Shim 2015.
| Study characteristics | |||
| Patient sampling | Aim of the study: to develop a PET/CT‐based nomogram for predicting incomplete cytoreduction in advanced‐ovarian cancer patients. Type of study: retrospective study. A nomogram predicting incomplete debulking was constructed in a model development cohort (n = 240) and used in the validation cohort (n = 103). Enrolled/eligible: 343/343 Inclusion period: 2006 to 2012 |
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| Patient characteristics and setting | Inclusion criteria: patients between 18 and 80 years with pathologically confirmed ovarian cancer FIGO stage III to IV undergoing cytoreductive surgery Exclusion criteria: patients receiving neoadjuvant chemotherapy, patients with history of other malignancies, and patients treated in another institute Median age (range): 55 years (27 to 80) Setting: Department of Obstetrics and Gynecology, Asan Medical Center, Seoul, Republic of Korea |
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| Index tests | A nomogram including five FDG‐PET/CT features: involvement of diaphragm, small bowel mesentery, presence of ascites, peritoneal carcinomatosis, and tumoral uptake ratio and one non‐imaging related feature (an unvalidated surgical aggressiveness index) | ||
| Target condition and reference standard(s) | Target condition: macroscopic complete debulking Reference standard: primary debulking surgery |
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| Flow and timing | PET/CT was performed within 4 weeks of surgery. Patients undergoing neoadjuvant chemotherapy (due to poor physical condition for surgery or presence of extra‐abdominal disease) were excluded. | ||
| 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 PET/CT | |||
| 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? | Unclear | ||
| 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? | Unclear | ||
| 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 | |||
CEA: carcinoembryonic antigen CT: computed tomography FDG: fluorodeoxyglucose‐18 FIGO: International Federation of Gynaecology and Obstetrics PET: positron emission tomography