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International audience; Outcomes reported in randomized controlled trials in peritoneal dialysis (PD) are diverse, are measured inconsistently, and may not be important to patients, families, and clinicians. The Standardized Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD) initiative aims to establish a core outcome set for trials in PD based on the shared priorities of all stakeholders. We convened an international SONG-PD stakeholder consensus workshop in May 2018 in Vancouver, Canada. Nineteen patients/caregivers and 51 health professionals attended. Participants discussed core outcome domains and implementation in trials in PD. Four themes relating to the formation of core outcome domains were identified: life participation as a main goal of PD, impact of fatigue, empowerment for preparation and planning, and separation of contributing factors from core factors. Considerations for implementation were identified: standardizing patient-reported outcomes, requiring a validated and feasible measure, simplicity of binary outcomes, responsiveness to interventions, and using positive terminology. All stakeholders supported inclusion of PD-related infection, cardiovascular disease, mortality, technique survival, and life participation as the core outcome domains for PD.

It is unknown to what degree physicians adjust erythropoietin doses to achieve hemoglobin levels (11.0 to 12.0 g/dL [110 to 120 g/L]) recommended by the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) for patients with end-stage renal disease receiving hemodialysis. Our objective is to examine epoetin alfa prescribing patterns for achieving the target hemoglobin level range in this population.Monthly hemoglobin levels and epoetin alfa doses from 2 large databases were retrospectively analyzed. One data set comprised 31,267 patients from the Fresenius Medical Care-North America (FMC-NA) database, and the other comprised 128,761 patients based on claims for Medicare services.Longitudinal evaluation of the FMC-NA data set showed that hemoglobin levels in patients administered epoetin alfa cycled in and out of the NKF-K/DOQI hemoglobin target range, and doses were decreased in 98.8% of patients with persistent hemoglobin levels greater than 12.0 g/dL (120 g/L). Hemoglobin levels in patients from the Medicare data set that initially were outside the target range migrated into the range with epoetin alfa dose titration. FMC-NA patients with a 3-month average hemoglobin level less than 11.0 g/dL (110 g/L) were administered significantly greater epoetin alfa doses than those with average hemoglobin levels greater than 12.0 g/dL (120 g/L; 21,838 versus 13,503 U/wk; P0.0001). Less than 0.4% of patients administered epoetin alfa were persistently anemic (hemoglobin11.0 g/dL [110 g/L]) and were administered persistently high doses (30,000 U/wk), but failed to respond with a 0.5-g/dL or greater (or = 5-g/L) increase in hemoglobin levels.In these analyses, few hemodialysis patients experienced persistent anemia while being administered high epoetin alfa doses. Physicians appeared to appropriately adjust doses to achieve hemoglobin levels recommended by the NKF-K/DOQI guidelines.

EFFECT OF MAINTENANCE IRON PROTOCOLS ON ESA DOSING AND ANEMIA OUTCOMES Mahesh Krishnan; Joe Weldon; Steve Wilson; Irina Goyhkman; David Van Wyck; DaVita Inc., Denver, CO, USA Although intravenous (IV) iron was initially for use as a bolus, over half of the hemodialysis population receives IV iron for maintenance dosing. We determined the association between various maintenance iron protocols and anemia management outcomes by constructing a facility level analysis for maintenance iron use. IV iron sucrose dosing patterns were assessed in facilities with ≥10 prevalent (≤90 days) patients in 01/10. Facilities were categorized to a dosing pattern if >40% of patients received the same dose [25 mg 1x/wk (n=234), 50 mg 1x/wk (n=180) or 100 mg 1x/wk (n=285)]. Medication and laboratory values were then summarized across all patients in those clinics in each category. Reported lab values lagged by one month to allow for the effect of iron dosing patterns from the previous month. The anemia management outcomes are listed by pattern (Table). Median ESA dose was significantly lower in facilities dosing 100 mg than 25 mg/wk (P = 0.002). Hb levels did not differ. Dosing Pattern/ wk Median ESA Dose (U/month) Mean Iron Dose (mg/month) TSAT (%) mean±SD Ferritin (ng/ml) mean±SD 25 mg reference reference 30.0 ± 13.0 531 ± 320 50 mg -1,100 +66 30.6 ± 13.4 606 ± 352 100 mg -2,200 +123 32.4 ± 15.1 728 ± 429 This retrospective analysis suggests that monthly ESA requirements to maintain target hemoglobin may be lower with larger doses of maintenance iron. More detailed analyses and prospective studies are indicated to explore this possibility.

Summary Background and objectives Numerous studies have shown the overall benefits of dialysis filter reuse, including superior biocompatibility and decreased nonbiodegradable medical waste generation, without increased risk of mortality. A recent study reported that dialyzer reprocessing was associated with decreased patient survival; however, it did not control for sources of potential confounding. We sought to determine the effect of dialyzer reprocessing with peracetic acid on patient mortality using contemporary outcomes data and rigorous analytical techniques. Design, setting, participants, & measurements We conducted a series of analyses of hemodialysis patients examining the effects of reuse on mortality using three techniques to control for potential confounding: instrumental variables, propensity-score matching, and time-dependent survival analysis. Results In the instrumental variables analysis, patients at high reuse centers had 16.2 versus 15.9 deaths/100 patient-years in nonreuse centers. In the propensity-score matched analysis, patients with reuse had a lower death rate per 100 patient-years than those without reuse (15.2 versus 15.5). The risk ratios for the time-dependent survival analyses were 0.993 (per percent of sessions with reuse) and 0.995 (per unit of last reuse), respectively. Over the study period, 13.8 million dialyzers were saved, representing 10,000 metric tons of medical waste. Conclusions Despite the large sample size, powered to detect miniscule effects, neither the instrumental variables nor propensity-matched analyses were statistically significant. The time-dependent survival analysis showed a protective effect of reuse. These data are consistent with the preponderance of evidence showing reuse limits medical waste generation without negatively affecting clinical outcomes. Clin J Am Soc Nephrol 6: 1368–1374, 2011. doi: 10.2215/CJN.10391110