Publications by authors named "Brian Bieber"

88 Publications

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

ESC Heart Fail 2022 Jan 13. Epub 2022 Jan 13.

Fukuoka Renal Clinic, Fukuoka, Japan.

Aims: Cardiac 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 Results: Pre-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.

Conclusions: Routinely 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.
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http://dx.doi.org/10.1002/ehf2.13784DOI Listing
January 2022

The global impact of the Coronavirus 2019 pandemic on in-centre haemodialysis services: an International Society of Nephrology -Dialysis Outcomes Practice Patterns Study survey.

Kidney Int Rep 2021 Dec 13. Epub 2021 Dec 13.

Population Health Sciences, Bristol Medical School, University of Bristol, United Kingdom.

Introduction: To assess the impact of the COVID-19 pandemic impact on haemodialysis centres, The Dialysis Outcomes and Practice Patterns Study and International Society of Nephrology (ISN) collaborated on a web-survey of centres.

Methods: A combined approach of random sampling and open invitation was used between March 2020 and March 2021. Responses were obtained from 412 centres in 78 countries and all 10 ISN regions.

Results: In 8 regions, rates of SARS-CoV-2 infection were <20% in most centres, but in North East Asia and Newly Independent States and Russia rates were ≥20% and ≥30%, respectively. Mortality was ≥10% in most centres in 8 regions, though lower in North America and Caribbean and North East Asia. Diagnostic testing was not available in 33%, 37%, and 61% of centres in Latin America, Africa, and East and Central Europe, respectively. Surgical masks were widely available, but severe shortages of particulate-air filter masks were reported in Latin America (18%) and Africa (30%). Rates of infection in staff ranged from 0% in 90% of centres in North East Asia to ≥50% in 63% of centres in the Middle East and 68% of centres in Newly Independent States and Russia. In most centres <10% of staff died, but in Africa and South Asia 2% and 6% of centres reported ≥50% mortality, respectively.

Conclusion: There has been wide global variation in SARS-CoV-2 infection rates amongst haemodialysis patients and staff, PPE availability, and testing, and the ways in which services have been redesigned in response to the pandemic.
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http://dx.doi.org/10.1016/j.ekir.2021.12.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8684834PMC
December 2021

Representativeness of the PDOPPS cohort compared to the Australian PD population.

Perit Dial Int 2021 Nov 10:8968608211056242. Epub 2021 Nov 10.

Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.

Background: The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is an international, prospective study following persons treated by peritoneal dialysis (PD) to identify modifiable practices associated with improvements in PD technique and person survival. The aim of this study was to assess the representativeness of the Australian cohort included in PDOPPS compared to the complete Australian PD population, as reported to the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry.

Methods: Adults with at least one PD treatment reported to ANZDATA Registry during the census period of PDOPPS Phase I (November 2014 to April 2018) were compared to the Australian PDOPPS cohort. The primary outcomes were the representativeness of centres and persons. Secondary outcomes explored the association of person characteristics with consent to study participation.

Results: After data linkage, 511 PDOPPS participants were compared to 5616 Australians treated with PD. Within centres eligible for PDOPPS, selected centres were similar to other Australian centres. The PDOPPS participants' cohort tended to include older persons, more males, a higher proportion of Caucasians and more persons with higher socioeconomic advantage compared to the Australian PD population. Differences in distribution across sex and ethnicities between the PDOPPS cohort and the overall PD population were in part due to the selection and consent processes, during which females and non-Caucasians were more likely to not consent to PDOPPS participation.

Conclusion: Sampling methods used in PDOPPS allowed for good national representativeness of the included centres. However, representativeness of the unweighted PDOPPS sample was suboptimal in regard to some participant characteristics.
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http://dx.doi.org/10.1177/08968608211056242DOI Listing
November 2021

Changes in practice patterns in Japan from before to after JSDT 2013 guidelines on hemodialysis prescriptions: results from the JDOPPS.

BMC Nephrol 2021 Oct 14;22(1):339. Epub 2021 Oct 14.

Arbor Research Collaborative for Health, Ann Arbor, USA.

Background: The Japanese Society for Dialysis Therapy (JSDT) published in 2013 inaugural hemodialysis (HD) guidelines. Specific targets include 1.4 for single-pool Kt/V (spKt/V) with a minimum dose of 1.2, minimum dialysis session length of 4 hours, minimum blood flow rate (BFR) of 200 mL/min, fluid removal rate no more than 15 mL/kg/hr, and hemodiafiltration (HDF) therapy for certain identified symptoms. We evaluated the effect of these guidelines on actual practice in the years spanning 2005 - 2018.

Methods: Analyses were carried out to describe trends in the above HD prescription practices from December 2005 to April 2013 (before guideline publication) to August 2018 based on prevalent patient cross-sections from approximately 60 randomly selected HD facilities participating in the Japan Dialysis Outcomes and Practice Patterns Study.

Results: From April 2006 to August 2017 continual rises occurred in mean spKt/V (from 1.35 to 1.49), and percent of patients having spKt/V>1.2 (71% to 85%). Mean BFR increased with time from 198.3 mL/min (April 2006) to 218.4 mL/min (August 2017) , along with percent of patients with BFR >200 ml/min (65% to 85%). HDF use increased slightly from 6% (April 2006 and August 2009) to 8% by April 2013, but increased greatly thereafter to 23% by August 2017. In contrast, mean HD treatment time showed little change from 2006-2017, whereas mean UFR declined from 11.3 in 2006 to 8.4 mL/Kg/hour in 2017.

Conclusions: From 2006 - 2018 Japanese HD patients experienced marked improvement in reaching the spKt/V target specified by the 2013 JSDT guidelines. This may have been due to moderate increase in mean BFR even though mean HD session length did not change much. In addition, HDF use increased dramatically in this time period. Other HD delivery changes during this time, such as increased use of super high flux dialyzers, also merit study. While we cannot definitively conclude a causal relationship between the publication of the guidelines and the subsequent practice changes in Japan, those changes moved practice closer to the recommendations of the guidelines.
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http://dx.doi.org/10.1186/s12882-021-02543-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518149PMC
October 2021

Prescription of Direct Oral Anticoagulants to Patients With Moderate-to-Advanced CKD: Too Little or Just Right?

Kidney Int Rep 2021 Sep 12;6(9):2496-2500. Epub 2021 Jun 12.

Clinical Epidemiology Team, CESP (Centre de recherche en Epidémiologie et Santé des Populations), Université Paris-Saclay, UVSQ, Inserm, Villejuif, France.

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http://dx.doi.org/10.1016/j.ekir.2021.06.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8418947PMC
September 2021

Serum Biomarkers of Iron Stores Are Associated with Increased Risk of All-Cause Mortality and Cardiovascular Events in Nondialysis CKD Patients, with or without Anemia.

J Am Soc Nephrol 2021 08 8;32(8):2020-2030. Epub 2021 Jul 8.

Arbor Research Collaborative for Health, Ann Arbor, Michigan.

Background: Approximately 30%-45% of patients with nondialysis CKD have iron deficiency. Iron therapy in CKD has focused primarily on supporting erythropoiesis. In patients with or without anemia, there has not been a comprehensive approach to estimating the association between serum biomarkers of iron stores, and mortality and cardiovascular event risks.

