The impact of shortening patient-doctor contact duration on early peritoneal dialysis-related infections.

Early peritoneal dialysis (PD)-related infection is a severe complication. This study investigated the relationship between patient-doctor contact (PDC) duration and early PD-related infection. In the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) Korea, incident dialysis patients receiving PD were divided into two groups based on PDC duration (< 15 min versus ≥ 15 min), which was defined as the duration a nephrologist typically spends with a patient receiving PD during each visit according to the facility practice pattern. Early risks of PD-related infections, such as peritonitis and catheter-related infection (onset within 3 and 12 months of PD), were compared to the PDC duration using Cox regression. The study included 276 patients (184 [66.7%] in the shorter PDC group [< 15 min] and 92 [33.3%] in the longer PDC group [≥ 15 min]). The average age did not differ between the groups. The incidences of 3- and 12-month PD-related infections were significantly lower in the longer PDC group than in the shorter PDC group (3 months: 1.1% versus 9.8%, P = 0.007; 12 months: 9.8% versus 23.4%, P = 0.007). Longer PDC was independently associated with a lower risk of PD-related infections at 3 and 12 months (3 months: adjusted hazard ratio [aHR], 0.11; 95% confidence interval [CI], 0.02-0.85, P = 0.034; 12 months: aHR, 0.43; 95% CI 0.19-0.99, P = 0.048). Overall, a longer PDC duration was associated with a significantly lower risk of early PD-related infection.

Prevalence and Outcomes of Chronic Kidney Disease Associated Pruritus: International Results from PDOPPS.

BACKGROUND: Pruritus is common in hemodialysis (HD) patients. Less is known about the prevalence and outcomes of pruritus among patients receiving peritoneal dialysis (PD). Herein, we describe the prevalence of pruritus and its associations with patient-reported outcomes (PROs) and mortality/transfer to HD. METHODS: We analyzed a multicenter, international cohort of PD patients enrolled in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) from 2014-2022. Pruritus was assessed at entry into PDOPPS with a single-question Likert Scale capturing the extent to which patients were bothered by itch ranging from 1: Not at all, to 5: Extremely. The KDQOL-36 and the Centre for Epidemiological Studies Depression Scale assessed various PROs. Moderate to extreme pruritus was defined as a Likert scale score ≥3. The associations of pruritus with PROs were assessed using linear/logistic regression where appropriate. Death or HD transfer was assessed using multivariable Cox regression models. RESULTS: Overall, 5535 patients from seven countries were included; 43% had moderate to extreme pruritus which was highest in Thailand (50%) and lowest in the United States (33%). The adjusted odds ratios (aOR) of moderate to extreme pruritus were higher for diabetes, low albumin, and elevated phosphorus but lower for residual urine volume (aOR= 0.98 per 200 ml increase in 24-hour urine volume, 95% confidence interval [CI]; 0.96-1.00, P=0.05). Patients with extreme pruritus had the lowest mental and physical health component scores and a higher burden of other PROs including restless legs and disturbed sleep. Overall, 899 patients died and 1221 transferred to HD. Patients with moderate to extreme pruritus were at higher adjusted risk for death or HD transfer (adjusted hazard ratio [aHR] 1.12, 95% CI 1.02-1.23, P=0.02) with similar point estimates for each subcomponent of the composite outcome. CONCLUSIONS: Pruritus is highly prevalent in PD and associated with poor health outcomes. Efforts to better identify and manage pruritus should be considered in this population.

Risk factors of peritoneal dialysis-related peritonitis in the Japan Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

