International Comparisons to Assess Effects of Payment and Regulatory Changes in the United States on Anemia Practice in Patients on Hemodialysis: The Dialysis Outcomes and Practice Patterns Study.
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SUBMITTER: Fuller DS
PROVIDER: S-EPMC4926983 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and objectives: Peritoneal dialysis (PD) for ESKD is associated with similar mortality, higher quality of life, and lower costs compared with hemodialysis (HD), but has historically been underused. We assessed the effect of the 2011 Medicare prospective payment system (PPS) for dialysis on PD initiation, modality switches, and stable PD use.Design, setting, participants, & measurements: Using US Renal Data System and Medicare data, we identified all United States patients with ESKD initiating dialysis before (2006-2010) and after (2011-2013) PPS implementation, and observed their modality for up to 2 years after dialysis initiation. Using logistic regression models, we examined the associations between PPS and early PD experience (any PD 1-90 days after initiation), late PD use (any PD 91-730 days after initiation), and modality switches (PD-to-HD or HD-to-PD 91-730 days after initiation). We adjusted for patient, dialysis facility, and regional characteristics.Results: Overall, 619,126 patients with incident ESKD received dialysis at Medicare-certified facilities, 2006-2013. Observed early PD experience increased from 9.4% before PPS to 12.6% after PPS. Observed late PD use increased from 12.1% to 16.1%. In adjusted analyses, PPS was associated with increased early PD experience (odds ratio [OR], 1.51; 95% confidence interval [95% CI], 1.47 to 1.55; P<0.001) and late PD use (OR, 1.47; 95% CI, 1.45 to 1.50; P<0.001). In subgroup analyses, late PD use increased in part due to an increase in HD-to-PD switches among those without early PD experience (OR, 1.59; 95% CI, 1.52 to 1.66; P<0.001) and a decrease in PD-to-HD switches among those with early PD experience (OR, 0.92; 95% CI, 0.87 to 0.98; P=0.004).Conclusions: More patients started, stayed on, and switched to PD after dialysis payment reform. This occurred without a substantial increase in transfers to HD.
| S-EPMC6895485 | biostudies-literature
Project description:BackgroundAnemia at hemodialysis (HD) initiation is common. Correcting low hemoglobin (Hgb) before HD initiation may improve survival by avoiding potential harms of chronic anemia, high doses of erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron in the early HD period, and/or rapid Hgb rise.MethodsWe included 4604 incident HD patients from 21 countries in the Dialysis Outcomes and Practice Patterns Study Phases 4-5 (2009-15). Because low Hgb at HD start may reflect comorbidity or ESA hyporesponse, we restricted our analysis to the 80% of patients who achieved Hgb ≥10 g/dL 91-120 days after HD start (Month 4).ResultsAbout 53% of these patients had Hgb <10 g/dL in Month 1 (<30 days after HD start); they were younger with a similar comorbidity profile (versus Hgb ≥10 g/dL). Month 1 Hgb was associated with first-year HD mortality (adjusted hazard ratio for 1 g/dL higher Hgb was 0.89; 95% confidence interval: 0.81-0.97), despite minimal differences in Month 4 Hgb. Patients with lower Hgb in Month 1 received higher doses of ESA, but not IV iron, over the first 3 months of HD. Results were consistent when excluding catheter users or adjusting for IV iron and ESA dose over the first 3 months.ConclusionsEven among patients with Hgb ≥10 g/dL 3 months later, anemia at HD initiation was common and associated with elevated mortality. A more proactive approach to anemia management in advanced chronic kidney disease (CKD) may thus improve survival on HD, though long-term prospective studies of non-dialysis CKD patients are needed.
