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 |
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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 |
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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] |
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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. |
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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 |