Background: Peritoneal dialysis (PD)-related peritonitis is a major complication of PD. Wide variations in peritonitis prevention, treatment strategies and consequences are seen between countries. These between-country differences may result from modifiable risk factors and clinical practices. Methods: A total of 1225 Japanese PD patients were included and prospectively followed in the Peritoneal Dialysis Outcomes and Practice Patterns Study phase 1 (2014-2018) and phase 2 (2018-2022). Associations between PD-related peritonitis and various risk factors were assessed by Cox proportional hazards survival models. Results: During follow-up (median 1.52 years), 539 peritonitis episodes were experienced by 364 patients. The country crude peritonitis rate was 0.27 episodes/patient-year. In the fully adjusted model, noticeable patient-level factors associated with experiencing any peritonitis included age {hazard ratio [HR] 1.07 per 5-year increase [95% confidence interval (CI) 1.01-1.14]}, serum albumin level [HR 0.63 per 1 g/dl higher (95% CI 0.48-0.82)] and continuous ambulatory peritoneal dialysis (PD) [HR 1.31 versus automated PD (95% CI 1.05-1.63)]. The adoption of antibiotic prophylaxis practice at the time of PD catheter insertion [HR 0.63 (95% CI 0.51-0.78)] or when having complicated dental procedures [HR 0.74 (95% CI 0.57-0.95)] or lower endoscopy [HR 0.69 (95% CI 0.54-0.89)] were associated with lower hazards of any peritonitis, while a routine facility practice of having more frequent regular medical visits was associated with a higher hazard. Conclusion: Identification of risk factors in Japan may be useful for developing future versions of guidelines and improving clinical practices in Japan. Investigation of country-level risk factors for PD-related peritonitis is useful for developing and implementing local peritonitis prevention and treatment strategies.

Erythropoiesis-stimulating agent hyporesponsiveness was associated with worse survival of hemodialysis patients independent of the serum ferritin level.

INTRODUCTION: Ferritin level and erythropoiesis-stimulating agent (ESA) responsiveness are each associated with hemodialysis patient survival. We assessed interrelationships between these two vs. survival. METHODS: Patients in the Japan Dialysis Outcomes and Practice Patterns Study Phases 4-6 (2009-2018) were included. All-cause mortality associations were assessed with progressive adjustment to evaluate covariate influence. RESULTS: During follow-up (median 2.6 years), 773 of 5154 patients died. After covariate adjustment, the mortality hazard ratio (HR) was 0.99 (95% CI: 0.81, 1.20) for low serum ferritin and 1.12 (CI: 0.89, 1.41) for high serum ferritin. By contrast, mortality risk with elevated ESA resistance index (ERI) persisted after covariate adjustment (HR 1.44, CI [1.17-1.78]). The serum ferritin and ERI interaction was not significant; p > 0.96 across all models. CONCLUSIONS: Japanese hemodialysis patients with high ERI experienced worse survival independent of serum ferritin levels, highlighting the importance of identifying and mitigating ESA hyporesponsiveness among dialysis patients.

Diuretic prescriptions in the first year of haemodialysis: international practice patterns and associations with outcomes.

Background: The use of diuretics in patients on haemodialysis (HD) is thought to maintain diuresis. However, this assumption and the optimal dose are based on little scientific evidence, and associations with clinical outcomes are unclear. Methods: We reported international variations in diuretic use and loop diuretic dose across 27 759 HD patients with dialysis vintage <1 year in the Dialysis Outcomes and Practice Patterns Study phases 2-5 (2002-2015), a prospective cohort study. Doses of torsemide (4:1) and bumetanide (80:1) were converted to oral furosemide-equivalent doses. Adjusted Cox, logistic and linear regressions were used to investigate the association of diuretic use and dose with outcomes. Results: Diuretic utilization varied widely by country at vintage <3 months, ranging from >80% in Germany and Sweden to <35% in the USA, at a median dose ranging from 400-500 mg/day in Germany and Sweden to <100 mg/day in Japan and the USA. Neither diuretic use nor higher doses were associated with a lower risk of all-cause mortality, a higher risk of hospitalization for fracture or elevated parathyroid hormone levels, but the prescription of higher doses (>200 mg/day) was associated with a higher risk of all-cause hospitalization. Conclusions: Substantial international differences exist in diuretic prescriptions, with use and doses much higher in some European countries than the USA. The prescription and higher doses of loop diuretics was not associated with improved outcomes.

