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 |
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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 |
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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 |
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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 |