Study characteristics | |||
Patient sampling | Retrospective study | ||
Patient characteristics and setting | Sample size: 55 patients Mean age: 62 years (range 21‐88) Presentation: Patients with primary ovarian cancer FIGO stage III/IV, no contraindication for surgery or malnutrition, evaluation for PDS Diagnostics before index test: physical/gynaecological examination, CA 125, CT abdomen/pelvis, Thorax x‐ray/CT, routine blood test Kind of surgery: PDS 26; IDS 26: No debulking surgery 3 Setting: Department of gynaecology hospital Tenon, Paris, France. |
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Index tests | Open diagnostic laparoscopy performed by 7 surgeons, 3 gynaecological oncologists, 4 non‐gynaecological surgeons. Frozen section of tumour/metastasis. In case of operability direct cytoreduction by laparotomy Cut‐off test‐positivity: absence of visible residual tumour was considered feasible Complications of index test: 1 trocar metastasis occurred in PDS group (2%) |
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Target condition and reference standard(s) | Target condition: macroscopic residual tumour. Criteria for target condition: extensive peritoneal carcinomatosis/involvement of bowel mesentery/bulky disease diaphragm/unresectable upper abdomen metastases. Reference standard: Laparotomy. Test operators: gynaecological oncologists and general gynaecologists. Percentage of patients in whom reference standard performed: 47% Unresectable disease at laparotomy: 12 |
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Flow and timing | Time between reference standard and Index test: 0 day | ||
Comparative | |||
Notes | Same population as Brun 2008. 52 patients had a diagnostic laparoscopy. 26 of these patients were considered suitable for laparotomy. However 8 had more than 1 cm of residual disease left after laparotomy. The other 26 patients received NACT and interval debulking surgery. Cytoreduction only when absence of visible residual tumour was considered feasible. | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
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? | Unclear | ||
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? | Yes | ||
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? | Unclear | ||
Did patients receive the same reference standard regardless of the index test result? | No | ||