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. 2014 Feb 21;2014(2):CD009786. doi: 10.1002/14651858.CD009786.pub2

Vergote 1998

Study characteristics
Patient sampling Retrospective study design
Patient characteristics and setting Sample size: 77 Diagnostics before index test: radiological examination Mean age: not mentioned Presentation: Patients with obvious metastatic disease of ovarian cancer on radiological examination, planned for PDS Kind of surgery: Primary debulking in 28 patients, IDS 31, 18 no surgery
Setting: Division of Gynaecologic Oncology, University hospital, Brussels, Belgium
Index tests Decision to give NACT of primary debulking with the help of an open laparoscopy
Cut‐off test‐positivity: not reported
Complications of index test: two port site metastases (3%)
Target condition and reference standard(s) Target condition: unresectability leaving more than 0.5 cm of residual tumour
Criteria for target condition: not mentioned
Reference standard: Explorative laparotomy.
Test operators: not reported
Percentage of patients in whom reference standard performed: 36% (28 patients)
Unresectable disease at laparotomy: 21% (6 patients)
Flow and timing Time between ref standard and indextest not mentioned
Comparative  
Notes Decision to give NACT or PDS in all patients with advanced ovarian cancer, subgroup in paper about NACT or PDS retrospectively. 77 patients had a diagnostic laparoscopy. Of these 28 underwent a laparotomy and 21 had resectable disease. 49 patients received NACT and IDS.
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? No
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work‐up? Yes
Were patients planned for primary cytoreductive surgery after conventional diagnostic work‐up? Yes
Low
DOMAIN 2: Index Test Diagnostic open laparoscopy
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? No
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? Yes
Did the study provide a clear definition of what was considered to be a "positive "result for the index test? No
High
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? No
Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes
Were all patients included in the analysis? Yes
Did patients receive the same reference standard regardless of the index test result? No

ASA: American Society of Anesthesiology CA125: cancer antigen 125 CT: computed tomography IDS: interval debulking surgery NACT: neoadjuvant chemotherapy PDS: primary debulking surgery PIV: Predictive Index Value RT: Residual Tumour WHO: World Health Organization