Dialysis Outcomes And Practice Patterns Study Research Articles

Comparison of β-blocker agents and mortality in maintenance hemodialysis patients: an international cohort study

ABSTRACT Background Despite a lack of clinical trial data, β-blockers are widely prescribed to dialysis patients. Whether specific β-blocker agents are associated with improved long-term outcomes compared with alternative β-blocker agents in the dialysis population remains uncertain. Methods We analyzed data from an international cohort study of 10 125 patients on maintenance hemodialysis across 18 countries that were newly prescribed a β-blocker medication within the Dialysis Outcomes and Practice Patterns Study (DOPPS). The following β-blocker agents were compared: metoprolol, atenolol, bisoprolol and carvedilol. Multivariable Cox proportional hazards models were used to estimate the association between the newly prescribed β-blocker agent and all-cause mortality. Stratified analyses were performed on patients with and without a prior history of cardiovascular disease. Results The mean (standard deviation) age in the cohort was 63 (15) years and 57% of participants were male. The most commonly prescribed β-blocker agent was metoprolol (49%), followed by carvedilol (29%), atenolol (11%) and bisoprolol (11%). Compared with metoprolol, atenolol {adjusted hazard ratio (HR) 0.77 [95% confidence interval (CI) 0.65–0.90]} was associated with a lower mortality risk. There was no difference in mortality risk with bisoprolol [adjusted HR 0.99 (95% CI 0.82–1.20)] or carvedilol [adjusted HR 0.95 (95% CI 0.82–1.09)] compared with metoprolol. These results were consistent upon stratification of patients by presence or absence of a prior history of cardiovascular disease. Conclusions Among patients on maintenance hemodialysis who were newly prescribed β-blocker medications, atenolol was associated with the lowest mortality risk compared with alternative agents.

The influencing factors of the erythropoietin resistance index and its association with all-cause mortality in maintenance hemodialysis patients

Anemia is a common complication of chronic kidney disease with major option treatment of erythropoiesis-stimulating agents (ESAs). This study aimed to investigate the influencing factors of erythropoietin resistance index (ERI) and its association with mortality in maintenance hemodialysis (MHD) patients. Patients enrolled from China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5 were included. ERI was calculated as follows: ESA (IU/week)/weight (kg, post-dialysis)/hemoglobin level (g/dL). The Cox regression model was used to analyze the influencing factors on survival outcomes. Stepwise multivariate logistic regression was used to identify the related risk factors, and subgroup analyses were performed. A total of 1270 MHD subjects (687 males and 583 females) were included, with an average age of 60 (49.0, 71.0) years. All subjects were divided into two groups by the median ERI of 14.03. Multivariate logistic regression showed that dialysis vintage (OR 0.957, 95% CI: 0.929–0.986), white blood cells (OR 0.900, 95% CI: 0.844–0.960), high flux dialyzer use (OR 0.866, 95% CI: 0.755–0.993), body mass index (OR 0.860, 95% CI: 0.828–0.892), males (OR 0.708, 95% CI: 0.625–0.801), and albumin (OR 0.512, 95% CI: 0.389–0.673) had a negative association with high ERI baseline (all p < 0.05). There were 176 (13.9%) deaths in total including 89 cardiac/vascular deaths during follow-up. Cox regression analysis showed that ERI was positively associated with all-cause mortality, especially in some subgroups. ERI was associated with increased all-cause mortality in MHD patients, indicating the possibility of death prediction by ERI. Patients with high ERI warrant more attention.

Active Vitamin D Use and Fractures in Hemodialysis Patients: Results from the International DOPPS.

Active vitamin D is commonly used to control secondary hyperparathyroidism in dialysis patients, but it is unknown whether active vitamin D directly improves bone strength, independently of its ability to suppress parathyroid hormone (PTH). We analyzed the association between the prescription of active vitamin D and incidence of any fracture and hip fracture in 41,677 in-center hemodialysis patients from 21 countries in phases 3 to 6 (2005 to 2018) of the Dialysis Outcomes and Practice Patterns Study (DOPPS). We used Cox regression, adjusted for PTH and other potential confounders, and used a per-protocol approach to censor patients at treatment switch during follow-up. We also used a facility preference approach to minimize confounding by indication. Overall, 55% of patients were prescribed active vitamin D at study enrollment. Event rates (per patient-year) were 0.024 for any fracture and 0.010 for hip fracture. The adjusted hazard ratio (95% confidence interval) comparing patients prescribed versus not prescribed active vitamin D was 1.02 (0.90 to 1.17) for any fracture and 1.00 (0.81 to 1.23) for hip fracture. In the facility preference approach, there was no difference in fracture rate between facilities with higher versus lower active vitamin D prescriptions. Thus, our results do not suggest a PTH-independent benefit of active vitamin D in fracture prevention and support the current KDIGO guideline suggesting the use of active vitamin D only in subjects with elevated or rising PTH. Further research is needed to determine the role of active vitamin D beyond PTH control. © 2023 American Society for Bone and Mineral Research (ASBMR).

Receiving hemodialysis in Hispanic ethnic dense communities is associated with better adherence and outcomes among young patients: a retrospective analysis of the Dialysis Outcomes and Practice Patterns Study

