Comparative Effectiveness of mRNA-based BNT162b2 Vaccine versus Adenovirus Vector-Based Ad26.COV2.S Vaccine for the Prevention of COVID-19 among Dialysis Patients.

BACKGROUND: Studies have demonstrated that mRNA-based SARS-CoV-2 vaccines are highly effective among patients on dialysis. Because individual vaccines may be differentially available or acceptable to patients, it is important to understand comparative effectiveness relative to other vaccines, such those on the basis of adenovirus technologies. METHODS: In this retrospective study, we compared the clinical effectiveness of adenovirus vector-based Ad26.COV2.S (Janssen/Johnson & Johnson) to mRNA-based BNT162b2 (Pfizer/BioNTech) in a contemporary cohort of patients on dialysis. Patients who received a first BNT162b2 dose were matched 1:1 to Ad26.COV2.S recipients on the basis of date of first vaccine receipt, US state of residence, site of dialysis care (in-center versus home), history of COVID-19, and propensity score. The primary outcome was the comparative rate of COVID-19 diagnoses starting in the 7th week postvaccination. In a subset of consented patients who received Ad26.COV2.S, blood samples were collected ≥28 days after vaccination and anti-SARS-CoV-2 immunoglobulin G antibodies were measured. RESULTS: A total of 2572 matched pairs of patients qualified for analysis. Cumulative incidence rates of COVID-19 did not differ for BNT162b2 versus Ad26.COV2.S. No differences were observed in peri-COVID-19 hospitalizations and deaths among patients receiving BNT162b2 versus Ad26.COV2.S, who were diagnosed with COVID-19 during the at-risk period. Results were similar when excluding patients with a history of COVID-19, in subgroup analyses restricted to patients who completed the two-dose BNT162b2 regimen, and in patients receiving in-center hemodialysis. SARS-CoV-2 antibodies were detected in 59.4% of 244 patients who received Ad26.COV2.S. CONCLUSIONS: In a large real-world cohort of patients on dialysis, no difference was detected in clinical effectiveness of BNT162b2 and Ad26.COV2.S over the first 6 months postvaccination, despite an inconsistent antibody response to the latter.

Real-World Effectiveness and Immunogenicity of BNT162b2 and mRNA-1273 SARS-CoV-2 Vaccines in Patients on Hemodialysis.

BACKGROUND: Patients on hemodialysis have an elevated risk for COVID-19 but were not included in efficacy trials of SARS-CoV-2 vaccines. METHODS: We conducted a retrospective, observational study to estimate the real-world effectiveness and immunogenicity of two mRNA SARS-CoV-2 vaccines in a large, representative population of adult hemodialysis patients in the United States. In separate, parallel analyses, patients who began a vaccination series with BNT162b2 or mRNA-1273 in January and February 2021 were matched with unvaccinated patients and risk for outcomes were compared for days 1-21, 22-42, and ≥43 after first dose. In a subset of consented patients, blood samples were collected approximately 28 days after the second dose and anti-SARS-CoV-2 immunoglobulin G was measured. RESULTS: A total of 12,169 patients received the BNT162b2 vaccine (matched with 44,377 unvaccinated controls); 23,037 patients received the mRNA-1273 vaccine (matched with 63,243 unvaccinated controls). Compared with controls, vaccinated patients' risk of being diagnosed with COVID-19 postvaccination became progressively lower during the study period (hazard ratio and 95% confidence interval for BNT162b2 was 0.21 [0.13, 0.35] and for mRNA-1273 was 0.27 [0.17, 0.42] for days ≥43). After a COVID-19 diagnosis, vaccinated patients were significantly less likely than unvaccinated patients to be hospitalized (for BNT162b2, 28.0% versus 43.4%; for mRNA-1273, 37.2% versus 45.6%) and significantly less likely to die (for BNT162b2, 4.0% versus 12.1%; for mRNA-1273, 5.6% versus 14.5%). Antibodies were detected in 98.1% (309/315) and 96.0% (308/321) of BNT162b2 and mRNA-1273 patients, respectively. CONCLUSIONS: In patients on hemodialysis, vaccination with BNT162b2 or mRNA-1273 was associated with a lower risk of COVID-19 diagnosis and lower risk of hospitalization or death among those diagnosed with COVID-19. SARS-CoV-2 antibodies were detected in nearly all patients after vaccination. These findings support the use of these vaccines in this population.

