Iskender 2012.

Study characteristics
Patient sampling	Prospective? consecutive patient series
Patient characteristics and setting	286 participants, mean age = 58.5 (SD = 9.3, range = 33 to 81) years, 262 males/24 females, Turkey Histology of primary tumour Adenocarcinoma: N = 90; squamous cell carcinoma: N = 158; large cell: N = 5; adenosquamous carcinoma: N = 4; carcinosarcoma: N = 3; spindle cell carcinoma: N = 1; NSCLC NOS: N = 25; comorbidities: not reported Inclusion criteria From September 2005 to March 2009, consecutive participants with NSCLC histology were imaged with PET‐CT within 90 days before mediastinoscopy, thoracotomy, or both Exclusion criteria Neoadjuvant chemotherapy (N = 22), previous history of NSCLC (N = 9), or other malignancies within 5 years (N = 11) and clinical stage IV Previous/all tests None reported Clinical setting Department of Thoracic Surgery
Index tests	PET/CT images were obtained at 10 different centres, all of which used multidetector CT‐integrated PET scanners. 225 participants were imaged at 4 different imaging centres that used the same detector (Siemens Biograph LSO HI‐RES PET/CT; Siemens AG, Erlangen, Germany). All integrated PET‐CTs were performed with participants fasting for at least 6 hours, and the blood glucose level was below 8.3 mmol/l before FDG injection. Whole‐body scans were obtained 60 min after intravenous injection of 10 to 20 mCi FDG. For PET‐CT imaging, simultaneously acquired CT data were used to correct attenuation. Scans from centres other than those using the Siemens PET‐CT scanner were also eligible. Nuclear medicine physicians experienced in interpreting PET‐scans visually evaluated images acquired to detect mediastinal metastasis. In the visual evaluation, FDG uptake was considered to be positive in the evaluation of mediastinal lymph nodes if tracer activity was significantly higher than mediastinal background activity. The SUVmax for all primary tumours and positive lymph nodes was provided. A PET‐CT scan was interpreted as positive if the SUVmax of mediastinal lymph nodes exceeded 2.5 Covariates Type of PET‐CT scanner: Biograph LSO HI‐RES (Siemens AG, Erlangen, Germany) FDG dose: 10 to 20 mCi Injection‐to‐scan time: 60 min Attenuation correction: yes Cut‐off values for test positivity (malignancy): maximum SUV > 2.5
Target condition and reference standard(s)	Mediastinal lymph node staging was completed in all participants by means of standard cervical mediastinoscopy, extended cervical mediastinoscopy, thoracotomy, or a combination of the aforementioned. Participants with negative mediastinoscopy underwent resection and systematic lymph node sampling. Participants with positive mediastinoscopy were referred to the oncology clinic for neoadjuvant or definitive treatment
Flow and timing	All participants were accounted for. The mean time interval between PET‐CT and surgical staging was 16.3 (SD = 11.5, range = 2 to 90) days
Comparative
Notes	No details of funding were reported. The authors declared no conflicts of interest 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?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
		Low