Predicting hospitalizations for patients with chronic kidney disease.

OBJECTIVES: Patients with chronic kidney disease (CKD) are at higher risk of being admitted to the hospital than the general population. Hospitalizations in patients with CKD are associated with higher medical costs and increased morbidity and mortality. Identification of patients with CKD who are at greatest risk of hospitalization may hold promise to improve clinical outcomes and enable judicious allocation of health care resources. STUDY DESIGN: Retrospective, observational cohort study. METHODS: Medicare Part A and Part B claims from calendar years 2017 and 2018 from 50,000 unique patients with a diagnosis of stage 3 to 5 CKD were used for this study. Data were split into training (n = 40,000) and test (n = 10,000) sets. A variety of model types were built to predict all-cause hospitalization within 90 days. RESULTS: The final model was a gradient-boosting machine with 399 input terms. The model demonstrated good ability to discriminate (area under the curve [AUC] for the receiver operating characteristic curve = 0.73), which was stable when tested in the test set (AUC = 0.73). The positive predictive value in the test set was 0.306, 0.240, and 0.216 at the 10%, 20%, and 30% thresholds, respectively. The sensitivity in the test set was 0.288, 0.453, and 0.609 at the 10%, 20%, and 30% thresholds, respectively. CONCLUSIONS: We developed an algorithm that uses medical claims to identify Medicare patients with CKD stages 3 to 5 who are at highest risk of being hospitalized in the near term. This algorithm could be used as a decision support tool for clinical programs focusing on management of patient populations with CKD.

Association of Chronic Condition Special Needs Plan With Hospitalization and Mortality Among Patients With End-Stage Kidney Disease.

Importance: While several studies have demonstrated the benefit of enrollment in chronic condition special needs plans (C-SNPs) for other chronic diseases (eg, diabetes), there is no evaluation of the association of C-SNPs with outcomes among patients with end-stage kidney disease (ESKD). Objective: To examine whether and to what degree C-SNP enrollment was associated with improved clinical outcomes and quality of life in patients with ESKD. Design, Setting, and Participants: This multicenter cohort study included 2718 patients who were newly enrolled in an ESKD C-SNP between January 1, 2013, and September 30, 2017, and receiving dialysis from DaVita Kidney Care. Patients were followed up until death, loss to follow-up, or end of study (ie, December 31, 2018). Enrollees in C-SNP were matched via multiple clinical and demographic characteristics with 2 different control populations, as follows: (1) those in the same facilities (n = 2545) or (2) those in similar counties (n = 1986). Patients enrolled in CareMore C-SNPs (n = 206) were excluded from the study. Data analysis was conducted June to December 2019. Exposures: Standard ESKD care with dialysis plus access to an integrated care team who worked with the patient and the dialysis team, comprehensive health assessments done by the integrated care team, and access to select benefits (such as vision and dental care) as a C-SNP enrollee. Main Outcomes and Measures: Hospitalizations, mortality, laboratory values indicative of metabolic control, and Kidney Disease Quality of Life 36-item (KDQOL-36) survey scores. Results: The 2545 C-SNP enrollees in the facility-matched analysis had a mean (SD) age of 57.2 (12.9) years, and included 968 (38.0%) women, 1328 (52.2%) Hispanic individuals, and 553 (21.7%) African American individuals. The 1986 C-SNP enrollees in the county-matched analysis had a mean (SD) age of 57.8 (12.2) years, with 705 (35.5%) women, 1085 (54.6%) Hispanic individuals, and 472 (23.8%) African American individuals. Compared with patients not enrolled in C-SNP, enrollees had lower hospitalization rates, with incidence rate ratios of 0.90 (95% CI, 0.84-0.97; P = .006) in the facility-matched analysis and 0.76 (95% CI, 0.70-0.83; P < .001) in the county-matched analysis. Compared with patients not enrolled in C-SNP, enrollees had decreased mortality risk in the same facilities (hazard ratio, 0.77; 95% CI, 0.68-0.88; P < .001) and in the same counties (hazard ratio, 0.77; 95% CI, 0.66-0.88; P < .001). No significant differences were observed between C-SNP enrollees and matched patients in metabolic laboratory values or KDQOL-36 survey scores. Conclusions and Relevance: This cohort study found a positive association of C-SNP enrollment with lower rates of hospitalization and mortality. The findings suggest that the additional services and benefits C-SNPs provide may improve outcomes compared with standard of care for patients with ESKD.

