Czepczynski 2011.
| Study characteristics | |||
| Patient sampling | Patient series | ||
| Patient characteristics and setting | 51 participants, median age = not reported (range = 39 to 73 years), numbers of males/females not reported, Poland Histology of primary tumour Not reported; comorbidities: not reported Inclusion criteria Participants with newly diagnosed stage I to IIIa NSCLC who were treated with surgery at the authors' institutions in 2008 to 2009 Exclusion criteria None listed Previous/all reported tests Not reported Clinical setting Secondary/tertiary setting The inclusion of only participants who received surgery narrows the range of patients who would receive PET‐CT in practice, namely, patients (clinically) with suspected resectable non‐small cell lung cancer, a proportion of whom would have N2 or N3 disease already on PET‐CT |
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| Index tests |
Covariates Type of PET‐CT scanner: Discovery ST PET‐CT scanner (GE) FDG dose: 5 MBq/kg Injection‐to‐scan time: 50 to 70 min Attenuation correction: not reported Cut‐off values for test positivity (malignancy): not reported |
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| Target condition and reference standard(s) | Histopathology after anatomical resection of the lung tumour and the mediastinal lymph nodes ≤ 6 weeks after the PET‐CT | ||
| Flow and timing | 51/440 participants with NSCLC who had PET‐CT scans in 2008 to 2009 "were qualified to the study" | ||
| Comparative | |||
| Notes | Author sent test accuracy data on request. As the study was only published as an abstract, we contacted the author (on 5 November 2012) to request the following information: How was the sample recruited? ‐ Did the study population consist of a consecutive sample? ‐ Was the recruitment prospective or retrospective? Characteristics of the 51 participants: ‐ Median age = () years ‐ (number of males) males/(number of females) females ‐ Histology of primary tumour? () ‐ Comorbidities: () ‐ Inclusion criteria? ‐ Exclusion criteria? ‐ Previous/all reported tests? Clinical setting: ‐ Thoracic surgery unit? ‐ Were any participants excluded from the analyses? PET‐CT scanning: ‐ 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 results? Pathological staging ‐ Was the pathological staging results interpreted without knowledge of the PET‐CT results? 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 | High | ||
| 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? | No | ||
| Was a positive result defined? | No | ||
| Unclear | Unclear | ||
| 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? | Yes | ||
| Did all patients receive the same reference standard? | Yes | ||
| Were all patients included in the analysis? | Unclear | ||
| Unclear | |||