Hall 2004.
Methods | Randomised controlled trial Trial duration: 7 years and 5 months, from February 1990 to July 1997 Trial location: 14 centres across the United Kingdom |
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Participants | Number of participants: 300 randomised (interferon‐149, control‐151) Inclusion criteria: Patients had histologically proven epithelial ovarian cancer that showed no evidence of disease progression after post‐operative chemotherapy. The percentage of participants with FIGO stage I, II, III and IV ovarian cancer in the interferon group was 7%, 22%, 63% and 15% while in the chemotherapy group was 8%, 13%, 64% and 15% respectively Exclusion criteria: not specified |
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Interventions | Intervention: Interferon‐alpha: INF‐α 2a (Roferon‐A, Roche) (4.5 mega‐units subcutaneously 3 days per week). Interferon was continued until disease progression or in response to toxicity or patient request Control: No maintenance treatment |
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Outcomes |
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Notes | Ethics approval: study was approved by the Local Research Ethics Commitee of each participating centre Informed consent: written informed consent was obtained from patients prior to randomisation Funding: not mentioned Correspondence with authors: g.hall@leeds.ac.uk on date on 3rd July 2012 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described how randomisation was done |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described if participants were blinded to the treatment assigned. Control group did not receive any treatment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described if outcome assessors were blinded to treatment assignment but inlikely to have any effect on the outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat (ITT) analysis was done on all the patients. Eight patients (2 interferon and 6 observation) died without any follow‐up visits). 144 of 149 participants in the interferon group received at least one injection |
Selective reporting (reporting bias) | Unclear risk | Protocol was not available |
Other bias | Low risk | No reason to suspect other bias |