Alberts 2006.
Methods | Randomised controlled trial Trial duration: 11 years, from March 1988 to June 1999 Trial location: USA ‐ 66 participants from South West Oncology Group (SWOG) and 4 from Gynecologic Oncology Group (GOG) |
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Participants | Number of participants: 70 randomised (35 treatment group, 35 observation alone) Inclusion criteria:
Exclusion criteria: not specified |
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Interventions | Intervention: Alpha‐interferon (IFNα‐26, Schering‐Plough Kenilworth, NJ) in weekly doses of 50x106 IU (for 6 doses) Control: observation alone |
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Outcomes |
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Notes | Ethics approval: the trial received local institutional review board (IRB) review and approval according to institutional guidelines Informed consent: IRB approved consent forms were signed by the patients Funding: source of funding/conflict of interest not declared Correspondence with authors: dalberts@azcc.arizona.edu on the 3rd July 2012 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | It is reported that patients were randomised but the method of randomisation is not described |
Allocation concealment (selection bias) | Unclear risk | Not reported on |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported on. Control group was merely observed |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up was minimal and similar in both groups (3/35 intervention, 0/35 control) |
Selective reporting (reporting bias) | Unclear risk | Protocol was not obtained |
Other bias | Unclear risk | Trial stopped early due to poor accrual of patients |