Methods: The study included 5145 patients from Brazil, France, the United States, and Germany enrolled in the Chronic Kidney Disease Outcomes and Practice Patterns Study, with first available transferrin saturation (TSAT) and ferritin levels as exposure variables. We used Cox models to estimate hazard ratios (HRs) for all-cause mortality and major adverse cardiovascular events (MACE), with progressive adjustment for potentially confounding variables. We also used linear spline models to further evaluate functional forms of the exposure-outcome associations.

Results: Compared with patients with a TSAT of 26%-35%, those with a TSAT ≤15% had the highest adjusted risks for all-cause mortality and MACE. Spline analysis found the lowest risk at TSAT 40% for all-cause mortality and MACE. Risk of all-cause mortality, but not MACE, was also elevated at TSAT ≥46%. Effect estimates were similar after adjustment for hemoglobin. For ferritin, no directional associations were apparent, except for elevated all-cause mortality at ferritin ≥300 ng/ml.

Conclusions: Iron deficiency, as captured by TSAT, is associated with higher risk of all-cause mortality and MACE in patients with nondialysis CKD, with or without anemia. Interventional studies evaluating the effect on clinical outcomes of iron supplementation and therapies for alternative targets are needed to better inform strategies for administering exogenous iron.
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http://dx.doi.org/10.1681/ASN.2020101531DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8455257PMC
August 2021

Beta-2 microglobulin and all-cause mortality in the era of high-flux hemodialysis: results from the Dialysis Outcomes and Practice Patterns Study.

Clin Kidney J 2021 May 27;14(5):1436-1442. Epub 2020 Oct 27.

Division of Nephrology, Michael's Hospital, University of Toronto, Toronto, ON, Canada.

Background: Beta-2 microglobulin (β2M) accumulates in hemodialysis (HD) patients, but its consequences are controversial, particularly in the current era of high-flux dialyzers. High-flux HD treatment improves β2M removal, yet β2M and other middle molecules may still contribute to adverse events. We investigated patient factors associated with serum β2M, evaluated trends in β2M levels and in hospitalizations due to dialysis-related amyloidosis (DRA), and estimated the effect of β2M on mortality.

Methods: We studied European and Japanese participants in the Dialysis Outcomes and Practice Patterns Study. Analysis of DRA-related hospitalizations spanned 1998-2018 ( = 23 976), and analysis of β2M and mortality in centers routinely measuring β2M spanned 2011-18 ( = 5332). We evaluated time trends with linear and Poisson regression and mortality with Cox regression.

Results: Median β2M changed nonsignificantly from 2.71 to 2.65 mg/dL during 2011-18 (P = 0.87). Highest β2M tertile patients (>2.9 mg/dL) had longer dialysis vintage, higher C-reactive protein and lower urine volume than lowest tertile patients (≤2.3 mg/dL). DRA-related hospitalization rates [95% confidence interval (CI)] decreased from 1998 to 2018 from 3.10 (2.55-3.76) to 0.23 (0.13-0.42) per 100 patient-years. Compared with the lowest β2M tertile, adjusted mortality hazard ratios (95% CI) were 1.16 (0.94-1.43) and 1.38 (1.13-1.69) for the middle and highest tertiles. Mortality risk increased monotonically with β2M modeled continuously, with no indication of a threshold.

Conclusions: DRA-related hospitalizations decreased over 10-fold from 1998 to 2018. Serum β2M remains positively associated with mortality, even in the current high-flux HD era.
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http://dx.doi.org/10.1093/ckj/sfaa155DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087125PMC
May 2021

Association between Dipeptidyl Peptidase-4 Inhibitor Prescription and Erythropoiesis-Stimulating Agent Hyporesponsiveness in Hemodialysis Patients with Diabetes Mellitus.

Kidney Blood Press Res 2021 22;46(3):352-361. Epub 2021 Apr 22.

Division of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.

Introduction: Dipeptidyl peptidase-4 (DPP-4) has been hypothesized to improve responsiveness to erythropoiesis-stimulating agent (ESA). We aimed to describe the trend in DPP-4 inhibitor prescription patterns and assess the association between DPP-4 inhibitor prescription and ESA hyporesponsiveness (eHypo) in Japanese hemodialysis (HD) patients with diabetes mellitus (DM).

Methods: We analyzed data from the Japan Dialysis Outcomes and Practice Patterns Study phase 4-6 (2009-2017) on patients with DM who underwent HD thrice per week for at least 4 months. The primary exposure of interest was having a DPP-4 inhibitor prescription. The primary analysis outcomes were a binary indicator of eHypo (mean hemoglobin <10 and mean ESA dose >6,000 units/week over 4 months) and the natural log-transformed ESA resistance index (ERI). We used conditional logistic regression to compare within-patient changes in eHypo before and after initial DPP-4 inhibitor prescription. We used linear generalized estimating equation models to compare continuous ERI outcomes while accounting for within-patient repeated measurements with an exchangeable correlation structure.

Results: There was a monotonic increase in DPP-4 inhibitor prescription according to study year up to 20% in 2017. Moreover, 12.8% of patients with a DPP-4 inhibitor prescription were ESA hyporesponsive before the initial DPP-4 inhibitor prescription. After DPP-4 inhibitor prescription, the odds of eHypo and mean log-ERI remained unchanged in the whole cohort of our study. The interaction analysis of DPP-4 inhibitor and sideropenia showed that DPP-4 inhibitors attenuated eHypo in the patients without iron deficiency.

Conclusion: Our findings indicate a recent increase in DPP-4 inhibitor prescription among Japanese HD patients with DM. DPP-4 inhibitors could improve ERI in patients undergoing HD without iron deficiency.
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http://dx.doi.org/10.1159/000515704DOI Listing
July 2021

Burden of Kidney Disease, Health-Related Quality of Life, and Employment Among Patients Receiving Peritoneal Dialysis and In-Center Hemodialysis: Findings From the DOPPS Program.

Am J Kidney Dis 2021 10 16;78(4):489-500.e1. Epub 2021 Apr 16.

St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. Electronic address:

Rationale & Objective: Individuals faced with decisions regarding kidney replacement therapy options need information on how dialysis treatments might affect daily activities and quality of life, and what factors might influence the evolution over time of the impact of dialysis on daily activities and quality of life.

Study Design: Observational cohort study.

Setting & Participants: 7,771 hemodialysis (HD) and peritoneal dialysis (PD) participants from 6 countries participating in the Peritoneal and Dialysis Outcomes and Practice Patterns Studies (PDOPPS/DOPPS).

Predictors: Patient-reported functional status (based on daily living activities), country, demographic and clinical characteristics, and comorbidities.

Outcome: Employment status and patient-reported outcomes (PROs) including Kidney Disease Quality of Life (KDQOL) instrument physical and mental component summary scores (PCS, MCS), kidney disease burden score, and depression symptoms (Center for Epidemiologic Studies Depression Scale [CES-D] score > 10).

