Lins 2004.
| Study characteristics | |||
| Patient Sampling | CSF samples archived for research purposes from patients with probable AD, VD, iNHP dementia, Parkinson disease without dementia and controls were selected. Separate data on the performance of biomarkers to distinguish between AD from VD and iNPH dementia have been reported. Sample procedure not reported. Exclusion criteria not reported. |
||
| Patient characteristics and setting | CSF samples from 36 participants: 12 ADD, 12 VD and 12 iNPH. Sex: 5 males and 7 females for AD; 4 males and 8 females for VD; 9 males and 3 females for iNPH Age (SD) (y): 71.8 ±1.7 AD; 76.4 ±1.9 for VD; 75.0 ±1.9 for iNPH Sources of recruitment: not reported. Not reported whether the study was conducted in Germany or Austria. |
||
| 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: 562 pg/ml; not prespecified; Cut‐offs were determined by ROC analysis. 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 (1. differential diagnosis of AD from VD; 2. differential diagnosis of AD from iNPH) Reference standards: NINCDS‐ADRDA criteria for ADD. Clinical diagnosis of VD was based on NINDS‐AIREN and ICD‐10 criteria. Clinical diagnosis of iNPH was based on clinical symptoms (Keifer index), the results of neuroimaging and improvement after CSF withdrawal. Clinical diagnosis was established prior the results of the index test. |
||
| Flow and timing | Retrospective analysis. The interval between established clinical diagnosis and CSF sample collection was not reported. Sample included in the analysis: 12 AD, 12 VD; 12 iNPH. AD vs VD (n=24) TP=8; FP=6; FN=4; TN=6 (Fig 1, p277) Sensitivity=67%; Specificity=50% (Calculated in RevMan5) AD vs iNPH (n=24) TP=8; FP=8; FN=4; TN=4 (Fig 1, p277) Sensitivity=67%; Specificity=33% (Calculated in RevMan5) |
||
| 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? | No | ||
| 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? | Unclear | ||
| 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? | Unclear | ||
| Were all patients included in the analysis? | Yes | ||
| Could the patient flow have introduced bias? | Unclear risk | ||