Ohnishi 2011.

Study characteristics
Patient sampling	Prospective consecutive patient series
Patient characteristics and setting	120 participants, median age = 69 (range = 40 to 85) years, 79 males/41 females, Japan Histology of primary tumour (only available for 84/120 participants) Adenocarcinoma: N = 47; squamous cell: N = 19; adenosquamous cell carcinoma: N = 2; bronchioalveolar carcinoma: N = 5; large cell carcinoma: N = 2; mucoepidermoid carcinoma: N = 1; large cell neuroendocrine carcinoma: N = 3; benign: N = 5 (sarcoidosis: N = 1, atypical adenomatous hyperplasia: N = 2, intrapulmonary lymph node: N = 1, pulmonary tuberculosis: N = 1); comorbidities: diabetes (N = 8); no others reported Inclusion criteria Participants with newly diagnosed or suspected lung cancer based on CT findings whose clinical TNM stage was < T4, any N and M0 based on CT. All participants with potentially resectable lung cancer were included; therefore, both participants with and without swollen mediastinal lymph nodes regardless of location were included Exclusion criteria Participants with poor medical conditions of grades 4 and 5 according to the American Society of Anesthesiologists Physical status classification system and participants with bleeding tendency and coagulopathy Previous tests None reported apart from chest and upper abdominal CT Clinical setting Secondary/tertiary care
Index tests	PET‐CT was performed using a Discovery ST Elite Performance scanner (GE Healthcare, Tokyo, Japan) with whole‐body attenuation. After participants had fasted for 4 hours and their blood glucose levels had been confirmed to be < 200 mg/dl, they were injected with an intravenous dose of 190 to 300 MBq FDG. The emission study commenced 50 min later. FDG uptake in the mediastinum was first examined based on visual interpretation. Lymph nodes with significantly higher accumulation of FDG than surrounding mediastinum levels were identified, and a SUV > 3 was judged to be positive Covariates Type of PET‐CT scanner: Discovery ST Elite Performance scanner (GE Healthcare, Tokyo, Japan) FDG dose: 190 to 300 MBq Injection‐to‐scan time: 50 min Attenuation correction: yes Cut‐off values for test positivity (malignancy): SUV > 3 was judged to be positive
Target condition and reference standard(s)	Pathological results from surgery, EBUS‐TBNA, and EUS‐FNA
Flow and timing	Data only available from 110/120 participants
Comparative
Notes	No details of funding were reported, but the authors report that they had no competing interests Adverse events: none 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?	Yes
		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
		High