Antibody Status, Disease History, and Incidence of SARS-CoV-2 Infection Among Patients on Chronic Dialysis.

BACKGROUND: Although reinfection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is rare among individuals with few coronavirus disease 2019 (COVID-19) risk factors, the ability of naturally acquired immunity to prevent reinfection among patients with ESKD is not known. METHODS: This prospective study was conducted among adults with ESKD treated with in-center hemodialysis (ICHD) in the United States. Exposure was ascribed on the basis of the presence or absence of IgG against SARS-CoV-2 at baseline, and separately, a history of documented COVID-19 before study entry. Outcomes were assessed after an infection-free period, and were any SARS-CoV-2 infection (i.e., detected by protocolized PCR tests or during routine clinical surveillance), and clinically manifest COVID-19 (consisting of only the latter). RESULTS: Of 2337 consented participants who met study inclusion criteria, 9.5% were anti-SARS-CoV-2 IgG positive at baseline; 3.6% had a history of COVID-19. Over 6679 patient-months of follow-up, 263 participants had evidence of any SARS-CoV-2 infection, including 141 who had clinically manifest COVID-19. Presence of anti-SARS-CoV-2 IgG (versus its absence) at baseline was associated with lower risk of any SARS-CoV-2 infection (incidence rate ratio, 0.55; 95% confidence interval, 0.32 to 0.95) and clinically manifest COVID-19 0.21 (95% confidence interval, 0.07 to 0.67). CONCLUSION: Among patients with ESKD, naturally acquired anti-SARS-CoV-2 IgG positivity is associated with a 45% lower risk of subsequent SARS-CoV-2 infection, and a 79% lower risk of clinically manifest COVID-19. Because natural immunity is incomplete, patients with ESKD should be prioritized for SARS-CoV-2 vaccination, independent of their COVID-19 disease history.

Use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States.

BACKGROUND: Health-related quality of life (HRQOL) is a key outcome for dialysis patients, and its assessment is mandated by the Centers for Medicaid and Medicare Services. The Kidney Disease Quality of Life (KDQOL-36™) survey is widely used for this assessment. KDQOL-36™ completion rates, and the distributions of scores and item responses, have not been examined in a large, nationally representative cohort of dialysis patients. METHODS: This retrospective, observational study considered 413,951 survey opportunities contributed by adult patients who received dialysis at a large dialysis organization in the United States during calendar years 2014, 2015, and 2016 and were not Veterans Affairs beneficiaries. RESULTS: During the study period, 240,343 unique patients completed a total of 330,412 surveys (overall completion rate 79.8%). Mean domain scores on the physical component summary (PCS), mental component summary (MCS), burden of kidney disease (BKD), symptoms and problems of kidney disease (SPKD), and effects of kidney disease (EKD) subscales were 36.6, 49.0, 51.3, 78.1, and 73.0, respectively. Scores were similar across dialysis modalities. Patient perceptions of general health were not correlated (R < 0.05) with PCS or SPKD. The SPKD showed ceiling effects: among patients treated with in-center hemodialysis, for all 12 items, < 10% of patients were "extremely bothered," while > 65% of patients reported being "not at all" or only "somewhat bothered;" for 3 items, > 85% of patients gave these latter two responses. Interdialytic weight gain was not correlated with patient-reported shortness of breath, PCS, or SPKD. CONCLUSIONS: Survey completion rates for the KDQOL-36™ were high, and scores were similar across dialysis modalities. Ceiling effects were observed for SPKD. Revision of the KDQOL-36™ to address factors that are most important to contemporary dialysis patients may be warranted.

Correction to: Use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States.

Following publication of the original article [1], the authors reported an error in Figs. 3 and S3.

Response to correspondence from Hays and colleagues concerning our paper entitled, use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States.

