Hermite 2012.
Methods |
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Participants |
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Interventions | Treatment group
Control group
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Outcomes |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study was described as randomised, method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | This was an open‐label trial; but "as far as possible, the nurses and physicians in the unit in charge of the routine care were blinded to each patient’s treatment." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes were evaluated by an independent clinical event committee who were blinded to participants’ treatment group assignments. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Selective reporting (reporting bias) | Low risk | Describes the outcome according to protocol |
Other bias | Low risk | Study appears free of other biases |