Correction to: Use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States.

Following publication of the original article [1], the authors reported an error in Figs. 3 and S3.

Response to correspondence from Hays and colleagues concerning our paper entitled, use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States.

In their correspondence, Hays et al. raise two main critiques of our recently published article entitled "Use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States." First, Hays et al. expressed concerns regarding the comparison of mean scores on five Kidney Disease Quality of Life (KDQOL) subscales, given that the Physical Component Summary (PCS) and Mental Component Summary (MCS) are scored on a different numeric scale compared to the other three subscales. Second, Hays et al. note that the correlations reported in our manuscript between the general health perceptions item ("In general, would you say your health is excellent, very good, good, fair, or poor") and the 5 KDQOL subscales were inconsistent with findings derived from other KDQOL datasets. Here, we respond to these two critiques.

Use of the KDQOL-36™ for assessment of health-related quality of life among dialysis patients in the United States.

BACKGROUND: Health-related quality of life (HRQOL) is a key outcome for dialysis patients, and its assessment is mandated by the Centers for Medicaid and Medicare Services. The Kidney Disease Quality of Life (KDQOL-36™) survey is widely used for this assessment. KDQOL-36™ completion rates, and the distributions of scores and item responses, have not been examined in a large, nationally representative cohort of dialysis patients. METHODS: This retrospective, observational study considered 413,951 survey opportunities contributed by adult patients who received dialysis at a large dialysis organization in the United States during calendar years 2014, 2015, and 2016 and were not Veterans Affairs beneficiaries. RESULTS: During the study period, 240,343 unique patients completed a total of 330,412 surveys (overall completion rate 79.8%). Mean domain scores on the physical component summary (PCS), mental component summary (MCS), burden of kidney disease (BKD), symptoms and problems of kidney disease (SPKD), and effects of kidney disease (EKD) subscales were 36.6, 49.0, 51.3, 78.1, and 73.0, respectively. Scores were similar across dialysis modalities. Patient perceptions of general health were not correlated (R < 0.05) with PCS or SPKD. The SPKD showed ceiling effects: among patients treated with in-center hemodialysis, for all 12 items, < 10% of patients were "extremely bothered," while > 65% of patients reported being "not at all" or only "somewhat bothered;" for 3 items, > 85% of patients gave these latter two responses. Interdialytic weight gain was not correlated with patient-reported shortness of breath, PCS, or SPKD. CONCLUSIONS: Survey completion rates for the KDQOL-36™ were high, and scores were similar across dialysis modalities. Ceiling effects were observed for SPKD. Revision of the KDQOL-36™ to address factors that are most important to contemporary dialysis patients may be warranted.

Vocational activity and health insurance type among patients with end-stage renal disease: association with outcomes.