| S-EPMC7367115 | biostudies-literature
Project description:Background and objectivesWe investigated whether the recent growth in home dialysis use was proportional among all racial/ethnic groups and also whether there were changes in racial/ethnic differences in home dialysis outcomes.Design, setting, participants, & measurementsThis observational cohort study of US Renal Data System patients initiating dialysis from 2005 to 2013 used logistic regression to estimate racial/ethnic differences in home dialysis initiation over time, and used competing risk models to assess temporal changes in racial/ethnic differences in home dialysis outcomes, specifically: (1) transfer to in-center hemodialysis (HD), (2) mortality, and (3) transplantation.ResultsOf the 523,526 patients initiating dialysis from 2005 to 2013, 55% were white, 28% black, 13% Hispanic, and 4% Asian. In the earliest era (2005-2007), 8.0% of white patients initiated dialysis with home modalities, as did a similar proportion of Asians (9.2%; adjusted odds ratio [aOR], 0.95; 95% confidence interval [95% CI], 0.86 to 1.05), whereas lower proportions of black [5.2%; aOR, 0.71; 95% CI, 0.66 to 0.76] and Hispanic (5.7%; aOR, 0.83; 95% CI, 0.86 to 0.93) patients did so. Over time, home dialysis use increased in all groups and racial/ethnic differences decreased (2011-2013: 10.6% of whites, 8.3% of blacks [aOR, 0.81; 95% CI, 0.77 to 0.85], 9.6% of Hispanics [aOR, 0.94; 95% CI, 0.86 to 1.00], 14.2% of Asians [aOR, 1.04; 95% CI, 0.86 to 1.12]). Compared with white patients, the risk of transferring to in-center HD was higher in blacks, similar in Hispanics, and lower in Asians; these differences remained stable over time. The mortality rate was lower for minority patients than for white patients; this difference increased over time. Transplantation rates were lower for blacks and similar for Hispanics and Asians; over time, the difference in transplantation rates between blacks and Hispanics versus whites increased.ConclusionsFrom 2005 to 2013, as home dialysis use increased, racial/ethnic differences in initiating home dialysis narrowed, without worsening rates of death or transfer to in-center HD in minority patients, as compared with white patients.
| S-EPMC6682814 | biostudies-literature
Project description:Rationale & objectiveTransitions between dialysis modalities can be disruptive to care. Our goals were to evaluate rates of transition from peritoneal dialysis (PD) to in-center hemodialysis (HD), mortality, and transplantation among incident PD patients in the US Renal Data System from 1996 to 2015 and identify factors associated with these outcomes.Study designObservational registry-based retrospective cohort study.Setting & participantsMedicare patients incident to end-stage renal disease (ESRD) from January 1, 1996, through December 31, 2011 (for adjusted analyses; through December 31, 2014, for unadjusted analyses), and treated with PD 1 or more days within 180 days of ESRD incidence (n = 173,533 for adjusted analyses; n = 219,787 for unadjusted analyses).Exposure & predictorsExposure: 1 or more days of PD. Predictors: patient- and facility-level characteristics obtained from Centers for Medicare & Medicaid Services Form 2728 and other data sources.OutcomesPatients were followed up for 3 years until transition to in-center HD, death, or transplantation.Analytical approachMultivariable Cox regression was used to estimate hazards over time and associations with predictors.ResultsCompared with earlier cohorts, recent incident PD patient cohorts had lower rates of death (48% decline) and transition to in-center HD (13% decline). Among many other findings, we found that: (1) rates of transition to in-center HD and death were lowest in the 2008 to 2011 cohort, (2) longer time receiving PD was associated with higher mortality risk but lower risk for transition to in-center HD, and (3) larger PD programs (≥25 vs ≤6 patients) displayed lower risks for death and transition to in-center HD.LimitationsData collected on Form 2728 are only at the time of ESRD incidence and do not provide information at the time of transition to in-center HD, death, or transplantation.ConclusionsRates of transition from PD to in-center HD and death rates for PD patients decreased over time and were lowest in PD programs with 25 or more patients. Implications of the observed improved technique survival warrant further investigation, focusing on modifiable factors of center-level performance to create opportunities for improved patient outcomes.