Analytical Approach: Linear regression (PCS, MCS, kidney disease burden score), logistic regression (depression symptoms), adjusted for predictors plus 12 additional comorbidities.

Results: In both dialysis modalities, patients in Japan had the highest PCS and employment (55% for HD and 68% for PD), whereas those in the United States had the highest MCS score, lowest kidney disease burden, and lowest employment (20% in HD and 42% in PD). After covariate adjustment, the association of age, sex, dialysis vintage, diabetes, and functional status with PROs was similar in both modalities, with women having lower PCS and kidney disease burden scores. Lower functional status (score <11) was strongly associated with lower PCS and MCS scores, a much greater burden of kidney disease, and greater likelihood of depression symptoms (CES-D, >10). The median change in KDQOL-based PROs was negligible over 1 year in participants who completed at least 2 annual questionnaires.

Limitations: Selection bias due to incomplete survey responses. Generalizability was limited to the dialysis populations of the included countries.

Conclusions: Variation exists in quality of life, burden of kidney disease, and depression across countries but did not appreciably change over time. Functional status remained one of the strongest predictors of all PROs. Routine assessment of functional status may provide valuable insights for patients and providers in anticipating outcomes and support needs for patients receiving either PD or HD.
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http://dx.doi.org/10.1053/j.ajkd.2021.02.327DOI Listing
October 2021

Serum total indoxyl sulfate and clinical outcomes in hemodialysis patients: results from the Japan Dialysis Outcomes and Practice Patterns Study.

Clin Kidney J 2021 Apr 31;14(4):1236-1243. Epub 2020 Jul 31.

Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.

Background: Uremic toxins are associated with various chronic kidney disease-related comorbidities. Indoxyl sulfate (IS), a protein-bound uremic toxin, reacts with vasculature, accelerating atherosclerosis and/or vascular calcification in animal models. Few studies have examined the relationship of IS with clinical outcomes in a large cohort of hemodialysis (HD) patients.

Methods: We included 1170 HD patients from the Japan Dialysis Outcomes and Practice Patterns Study Phase 5 (2012-15). We evaluated the associations of serum total IS (tIS) levels with all-cause mortality and clinical outcomes including cardiovascular (CV)-, infectious- and malignancy-caused events using Cox regressions.

Results: The median (interquartile range) serum tIS level at baseline was 31.6 μg/mL (22.6-42.0). Serum tIS level was positively associated with dialysis vintage. Median follow-up was 2.8 years (range: 0.01-2.9). We observed 174 deaths (14.9%; crude rate, 0.06/year). Serum tIS level was positively associated with all-cause mortality [adjusted hazard ratio per 10 μg/mL higher, 1.16; 95% confidence interval (CI) 1.04-1.28]. Association with cause-specific death or hospitalization events, per 10 μg/mL higher serum tIS level, was 1.18 (95% CI 1.04-1.34) for infectious events, 1.08 (95% CI 0.97-1.20) for CV events and 1.02 (95% CI 0.87-1.21) for malignancy events after adjusting for covariates including several nutritional markers.

Conclusions: In a large cohort study of HD patients, serum tIS level was positively associated with all-cause mortality and infectious events.
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http://dx.doi.org/10.1093/ckj/sfaa121DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023193PMC
April 2021

Medical Director Practice of Advising Increased Dietary Protein Intake in Hemodialysis Patients With Hyperphosphatemia: Associations With Mortality in the Dialysis Outcomes and Practice Patterns Study.

J Ren Nutr 2021 Apr 2. Epub 2021 Apr 2.

Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.

Objectives: Patients undergoing hemodialysis (HD) may have poor nutritional status and hyperphosphatemia. Nephrologists sometimes manage hyperphosphatemia by prescribing phosphate binders and/or recommending restriction of dietary phosphate including protein-rich foods; the later may, however, adversely affect nutritional status.

Design And Methods: The analysis includes 8805 HD patients on dialysis ≥ 120 days in 12 countries in Dialysis Outcomes and Practice Patterns Study (DOPPS) phase 4 (2009-2011), from 248 facilities. The primary exposure variable was response to the following question: "For patients with serum albumin 3.0 g/dL and phosphate 6.0 mg/dL, do you recommend to (A) increase or (B) decrease/no change in dietary protein intake (DPI)?". The association between medical director's practice of recommending an increase in DPI and all-cause mortality was analyzed with Cox regression adjusted for potential confounders. Linear and logistic regressions were used to model the cross-sectional associations between DPI advice practice and intermediate markers of patient nutrition.

Results: Median follow-up was 1.6 years. In the case scenario, 91% of medical directors in North America had a practice of recommending DPI increase compared to 58% in Europe (range = 36%-83% across 7 countries) and 56% in Japan. The practice of advising DPI increase was weakly associated with lower mortality [HR (95% CI): 0.88 (0.76-1.02)]. The association tended to be stronger in patients with age 70+ years [HR (95% CI): 0.82 (0.69-0.97), P = .12 for interaction]. The practice of advising DPI increase was associated with 0.276 mg/dL higher serum creatinine levels (95% CI: 0.033-0.520) after adjustment for case mix.

Conclusions: Medical director's practice of recommending an increase in DPI for HD patients with low albumin and high phosphate levels was associated with higher serum creatinine levels and potentially lower all-cause mortality. To recommend protein intake liberalization in parallel with phosphate management by physicians may be a critical practice for better nutritional status and outcomes in HD patients.
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http://dx.doi.org/10.1053/j.jrn.2021.02.007DOI Listing
April 2021

Low Serum Potassium Levels and Clinical Outcomes in Peritoneal Dialysis-International Results from PDOPPS.

Kidney Int Rep 2021 Feb 22;6(2):313-324. Epub 2020 Nov 22.

St. Michael's Hospital, Toronto, Ontario, Canada.

Introduction: Hypokalemia, including normal range values <4 mEq/l, has been associated with increased peritonitis and mortality in patients with peritoneal dialysis. This study sought to describe international variation in hypokalemia, potential modifiable hypokalemia risk factors, and the covariate-adjusted relationship of hypokalemia with peritonitis and mortality.

Methods: Baseline serum potassium was determined in 7421 patients from 7 countries in the Peritoneal Dialysis Outcomes and Practice Patterns Study (2014-2017). Association of baseline patient and treatment factors with subsequent serum potassium <4 mEq/l was evaluated by logistic regression, whereas baseline serum potassium levels (4-month average and fraction of 4 months having hypokalemia) on clinical outcomes was assessed by Cox regression.

Results: Hypokalemia was more prevalent in Thailand and among black patients in the United States. Characteristics/treatments associated with potassium <4 mEq/l included protein-energy wasting indicators, lower urine volume, lower blood pressure, higher dialysis dose, greater diuretic use, and not being prescribed a renin-angiotensin system inhibitor. Persistent hypokalemia (all 4 months vs. 0 months over the 4-month exposure period) was associated with 80% higher subsequent peritonitis rates (at K <3.5 mEq/l) and 40% higher mortality (at K <4.0 mEq/l) after extensive case mix/potential confounding adjustments. Furthermore, adjusted peritonitis rates were higher if having mean serum K over 4 months <3.5 mEq/l versus 4.0-4.4 mEq/l (hazard ratio, 1.15 [95% confidence interval, 0.96-1.37]), largely because of Gram-positive/culture-negative infections.

