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. 2020 Mar 2;2020(3):CD009628. doi: 10.1002/14651858.CD009628.pub2

deToledo‐Morell 2004.

Study characteristics
Patient sampling Primary objectives: to compare the entorhinal cortex and hippocampal volumes as predictors of conversion to AD in a group of patients diagnosed with amnestic MCI
Study population: participants with amnestic MCI
Selection criteria: exclusion criteria: < 65 years, neurologic, psychiatric, or systemic conditions that may cause cognitive impairment (e.g. clinical stroke, alcoholism, major depression, a history of temporal lobe seizures)
Study design: prospective longitudinal
Patient characteristics and setting Clinical presentation: amnestic MCI defined according to Petersen 2001 diagnostic criteria
Age mean (SD): people with MCI who progressed to AD: 83 ± 5 years; stable MCI: 81 ± 8 years
Gender (% men): MCI who progressed to AD 40%; MCI non‐converters 47%
Education years mean (SD) MCI who progressed to AD: 18.4 ± 2.1; MCI non‐converters: 15.2 ± 3.1
ApoE4 carriers (%): not reported
Neuropsychological tests: MMSE mean (SD): people with MCI who progressed to AD: 26.1 ± 1.4; MCI non‐converters: 28.0 ± 1.8
Clinical stroke excluded: yes
Co‐morbidities: not reported
Number enrolled: 27
Number available for analysis: 27
Setting: a tertiary university hospital; the Rush Alzheimer's Disease Center
Country: USA
Period of study: not reported
Language: English
Index tests Index test: MRI manual method for estimation of hippocampal and entorhinal cortex volumes
Manufacturer: GE (Signa scanners)
Tesla strength: 1.5
Assessment methods: Analyze software package (Mayo Clinic Foundation) was used for determining the volumes of ROI. Both the hippocampal and the entorhinal cortex volumes were manually segmented respectively according to deToledo‐Morrell 1997 and Goncharova 2001
Description of positive cases definition by index test as reported: not specified
Examiners: all tracings were carried out by T.R.S. (who was trained to be within 95% of L.deT.‐M.) and were checked, slice by slice, by L.deT.‐M. Investigators involved in the MRI analyses were blinded to clinical information until all volumetric determinations were completed
Interobserver variability: inter‐ and intra‐rater correlation coefficients, based on a sample of 10 MRI scans, were 0.97 and 0.97, respectively, for the hippocampal, 0.99 and 0.99, respectively, for the entorhinal cortex
Target condition and reference standard(s) Target condition: AD
Prevalence of AD in the sample: 10/27 (37% of cases enrolled in the study)
Stable MCI or converted to other dementia: 17 (63%)
Reference standard: NINCDS‐ADRDA (McKhann 1984)
Mean clinical follow‐up: 3 years
Flow and timing Withdrawals and losses to follow‐up: none reported
Uninterpretable MRI results have not been reported
Comparative  
Key conclusions by the authors Results of the study were in agreement with post mortem pathological findings and underscored the early involvement of the entorhinal cortex in AD. Findings demonstrated the potential of sensitive neuroimaging techniques for the development of early anatomical markers of AD and for tracking, longitudinally, MCI at risk of developing AD
Conflict of interests Not reported
Notes Source of funding: this research was supported by Grants P01 AG09466, P30 AG10161, and R01 AG17917 from the NIA, NIH
2 x 2 table: data to complete 2 x 2 table provided by the study authors
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? Yes    
    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