Hemoglobin and Clinical Outcomes in Hemodialysis: An Analysis of US Medicare Data From 2018 to 2020.

Rationale & Objective: Anemia management in patients treated with maintenance dialysis remains a challenge. We sought to update information in this area by evaluating the association between hemoglobin and various outcome and utilization measures using data-rich Medicare sources. Study Design: Observational cohort study using data from the Consolidated Renal Operations in a Web-enabled Network and Medicare claims. Setting & Participants: We studied 371,250 prevalent patients treated with hemodialysis, covering 3,326,072 patient-months in 2019. Exposure: Monthly patient hemoglobin concentrations. Outcomes: We examined several outcomes, including mortality, all-cause hospitalization, cause-specific hospitalization, and emergency department utilization in the month following the exposure measurement. Analytical Approach: For each monthly observation period, we calculated unadjusted and adjusted (for demographics and comorbid condition) hazard ratios using Cox regression. Results: The hemoglobin concentration was <10.5 g/dL for 40% of observations. We found an inverse association between mortality and hemoglobin measured over a range from <9 g/dL (HR, 2.53; 95% CI, 2.45-2.61; P < 0.0001, reference = 10.5-11 g/dL) to 11-11.5 g/dL (HR, 0.92; 95% CI, 0.89-0.96; P < 0.0001). Mortality risk started to increase at hemoglobin levels >11.5 g/dL. All-cause hospitalization, cause-specific hospitalization (including cardiovascular, infection, and several subcategories including coronavirus disease 2019 hospitalization), and emergency department utilization were inversely associated with hemoglobin concentration, with risk reduction stabilizing at hemoglobin levels of approximately 11.5-12 g/dL and higher. Limitations: As with prior observational studies, the observed associations are not necessarily causal. Conclusions: In a large US hemodialysis population, there were better clinical outcomes at higher hemoglobin concentrations over short exposure and follow-up periods, consistent with other observational studies that generally used longer exposure and follow-up times. Mortality risk increased at hemoglobin concentrations >11.5 g/dL, consistent with findings from erythropoiesis-stimulating agent clinical trials. The apparently beneficial short-term effects associated with higher hemoglobin concentrations suggest that hemoglobin measurements capture unmeasured elements of patient risk.

Excess Death Estimates in Patients with End-Stage Renal Disease - United States, February-August 2020.

End-stage renal disease (ESRD) is a condition in which kidney function has permanently declined such that renal replacement therapy* is required to sustain life (1). The mortality rate for patients with ESRD in the United States has been declining since 2001 (2). However, during the COVID-19 pandemic, ESRD patients are at high risk for COVID-19-associated morbidity and mortality, which is due, in part, to weakened immune systems and presence of multiple comorbidities (3-5). The ESRD National Coordinating Center (ESRD NCC) supports the Centers for Medicare & Medicaid Services (CMS) and the ESRD Networks†,§ through analysis of data, dissemination of best practices, and creation of educational materials. ESRD NCC analyzed deaths reported to the Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb), a system that facilitates the collection of data and maintenance of information about ESRD patients on chronic dialysis or receiving a kidney transplant who are treated in Medicare-certified dialysis facilities and kidney transplant centers in the United States. Excess death estimates were obtained by comparing observed and predicted monthly numbers of deaths during February 1-August 31, 2020; predicted deaths were modeled based on data from January 1, 2016, through December 31, 2019. The analysis estimated 8.7-12.9 excess deaths per 1,000 ESRD patients, or a total of 6,953-10,316 excess deaths in a population of 798,611 ESRD patients during February 1-August 31, 2020. These findings suggest that deaths among ESRD patients during the early phase of the pandemic exceeded those that would have been expected based on previous years' data. Geographic and temporal patterns of excess mortality, including those among persons with ESRD, should be considered during planning and implementation of interventions, such as COVID-19 vaccination, infection control guidance, and patient education. These findings underscore the importance of data-driven technical assistance and further analyses of the causes and patterns of excess deaths in ESRD patients.

