Peritoneal Dialysis Technique Survival: A Cohort Study.

RATIONALE & OBJECTIVE: Reasons for transfer from peritoneal dialysis (PD) to hemodialysis (HD) remain incompletely understood. Among incident and prevalent patients receiving PD, we evaluated the association between prior treatment with HD and PD technique survival. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Adults who initiated PD at a Dialysis Clinic, Inc. (DCI) outpatient facility between January 1, 2010 and September 30, 2019. EXPOSURES: The primary exposure of interest was timing of PD start, categorized as PD-first, PD-early, or PD-late. Other covariates included demographics, clinical characteristics, and routine laboratory results. OUTCOMES: Modality switch from PD to HD sustained for more than 90 days. ANALYTICAL APPROACH: Multivariable Fine-Gray models with competing risks and time-varying covariates, stratified at 9 months to account for lack of proportionality. RESULTS: Among 5224 patients who initiated PD at a DCI facility, 3174 initiated dialysis with PD ("PD-first"), 942 transitioned from HD to PD within 90 days ("PD-early"), and 1108 transitioned beyond 90 days ("PD-late"); 1472 (28%) subsequently transferred from PD to HD. PD-early and PD-late patients had higher risk of transfer to HD as compared to PD-first patients [adjusted hazard ratio (aHR) 1.51 (95% CI: 1.17-1.96) and 2.41 (1.94-3.00), respectively, in the first 9 months and aHR 1.16 (0.99-1.35) and 1.43 (1.24-1.65), respectively, after 9 months]. More peritonitis episodes, fewer home visits, lower serum albumin, lower residual kidney function, and lower peritoneal clearance calculated with weekly Kt/V were additional risk factors for PD-to-HD transfer. LIMITATIONS: Missing data on dialysis adequacy and residual kidney function, confounded by short PD technique survival. CONCLUSIONS: Initiating dialysis with PD is associated with greater PD technique survival, though many of those who initiate PD late in their dialysis course still experience substantial time on PD. Peritonitis, lower serum albumin, and lower Kt/V are risk factors for PD-to-HD transfer that may be amenable to intervention.

Acute Kidney Injury Receiving Dialysis and Dialysis Care following Hospital Discharge.

The number of individuals with acute kidney injury receiving outpatient dialysis (AKI-D) is increasing. At present, based on limited data, approximately one third of individuals with AKI-D who receive outpatient dialysis after hospital discharge survive and regain sufficient kidney function to discontinue dialysis. Data to inform dialysis management strategies that promote kidney function recovery and processes of care among individuals with AKI-D receiving outpatient dialysis are lacking. In this article, we detail current trends in the incidence, risk factors, clinical outcomes, proposed management, and health policy landscape for individuals with AKI-D receiving outpatient dialysis and identify areas for further research.

Designing an Implementable Clinical Prediction Model for Near-Term Mortality and Long-Term Survival in Patients on Maintenance Hemodialysis.

