obtained from Innogenetics NV, Gent, Belgium.
Threshold: 500ng/L, 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 DLB)
Reference standards: McKhann's criteria and Duboi's criteria for ADD.
Diagnosis for DLB was established on the McKeith's and DSM‐V criteria. Clinicians were blinded to biomarker results.
Flow and timing The interval between established clinical diagnosis and CSF sample collection was not reported.
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? Unclear    
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?     Low concern
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?     Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? No    
Were all patients included in the analysis? Unclear    
Could the patient flow have introduced bias?   Unclear risk