Pre-ESRD Care and Mortality in Incident ESRD Patients With Multiple Myeloma.

OBJECTIVES: The relationship between mortality and pre-ESRD (end-stage renal disease) nephrology care in incident ESRD patients with multiple myeloma (MM) as the primary cause of renal failure has not been examined. MATERIALS AND METHODS: Among 439,206 incident US hemodialysis patients with MM as the primary cause of ESRD (June 1, 2005 to May 31, 2009) identified using the US Renal Data System, adjusted odds ratios (OR) for reported pre-ESRD nephrology care for ESRD due to MM (n=4561) versus other causes (n=434,645) were calculated. The association of pre-ESRD nephrology care with subsequent mortality in MM-ESRD patients was examined. RESULTS: MM-ESRD patients were less likely to have any predialysis nephrology care in the year before initiation of dialysis (34.8% vs. 58.5%; OR=0.38; 95% confidence interval [CI], 0.34-0.43) compared with patients with ESRD due to other causes. MM-ESRD patients compared with others were more likely to have catheters on first dialysis (91.8% vs. 75.6%; OR=4.15; 95% CI, 3.54-4.86). Incident MM-ESRD patients receiving predialysis care for ≥6 months had significantly lower 1-year mortality (hazard ratio 0.89; 95% CI, 0.82-0.97 and 0.88; 95% CI, 0.80-0.96, respectively), relative to those without this care. A catheter for dialysis access was associated with a 1.6-fold increase in 1-year mortality in incident MM-ESRD (hazard ratio 1.55; 95% CI, 1.32-1.83). CONCLUSIONS: MM-ESRD patients were less likely to have predialysis nephrology care and more likely to use catheters on first dialysis. However, predialysis care is independently associated with lower mortality in MM-ESRD patients. Predialysis care should be prioritized in MM patients approaching ESRD.

A Peer-to-Peer Mentoring Program for In-Center Hemodialysis: A Patient-Centered Quality Improvement Program.

A patient-centered quality improvement program implemented in one Virginia hemodialysis facility sought to determine if peer-to-peer (P2P) programs can assist patients on in-center hemodialysis with self-management and improve outcomes. Using a single-arm, repeatedmeasurement, quasi-experimental design, 46 patients participated in a four-month P2P intervention. Outcomes include knowledge, self-management behaviors, and psychosocial health indicators: self-efficacy, perceived social support, hemodialysis social support, and healthrelated quality of life (HRQoL). Physiological health indicators included missed and shortened treatments, arteriovenous fistula placement, interdialytic weight gain, serum phosphorus, and hospitalizations. Mentees demonstrated increased knowledge, self-efficacy, perceived social support, hemodialysis social support, and HRQoL. Missed treatments decreased. Mentors experienced increases in knowledge, self-management, and social support. A P2P mentoring program for in-center hemodialysis can benefit both mentees and mentors.

High one year mortality in adults with sickle cell disease and end-stage renal disease.

Adequate pre-dialysis care reduces mortality among end-stage renal disease (ESRD) patients. We tested the hypothesis that individuals with ESRD due to sickle cell disease (SCD-ESRD) receiving pre-ESRD care have lower mortality compared to individuals without pre-ESRD care. We examined the association between mortality and pre-ESRD care in incident SCD-ESRD patients who started haemodialysis between 1 June, 2005 and 31 May, 2009 using data provided by the Centers for Medicare and Medicaid Services (CMS). SCD-ESRD was reported for 410 (0·1%) of 442 017 patients. One year after starting dialysis, 108 (26·3%) patients with incident ESRD attributed to SCD died; the hazard ratio (HR) for mortality among patients with SCD-ESRD compared to those without SCD as the primary cause of renal failure was 2·80 (95% confidence interval [CI] 2·31-3·38). Patients with SCD-ESRD receiving pre-dialysis nephrology care had a lower death rate than those with SCD-ESRD who did not receive pre-dialysis nephrology care (HR = 0·67, 95% CI 0·45-0·99). The one-year mortality rate following an ESRD diagnosis was almost three times higher in individuals with SCD when compared to those without SCD but with ESRD and could be attenuated by pre-dialysis nephrology care.

