Julian 1993.
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 | Computer‐generated 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. Reporting of adverse events may have been influenced by knowledge of treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | This is a preliminary report ‐ only 3 patients had completed the full 2 year study; 24 remain in the study and 21 of these have completed at least 6 months and 16 have completed 12 months |
Selective reporting (reporting bias) | High risk | There was no pre‐specified protocol identified for this study. The study did not report extractable data for the key outcomes that would be expected for a study of this type (e.g., death (any cause), GFR loss, infection) |
Other bias | Unclear risk | Insufficient information to permit judgement. Methods of randomisation, baseline characteristics were not reported to assess quality of randomisation |