RATIONALE & OBJECTIVE: The life expectancy of patients treated with maintenance hemodialysis (MHD) is heterogeneous. Knowledge of life-expectancy may focus care decisions on near-term versus long-term goals. The current tools are limited and focus on near-term mortality. Here, we develop and assess potential utility for predicting near-term mortality and long-term survival on MHD. STUDY DESIGN: Predictive modeling study. SETTING & PARTICIPANTS: 42,351 patients contributing 997,381 patient months over 11 years, abstracted from the electronic health record (EHR) system of midsize, nonprofit dialysis providers. NEW PREDICTORS & ESTABLISHED PREDICTORS: Demographics, laboratory results, vital signs, and service utilization data available within dialysis EHR. OUTCOME: For each patient month, we ascertained death within the next 6 months (ie, near-term mortality) and survival over more than 5 years during receipt of MHD or after kidney transplantation (ie, long-term survival). ANALYTICAL APPROACH: We used least absolute shrinkage and selection operator logistic regression and gradient-boosting machines to predict each outcome. We compared these to time-to-event models spanning both time horizons. We explored the performance of decision rules at different cut points. RESULTS: All models achieved an area under the receiver operator characteristic curve of≥0.80 and optimal calibration metrics in the test set. The long-term survival models had significantly better performance than the near-term mortality models. The time-to-event models performed similarly to binary models. Applying different cut points spanning from the 1st to 90th percentile of the predictions, a positive predictive value (PPV) of 54% could be achieved for near-term mortality, but with poor sensitivity of 6%. A PPV of 71% could be achieved for long-term survival with a sensitivity of 67%. LIMITATIONS: The retrospective models would need to be prospectively validated before they could be appropriately used as clinical decision aids. CONCLUSIONS: A model built with readily available clinical variables to support easy implementation can predict clinically important life expectancy thresholds and shows promise as a clinical decision support tool for patients on MHD. Predicting long-term survival has better decision rule performance than predicting near-term mortality. PLAIN-LANGUAGE SUMMARY: Clinical prediction models (CPMs) are not widely used for patients undergoing maintenance hemodialysis (MHD). Although a variety of CPMs have been reported in the literature, many of these were not well-designed to be easily implementable. We consider the performance of an implementable CPM for both near-term mortality and long-term survival for patients undergoing MHD. Both near-term and long-term models have similar predictive performance, but the long-term models have greater clinical utility. We further consider how the differential performance of predicting over different time horizons may be used to impact clinical decision making. Although predictive modeling is not regularly used for MHD patients, such tools may help promote individualized care planning and foster shared decision making.

Dialysate Sodium Lowering in Maintenance Hemodialysis A Randomized Clinical Trial.

INTRODUCTION: Lowering dialysate sodium may improve volume and blood pressure control in maintenance hemodialysis patients. METHODS: We randomized 42 participants 2:1 to dialysate sodium 135 vs. 138 mEq/L for 6 months. This was followed by a 12 week extension in which sodium was increased to 140 mEq/L in low arm participants. The primary outcome was intradialytic hypotension (IDH). Secondary outcomes included dialysis disequilibrium symptoms, ER visits/hospitalizations, interdialytic weight gain, blood pressure (BP). Longitudinal changes across arms were analyzed using linear mixed regression. RESULTS: Treatment to dialysate sodium 135 vs. 138 mEq/L was not associated with a difference in a change in the rate of IDH (mean change (95%CI) 2.8 (0.8,9.5) vs. 2.7 (1.1, 6.2) events per 100 treatments per month; ratio of slopes 0.96(0.26,3.61) or ER visits/hospitalizations (7.3 (2.3, 12.4) vs. 6.7 (2.9, 10.6) events per 100 patient months; difference 0.6(-6.9,5.8). Symptom score was unchanged in the 135 mEq/L arm (0.7 (-1.4,2.7) and decreased in the 138 mEq/l arm (5.0,8.5,2.0); difference 6.0 (2.1,9.8)). Interdialytic weight gain declined in the 135 mEq/L arm and was unchanged in the 138 mEq/L arm,(-0.3(-0.5,0.0) vs. 0.3 (0.0, 0.6) kg over 6 months; difference (-0.6 (-0.1,-1.0) kg). In the extension phase, raising dialysate sodium from 135 to 140 mEq/L was associated with an increase in interdialytic weight gain (0.2 (0.1, 0.3) kg), predialysis BP (7.0 (4.8, 9.2)/ 3.9 (2.6, 5.1) mm Hg) and a reduction in IDH [OR 0.66 (0.45, 0.97)]. CONCLUSION: Use of a dialysate sodium of 135 as compared with 138 mEq/L was associated with a small reduction in interdialytic weight gain without impact on IDH or predialysis BP, but with an increase in symptoms. Raising dialysate sodium from 135 to 140mEq/L was associated with a reduction in IDH, a small increase in interdialytic weight gain and a marked increase in predialysis BP.

Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study.

BACKGROUND: OPTIMIZE was a randomized, open-label study evaluating different tenapanor initiation methods. OPTIMIZE evaluated tenapanor alone and in combination with phosphate binders (PBs) to achieve target serum phosphate (P) ≤5.5 mg/dL. METHODS: Patients with inadequately controlled P receiving maintenance dialysis from 42 US locations who were taking PBs with baseline P >5.5 mg/dL and ≤10.0 mg/dL, or were PB-naive with baseline P >4.5 mg/dL and ≤10.0 mg/dL, were included in OPTIMIZE. Participants taking PBs at baseline were randomized to switch from PBs to tenapanor (Straight Switch; n = 151) or reduce PB dosage by ≥50% and add tenapanor (Binder Reduction; n = 152); PB-naive patients started tenapanor alone (Binder-Naive; n = 30). Participants received tenapanor 30 mg twice a day for 10 weeks (part A), followed by an elective, 16-week open-label extension (part B). Outcomes included changes from baseline in P, intact fibroblast growth factor 23 (iFGF23), parathyroid hormone (PTH), serum calcium, and medication burden; patient-reported outcomes; and safety. RESULTS: By part A endpoint, 34.4% (Straight Switch), 38.2% (Binder Reduction), and 63.3% (Binder-Naive) of patients achieved P ≤5.5 mg/dL. Mean P reduction and median pill burden reduction from baseline to part A endpoint were 0.91± 1.7 mg/dL and 4 pills/day for the Straight Switch and 0.99± 1.8 mg/dL and 1 pill/day for the Binder Reduction group. The mean P reduction for Binder-Naive patients was 0.87± 1.5 mg/dL. Among Straight Switch and Binder Reduction patients who completed patient experience questionnaires, 205 of 243 (84.4%) reported an improved phosphate-management routine. Diarrhea was the most common adverse event (133 of 333 [39.9%]). CONCLUSIONS: Tenapanor as monotherapy or in combination with PBs effectively lowered P toward the target range in patients who were PB naïve or who were not at goal despite PB use. FUNDING: Ardelyx, Inc. TRIAL REGISTRATION: NCT04549597.

Home Dialysis in Patients with Cardiovascular Diseases.

Kidney failure with replacement therapy and cardiovascular disease are frequently comorbid. In patients with kidney failure with replacement therapy, cardiovascular disease is a major contributor to morbidity and mortality. Conventional thrice-weekly in-center dialysis confers risk factors for cardiovascular disease, including acute hemodynamic fluctuations and rapid shifts in volume and solute concentration. Home hemodialysis and peritoneal dialysis (PD) may offer benefits in attenuation of cardiovascular disease risk factors primarily through improved volume and BP control, reduction (or slowing progression) of left ventricular mass, decreased myocardial stunning, and improved bone and mineral metabolism. Importantly, although trial data are available for several of these risk factors for home hemodialysis, evidence for PD is limited. Among patients with prevalent cardiovascular disease, home hemodialysis and PD may also have potential benefits. PD may offer particular advantages in heart failure given it removes volume directly from the splanchnic circulation, thus offering an efficient method of relieving intravascular congestion. PD also avoids the risk of blood stream infections in patients with cardiac devices or venous wires. We recognize that both home hemodialysis and PD are also associated with potential risks, and these are described in more detail. We conclude with a discussion of barriers to home dialysis and the critical importance of interdisciplinary care models as one component of advancing health equity with respect to home dialysis.

Comparative Effectiveness of Alternative Treatment Approaches to Secondary Hyperparathyroidism in Patients Receiving Maintenance Hemodialysis: An Observational Trial Emulation.