| S-EPMC7568078 | biostudies-literature
Project description:Serum albumin level predicts mortality in dialysis patients and is used to assess their health status and the quality of delivered care. Whether the threshold level of serum albumin at which mortality risk increases in peritoneal dialysis (PD) patients is the same as for hemodialysis (HD) patients has not been studied.Observational cohort study of dialysis patients undertaken to determine the survival-predictability of serum albumin level in PD patients and compare it with that in HD patients.130,052 dialysis patients (PD, 12,171; HD, 117,851) who received treatment in any of the 580 dialysis units owned by DaVita Inc between July 1, 2001, through June 30, 2006, followed up through June 30, 2007.Baseline and time-averaged serum albumin level (assayed using bromcresol green) and change in serum albumin level over 6 months.All-cause, cardiovascular, and infection-related mortality.PD patients with baseline serum albumin level <3.0 g/dL had a more than 3-fold higher adjusted risk of all-cause and cardiovascular mortality and 3.4-fold higher risk of infection-related mortality (reference group: serum albumin, 4.00-4.19 g/dL). Adjusted all-cause mortality was significantly lower in PD patients with a ?0.3-g/dL increase in serum albumin level over 6 months and significantly higher in those for whom it decreased by ?0.2 g/dL (reference group: serum albumin change, +0.1 to -0.1 g/dL). A significant increase in death risk was evident for HD patients with serum albumin level <4.0 g/dL, but at <3.8 g/dL for PD patients. For each albumin category, overall death risk for PD patients was lower than for HD patients (reference group: HD patients with serum albumin of 4.00-4.19 g/dL).Study can identify associations only without attribution of causality and residual confounding cannot be excluded.Serum albumin predicts all-cause, cardiovascular, and infection-related mortality in both PD and HD patients. However, the threshold at which risk of death increases varies by dialysis modality, and this difference should be considered by agencies or organizations that set quality standards.
| S-EPMC3159826 | biostudies-literature
Project description:BackgroundThe objective of the study was to examine overall anemia management trends in non-dialysis patients with chronic kidney disease (CKD) from 2006 to 2015, and to evaluate the impact of Trial to Reduced Cardiovascular Events with Ananesp Therapy (TREAT)'s study results (October 2009) and the US Food and Drug Administration (FDA)'s (June 2011) safety warnings and guidelines on the use of ESA therapy in the current treatment of anemia.MethodsA retrospective cohort analysis of anemia management in CKD patients using Truven MarketScan Commercial and Medicare Supplemental databases was conducted. Monthly rates and types of anemia treatment for post-TREAT and post-FDA safety warning periods were compared to pre-TREAT period. Anemia management included ESA, intravenous iron, and blood transfusion. A time-series analysis using Autoregressive Integrated Moving Average (ARIMA) model and a Generalized Estimating Equation (GEE) model were used.ResultsBetween 2006 and 2015, CKD patients were increasingly less likely to be treated with ESAs, more likely to receive intravenous iron supplementation, and blood transfusions. The adjusted probabilities of prescribing ESAs were 31% (odds ratio (OR) = 0.69, 95% confidence interval (CI): 0.67-0.71) and 59% (OR = 0.41, 95% CI: 0.40, 0.42) lower in the post-TREAT and post-FDA warning periods compared to pre-TREAT period. The probability of prescribing intravenous iron was increased in the post-FDA warning period (OR = 1.11, 95% CI: 1.03-1.19) although the increase was not statistically significant in the post-TREAT period (OR = 1.03, 95% CI: 0.94-1.12). The probabilities of prescribing blood transfusion during the post-TREAT and post-FDA warning periods increased by 14% (OR = 1.14, 95% CI: 1.06-1.23) and 31% (OR = 1.31, 95% CI: 1.22-1.39), respectively. Similar trends of prescribing ESAs and iron supplementations were observed in commercially insured CKD patients but the use of blood transfusions did not increase.ConclusionsAfter the 2011 FDA safety warnings, the use of ESA continued to decrease while the use of iron supplementation continued to increase. The use of blood transfusions increased significantly in Medicare patients while it remained stable in commercially insured patients. Results suggest the TREAT publication had effected treatment of anemia prior to the FDA warning but the FDA warning solidified TREAT's recommendations for anemia treatment for non- dialysis dependent CKD patients.
