Santangelo 2017.
Study characteristics | |||
Patient Sampling | 326 patients were included: 165 patients with AD, 34 with NPH, 43 with FTD, 22 with LBD, 19 with PSP/CBS, 11 with VaD. Sample procedure not reported. We did not include data on performance of the index test to discriminate AD participants from controls or AD participants from patients with PSP/CBS. Exclusion criteria: reported. |
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Patient characteristics and setting |
Age at diagnosis and disease duration and education:Reported Sex: 64 males and 101 females for AD; 6 males and 5 females for VD, 26 males and 17 females for FTD, 14 males and 8 females for DLB, 23 males and 11 females for NPH Sources of recruitment: A sample who were admitted to the Memory Centre of IRCCS‐San Raffaele Hospital, Milan, Italy between December 2008 and July 2015. |
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Index tests | Patients gave CSF samples. The samples were collected in polypropylene tubes and 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? [Not reported] |
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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. |
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Flow and timing | The interval between established clinical diagnosis and CSF sample collection was not reported. Patients underwent lumbar puncture at the baseline 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? | No | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Could the selection of patients have introduced bias? | Low 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? | Low concern | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Were all patients included in the analysis? | No | ||
Could the patient flow have introduced bias? | Unclear risk |