TY - JOUR
T1 - The incident patient cohort study design with uncontrolled dose
T2 - Substantial over-estimation of mortality as a function of peritoneal dialysis dose?
AU - Gotch, Frank A.
AU - Gentile, Dominick E.
AU - Keen, Marcia L.
AU - Amerling, Richard
AU - Folkert, Vaughn W.
AU - Kliger, Alan S.
AU - Shapiro, Warren B.
PY - 1996
Y1 - 1996
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0030250880&partnerID=8YFLogxK
U2 - 10.1097/00002480-199609000-00039
DO - 10.1097/00002480-199609000-00039
M3 - Review article
C2 - 8944932
AN - SCOPUS:0030250880
SN - 1058-2916
VL - 42
SP - M514-M517
JO - ASAIO Journal
JF - ASAIO Journal
IS - 5
ER -