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. 2018 Oct 8;2018(10):CD012567. doi: 10.1002/14651858.CD012567.pub2

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
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
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
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
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.
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