Conclusions: Persistent hypokalemia is associated with higher mortality and peritonitis even after extensive adjustment for patient factors. Further studies are needed to elucidate mechanisms of these poorer outcomes and modifiable risk factors for persistent hypokalemia.
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http://dx.doi.org/10.1016/j.ekir.2020.11.021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879114PMC
February 2021

Association between self-reported appetite and clinical outcomes of peritoneal dialysis patients: Findings from a low middle-income country.

Nephrology (Carlton) 2021 May 10;26(5):454-462. Epub 2021 Mar 10.

Division of Nephrology, Department of Medicine, Chulalongkorn University, Bangkok, Thailand.

Aim: Patient-reported outcome measures (PROM) has gained international recognition as important predictors of clinical outcomes in peritoneal dialysis (PD). We sought to understand the associations between patient-reported appetite and clinical outcomes.

Methods: In the Thailand Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS), 690 of 848 randomly selected PD patients from 22 facilities reported their appetite by using the short form (three items) of the Appetite and Diet Assessment Tool (ADAT), between 2016 and 2018. In this questionnaire, the patients rated their appetite as well as a change in appetite over time. Cox proportional hazards model regression was used to estimating associations between self-reported appetite and clinical outcomes, including mortality, haemodialysis (HD) transfer and peritonitis.

Results: Half of the PD patients reported a good appetite, whereas 34% and 16% reported fair and poor appetites, respectively. Poor appetite was more prevalent among female, diabetic, congestive heart failure, older age and patients who had worse nutritional indicators, including lower time-averaged serum albumin and serum creatinine concentrations, as well as a higher proportions of hypokalaemia and severe hypoalbuminemia (serum albumin <3 g/dl). After adjusting for age, sex, comorbidities, and PD vintage, poor appetite was associated with increased risks of peritonitis (adjusted hazard ratio [HR] 1.73, 95% confidence interval [CI] 1.14-2.62), HD transfer (adjusted HR 2.25, 95% CI 1.24-4.10) and all-cause mortality (adjusted HR 1.60, 95% CI 1.08-2.39) compared to patients with good appetite.

Conclusion: Patient-reported poor appetite was independently associated with higher risks of peritonitis, HD transfer and all-cause mortality. This warrants further investigation to identify effective interventions.
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http://dx.doi.org/10.1111/nep.13859DOI Listing
May 2021

The combination of malnutrition-inflammation and functional status limitations is associated with mortality in hemodialysis patients.

Sci Rep 2021 01 15;11(1):1582. Epub 2021 Jan 15.

Arbor Research Collaborative for Health, Ann Arbor, MI, USA.

The identification of malnutrition-inflammation-complex (MIC) and functional status (FS) is key to improving patient experience on hemodialysis (HD). We investigate the association of MIC and FS combinations with mortality in HD patients. We analyzed data from 5630 HD patients from 9 countries in DOPPS phases 4-5 (2009-2015) with a median follow-up of 23 [IQR 11, 31] months. MIC was defined as serum albumin < 3.8 g/dL and serum C-reactive protein > 3 mg/L in Japan and > 10 mg/L elsewhere. FS score was defined as the sum of scores from the Katz Index of Independence in Activities of Daily Living and the Lawton-Brody Instrumental Activities of Daily Living Scale. We investigated the association between combinations of MIC (+/-) and FS (low [< 11]/high [≥ 11]) with death. Compared to the reference group (MIC-/high FS), the adjusted hazard ratios [HR (95% CI)] for all-cause mortality were 1.82 (1.49, 2.21) for MIC-/low FS, 1.57 (1.30, 1.89) for MIC+/high FS, and 3.44 (2.80, 4.23) for MIC+/low FS groups. Similar associations were observed with CVD-related and infection-related mortality. The combination of MIC and low FS is a strong predictor of mortality in HD patients. Identification of MIC and poor FS may direct interventions to lessen adverse clinical outcomes in the HD setting.
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http://dx.doi.org/10.1038/s41598-020-80716-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7811014PMC
January 2021

Baseline data report of the China Dialysis Outcomes and Practice Patterns Study (DOPPS).

Sci Rep 2021 01 13;11(1):873. Epub 2021 Jan 13.

Department of Nephrology, Peking University People's Hospital, Unit 10C in Ward Building, 11 Xizhimennan Street, Xicheng District, Beijing, 100044, China.

The number of patients on hemodialysis (HD) is rapidly increasing in China. As an Asian country with a large number of HD patients, understanding the status of Chinese HD patients has a special significance. We reported here the baseline data for China Dialysis Outcomes and Practice Pattern Study Phase 5 (DOPPS5). The DOPPS is an international prospective, observational cohort study. Patients were restricted to the initial sample of patients who participated in China DOPPS5. We summarized the baseline demographic and clinical data of patients. Results were weighted by facility sampling fraction. 1186 patients were initial patients in China DOPPS5. The mean age was 58.7 ± 3.5 years, with 54.6% males. The median dialysis vintage was 3.4 (1.5, 6.3) years. The main assigned primary end-stage kidney disease (ESKD) causes was chronic glomerulonephritis (45.9%), followed by diabetes (19.9%). 17.6% patients had hepatitis B infection, and 10.0% patients had hepatitis C infection. 25.9% patients had a single-pooled Kt/V < 1.2. 86.6% patients had albumin > 3.5 g/dl. 18.8% patients had hemoglobin < 9 g/dl. 66.5% patients had serum calcium in target range (8.4-10.2 mg/dl), 41.5% patients had serum phosphate in target range (3.5-5.5 mg/dl) and 51.2% patients maintained PTH in 150-600 pg/dl. 88.2% patients used fistula as their vascular access. Meanwhile, there were differences in the demographic, clinical, laboratory, and treatment characteristics among the three cities participated in China DOPPS. We observed a relatively higher albumin level and a higher rate of fistula usage in our patients. But it remains a major challenge to us on the management of CKD-MBD and anemia. This study did not include patients in small cities and remote areas, where the situation of HD patients might be worse than reported.
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http://dx.doi.org/10.1038/s41598-020-79531-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806992PMC
January 2021

Fibroblast Growth Factor 23 and Mortality Among Prevalent Hemodialysis Patients in the Japan Dialysis Outcomes and Practice Patterns Study.

Kidney Int Rep 2020 Nov 20;5(11):1956-1964. Epub 2020 Aug 20.

Division of Nephrology, Endocrinology, and Metabolism, Tokai University School of Medicine, Isehara, Japan.

Introduction: Elevated fibroblast growth factor 23 (FGF23) levels have been strongly associated with mortality in the predialysis and incident hemodialysis populations, but few studies have examined this relationship in a large cohort of prevalent hemodialysis patients and in particular among persons with high dialysis vintage. To address this, we analyzed data from the Japan Dialysis Outcomes and Practice Patterns Study (J-DOPPS).

Methods: We included 1122 prevalent hemodialysis patients from the J-DOPPS phase 5 (2012-2015) who had FGF23 measurements. We evaluated the association of FGF23 levels with all-cause mortality and cardiovascular composite outcome using Cox regression adjusted for potential confounders.