It is widely thought that patients with end-stage renal disease who remain vocationally active and/or commercially insured following dialysis initiation have better clinical outcomes and higher quality of life than those who do not. However, scientifically robust data are lacking. Here, we examined whether vocational status (active, N = 1848; inactive, N = 10,001) and, separately, insurance status (commercial, N = 4858; Medicare/self-pay, N = 13,329; Medicaid, N = 3528) were associated with clinical outcomes and Kidney Disease Quality of Life (KDQOL) scores among a cohort of patients who initiated dialysis at a large US dialysis organization during 2015-2016. Outcomes were considered from the day after index (31 days after dialysis initiation for vocational status and 1 day after initiation for insurance status) until the earliest of death, discontinuation of dialysis, transplant, loss to follow-up, or end of study (30 September 2016). Comparisons were made using intention-to-treat principles and generalized linear models adjusted for imbalanced patient characteristics, including sociodemographic variables. Vocational inactivity (vs. vocational activity) was independently associated with higher rates of mortality and hospitalization, lower rates of transplant, and lower KDQoL scores in 4 of 5 domains. Similar trends were observed when comparing Medicare/self-pay or Medicaid insurance to commercial insurance. Vocational activity, and separately, commercial insurance, were independently associated with better clinical and quality of life outcomes compared to other insurance and vocational categories. These findings may inform patient and physician education, and guide advocacy efforts.

Measuring patient experience in dialysis: a new paradigm of quality assessment.

Patients' experience of care (PEC) is as an important dimension in quality of care. As a distinct entity from patient satisfaction and patient health-related quality of life, PEC is defined as patients' perceptions of the range of interactions they have with the health care system, including care from providers, facilities, and health plans. While traditionally PEC may be ascertained via informal assessments, in recent years, especially in the United States, there has been a shift towards standardized surveillance of PEC amongst dialysis patients in order to: (1) set a normative expectation regarding the importance of PEC; (2) standardize the components of patients' experience that are assessed to minimize potential "blind spots"; (3) provide a direct "voice" to the patient in communicating perceptions of their care; (4) facilitate comparisons of quality across facilities; and (5) broaden accountability for PEC to the entire multidisciplinary dialysis care team. In this review, we will discuss the significance of PEC as a quality of care metric in dialysis patients; the history of PEC assessment across other health care arenas; the development of the In-Center Hemodialysis Consumer Assessment of Healthcare Provider and Systems survey as a means to standardize PEC assessment among US dialysis patients; experiences in PEC assessment across international dialysis populations; and future areas of research needed to refine the ascertainment of PEC and its impact upon patient outcomes.

Net Budgetary Impact of Ferric Citrate as a First-Line Phosphate Binder for the Treatment of Hyperphosphatemia: A Markov Microsimulation Model.

Ferric citrate (FC) has demonstrated efficacy as a phosphate binder and reduces the requirements for erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron in dialysis patients. We developed a net budgetary impact model to evaluate FC vs. other phosphate binders from the vantage of a large dialysis provider. We used a Markov microsimulation model to simulate mutually referential longitudinal effects between serum phosphate and phosphate binder dose; categories of these defined health states. Health states probabilistically determined treatment attendance and utilization of ESA and IV iron. We derived model inputs from a retrospective analysis of incident phosphate binder users from a large dialysis organization (January 2011-June 2013) and incorporated treatment effects of FC from a phase III trial. The model was run over a 1-year time horizon. We considered fixed costs of providing dialysis; costs of administering ESA and IV iron; and payment rates for dialysis, ESAs, and IV iron. In the base-case model, FC had a net budgetary impact (savings) of +US$213,223/year per 100 patients treated vs. standard of care. One-way sensitivity analyses showed a net budgetary impact of up to +US$316,296/year per 100 patients treated when higher hemoglobin levels observed with FC translated into a 30% additional ESA dose reduction, and up to +US$223,281/year per 100 patients treated when effects on missed treatment rates were varied. Two-way sensitivity analyses in which acquisition costs for ESA and IV iron were varied showed a net budgetary impact of +US$104,840 to +US$213,223/year per 100 patients treated. FC as a first-line phosphate binder would likely yield substantive savings vs. standard of care under current reimbursement.

The clinical and economic burden of pneumonia in patients enrolled in Medicare receiving dialysis: a retrospective, observational cohort study.