BackgroundHispanic ethnic density (HED) is a marker of better health outcomes among Hispanic patients with chronic disease. It is unclear whether community HED is associated with mortality risk among ethnically diverse patients receiving maintenance hemodialysis.MethodsA retrospective analysis of patients in the United States cohort of the Dialysis Outcomes and Practice Patterns Study (DOPPS) database (2011–2015) was conducted (n = 4226). DOPPS data was linked to the American Community Survey database by dialysis facility zip code to obtain % Hispanic residents (HED). One way ANOVA and Kruskal Wallis tests were used to estimate the association between tertiles of HED with individual demographic, clinical and adherence characteristics, and facility and community attributes. Multivariable Cox proportional hazards models were used to estimate the mortality hazard ratio (HR) and 95% CIs by tertile of HED, stratified by age; a sandwich estimator was used to account for facility clustering.ResultsPatients dialyzing in facilities located in the highest HED tertile communities were younger (61.4 vs. 64.4 years), more commonly non-White (62.4% vs. 22.1%), had fewer comorbidities, longer dialysis vintage, and were more adherent to dialysis treatment, but had fewer minutes of dialysis prescribed than those in the lowest tertile. Dialyzing in the highest HED tertile was associated with lower hazard of mortality (HR, 0.86; 95% CI, 0.72-1.00), but this association attenuated with the addition of individual race/ethnicity (HR, 0.92; 95% CI, 0.78–1.09). In multivariable age-stratified analyses, those younger than 64 showed a lower hazard for mortality in the highest (vs. lowest) HED tertile (HR, 0.66; 95% CI, 0.49–0.90). Null associations were observed among patients ≥ 64 years.ConclusionsTreating in communities with greater HED and racial/ethnic integration was associated with lower mortality among younger patients which points to neighborhood context and social cohesion as potential drivers of improved survival outcomes for patients receiving hemodialysis.

Pruritus in Hemodialysis Patients: Longitudinal Associations With Clinical and Patient-Reported Outcomes

Cross-sectional studies have reported an association of chronic kidney disease-associated pruritus (CKD-aP) with adverse clinical events and patient-reported outcomes (PROs). We studied the longitudinal associations between changes in CKD-aP and clinical outcomes among patients receiving maintenance hemodialysis. Prospective cohort study. 7,976 hemodialysis recipients across 21 countries in phases 4-6 (2009-2018) of the Dialysis Outcomes and Practice Patterns Study (DOPPS) who had 2 CKD-aP assessments approximately 12 months apart. Exposure status was based on the assessment of pruritis initially and again approximately 1 year later. Four groups were identified, including those with moderate or more severe pruritis only at the initial assessment (resolved), only at the second assessment (incident), at neither assessment (absent), or at both assessments (persistent). Laboratory values and PROs ascertained at the initial assessment of pruritis and 1 year later. Linear mixed model to investigate changes in laboratory values and PROs over the 1-year study period across the 4 exposure groups. 51% of patients had moderate to severe CKD-aP symptoms at either assessment (22% at both). The prevalences of depression, restless sleep, and feeling drained increased over the study period (+13%,+10%, and+14%, respectively) among patients with incident pruritus and decreased (-5%,-8%, and-12%, respectively) among patients with resolved pruritus. Minimal changes in PROs over time were observed for the absent and persistent groups. Changes over time in laboratory values (phosphorus, Kt/V) were not detected for either of these groups. Compared with patients with absent CKD-aP, the adjusted HRs for patients with persistent CKD-aP were 1.29 (95% CI, 1.09-1.53) for all-cause mortality, 1.17 (1.07-1.28) for all-cause hospitalization, and 1.48 (1.26-1.74) for cardiovascular events. No interim evaluation of CKD-aP symptoms between the 2 assessments; potential selection bias from patients who died or were otherwise lost to follow-up before the second assessment. CKD-aP symptoms are chronic, and these findings highlight the potential value of repeated assessment of this symptom using standardized approaches. Future research should systematically investigate potential causes of CKD-aP and options for its effective treatment. Previous research has studied itching and its consequences in hemodialysis recipients only at a single time point. We surveyed 7,976 patients receiving maintenance hemodialysis to assess itching over a period of 1 year. We found that, among those experiencing itching at the initial assessment, more than half had persistent symptoms 1 year later. Those in whom itching developed during follow-up were more likely to experience depression, poor sleep, long recovery times after dialysis, and feeling faint or drained. These patients also rated their quality of life as poorer than those who did not experience itching. These findings emphasize the potential value of clinical detection of itching and the pursuit of effective treatments for patients receiving dialysis experiencing these symptoms.

#5529 RED BLOOD CELL TRANSFUSION RATES IN THE INTERNATIONAL DOPPS PROGRAM (2012–2022): HEMODIALYSIS, PERITONEAL DIALYSIS, AND NON-DIALYSIS CKD POPULATIONS

