Subedi 2009.
Study characteristics | |||
Patient sampling | Retrospective consecutive patient series | ||
Patient characteristics and setting | 161 participants, mean age = 70.2 (range = 37 to 89) years, 85 males/76 females, UK Histology of primary tumour Not reported; comorbidities: not reported Inclusion criteria Participants with known or suspected primary bronchogenic carcinoma who underwent half‐body FDG PET–CT from 1 April 2006 to 31 March 2007 Exclusion criteria None listed Previous tests Chest radiograph, CT scan of the thorax and upper abdomen, fibreoptic bronchoscopy, or image‐guided transthoracic fine‐needle biopsy Clinical setting Secondary |
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Index tests | A standard dose of 375 MBq of ‐FDG was administered intravenously. PET and CT images were acquired from skull base to
upper thigh after an uptake period of 60 min on either a Discovery ST or STE PET–CT camera (GE Healthcare, Milwalkee, WI, USA). The CT component of the PET–CT was performed according to a standardised protocol with the following settings: 140 kV; 80 mA; tube rotation time, 0.5 s per rotation; pitch, 6; section thickness, 3.75 mm (to match the PET section thickness). Participants maintained normal shallow respiration during the CT acquisition. No iodinated contrast material was administered. PET–CT was regarded as negative if there was no or very low metabolic activity (below mediastinal blood pool activity) within lesions. A maximum standardised uptake value (SUV) of 2.5 was used as an arbitrary cut‐off Covariates Type of PET‐CT scanner: integrated PET‐CT scanner (Discovery ST; GE Medical systems) FDG dose: 375 MBq Injection‐to‐scan time: 60 min Attenuation correction: not reported Cut‐off values for test positivity (malignancy): SUVmax of 2.5 |
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Target condition and reference standard(s) | Pathological staging: 47 underwent complete lymphadenectomy, 22 underwent systematic lymph node sampling, and 4 had no nodal tissue present in their histopathological specimen | ||
Flow and timing | Only data from 91/161 included participants were presented. It appears that the remainder did not receive pathological confirmation of their test result | ||
Comparative | |||
Notes | There was no mention of funding source, but since this was a retrospective database study, it is likely that the study received no explicit funding Adverse events: not 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? | Unclear | ||
Was there a pre‐specified cut‐off value? | Yes | ||
Was a positive result defined? | Yes | ||
Unclear | 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? | Unclear | ||
Did all patients receive the same reference standard? | Unclear | ||
Were all patients included in the analysis? | No | ||
High |