Angioli 2005

Study characteristics
Patient sampling	Retro‐ or prospective enrolment not known
Patient characteristics and setting	Sample size: 87 patients Mean age: 58 years (range 19‐79) Presentation: Patients with primary ovarian cancer FIGO Stage IIIC/IV, good nutrition status, WHO < 2, no contraindications for surgery, evaluation for optimal primary debulking surgery (RT = 0) Diagnostics before index test: physical/gynaecological examination, ultrasonography, CA 125, CT abdomen/pelvis, Thorax x‐ray/CT Kind of surgery: PDS 53; IDS 25: No debulking surgery: 9 Setting: Department of gynaecology, University hospital Rome, Italy
Index tests	Open diagnostic laparoscopy; examination of the whole abdominal cavity, biopsies for frozen section, performed by gynaecological oncologist. If judged resectable direct cytoreduction                           Cut‐off test‐positivity: prediction of complete absence of disease after cytoreduction Complications of index test: trocar metastasis 2 cases (6%), intraoperative complication 1 (3%)
Target condition and reference standard(s)	Target condition: possibility of leaving no macroscopic disease at debulking surgery                                  Criteria for target condition: extensive peritoneal carcinomatosis/involvement of bowel mesentery/bulky disease diaphragm/ multiple liver metastases/heavily bleeding tumoral tissue Reference standard: Laparotomy.Test operators: gynaecological oncologist Percentage of patients reference standard performed: 61% Unresectable disease at laparotomy: 2
Flow and timing	Time between reference standard and Index test: 0 day.
Comparative
Notes	87 patients had a laparoscopy, 53 where indicated to be operable. Of these 51 had operable disease at laparotomy and 2 not. The other 34 patients were treated with NACT and 25 received an interval debulking surgery after 3 courses of chemotherapy.
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 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?	No
Did the study provide a clear definition of what was considered to be a "positive "result for the index test?	No
			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?	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