Michielsen 2017.
Study characteristics | |||
Patient sampling | Aim of the study: to evaluate whole body DW‐MRI for diagnosis, staging, and operability assessment of patients suspected for ovarian cancer compared to abdominal CT Type of study: prospective study Enrolled/eligible: 167/94 Inclusion period: 2010 to 2013 |
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Patient characteristics and setting | Inclusion criteria: ‐ suspicion of ovarian cancer by clinical assessment, serum CA‐125, carcinoembryonic antigen (CEA) and gynaecological ultrasound, and ‐ staging by abdominal CT Exclusion criteria: contraindication for MRI Median age (range): 61 years (14 to 88) Setting: Department of Obstetrics and Gynaecology, University Hospitals, Leuven, Belgium |
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Index tests | Whole body diffusion‐weighted MRI Criteria to consider primary debulking unfeasible: extra‐abdominal distant metastasis, hepatic metastases, tumour infiltration of duodenum, stomach, pancreas, large vessels of coeliac trunk, hepatoduodenal ligament, metastases behind the portal vein, bowel involvement necessitating multiple bowel resections, deep tumoural involvement of superior mesenteric artery and root, retroperitoneal lymph node metastases above level of renal veins |
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Target condition and reference standard(s) | Target condition: debulking with no macroscopically visible tumour remaining after surgery Reference standard: explorative laparotomy, diagnostic laparoscopy or image‐guided biopsy of surgical‐critical distant lesions |
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Flow and timing | No information was provided about the time period between the index test and reference standard. All patients received (primary or interval) debulking surgery except for 4 patients who were medically unfit to undergo surgery. In patients where surgery was considered unfeasible, diagnostic laparoscopy was used as a reference standard to confirm irresectability. | ||
Comparative | |||
Notes | |||
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 diagnosed by conventional diagnostic work‐up for advanced stage cancer? | Yes | ||
Were the patients planned for primary debulking surgery after conventional diagnostic work‐up? | Yes | ||
Low | Low | ||
DOMAIN 2: Index Test MRI | |||
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? | Yes | ||
Did the whole sample, or a random selection of the sample, receive verification using a reference standard of diagnosis? | Yes | ||
Did patients receive the same reference standard regardless of the index test result? | No | ||
Were the same clinical data available when test results were interpreted as would be available when the test is used in clinical practice? | Yes | ||
Did the study provide a clear definition of what was considered to be a ’positive’ result for the index test? | 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? | Yes | ||
Is the surgeon's expertise adequate to perform the reference standard? | Yes | ||
Did the study provide a clear definition of what was considered to be a ’positive’ result for the reference standard? | Yes | ||
Low | Low | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Did all patients receive the same reference standard? | No | ||
Were all patients included in the analysis? | Yes | ||
Were withdrawals from the study reported? | Yes | ||
Unclear |