In their correspondence, Hays et al. raise two main critiques of our recently published article entitled "Use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States." First, Hays et al. expressed concerns regarding the comparison of mean scores on five Kidney Disease Quality of Life (KDQOL) subscales, given that the Physical Component Summary (PCS) and Mental Component Summary (MCS) are scored on a different numeric scale compared to the other three subscales. Second, Hays et al. note that the correlations reported in our manuscript between the general health perceptions item ("In general, would you say your health is excellent, very good, good, fair, or poor") and the 5 KDQOL subscales were inconsistent with findings derived from other KDQOL datasets. Here, we respond to these two critiques.

The association between cinacalcet use and missed in-center hemodialysis treatment rate.

PURPOSE: Missed in-center hemodialysis treatments (MHT) are a general indicator of health status in hemodialysis patients. This analysis was conducted to estimate the association between cinacalcet use and MHT rate. METHODS: We studied patients receiving hemodialysis and prescription benefits services from a large dialysis organization. Incident cinacalcet users were propensity score matched to controls on 31 demographic, clinical, and laboratory variables. We applied inverse probability (IP) of censoring and crossover weights to account for informative censoring. Weighted negative binomial modeling was used to estimate MHT rates and pooled logistics models were used to estimate the association between cinacalcet use and MHT. RESULTS: Baseline demographic and clinical variables included serum calcium, phosphorus, parathyroid hormone, and vitamin D use, and were balanced between 15,474 new cinacalcet users and 15,474 matched controls. In an analysis based on intention-to-treat principles, 40.8% of cinacalcet users and 46.5% of nonusers were censored. MHT rate was 13% lower among cinacalcet initiators versus controls: IP of censoring weighted incidence rate ratio was 0.87 (95% confidence interval [CI]: 0.84-0.90 p < 0.001). In analyses based on as-treated principles, 72.8% and 61.5% of cinacalcet users and nonusers, respectively, crossed over or were censored. MHT rate was 15% lower among cinacalcet initiators versus controls: IP of censoring/crossover weighted incidence rate ratio was 0.85 (95%CI: 0.82-0.87 p < 0.001). CONCLUSIONS: After controlling for indication and differential censoring, cinacalcet treatment was associated with lower MHT rates, which may reflect better health status. Copyright © 2016 John Wiley & Sons, Ltd.

The clinical and economic burden of pneumonia in patients enrolled in Medicare receiving dialysis: a retrospective, observational cohort study.

BACKGROUND: End-stage renal disease (ESRD) patients receiving dialysis are at particular risk for infection. We assessed the clinical and economic burden of pneumonia in a population of Medicare-enrolled ESRD patients with respect to incidence and case fatality rates, rates of all-cause and cardiovascular hospitalization, and costs. METHODS: Patients received dialysis between 01 January 2009 and 31 December 2011 and were enrolled in Medicare Parts A and B. Pneumonia episodes were identified from institutional and supplier claims. Patients were considered at-risk from first date of Medicare coverage and were censored upon transplant, withdrawal from dialysis, recovery of renal function, loss of Medicare benefits, or death. Linear mixed-effects models were used to assess hospitalization rates and costs over the 3 months prior to and 12 months following pneumonia episodes. RESULTS: The pneumonia incidence rate for the study period was 21.4 events/100 patient-years; the majority of episodes (90.1%) required inpatient treatment. The 30-day case fatality rate was 10.7%. Compared to month -3 prior to event, rates of all-cause and cardiovascular hospitalization were higher in the month of the pneumonia episode (IRR, 4.61 and 4.30). All-cause admission rates remained elevated through month 12; cardiovascular admission rates remained elevated through month 6. Mean per-patient per-month costs were $10,976 higher in the month of index episode compared to month -3, largely driven by increased inpatient costs, and remained elevated through end of 12-month follow-up. CONCLUSION: Pneumonia episodes are frequent among ESRD patients and result in hospitalizations and greater overall costs to Medicare over the following year.

Facility Dialysate Calcium Practices and Clinical Outcomes Among Patients Receiving Hemodialysis: A Retrospective Observational Study.

