A03 Mineo.
Methods | RCT: 1988 to 1994 | |
Participants | 66 patients Stage IB |
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Interventions | surgery vs surgery + chemotherapy 6 cycles of chemotherapy cisplatin 100 mg/m2etoposide 120 mg/m2 Complete resection |
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Outcomes | Overall survival 5 year recurrence‐free survival Recurrence rates Cause of death |
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Notes | 140 patients in trial, only 66 reported at time of data collection, therefore only 66 patients included | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Data checks on IPD provided suggest adequate sequence generation |
Allocation concealment (selection bias) | Low risk | Central computer randomisation |
Selective reporting (reporting bias) | Low risk | IPD supplied for outcomes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Trial not blinded due to nature of intervention, outcome not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Trial not blinded due to nature of intervention, primary outcome not likely to be influenced by lack of blinding |