| S-EPMC6230235 | biostudies-literature
Project description:BackgroundThere are no guidelines for transitioning patients from chronic kidney disease stage 5 to hemodialysis. We conducted this study to determine if there are uniform patterns in how nephrologists transition patients to dialysis.MethodsWe designed an electronic survey with 39 questions and sent it to a database of practicing nephrologists at the National Kidney Foundation. Factors that were important for transitioning a patient to hemodialysis were evaluated, including medication changes on dialysis initiation, dry weight and dialysis prescription.Results160 US Nephrologists replied to the survey; 18% (29/160) of the responses were completed via social media sites. Prior to dialysis, 74% (118/160), prescribed furosemide and 67% (107/160) used furosemide with metolazone. Once dialysis started, only 46% (74/160) of the responders continued patients on diuretics daily. Hypertension medications prescribed in dialysis were calcium channel blockers 69% (112/160), beta blockers 36% (58/160), angiotensin converting enzyme inhibitor 32% (53/160), angiotensin receptor blocker 29% (46/160) and diuretics 25% (42/160). Once dialysis started, 68% (109/160) routinely changed medications. Most, 67% (107/160) ordered patients to avoid anti-hypertensive medications on dialysis days to allow for ultrafiltration. Dry weight was determined in the first week by 29% (46/160) and in the first month by 53% (85/160). Most, 59% (94/160) felt that multiple causes lead to hypertension. Most nephrologists would prescribe small dialyzers and a shorter period of time for the first dialysis session.ConclusionThe transition period to chronic hemodialysis has variations in practice patterns and may benefit from further studies to optimize clinical practice.
| S-EPMC6013940 | biostudies-literature
Project description:The number of dialysis patients continues to grow. In many parts of the world, peritoneal dialysis (PD) is a less expensive form of treatment. However, it has been questioned whether patients treated with PD can have as good a long-term outcome as that achieved with hemodialysis (HD). This skepticism has fueled ongoing comparisons of outcomes of patients treated with in-center HD and PD using data from national registries or prospective cohort studies. There are major challenges in comparing outcomes with two therapies when the treatment assignment is nonrandom. Furthermore, many of the intermodality comparisons include patients who started dialysis therapy in the 1990s. In many parts of the world, improvements in PD outcome have outpaced those seen with in-center HD. It is not surprising, then, that virtually all the recent observational studies from different parts of the world consistently show that long-term survival of HD and PD patients is remarkably similar. These studies support the case for a greater use of PD for the treatment of end-stage renal disease. This, in turn, could allow more patients to be treated for any given budgetary allocation to long-term dialysis.
| S-EPMC3073732 | biostudies-literature
Project description:Background and objectivePrevious reports indicated that patients on thrice-weekly hemodialysis (HD) had higher mortality rates after the 3-day interdialytic interval. However, day-of-the-week patterns of emergency department (ED) visits and hospitalizations remain under-investigated.MethodsWe conducted a retrospective cohort study of HD patients on thrice-weekly dialysis, using 2013 data from the United States Renal Data System (USRDS). We estimated crude incidence rates of ED visits and hospitalizations by day of the week and dialysis schedule (Monday, Wednesday, Friday or Tuesday, Thursday, Saturday). Using Poisson regression, we estimated case-mix adjusted rate ratios of all-cause ED visits and hospitalizations, and adjusted rates of cause-specific ED visits and hospitalizations.ResultsWe identified 241,093 eligible HD patients in 2013, who had 514,773 ED visits and 301,674 hospitalizations that year. Three distinct but related patterns of outcome events were observed. Crude and adjusted incidence rates of all-cause, cardiovascular, and infection-related ED visits and hospitalizations, but not vascular-access-related events, were higher on all three HD treatment days ("dialysis-day effect"). Rates for ED visits and hospitalizations were lower on weekends than weekdays, rising appreciably from Sunday to Monday for both dialysis schedules ("post-weekend effect"); and rates were highest after the long 3-day interval between dialysis sessions for both dialysis schedules ("interdialytic-gap effect"). In contrast, rates of hospitalizations not preceded by an ED visit were nearly the same Monday through Friday and lower on weekends for both dialysis schedules.ConclusionsHigher rates of ED visits and hospitalizations on the days of HD sessions and early in the week are a public-health concern that should stimulate research to explain these patterns and reduce the excessive morbidity and associated costs among patients on thrice-weekly HD, while improving quality of care and patient experience with dialysis.
