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. 2016 Aug 22;2016(8):CD005632. doi: 10.1002/14651858.CD005632.pub3

Albert 1985.

Methods

  • Study design: parallel RCT

  • Time frame: 1983 to 1984

  • Follow‐up period: 13 (2 to 23) months

  • Primary endpoint: not reported
Participants

  • Country: Germany

  • Setting: single centre

  • Inclusion criteria: not reported

  • Number analysed: avoidance group (25); withdrawal group (25)

  • Mean age, range (years): avoidance group (38, 10 to 51); withdrawal group (36, 21 to 54)

  • Sex (female): avoidance group (44%); withdrawal group (32%)

  • Exclusion criteria: not reported
Interventions Avoidance group

  • CsA monotherapy


Withdrawal group

  • Steroid withdrawal 3 to 6 months after transplantation


Baseline immunosuppression

  • CsA

    • Started with 15 mg/kg, divided into two daily doses, adjusted to trough levels 250 to 700 ng/mL

  • Steroids

    • Steroid avoidance group: no steroids

    • Steroid withdrawal group: oral fluocortolone: 0.5 mg/kg, withdrawn 3 to 6 months after transplantation
Outcomes

  • Mortality

  • Graft loss
Notes

  • Did not report the number screened for eligibility or randomised

  • Number of patients discontinued treatment

    • Switched from avoidance group to withdrawal group: 13

    • Switched from withdrawal group to avoidance group: 1

    • 4 patients in avoidance group and 5 patients in withdrawal group switched to AZA and steroids
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Stated 'randomised' but no further information provided
Allocation concealment (selection bias) Unclear risk not reported
Blinding (performance bias and detection bias) 
 All outcomes High risk Open‐label
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcomes are objective hard endpoints
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear whether ITT analysis performed, total number of patients by group analysed not reported, results presented as percentages/rates
Selective reporting (reporting bias) High risk Acute rejection not reported
Other bias Unclear risk Funding sources not reported