Sanli 2009.

Study characteristics
Patient sampling	Prospective consecutive patient series
Patient characteristics and setting	78 participants, mean age = 61.3 (range = 44 to 79) years, 73 males/5 females, Turkey Histology of primary tumour Adenocarcinoma: N = 16; epidermoid carcinoma: N = 41; adenosquamous carcinoma: N = 5; large cell or undifferentiated carcinoma: N = 16: comorbidities: not reported Inclusion criteria Consecutive participants with NSCLC who were potential candidates for surgical resection and were admitted to the thoracic surgery unit of the authors' hospital from March 2006 to June 2008 Exclusion criteria Participants with evidence of metastatic disease, except for those with solitary brain or adrenal metastasis, participants who had not undergone PET‐CT scanning as part of their preoperative evaluation or who had undergone FDG PET scanning in another centre, participants with diabetes mellitus whose blood glucose levels could not be controlled and brought to normal values, and participants receiving neoadjuvant treatment All/Previous tests Complete blood counts and blood chemistry tests, chest radiographs, thoracic CT scans, PET‐CT scans, pulmonary function tests, and if clinically indicated, bone scans and cranial magnetic resonance imaging were performed in all cases Clinical setting Thoracic surgery unit It is unclear if the inclusion criteria narrow 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	Whole‐body PET‐CT scanning was performed with Siemens Biograph 2 PET‐CT system (Siemens, Munich, Germany). A whole‐body acquisition was performed immediately 1 hour after intravenous administration of FDG (11 to 16 mCi), and images were obtained from the vertex to the upper thigh region. High‐quality images were acquired, and semiquantitative measurements of glucose metabolism were obtained. All participants fasted for at least 4 hours before imaging; their fasting blood glucose levels were within the normal range, and none received insulin to return blood glucose to normal levels. The SUVs of hilar lymph nodes and MLNs were determined from the transverse views by the nuclear medicine physician blinded to results of reference tests. Coronal–sagittal images and their correlation with CT scans were used when the exact location was uncertain Regions of interest were drawn on the images, and semiquantitative SUV measurements were defined as the regional tissue radioactivity concentration normalised for injected dose and body weight. There were no details reported about attenuation correction Covariates Type of PET‐CT scanner: Siemens Biograph 2 PET‐CT system (Siemens, Munich, Germany) FDG dose: 11 to 16 mCi Injection‐to‐scan time: 60 min Attenuation correction: not reported Cut‐off values for test positivity (malignancy): Results of PET‐CT scans were considered positive in the mediastinum and hilar area that was separate from the primary mass if the SUV in participants suspected to have lymph node metastases was > 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)	Definitive diagnosis was established based on the histopathologic findings of lymph node sampling in mediastinoscopy or biopsy during the surgical procedure. If a mediastinoscopy was performed, histologic evaluation of the specimens was performed with a frozen section. If N2 disease was present, definitive resection was not performed at that time. These participants received neoadjuvant therapy. Participants with resectable disease on mediastinoscopy underwent further operative procedures. 3 participants underwent transcarinal sleeve pneumonectomy, 16 underwent pneumonectomy (invasion of the left atrium, main pulmonary artery, carina, distal trachea, and proximal main bronchus, with some major fissure invasion), 4 underwent bilobectomy, 2 underwent sleeve lobectomy, and 46 underwent lobectomy. 1 participant was identified as unresectable (M1) during thoracotomy. 6 participants did not undergo thoracotomy because of positive results on mediastinoscopy. 1 participant given a positive diagnosis after mediastinoscopy underwent resection as a result of drainage to the pleural space caused by tumour necrosis and haemoptysis. Multistation nodal mediastinal sampling was performed, with removal of levels 2, 4, 7, 8, and 9 on the right side. For left‐sided tumours, lymph nodes at levels 5 and 6 were dissected also. However, non‐palpable station 2L could not be removed in some participants. Hilar lymph nodes were also dissected. All participants underwent tissue sampling of MLNs to compare sampling results with imaging results
Flow and timing	All participants were accounted for in the results. All participants received the reference standard. There were no uninterpretable results
Comparative
Notes	No details of funding were reported. However, the study was probably not externally funded because although this data collection was prospective, it appears to be collected as part of normal practice 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	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?	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?	No
		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?	Yes
		Low