Ossenkoppele 2012b.
Study characteristics | |||
Patient sampling | 154 participants included from the outpatient memory clinic of for assessing the impact of molecular imaging on the diagnostic process. Among those participants there were 30 people with MCI. No further details of participant sampling and recruitment were reported. We only include data on performance of the index test to discriminate between people with MCI who converted to dementia and those who remained stable. Exclusion criteria: major clinical and psychiatric disorders, recent vascular events and excessive substance abuse. |
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Patient characteristics and setting | 30 MCI participants diagnosed by the Petersen 2001 criteria at baseline. Gender: 23 men; 7 women Age: 64 ± 9 APOE ϵ4 carrier: not reported MMSE: 27 ± 2 Education: not reported Sources of referral: not reported Sources of recruitment: Outpatient Memory Clinic,the VU University Medical Centre, The Netherlands. |
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Index tests | ¹⁸F‐FDG PET scan Threshold: visual inspection. Threshold (SUVr of ROI) not reported. Index test was conducted before follow‐up. |
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Target condition and reference standard(s) | Target condition: conversion from MCI to Alzheimer's disease dementia or other forms of dementia Reference standards: NINCDS‐ADRDA criteria for ADD (McKhann 1984); Reference standard for the clinical criteria for FTD not reported. Reference standards performed both with and without the index test results on the total sample. Unclear whether the data reported on 12 participants relate to the reference standards performed with or without the index test results. |
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Flow and timing |
Duration of follow‐up: 2 years At baseline: 30 MCI: 15 FDG positive test; 15 FDG negative test (Table 1, p 4) At follow‐up: 12 participants: 7 MCI‐converters (6 MCI‐ADD; 1 FTD); 5 MCI‐non‐converters MCI (5 MCI‐MCI) (from the author) Number included in analysis: 12 Conversion from MCI to ADD: TP = 5; FP = 0; FN = 1; TN = 6 Conversion from MCI to all dementia: TP = 5; FP = 0; FN = 2; TN = 5 Loss to follow‐up:18 MCI participants. No further information. |
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Comparative | |||
Notes | We contacted the trial investigators contacted who provided relevant data tor the 2 x 2 table to be completed and confirmed there are no overlapping participants with the Ossenkoppele 2012a study (email on 25th July 2013) | ||
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? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | No | ||
High |