The incident patient cohort study design with uncontrolled dose

Substantial over-estimation of mortality as a function of peritoneal dialysis dose?

Frank A. Gotch, Dominick E. Gentile, Marcia L. Keen, Richard Amerling, Vaughn Wesley Folkert, Alan S. Kliger, Warren B. Shapiro

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Abstract

In the Canada-USA (CANUSA) Study, the dialysis dose was neither randomized nor held constant, was measured at 6 month intervals, and the relative risk of mortality (R) was found to correlate linearly to mean values of weekly peritoneal plus renal urea clearance normalized to volume, (KprT/V)m, ranging from 1.5 to 2.3. A risk/dose (R/D) function was derived for continuous ambulatory peritoneal dialysis from kinetic criteria for dose equivalency in hemodialysis (HD) and peritoneal dialysis (PD) and the HD R/D function. This PD R/D function was nonlinear with breakpoint from steep to shallow slope at (KprT/V)ud = 2.00, where ud refers to uniform single doses in contrast to mean doses with wide variances on the mean. The predicted decrease in renal urea clearance KrT/V per 6 months of CANUSA follow-up was computed from serial measured KrT/V in the Randomized Dialysis Prescription and Clinical Outcomes Study and showed it to be 0.21 ± 0.34. The CANUSA (KprT/V)m values were corrected for the distributed values of 3 month decrements in KrT/V, and the population mortality risk at each (KprT/V)m dose level reported in CANUSA was computed from summation of the product of the R/D curve and fractional distribution of (KprT/V)ud values. From these calculations, the authors conclude that maximum (KprT/V)ud level achieved in CANUSA was 2.00, and the study does not define R/D response above this level.

Original languageEnglish (US)
JournalASAIO Journal
Volume42
Issue number5
StatePublished - Sep 1996

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Dialysis
Peritoneal Dialysis
Cohort Studies
Canada
Mortality
Renal Dialysis
Urea
Kidney
Continuous Ambulatory Peritoneal Dialysis
Prescriptions
Outcome Assessment (Health Care)
Kinetics

ASJC Scopus subject areas

  • Biophysics
  • Bioengineering

Cite this

The incident patient cohort study design with uncontrolled dose : Substantial over-estimation of mortality as a function of peritoneal dialysis dose? / Gotch, Frank A.; Gentile, Dominick E.; Keen, Marcia L.; Amerling, Richard; Folkert, Vaughn Wesley; Kliger, Alan S.; Shapiro, Warren B.

In: ASAIO Journal, Vol. 42, No. 5, 09.1996.

Research output: Contribution to journalArticle

Gotch, Frank A. ; Gentile, Dominick E. ; Keen, Marcia L. ; Amerling, Richard ; Folkert, Vaughn Wesley ; Kliger, Alan S. ; Shapiro, Warren B. / The incident patient cohort study design with uncontrolled dose : Substantial over-estimation of mortality as a function of peritoneal dialysis dose?. In: ASAIO Journal. 1996 ; Vol. 42, No. 5.
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