BACKGROUND: End-stage renal disease (ESRD) patients receiving dialysis are at particular risk for infection. We assessed the clinical and economic burden of pneumonia in a population of Medicare-enrolled ESRD patients with respect to incidence and case fatality rates, rates of all-cause and cardiovascular hospitalization, and costs. METHODS: Patients received dialysis between 01 January 2009 and 31 December 2011 and were enrolled in Medicare Parts A and B. Pneumonia episodes were identified from institutional and supplier claims. Patients were considered at-risk from first date of Medicare coverage and were censored upon transplant, withdrawal from dialysis, recovery of renal function, loss of Medicare benefits, or death. Linear mixed-effects models were used to assess hospitalization rates and costs over the 3 months prior to and 12 months following pneumonia episodes. RESULTS: The pneumonia incidence rate for the study period was 21.4 events/100 patient-years; the majority of episodes (90.1%) required inpatient treatment. The 30-day case fatality rate was 10.7%. Compared to month -3 prior to event, rates of all-cause and cardiovascular hospitalization were higher in the month of the pneumonia episode (IRR, 4.61 and 4.30). All-cause admission rates remained elevated through month 12; cardiovascular admission rates remained elevated through month 6. Mean per-patient per-month costs were $10,976 higher in the month of index episode compared to month -3, largely driven by increased inpatient costs, and remained elevated through end of 12-month follow-up. CONCLUSION: Pneumonia episodes are frequent among ESRD patients and result in hospitalizations and greater overall costs to Medicare over the following year.

Clinical and economic burden of bloodstream infections in critical care patients with central venous catheters.

PURPOSE: Bloodstream infections (BSIs) complicate the management of intensive care unit (ICU) patients. We assessed the clinical and economic impact of BSI among patients of a managed care provider group who had a central venous catheter (CVC) placed in the ICU. METHODS: We considered hospitalizations occurring between January 1, 2011, and September 30, 2014, that involved an ICU stay during which a CVC was placed. Comparisons were made between episodes where the patient did vs did not develop BSI after CVC insertion. Length of stay, costs of index hospitalization, and total costs over the 180 days after discharge were compared using linear mixed models. Inhospital mortality and 30-day readmission rates were compared using negative binomial regression models. RESULTS: Development of BSI was associated with longer hospital stay (+7 days), more than 3-fold increase in risk of inhospital death, and an additional $129 000 in costs for the index hospitalization. No statistically significant differences in 30-day readmission rates or costs of care over the 180-day period after discharge from the index admission were observed. CONCLUSION: Bloodstream infections after CVC placement in ICU patients are associated with significant increases in costs of care and risk of death during the index hospitalization but no differences in readmissions or costs after discharge.

Stage 2 hypertension: predictors of failure to achieve blood pressure control and the impact of adding one additional antihypertensive class.

BACKGROUND AND OBJECTIVE: Controlling blood pressure (BP) for patients with stage 2 hypertension remains challenging. This research aimed to: (i) identify predictors of failure to achieve BP control, (ii) determine the association of adding one additional antihypertensive class with achieving BP control, and (iii) describe the prescribed antihypertensive regimens. METHODS: Electronic medical record data from 25 multi-specialty medical groups in the USA were used. The study cohort included patients with stage 2 hypertension in 2012. BP control rates were determined at 6 months from the date of the stage 2 BP. Using multivariable logistic regression and validation by Monte Carlo simulation, we determined independent baseline predictors of not achieving BP control (<140/90). RESULTS: Included were 107 903 patients. Baseline predictors of failure to achieve BP control included the following: a prior stage 2 BP, systolic BP ≥ 165, Black race, male sex, income ≤ $35 000, body mass index ≥ 30, age ≥ 65 years, and no office visits. Increasing from single-class to dual-class antihypertensive therapy was associated with a 42% increased odds of achieving BP control (odds ratio 1.42; 95% CI 1.22, 1.64); however, this effect was attenuated as the number of baseline antihypertensive classes increased. The 10 most frequently prescribed regimens accounted for only 40% of all antihypertensive regimens. CONCLUSIONS: Among patients with stage 2 hypertension, a prior stage 2 BP, a systolic BP ≥ 165, and fewer office visits were strong predictors of failure to achieve BP control. Increasing to dual-class antihypertensive therapy was significantly associated with achieving BP control. There is broad heterogeneity in the antihypertensive regimens prescribed.

