Methods |
For characteristics see Poordad 2011a1
|
Participants |
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Interventions |
|
Outcomes |
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated random code |
Allocation concealment (selection bias) |
Low risk |
Allocation concealment was done through interactive voice‐response system |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
In the trial's protocol it is described that placebo would be matched to boceprevir and would be given in the same manner |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
It was not mentioned if the outcome assessors were blinded, or the extent of blinding was insufficiently described |
Incomplete outcome data (attrition bias) All outcomes |
High risk |
49/1099 (4.5%) participants discontinued the peg‐IFN+RBV therapy during the lead‐in period. No specific reasons were given. Due to futility at week 24 another 108, 33, and 36 participants in groups 1, 2, and 3, respectively, discontinued treatment. In total 226/1099(20,5%) of participants discontinued treatment. No other drop‐outs were stated |
Selective reporting (reporting bias) |
Low risk |
A protocol was published before randomisation began and all outcome results were reported adequately |
Vested‐interest bias |
High risk |
The sponsor (Merck) was directly involved in trial's design, managing, analyses, as well as, writing, decision of submission for publication, reviewing and drafting the manuscript |
Other bias |
Low risk |
The trial appeared to be free of other bias domains that could put it at risk of bias |