PubMed · 5549819
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F Cole, J W Retan. 1971-04-15. Reporting laboratory tests.. https://pubmed.ncbi.nlm.nih.gov/5549819/
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The purpose of this study was to determine whether an observed difference in hemodialysis adequacy between states in Network 5 was due to variations in patient characteristics and to what extent dialysis center effects played a role in the observed disparity between states. This was a retrospective observational study of 6,969 patients dialyzed at centers in Maryland and Virginia. There were 3,919 patients on hemodialysis at 89 facilities in Virginia and 3,050 subjects dialyzed at 65 centers in Maryland. The mean urea reduction ratio (URR) was higher in Virginia compared with Maryland (68.2 +/- 0.1% v 66.0 +/- 0.2%, P < 0.0001, respectively), and there continued to be a mean difference in URR of 1.8% between VA and MD (P < 0.0001) after adjusting for several covariates. The differences in URR between states varied depending on facility proprietary status, size as measured by number of stations, and relationship to hospital (free-standing or hospital-based). Furthermore, the center where a patient dialyzed, when treated as a fixed effect, accounted for 15% of the variance in URR. The mean difference of 1.8% in URR between states persisted in a mixed-effects model that included all covariates along with adjusting for dialysis centers as a random effect. The disparity in dialysis adequacy between states in Network 5 could not be accounted for by demographic characteristics, case mix factors, or a large center effect observed in the region. Therefore, we conclude that underlying national reports on dialysis adequacy are heterogeneous results related to differences across regions such as states within a given Network. This difference between states is not explained by the strong center effect found on adequacy in this population of hemodialysis patients.
The Hemodialysis (HEMO) Study is a multicenter, prospective, randomized, 2 x 2 factorial clinical trial designed to evaluate the efficacy of the dose of dialysis delivered ("standard" v "high") and dialysis membrane flux ("low" v "high") in reducing the morbidity and mortality of patients. The study is nearly half complete. Although both patients and investigators are blinded to the overall findings, which will not be available for another 3 years, important data have been generated from which a more accurate expression has been derived for the dose of dialysis received by each patient in the trial. This new expression of the effectiveness of dialysis, eKt/V, is a two-pool approximation derived from the traditional single-pool Kt/V (spKt/V) and time on dialysis. The dialysis prescription for the HEMO Study subjects is individualized to achieve the target dose for each patient and is closely monitored by measuring the more accurate and validated expression of eKt/N. Comparisons of the HEMO Study dose of dialysis with other studies have been confused by this unique expression (eKt/V) of the dialysis dose and adequacy adopted for the HEMO Study. The target eKt/V dose in the "standard" arm of the Study is 1.05 and in the "high" arm is 1.45 per dialysis thrice weekly. Based on data available from 426 subjects randomized to each arm, the target of 1.05 in the "standard" dose of the HEMO Study is equivalent to an spKt/V of 1.32, and that of the "high" dose, 1.67. Thus, volunteers in the "standard" arm of the Study are receiving a tightly controlled and closely monitored dose, which is above the current national mean spKt/V, and above that of the accepted minimum standard spKt/N of 1.2. When completed, the HEMO Study will show whether there are merits of a tightly controlled hemodialysis dose that is consistently delivered over a prolonged period and whether a high dose is beneficial and safe to prescribe.
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