Abstract Background and Aims Anemia is a common complication of chronic kidney disease (CKD), and affects the majority of patients on hemodialysis (HD) and peritoneal dialysis (PD). Consequences of anemia include lower quality of life, increased healthcare utilization, and greater mortality risk. Current international guidelines recommend treating patients with iron and erythropoiesis-stimulating agents (ESAs) to a target hemoglobin (Hb) range, and avoiding red blood cell transfusions (RBCT) when possible, given the associated short- and long-term adverse consequences including hyperkalemia and allosensitization. A description of contemporary RBCT rates – after the 2012 KDIGO guideline changes – across the spectrum of CKD and different geographies is lacking. In this analysis, we estimated RBCT rates in non-dialysis CKD (ND-CKD), PD, and HD patients in a multinational setting, overall and stratified by Hb levels. Method We used data from 3 ongoing prospective cohort studies from the Dialysis Outcomes and Practice Patterns Study (DOPPS) Program: 2443 Stage 3–4 ND-CKD patients from 2 countries in CKDopps phases 1–2 (2013–2022), 3557 PD patients from 6 countries in PDOPPS phase 1 (2014–2018), and 22,771 HD patients from 20 countries in DOPPS phases 5–7 (2012–2022). Within each study, patients were randomly selected from stratified national samples of clinics, representative of a snapshot in time at study entry. Prospective information on RBCT receipt (yes/no) was captured at the patient-month level; thus, multiple events per patient were considered in the rate calculation, if they occurred in different months. RBCT rates were calculated as a count of the total patient-months with an RBCT event divided by the total patient-months with RBCT data available. Rates (per patient-month) were converted to per 100 patient-years, with 95% confidence intervals estimated by Poisson regression. RBCT rates are presented in each population (ND-CKD, PD, HD) across strata of interest, including CKD stage, country/region, and baseline Hb levels. Results Mean age (years) of the cohort was 68.6 for ND-CKD, 59.1 for PD, and 63.2 for HD. Mean (std dev) baseline Hb levels (g/dL) were 12.1 (1.9) in ND-CKD compared to 10.9 (1.7) in PD and 10.9 (1.5) in HD. Median [IQR] months of follow up (with RBCT data available) was 17 [6, 27] for ND-CKD, 16 [9, 20] for PD, and 8 [4, 19] for HD. Table 1 shows crude RBCT rates (per 100 patient-years) in the ND-CKD, PD, and HD populations, overall, by CKD stage and country/region. For ND-CKD, the RBCT rate was 6.7 (95% CI: 5.9, 7.6) overall, including 7.0 in the US and 5.5 in Brazil. RBCT rates increased with ND-CKD stage, from 2.2 in Stage 3a to 4.5 in Stage 3b to 8.5 in Stage 4. For PD, the RBCT rate was 20.3 (95% CI: 19.1, 21.6), higher than in ND-CKD, with substantial variation across countries, from 7.3 in the UK to 45.6 in Thailand. For HD, the RBCT rate was 23.9 (95% CI: 23.3, 24.5), also higher than in ND-CKD, with international variation observed. In the HD cohort, RBCT rates were lower in China (6.3) compared to the US (21.9), Canada (34.4), and the Gulf Cooperation Council region (34.8). Within HD-Europe, RBCT rates were highest in Belgium (48.1) and Sweden (42.4), and lowest in Germany (15.4), France (19.0), and Italy (20.4). Table 2 shows crude RBCT rates by baseline Hb levels. In all 3 cohorts (ND-CKD, PD, HD), RBCT rates appeared higher among patients with lower versus higher baseline Hb levels. In the PD and HD populations, patients with baseline Hb &amp;lt;8 g/dL had RBCT rates &amp;gt;100. Conclusion Our multinational study used uniform and standardized data collection tools, procedures, and processes to estimate RBCT rates in the post-2012 era following the revision of international guidelines. As expected, we observed higher RBCT rates in the PD and HD (vs. ND-CKD) populations, and higher RBCT rates among patients with lower baseline Hb levels. Interestingly, we also observed substantial international variation in RBCT rates in all 3 cohorts (ND-CKD, PD, HD). Further research is needed to better understand the reasons why RBCT use is higher or lower in certain countries, and to investigate predisposing and modifiable risk factors for RBCT. Funding: GSK (study 218930)

High facility-level serum potassium variability associated with mortality in hemodialysis patients: results from Chinese Dialysis Outcomes and Practice Patterns Study (DOPPS)

The role of facility-level serum potassium (sK+) variability (FL-SPV) in dialysis patients has not been extensively studied. This study aimed to evaluate the association between FL-SPV and clinical outcomes in hemodialysis patients using data from the China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5. FL-SPV was defined as the standard deviation (SD) of baseline sK+ of all patients in each dialysis center. The mean and SD values of FL-SPV of all participants were calculated, and patients were divided into the high FL-SPV (>the mean value) and low FL-SPV (≤the mean value) groups. Totally, 1339 patients were included, with a mean FL-SPV of 0.800 mmol/L. Twenty-three centers with 656 patients were in the low FL-SPV group, and 22 centers with 683 patients were in the high FL-SPV group. Multivariate logistic regression analysis showed that liver cirrhosis (OR = 4.682, 95% CI: 1.246–17.593), baseline sK+ (<3.5 vs. 3.5 ≤ sK+ < 5.5 mmol/L, OR = 2.394, 95% CI: 1.095–5.234; ≥5.5 vs. 3.5 ≤ sK+ < 5.5 mmol/L, OR = 1.451, 95% CI: 1.087–1.939), dialysis <3 times/week (OR = 1.472, 95% CI: 1.073–2.020), facility patients’ number (OR = 1.088, 95% CI: 1.058–1.119), serum HCO3 – level (OR = 0.952, 95% CI: 0.921–0.984), dialysis vintage (OR = 0.919, 95% CI: 0.888–0.950), other cardiovascular disease (OR = 0.508, 95% CI: 0.369–0.700), and using high-flux dialyzer (OR = 0.425, 95% CI: 0.250–0.724) were independently associated with high FL-SPV (all p < .05). After adjusting potential confounders, high FL-SPV was an independent risk factor for all-cause death (HR = 1.420, 95% CI: 1.044–1.933) and cardiovascular death (HR = 1.827, 95% CI: 1.188–2.810). Enhancing the management of sK+ of hemodialysis patients and reducing FL-SPV may improve patient survival.

Clinical Outcomes in Patients on Hemodialysis with Congestive Heart Failure.

Congestive heart failure (CHF) is one of the common complications in patients with end-stage kidney disease. In the general population, CHF increases the risk of the death. However, there is no well-designed relevant study in the Chinese hemodialysis (HD) population addressing the risks associated with CHF. The aim of this study was to explore the impact of CHF on clinical outcomes in HD patients. Data from a prospective cohort study, the China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5 (2012-2015), were analyzed. Demographic data, comorbidities, lab data, and death records were extracted. CHF was defined by the diagnosis records upon study inclusion. Our primary outcome was all-cause and cardiovascular (CV) mortality; secondary outcomes were all-cause and cause-specific hospitalization risk. Associations between CHF and outcomes were evaluated using Cox regression models. Stepwise multivariate logistic regression was used to identify the related risk factors, and subgroup analyses were carried out. Of 1,411 patients without missing CHF history information, 24.1% (340) had CHF diagnosis at enrollment. The overall mortality rates were 21.8% versus 12.0% (p < 0.001) in patients with and without CHF during follow-up, respectively. CHF was associated with higher all-cause mortality (adjusted HR: 1.72, 95% confidence interval [CI]: 1.17-2.53, p = 0.006), and the association with CV death was of similar magnitude (HR: 1.60, 95% CI: 0.91-2.81, p = 0.105). CHF patients had more episodes of hospitalization due to heart failure (HR: 2.93, 95% CI: 1.49-5.76, p < 0.01). However, compared with patients without CHF, the all-cause hospitalization risk was not much higher in CHF patients (HR: 1.09, 95% CI: 0.90-1.33, p = 0.39). Subgroup analysis found that the effect of CHF on all-cause mortality was stronger for male patients, patients with residual renal function, the elderly (≥60 years of age), patients with arteriovenous fistulae vascular accesses, nondiabetic patients, low-flux dialyzer users, and inadequately dialyzed patients (standardized Kt/V <2). In HD patients, CHF was found to be associated with a higher risk of all-cause mortality and cause-specific hospitalization risk. Further research is needed to identify opportunities to improve care for HD patients combined with CHF.

