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. 2020 Oct 29;2020(10):CD001892. doi: 10.1002/14651858.CD001892.pub5

Rosman 1 1984.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: January 1982 to January 1984

  • Follow up: 153/248 followed up for at least 36 months

Participants
  • Country: Netherlands

  • Setting: single centre

  • Patients with CKD with CrCl 30 to 60 mL/min/1.73 m2; aged 15 to 73 years

  • Number: low protein diet group (74); normal protein diet group (77)

  • Mean age (range): 48 years (15 to 73)

  • Sex M/F ratio: 0.54

  • Exclusion criteria: immunological diseases or cancer; patients on NSAIDs

Interventions Low protein diet group (group B)
  • Prescribed protein diet: 0.6 g protein/kg/day

  • Calculated protein intake: not available (graphical only)


Normal protein diet groups (Groups A1, A2)
  • Prescribed protein diet: free diet

  • Calculated protein intake: not available (graphical only)


Co‐interventions
  • Antihypertensive medications; sodium restriction; vitamin supplement; phosphate binders

Outcomes
  • GFR decline measured by slope of reciprocal SCr (1/SCr) over time

  • Number with ESKD

  • Number of deaths

  • Weight

Notes
  • Updated report (1989) from previous paper (Lancet 1984; ii:1291‐1296)

  • Eight participants received a kidney transplant in the low protein diet group and four in the control group and were counted as kidney death events

  • Urea excretion given graphically only

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk Not blinded and lack of blinding may influence patient management
Blinding of outcome assessment (detection bias): End or change in GFR
End of change in GFR Low risk End point of CrCl is a laboratory outcome and unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias): Need to start dialysis
Need to start dialysis Low risk Need to start dialysis determined by CrCl < 4 mL/min/1.73 m2
Also included in analysis of ESKD were participants who received pre‐emptive transplants
Incomplete outcome data (attrition bias)
All outcomes Low risk 4% (10/248) excluded from analysis (lost to follow‐up 9, withdrawn 1)
Selective reporting (reporting bias) Low risk Reported ESKD, GFR, death and weight but weight and GFR data not able to be included in meta‐analyses
Other bias Unclear risk Insufficient information to permit judgement