BACKGROUND: Some US dialysis facilities have reduced default dialysate calcium concentrations from 2.5 mEq/L to lower levels. There has been no rigorous systematic examination of the effects of such a reduction on clinical and biochemical outcomes. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Medicare-eligible patients who received in-center hemodialysis at a large dialysis organization in January 2008 to December 2010. PREDICTOR: Facility conversion from predominant use (≥75% patients) of 2.50-mEq/L dialysate calcium to predominant use of lower dialysate calcium concentrations versus maintenance of predominant use of 2.50-mEq/L dialysate calcium. OUTCOMES: All-cause and cause-specific mortality and hospitalization, laboratory markers of metabolic bone disease, and drug utilization. MEASUREMENTS: Hierarchical mixed linear and Poisson models were fit to compare pre- to postconversion differences in outcomes between converter and matched control facilities. Results, expressed as relative rate ratios (RRRs) and delta-delta (change in mean values), were estimated for early (months 0-2) and late (months 3-12) postconversion to allow for possible latent effects. RESULTS: Facility conversion was associated with greater rates of hospitalization for heart failure exacerbation (late RRR, 1.27 [95% CI, 1.06-1.51]), hypocalcemia (early RRR, 1.19 [95% CI, 1.05-1.35]; late RRR, 1.39 [95% CI, 1.20-1.60]), and intradialytic hypotension (early RRR, 1.07 [95% CI, 1.02-1.11]; late RRR, 1.05 [95% CI, 1.01-1.10]), but no differences were observed for all-cause mortality or hospitalization rates. Facility conversion was also associated with comparative temporal decreases in serum calcium level, increases in serum phosphate and parathyroid hormone levels, and increases in use of phosphate binders, vitamin D, and calcimimetics. LIMITATIONS: Possible residual confounding, generalizability beyond Medicare patients uncertain. CONCLUSIONS: There are potential safety concerns associated with the default use of dialysate calcium concentrations < 2.50 mEq/L, as well as biochemical evidence of poorer disease control despite associated greater medication use. Individualization of dialysate calcium concentration rather than predominant use of dialysate calcium concentrations < 2.50 mEq/L should be considered.

Management of serum calcium reductions among patients on hemodialysis following cinacalcet initiation.

PURPOSE: Cinacalcet is indicated for treatment of secondary hyperparathyroidism in patients receiving hemodialysis. Cinacalcet reduces serum calcium concentrations by decreasing parathyroid hormone secretion, but the frequency and degree of calcium reduction following cinacalcet initiation, subsequent physician response, and ultimate calcium recovery in clinical practice are not well described. METHODS: Patients receiving hemodialysis at a large dialysis organization who enrolled in the organization's prescription benefits service and initiated cinacalcet at serum calcium ≥8.4 mg/dL were studied (N = 13 723). Patients were categorized by whether they experienced a reduction in calcium to <8.4 mg/dL and to what level (<7.5, 7.5-7.9, and 8.0-8.3 mg/dL). Baseline characteristics, frequency of subsequent intervention, and calcium recovery were compared. RESULTS: Of those who experienced a reduction in calcium to <8.4 mg/dL (n = 6437 [46.9%]), 6.6% had calcium <7.5 mg/dL and 24.5% had calcium 7.5-7.9 mg/dL, while the majority (68.9%) had a level of 8-8.3 mg/dL. Higher baseline parathyroid hormone and alkaline phosphatase were associated with lower resultant calcium. Among patients with calcium reductions, 45.6-63.5% received one or more directed clinical therapeutic responses, including 15.6-28.4% for whom cinacalcet was discontinued; the majority of patients recovered to calcium ≥8.4 mg/dL within 90 days of first detection. Only modest differences in recovery were noted between patients who did and did not receive any therapeutic response and patients who did and did not discontinue cinacalcet. CONCLUSION: Serum calcium reductions following cinacalcet initiation were common; declines <7.5 mg/dL were infrequent. Calcium recovery occurred in the majority of patients, with or without therapeutic intervention.

Characterization of chronic and acute ESA hyporesponse: a retrospective cohort study of hemodialysis patients.