Serum Phosphorus Level Rises in US Hemodialysis Patients Over the Past Decade: A DOPPS Special Report

Mineral bone disorder (MBD) is a frequent consequence of chronic kidney disease, more so in patients with kidney failure treated by kidney replacement therapy. Despite the wide availability of interventions to control serum phosphate and parathyroid hormone levels, unmet gaps remain on optimal targets and best practices, leading to international practice pattern variations over time. In this Special Report, we describe international trends from the Dialysis Outcomes and Practice Patterns Study (DOPPS) for MBD biomarkers and treatments from 2002-2021, including data from a group of 7 European countries (Belgium, France, Germany, Italy, Spain, Sweden, United Kingdom), Japan, and the United States. From 2002-2012, mean phosphate levels declined in Japan (5.6 to 5.2mg/dL), Europe (5.5 to 4.9mg/dL), and the United States (5.7 to 5.0mg/dL). Since then, levels rose in the United States (to mean 5.6mg/dL, 2021), were stable in Japan (5.3mg/dL), and declined in Europe (4.8mg/dL). In 2021, 52% (United States), 27% (Europe), and 39% (Japan) had phosphate>5.5mg/dL. In the United States, overall phosphate binder use was stable (80%-84% over 2015-2021), and parathyroid hormone levels rose only modestly. Although these results potentially stem from pervasive knowledge gaps in clinical practice, the noteworthy steady increase in serum phosphate in the United States over the past decades may be consequential to patient outcomes, an uncertainty that hopefully will soon be addressed by ongoing clinical trials. The DOPPS will continue to monitor international trends as new interventions and strategies ensue for MBD management in chronic kidney disease.

Hepatitis C Prevalence, Incidence, and Treatment in Chinese Hemodialysis Patients: Results From the Dialysis Outcomes and Practice Patterns Study-China (2019-21).

BackgroundPrior work from the Dialysis Outcomes and Practice Patterns Study (DOPPS) showed HCV prevalence in China in 2012–2015 being in the upper third and HCV incidence the 2nd highest among 15 different countries/regions investigated. The goal of the present investigation was to: (1) determine if HCV prevalence and incidence has changed, and (2) collect detailed data to understand how HCV is treated, monitored, and managed in Chinese HD facilities and non-dialysis chronic kidney disease (CKD) clinics.Data and MethodsDetailed data for 1,700 randomly selected HD patients were reported by 39 randomly selected HD facilities from Beijing, Shanghai, and Guangzhou participating in the DOPPS 7-China study from 2019 to 2021. The study site medical directors completed a survey regarding numerous aspects of HCV treatment and management in HD and ND-CKD patients.ResultsIn this 2019 to 2021 cohort, HCV prevalence was 7.4%, which was lower than the 14.8 and 11.5% HCV prevalence for the 2009–2011 and 2012–2015 cohorts, respectively. HCV incidence of 1.2 cases per 100 pt-yrs also was lower compared to the incidence of 2.1 for the 2012–2015 cohort. Although the great majority of study site medical directors indicated that all or nearly HCV+ patients should be treated for their HCV, very few HCV+ patients have been treated presumably due to substantial cost barriers for affording the new direct acting antivirals (DAAs). The randomly selected facilities in our DOPPS 7-China study appear to have excellent programs in place for frequent monitoring of patients and staff for HCV, education of staff, and referral of HCV cases to external infectious disease, gastroenterology, and liver disease specialists. Liver biopsies were not commonly performed in HCV+ HD patients. HCV genotyping also was rarely performed in participating units.ConclusionsOur study indicates a 50% decline in HCV prevalence and a >40% decline in HCV incidence in Chinese HD patients over the past 10–12 yrs. Chinese HD facilities and associated specialists appear to be well-equipped and organized for successfully treating and managing their HCV+ HD and CKD patients in order to achieve the WHO goal of eliminating HCV by 2030.

MO863: Electronic Patient Reported Outcome (EPRO) Collection in Dopps: Prospective Study Designed to Understand the Severity and Temporal Changes in Pruritus Symptoms in Hemodialysis Patients