Facility Dialysate Calcium Practices and Clinical Outcomes Among Patients Receiving Hemodialysis: A Retrospective Observational Study.

BACKGROUND: Some US dialysis facilities have reduced default dialysate calcium concentrations from 2.5 mEq/L to lower levels. There has been no rigorous systematic examination of the effects of such a reduction on clinical and biochemical outcomes. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Medicare-eligible patients who received in-center hemodialysis at a large dialysis organization in January 2008 to December 2010. PREDICTOR: Facility conversion from predominant use (≥75% patients) of 2.50-mEq/L dialysate calcium to predominant use of lower dialysate calcium concentrations versus maintenance of predominant use of 2.50-mEq/L dialysate calcium. OUTCOMES: All-cause and cause-specific mortality and hospitalization, laboratory markers of metabolic bone disease, and drug utilization. MEASUREMENTS: Hierarchical mixed linear and Poisson models were fit to compare pre- to postconversion differences in outcomes between converter and matched control facilities. Results, expressed as relative rate ratios (RRRs) and delta-delta (change in mean values), were estimated for early (months 0-2) and late (months 3-12) postconversion to allow for possible latent effects. RESULTS: Facility conversion was associated with greater rates of hospitalization for heart failure exacerbation (late RRR, 1.27 [95% CI, 1.06-1.51]), hypocalcemia (early RRR, 1.19 [95% CI, 1.05-1.35]; late RRR, 1.39 [95% CI, 1.20-1.60]), and intradialytic hypotension (early RRR, 1.07 [95% CI, 1.02-1.11]; late RRR, 1.05 [95% CI, 1.01-1.10]), but no differences were observed for all-cause mortality or hospitalization rates. Facility conversion was also associated with comparative temporal decreases in serum calcium level, increases in serum phosphate and parathyroid hormone levels, and increases in use of phosphate binders, vitamin D, and calcimimetics. LIMITATIONS: Possible residual confounding, generalizability beyond Medicare patients uncertain. CONCLUSIONS: There are potential safety concerns associated with the default use of dialysate calcium concentrations < 2.50 mEq/L, as well as biochemical evidence of poorer disease control despite associated greater medication use. Individualization of dialysate calcium concentration rather than predominant use of dialysate calcium concentrations < 2.50 mEq/L should be considered.

End-stage renal disease in autosomal dominant polycystic kidney disease: a comparison of dialysis-related utilization and costs with other chronic kidney diseases.

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is the leading inheritable cause of end-stage renal disease (ESRD) and one of the leading causes of ESRD overall. ADPKD patients differ from the overall dialysis population; however, there is little published data regarding health care costs for ADPKD patients on dialysis. METHODS: This retrospective observational cohort study was designed to quantify health care utilization and costs for ADPKD patients with ESRD who received initial services at a single large dialysis organization between January 1, 2007 and December 31, 2009. Parallel results and baseline patient characteristics for control patients with ESRD etiologies other than ADPKD were performed for reference. Dialysis-related utilization and health care costs for patients with ADPKD in ESRD overall and during time horizons that correspond to Medicare-eligibility benchmarks were analyzed. Baseline patient characteristics were described for all patients and included demographics, comorbid illnesses, and clinical characteristics. Dialysis-related utilization, hospitalization rates, and health care costs were considered longitudinally. RESULTS: Total health care costs for ADPKD patients were high at US$51,048 per patient-year based on the overall analysis. Total health care costs were lower for ADPKD patients than for control patients on dialysis. Patients with ADPKD were generally younger, had a lower Charlson Comorbidity Index, and had lower rates of comorbid conditions, which may have contributed to the lower overall costs seen for patients with ADPKD. CONCLUSION: Health care resource utilization and costs for patients with ADPKD in ESRD requiring dialysis were high, and therapeutic interventions that can prevent or delay the progression to ESRD may increase dialysis-free life for patients with ADPKD.

