Horsmans 2008.
Methods | Study design: multi‐centre, controlled randomised trial comparing three groups. ITT analysis: performed. |
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Participants | Country: Belgium. Total number (sample size): 258 (initially 336, but 78 had not commenced treatment). Age, years (STD) : 45, 46, and 45. Sex (male, number): 63, 62, and 36. Genotype: one, two, and three. Previous HCV treatment: naive. Inclusion criteria: chronic hepatitis C diagnosed by the following.
Exclusion criteria.
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Interventions | Group 1 (n = 101).
Group 2 (n = 98).
Group 3 (n = 59).
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Outcomes | End of treatment response; sustained virological response; adverse events. | |
Notes | Inconsistency in the figures across the study report is evident: total number (sample size): 258 (initially 336, but 78 had not commenced treatment). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comments: Method of sequence generation is not mentioned. Randomisation process is not well described. |
Allocation concealment (selection bias) | Unclear risk | Comments: The allocation concealment process is not mentioned. |
Blinding (performance bias and detection bias) All outcomes | High risk | Coments: open‐label trial. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 78 participants had not commenced treatment; it is not clear whether the trial adhered to the intention‐to‐treat analysis. |
Selective reporting (reporting bias) | Low risk | Comment: All clinically relevant and reasonably expected outcomes were reported. |
Other bias | Unclear risk | All medication was provided by Schering‐Plough. |