Abstract BACKGROUND AND AIMS Chronic kidney disease-associated pruritus (CKD-aP) is often seen to affect 30–40% of hemodialysis (HD) patients, and baseline CKD-aP symptoms have been associated with worse quality of life, poor sleep quality, depression and survival. A need exists for documenting CKD-aP severity longitudinally via several CKD-aP instruments to allow for temporal evaluation of different domains of CKD-aP burden, and their relationships to other patient-reported outcomes (PROs). This will help to further inform the extent to which different domains of well-being are impacted by CKD-aP over time, and its variability across patients, for tailoring individualized clinical care of HD patients afflicted by CKD-aP. The Dialysis Outcomes and Practice Patterns Study (DOPPS) is an international prospective cohort of adult in-centre HD patients, with patients randomly selected from representative national samples of HD facilities. Many prior studies by DOPPS and others have used only a baseline measure of CKD-aP, which may underestimate the strength of the true associations with clinical outcomes. With more frequent data collection to update exposures and understand trajectories, we can better evaluate the extent to which CKD-aP is episodic versus chronic. We can also assess whether patients with more consistently severe CKD-aP have worse PROs than patients who are currently—but only recently—bothered by CKD-aP. These gaps in knowledge present an opportunity to undertake a prospective study to link longitudinal clinical data with focused and frequent capture of CKD-aP and PROs to better understand the prevalence, burden and management of CKD-aP from HD patients’ perspectives. METHOD This prospective electronic PRO (ePRO) study involves &amp;gt;100 HD units from the 7 European countries participating in DOPPS 7 (Belgium, France, Germany, Italy, Spain, Sweden, UK). The ePRO will be distributed at HD facilities at 3-month intervals during an 18-month data collection period from 2021–3. The ePRO will be offered to all patients enrolled in the DOPPS, yielding a potential sample of 2000–500 patients based on expected participation and return rates (∼67%). The ePRO data collection is focused on use of mobile (tablet, phone) devices used frequently by patients, but will also be operational on a desktop or laptop computer. Patients will use their personal device to scan a unique QR code, and typically complete the questionnaire while on site at their HD facility. The ePRO will include a combination of validated CKD-aP scales, general quality of life related instruments and healthcare resource utilization (HCRU), i.e. patient reported capture of itch medications and specialist visits known to the patient but not typically in the dialysis chart. A complete list of the ePRO components is shown in Table 1. These ePRO data, together with linked longitudinal clinical data captured in DOPPS, will serve as the analytical basis for several planned research projects, including (i) comparing approaches to measure CKD-aP burden; (ii) describing within-patient trajectories of CKD-aP burden and associations with PROs; and (iii) CKD-aP and short-term outcomes including HCRU, hospitalization and mortality in the 3-months following each CKD-aP assessment. RESULTS Data collection is underway as of August 2021, with initial data expected in early 2022. While not yet available, we expect to present preliminary descriptive data at the ERA-EDTA in May 2022. CONCLUSION The community lacks longer-term, frequently captured data on pruritus severity and management in the HD setting. This DOPPS 18-month prospective ePRO will help address novel research questions investigating the longitudinal burden of pruritus from the patient perspective, using multiple validated instruments and relationships to PROs, clinical outcomes and healthcare resource utilization.

MO829: Hepatitis C Prevalence, Incidence and Treatment in Chinese Hemodialysis Patients: Results From the Dialysis Outcomes and Practice Patterns Study-China (2019–21)

Abstract BACKGROUND AND AIMS Prior work from the Dialysis Outcomes and Practice Patterns Study (DOPPS) showed the HCV incidence and prevalence in China in 2012–15 to be the second highest and upper third, respectively, among 15 different countries/regions. With direct-acting antivirals (DAA) approved in 2017 in China, we have utilized the DOPPS-China study to: (1) determine if HCV prevalence and incidence in Chinese HD patients has changed after DAAs became available and (2) to understand how HCV is treated, monitored and managed in Chinese HD facilities and non-dialysis chronic kidney disease (CKD) clinics. METHOD Detailed data for 1700 HD patients were collected from 39 randomly selected HD facilities in Beijing, Shanghai and Guangzhou participating in the DOPPS 7-China study (2019–21). Study site medical directors completed a survey regarding HCV treatment and management practices for HD and ND-CKD patients. HCV prevalence was calculated based on an initial cross-section (n = 1279) of study patients, and HCV incidence was based on 1197 patients who were HCV negative at baseline, had ≥2 HCV antibody measurements during follow-up, and were treated in facilities accepting HCV + patients. The median study follow-up was 1.2 years. RESULTS HCV prevalence in this 2019–21 cohort was 7.4% (Table 1), which was &amp;lt;14.8% and 11.5% HCV prevalences reported in DOPPS-China for the 2009–11 and 2012–5 cohorts, respectively (Jadoul et al. 2019). HCV incidence was also lower in the 2019–21 cohort (1.2 cases/100 pt-years) versus that in the 2012–5 cohort (2.1 cases/100 pt-years). Although nearly all study site medical directors indicated that all or nearly all HCV + patients should be treated for HCV (data not shown), medical directors indicated that relatively few HCV + patients have been treated as yet at most dialysis units (Table 2). The DOPPS 7-China study appeared to have excellent programs in place for frequent monitoring of patients and staff for HCV, education of staff and referral of HCV cases in most HD units to infectious disease, gastroenterology and liver disease specialists. Liver biopsies were not commonly performed in HCV + HD patients. HCV genotyping was also rarely performed. Admittedly, data were not collected from the specialist clinics where genotyping may have occurred. CONCLUSION HCV continues to be prevalent among Chinese HD patients despite the prevalence appearing to be lower now than that seen in the 2009–15 DOPPS-China cohorts. However, most HCV + HD patients remain untreated, which may be due to financial/cost reimbursement barriers and patients’ non-acceptance of HCV treatment. If such barriers can be overcome, then Chinese HD facilities and associated specialists, as described here in DOPPS 7, appear to be well-equipped and organized to successfully treating and managing their HCV + HD and CKD patients in order to achieve the WHO goal of eliminating HCV by 2030.

