Espada 2013.
Study characteristics | |||
Patient sampling | Aim of the study: to analyse the diagnostic accuracy of diffusion‐weighted MRI for predicting suboptimal cytoreductive surgery Type of study: prospective study Enrolled/eligible: 36/34 Inclusion period: 2006 to 2012 |
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Patient characteristics and setting | Inclusion criteria: patients undergoing surgery for suspected ovarian carcinoma Exclusion criteria: none Mean age (SD): 53 years (11) Setting: Gynaecology Department, Hospital Universitario Quiron, Madrid, Spain |
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Index tests | Pelvic and abdominal diffusion‐weighted MRI Criteria to consider primary debulking unfeasible: involvement of stomach, lesser sac, liver, small bowel mesentery, splenic hilium, para‐aortic lymph nodes above level of renal vessels |
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Target condition and reference standard(s) | Target condition: optimal debulking with residual disease of maximal 1 cm in diameter Reference standard: primary debulking surgery |
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Flow and timing | MRI was performed within 15 days of surgery. All patients received debulking surgery. 34 out of 36 patients had ovarian cancer and were eligible for analysis. |
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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? | Unclear | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Were the patients diagnosed by conventional diagnostic work‐up for advanced stage cancer? | Unclear | ||
Were the patients planned for primary debulking surgery after conventional diagnostic work‐up? | Yes | ||
Unclear | 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? | Yes | ||
Were the same clinical data available when test results were interpreted as would be available when the test is used in clinical practice? | No | ||
Did the study provide a clear definition of what was considered to be a ’positive’ result for the index test? | Yes | ||
Low | 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? | 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? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Were withdrawals from the study reported? | Yes | ||
Low |