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 |
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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%) |
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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) |
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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