Belli 2001.
| Methods | Trial design: randomised, single‐centre clinical trial Mean follow‐up: not reported Intervention A: 22 months Intervention B: 21 months Study duration: randomisation from November 1997 to November 1999, duration from randomisation not reported Language: English Type of information: journal article Judgement on quality: high risk of bias |
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| Participants | Setting: Ospedale Niguarda Ca' Granda, Milan, Italy Allocation of participants: 24 participants, 13 allocated to glucocorticosteroids, 11 allocated to no intervention Sex ratio: total: not reported Intervention A: not reported Intervention B: not reported Mean age: total: not reported Intervention A: not reported Intervention B: not reported Indication (no. (%)): HCV cirrhosis: total: 24 (100%), Intervention A: 13 (100%), Intervention B: 11 (100%) Type of donor: not reported Inclusion criteria: adult liver transplant recipients with HCV cirrhosis Exclusion criteria: not reported |
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| Interventions | Intervention A: no intervention Intervention B: glucocorticosteroids for 3 months, doses not reported Concomitant immunosuppression: Rabbit antithymocyte globulin: dose not reported, given for 5 days Azathioprine: dose not reported, given for 1 month Cyclosporine A: dose not reported |
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| Outcomes | Acute rejection, chronic rejection, recurrent hepatitis C, severe cholestasis, ALT, mortality, portal vein thrombosis | |
| Notes | Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: not reported One intervention group was excluded from the meta‐analysis as differences between hepatitis C virus prophylaxis (ribavirin) were noted Although the overall data for mortality and portal vein thrombosis have been reported, the exact number of participants in each group with these outcomes is not reported, therefore these results are not included in the meta‐analysis but are included in the best‐worst worst‐best analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote from the publication: "Between November 1997 and November 1999 37 patients (pts) were randomized to one of three groups: ..." Comment: Generation of randomisation sequence not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: Allocation concealment not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Blinding of participants and medical staff not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment:Blinding of outcome assessors not described |
| Incomplete outcome data (attrition bias) | High risk | Quote from the publication: "Of these 37 pts, only 30 were considered in the analysis. Seven pts were excluded because of early death after transplant (6 pts) or because of concurrent confounding clinical problems (1 pt with portal vein thrombosis)." Comment: Mortality and portal vein thrombosis not reported fully. As this is a three‐arm trial it is not possible to accurately record data on mortality within each group as the trial does not report which arm of the trial the portal vein thrombosis occurred in and which arms of the trial each mortality occurred in. Therefore, the outcomes have not been included in the meta‐analysis but have been included in the best‐worst worst‐best analyses. Otherwise, number of withdrawals and reasons for withdrawal not reported |
| Selective reporting (reporting bias) | Low risk | Comment: All outcomes appear to be fully reported |
| Other bias | Unclear risk | Comment: No sample size calculation reported |
| Free of early stopping? | Low risk | Comment: Study not stopped early |
| Free of baseline imbalance? | Unclear risk | Comment: Baseline characteristics not reported |