MO901: Longitudinal Pruritus Assessment in Hemodialysis Patients: 1-Year Course of Symptoms and Associations With Clinical and Patient-Reported Outcomes

Abstract BACKGROUND AND AIMS The burden of chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis (HD) patients, and its association with adverse clinical events and patient-reported outcomes (PROs) has been well-established. However, most studies focus on a single baseline CKD-aP assessment. In this study, we quantify the extent to which pruritus symptoms vary &amp;gt;1 year, and relationship with associated clinical and patient-reported outcomes. METHOD We included 7976 HD patients across 21 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS) phases 4–6 (2009–18) who had 2 CKD-aP assessments 12 months (±6 months) apart, with concurrent PRO collection. CKD-aP intensity was assessed by a single question in the KDQOL-36 asking about the extent patients were bothered by itch over the past 4 weeks. We categorized patients into 4 groups—those at least moderately (versus somewhat or not at all) bothered by itchy skin in Year 1 only (Yes/No), Year 2 only (No/Yes), neither (No/No), or both (Yes/Yes) time points. Difference-in-difference analyses were used to estimate changes in laboratory values and PROs between Years 1 and 2, by within-patient changes in CKD-aP severity. Cox regression was used to estimate rates of mortality and hospitalization, with follow-up starting after the Year 2 CKD-aP assessment, across the 4 exposure groups, adjusted for confounders. RESULTS Half of the patients were at least moderately bothered by pruritus over the course of 1 year: 22% of patients were at least moderately bothered by CKD-aP at each annual assessment (Yes/Yes); 14% each were bothered at Year 1 only (Yes/No) or Year 2 only (No/Yes); 49% were not bothered at either CKD-aP assessment (No/No). These proportions were similar across DOPPS regions. Changes in laboratory values—including calcium, phosphorus, parathyroid hormone (PTH), albumin, hemoglobin, single pool Kt/V—between Years 1 and 2 varied minimally by within-patient changes in CKD-aP. Changes in some targeted PROs (depression, sleep quality, feeling faint or drained) tracked closely with changes in CKD-aP: the proportion of patients reporting &amp;gt; = 3 nights/week of restless sleep increased from 38% to 48% in the No/Yes group, decreased from 48% to 40% in the Yes/No group, and was unchanged between Years 1 and 2 in the No/No and Yes/Yes groups (Table 1). Changes in more general PROs (physical [PCS] and mental [MCS] component summary scores) were modest, and only varied by 2–3 points across the 4 CKD-aP exposure groups. The all-cause mortality HR (95% confidence interval), compared with the No/No reference group, was 1.22 (0.99–1.51) for Yes/No, 1.32 (1.07–1.63) for No/Yes and 1.31 (1.11–1.56) for Yes/Yes. Results for hospitalization and other clinical outcomes are shown in Figure 1. CONCLUSION Our findings indicate that half of chronic HD patients were at least moderately bothered by CKD-aP at some point over the course of 1 year, reflecting an unmet medical need, and that CKD-aP symptoms remained unresolved 12 months later for the majority of HD patients who were bothered by itchy skin at baseline, highlighting the chronic nature of the condition. The trend towards worse patient-reported outcomes for those affected in Year 2 but not Year 1 implicates the consequences of patients’ significant adjustment to this new, often unrelenting, symptom. Those with chronic pruritus had higher rates of hospitalization and cardiovascular events, underscoring the impact of patients with chronic pruritus on hospital systems. Moreover, those affected by pruritus at any point in the year had higher rates of mortality, further highlighting the importance of diagnosing pruritus and investigating its effect on cardiovascular events. Future research should investigate potential causes of CKD-aP symptoms more systematically and focus on how potential treatments can aide in patients’ relief.

MO900: Diuretic Prescription Patterns in Haemodialysis Patients: International Variation Reported in the Dopps

Abstract BACKGROUND AND AIMS Loop diuretic use during maintenance haemodialysis (HD), including use of very high doses in Europe, is thought to maintain diuresis and reduce interdialytic weight gain, but is based on little evidence, with impact on clinical outcomes unclear. To help better inform international therapeutic strategies, we investigate regional variation in loop diuretic use and dosing strategies. METHOD This study included 71 756 HD patients from the international Dialysis Outcomes and Practice Patterns Study (DOPPS) phases 2–5 (2002–15), including 27 759 patients with dialysis vintage (time since HD initiation) &amp;lt;1 year. We report the proportion of patients in each country prescribed a diuretic (loop, thiazide or other) by dialysis vintage. Among patients with vintage &amp;lt; 1 year at enrollment and prescribed a loop diuretic, we report the distribution of loop diuretic dose (mg/day) by country. Doses of torsemide (4:1) and bumetanide (80:1) were converted to oral furosemide-equivalent dose. RESULTS Diuretic use varied widely by country, ranging at vintage &amp;lt; 3 months from &amp;gt;80% in Germany and Sweden to &amp;lt; 35% in the US, Spain, and Gulf Cooperation Council (GCC) countries (Figure 1). The proportion of patients prescribed a diuretic decreased with dialysis vintage in all countries. At vintage &amp;gt;5 years, diuretic use was 30%–35% in Germany and Sweden and &amp;lt; 20% in other countries. In all countries, &amp;gt;90% of diuretic prescriptions were for loop diuretics. Loop diuretic dose varied widely across countries. Among patients with vintage &amp;lt; 1 year, median dose ranged from 400–500 mg/day in Belgium, France, Germany and Sweden to &amp;lt; 100 mg/day in the GCC, Japan, Spain and the US (Figure 2). CONCLUSION We observed substantial international differences in diuretic prescription patterns to HD patients, with usage and doses much higher in some European countries than the US, where high-dose formulations are not available. The potential impact of diuretic prescription patterns on outcomes, including residual urine volume, volume-related complications and others should be investigated.

