Pozzi 1999.
Methods |
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Participants |
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Interventions | Treatment group
Control group
Co‐interventions
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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) | Low risk | Centralised table of random numbers |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding of outcome assessment not specifically reported. Key outcomes were objective laboratory measures and were unlikely to be affected by any knowledge of treatment allocation. However, reporting of adverse events may have been influenced by knowledge of treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | All patients in the steroid group completed the 6 months of therapy; high dropout in both groups after this period |
Selective reporting (reporting bias) | Low risk | Data for outcomes such as death (any cause), and infection were not reported. All other outcomes that would be expected for this type of study were reported |
Other bias | High risk | Four patients in the control group received steroids as rescue therapy |