Results: At study enrollment, median dialysis vintage was 5.8 years (interquartile range, 2.7-12.4 years) and median FGF23 level was 2113 pg/ml (interquartile range, 583-6880 pg/ml). During 3-year follow-up, 154 of the 1122 participants died. In adjusted analyses, higher FGF23 was associated with a greater hazard of death (hazard ratio per doubling of FGF23, 1.12; 95% confidence interval, 1.03-1.21); however, the association became weaker as the dialysis vintage increased and finally disappeared in the highest tertile (>9.4 years). Similar patterns of effect modification by dialysis vintage were observed for cardiovascular composite outcome and in time-dependent models.

Conclusion: Elevated FGF23 was associated with mortality and cardiovascular events in prevalent hemodialysis patients, but the association was attenuated at longer dialysis vintages. This novel finding suggests that long-term hemodialysis patients may be less susceptible to the detrimental effects of FGF23 or correlated biological processes, and additional studies are needed to gain understanding of these possibilities.
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http://dx.doi.org/10.1016/j.ekir.2020.08.013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7609896PMC
November 2020

Impact of longer term phosphorus control on cardiovascular mortality in hemodialysis patients using an area under the curve approach: results from the DOPPS.

Nephrol Dial Transplant 2020 10;35(10):1794-1801

Arbor Research Collaborative for Health, Ann Arbor, MI, USA.

Background: Serial assessment of phosphorus is currently recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, but its additional value versus a single measurement is uncertain.

Methods: We studied data from 17 414 HD patients in the Dialysis Outcomes and Practice Patterns Study, a prospective cohort study, and calculated the area under the curve (AUC) by multiplying the time spent with serum phosphorus >4.5 mg/dL over a 6-month run-in period by the extent to which this threshold was exceeded. We estimated the association between the monthly average AUC and cardiovascular (CV) mortality using Cox regression. We formally assessed whether AUC was a better predictor of CV mortality than other measures of phosphorus control according to the Akaike information criterion.

Results: Compared with the reference group of AUC = 0, the adjusted hazard ratio (HR) of CV mortality was 1.12 [95% confidence interval (CI) 0.90-1.40] for AUC > 0-0.5, 1.26 (95% CI 0.99-1.62) for AUC > 0.5-1, 1.44 (95% CI 1.11-1.86) for AUC > 1-2 and 2.03 (95% CI 1.53-2.69) for AUC > 2. The AUC was predictive of CV mortality within strata of the most recent phosphorus level and had a better model fit than other serial measures of phosphorus control (mean phosphorus, months out of target).

Conclusions: We conclude that worse phosphorus control over a 6-month period was strongly associated with CV mortality. The more phosphorus values do not exceed 4.5 mg/dL the better is survival. Phosphorus AUC is a better predictor of CV death than the single most recent phosphorus level, supporting with real-world data KDIGO's recommendation of serial assessment of phosphorus to guide clinical decisions.
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http://dx.doi.org/10.1093/ndt/gfaa054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538234PMC
October 2020

Pattern of Laboratory Parameters and Management of Secondary Hyperparathyroidism in Countries of Europe, Asia, the Middle East, and North America.

Adv Ther 2020 06 14;37(6):2748-2762. Epub 2020 May 14.

AbbVie Inc., North Chicago, IL, USA.

Introduction: This analysis explored laboratory mineral and bone disorder parameters and management of secondary hyperparathyroidism in patients undergoing hemodialysis in Belgium, Canada, China, France, Germany, Italy, Japan, Russia, Saudi Arabia, Spain, Sweden, the UK, and the USA.

Methods: Analyses used demographic, medication, and laboratory data collected in the prospective Dialysis Outcomes and Practice Patterns Study (2012-2015). The analysis included 20,612 patients in 543 facilities. Descriptive data are presented as regional mean (standard deviation), median (interquartile range), or prevalence, weighted for facility sampling fraction. No testing of statistical hypotheses was conducted.

Results: The frequency of serum intact parathyroid hormone levels > 600 pg/mL was lowest in Japan (1%) and highest in Russia (30%) and Saudi Arabia (27%). The frequency of serum phosphorus levels > 7.0 mg/dL was lowest in France (4%), the UK (6%), and Spain (6%), and highest in China (27%). The frequency of serum calcium levels > 10.0 mg/dL was highest in the UK (14%) and China (13%) versus 2% to 9% elsewhere. Dialysate calcium concentrations of 2.5 mEq/mL were common in the USA (78%) and Canada (71%); concentrations of 3.0-3.5 mEq/L were almost universal at facilities in Italy, France, and Saudi Arabia (each ≥ 99%).

Conclusions: Wide international variation in mineral and bone disorder laboratory parameters and management practices related to secondary hyperparathyroidism suggests opportunities for optimizing care.
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http://dx.doi.org/10.1007/s12325-020-01359-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7467455PMC
June 2020

International comparison of peritoneal dialysis prescriptions from the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

Perit Dial Int 2020 05 17;40(3):310-319. Epub 2020 Jan 17.

Faculty of Medicine and Health Sciences, Keele University and University Hospitals of North Midlands, Stoke-on-Trent, UK.

Background: We describe peritoneal dialysis (PD) prescription variations among Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) participants on continuous ambulatory PD (CAPD) and automated PD (APD; = 4657) from Australia/New Zealand (A/NZ), Canada, Japan, Thailand, United Kingdom (UK), and United States (US).

Results: CAPD was more commonly used in Thailand and Japan, while APD predominated over CAPD in A/NZ, Canada, the US, and the UK. Total prescribed PD volume normalized to the surface area was the highest in Thailand and the lowest in Japan (for both APD and CAPD) and the UK (for CAPD). PD patients from Thailand had the lowest residual urine volume and residual renal urea clearance, yet achieved the highest dialysis urea clearance. Japanese patients had the lowest dialysis urea clearances for both APD and CAPD. Despite having similar urine volumes to patients in A/NZ, Canada, Japan, and the UK, US CAPD and APD patients used 2.5% and 3.86% glucose PD solutions more frequently, whereas fewer than 25% of these patients used icodextrin. Over half of the patients in A/NZ, Canada, the UK, and Japan used icodextrin, whereas it was hardly used in Thailand. Japan and Thailand were more likely to use 1.5% glucose solutions for their PD prescription.

Conclusions: There are considerable international variations in PD modality use and prescription patterns that translate into important differences in achieved dialysis clearances. Ongoing recruitment of additional PDOPPS participants and accrual of follow-up time will allow us to test the associations between specific PD prescription regimens and clinical and patient-reported outcomes.
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http://dx.doi.org/10.1177/0896860819895356DOI Listing
May 2020

Estimating the Fraction of First-Year Hemodialysis Deaths Attributable to Potentially Modifiable Risk Factors: Results from the DOPPS.

Clin Epidemiol 2020 16;12:51-60. Epub 2020 Jan 16.

Arbor Research Collaborative for Health, Ann Arbor, MI, USA.