| S-EPMC6695146 | biostudies-literature
Project description:Rationale & objectiveSome US hemodialysis (HD) facilities switched from oral cinacalcet to intravenous etelcalcetide as the primary calcimimetic therapy to control parathyroid hormone (PTH) levels after the introduction of etelcalcetide in 2017. Although clinical trials have demonstrated the superior efficacy of etelcalcetide versus cinacalcet, evidence comparing real-world effectiveness is lacking.Study designProspective cohort.Setting & participantsPatients receiving HD enrolled in US Dialysis Outcomes and Practice Patterns Study facilities.ExposureWe classified HD facilities on the basis of whether >75% of calcimimetic users were prescribed etelcalcetide ("etelcalcetide-first") or cinacalcet ("cinacalcet-first") from March-August 2019.OutcomesPTH, calcium, and phosphorus levels among calcimimetic users, all averaged in the 6 months after the exposure assessment period.Analytical approachWe used adjusted linear regression to compare outcomes using 2 approaches: (1) cross-sectional comparison of etelcalcetide-first and cinacalcet-first HD facilities; (2) pre-post comparison of HD facilities that switched from cinacalcet-first to etelcalcetide-first using facilities that remained cinacalcet-first as a comparison group.ResultsWe identified 45 etelcalcetide-first and 67 cinacalcet-first HD facilities; etelcalcetide-first (vs cinacalcet-first) facilities were more likely to be from small or independent dialysis organizations (86% vs 22%) and had higher total calcimimetic use (43% vs 29%) and lower active vitamin D use (66% vs 82%). In the cross-sectional analysis comparing etelcalcetide-first and cinacalcet-first HD facilities, the adjusted mean difference in PTH levels was -115 pg/mL (95% CI, -196 to -34) and the prevalence of a PTH level of >600 pg/mL was lower (prevalence difference, -11.4%; 95% CI, -19.3% to -3.5%). Among facilities that switched to etelcalcetide-first, the mean PTH level decreased from 671 to 484 pg/mL and the prevalence of a PTH level of >600 pg/mL decreased from 39% to 21%. Among facilities that remained cinacalcet-first, the mean PTH level increased from 632 to 698 pg/mL and the prevalence of a PTH level of >600 pg/mL increased from 37% to 43%. The adjusted difference-in-difference between the switch to etelcalcetide-first and the continuation of cinacalcet-first was -169 pg/mL (-249 to -90 pg/mL) for the mean PTH and -14.4% (-22.0% to -6.8%) for a PTH level of >600 pg/mL. We also observed slightly lower serum calcium levels and minimal differences in serum phosphorus levels between the etelcalcetide-first and the cinacalcet-first facilities.LimitationsResidual confounding.ConclusionsWe observed better PTH control in HD facilities that switched from using cinacalcet to etelcalcetide as the primary calcimimetic therapy. Further research is needed to investigate how the greater real-world effectiveness of intravenous etelcalcetide (vs oral cinacalcet) may affect clinical outcomes.
| S-EPMC9142674 | biostudies-literature