Medicare Advantage associated with lower mortality for incident dialysis patients.

Physicians across the care continuum are increasingly aligned around the belief that coordinated care can improve patient outcomes. As the principal caregivers for one of the most medically fragile patient groups in healthcare, nephrologists are especially attuned to the potential value of integrated care. Medicare Advantage (MA) offers one way to test this hypothesis. By law, end-stage renal disease patients currently cannot enroll into an MA plan, but if they develop ESRD while in such a plan, they may continue to be enrolled. The contrast between these patients and their counterparts who carry Medicare fee for service (MFFS) thereby represents a natural experiment that affords an opportunity to examine whether enrollment in a coordinated care system may improve outcomes. In order to promote (unbiased) comparison of patients in a non-randomized context, we propensity score-matched incident dialysis patients enrolled in MA versus those in MFFS. The data demonstrate that patients who were enrolled in an MA plan upon initiation of dialysis had a 9% lower mortality rate than their MFFS counterparts. This beneficial association of MA enrollment was found to be sustained over the first two years of dialysis treatment.

Real-world dose-relativity, tablet burden, and cost comparison of conversion between sevelamer hydrochloride/carbonate and lanthanum carbonate monotherapies.

PURPOSE: Sevelamer hydrochloride/carbonate (SH/C) and lanthanum carbonate (LC) are noncalcium-based phosphate binders used for the management of hyperphosphatemia in patients with end-stage renal disease (ESRD). The objectives of this study were to examine the dose-relativity, tablet burden, and cost difference of bidirectional conversion between SH/C and LC monotherapy in a large cohort of real-world patients with ESRD. METHODS: This retrospective cohort study included three 30-day preconversion periods (days -90 to -61, -60 to -31, and -30 to -1) followed by three 30-day postconversion periods (days 1 to 30, 31 to 60, and 61 to 90); day 0 was the index date of conversion. The full analysis population (FAP) comprised two cohorts: SH/C to LC (S-L) converters and LC to SH/C (L-S) converters. The SH/C:LC dose-relativity ratio was assessed in the dose-relativity subset, defined as patients whose serum phosphate levels fell within a caliper range of ± 0.5 mg/dL in the final preconversion (days -30 to -1) and postconversion (days 61 to 90) periods. Tablet burden and phosphate binder costs were assessed in the FAP. Phosphate binder costs were based on average wholesale prices. FINDINGS: The FAP contained a total of 303 patients, comprising the S-L (128 patients) and L-S (175 patients) converter cohorts. The dose-relativity subset contained 159 patients, 72 from the S-L cohort and 87 from the L-S cohort. The overall mean SH/C:LC dose-relativity ratio was 2.27 (95% CI, 2.04 to 2.52). In SH/C dose strata >800 to 2400, >2400 to 4800, >4800 to 7200, and >7200 mg/d, overall mean dose-relativity ratios were 0.79 (95% CI, 0.57 to 1.10), 1.45 (95% CI, 1.20 to 1.75), 2.05 (95% CI, 1.75 to 2.39), and 3.24 (95% CI, 2.89 to 3.66), respectively. The overall mean tablet burden was 6.6 tablets per day lower with LC monotherapy than with SH/C monotherapy (95% CI, -7.1 to -6.0; P < 0.0001). The overall mean binder cost/patient per month was $1080.40 for SH/C compared with $1006.20 for LC, corresponding to a mean binder cost saving for LC of $74.20/patient per month (95% CI, -141.80 to -6.63; P = 0.032). SH/C >7800 mg/d was the inflection point at which conversion to LC resulted in mean cost savings. Patients requiring SH/C >7800 mg/d comprised 50% of the FAP. IMPLICATIONS: Converting patients with ESRD and hyperphosphatemia from SH/C to LC monotherapy offers potential drug cost savings and a significant reduction in the daily tablet burden, without compromising the effective management of serum phosphate levels.