Purpose: Mortality among first-year hemodialysis (HD) patients remains unacceptably high. To address this problem, we estimate the proportions of early HD deaths that are potentially preventable by modifying known risk factors.

Methods: We included 15,891 HD patients (within 60 days of starting HD) from 21 countries in the Dialysis Outcomes and Practice Patterns Study (1996-2015), a prospective cohort study. Using Cox regression adjusted for potential confounders, we estimated the fraction of first-year deaths attributable to one or more of twelve modifiable risk factors (the population attributable fraction, AF) identified from the published literature by comparing predicted survival based on risk factors observed vs counterfactually set to reference levels.

Results: The highest AFs were for catheter use (22%), albumin <3.5 g/dL (19%), and creatinine <6 mg/dL (12%). AFs were 5%-9% for no pre-HD nephrology care, no residual urine volume, systolic blood pressure <130 or ≥160 mm Hg, phosphorus <3.5 or ≥5.5 mg/dL, hemoglobin <10 or ≥12 g/dL, and white blood cell count >10,000/μL. AFs for ferritin, calcium, and PTH were <3%. Overall, 65% (95% CI: 59%-71%) of deaths were attributable to these 12 risk factors. Additionally, the AF for C-reactive protein >10 mg/L was 21% in facilities where it was routinely measured.

Conclusion: A substantial proportion of first-year HD deaths could be prevented by successfully modifying a few risk factors. Highest priorities should be decreasing catheter use and limiting malnutrition/inflammation whenever possible.
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http://dx.doi.org/10.2147/CLEP.S233197DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6974411PMC
January 2020

Associations of Hemoglobin Levels With Health-Related Quality of Life, Physical Activity, and Clinical Outcomes in Persons With Stage 3-5 Nondialysis CKD.

J Ren Nutr 2020 09 21;30(5):404-414. Epub 2020 Jan 21.

Arbor Research Collaborative for Health, Ann Arbor, Michigan. Electronic address:

Objective: Conflicting findings and knowledge gaps exist regarding links between anemia, physical activity, health-related quality of life (HRQOL), chronic kidney disease (CKD) progression, and mortality in moderate-to-advanced CKD. Using the CKD Outcomes and Practice Patterns Study, we report associations of hemoglobin (Hgb) with HRQOL and physical activity, and associations of Hgb and physical activity with CKD progression and mortality in stage 3-5 nondialysis (ND)-CKD patients.

Design And Methods: Prospectively collected data were analyzed from 2,121 ND-CKD stage 3-5 patients, aged ≥18 years, at 43 nephrologist-run US and Brazil CKD Outcomes and Practice Patterns Study-participating clinics. Cross-sectional associations were assessed of Hgb levels with HRQOL and physical activity levels (from validated Kidney Disease Quality of Life Instrument and Rapid Assessment of Physical Activity surveys). CKD progression (first of ≥40% estimated glomerular filtration rate [eGFR] decline, eGFR<10 mL/min/1.73 m, or end-stage kidney disease) and all-cause mortality with Hgb and physical activity levels were also evaluated. Linear, logistic, and Cox regression analyses were adjusted for country, demographics, smoking, eGFR, serum albumin, very high proteinuria, and 13 comorbidities.

Results: HRQOL was worse, with severe anemia (Hgb<10 g/dL), but also evident for mild/moderate anemia (Hgb 10-12 g/dL), relative to Hgb>12 g/dL. Odds of being highly physically active were substantially greater at Hgb>10.5 g/dL. Lower Hgb was strongly associated with greater CKD progression and mortality, even after extensive adjustment. Physical inactivity was strongly associated with greater mortality and weakly associated with CKD progression. Possible residual confounding is a limitation.

Conclusion: This multicenter international study provides real-world observational evidence for greater HRQOL, physical activity, lower CKD progression, and greater survival in ND-CKD patients with Hgb levels >12 g/dL, exceeding current treatment guideline recommendations. These findings help inform future studies aimed at understanding the impact of new anemia therapies and physical activity regimens on improving particular dimensions of ND-CKD patient well-being and clinical outcomes.
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http://dx.doi.org/10.1053/j.jrn.2019.11.003DOI Listing
September 2020

The authors reply.

Kidney Int 2020 02;97(2):421-422

Arbor Research Collaborative for Health, Ann Arbor, Michigan, USA.

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http://dx.doi.org/10.1016/j.kint.2019.11.005DOI Listing
February 2020

: achievement, predictors and relationship to mortality in hemodialysis patients in the Gulf Cooperation Council countries: results from DOPPS (2012-18).

Clin Kidney J 2021 Mar 22;14(3):820-830. Epub 2020 Jan 22.

Arbor Research Collaborative for Health, Ann Arbor, MI, USA.

Background: Dialysis adequacy, as measured by single pool , is an important parameter for assessing hemodialysis (HD) patients' health. Guidelines have recommended of 1.2 as the minimum dose for thrice-weekly HD. We describe achievement, its predictors and its relationship with mortality in the Gulf Cooperation Council (GCC) (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates).

Methods: We analyzed data (2012-18) from the prospective cohort Dialysis Outcomes and Practice Patterns Study for 1544 GCC patients ≥18 years old and on dialysis >180 days.

Results: Thirty-four percent of GCC HD patients had low (<1.2) versus 5%-17% in Canada, Europe, Japan and the USA. Across the GCC countries, low prevalence ranged from 10% to 54%. In multivariable logistic regression, low was more common (P < 0.05) with larger body weight and height, being male, shorter treatment time (TT), lower blood flow rate (BFR), greater comorbidity burden and using HD versus hemodiafiltration. In adjusted Cox models, low was strongly related to higher mortality in women [hazard ratio (HR) = 1.91, 95% confidence interval (CI) 1.09-3.34] but not in men (HR = 1.16, 95% CI 0.70-1.92). Low BFR (<350 mL/min) and TT (<4 h) were common; 41% of low cases were attributable to low BFR or TT (52% for women and 36% for men).

Conclusion: Relatively large proportions of GCC HD patients have low . Increasing BFR to ≥350 mL/min and TT to ≥4 h thrice weekly will reduce low prevalence and may improve survival in GCC HD patients-particularly among women.
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http://dx.doi.org/10.1093/ckj/sfz195DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986324PMC
March 2021

Peritoneal Dialysis-Related Infection Rates and Outcomes: Results From the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

Am J Kidney Dis 2020 07 10;76(1):42-53. Epub 2020 Jan 10.

Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia; Australasian Kidney Trials Network, University of Queensland, Brisbane, Australia; Translational Research Institute, Brisbane, Australia.

Rationale & Objective: Peritoneal dialysis (PD)-related peritonitis carries high morbidity for PD patients. Understanding the characteristics and risk factors for peritonitis can guide regional development of prevention strategies. We describe peritonitis rates and the associations of selected facility practices with peritonitis risk among countries participating in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

Study Design: Observational prospective cohort study.

Setting & Participants: 7,051 adult PD patients in 209 facilities across 7 countries (Australia, New Zealand, Canada, Japan, Thailand, United Kingdom, United States).

Exposures: Facility characteristics (census count, facility age, nurse to patient ratio) and selected facility practices (use of automated PD, use of icodextrin or biocompatible PD solutions, antibiotic prophylaxis strategies, duration of PD training).

