Uskul 2009.
Study characteristics | |||
Patient sampling | Retrospective patient series | ||
Patient characteristics and setting | 37 participants, mean age = 59 (SD? = 9) years, 34 males/3 females, Turkey Histology of primary tumour Adenocarcinoma: N = 11; squamous cell, N = 26; comorbidities: not reported Inclusion criteria Participants with NSCLC who underwent TBNA (i.e., who had mediastinal nodes ≥ 10 mm on CT) of mediastinal lymph nodes during fibreoptic bronchoscopy and PET‐CT examination at the authors' institution during a 2‐year period Exclusion criteria None listed Previous tests CT Clinical setting Secondary/tertiary |
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Index tests | PET‐CT scans were performed using a multidetector CT integrated high‐resolution PET‐CT scanner (Siemens Biograph LSO HI‐RES Integrated PET‐CT Scanner; Siemens Medical Solutions, Knoxville, TN, USA) 60 min after an intravenous injection of FDG at a dose of 5 MBq/kg body weight. To minimise insulin activity, participants were required to fast for a minimum of 12 hours prior to FDG administration. The CT component of the procedure was performed without intravenous contrast and with low current (70 mA, 5 mm section thickness), and was only used for the purpose of attenuation correction and assistance in the localisation of the PET images. 2 experienced nuclear medicine physicians, who were blind to the pathology results, evaluated images, and their consensus was classified as either negative (no typical uptake for malignancy, SUV < 2.5) or positive (typical uptake for malignancy, SUV ≥ 2.5) Covariates Type of PET‐CT scanner: Siemens Biograph LSO HI‐RES Integrated PET‐CT Scanner (Siemens Medical Solutions, Knoxville, TN, USA) FDG dose: 5 MBq/kg Injection‐to‐scan time: 60 min Attenuation correction: yes Cut‐off values for test positivity (malignancy): Consensus was from 2 nuclear medicine physicians and classified as either negative (no typical uptake for malignancy, SUV < 2.5) or positive (typical uptake for malignancy, SUV ≥ 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 |
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Target condition and reference standard(s) | Pathological staging (TBNA and surgical resection). All TBNA preparations positive for malignancy were considered true positives; whereas, only those TBNA preparations negative for malignancy that were confirmed by mediastinoscopy/mediastinal lymph node dissection were considered true negatives. All inadequate TBNA samples or adequate negative TBNA samples not confirmed by surgery were considered false negatives. All the TBNA data were examined by the same pathologist who was blinded to the participants' data | ||
Flow and timing | 1/37 included participants did not receive the reference standard; thus, data were only available for 36 participants | ||
Comparative | |||
Notes | There was no mention of funding source, but since this was a retrospective 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? | No | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Unclear | 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? | Unclear | ||
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 | Unclear | ||
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 | ||
Unclear |