Confounders of mortality and hospitalization rate calculations for profit and nonprofit dialysis facilities: analytic augmentation.

BACKGROUND: Patient outcomes have been compared on the basis of the profit status of the dialysis provider (for-profit [FP] and not-for-profit [NFP]). In its annual report, United States Renal Data System (USRDS) provides dialysis provider level death and hospitalization rates adjusted by age, race, sex, and dialysis vintage; however, recent analyses have suggested that other variables impact these outcomes. Our current analysis of hospitalization and mortality rates of hemodialysis patients included adjustments for those used by the USRDS plus other potential confounders: facility geography (end-stage renal disease network), length of facility ownership, vascular access at first dialysis session, and pre-dialysis nephrology care. METHODS: We performed a provider level, retrospective analysis of 2010 hospitalization and mortality rates among US hemodialysis patients exclusively using USRDS sources. Crude and adjusted incidence rate ratios (IRRs) were calculated using the 4 standard USRDS patient factors plus the 4 potential confounders noted above. RESULTS: The analysis included 366,011 and 34,029 patients treated at FP and NFP facilities, respectively. There were statistical differences between the cohorts in geography, facility length of ownership, vascular access, and pre-dialysis nephrology care (p < 0.001), as well as age (p < 0.01), race (p < 0.001), and vintage (p < 0.001), but not sex (p = 0.12). When using standard USRDS adjustments, hospitalization and mortality rates for FP and NFP facilities were most disparate, favoring the NFP facilities. Rates were most similar between providers when adjustments were made for each of the 8 factors. With the FP IRR as the referent (1.0), the hospitalization IRR for NFP facilities was 1.00 (95% confidence interval [CI] 0.97-1.02; p = 0.69), while the NFP mortality IRR was 1.01 (95% CI 0.97-1.05; p = 0.64). CONCLUSIONS: These data suggest there is no difference in mortality and hospitalization rates between FP and NFP dialysis clinics when appropriate statistical adjustments are made.

Guiding principles and checklist for population-based quality metrics.

The Centers for Medicare and Medicaid Services oversees the ESRD Quality Incentive Program to ensure that the highest quality of health care is provided by outpatient dialysis facilities that treat patients with ESRD. To that end, Centers for Medicare and Medicaid Services uses clinical performance measures to evaluate quality of care under a pay-for-performance or value-based purchasing model. Now more than ever, the ESRD therapeutic area serves as the vanguard of health care delivery. By translating medical evidence into clinical performance measures, the ESRD Prospective Payment System became the first disease-specific sector using the pay-for-performance model. A major challenge for the creation and implementation of clinical performance measures is the adjustments that are necessary to transition from taking care of individual patients to managing the care of patient populations. The National Quality Forum and others have developed effective and appropriate population-based clinical performance measures quality metrics that can be aggregated at the physician, hospital, dialysis facility, nursing home, or surgery center level. Clinical performance measures considered for endorsement by the National Quality Forum are evaluated using five key criteria: evidence, performance gap, and priority (impact); reliability; validity; feasibility; and usability and use. We have developed a checklist of special considerations for clinical performance measure development according to these National Quality Forum criteria. Although the checklist is focused on ESRD, it could also have broad application to chronic disease states, where health care delivery organizations seek to enhance quality, safety, and efficiency of their services. Clinical performance measures are likely to become the norm for tracking performance for health care insurers. Thus, it is critical that the methodologies used to develop such metrics serve the payer and the provider and most importantly, reflect what represents the best care to improve patient outcomes.

Incidence, outcomes, and comparisons across definitions of AKI in hospitalized individuals.