Outcomes: Peritonitis rate (by country, overall and variation across facilities), microbiology patterns.

Analytical Approach: Poisson rate estimation, proportional rate models adjusted for selected patient case-mix variables.

Results: 2,272 peritonitis episodes were identified in 7,051 patients (crude rate, 0.28 episodes/patient-year). Facility peritonitis rates were variable within each country and exceeded 0.50/patient-year in 10% of facilities. Overall peritonitis rates, in episodes per patient-year, were 0.40 (95% CI, 0.36-0.46) in Thailand, 0.38 (95% CI, 0.32-0.46) in the United Kingdom, 0.35 (95% CI, 0.30-0.40) in Australia/New Zealand, 0.29 (95% CI, 0.26-0.32) in Canada, 0.27 (95% CI, 0.25-0.30) in Japan, and 0.26 (95% CI, 0.24-0.27) in the United States. The microbiology of peritonitis was similar across countries, except in Thailand, where Gram-negative infections and culture-negative peritonitis were more common. Facility size was positively associated with risk for peritonitis in Japan (rate ratio [RR] per 10 patients, 1.07; 95% CI, 1.04-1.09). Lower peritonitis risk was observed in facilities that had higher automated PD use (RR per 10 percentage points greater, 0.95; 95% CI, 0.91-1.00), facilities that used antibiotics at catheter insertion (RR, 0.83; 95% CI, 0.69-0.99), and facilities with PD training duration of 6 or more (vs <6) days (RR, 0.81; 95% CI, 0.68-0.96). Lower peritonitis risk was seen in facilities that used topical exit-site mupirocin or aminoglycoside ointment, but this association did not achieve conventional levels of statistical significance (RR, 0.79; 95% CI, 0.62-1.01).

Limitations: Sampling variation, selection bias (rate estimates), and residual confounding (associations).

Conclusions: Important international differences exist in the risk for peritonitis that may result from varied and potentially modifiable treatment practices. These findings may inform future guidelines in potentially setting lower maximally acceptable peritonitis rates.
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http://dx.doi.org/10.1053/j.ajkd.2019.09.016DOI Listing
July 2020

Mineral and bone disorder and management in the China Dialysis Outcomes and Practice Patterns Study.

Chin Med J (Engl) 2019 Dec;132(23):2775-2782

Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA, USA.

Background: Despite a growing population of patients starting hemodialysis in China, little is known about markers of mineral bone disease (MBD) and their management. We present data on prevalence and correlates of hypocalcemia, hyperphosphatemia, and secondary hyperparathyroidism from the China Dialysis Outcomes and Practice Patterns Study (DOPPS), with evaluation of whether these laboratory markers triggered changes in management.

Methods: We compared the frequency of measurement and prevalence of poor control of MBD markers in China DOPPS with other DOPPS regions. We also used generalized estimating equations to assess correlates of MBD markers, and separate models to assess predictors of vitamin D and phosphate binder prescriptions in the China DOPPS.

Results: Severe hyperphosphatemia (>7 mg/dL) and secondary hyperparathyroidism (>600 pg/mL) were common (27% and 21% prevalence, respectively); both were measured infrequently (14.9% and 3.2% of patients received monthly measurements in China). Frequency of dialysis sessions was positively associated with hyperphosphatemia; presence of residual kidney function was negatively associated with both hyperphosphatemia and secondary hyperparathyroidism. Laboratory measures indicating poor control of MBD were not associated with subsequent prescription of active vitamin D or phosphate binder.

Conclusions: There are substantial opportunities for improvement and standardization of MBD management in China. Development of country-specific guidelines may yield realistic targets and standardization of medication use accounting for availability and cost.
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http://dx.doi.org/10.1097/CM9.0000000000000533DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6940068PMC
December 2019

Facility Variation and Predictors of Do Not Resuscitate Orders of Hemodialysis Patients in Canada: DOPPS.

Can J Kidney Health Dis 2019 4;6:2054358119879777. Epub 2019 Oct 4.

The Ottawa Hospital, ON, Canada.

Background: Life expectancy in patients with end-stage kidney disease treated with hemodialysis (HD) is limited, and as such, the presence of an advanced care directive (ACD) may improve the quality of death as experienced for patients and families. Strategies to discuss and implement ACDs are limited with little being known about the status of Do Not Resuscitate (DNR) orders in the Canadian HD population.

Objectives: Using data from the Dialysis Outcomes and Practice Patterns Study (DOPPS), we set out to (1) examine the variability in DNR orders across Canada and its largest province, Ontario and (2) identify clinical and functional status measures associated with a DNR order.

Design: We conducted a retrospective cohort study using data from the DOPPS Canada Phase 4 to 6 from 2009 to 2017.

Setting: DOPPS facilities in Canada.

Patients: All adults (>18 years) who initiated chronic HD with a documented ACD were included.

Measurements: ACD and DNR orders.

Methods: Descriptive statistics were compared for baseline characteristics (demographics, comorbidities, medications, facility characteristics, and patient functional status) and DNR status. The crude proportion of patients per facility with a DNR order was calculated across Canada and Ontario. Functional status was determined by activities of daily living and components of the Kidney Disease Quality of Life (KDQOL)-validated questionnaire. We used generalized estimating equations (GEEs) to create sequential multivariable models (demographics, comorbidities, and functional status) of variables associated with DNR status.

Results: A total of 1556 (96% of total) patients treated with HD had a documented ACD and were included. A total of 10% of patients had a DNR order. The crude variation of DNR status differed considerably across facilities within Canada, between Ontario and non-Ontario, and within Ontario (interprovince variation = 6.3%-17.1%, Ontario vs non-Ontario = 8.2% vs 11.7%, intraprovincial variation [Ontario] = 1%-26%). Patients with a DNR order were more commonly older, white, with cardiac comorbidities, with less or shorter predialysis care compared with those without a DNR order. Patients with a DNR order reported lower energy, more difficulty with transfers, meal preparation, household tasks, and financial management. In a multivariate model, age, cardiac disease, stroke, dialysis duration, and intradialytic weight gain were associated with DNR status.

Limitations: Relatively small number of events or measures in certain categories.

Conclusions: A large inter- and intraprovincial (Ontario) variation was observed regarding DNR orders across Canada highlighting areas for potential quality improvement. While functional status did not appear to have a bearing on the presence of a DNR order, the presence of various comorbidities was associated with the presence of a DNR order.
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http://dx.doi.org/10.1177/2054358119879777DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6778991PMC
October 2019

International Anemia Prevalence and Management in Peritoneal Dialysis Patients.

Perit Dial Int 2019 Nov-Dec;39(6):539-546. Epub 2019 Oct 3.

St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.