BACKGROUND: Some patients with chronic kidney disease do not respond adequately to erythropoiesis-stimulating agent (ESA) treatment; these patients are referred to as ESA hyporesponders. There is no widely accepted contemporary definition for chronic ESA hyporesponse. The study objective was to propose and validate an operational definition for chronic ESA hyporesponse. METHODS: This was a retrospective cohort study using electronic health care records. Participants were anemic hemodialysis patients treated during February 2012 and were followed for 15 months. Patients' ESA response (responders) or lack of response (chronic and acute hyporesponders) based on longitudinal patterns of ESA dose and hemoglobin level was assessed. Persistence of hyporesponse, longitudinal iron measures, transfusion rates, and mortality rates were analyzed. Frequency of blood transfusions (monthly) and death rates (quarterly) were calculated. Log normalized serum ferritin concentration was analyzed. RESULTS: Of 97,677 eligible patients, 6632 had acute hyporesponsiveness (ESA responsiveness restituted in ≤ 4 months) and 3086 had chronic hyporesponsiveness (lack of ESA response for > 4 months). Over months 1-4 among chronic hyporesponders, mean serum ferritin (722-785 ng/mL) and transferrin saturation (TSAT; 26.76 %-27.08 %) were constant, while acute hyporesponsive patients experienced increased ferritin (654-760 ng/mL) and TSAT (25.71-30.88 %) levels. Compared to ESA responders (0.19-0.30 %), chronic hyporesponders were transfused 7-times (1.20-2.17 %) more frequently over follow-up. Quarterly mortality was greatest in chronic ESA hyporesponders (2.98-5.48 %), followed by acute ESA hyporesponders (2.17-3.30 %) and ESA responders (1.43-2.49 %). With consistence over the study, chronic hyporesponders died more frequently than patients in the other study cohorts. CONCLUSIONS: Findings indicate that 4 months of continuous ESA hyporesponsiveness can be used to differentiate acute from chronic hyporesponsiveness. This definition of chronic hyporesponsiveness is supported by outcome data showing higher mortality and transfusion rates in chronic hyporesponders compared to acute hyporesponders.

Medicare Advantage associated with lower mortality for incident dialysis patients.

Physicians across the care continuum are increasingly aligned around the belief that coordinated care can improve patient outcomes. As the principal caregivers for one of the most medically fragile patient groups in healthcare, nephrologists are especially attuned to the potential value of integrated care. Medicare Advantage (MA) offers one way to test this hypothesis. By law, end-stage renal disease patients currently cannot enroll into an MA plan, but if they develop ESRD while in such a plan, they may continue to be enrolled. The contrast between these patients and their counterparts who carry Medicare fee for service (MFFS) thereby represents a natural experiment that affords an opportunity to examine whether enrollment in a coordinated care system may improve outcomes. In order to promote (unbiased) comparison of patients in a non-randomized context, we propensity score-matched incident dialysis patients enrolled in MA versus those in MFFS. The data demonstrate that patients who were enrolled in an MA plan upon initiation of dialysis had a 9% lower mortality rate than their MFFS counterparts. This beneficial association of MA enrollment was found to be sustained over the first two years of dialysis treatment.

Effects of Crit-Line® monitor use on patient outcomes and epoetin alfa dosing following onset of hemodialysis: a propensity score-matched study.

BACKGROUND: The Crit-Line® monitor (CLM) is a device for monitoring hematocrit, oxygen saturation and change in intravascular blood volume during hemodialysis. Prior studies have evaluated CLM use in dialysis patients, but not specifically in those new to dialysis. METHODS: In this retrospective analysis, 199 patients initiating dialysis at 8 facilities routinely using CLM were compared with 796 propensity score-matched non-CLM patients initiating dialysis at facilities not using CLM. Outcomes were considered over the first 180 days on dialysis. RESULTS: Overall, the CLM group had higher StdKt/V (p = 0.06) and received lower doses of intravenous iron than the non-CLM group (p < 0.001). Erythropoiesis-stimulating agent doses were lower in the CLM group in months 1-5. Serum iron and transferrin saturation levels were higher overall for the CLM group than the non-CLM group (p = 0.004 and 0.01, respectively). Hemoglobin levels and time to first hospitalization were similar for both groups. CONCLUSION: Use of CLM is associated with lower erythropoiesis-stimulating agent and iron use in incident hemodialysis patients.