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

Background: Despite a lack of clinical trial data, ß-blockers are widely prescribed to dialysis patients. Whether specific ß-blocker agents are associated with improved long-term outcomes compared with alternative ß-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 ß-blocker medication within the Dialysis Outcomes and Practice Patterns Study (DOPPS). The following ß-blocker agents were compared: metoprolol, atenolol, bisoprolol and carvedilol. Multivariable Cox proportional hazards models were used to estimate the association between the newly prescribed ß-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 ß-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 ß-blocker medications, atenolol was associated with the lowest mortality risk compared with alternative agents.

Characteristics of patients and facility of peritoneal dialysis in Korea: Results from the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) Korea.

BACKGROUND: Varying peritoneal dialysis (PD)-related clinical outcomes have been reported in different countries. As a participant of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS), this study investigated the characteristics of Korean PD patients, PD facilities and the incidence rates of clinical outcomes including mortality and PD-related outcomes. METHODS: From July 2019 to December 2021, a total of 766 Korean PD patients were included for analysis. Poisson regression analysis was used to explore the incidence rates of various clinical events including mortality, modality transfer, exit site or catheter tunnel infection and peritonitis. RESULTS: Among the 766 patients (median age 55.5 years, males 59.5%), 276 were incident and 490 were prevalent PD patients. The incidence rates of events were as follows: all-cause mortality (0.048), modality transfer (0.051), exit site or catheter tunnel infection (0.054) and peritonitis (0.136) events per person year. The most common causative organism for exit site or tunnel infection was staphylococcus species (47%) and that for peritonitis was streptococcus (28%) followed by staphylococcus (27%) species. CONCLUSIONS: Up to now, PDOPPS Korea has recruited 766 Korean PD patients and started documentation of major PD-related outcomes which occurred during the follow-up period. The overall incidence rates of clinical outcomes in Korean PD patients were relatively favourable. There was no statistically significant difference in the incidence rates of clinical outcomes according to both facility and patient factors.

Alkaline Phosphatase and Parathyroid Hormone Levels: International Variation and Associations With Clinical Outcomes in the DOPPS.

Introduction: Secondary hyperparathyroidism (SHPT) increases the risk of fractures and cardiovascular (CV) disease in patients on hemodialysis (HD). The relationship between parathyroid hormone (PTH) and outcomes has been inconsistent, possibly due to variable bone responsiveness to PTH. The KDIGO guideline suggests monitoring total alkaline phosphatase (ALP), but the role of ALP versus PTH in the management of mineral and bone disorder (MBD) is not clear. Methods: The analysis included 28,888 patients on HD in 9 countries in Dialysis Outcomes and Practice Patterns Study (DOPPS) phase 3 to 7 (2005-2021). The primary exposures of interest were normalized ALP and PTH, which are raw values divided by facility upper normal limit, measured at study enrollment. Cox models were used to estimate hazard ratios of all-cause or CV mortality and any or hip fracture adjusted for potential confounders. Linear mixed models, adjusted for potential confounders, were employed to investigate the relationship between normalized ALP levels and patient characteristics. Results: Normalized PTH showed a J-shaped association with all-cause or CV mortality, and a weak linear association with fracture. In contrast, normalized ALP showed a strong association with all outcomes. Factors associated with higher ALP levels after controlling for PTH included Black race, longer dialysis vintage, diabetes mellitus, hypocalcemia, hypophosphatemia, elevated C-reactive protein (CRP), and the use of cinacalcet. Conclusion: Total ALP is a more robust exposure of adverse outcomes than PTH in patients on HD. PTH responsiveness is affected by race, primary renal disease, comorbidities, and mineral metabolism and therapy. Our results indicate that it may be useful to evaluate target organ response, rather than PTH alone when considering the consequences of (SHPT).

International variations in serum PTH and calcium levels and their mortality associations in peritoneal dialysis patients: Results from PDOPPS.