The optimal treatment for managing anemia in peritoneal dialysis (PD) patients and best clinical practices are not completely understood. We sought to characterize international variations in anemia measures and management among PD patients.The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) enrolled adult PD patients from 6 countries from 2014 to 2017. Hemoglobin (Hb), ferritin levels, and transferrin saturation (TSAT), as well as erythropoiesis stimulating agents (ESAs) and iron use were compared cross-sectionally at study enrollment in Australia and New Zealand (A/NZ), Canada, Japan, the United Kingdom (UK), and the United States (US).Among 3,603 PD patients from 193 facilities, mean Hb ranged from 11.0 - 11.3 g/dL across countries. The majority of patients (range 53% - 59%) had Hb 10 - 11.9 g/dL, with 4% - 12% patients ≥ 13 g/dL and 16% - 23% < 10 g/dL. Use of ESAs was higher in Japan (94% of patients) than elsewhere (66% - 79% of patients). In the US, 63% of patients had a ferritin level > 500 ng/mL, compared with 5% - 38% in other countries. In the US and Japan, 87% - 89% of PD patients had TSAT ≥ 20%, compared with 73% - 76% in other countries. Intravenous (IV) iron use within 4 months of enrollment was higher in the US (55% of patients) than elsewhere (6% - 17% patients).In this largest international observational study of anemia and anemia management in patients receiving PD, comparable Hb levels across countries were observed but with notable differences in ESA and iron use. Peritoneal dialysis patients in the US have higher ferritin levels and higher IV iron use than other countries.
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http://dx.doi.org/10.3747/pdi.2018.00249DOI Listing
August 2020

Increased Risk of Bone Fractures in Hemodialysis Patients Treated with Proton Pump Inhibitors in Real World: Results from the Dialysis Outcomes and Practice Patterns Study (DOPPS).

J Bone Miner Res 2019 12 3;34(12):2238-2245. Epub 2019 Oct 3.

Clinical Epidemiology and Physiopathology of Renal Diseases and Hypertension, National Research Council (CNR), Institute of Clinical Physiology (IFC), Reggio Calabria, Italy.

Long-term treatment with proton pump inhibitors (PPIs) is associated with an increased risk of fractures in the general population. PPIs are widely prescribed to dialysis patients but to date no study has specifically tested, by state-of-art statistical methods, the relationship between use of PPIs and fractures in this patient population. This study aimed to assess whether use of PPIs is associated with bone fractures (ie, hip fractures and fractures other than hip fractures) in a large international cohort of hemodialysis patients. We considered an observational prospective cohort of 27,097 hemodialysis patients from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Data analysis was performed by the Fine and Gray method, considering the competitive risk of mortality, as well as by a cause-specific hazards Cox model with death as a censoring event and matching patients according to the prescription time. Of 27,097 hemodialysis patients, 13,283 patients (49%) were on PPI treatment. Across the follow-up period (median, 19 months), 3.8 bone fractures × 100 person-years and 1.2 hip fractures × 100 person-years occurred. In multiple Cox models, considering the competitive risk of mortality, the incidence rate of bone (subdistribution hazard ratio [SHR] 1.22; 95% CI, 1.10 to 1.36; p < 0.001) and hip fractures (SHR 1.35; 95% CI, 1.13 to 1.62; p = 0.001) was significantly higher in PPI-treated than in PPI-untreated patients. These findings also held true in multiple, cause-specific, hazards Cox models matching patients according to the prescription time (bone fractures: HR 1.47; 95% CI, 1.23 to 1.76; p < 0.001; hip fractures: HR 1.85; 95% CI, 1.37 to 2.50; p < 0.001). The use of PPIs requires caution and a careful evaluation of risks/benefits ratio in hemodialysis patients. © 2019 American Society for Bone and Mineral Research.
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http://dx.doi.org/10.1002/jbmr.3842DOI Listing
December 2019

Cardiovascular Event Rates Among Hemodialysis Patients Across Geographical Regions-A Snapshot From The Dialysis Outcomes and Practice Patterns Study (DOPPS).

Kidney Int Rep 2019 Jun 28;4(6):864-872. Epub 2019 Mar 28.

Arbor Research Collaborative for Health, Ann Arbor, Michigan, USA.

Introduction: Cardiovascular (CV) morbidity and mortality are excessively high among hemodialysis (HD) patients. Anemia is a common complication of chronic kidney disease (CKD) and a known risk factor for CV events. To understand the impact of the recent regulatory and guideline changes in anemia management, we examined regional CV event rates in high-risk and erythropoiesis-stimulating agent (ESA)-hyporesponsive HD patients.

Methods: A prospective cohort study including 16,560 HD patients, 8660 CV high-risk, and 884 hyporesponsive to ESAs, from the Dialysis Outcomes and Practice Patterns Study (DOPPS) phase 4 (2009-2011) and phase 5 (2012-2015) was conducted to quantify all-cause mortality, major adverse cardiovascular events (MACE), and MACE plus heart failure and thromboembolic events (MACE+).

Results: The MACE+ rates (per 100 patient-years) were highest in North America (NA) (19.4; 95% CI = 18.2-20.7), followed by Europe (EU) (17.4; 95% CI = 16.6-18.1) and lowest in Japan (7.5; 95% CI = 6.9-8.1). When restricted to the high CV risk population, rates increased by 36% in NA, 45% in EU, and 72% in Japan. Mortality accounted for >74% of MACE+ events. MACE+ rates in ESA-hyporesponsive patients and high CV risk patients were similar in NA and EU cohorts. There were minimal differences in outcomes between the DOPPS phases 4 and 5.

Conclusion: Cardiovascular event rates are high in the HD population, vary by geographic region, and are substantially higher in high CV risk patients and ESA-hyporesponsive patients; however, the rates appear not to be affected by anemia guideline changes. The findings from this study will be essential to contextualize the design of future CV anemia-related outcome studies and clinical trials.
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http://dx.doi.org/10.1016/j.ekir.2019.03.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6551512PMC
June 2019

Prescription of renin-angiotensin-aldosterone system inhibitors (RAASi) and its determinants in patients with advanced CKD under nephrologist care.

J Clin Hypertens (Greenwich) 2019 07 6;21(7):991-1001. Epub 2019 Jun 6.

CESP, Center for Research in Epidemiology and Population Health, University Paris-Saclay, University Paris-Sud, UVSQ, Villejuif, France.

Renin-angiotensin-aldosterone system inhibitors (RAASi) are recommended for chronic kidney disease (CKD) patients. In this study, we describe RAASi prescription patterns in the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps) in Brazil, Germany, France, and the United States (US). 5870 patients (mean age 66-72 years; congestive heart failure [CHF] in 11%-19%; diabetes in 43%-54%; serum potassium ≥5 in 20%-35%) were included. RAASi prescription was more common in Germany (80%) and France (77%) than Brazil (66%) and the United States (52%), where the prevalence of prescription decreases particularly in patients with CKD stage 5. In the multivariable regression model, RAASi prescription was least common in the United States and more common in patients who were younger, had diabetes, hypertension, or less advanced CKD. In conclusion, RAASi prescription patterns vary by country, and by demographic and clinical characteristics. RAASi appear to be underused, even among patients with strong class-specific recommendations. Although the reasons for this variation could not be fully identified in this cross-sectional observation, our data indicate that the risk of hyperkalemia may contribute to the underuse of this class of agents in moderate to advanced CKD.
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http://dx.doi.org/10.1111/jch.13563DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771881PMC
July 2019
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