Lee 2011.
Study characteristics | |||
Patient sampling | Retrospective patient series | ||
Patient characteristics and setting | 54 participants, median age = 66 (range = 45 to 83) years, 48 males/6 females, South Korea Histology of primary tumour Not reported. Comorbidities: diabetes: N = 7; hypertension: N = 15; chronic renal failure: N = 1; gastric ulcer or early gastric cancer: N = 4; chronic obstructive pulmonary disease: N = 2; history of tuberculosis: N = 14; stage IA to IIB: N = 36; stage IIIA: N = 10; stage IIIB: N = 4; other cancer metastasis to the lung: N = 4 Inclusion criteria Participants who had undergone both chest CT and FDG PET‐CT before surgical resection with at least ipsilateral 4‐ and 7‐lymph node dissection for the treatment of primary or metastatic lung cancer between January 2004 and December 2006 at the Seoul National University Hospital, and who had radiographic TB sequelae ipsilateral to the resected lung in the form of fibrotic bands, small calcified nodules, or bronchiectasis in the upper lobes observed on chest CT preoperatively Exclusion criteria None listed Previous/all tests None listed apart form CT Clinical setting Tertiary referral hospital |
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Index tests | On CT, mediastinal lymph node enlargement (i.e., positive) was defined as the presence of lymph nodes larger than 1 cm in their smallest diameter Covariates Type of PET‐CT scanner: not reported FDG dose: not reported Injection‐to‐scan time: not reported Attenuation correction: not reported Cut‐off values for test positivity (malignancy): On FDG PET‐CT, mediastinal nodes with increased glucose uptake satisfying both qualitative (greater than that of the surrounding tissue) and quantitative (a maximum standardised uptake value (SUV) adjusted for participant body weight of ≥ 3.0 with a distinct margin) criteria were considered positive |
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Target condition and reference standard(s) | Pathologic findings in resected specimens | ||
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 the data are retrospective and apparently collected as part of normal practice Population of TB participants 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 | High | ||
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 | ||
Unclear | 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 | ||
Unclear |