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. 2015 Mar 18;2015(3):CD001533. doi: 10.1002/14651858.CD001533.pub5

Ksiazek 1995.

Methods
  • Study design: parallel RCT

  • Time frame: not reported

  • Follow‐up: two years

Participants
  • Country: Poland

  • Setting: renal clinic

  • Inclusion criteria: children with initial episode SSNS

  • Number: treatment group 1 (72); treatment group 2 (68); treatment group 3 (44)

  • Mean age (range): 3.6 years (13 months to 11 years)

  • Sex (M/F): 113/71

  • Exclusion criteria: not reported

Interventions Treatment group 1 (6 months)
  • Prednisone: 1 to 2 mg/kg/d for 4 weeks, 1 mg/kg on alternate days for 4 weeks and taper by 25% each month for 4 months

  • Total duration: 6 months

  • Total calculated steroid dose 2922 mg/m2


Treatment group 2 (3 months)
  • Prednisone 1 to 2 mg/kg/d for 4 weeks, 1 mg/kg on alternate days for 4 weeks and taper by 25%/week for 4 weeks.

  • Total duration: 3 months

  • Total calculated steroid dose 2410 mg/m2


Treatment group 3 (2 months)
  • Prednisone 4 weeks each of 1 to 2 mg/kg/d and 1 mg/kg on alternate days

  • Total duration: 2 months

Outcomes
  • Number relapsing by 6 months and 2 years after completing daily and alternate‐day prednisone

  • Relapse rate/patient/y

Notes
  • Unequal numbers in groups

  • Only treatment group 2 used in analyses

    • Definitions

    • FRNS: ISKDC definition

    • Relapse: ISKDC definition

    • Remission: ISKDC definition

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomly assigned", insufficient information about sequence generation to permit judgement
Allocation concealment (selection bias) High risk "Parents had an influence on assignment, favouring Protocol C"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding not reported and the outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Blinding of outcome assessment not reported and outcome measurement likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All patients followed for two years
Selective reporting (reporting bias) High risk Not all review's pre‐specified outcomes have been reported.
No data on numbers with FRNS
Other bias Unclear risk Insufficient information to assess whether an important risk of bias exists