BACKGROUND AND OBJECTIVES: At least four definitions of AKI have recently been proposed. This study sought to characterize the epidemiology of AKI according to the most recent consensus definition proposed by the Kidney Disease Improving Global Outcomes (KDIGO) Work Group, and to compare it with three other definitions. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This was a retrospective cohort study of 31,970 hospitalizations at an academic medical center in 2010. AKI was defined and staged according to KDIGO criteria, the Acute Dialysis Quality Initiative's RIFLE criteria, the Acute Kidney Injury Network (AKIN) criteria, and a definition based on a model of creatinine kinetics (CK). Outcomes of interest were incidence, in-hospital mortality, length of stay, costs, readmission rates, and posthospitalization disposition. RESULTS: AKI incidence was highest according to the KDIGO definition (18.3%) followed by the AKIN (16.6%), RIFLE (16.1%), and CK (7.0%) definitions. AKI incidence appeared markedly higher in those with low baseline serum creatinine according to the KDIGO, AKIN, and RIFLE definitions, in which AKI may be defined by a 50% increase over baseline. AKI according to all definitions was associated with a significantly higher risk of death and higher resource utilization. The adjusted odds ratios for in-hospital mortality in those with AKI were highest with the CK definition (5.2; 95% confidence interval [95% CI], 4.1 to 6.6), followed by the RIFLE (2.9; 95% CI, 2.2 to 3.6), KDIGO (2.8; 95% CI, 2.2 to 3.6), and AKIN (2.6; 95% CI, 2.0 to 3.3) definitions. Concordance in diagnosis and staging was high among the KDIGO, AKIN, and RIFLE definitions. CONCLUSIONS: The incidence of AKI in hospitalized individuals varies depending on the definition used. AKI according to all definitions is associated with higher in-hospital mortality and resource utilization. AKI may be inappropriately diagnosed in those with low baseline serum creatinine using definitions that incorporate percentage increases over baseline.

Early trends from the Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations (STEPPS).

BACKGROUND: Launched in January 2011, the prospective payment system (PPS) for the US Medicare End-Stage Renal Disease Program bundled payment for services previously reimbursed independently. Small dialysis organizations may be particularly susceptible to the financial implications of the PPS. The ongoing Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations (STEPPS) was designed to describe trends in care and outcomes over the period of PPS implementation. This report details early results between October 2010 and June 2011. STUDY DESIGN: Prospective observational cohort study of patients from a sample of 51 small dialysis organizations. SETTING & PARTICIPANTS: 1,873 adult hemodialysis and peritoneal dialysis patients. OUTCOMES: Secular trends in processes of care, anemia, metabolic bone disease management, and red blood cell transfusions. MEASUREMENTS: Facility-level data are collected quarterly. Patient characteristics were collected at enrollment and scheduled intervals thereafter. Clinical outcomes are collected on an ongoing basis. RESULTS: Over time, no significant changes were observed in patient to staff ratios. There was a temporal trend toward greater use of peritoneal dialysis (from 2.4% to 3.6%; P = 0.09). Use of cinacalcet, phosphate binders, and oral vitamin D increased; intravenous (IV) vitamin D use decreased (P for trend for all <0.001). Parathyroid hormone levels increased (from 273 to 324 pg/dL; P < 0.001). Erythropoiesis-stimulating agent doses decreased (P < 0.001 for IV epoetin alfa and IV darbepoetin alfa), particularly high doses. Mean hemoglobin levels decreased (P < 0.001), the percentage of patients with hemoglobin levels <10 g/dL increased (from 12.7% to 16.8%), and transfusion rates increased (from 14.3 to 19.6/100 person-years; P = 0.1). Changes in anemia management were more pronounced for African American patients. LIMITATIONS: Limited data were available for the prebundle period. Secular trends may be subject to the ecologic fallacy and are not causal in nature. CONCLUSIONS: In the period after PPS implementation, IV vitamin D use decreased, use of oral therapies for metabolic bone disease increased, erythropoiesis-stimulating agent use and hemoglobin levels decreased, and transfusion rates increased numerically.