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. 2014 Nov 13;2014(11):CD009519. doi: 10.1002/14651858.CD009519.pub2

Carnochan 2009.

Study characteristics
Patient sampling Retrospective consecutive (?) patient series
Patient characteristics and setting 200 participants, 95 females (mean age = 63.7 years, SD = 9.2 years, range = 40 to 81 years) and 105 males (mean age = 66.4 years, SD = 7.9 years, range = 44 to 84 years), Scotland
Histology of primary tumour 
 Not reported; comorbidities: not reported
Inclusion criteria 
 Participants referred for consideration of surgery with a diagnosis or presumptive diagnosis of bronchogenic carcinoma to the authors' unit between June 2006 and January 2008
Exclusion criteria 
 None listed
Previous tests 
 Spiral CT (all participants), and additional imaging (including ultrasound, MRI, and isotope scanning) was utilised where appropriate
Clinical setting 
 Thoracic surgery unit
Index tests The participants were referred from different regions, which meant that both the primary CT and subsequent PET‐CT imaging was undertaken at different sites. All PET‐CT scans were reported by 2 radiologists, with node positivity based on SUV criteria selected by the scanning unit
Covariates
Type of PET‐CT scanner: not reported, but undertaken at different sites
FDG dose: not reported
Injection‐to‐scan time: not reported
Attenuation correction: not reported
Cut‐off values for test positivity (malignancy): node positivity based on SUV criteria selected by the scanning unit
Target condition and reference standard(s) Mediastinoscopy with or without surgical resection (performed within 4 weeks of the PET‐CT scan)
Flow and timing Data from 194/200 were available. The remaining 6 participants were classified as having benign disease by PET‐CT, but histology later showed that they all had NSCLC. However, the N‐stage for these participants was not reported
Comparative  
Notes There was no mention of funding source, but since this was a retrospective database study, it is likely that the study received no explicit funding
Adverse events: not reported
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? Unclear    
    Unclear Low
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Yes    
Was there a pre‐specified cut‐off value? No    
Was a positive result defined? No    
    Unclear 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? Unclear    
    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? No    
    Low