Methods |
For characteristics see Bacon 2011a1
|
Participants |
|
Interventions |
|
Outcomes |
|
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated random sequence |
Allocation concealment (selection bias) |
Low risk |
Allocation of participants through interactive voice‐response system in a 1:2:2 ratio |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
A boceprevir‐matched placebo was used. |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
It was not mentioned if the outcome assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Treatment discontinuation due to AE was 2% to 12%. Seems no other drop‐outs occurred. |
Selective reporting (reporting bias) |
Low risk |
A study protocol was published prior to randomisation (NCT00708500). All pre‐specified outcomes were reported on. |
Vested‐interest bias |
High risk |
Trial was sponsored by a pharmaceutical company (Schering‐Plough/Merck). The company was directly involved in trial design and managing, data analysis, and writing of article. |
Other bias |
Low risk |
Seems there were no other potential sources of bias. |