BACKGROUND: Mineral bone disorder (MBD) in chronic kidney disease (CKD) is associated with high symptom burden, fractures, vascular calcification, cardiovascular disease and increased morbidity and mortality. CKD-MBD studies have been limited in peritoneal dialysis (PD) patients. Here, we describe calcium and parathyroid hormone (PTH) control, related treatments and mortality associations in PD patients. METHODS: We used data from eight countries (Australia and New Zealand (A/NZ), Canada, Japan, Thailand, South Korea, United Kingdom, United States (US)) participating in the prospective cohort Peritoneal Dialysis Outcomes and Practice Patterns Study (2014-2022) among patients receiving PD for >3 months. We analysed the association of baseline PTH and albumin-adjusted calcium (calciumAlb) with all-cause mortality using Cox regression, adjusted for potential confounders, including serum phosphorus and alkaline phosphatase. RESULTS: Mean age ranged from 54.6 years in South Korea to 63.5 years in Japan. PTH and serum calciumAlb were measured at baseline in 12,642 and 14,244 patients, respectively. Median PTH ranged from 161 (Japan) to 363 pg/mL (US); mean calciumAlb ranged from 9.1 (South Korea, US) to 9.8 mg/dL (A/NZ). The PTH/mortality relationship was U-shaped, with the lowest risk at PTH 300-599 pg/mL. Mortality was nearly 20% higher at serum calciumAlb 9.6+ mg/dL versus 8.4-<9.6 mg/dL. MBD therapy prescriptions varied substantially across countries. CONCLUSIONS: A large proportion of PD patients in this multi-national study have calcium and/or PTH levels in ranges associated with substantially higher mortality. These observations point to the need to substantially improve MBD management in PD to optimise patient outcomes. LAY SUMMARY: Chronic kidney disease-mineral bone disorder (MBD) is a systemic condition, common in dialysis patients, that results in abnormalities in parathyroid hormone (PTH), calcium, phosphorus and vitamin D metabolism. A large proportion of peritoneal dialysis (PD) patients in this current multi-national study had calcium and/or PTH levels in ranges associated with substantially higher risks of death. Our observational study design limits our ability to determine whether these abnormal calcium and PTH levels cause more death due to possible confounding that was not accounted for in our analysis. However, our findings, along with other recent work showing 48-75% higher risk of death for the one-third of PD patients having high phosphorus levels (>5.5 mg/dL), should raise strong concerns for a greater focus on improving MBD management in PD patients.

Kidney Function Decline and Serious Adverse Drug Reactions in Patients With CKD.

RATIONALE & OBJECTIVE: Adverse drug reactions (ADRs) are common in patients with chronic kidney disease (CKD). The impact of kidney function decline on serious ADR risk has been poorly investigated. We comprehensively describe ADRs and assess the relationship between estimated glomerular filtration rate (eGFR) and serious ADR risk. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: 3,033 participants in French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort study, a nationwide sample of nephrology outpatients with moderate to advanced CKD. PREDICTORS: Demographic and biological data (including eGFR), medication prescriptions. OUTCOME: ADRs (preventable or not) were prospectively identified from hospital discharge reports, medical records, and patient interviews. Expert pharmacologists used validated tools to adjudicate ADRs. ANALYTICAL APPROACH: Restricted cubic splines in fully adjusted cause-specific Cox proportional hazard models were used to evaluate the relationship between eGFR and the risk of serious ADRs (overall and by subtype). RESULTS: During a median follow-up period of 4.7 years, 360 patients experienced 488 serious ADRs. Kidney and urinary disorders (n=170) and hemorrhage (n=170) accounted for 70% of serious ADRs. The most common medications classes were antithrombotics and renin-angiotensin system inhibitors. The majority of those serious ADRs were associated with hospitalization (n=467), with 32 directly or indirectly associated with death and 22 associated with a life-threatening event. More than 27% of the 488 serious ADRs were preventable or potentially preventable. The eGFR is a major risk factor for serious ADRs. The risk of acute kidney injury was 2.2% higher and risk of bleeding ADRs was 8% higher for each 1mL/min/1.73m2 lower baseline eGFR. LIMITATIONS: The results cannot be extrapolated to patients who are not being treated by a nephrologist. CONCLUSIONS: ADRs constitute a major cause of hospitalization in CKD patients for whom lower eGFR level is a major risk factor. PLAIN-LANGUAGE SUMMARY: Patients with chronic kidney disease (CKD) have complex clinical presentations, take multiple medications, and often receive inappropriate prescriptions. Using data from a large, prospective CKD cohort, we found a high incidence of serious adverse drug reactions (ADRs). The 2 most common serious ADRs were drug-induced acute kidney injury and bleeding. A large proportion of serious ADRs required hospital admission, and 11% led to death or were life threatening. Lower kidney function was a major risk factor for serious ADRs. Many of these serious ADRs were determined to be partly preventable through greater adherence to prescription guidelines. This report enhances our understanding of the potential toxicity of drugs taken by patients with moderate to advanced CKD. It emphasizes the importance of monitoring kidney function when prescribing drugs, particularly for high-risk medications such as antithrombotic agents.

