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. 2017 Jan 11;2017(1):CD004759. doi: 10.1002/14651858.CD004759.pub2

Shield 1993.

Methods
  • Study design: parallel RCT

  • Study duration: June 1986 to January 1991

  • Study follow‐up: 3 years

Participants
  • Country: USA

  • Setting: single centre

  • Inclusion criteria: DD kidney transplant recipients

  • Number: treatment group (99); control group (31)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Exclusion criteria: possessed anti‐mouse Ab; refused the drug

Interventions Treatment group
  • OKT3: 5 mg IV bolus given in operating theatre after induction and intubation; no further information provided


Control
  • No OKT3


Immunosuppression (both groups)
  • MP: dose not reported

  • AZA: dose not reported

  • No patient received CSA within 36 h of the transplant

Outcomes
  • Death

  • Graft loss

  • DGF

Notes
  • Records of all kidney transplant recipients analysed: 31 patients LD (no OKT3); all DD transplant recipients received OKT3 intra‐op unless they were ‘randomised’ to non‐OKT3 arm (may not be truly randomised)

  • Authors made decision to include with sensitivity analysis

  • DD only used for our comparisons

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Limited information but no reason for severe imbalance in LD vs DD patients and unequal numbers in intervention and treatment groups. Likely selection bias; possibly post‐hoc report of unpublished RCT
Allocation concealment (selection bias) High risk As above
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Unlikely to influence outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Unlikely to influence outcomes
Incomplete outcome data (attrition bias) 
 All outcomes High risk Percentages given but no actual numbers for survival and no causes of patient or graft loss
Selective reporting (reporting bias) High risk Acute rejection not reported
Other bias Unclear risk Insufficient information to permit judgement and funding not declared