Fischer 2011.

Study characteristics
Patient sampling	Prospective random patient series
Patient characteristics and setting	98 participants, mean age = 62 (range = 42 to 80) years, 53 males/45 females, Denmark Histology of primary tumour Adenocarcinoma: N = 29; squamous cell: N = 20; large cell: N = 4; NSCLC other: N = 7; comorbidities: not reported Inclusion criteria Participants between 18 and 80 years with newly diagnosed NSCLC that was considered operable after conventional staging procedures Exclusion criteria Type 1 diabetes, another malignant condition, confirmed distant metastases, known claustrophobia, and an estimated forced expiratory volume in 1 second of less than 30% after surgery Previous/all reported tests CT then FDG‐PET/CT followed by invasive diagnostic procedures. Standard staging procedures were governed by local routine based on current guidelines; however, mediastinoscopy was considered mandatory Clinical setting Departments of Pulmonology
Index tests	After a 6‐hour fast, 400 MBq of (¹⁸F)‐2‐fluoro‐deoxy‐D‐glucose (FDG) was given intravenously, and after a 1‐hour rest, the participantwas scanned from the head to the upper thigh with the use of an integrated PET–CT system (GE Discovery LS, GE Healthcare). A diagnostic CT scan, obtained with the use of a standard protocol (80 to 100 mA, 120 kV, a tube‐rotation time of 0.5 second per rotation, a pitch of 6, and a slice thickness of 5 mm, with 70 ml of intravenous contrast medium containing 300 mg of iodine per millilitre (Ultravist, Bayer Schering), administered at a rate of 2.5 ml per second), preceded the PET scan (a 5‐minute emission scan per table position and 25 minutes total). The PET scan was reconstructed by filtered back‐projection and ordered‐subset expectation‐maximisation (OS‐EM), with data from the CT scan used for attenuation correction. An experienced radiologist and a nuclear medicine specialist evaluated the FDG‐PET/CT images side by side, and a consensus was reached on the findings Covariates Type of PET‐CT scanner: integrated PET‐CT scanner (Discovery LS; GE Healthcare) FDG dose: 400 MBq Injection‐to‐scan time: 60 min Attenuation correction: yes Cut‐off values for test positivity (malignancy): A lesion with increased uptake of FDG in 3 planes when compared with background on a PET scan was classified as malignant. If the image could not be interpreted with confidence, the SUV, defined as the activity per ml within the region of interest divided by the injected dose in megabecquerels per gram of body weight, was calculated, and lesions with a SUV > 2.5 were deemed malignant
Target condition and reference standard(s)	Thoracotomy: N = 60; mediastinoscopy: N = 9; EUS‐FNA: N = 19; EBUS‐TBNA: N = 4; not applicable: N = 6, as N = 4 had M1 disease, N = 1 had inoperable T4, and N = 1 was N0 or N1, but considered inoperable because of coexisting disease
Flow and timing	All participants were accounted for in the results. 14/98 participants did not receive FDG PET‐CT, and 5 participants did not receive the reference standard. Total N reported in the results was therefore = 79
Comparative
Notes	Funded by the Danish Cancer Society and the Danish Center for Health Technology. The authors stated that the study was subject to no competing interests 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?	Yes
Was there a pre‐specified cut‐off value?	Yes
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?	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?	Yes
Were all patients included in the analysis?	No
		Unclear