Yang 2010.

Study characteristics
Patient sampling	Prospective consecutive (?) patient series
Patient characteristics and setting	31 participants, mean age = 59 (range = 38 to 84) years, 22 males/9 females, China Histology of primary tumour Adenocarcinoma: N = 13; squamous cell carcinoma: N = 11; adenosquamous carcinoma: N = 3; bronchoalveolar: N = 2; large cell neuroendocrine cancer: N = 2; comorbidities: not reported Inclusion criteria Participants with NSCLC Exclusion criteria Allergy to iodine contrast and hyperglycemia over 9 mmol/L on the day when the FDG PET‐CT scan was performed, participants with other extra‐thoracic metastasis or who had received prior chemotherapy or radiotherapy Previous tests Conventional lung cancer staging on the basis of clinical information and both FLT‐ and FDG PET‐CT studies Clinical setting Cancer hospital The inclusion of only participants who received surgery narrows the range of patients who would receive PET‐CT in practice, namely, patients (clinically) with suspected resectable non‐small cell lung cancer, a proportion of whom would have N2 or N3 disease already on PET‐CT
Index tests	All participants fasted for at least 6 h before examination, then received an intravenous injection of 300 to 400 MBq of FDG and rested for approximately 60 min before scanning. Scanning was performed with an integrated in‐line PET‐CT system (Discovery LS; GE Healthcare). Unenhanced CT was performed first, from the head to the thigh, with the following settings: 140 kV; 80 mA; tube rotation time, 0.5 s per rotation; a pitch of .75; and section thickness, 4.25 mm, which match the PET section thickness. A PET emission scan was performed that covered the identical transverse field of view immediately after CT. Acquisition time for PET was 4 min per table position. Participants were in normal shallow respiration during the image acquisition. PET data sets were reconstructed iteratively using CT data for attenuation correction, and coregistered images were displayed on a workstation (Xeleris; GE Healthcare). 2 experienced nuclear medicine physicians, unaware of surgical or pathological findings and any clinical information except for the participants with NSCLC, prospectively interpreted the PET‐CT images. Tumour lesions were identified as areas of focally increased uptake exceeding that of the surrounding normal tissue. For primary tumours visualised on PET, a region of interest (ROI) was placed over the entire FDG‐avid lesion on all transverse planes in which the tumour appeared and the SUVmax was calculated. For lesions not visible on the PET scan, an ROI was drawn on the scan corresponding to the area of abnormality on the CT image Covariates Type of PET‐CT scanner: integrated PET‐CT scanner (Discovery LS; GE Healthcare) FDG dose: 300 to 400 MBq Injection‐to‐scan time: 60 min Attenuation correction: yes Cut‐off values for test positivity (malignancy): Lesions were considered positive if a definite localised area of higher FDG uptake than in the surrounding normal tissue was present, excluding physiologic uptake. There was no prespecified cut‐off value
Target condition and reference standard(s)	Pathological results from lung cancer surgery performed within 2 weeks of PET‐CT
Flow and timing	All participants were accounted for in the results. All participants received the reference standard. There were no uninterpretable results
Comparative
Notes	Supported by the Research Fund of Shandong Provincial Health Bureau of China (grant 2009HZ088) and by the Research Fund of Shandong Cancer Hospital and Institute (no. 2009 to 11) 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	High
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?	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?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
		Low