RATIONALE & OBJECTIVE: Optimal approaches to treat secondary hyperparathyroidism (SHPT) in patients on maintenance hemodialysis (HD) have yet to be established in randomized controlled trials (RCTs). STUDY DESIGN: Two observational clinical trial emulations. SETTING & PARTICIPANTS: Both emulations included adults receiving in-center HD from a national dialysis organization. The patients who had SHPT in the period between 2009 and 2014, were insured for≥180 days by Medicare as primary payer, and did not have contraindications or poor health status limiting theoretical trial participation. EXPOSURE: The parathyroid hormone (PTH) Target Trial emulation included patients with new-onset SHPT (first PTH 300-600pg/mL), with 2 arms defined as up-titration of either vitamin D sterols or cinacalcet within 30 days (lower target) or no up-titration (higher target). The Agent Trial emulation included patients with a PTH≥300 pg/mL while on≥6µg weekly of vitamin D sterol (paricalcitol equivalent dose) and no prior history of cinacalcet. The 2 arms were defined by the first dose or agent change within 30 days (vitamin D-favoring [vitamin-D was up-titrated] vs cinacalcet-favoring [cinacalcet was added] vs nondefined [neither applies]). Multiple trials per patient were allowed in trial 2. OUTCOME: The primary outcome was all-cause death over 24 months; secondary outcomes included cardiovascular (CV) hospitalization or the composite of CV hospitalization or death. ANALYTICAL APPROACH: Pooled logistic regression. RESULTS: There were 1,152 patients in the PTH Target Trial (635 lower target and 517 higher target). There were 2,726 unique patients with 6,727 patient trials in the Agent Trial (6,268 vitamin D-favoring trials and 459 cinacalcet-favoring trials). The lower PTH target approach was associated with reduced adjusted hazard of death (HR, 0.71 [95% CI, 0.52-0.93]), CV hospitalization (HR, 0.78 [95% CI, 0.63-0.98]), and their composite (HR, 0.74 [95% CI, 0.61-0.89]). The cinacalcet-favoring approach demonstrated lower adjusted hazard of death compared to the vitamin D-favoring approach (HR, 0.79 [95% CI, 0.62-0.99]), but not of CV hospitalization or the composite outcome. LIMITATIONS: Potential for residual confounding; low use of cinacalcet with low power. CONCLUSIONS: SHPT management that is focused on lower PTH targets may lower mortality and CV disease in patients receiving HD. These findings should be confirmed in a pragmatic randomized trial. PLAIN-LANGUAGE SUMMARY: Optimal approaches to treat secondary hyperparathyroidism (SHPT) have not been established in randomized controlled trials. Data from a national dialysis organization was used to identify patients with SHPT in whom escalated treatment may be indicated. The approach to treatment was defined based on observed upward titration of SHPT-controlling medications: earlier titration (lower target) versus delayed titration (higher target); and the choice of medication (cinacalcet vs vitamin D sterols). In the first trial emulation, we estimated a 29% lower rate of death and 26% lower rate of cardiovascular disease or death for patients managed with a lower versus higher target approach. Cinacalcet versus vitamin D-favoring approaches were not consistently associated with outcomes in the second trial emulation. This observational study suggests the need for additional clinical trials of SHPT treatment intensity.

Development and Validation of the Rating of CKD Knowledge Among Older Adults (Know-CKD) With Kidney Failure.