Predicting hospitalizations for patients with chronic kidney disease.

OBJECTIVES: Patients with chronic kidney disease (CKD) are at higher risk of being admitted to the hospital than the general population. Hospitalizations in patients with CKD are associated with higher medical costs and increased morbidity and mortality. Identification of patients with CKD who are at greatest risk of hospitalization may hold promise to improve clinical outcomes and enable judicious allocation of health care resources. STUDY DESIGN: Retrospective, observational cohort study. METHODS: Medicare Part A and Part B claims from calendar years 2017 and 2018 from 50,000 unique patients with a diagnosis of stage 3 to 5 CKD were used for this study. Data were split into training (n = 40,000) and test (n = 10,000) sets. A variety of model types were built to predict all-cause hospitalization within 90 days. RESULTS: The final model was a gradient-boosting machine with 399 input terms. The model demonstrated good ability to discriminate (area under the curve [AUC] for the receiver operating characteristic curve = 0.73), which was stable when tested in the test set (AUC = 0.73). The positive predictive value in the test set was 0.306, 0.240, and 0.216 at the 10%, 20%, and 30% thresholds, respectively. The sensitivity in the test set was 0.288, 0.453, and 0.609 at the 10%, 20%, and 30% thresholds, respectively. CONCLUSIONS: We developed an algorithm that uses medical claims to identify Medicare patients with CKD stages 3 to 5 who are at highest risk of being hospitalized in the near term. This algorithm could be used as a decision support tool for clinical programs focusing on management of patient populations with CKD.

Urgent-start peritoneal dialysis: Association with outcomes.

The majority of end-stage kidney disease (ESKD) patients start dialysis without adequate pre-dialysis planning. Of these patients, the vast majority initiate in-centre haemodialysis using a central venous catheter (ICHD-CVC). A minority utilise urgent-start peritoneal dialysis (USPD), whereby a peritoneal dialysis catheter is placed and used for dialysis without the usual 2-4-week waiting period. In this multicentre, retrospective study of adult patients initiating dialysis during 2018, we compared outcomes among patients utilising these two dialysis initiation routes. Patients who initiated dialysis via ICHD-CVC were matched 1:1 to patients who utilised USPD on the basis of aetiology of ESKD, race, diabetes status and insurance type. Hospitalisation and mortality were evaluated from dialysis initiation through the first of death, transplant, loss to follow-up or study end (30 June 2019). Outcomes were compared using models adjusted for age and sex. A total of 717 USPD patients were matched to ICHD-CVC patients. During follow-up, USPD patients were hospitalised at a rate of 1.21 admissions/patient-year (pt-yr) versus 1.51 admissions/pt-yr for ICHD-CVC. This corresponded to a 24% lower rate of hospitalisation among USPD patients (adjusted incidence rate ratio 0.76, 95% confidence interval [CI] 0.65-0.88). Mortality rates were 0.08 and 0.11 deaths/pt-yr among USPD patients and ICHD-CVC patients, respectively (adjusted hazard ratio 0.84, 95% CI 0.62, 1.15). These findings suggest that more widespread adoption of USPD may be beneficial among patients with limited pre-dialysis planning.

Utilization of Home Dialysis and Permanent Vascular Access at Dialysis Initiation Following a Structured CKD Education Program.