The COVID-19 Pandemic Identifies Significant Global Inequities in Hemodialysis Care in Low and Lower-Middle Income Countries—An ISN/DOPPS Survey

IntroductionIt is unknown how the COVID-19 pandemic has affected the care of vulnerable chronic hemodialysis (HD) patients across regions, particularly in low and lower-middle income countries (LLMICs). We aimed to identify global inequities in HD care delivery during the COVID-19 pandemic.MethodsThe ISN and the Dialysis Outcomes and Practice Patterns Study (DOPPS) conducted a global online survey of HD units between March and November, 2020, to ascertain practice patterns and access to resources relevant to HD care during the COVID-19 pandemic. Responses were categorized according to World Bank income classification for comparisons.ResultsSurveys were returned from 412 facilities in 78 countries: 15 (4%) in low-income countries (LICs), 111 (27%) in lower-middle income countries (LMICs), 145 (35%) in upper-middle income countries (UMICs), and 141 (34%) in high-income countries (HICs). Respondents reported that diagnostic tests for SARS-CoV-2 were unavailable or of limited availability in LICs (72%) and LMICs (68%) as compared with UMICs (33%) and HICs (20%). The number of patients who missed HD treatments was reported to have increased during the COVID-19 pandemic in LICs (64%) and LMICs (67%) as compared with UMICs (31%) and HICs (6%). Limited access to HD, intensive care unit (ICU) care, and mechanical ventilation among hospitalized patients on chronic dialysis with COVID-19 were also reportedly higher in LICs and LMICs as compared with UMICs and HICs. Staff in LLMICs reported less routine testing for SARS-CoV-2 when asymptomatic as compared with UMICs and HICs—14% in LICs and 11% in LMICs, compared with 26% and 28% in UMICs and HICs, respectively. Severe shortages of personal protective equipment (PPE) were reported by the respondents from LICs and LMICs compared with UMICs and HICs, especially with respect to the use of the N95 particulate-air respirator masks.ConclusionStriking global inequities were identified in the care of chronic HD patients during the pandemic. Urgent action is required to address these inequities which disproportionately affect LLMIC settings thereby exacerbating pre-existing vulnerabilities that may contribute to poorer outcomes.

Diabetes Prevalence, Treatment, Control, and Outcomes Among Hemodialysis Patients in the Gulf Cooperation Council Countries

IntroductionDiabetes mellitus (DM) is a leading cause of end-stage kidney disease (ESKD). We provide the first description of DM prevalence, related outcomes, and the hemoglobin A1c (HbA1c)/mortality relationship in national hemodialysis (HD) patient samples across the Gulf Cooperation Council (GCC) countries.MethodsWe analyzed data from the prospective Dialysis Outcomes and Practice Patterns Study (DOPPS) in the GCC (2012–2018, N = 2274 HD patients ≥18 years old). Descriptive statistics were calculated, and all-cause mortality was analyzed for patients with DM versus without DM and by HbA1c levels in patients with DM by Cox regression with progressive confounder adjustments.ResultsDM in the GCC ranged from 45% to 74% in patients with HD by country. Patients with DM were 13 years older (59.9 vs. 46.7 years) and had greater body mass index (BMI), shorter median years on dialysis (1.5 vs. 3.0 years), and higher comorbidity burden. In patients with DM, insulin use was 26% to 50% across countries, with variable oral antidiabetic drug use (2%–32%); median HbA1c levels were 6.1% to 7.5% across countries. Patients with DM (vs. without DM) had higher crude death rates (15.6 vs. 6.2 deaths per 100 patient-years, mean follow-up 1.3 years) and adjusted mortality (hazard ratio [HR] = 1.72 [95% CI 1.23–2.39]). In patients with DM, mortality was lowest at HbA1c 6.5% to 7.5%, with mortality particularly elevated at high HbA1c >9% (HR = 2.13 [95% CI 1.10–4.10]).ConclusionPatients with DM in the GCC have high comorbidity burden and mortality rates despite a relatively young mean age. In GCC countries, a holistic strategy for improving diabetes care and outcomes for HD patients is needed at the primary, secondary, and tertiary levels.

Sex differences in clinical outcomes in Japanese incident dialysis patients: a prospective observational multicenter study.

A Dialysis Outcomes and Practice Patterns Study (DOPPS) has shown a one-to-one male-to-female mortality ratio, notwithstanding the statistically longer life expectancy of women in the general population. This finding contrasts with the recent report that Japanese women on dialysis treatment have a more favorable longevity. Accordingly, we further investigated the clinical procedures and outcomes to clarify the sex differences in Japanese patients undergoing dialysis treatment. Subjects were incident dialysis patients who participated in a multicenter prospective cohort study from October 2011 to September 2013. The all-cause mortality was analyzed by a Cox proportional hazard regression model and studied separately in women and men with or without cardiovascular disease (CVD) at baseline. Overall, 492 (32.3%) of the 1520 test subjects were women. All-cause mortality was higher in men (28.6%) than in women (19.9%, p < 0.001). Female sex (hazard ratio [HR]: 0.70, 95% confidence interval [CI]: 0.54-0.90) and history of CVD (HR: 1.51, 95% CI: 1.18-1.95) were independent predictors of all-cause mortality. In patients without CVD, female gender was strong independent contributor (HR = 0.46, 95% CI: 0.30-0.70, p < 0.001). In contrast, patients with CVD showed no difference in survival between the sexes (HR: 0.92, 95% CI: 0.67-1.24, p = 0.597). Our study demonstrated that women undergoing chronic dialysis therapy had a lower mortality risk than men. However, complication with CVD canceled out the survival advantage in Japanese women on chronic dialysis. We should reevaluate the risk of women with CVD undergoing dialysis and apply the optimal care for CVD.

The prevalence of predialysis hyperkalemia and associated characteristics among hemodialysis patients: The RE-UTILIZE study.

