Herukka 2008.
| Study characteristics | |||
| Patient sampling |
Primary objectives: investigate the association between the CSF biomarkers and MTA and the ability of these measures to predict AD in MCI Study population: MCI according to Petersen 2001 Selection criteria: the substudy included all participants for whom both lumbar puncture and a volumetric MRI scan had been performed. Exclusion criteria not reported Study design: prospective longitudinal study |
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| Patient characteristics and setting |
Clinical presentations: MCI had an objective impairment in at least 1 cognitive domain (performance < 1.5 SD below age‐adjusted values) and a CDR score of 0.5 Age mean (SD): MCI who progressed to AD: 72 ± 5; stable MCI:71 ± 5 Gender (% men): MCI who progressed to AD: 37.5%; stable MCI: 31% Education years mean (SD): not reported ApoE4 carriers (%): not reported Neuropsychological tests: employed; MMSE mean (SD): not available Clinical stroke excluded: not specified Co‐morbidities: not reported Number enrolled: 21 Number available for analysis: 21 Setting: participants examined in Neurological Department of Kuopio University Hospital and participants in an ongoing population‐based follow‐up study in the University of Kuopio Country: Finland Period: not reported Language: English |
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| Index tests |
Index test: MRI manual method for estimation of left, right, and total volumes of hippocampus and entorhinal cortex Manufacturer: Siemens Tesla strength: 1.5 Assessment methods: the hippocampi and entorhinal cortex were manually traced using custom‐made software for a standard Siemens work console Description of positive cases definition by index test as reported: not specified Examiners: single rater, blinded to clinical data Interobserver variability: ICCs for intra‐rater reliability were 0.96 for the hippocampus and 0.95 for the entorhinal cortex measured from 10 participants |
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| Target condition and reference standard(s) |
Target condition: AD Prevalence of AD in the sample: 8/21 (38% of enrolled participants) Stable MCI or converted to other dementia: 13 (62%) stable MCI Reference standards: NINCDS‐ADRDA criteria (McKhann 1984) Mean clinical follow‐up: MCI who progressed to AD: 3.38 ± 1.85 years; stable MCI: 4.77 ± 1.09 years |
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| Flow and timing | Withdrawals explained and losses to follow‐up: none reported Uninterpretable MRI results have not been reported | ||
| Comparative | |||
| Key conclusions by the authors | The results of the study suggest that cerebrospinal fluid biomarkers and MTA measured by volumetric MRI correlate with each other and are associated with impairment in memory performance. These findings provide further evidence that both cerebrospinal fluid biomarkers and MRI of the medial temporal lobe structures are useful in the confirmation of early, perhaps even the preclinical diagnosis of AD | ||
| Conflict of interests | Study authors declared no conflict of interest | ||
| Notes |
Source of funding: study was supported by Academy of Finland grant number 201495, Kuopio University Hospital EVO grants 5883, 5772720 and 5772725 2 x 2 table: data to complete 2 x 2 table provided by the study authors |
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| 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? | Yes | ||
| Did the study avoid inappropriate exclusions? | No | ||
| High | Low | ||
| DOMAIN 2: Index Test All tests | |||
| Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
| Did the study provide a clear pre‐specified definition of what was considered to be a "positive" result of the index test? | No | ||
| Was the index test performed by a single operator or interpreted by consensus in a joint session? | Yes | ||
| 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? | Yes | ||
| Low | Low | ||
| DOMAIN 4: Flow and Timing | |||
| Was there an appropriate interval between index test and reference standard? | Yes | ||
| Did all patients receive the same reference standard? | Yes | ||
| Were all patients included in the analysis? | Yes | ||
| Low | |||