Rationale & Objective: Treatment options for kidney failure are complex, and the majority of patients transitioning to dialysis lack important information about treatment options and are not prepared to make informed decisions about their care. Correspondingly, the majority of patients who start dialysis default to in-center hemodialysis using a central venous catheter for vascular access as the initial modality; furthermore, hospital admissions, mortality, and infections are exceedingly common over the first few months. Study Design: Matched retrospective cohort study. Setting & Patients: 2,398 adult patients with chronic kidney disease (CKD) who attended a structured CKD education program and pair-matched control patients who did not receive education before starting dialysis between January 2018 and June 2019. Exposure: CKD education attendance documented from 2 months (60 days)-3 years before dialysis initiation. CKD education consisted of a 1-time, 90-minute, inperson or virtual class. Outcome: Primary outcomes were dialysis modality and vascular access type on the first day of dialysis (day 0) and at day 90 after dialysis initiation. Secondary outcomes included hospitalizations and deaths during the first year of receiving dialysis. Analytical Approach: Generalized linear models were used to compare outcomes between patients receiving CKD education and controls. Results: Compared with controls, CKD education patients were more frequently receiving home dialysis (38.5% vs 12.6%, P < 0.001) and used a permanent vascular access (57.9% vs 33.8%, P < 0.001) at dialysis initiation; differences were minimally attenuated and remained statistically significant at day 90. Hospitalization rates were lower among CKD education patients than among controls during the first year of receiving dialysis (1.00 vs 1.38 admissions per patient-year; P < 0.001). CKD education patients also had lower mortality over the first year of receiving dialysis (P < 0.001). Limitations: Bias and confounding cannot fully be accounted for in an observational study. Analyses only included patients with commercial and Medicare insurance who received CKD care before dialysis initiation and may not be generalizable to other patient populations. Conclusions: Our findings indicate that attending a CKD education class before starting dialysis resulted in positive clinical outcomes, including reduction in hospitalization and mortality rates. Broad implementation of structured CKD education may result in more patients choosing home dialysis as their first treatment option and reduce the risk of adverse outcomes in the crucial early period after dialysis initiation.

A systematic review of hepatitis C virus epidemiology in Europe, Canada and Israel.

BACKGROUND AND AIM: Decisions on public health issues are dependent on reliable epidemiological data. A comprehensive review of the literature was used to gather country-specific data on risk factors, prevalence, number of diagnosed individuals and genotype distribution of the hepatitis C virus (HCV) infection in selected European countries, Canada and Israel. METHODOLOGY: Data references were identified through indexed journals and non-indexed sources. In this work, 13,000 articles were reviewed and 860 were selected based on their relevance. RESULTS: Differences in prevalence were explained by local and regional variances in transmission routes or different public health measures. The lowest HCV prevalence (≤ 0.5%) estimates were from northern European countries and the highest (≥ 3%) were from Romania and rural areas in Greece, Italy and Russia. The main risk for HCV transmission in countries with well-established HCV screening programmes and lower HCV prevalence was injection drug use, which was associated with younger age at the time of infection and a higher infection rate among males. In other regions, contaminated glass syringes and nosocomial infections continue to play an important role in new infections. Immigration from endemic countries was another factor impacting the total number of infections and the genotype distribution. Approximately 70% of cases in Israel, 37% in Germany and 33% in Switzerland were not born in the country. In summary, HCV epidemiology shows a high variability across Europe, Canada and Israel. CONCLUSION: Despite the eradication of transmission by blood products, HCV infection continues to be one of the leading blood-borne infections in the region.

A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt.

BACKGROUND: The hepatitis C pandemic has been systematically studied and characterized in North America and Europe, but this important public health problem has not received equivalent attention in other regions. AIM: The objective of this systematic review was to characterize hepatitis C virus (HCV) epidemiology in selected countries of Asia, Australia and Egypt, i.e. in a geographical area inhabited by over 40% of the global population. METHODOLOGY: Data references were identified through indexed journals and non-indexed sources. In this work, 7770 articles were reviewed and 690 were selected based on their relevance. RESULTS: We estimated that 49.3-64.0 million adults in Asia, Australia and Egypt are anti-HCV positive. China alone has more HCV infections than all of Europe or the Americas. While most countries had prevalence rates from 1 to 2% we documented several with relatively high prevalence rates, including Egypt (15%), Pakistan (4.7%) and Taiwan (4.4%). Nosocomial infection, blood transfusion (before screening) and injection drug use were identified as common risk factors in the region. Genotype 1 was common in Australia, China, Taiwan and other countries in North Asia, while genotype 6 was found in Vietnam and other Southeast Asian countries. In India and Pakistan genotype 3 was predominant, while genotype 4 was found in Middle Eastern countries such as Egypt, Saudi Arabia and Syria. CONCLUSION: We recommend implementation of surveillance systems to guide effective public health policy that may lead to the eventual curtailment of the spread of this pandemic infection.

