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. 2018 Oct 4;2018(10):CD001892. doi: 10.1002/14651858.CD001892.pub4

Rosman Study 2 1984.

Methods
  • Study design: parallel RCT

  • Study duration: January 1982 to January 1984

  • Study follow‐up period: 153 of 248 followed up for at least 36 months

Participants
  • Country: Netherlands

  • Setting: single centre

  • CKD with CrCl 10 to 30 mL/min/1.73 m2

  • Number: very low protein diet (56); normal protein diet group (41)

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

  • Sex M/F ratio: 0.54

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

Interventions Very low protein diet group (Group C)
  • Prescribed protein intake: 0.4 g protein/kg/d

  • Calculated protein intake: not reported (graphical only)


Normal protein diet group (Group A2)
  • Prescribed protein intake: free diet

  • Calculated protein intake: not reported (graphical only)


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

Outcomes
  • GFR 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 renal transplant in the low protein diet group and four in the control group and were counted as renal death event

  • Data from total of 248 participants included in review

  • 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 All outcomes Low risk 4% (10/248) excluded from analysis (lost to follow up 9, withdrawn 1)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