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

Uskul 2009.

Study characteristics
Patient sampling Retrospective patient series
Patient characteristics and setting 37 participants, mean age = 59 (SD? = 9) years, 34 males/3 females, Turkey
Histology of primary tumour 
 Adenocarcinoma: N = 11; squamous cell, N = 26; comorbidities: not reported
Inclusion criteria
Participants with NSCLC who underwent TBNA (i.e., who had mediastinal nodes ≥ 10 mm on CT) of mediastinal lymph nodes during fibreoptic bronchoscopy and PET‐CT examination at the authors' institution during a 2‐year period
Exclusion criteria 
 None listed
Previous tests 
 CT
Clinical setting 
 Secondary/tertiary
Index tests PET‐CT scans were performed using a multidetector CT integrated high‐resolution PET‐CT scanner (Siemens Biograph LSO HI‐RES Integrated PET‐CT Scanner; Siemens Medical Solutions, Knoxville, TN, USA) 60 min after an intravenous injection of FDG at a dose of 5 MBq/kg body weight. To minimise insulin activity, participants were required to fast for a minimum of 12 hours prior to FDG administration. The CT component of the procedure was performed without intravenous contrast and with low current (70 mA, 5 mm section thickness), and was only used for the purpose of attenuation correction and assistance in the localisation of the PET images. 2 experienced nuclear medicine physicians, who were blind to the pathology results, evaluated images, and their consensus was classified as either negative (no typical uptake for malignancy, SUV < 2.5) or positive (typical uptake for malignancy, SUV ≥ 2.5)
Covariates
Type of PET‐CT scanner: Siemens Biograph LSO HI‐RES Integrated PET‐CT Scanner (Siemens Medical Solutions, Knoxville, TN, USA)
FDG dose: 5 MBq/kg
Injection‐to‐scan time: 60 min
Attenuation correction: yes
Cut‐off values for test positivity (malignancy): Consensus was from 2 nuclear medicine physicians and classified as either negative (no typical uptake for malignancy, SUV < 2.5) or positive (typical uptake for malignancy, SUV ≥ 2.5). Please note, it is not specified that it is SUVmax; however, for the subgroup analyses of the criteria for test positivity, we categorised this study in the SUVmax ≥ 2.5 group
Target condition and reference standard(s) Pathological staging (TBNA and surgical resection). All TBNA preparations positive for malignancy were considered true positives; whereas, only those TBNA preparations negative for malignancy that were confirmed by mediastinoscopy/mediastinal lymph node dissection were considered true negatives. All inadequate TBNA samples or adequate negative TBNA samples not confirmed by surgery were considered false negatives. All the TBNA data were examined by the same pathologist who was blinded to the participants' data
Flow and timing 1/37 included participants did not receive the reference standard; thus, data were only available for 36 participants
Comparative  
Notes There was no mention of funding source, but since this was a retrospective 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? No    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
    Unclear Unclear
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? Unclear    
Was a positive result defined? Yes    
    Low 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 Unclear
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? Yes    
Were all patients included in the analysis? No    
    Unclear