IntroductionHyperkalemia (HK), defined as serum potassium (K+) >5.0 mEq/L, is an independent predictor of mortality in patients on maintenance hemodialysis (HD). This study investigated the annual prevalence of HK and examined patient characteristics potentially associated with a higher annual HK prevalence.MethodsThis retrospective observational cohort study used Dialysis Outcomes and Practice Patterns Study (DOPPS) survey data from US patients undergoing in‐center HD thrice weekly from 2018 to 2019. The primary endpoint was the proportion of patients with any predialysis HK (K+ >5.0 mEq/L) within 1 year from the index date (date of DOPPS enrollment), using the first hyperkalemic K+ value. Secondary endpoints were the proportion of patients with moderate‐to‐severe (K+ >5.5 mEq/L) or severe (K+ >6.0 mEq/L) HK.FindingsOverall, 9347 patients on HD were included in this analysis (58% male and 49% aged >66 years). Any predialysis HK (K+ >5.0 mEq/L) occurred in 74% of patients within 1 year of the index date, 52% within 3 months, and 38% within 1 month. The annual prevalence of moderate‐to‐severe and severe HK was 43% and 17%, respectively. Recurrent HK (at least two K+ >5.0 mEq/L within 1 year) occurred in 60% of patients, and 2.8% of patients were prescribed an oral K+ binder. Multivariable logistic regression analysis showed younger age, female sex, Hispanic ethnicity, and renin–angiotensin–aldosterone system inhibitor use were significantly associated with a higher annual prevalence of any predialysis HK, while Black race, obesity, recent initiation of HD, and dialysate K+ bath concentration ≥3 mEq/L were associated with a lower prevalence of HK.DiscussionThe annual prevalence of predialysis HK and recurrence were high among US patients on HD, whereas oral K+ binder use was low. Further studies are needed to understand the impact of dialysate K+ bath concentrations on predialysis HK among patients on HD.

Routinely measured cardiac troponin I and N-terminal pro-B-type natriuretic peptide as predictors of mortality in haemodialysis patients.

AimsCardiac troponin (cTn) and B‐type natriuretic peptide (BNP) are elevated in haemodialysis (HD) patients, and this elevation is associated with HD‐induced myocardial stunning/myocardial strain. However, studies using data from the international Dialysis Outcomes and Practice Patterns Study (DOPPS) have shown that these cardiac biomarkers are measured in <2% of HD patients in real‐world practice. This study aimed to examine whether routinely measured N‐terminal pro‐BNP (NT‐proBNP) and cTnI (contemporary assay) are more appropriate than clinical models for reclassifying the risk of HD patients who have the highest risk of death.Methods and resultsPre‐dialysis levels of cTnI and NT‐proBNP at study enrolment were measured in 1152 HD patients (Japan DOPPS Phase 5). The patients were prospectively followed for 3 years. Cox regression was used to test the associations of cardiac biomarkers with all‐cause mortality, adjusting for potential confounders. Subgroup analyses were performed to assess potential effect modification of clinical characteristics, such as age, systolic blood pressure, HD vintage, diabetes mellitus, coronary artery disease, and a history of congestive heart failure. At baseline, 337 (29%) patients had elevated cTnI (99th percentile of a healthy population: >0.04 ng/mL) with a median (inter‐quartile range) level of 0.020 (0.005–0.041) ng/mL, and 1140 (99%) patients had elevated NT‐proBNP (cut‐off for heart failure: >125 pg/mL) with a median level of 3658 (1689–9356) pg/mL. There were 167 deaths during a median follow‐up of 2.8 (2.2–2.8) years. Higher levels of both cardiac biomarkers were incrementally associated with mortality after adjustment for potential confounders. Even after adjustment for alternative cardiac biomarkers, the overall P value for the association was <0.01 for both biomarkers. However, the prognostic significance of NT‐proBNP was moderately diminished when cTnI was added to the model. The hazard ratios of mortality for cTnI > 0.04 ng/mL (vs. cTnI < 0.006 ng/mL) and NT‐proBNP > 8000 pg/mL (vs. NT‐proBNP < 2000 pg/mL) were 2.56 (95% confidence interval: 1.37–4.81) and 1.90 (95% confidence interval: 0.95–3.79), respectively. Subgroup analyses showed that the associations of both cardiac biomarkers with mortality were generally consistent between stratified groups.ConclusionsRoutinely measured NT‐proBNP and cTnI levels are strongly associated with mortality among prevalent HD patients. These associations remain robust, even after adjustment for alternative biomarkers, suggesting that cTnI and NT‐proBNP have identical prognostic significance and may reflect different pathological aspects of cardiac abnormalities.

Thrombocytopenia predicts mortality in Chinese hemodialysis patients- an analysis of the China DOPPS

BackgroundHemodialysis (HD) patients have a higher mortality rate compared with general population. Our previous study revealed that platelet counts might be a potential risk factor. The role of platelets in HD patients has rarely been studied. The aim of this study is to examine if there is an association of thrombocytopenia (TP) with elevated risk of all-cause mortality and cardiovascular (CV) death in Chinese HD patients.MethodsData from a prospective cohort study, China Dialysis Outcomes and Practice Patterns Study (DOPPS) 5, were analyzed. Demographic data, comorbidities, platelet counts and other lab data, and death records which extracted from the medical record were analyzed. TP was defined as the platelet count below the lower normal limit (< 100*109/L). Associations between platelet counts and all-cause and CV mortality were evaluated using Cox regression models. Stepwise multivariate logistic regression was used to identify the independent associated factors, and subgroup analyses were also carried out.ResultsOf 1369 patients, 11.2% (154) had TP at enrollment. The all-cause mortality rates were 26.0% vs. 13.3% (p < 0.001) in patients with and without TP. TP was associated with higher all-cause mortality after adjusted for covariates (HR:1.73,95%CI:1.11,2.71), but was not associated with CV death after fully adjusted (HR:1.71,95%CI:0.88,3.33). Multivariate logistic regression showed that urine output < 200 ml/day, cerebrovascular disease, hepatitis (B or C), and white blood cells were independent impact factors (P < 0.05). Subgroup analysis found that the effect of TP on all-cause mortality was more prominent in patients with diabetes or hypertension, who on dialysis thrice a week, with lower ALB (< 4 g/dl) or higher hemoglobin, and patients without congestive heart failure, cerebrovascular disease, or hepatitis (P < 0.05).ConclusionIn Chinese HD patients, TP is associated with higher risk of all-cause mortality, but not cardiovascular mortality. Platelet counts may be a useful prognostic marker for clinical outcomes among HD patients, though additional study is needed.