Forstner 1995.
Study characteristics | |||
Patient sampling | Aim of the study: to evaluate ovarian cancer staging and tumour resectability with abdominal CT or MRI Type of study: prospective study Enrolled/eligible: 128 were enrolled of whom 82 underwent abdominal CT or MRI. 50/82 patients underwent MRI and were included in our analysis. Inclusion period: 1990 to 1994 |
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Patient characteristics and setting | Inclusion criteria: patients suspected of ovarian cancer scheduled for surgical staging Exclusion criteria: after inclusion, patients with neoadjuvant chemotherapy, benign disease, other intra‐abdominal malignancies, or those who had undergone surgery more than one month after MRI were excluded from the statistical analysis (n = 46) Mean age (range): 52 years (17 to 82) Setting: Department of Gynecologic Oncology, University of California School of Medicine, San Francisco, America |
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Index tests | MRI and/or abdominal CT. Patients undergoing MRI (with or without abdominal CT) were included in our analysis. Criteria to consider primary debulking unfeasible: tumour larger than 2 cm at root of mesentery, porta hepatis, omentum of lesser sac, intersegmental fissure of the liver, gastrosplenic ligament, diaphragm, dome of liver, enlarged lymph nodes around coeliac axis, and presacral extraperitoneal disease |
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Target condition and reference standard(s) | Target condition: debulking with residual disease < 2 cm Reference standard: primary debulking surgery |
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Flow and timing | MRI was performed within four weeks of surgery. All patients received debulking surgery. | ||
Comparative | |||
Notes | Patient scheduling was based on a variety of factors, including scheduling availability, preference of referring physician, and contraindications to abdominal CT or MRI. Also, there was a change in study design. From the initial 128 recruited patients, 82 patients underwent surgery and imaging and formed the study population. |
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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 diagnosed by conventional diagnostic work‐up for advanced stage cancer? | Yes | ||
Were the patients planned for primary debulking surgery after conventional diagnostic work‐up? | Unclear | ||
High | Unclear | ||
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? | Unclear | ||
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 | ||
Unclear | 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? | Unclear | ||
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? | Unclear | ||
Low | Unclear | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Did all patients receive the same reference standard? | No | ||
Were all patients included in the analysis? | No | ||
Were withdrawals from the study reported? | Yes | ||
High |