Montine 2001.
Study characteristics | |||
Patient Sampling | Participants with probable AD and dementias other than AD, who were under care at Oregon Health Science University or Vandebilt University Medical Center, were recruited. Age‐matched non‐demented controls were also recruited. Separate data were available for the performance of biomarkers in distinguishing between AD and non‐AD dementia. We did not include data on performance of the index test to discriminate AD participants from controls. Sampling process and exclusion criteria not reported. |
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Patient characteristics and setting | The sample considered in the review comprises of 27 participants, 19 AD and 8 non‐AD dementia (1 DLB; 3 NPH; 3 primary progressive aphasia; 1 hippocampal sclerosis). Ten controls were also recruited in the primary study. Most patients were evaluated by neuroimaging biomarkers. There was no significant difference in age or education level among the study groups. Duration of dementia was not significantly different between patients with probable Alzheimer disease or other dementias Sex: Not reported Age (SD) (y): 65.3±8.7 for AD; 66.6±4.4 for non‐AD MMSE: 24 (19 to 27) for AD; 28 (25 to 29) for non‐AD Duration of disease (y): 4.2±0.7 for AD; 4.2±0.7 for non‐AD Sources of recruitment: patients under care of the Oregon Health Science University or Vandebilt University Medical Center, Nashville, USA. Not reported whether inpatients or outpatients. |
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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 Athena Diagnostics (Worcester, Mass). Threshold: 1125 pg/ml; prespecified using the published cut‐off (Fig 1, p512) 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. Clinical diagnosis of non‐AD dementia was established according to 'best clinical judgement'. No further details reported. Clinical diagnosis was established prior the results of the index test |
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Flow and timing | The interval between established clinical diagnosis and CSF sample collection was not reported. However, it appears that CSF samples were collected short after establishing the clinical diagnosis and following informed consent Sample included in the analysis: 19 AD; 8 non‐AD (1 DLB; 3 NPH; 3 primary progressive aphasia; 1 hippocampal sclerosis) AD vs non‐AD (n=27) TP=19; FP=6; FN=0; TN=2 (Fig 1A and Fig 2, p512) Sensitivity=100%; Specificity=25% (Calculated in RevMan5) |
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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? | 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? | Yes | ||
Could the patient flow have introduced bias? | Low risk |