RATIONALE & OBJECTIVE: Few older adults with kidney failure engage in shared decision making (SDM) for kidney replacement therapy. The lack of instruments to assess SDM-relevant knowledge domains may contribute to this. We assessed the reliability and validity of a new instrument, the Rating of CKD Knowledge Older Adults (Know-CKD). STUDY DESIGN: Multistage process, including a stakeholder-engaged development phase, pilot testing, and validation of a knowledge instrument using a cross-sectional survey of older adults with CKD. SETTING & PARTICIPANTS: 363 patients aged 70+years with nondialysis advanced chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR]<30mL/min/1.73m2) in Boston, Chicago, Portland, ME, and San Diego from June 2018 and January 2020. EXPOSURE: Educational level, higher literacy (Single Item Literacy Screener [SILS]) and numeracy (Subjective Numeracy Scale [SNS]), having participated in clinic-sponsored dialysis education, and self-reported "feeling informed" about options for treatment. OUTCOME: Validity and reliability of the Know-CKD instrument. ANALYTICAL APPROACH: Reliability was assessed with the Kuder-Richardson-20 coefficient. Construct validity was demonstrated by testing a priori hypotheses using t test, analysis of variance (ANOVA) tests, and linear regression analyses. RESULTS: The mean (± SD) participant age was 77.6±5.9 years, and mean eGFR was 22.7±7.2mL/min/1.73m2; 281 participants (78%) self-reported as White. The 12-item Know-CKD assessment had good reliability (Kuder-Richardson-20 reliability coefficient=0.75), and a mean score of 58.2% ± 22.3 SD. The subscales did not attain acceptable reliability. The proportion answering correctly on each item ranged from 20.1% to 91.7%. In examining construct validity, the hypothesized associations held; Know-CKD significantly associated with higher education (ß=6.98 [95% CI, 1.34-12.61], P=0.02), health literacy (ß = -12.67 [95% CI, -19.49 to-5.86], P≤0.001), numeracy per 10% higher (ß=1.85 [95% CI, 1.02-2.69], P≤0.001), and attendance at dialysis class (ß=18.28 [95% CI, 13.30-23.27], P≤0.001). These associations were also observed for the subscales except for prognosis (not associated with literacy or numeracy). LIMITATIONS: Know-CKD is only available in English and has been used only in research settings. CONCLUSIONS: For older adults facing dialysis initiation decisions, Know-CKD is a valid, reliable, and easy to administer measure of knowledge. Further research should examine the relationship of kidney disease knowledge and SDM, patient satisfaction, and clinical outcomes. PLAIN-LANGUAGE SUMMARY: The Rating of CKD Knowledge Among Older Adults (Know-CKD) study measures knowledge of chronic kidney disease (CKD) and is designed for older adults. Most existing knowledge measures for CKD focus on people of all ages and all CKD stages. This measure is useful because it will allow researchers to assess how well patient education efforts are working. Patient education is a way to help patients make decisions about their care. We describe how the measure was developed by a team of doctors, researchers, and patients, and how the measure performed among persons with advanced CKD aged 70 years and older. Know-CKD can inform efforts to improve shared decision-making research and practice for older patients with kidney disease.

Patient-Centered Quality Measures for Dialysis Care: A Report of a Kidney Disease Outcomes Quality Initiative (KDOQI) Scientific Workshop Sponsored by the National Kidney Foundation.

Providing high-quality patient-centered care is the central mission of dialysis facilities. Assessing quality and patient-centeredness of dialysis care is necessary for continuous dialysis facility improvement. Based predominantly on readily measured items, current quality measures in dialysis care emphasize biochemical and utilization outcomes, with very few patient-reported items. Additionally, current metrics often do not account for patient preferences and may compromise patient-centered care by limiting the ability of providers to individualize care targets, such as dialysis adequacy, based on patient priorities rather than a fixed numerical target. Developing, implementing, and maintaining a quality program using readily quantifiable data while also allowing for individualization of care targets that emphasize the goals of patients and their care partners provided the motivation for a September 2022 Kidney Disease Outcomes Quality Initiative (KDOQI) Workshop on Patient-Centered Quality Measures for Dialysis Care. Workshop participants focused on 4 questions: (1) What are the outcomes that are most important to patients and their care partners? (2) How can social determinants of health be accounted for in quality measures? (3) How can individualized care be effectively addressed in population-level quality programs? (4) What are the optimal means for collecting valid and robust patient-reported outcome data? Workshop participants identified numerous gaps within the current quality system and favored a conceptually broader, but not larger, quality system that stresses highly meaningful and adaptive measures that incorporate patient-centered principles, individual life goals, and social risk factors. Workshop participants also identified a need for new, low-burden tools to assess patient goals and priorities.

Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis.

BACKGROUND: Poor sleep quality is associated with increased mortality and lower quality of life in patients with chronic kidney disease-associated pruritus (CKD-aP). Difelikefalin reduces itch in patients with CKD-aP undergoing haemodialysis. This post hoc analysis of Phase 3 studies (3105 and the pooled dataset from KALM-1 and KALM-2) evaluated whether itch reduction in CKD-aP improved sleep quality. METHODS: Itch intensity was assessed in patients undergoing haemodialysis, who had moderate-to-severe CKD-aP treated with intravenous difelikefalin (0.5 µg/kg, three times weekly) (N = 222, Study 3105; N = 426, KALM-1/-2) or placebo (N = 425, KALM-1/-2) for 12 weeks, using the Worst Itch Intensity Numerical Rating Scale (WI-NRS). Sleep quality was assessed using the sleep disability question of the 5-D itch scale (5­D SDQ) in all studies and, in Study 3105, with the Sleep Quality Numeric Rating Scale (SQ-NRS). RESULTS: Greater improvements in sleep quality were observed in patients with ≥ 3-point, versus < 3-point WI-NRS improvement using SQ-NRS in Study 3105 (mean [95% confidence interval]: -5.2 [-5.6, -4.8] vs -1.5 [-2.0, -1.0]) and 5-D SDQ in KALM-1/-2 (-1.8 [-2.1, -1.6] vs -0.8 [-1.1, -0.4]). SQ-NRS and WI-NRS scores correlated strongly at baseline and Week 12 in Study 3105 (Spearman correlation coefficient: 0.77 and 0.84, respectively). Correlations were also observed between 5-D SDQ and WI-NRS scores in Study 3105 and KALM­1/­2. CONCLUSIONS: In patients undergoing haemodialysis with moderate-to-severe CKD-aP, itch reduction with intravenous difelikefalin was associated with improved sleep quality. As disturbed sleep may contribute to mortality and morbidity in CKD-aP, difelikefalin may help to address a major clinical burden by improving sleep quality, secondary to itch relief.

Serial SARS-CoV-2 Antibody Titers in Vaccinated Dialysis Patients: Prevalence of Unrecognized Infection and Duration of Seroresponse.

