Mannel 2011.
Study characteristics | ||
Methods | RCT | |
Participants | 542 women with early stage of epithelial ovarian cancer. stage ⅠA or B grade 3 or clear cell subtype, or any stage IC, or stage II disease. Mean age was 55.1 years old in maintenance chemotherapy group and 56 in observation group Mean follow‐up time was 6.7 years |
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Interventions | Weekly paclitaxel 40 mg/m² × 24 weeks versus observation | |
Outcomes | OS, PFS | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "treatment was randomly assigned through the GOG Statistical and Data Center prior to receiving any chemotherapy." Comment: Probably done |
Allocation concealment (selection bias) | Low risk | Quote: "The treatment assignment was not revealed until after the patient was successfully registered onto the study" Comment: Probably done |
Blinding (performance bias and detection bias) All outcomes | Low risk | No blinding, but the outcome and the outcome measurement are not likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "18 patients randomized to the additional 24 weeks of paclitaxel withdrew during the follow‐up,14 patients of the control group withdrew during the follow‐up." Comment: It is balanced between the two groups |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
Other bias | Low risk | The study appears to be free of other sources of bias |