Heiss 2010.
Methods | Randomised controlled open‐label phase II/III trial | |
Participants | 258 patients with malignant ascites due to epithelial cancer (ovarian cancer n = 129) | |
Interventions | Intraperitoneal trifunctional antibody (EpCAM) + paracentesis vs paracentesis | |
Outcomes | Survival (puncture‐free survival/overall survival) Immune responses (HAMA) Adverse events |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information about the sequence generation process insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Allocation concealment (selection bias) | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Incomplete outcome data (attrition bias) All outcomes | High risk | Reason for missing outcome data likely to be related to true outcome, with imbalance in numbers or reasons for missing data across intervention groups |
Selective reporting (reporting bias) | Unclear risk | Information insufficient to permit judgement of ‘low risk’ or ‘high risk’ |
Other bias | Low risk | No other sources of bias detected |