Prevalence of arteriovenous fistulas in incident hemodialysis patients: correlation with patient factors that may be associated with maturation failure.

BACKGROUND: Lok et al previously reported a risk equation for arteriovenous fistula (AVF) maturation failure. It is unclear whether this model or a more comprehensive model correlates with incident AVF use in the US hemodialysis population. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: 195,756 adult patients initiating outpatient hemodialysis therapy in the United States between July 1, 2005, and December 31, 2009, with 6 months or more prior nephrology care. PREDICTOR: Patient characteristics (age, peripheral vascular disease, coronary artery disease, and race) populating the AVF maturation failure risk equation and other demographic and clinical variables from the Centers for Medicare & Medicaid Services (CMS) Medical Evidence Report (CMS 2728). OUTCOMES & MEASUREMENTS: AVF use at first outpatient dialysis treatment as recorded on the CMS 2728. RESULTS: Using the risk categories defined by Lok et al, AVF use varied from 19.0% (very high risk) to 25.6% (low risk). In a model using only these risk categories, logistic regression showed lower ORs for moderate-, 0.90 (95% CI, 0.88-0.93); high-, 0.80 (95% CI, 0.78-0.83); and very high-risk patients, 0.68 (95% CI, 0.63-0.73) compared with low risk. In the expanded model, odds were lower for women, blacks, Hispanics, age older than 85 years, diabetes, peripheral vascular disease, congestive heart failure, other cardiac disease, and underweight. Odds were higher for hypertension, overweight, obesity, 12 months or more nephrologist care, most insurance types, and each successive year after 2005. Despite associations, the C statistic for the expanded model was 0.64. LIMITATIONS: This analysis is limited by lack of access creation history before dialysis therapy initiation and minimal external validation of CMS 2728 data. CONCLUSIONS: Clinical risk factors identified by Lok and expanded in this analysis have limited ability to predict incident AVF use. Even patients judged at highest risk can have successful AVF construction and initiate dialysis therapy through a functioning AVF.

Quality of care for myocardial infarction in rural and urban hospitals.

BACKGROUND: In the mid-1990s, significant gaps existed in the quality of acute myocardial infarction (AMI) care between rural and urban hospitals. Since then, overall AMI care quality has improved. This study uses more recent data to determine whether rural-urban AMI quality gaps have persisted. METHODS: Using inpatient records data for 34,776 Medicare beneficiaries with AMI from 2000-2001, unadjusted and logistic regression analysis compared receipt of 5 recommended treatments between admissions to urban, large rural, small rural, and isolated small rural hospitals as defined by Rural Urban Commuting Area codes. RESULTS: Substantial proportions of hospital admissions in all areas did not receive guideline-recommended treatments (eg, 17.0% to 23.6% without aspirin within 24 hours of admission, 30.8% to 46.6% without beta-blockers at arrival/discharge). Admissions to small rural and isolated small rural hospitals were least likely to receive most treatments (eg, 69.2% urban, 68.3% large rural, 59.9% small rural, 53.4% isolated small rural received discharge beta-blocker prescriptions). Adjusted analyses found no treatment differences between admissions to large rural and urban area hospitals, but admissions to small rural and isolated small rural hospitals had lower rates of discharge prescriptions such as aspirin and beta-blockers than urban hospital admissions. CONCLUSIONS: Many simple guidelines that improve AMI outcomes are inadequately implemented, regardless of geographic location. In small rural and isolated small rural hospitals, addressing barriers to prescription of beneficial discharge medications is particularly important. The best quality improvement practices should be identified and translated to the broadest range of institutions and providers.

