Lai 1987.
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) | High risk | Computer generated. However, "All patients were given a number in the trial based on their order of entry" |
Allocation concealment (selection bias) | High risk | All patients were given a number in the trial based on their order of entry, which determined their allocation to the treatment or placebo group |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Initially blinded however "We decided to reduce the dose of cyclosporin by 20% if plasma creatinine concentration exceeded 25% of the baseline value or the plasma cyclosporin trough concentration (concentration measured 12 hours after administration) reached 150 µg/l (evaluated by radioimmunoassay with a Sandoz kit). Similarly we decided to increase the dose of cyclosporin by 20% if the plasma cyclosporin trough concentration fell below 45 µg/l." |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported. The patients were interviewed by telephone weekly about any side effects. Interpretation of subjective outcomes may have been influenced by knowledge of treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Outcomes were reported for 9 participants in cyclosporin group and 10 participants in placebo group. However, in a secondary publication, there were 11 participants allocated to each treatment group |
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, malignancy) |
Other bias | High risk | Imbalance in baseline characteristics (age, plasma creatinine, urinary protein) |