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. 2013 Jun 29;2013(6):CD007414. doi: 10.1002/14651858.CD007414.pub3

Nicoletto 2004.

Study characteristics
Methods RCT
Participants 122 women with epithelial ovarian cancer achieved PCR
Stage 1c, 2b, 2c, 3 and 4
Mean age was 55 years old
Median follow‐up time was not reported
Interventions 5‐Fu + cisplatin versus observation
Outcomes 3‐year OS and 3‐year PFS; toxic events
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…at time of randomization"
Comment: Probably done
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
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: "one patient refused treatment entirely after randomization and is therefore not evaluable"
Comment: For OS and PFS, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate.
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