Ozkan 2011.
Study characteristics | |||
Patient sampling | Retrospective patient series | ||
Patient characteristics and setting | 153 NSCLC participants, mean age = 61.4 (SD = 9.97) years, 135 males/18 females, Turkey Histology of primary tumour Not reported; comorbidities: not reported Inclusion criteria Not reported Exclusion criteria Not reported Previous tests Not reported Clinical setting Secondary/tertiary care |
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Index tests | FDG‐PET‐CT 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): not reported |
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Target condition and reference standard(s) | Histopathology or clinical follow‐up decisions and the results of other imaging tests | ||
Flow and timing | If the whole sample only consisted of the 153 participants reported in the abstract, all participants were included in the analysis | ||
Comparative | |||
Notes | Author sent test accuracy data on request. As the study was only published as an abstract, we contacted the author (on 3 December 2012) to request the following information. How was the sample recruited? ‐ Did the study population consist of a consecutive sample? Characteristics of the 153 participants: ‐ Histology of primary tumour? ‐ Comorbidities? ‐ NSCLC stage? ‐ Inclusion criteria? ‐ Exclusion criteria? ‐ Previous/all reported tests? ‐ Clinical setting Thoracic surgery unit? ‐ Were any participants excluded from the analyses? PET‐CT scanning: ‐ What type of PET‐CT scanner was used? ‐ What FDG dose was used? ‐ What was the injection‐to‐scan time? ‐ Did you use attenuation correction? ‐ What was the criteria for a positive result? ‐ Did you use a prespecified cut‐off value for test positivity? ‐ Was the PET‐CT results interpreted without knowledge of the pathological/follow‐up results? Pathological staging: You state in the abstract that PET/CT results were confirmed histopathologically or according to clinical follow‐up decisions and the results of other imaging tests. ‐ How many participants received histopathological confirmation, and how many participants received non‐histopathological confirmation and why (including, what did their confirmation consist of instead)? ‐ Was the pathological staging results interpreted without knowledge of the PET‐CT results? Flow and timing: ‐ What was the interval between PET‐CT and histopathological/other confirmation of the PET‐CT results? ‐ Were there any adverse events of the PET‐CT? Funding ‐ Was the study funded and if yes, by whom? We received no response 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? | Unclear | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Unclear | Unclear | ||
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? | Unclear | ||
Was a positive result defined? | No | ||
Unclear | Unclear | ||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Unclear | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
Unclear | 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? | No | ||
Were all patients included in the analysis? | Yes | ||
Unclear |