Conservative Kidney Management Practice Patterns and Resources in the United States: A Cross-Sectional Analysis of CKDopps (Chronic Kidney Disease Outcomes and Practice Patterns Study) Data.

Rationale & Objective: Conservative kidney management (CKM) is a viable treatment option for many patients with chronic kidney disease. However, CKM practices and resources in the United States are not well described. We undertook this study to gain a better understanding of factors influencing uptake of CKM by describing: (1) characteristics of patients who choose CKM, (2) provider practice patterns relevant to CKM, and (3) CKM resources available to providers. Study Design: Cross-sectional study. Setting & Participants: This study is a cross-sectional analysis of data from US nephrology clinics enrolled in the chronic kidney disease Outcomes and Practice Patterns Study (CKDopps) collected between 2014 and 2020. Data for this study includes chart-abstracted characteristics of patients with an estimated glomerular filtration rate ≤30mL/min/1.73m2 (n=1018) and available information on whether a decision had been made to pursue CKM at the time of kidney failure, patient (n=407) reports of discussions about forgoing dialysis, and provider (n=26) responses about CKM delivery and available resources in their health systems. Analytical Approach: Descriptive statistics were used to report patient demographics, clinical information, provider demographics, and clinic characteristics. Results: Among data from 1018 patients, 68 (7%) were recorded as planning for CKM. These patients were older, had more comorbidities, and were more likely to require assistance with transfers. Of the 407 patient surveys, 18% reported a conversation about forgoing dialysis with their nephrologist. A majority of providers felt comfortable discussing CKM; however, no clinics had a dedicated clinic or protocol for CKM. Limitations: Inconsistent survey terminology and unlinked patient and provider responses. Conclusions: Few patients reported discussion of forgoing dialysis with their providers and even fewer anticipated a choice of CKM on reaching kidney failure. Most providers were comfortable discussing CKM, but practiced in clinics that lacked dedicated resources. Further research is needed to improve the implementation of a CKM pathway. Plain-Language Summary: For older comorbid adults with kidney failure, conservative kidney management (CKM) can be an appropriate treatment choice. CKM is a holistic approach with treatment goals of maximizing quality of life and preventing progression of chronic kidney disease (CKD) without initiation of dialysis. We investigated US CKM practices and found that among 1018 people with CKD, only 7% were planning for CKM. Of 407 surveyed patients, 18% reported a conversation with their provider about forgoing dialysis. In contrast, most providers felt comfortable discussing CKM; however, none reported working in an environment with a dedicated CKM clinic or protocol. Our data show the need for further CKM education in the United States as well as dedicated resources for its delivery.

Utility of the Kidney Failure Risk Equation and Estimated GFR for Estimating Time to Kidney Failure in Advanced CKD.