Assessment of the Medicare quality improvement organization program.

BACKGROUND: Studies have shown improvement in quality of health care in the United States. However, the factors responsible for this improvement are largely unknown. OBJECTIVE: To evaluate the effect of the Medicare Quality Improvement Organization (QIO) Program in 4 clinical settings by using performance data for 41 quality measures during the 7th Scope of Work. DESIGN: Observational study in which differences in quality measures were compared between baseline and remeasurement periods for providers that received different levels of QIO interventions. SETTING: Nursing homes, home health agencies, hospitals, and physician offices in the 50 U.S. states, the District of Columbia, and 2 U.S. territories. PARTICIPANTS: Providers receiving focused QIO assistance related to quality measures and providers receiving general informational assistance from QIOs. MEASUREMENTS: 5 nursing home quality measures, 11 home health measures, 21 hospital measures, and 4 physician office measures. RESULTS: For nursing home, home health, and physician office measures, providers recruited specifically by QIOs for receipt of assistance showed greater improvement in performance on 18 of 20 measures than did providers who were not recruited; similar improvement was seen on the other 2 measures. Nursing homes and home health agencies improved more in all measures on which they chose to work with the QIO than in other measures. Nineteen of 21 hospital measures showed improvement; in this setting, QIOs were contracted for improvement initiatives solely at the statewide level. Overall, improvement was seen in 34 of 41 measures from baseline to remeasurement in the 7th Scope of Work. LIMITATIONS: As in any observational study, selection bias, regression to the mean, and secular trends may have influenced the results. CONCLUSIONS: These findings are consistent with an impact of the QIO Program and QIO technical assistance on the observed improvement. Future evaluations of the QIO Program will attempt to better address the limitations of the design of this study.

Change in the quality of care delivered to Medicare beneficiaries, 1998-1999 to 2000-2001.

CONTEXT: Despite widespread concern regarding the quality and safety of health care, and a Medicare Quality Improvement Organization (QIO) program intended to improve that care in the United States, there is only limited information on whether quality is improving. OBJECTIVE: To track national and state-level changes in performance on 22 quality indicators for care of Medicare beneficiaries. DESIGN, PATIENTS, AND SETTING: National observational cross-sectional studies of national and state-level fee-for-service data for Medicare beneficiaries during 1998-1999 (baseline) and 2000-2001 (follow-up). MAIN OUTCOME MEASURES: Twenty-two QIO quality indicators abstracted from state-wide random samples of medical records for inpatient fee-for-service care and from Medicare beneficiary surveys or Medicare claims for outpatient care. Absolute improvement is defined as the change in performance from baseline to follow-up (measured in percentage points for all indicators except those measured in minutes); relative improvement is defined as the absolute improvement divided by the difference between the baseline performance and perfect performance (100%). RESULTS: The median state's performance improved from baseline to follow-up on 20 of the 22 indicators. In the median state, the percentage of patients receiving appropriate care on the median indicator increased from 69.5% to 73.4%, a 12.8% relative improvement. The average relative improvement was 19.9% for outpatient indicators combined and 11.9% for inpatient indicators combined (P<.001). For all but one indicator, absolute improvement was greater in states in which performance was low at baseline than those in which it was high at baseline (median r = -0.43; range: 0.12 to -0.93). When states were ranked on each indicator, the state's average rank was highly stable over time (r = 0.93 for 1998-1999 vs 2000-2001). CONCLUSIONS: Care for Medicare fee-for-service plan beneficiaries improved substantially between 1998-1999 and 2000-2001, but a much larger opportunity remains for further improvement. Relative rankings among states changed little. The improved care is consistent with QIO activities over this period, but these cross-sectional data do not provide conclusive information about the degree to which the improvement can be attributed to the QIOs' quality improvement efforts.