Skip to main content
. 2018 Oct 8;2018(10):CD012567. doi: 10.1002/14651858.CD012567.pub2

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
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
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
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
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