RATIONALE & OBJECTIVE: The Kidney Failure Risk Equation (KFRE) predicts the 2-year risk of kidney failure for patients with chronic kidney disease (CKD). Translating KFRE-predicted risk or estimated glomerular filtration rate (eGFR) into time to kidney failure could inform decision making for patients approaching kidney failure. STUDY DESIGN: Retrospective cohort. SETTING & PARTICIPANTS: CKD Outcomes and Practice Patterns Study (CKDOPPS) cohort of patients with an eGFR<60mL/min/1.73m2 from 34 US nephrology practices (2013-2021). EXPOSURE: 2-year KFRE risk or eGFR. OUTCOME: Kidney failure defined as initiation of dialysis or kidney transplantation. ANALYTICAL APPROACH: Accelerated failure time (Weibull) models used to estimate the median, 25th, and 75th percentile times to kidney failure starting from KFRE values of 20%, 40%, and 50%, and from eGFR values of 20, 15, and 10mL/min/1.73m2. We examined variability in time to kidney failure by age, sex, race, diabetes status, albuminuria, and blood pressure. RESULTS: Overall, 1,641 participants were included (mean age 69±13 years; median eGFR of 28mL/min/1.73m2 [IQR 20-37mL/min/1.73 m2]). Over a median follow-up period of 19 months (IQR, 12-30 months), 268 participants developed kidney failure, and 180 died before reaching kidney failure. The median estimated time to kidney failure was widely variable across patient characteristics from an eGFR of 20mL/min/1.73m2 and was shorter for younger age, male sex, Black (versus non-Black), diabetes (vs no diabetes), higher albuminuria, and higher blood pressure. Estimated times to kidney failure were comparably less variable across these characteristics for KFRE thresholds and eGFR of 15 or 10mL/min/1.73m2. LIMITATIONS: Inability to account for competing risks when estimating time to kidney failure. CONCLUSIONS: Among those with eGFR<15mL/min/1.73m2 or KFRE risk>40%), both KFRE risk and eGFR showed similar relationships with time to kidney failure. Our results demonstrate that estimating time to kidney failure in advanced CKD can inform clinical decisions and patient counseling on prognosis, regardless of whether estimates are based on eGFR or the KFRE. PLAIN-LANGUAGE SUMMARY: Clinicians often talk to patients with advanced chronic kidney disease about the level of kidney function expressed as the estimated glomerular filtration rate (eGFR) and about the risk of developing kidney failure, which can be estimated using the Kidney Failure Risk Equation (KFRE). In a cohort of patients with advanced chronic kidney disease, we examined how eGFR and KFRE risk predictions corresponded to the time patients had until reaching kidney failure. Among those with eGFR<15mL/min/1.73m2 or KFRE risk > 40%), both KFRE risk and eGFR showed similar relationships with time to kidney failure. Estimating time to kidney failure in advanced CKD using either eGFR or KFRE can inform clinical decisions and patient counseling on prognosis.

Development and Validation of a Predictive Risk Algorithm for Bleeding in Individuals on Long-term Hemodialysis: An International Prospective Cohort Study (BLEED-HD).

Background: Individuals with kidney disease are at a high risk of bleeding and as such tools that identify those at highest risk may aid mitigation strategies. Objective: We set out to develop and validate a prediction equation (BLEED-HD) to identify patients on maintenance hemodialysis at high risk of bleeding. Design: International prospective cohort study (development); retrospective cohort study (validation). Settings: Development: 15 countries (Dialysis Outcomes and Practice Patterns Study [DOPPS] phase 2-6 from 2002 to 2018); Validation: Ontario, Canada. Patients: Development: 53 147 patients; Validation: 19 318 patients. Measurements: Hospitalization for a bleeding event. Methods: Cox proportional hazards models. Results: Among the DOPPS cohort (mean age, 63.7 years; female, 39.7%), a bleeding event occurred in 2773 patients (5.2%, event rate 32 per 1000 person-years), with a median follow-up of 1.6 (interquartile range [IQR], 0.9-2.1) years. BLEED-HD included 6 variables: age, sex, country, previous gastrointestinal bleeding, prosthetic heart valve, and vitamin K antagonist use. The observed 3-year probability of bleeding by deciles of risk ranged from 2.2% to 10.8%. Model discrimination was low to moderate (c-statistic = 0.65) with excellent calibration (Brier score range = 0.036-0.095). Discrimination and calibration of BLEED-HD were similar in an external validation of 19 318 patients from Ontario, Canada. Compared to existing bleeding scores, BLEED-HD demonstrated better discrimination and calibration (c-statistic: HEMORRHAGE = 0.59, HAS-BLED = 0.59, and ATRIA = 0.57, c-stat difference, net reclassification index [NRI], and integrated discrimination index [IDI] all P value <.0001). Limitations: Dialysis procedure anticoagulation was not available; validation cohort was considerably older than the development cohort. Conclusion: In patients on maintenance hemodialysis, BLEED-HD is a simple risk equation that may be more applicable than existing risk tools in predicting the risk of bleeding in this high-risk population.

