Monge‐Argiles 2011.
| Study characteristics | |||
| Patient sampling | 37 patients with MCI, attending the cognitive deterioration out‐patients clinic of a general hospital and 24 control subjects without subjective memory loss or known cognitive deterioration. We only included data on performance of the index test to discriminate between patients with MCI who convert to dementia and those who remained stable. Participants with dementia or other neurological, psychiatric or medical disease which could provoke cognitive deterioration, anti‐coagulant therapy, failure to obtain informed consent, or a Yesavage depression scale score >5 were excluded |
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| Patient characteristics and setting | 37 participants diagnosed by the Petersen 2006 criteria at baseline Gender: 13 men; 24 women; MCI‐MCI: 11M, 15F; MCI‐AD: 2M, 9F Age: mean 73.43±6.63 years APOE ϵ4 carrier: not reported MMSE: mean 25±2.4; MCI‐AD: mean 23±1.2 Time between MCI diagnosis and study entry (months): 1‐12 (n=5); 13‐24 (n=9); 25‐36 (n=1); 37‐48 (n=3); 49‐60 (n=6); >61: 2 Setting: secondary care, outpatients ‐ General Hospital, Spain |
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| Index tests | CSF: Abeta42 The LP was performed by their own neurologist with a 20X3.5 gauge needle. CSF was collected in standard tubes and centrifuged if little sanguinolent, before being frozen. CSF samples with obvious blood were discarded. Abeta 1–42 was analysed using xMAP Luminex technology and INNO‐BIA Alzbio3 reagents (Innogenetics, Belgium). Threshold(s): 320 pg/ml; determined at follow‐up and derived from ROC analysis of controls and the whole MCI population (Table 6, p 990) At baseline 37 MCI: 18 with 'normal CSF Abeta amyloid level'; 19 with 'abnormal CSF Abeta amyloid level' Index test was conducted before clinical follow‐up |
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| Target condition and reference standard(s) | Target condition: Alzheimer's disease dementia Reference standard: NINCDS‐ADRDA criteria Unclear whether clinicians conducting follow‐up were aware of CSF biomarker results |
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| Flow and timing |
Duration of follow‐up: 6 months At follow‐up: 37MCI: 11 MCI‐AD; 26 MCI‐MCI (Table 1, p989); Sensitivity 82%; Specificity 62% (Table 6, p990) Number included in analyses=37 MCI: 18 with 'normal CSF Abeta amyloid level': 16 MCI‐MCI; 2 MCI‐converters; 19 with 'abnormal CSF Abeta amyloid level': 10 MCI‐MCI; 9 MCI‐converters TP=9, FP=10, FN=2, TN=16 Loss to follow‐up: CSF marker and follow‐up data appeared to have been available for all participants |
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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? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Low | Low | ||
| DOMAIN 2: Index Test All tests | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| If a threshold was used, was it pre‐specified? | No | ||
| High | Low | ||
| 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 | ||
| Unclear | Low | ||
| DOMAIN 4: Flow and Timing | |||
| Was there an appropriate interval between index test and reference standard? | No | ||
| Did all patients receive the same reference standard? | Yes | ||
| Were all patients included in the analysis? | Yes | ||
| High | |||