Rationale & Objective: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are likely underdiagnosed, but the degree of underdiagnosis among patients receiving maintenance dialysis is unknown. The durability of the immune response after the third vaccine dose in this population also remains uncertain. This descriptive study tracked antibody levels to (1) assess the rate of undiagnosed infections and (2) characterize seroresponse durability after the third dose. Study Design: Retrospective observational study. Setting & Participants: SARS-CoV-2-vaccinated patients receiving maintenance dialysis through a national dialysis provider. Immunoglobulin G spike antibodies [anti-spike immunoglobulin (Ig) G] titers were assessed monthly after vaccination. Exposures: Two and 3 doses of SARS-CoV-2 vaccine. Outcomes: Undiagnosed and diagnosed SARS-CoV-2 infections; anti-spike IgG titers over time. Analytical Approach: Undiagnosed SARS-CoV-2 infections were identified as an increase in anti-spike IgG titer of ≥100 BAU/mL, not associated with receipt of vaccine or diagnosed SARS-CoV-2 infection (by polymerase chain reaction test or antigen test). In descriptive analyses, anti-spike IgG titers were followed over time. Results: Among 2,703 patients without previous coronavirus disease 2019 (COVID-19) who received an initial 2-dose vaccine series, 271 had diagnosed SARS-CoV-2 infections (3.4 per 10,000 patient-days) and 129 had undiagnosed SARS-CoV-2 infections (1.6 per 10,000 patient-days). Among 1,894 patients without previous COVID-19 who received a third vaccine dose, 316 had diagnosed SARS-CoV-2 infections (7.0 per 10,000 patient-days) and 173 had undiagnosed SARS-CoV-2 infections (3.8 per 10,000 patient-days). In both cohorts, anti-spike IgG levels declined over time. Of the initial 2-dose cohort, 66% had a titer of ≥500 BAU/mL in the first month, with 24% maintaining a titer of ≥500 BAU/mL at 6 months. Of the third dose cohort, 95% had a titer of ≥500 BAU/mL in the first month after the third dose, with 77% maintaining a titer of ≥500 BAU/mL at 6 months. Limitations: The assays used had upper limits. Conclusions: Among patients receiving maintenance dialysis, about 1 in every 3 SARS-CoV-2 infections was undiagnosed. Given this population's vulnerability to COVID-19, ongoing infection control measures are needed. A 3-dose primary mRNA vaccine series optimizes seroresponse rate and durability. Plain-Language Summary: Patients receiving maintenance dialysis have been particularly vulnerable to COVID-19. Using serially measured antibodies, we found that a substantial proportion (about one-third) of SARS-CoV-2 infections among this population had been missed, both among those who had completed a 2-dose vaccine series and among those who had received a third vaccine dose. Such missed infections likely had only mild or minimal symptoms, but this failure to recognize all infections is concerning. Furthermore, vaccines have been effective among patients receiving dialysis, but our study additionally shows that the immune response wanes over time, even after a third dose. There is therefore a role for ongoing vigilance against this highly transmissible infection.

System-Level Strategies to Improve Home Dialysis: Policy Levers and Quality Initiatives.

Advocacy and policy change are powerful levers to improve quality of care and better support patients on home dialysis. While the kidney community increasingly recognizes the value of home dialysis as an option for patients who prioritize independence and flexibility, only a minority of patients dialyze at home in the United States. Complex system-level factors have restricted further growth in home dialysis modalities, including limited infrastructure, insufficient staff for patient education and training, patient-specific barriers, and suboptimal physician expertise. In this article, we outline trends in home dialysis use, review our evolving understanding of what constitutes high-quality care for the home dialysis population (as well as how this can be measured), and discuss policy and advocacy efforts that continue to shape the care of US patients and compare them with experiences in other countries. We conclude by discussing future directions for quality and advocacy efforts.

Optimal Care for Kidney Health: Development of a Merit-based Incentive Payment System (MIPS) Value Pathway.

The Merit-based Incentive Payment System (MIPS) is a mandatory pay-for-performance program through the Centers for Medicare & Medicaid Services (CMS) that aims to incentivize high-quality care, promote continuous improvement, facilitate electronic exchange of information, and lower health care costs. Previous research has highlighted several limitations of the MIPS program in assessing nephrology care delivery, including administrative complexity, limited relevance to nephrology care, and inability to compare performance across nephrology practices, emphasizing the need for a more valid and meaningful quality assessment program. This article details the iterative consensus-building process used by the American Society of Nephrology Quality Committee from May 2020 to July 2022 to develop the Optimal Care for Kidney Health MIPS Value Pathway (MVP). Two rounds of ranked-choice voting among Quality Committee members were used to select among nine quality metrics, 43 improvement activities, and three cost measures considered for inclusion in the MVP. Measure selection was iteratively refined in collaboration with the CMS MVP Development Team, and new MIPS measures were submitted through CMS's Measures Under Consideration process. The Optimal Care for Kidney Health MVP was published in the 2023 Medicare Physician Fee Schedule Final Rule and includes measures related to angiotensin-converting enzyme inhibitor and angiotensin receptor blocker use, hypertension control, readmissions, acute kidney injury requiring dialysis, and advance care planning. The nephrology MVP aims to streamline measure selection in MIPS and serves as a case study of collaborative policymaking between a subspecialty professional organization and national regulatory agencies.