Contexte: Les personnes atteintes d'insuffisance rénale présentent un risque élevé d'hémorragie. Des outils permettant de déceler les personnes les plus exposées au risque pourrait aider à mettre en œuvre des stratégies d'atténuation. Objectifs: Nous avons mis au point et validé une équation prédictive (BLEED-HD) afin d'identifier les patients sous hémodialyse d'entretien qui présentent un risque élevé d'hémorragie. Type d'étude: Étude de cohorte prospective internationale (développement); étude de cohorte rétrospective (validation). Cadre: Développement: dans 15 pays (étude DOPPS phases 2 à 6 entre 2002 et 2018); validation: en Ontario (Canada). Sujets: Développement: 53 147 patients; validation: 19 318 patients. Mesures: Hospitalisation pour un événement hémorragique. Méthodologie: Modèles à risques proportionnels de Cox. Résultats: Dans la cohorte DOPPS (âge moyen: 63,7 ans; 39,7 % de femmes), 2 773 patients avaient subi un événement hémorragique (5,2 %; taux d'événements: 32 pour 1 000 années-personnes) avec un suivi médian de 1,6 an (ÉIQ: 0,9 à 2,1). BLEED-HD prend six variables en compte: âge, sexe, pays d'origine, saignement gastro-intestinal antérieur, présence d'une valve cardiaque prothétique et utilisation d'un antagoniste de la vitamine K. La probabilité observée de saignements dans les 3 ans par déciles de risque allait de 2,2 à 10,8 %. La discrimination du modèle variait de faible à modérée (statistique c: 0,65) avec un excellent étalonnage (plage de score de Brier: 0,036-0,095). La discrimination et l'étalonnage de se sont avérés semblables lors de la validation externe auprès de 19 318 patients de l'Ontario (Canada). Par rapport aux scores d'hémorragie existants, l'équation BLEED-HD a démontré une meilleure discrimination et un meilleur étalonnage (statistique c: HEMORRHAGE 0,59; HAS-BLED 0,59 et ATRIA 0,57; différence dans les c-stat, indices NRI et IDI toutes valeurs de p < 0,0001). Limites: L'information sur l'anticoagulant utilisé dans la procédure de dialyse n'était pas disponible; la cohorte de validation était beaucoup plus âgée que la cohorte de développement. Conclusion: Pour les patients sous hémodialyse d'entretien, BLEED-HD est une équation simple de calcul du risque qui peut être plus facilement applicable que les outils existants pour prédire le risque d'hémorragie dans cette population à haut risque.

Patiromer utilization in patients with advanced chronic kidney disease under nephrology care in Germany.

Background: Hyperkalemia (HK) is a frequent condition in patients with chronic kidney disease (CKD) that is associated with high morbidity and mortality. Patiromer has recently been introduced as a potassium binder. Data on patiromer use in patients with CKD in the real-world setting in Europe are lacking. We describe time to discontinuation and changes in serum potassium levels among German CKD stage 3-5 patients starting patiromer. Methods: Duration of patiromer use was estimated by Kaplan-Meier curve, starting at patiromer initiation and censoring for death, dialysis, transplant or loss to follow-up. Serum potassium levels and renin-angiotensin-aldosterone system inhibitor (RAASi) use are described at baseline and during follow-up, restricted to patients remaining on patiromer. Results: We identified 140 patiromer users within our analysis sample [81% CKD stage 4/5, 83% receiving RAASi, and median K+ 5.7 (5.4, 6.3) mmol/L]. Thirty percent of patiromer users had prior history of polystyrene sulfonate use. Overall, 95% of patiromer users stayed on treatment past 1 month, with 53% continuing for over a year. Mean serum potassium levels decreased after patiromer initiation and remained stable under treatment during follow-up (up to 180 days). Among these patients, 73%-82% used RAASis during the time periods before and after patiromer initiation, with no obvious trend indicating discontinuation. Conclusion: Real-world evidence of patiromer use in Germany shows that, in line with what has been observed in clinical trials, patients on patiromer have a reduction in serum potassium when used long-term. Moreover, most patients on patiromer do not discontinue treatment prior to 1 year after initiation.

