Alessi 2016.
Study characteristics | |||
Patient sampling | Aim of the study: to investigate the role of PET(‐CT) in characterisation of ovarian masses and identification of critical areas of tumour spread affecting results of debulking surgery Type of study: prospective study Enrolled/eligible: 29/23 Inclusion period: 2013 to 2014 |
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Patient characteristics and setting | Inclusion criteria: elevated serum CA125 and ultrasound detection of suspected ovarian malignancies Exclusion criteria: blood glucose levels > 140 mg/dL Mean age (range): 62 years (21 to 82) Setting: Gynaecologic Oncology Unit, Fondazione IRCCS Instituto Nazionale dei Tumori, Milan, Italy |
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Index tests | Whole body FDG‐PET/CT Criteria to consider primary debulking unfeasible: involvement of porta hepatis, diffuse deep infiltration of root mesentery, diffuse carcinomatosis requiring complete colectomy or more than 4 bowel resections or total gastrectomy, deep infiltration of pancreas and duodenum, multiple liver metastases |
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Target condition and reference standard(s) | Target condition: debulking with no macroscopically visible tumour remaining after surgery Reference standard: all patients underwent explorative laparotomy and, where surgery was considered feasible, patients had primary debulking |
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Flow and timing | PET/CT was performed within 20 days of surgery. All patients received debulking surgery. 23 out of 29 patients were diagnosed with ovarian cancer and were eligible for analysis. |
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Comparative | |||
Notes | Four patients had stage IC disease, 14 stage IIIC and three stage IV so it seems that two patients were missing in the stage description (n = 23). | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Did the study avoid inappropriate exclusions? | Yes | ||
Were the patients diagnosed by conventional diagnostic work‐up for advanced stage cancer? | Yes | ||
Were the patients planned for primary debulking surgery after conventional diagnostic work‐up? | Yes | ||
Low | Low | ||
DOMAIN 2: Index Test PET/CT | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
If a threshold was used, was it pre‐specified? | Yes | ||
Did the whole sample, or a random selection of the sample, receive verification using a reference standard of diagnosis? | Yes | ||
Did patients receive the same reference standard regardless of the index test result? | Yes | ||
Were the same clinical data available when test results were interpreted as would be available when the test is used in clinical practice? | Yes | ||
Did the study provide a clear definition of what was considered to be a ’positive’ result for the index test? | 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? | Unclear | ||
Is the surgeon's expertise adequate to perform the reference standard? | Unclear | ||
Did the study provide a clear definition of what was considered to be a ’positive’ result for the reference standard? | Yes | ||
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? | Yes | ||
Were withdrawals from the study reported? | Yes | ||
Low |