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. 2016 Mar 1;2016(3):CD010360. doi: 10.1002/14651858.CD010360.pub2

Cross 2012.

Study characteristics
Patient sampling Design: Prospective diagnostic test accuracy
 Setting: UK
 Accrual dates: Jan 2000 to Dec 2010
 No participants: 1445
 No assessed: 1439
 Inclusion criteria: Women with possible ovarian malignancy were included. Women with obvious disseminated malignancy (FIGO stage III/IV) were excluded.
 Included previous histological diagnosis: yes, 6 cases
Patient characteristics and setting Women with possible ovarian malignancy were included. Women with obvious disseminated malignancy (FIGO stage III/IV) were excluded.Tertiary centre, UK.
Index tests Two pieces of tissue taken for FS staining and reporting by consultant pathologist. Report was then phoned through to surgeon who used the info to determine the extent of surgery.
Target condition and reference standard(s) Malignant or borderline on PS.
Flow and timing FS before PS.
Comparative  
Notes Women with borderline and malignant diagnosis underwent surgical staging.
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Was the sample representative of patients in practice (90% stage I/II with RMI>200)? Yes    
    Low Low
DOMAIN 2: Index Test All tests
Were the index tests interpreted without knowledge of the reference standard? Yes    
Were the index tests Interpreted by consultant or specialist gyn‐onc pathologist? 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    
    Unclear Low
DOMAIN 4: Flow and Timing
Did all patients receive a reference standard? Yes    
Did all patients receive the same reference standard? Yes    
Were un‐interpretable/intermediate test results reported? Yes    
Were withdrawals from the study explained? Yes    
    Low