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 5.2 mg/dL), Europe (5.5 to 4.9 mg/dL), and the United States (5.7 to 5.0 mg/dL). Since then, levels rose in the United States (to mean 5.6 mg/dL, 2021), were stable in Japan (5.3 mg/dL), and declined in Europe (4.8 mg/dL). In 2021, 52% (United States), 27% (Europe), and 39% (Japan) had phosphate >5.5 mg/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.

A different PET test: The relationship between pet ownership and peritonitis risk in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

Pet ownership is common around the world, with pet ownership increasing in many countries. Current guidelines are not supportive of pet ownership for peritoneal dialysis (PD) patients. We examined the association between ownership of cats and dogs and the incidence of peritonitis among PD patients participating in the prospective, observational Peritoneal Dialysis Outcomes and Practice Patterns Study. A total of 3655 PD patients from eight different countries was included, with a median follow-up of 14 months and a total exposure time of 55,475 patient-months. There were 1347 peritonitis episodes with an overall peritonitis rate of 0.29 episodes per patient year. There was no significant increased risk of peritonitis with any type of pet ownership, adjusted hazard ratio (HR) of 1.09 (95% confidence interval (95% CI): 0.96-1.25). However, patients who owned both cats and dogs had an increased risk of peritonitis compared to patients without pets, HR = 1.45 (95% CI: 1.14-1.86). These results suggest that there is no increased risk of peritonitis with pet ownership except for those with both cats and dogs. This information should not prevent PD patients from owning pets but may be helpful for PD patients and their care team to direct training to minimise the risk of peritonitis.

Understanding International Variations in Kidney Failure Incidence and Initiation of Replacement Therapy.

Introduction: Incidence of kidney replacement therapy (KRT) varies widely across countries. Its relations to individual characteristics, nephrology practices for slowing chronic kidney disease (CKD) progression, and KRT access remain unclear. Methods: We investigated intercountry differences in kidney failure (KF) rate, defined by a sustained estimated glomerular filtration rate (eGFR) <15 ml/min per 1.73 m2, and separately in KRT incidence, before and after adjusting for risk factors and blood pressure (BP) control or renin-angiotensin-aldosterone system inhibitor (RAASi) prescription practices in the CKD Outcomes and Practice Patterns Study (CKDopps) cohort study. Results: Among 7381 patients with CKD stage 3 to 4 at enrollment, 1297 progressed to KF and 947 initiated KRT over a 3-year follow-up period. Compared to the United States, demographic-adjusted and eGFR-adjusted hazard ratios (HRs) (HRs, 95% confidence intervals [CI]) for a sustained low eGFR were 0.77 (95% CI, 0.57-1.02) in Brazil, 0.90 (95% CI, 0.75-1.08) in France, and 1.03 (95% CI, 0.86-1.03) in Germany. Further adjustment for comorbidities, albuminuria, systolic BP, and RAASi prescription did not substantially change these HRs. In contrast, compared with the United States, the fully-adjusted HR for KRT remained significantly lower in Brazil (0.55, 95% CI 0.39-0.79), higher in Germany (95% CI, 1.36, 1.09-1.69), and similar in France (95% CI, 1.07, 0.81-1.39). Conclusion: Individual risk factors for CKD progression in nephrology patients appeared to explain most intercountry variations in KF but not KRT incidence. This suggests a prominent role for differences in practices related to KRT initiation or access, but not those for slowing disease progression. This study also shows that using KRT as a KF surrogate may bias estimates of associations with CKD progression risk factors.