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

Subedi 2009.

Study characteristics
Patient sampling Retrospective consecutive patient series
Patient characteristics and setting 161 participants, mean age = 70.2 (range = 37 to 89) years, 85 males/76 females, UK
Histology of primary tumour 
 Not reported; comorbidities: not reported
Inclusion criteria 
 Participants with known or suspected primary bronchogenic carcinoma who underwent half‐body FDG PET–CT from 1 April 2006 to 31 March 2007
Exclusion criteria 
 None listed
Previous tests 
 Chest radiograph, CT scan of the thorax and upper abdomen, fibreoptic bronchoscopy, or image‐guided transthoracic fine‐needle biopsy
Clinical setting 
 Secondary
Index tests A standard dose of 375 MBq of ‐FDG was administered intravenously. PET and CT images were acquired from skull base to
 upper thigh after an uptake period of 60 min on either a Discovery ST or STE PET–CT camera (GE Healthcare, Milwalkee, WI, USA). The CT component of the PET–CT was performed according to a standardised protocol with the following settings: 140 kV; 80 mA; tube rotation time, 0.5 s per rotation; pitch, 6; section thickness, 3.75 mm (to match the PET section thickness). Participants maintained normal shallow respiration during the CT acquisition. No iodinated contrast material was administered. PET–CT was regarded as negative if there was no or very low metabolic activity (below mediastinal blood pool activity) within lesions. A maximum standardised uptake value (SUV) of 2.5 was used as an arbitrary cut‐off
Covariates
Type of PET‐CT scanner: integrated PET‐CT scanner (Discovery ST; GE Medical systems)
FDG dose: 375 MBq
Injection‐to‐scan time: 60 min
Attenuation correction: not reported
Cut‐off values for test positivity (malignancy): SUVmax of 2.5
Target condition and reference standard(s) Pathological staging: 47 underwent complete lymphadenectomy, 22 underwent systematic lymph node sampling, and 4 had no nodal tissue present in their histopathological specimen
Flow and timing Only data from 91/161 included participants were presented. It appears that the remainder did not receive pathological confirmation of their test result
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? Yes    
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? Unclear    
Was there a pre‐specified cut‐off value? Yes    
Was a positive result defined? Yes    
    Unclear 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    
    Low Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Unclear    
Did all patients receive the same reference standard? Unclear    
Were all patients included in the analysis? No    
    High