SARS-CoV-2 Antibody Seroprevalence Among Maintenance Dialysis Patients in the United States.

RATIONALE & OBJECTIVE: Reported coronavirus disease 2019 (COVID-19) cases underestimate the actual number of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Patients receiving maintenance dialysis are at high risk for COVID-19 and higher case rates have been reported relative to the general population. To better understand infection patterns, we performed a seroprevalence study among maintenance dialysis patients at a large dialysis organization in the United States. STUDY DESIGN: Cross-sectional. SETTING & PARTICIPANTS: We measured immunoglobulin G antibodies in an institutional review board-approved study of remnant serum samples collected for routine laboratory screenings in a national sample of 12,932 maintenance dialysis patients (May 27 to July 1, 2020). EXPOSURE: State, sex, age, and race. OUTCOMES: Seropositivity; ratio of seropositivity to known COVID-19 case rate. ANALYTIC APPROACH: Seropositivity was calculated overall and by state, sex, age, and race. The ratio of seropositivity to known COVID-19 cases was calculated overall and by state. RESULTS: 747 (5.8%) samples were seropositive. Seroprevalence varied by state and was lowest in Kentucky (1.0%) and highest in New York (23.6%). Seroprevalence was similar among men and women. Among samples from patients younger than 70 years, 6.0% to 6.5% were seropositive; whereas 5.2% and 3.9% of samples from patients aged 70 to 79 and 80 years or older, respectively, were seropositive. Samples from Black and Hispanic patients were 7.3% and 7.7% positive, respectively, compared with 2.8% of samples from White patients. After adjustment, risk differences among racial groups were lower but not eliminated. During the study period, the known COVID-19 case rate was 3.3%. The ratio of seropositivity to known COVID-19 cases was 1.7. LIMITATIONS: Imperfect assay sensitivity; results represent infections occurring before July 2020; deidentification prevented comparison of antibodies to previous COVID-19 status for individual patients; may not generalize to patients dialyzing with other providers or in other countries. CONCLUSIONS: Seroprevalence was 5.8% among dialysis patients as of July 1, 2020. This indicates that the actual number of infections was 1.7 times greater than reported cases. This ratio is lower than reported in the general population, suggesting that there were fewer unknown infections among maintenance dialysis patients.

Association of Continuation of Loop Diuretics at Hemodialysis Initiation with Clinical Outcomes.

BACKGROUND AND OBJECTIVES: Loop diuretics are commonly used to manage nondialysis-dependent CKD. Despite benefits of augmented urine output, loop diuretics are often discontinued after dialysis initiation. Here, we assessed the association of the early decision to continue loop diuretics at hemodialysis start with clinical outcomes during the first year of dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We considered all patients on in-center hemodialysis at a large dialysis organization (2006-2013) with Medicare Part A and D benefits who had an active supply of a loop diuretic at dialysis initiation (n=11,297). Active therapy was determined on the basis of whether loop diuretic prescription was refilled after dialysis initiation and within 30 days of exhaustion of prior supply. Patients were followed under an intention-to-treat paradigm for up to 12 months for rates of death, hospitalization, and intradialytic hypotension and mean monthly values of interdialytic weight gain, serum potassium, predialysis systolic BP, and ultrafiltration rates. RESULTS: We identified 5219 patients who refilled a loop diuretic and 6078 eligible controls who did not. After adjustments for patient mix and clinical differences, continuation of loop diuretics was associated with lower hospitalization (adjusted incidence rate ratio, 0.93; 95% confidence interval, 0.89 to 0.98) and intradialytic hypotension (adjusted incidence rate ratio, 0.95; 95% confidence interval, 0.92 to 0.99) rates, no difference in death rate (adjusted hazard ratio, 0.92; 95% confidence interval, 0.84 to 1.01), and lower interdialytic weight gain (P=0.03). CONCLUSIONS: Continuation of loop diuretics after hemodialysis initiation was associated with lower rates of hospitalization and intradialytic hypotension as well as lower interdialytic weight gain, but there was no difference in mortality over the first year of dialysis.