Pelletier 2013.

Methods	Trial design: randomised, single‐centre, open‐label clinical trial Mean follow‐up: 2095 days ± 117 Study duration: 7 years, randomisation from June 2002 to May 2005 Language: English Type of information: journal article Judgement on quality: high risk
Participants	Setting: Section of Transplant Surgery, University of Michigan, Michigan, USA Allocation of participants: 100 participants, 50 allocated to Intervention A, 50 allocated to Intervention B Sex ratio: total: 76 (76%) males, 24 (24%) females Intervention A: 38 (76%) males, 12 (24%) females Intervention B: 38 (76%) males, 12 (24%) females Mean age: total: not reported Intervention A: 54 ± 1 Intervention B: 56 ± 1 Indication (no. (%)): (some patients reported as having multiple indications) HCV cirrhosis: total: 54 (54%), Intervention A: 31 (62%), Intervention B: 23 (46%) Alcoholic cirrhosis: total: 42 (42%), Intervention A: 19 (38%), Intervention B: 23 (46%) Hepatocellular carcinoma: total: 20 (20%), Intervention A: 9 (18%), Intervention B: 11 (22%) Primary biliary cirrhosis or primary sclerosing cholangitis: total: 6 (6%), Intervention A: 1 (2%), Intervention B: 5 (10%) Cryptogenic cirrhosis: total: 15 (15%), Intervention A: 8 (16%), Intervention B: 7 (14%) Type of donor: not reported Inclusion criteria: all consecutive, consenting participants undergoing liver transplantation at the University of Michigan between June 2002 and May 2005 Exclusion criteria: participants aged < 18 years, multiple organ recipients and participants who required post‐transplant steroid therapy for an indication other than prevention of rejection, such as autoimmune hepatitis or inflammatory bowel disease Other: BMI (kg/m2): total: not reported, Intervention A: 30 ± 1, Intervention B: 29 ± 1 Pretransplant antihypertensive: total: 73 (73%), Intervention A: 36 (72%), Intervention B: 37 (74%) Pretransplant diabetes mellitus: total: 32 (32%), Intervention A: 20 (40%), Intervention B: 12 (24%) Pretransplant coronary artery disease: total: 8 (8%), Intervention A: 5 (10%), Intervention B: 3 (6%) Pretransplant haemodialysis: total: 4 (4%), Intervention A: 3 (6%), Intervention B: 1 (2%) MELD score: total: not reported, Intervention A: 16 ± 1, Intervention B: 18 ± 1 Warm ischaemia time (minutes): total: not reported, Intervention A: 64 ± 7, Intervention B: 54 ± 3 Cold ischaemia time (minutes): total: not reported, Intervention A: 518 ± 34, Intervention B: 518 ± 24 Donor age: total: Intervention A: 38 ± 3, Intervention B: 37 ± 2 Donor sex ratio: total: 68 (68%) males, 32 (32%) females; Intervention A: 31 (62%) males, 19 (38%) females; Intervention B: 37 (74%) males, 13 (26%) females Donor ethnicity: total: 80 (80%) white, 20 (20%) non‐white; Intervention A: 39 (78%) white, 11 (22%) non‐white; Intervention B: 41 (82%) white, 9 (18%) non‐white Donor death from stroke: total: 50 (50%), Intervention A: 25 (50%), Intervention B: 25 (50%) Donor CMV positive: total: 67 (67%), Intervention A: 35 (70%), Intervention B: 32 (64%)
Interventions	Intervention A: no intervention Intervention B: Dexamethasone: 50 mg intraoperatively Prednisone: 3‐ to 6‐month taper (dose not reported) Concomitant immunosuppression: Tacrolimus: started within 24 hours aiming for trough levels of 10 ng/mL to 15 ng/mL for days 0 to 30, 8 ng//mL to 12 ng/mL days 31 to 60, 4 ng/mL to 8 ng/mL from day 61 (tacrolimus withheld until day 4 in patients who received basiliximab induction) MMF: dose and timings not reported Basiliximab: intraoperatively and day 4 (dose not reported) given to 12 (24%) patients receiving Intervention A and 13 (26%) patients receiving Intervention B
Outcomes	Mortality, graft loss, acute rejection, time to first rejection, chronic rejection, recurrent hepatitis C, primary non‐function, hepatic artery thrombosis, hepatic vein or IVC stenosis, biliary complications, postoperative acute renal failure, postoperative chronic renal failure, duration of high dependency stay, reoperation for bleeding, retransplantation, infections, surgical site infection, pneumonia, urinary tract infection, septicaemia, peritonitis, BMI, cholesterol, HDL, LDL, triglycerides, creatinine, diabetes mellitus, hypertension
Notes	Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: Astellas Pharma Inc.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: Generation of randomisation sequence not described
Allocation concealment (selection bias)	Low risk	Quote from the publication: "Enrolledcandidateswererandomizedtoeither the ‘steroids’ or ‘no‐steroids’ groups using a closed‐envelope system." Comment: Study used "closed envelope system"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote from the publication: "All consecutive, consenting candidates undergoing liver transplantation at the University of Michigan between June 2002 and May 2005 were enrolled into a prospective, open‐label, randomized controlled trial (RCT) to evaluate the effects of complete steroids avoidance." Comment: Blinding of participants and medical staff not performed
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote from the publication: "All consecutive, consenting candidates undergoing liver transplantation at the University of Michigan between June 2002 and May 2005 were enrolled into a prospective, open‐label, randomized controlled trial (RCT) to evaluate the effects of complete steroids avoidance." Comment: Blinding of outcome assessors not performed
Incomplete outcome data (attrition bias)	Unclear risk	Comment: 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	High risk	Quote from the publication: "This study was supported by a grant from Astellas Pharma, Inc., Deerfield, IL, USA." Comment: No sample size calculation reported, study is industry sponsored
Free of early stopping?	Low risk	Comment: Study not stopped early
Free of baseline imbalance?	Low risk	Quote from the publication: "Donor and recipient characteristics are summarized in Table 1. The two groups of recipients were well matched with respect to gender, age, race, cause of liver failure, comorbidities, Model of End‐stage Liver Disease (MELD) score, renal function and ischaemic times." Comment: Study is free from baseline imbalance