Schirinzi 2015.
Study characteristics | |||
Patient Sampling | Patients received lumbar puncture for diagnostic purposes at the Neurology unit of Policlinico Tor Vergata, Rome‐Italy between 2012 and 2014. | ||
Patient characteristics and setting | CSF samples from 28 participants: 14 ADD and 14 iNPH. Sex: 6 males and 8 females for AD and 8 males and 6 females for iNPH Age (SD) (y): 69.85 ± 7.42AD; 73.21 ± 4.63 for iNPH |
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Index tests | Patients gave CSF samples. The samples were collected in polypropylene tubes, stored on ice and sent to local laboratory and analysed (within 1 hour). Abeta42 was measured using enzyme‐linked immunosorbent assays, obtained from Innogenetics NV, Gent, Belgium. Threshold: 371pg/mL, not pre‐specified, determined by ROC analysis. 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 idiopathic NPH) Reference standards: NINCDS‐ADRDA criteria for AD. Subjects received a diagnosis according to iNPH guideline criteria for possible iNPH. It was not reported whether the results of the reference standard results were interpreted without knowledge of the results of the index test. |
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Flow and timing | Clinical diagnosis and CSF sample collection was done on the same day. | ||
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? | 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? | 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? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Low risk |