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

Ozkan 2011.

Study characteristics
Patient sampling Retrospective patient series
Patient characteristics and setting 153 NSCLC participants, mean age = 61.4 (SD = 9.97) years, 135 males/18 females, Turkey
Histology of primary tumour 
 Not reported; comorbidities: not reported
Inclusion criteria 
 Not reported
Exclusion criteria 
 Not reported
Previous tests 
 Not reported
Clinical setting 
 Secondary/tertiary care
Index tests FDG‐PET‐CT
Covariates
Type of PET‐CT scanner: not reported
FDG dose: not reported
Injection‐to‐scan time: not reported
Attenuation correction: not reported
Cut‐off values for test positivity (malignancy): not reported
Target condition and reference standard(s) Histopathology or clinical follow‐up decisions and the results of other imaging tests
Flow and timing If the whole sample only consisted of the 153 participants reported in the abstract, all participants were included in the analysis
Comparative  
Notes Author sent test accuracy data on request. As the study was only published as an abstract, we contacted the author (on 3 December 2012) to request the following information.
How was the sample recruited?
‐ Did the study population consist of a consecutive sample?  
Characteristics of the 153 participants:
‐ Histology of primary tumour?
‐ Comorbidities?
‐ NSCLC stage?
‐ Inclusion criteria?
‐ Exclusion criteria?
‐ Previous/all reported tests?
‐ Clinical setting Thoracic surgery unit?
‐ Were any participants excluded from the analyses?
PET‐CT scanning:
‐ What type of PET‐CT scanner was used?
‐ What FDG dose was used?
‐ What was the injection‐to‐scan time?
‐ Did you use attenuation correction?
‐ What was the criteria for a positive result?
‐ Did you use a prespecified cut‐off value for test positivity?
‐ Was the PET‐CT results interpreted without knowledge of the pathological/follow‐up results?
Pathological staging:
You state in the abstract that PET/CT results were confirmed histopathologically or according to clinical follow‐up decisions and the results of other imaging tests.
‐ How many participants received histopathological confirmation, and how many participants received non‐histopathological confirmation and why (including, what did their confirmation consist of instead)?
‐ Was the pathological staging results interpreted without knowledge of the PET‐CT results?
Flow and timing:
‐ What was the interval between PET‐CT and histopathological/other confirmation of the PET‐CT results?
‐ Were there any adverse events of the PET‐CT?
Funding
‐ Was the study funded and if yes, by whom?
We received no response
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 Unclear
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? Unclear    
Was a positive result defined? No    
    Unclear Unclear
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Unclear    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
    Unclear 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? No    
Were all patients included in the analysis? Yes    
    Unclear