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Introduction: The lingering burden of the COVID-19 pandemic on primary care clinicians and practices poses a public health emergency for the United States. This study uses clinician-reported data to examine changes in primary care demand and capacity., Methods: From March 2020 to March 2022, 36 electronic surveys were fielded among primary care clinicians responding to survey invitations as posted on listservs and identified through social media and crowd sourcing. Quantitative and qualitative analyses were performed on both closed- and open-ended survey questions., Results: An average of 937 respondents per survey represented family medicine, pediatrics, internal medicine, geriatrics, and other specialties. Responses reported increases in patient health burden, including worsening chronic care management and increasing volume and complexity. A higher frequency of dental- and eyesight-related issues was noted by respondents, as was a substantial increase in mental or emotional health needs. Respondents also noted increased demand, "record high" wait times, and struggles to keep up with patient needs and the higher volume of patient questions. Frequent qualitative statements highlighted the mismatch of patient needs with practice capacity. Staffing shortages and the inability to fill open clinical positions impaired clinicians' ability to meet patient needs and a substantial proportion of respondents indicated an intention to leave the profession or knew someone who had., Conclusion: These data signal an urgent need to take action to support the ability of primary care to meet ongoing patient and population health care needs., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: Contrast-sparing strategies have been developed for percutaneous coronary intervention (PCI) patients at increased risk of contrast-induced acute kidney injury (CI-AKI), and numerous CI-AKI risk prediction models have been created. However, the potential clinical and economic consequences of using predicted CI-AKI risk thresholds for assigning patients to contrast-sparing regimens have not been evaluated. We estimated the clinical and economic consequences of alternative CI-AKI risk thresholds for assigning Medicare PCI patients to contrast-sparing strategies., Methods: Medicare data were used to identify inpatient PCI from January 2017 to June 2021. A prediction model was developed to assign each patient a predicted probability of CI-AKI. Multivariable modeling was used to assign each patient two marginal predicted values for each of several clinical and economic outcomes based on (1) their underlying clinical and procedural characteristics plus their true CI-AKI status in the data and (2) their characteristics plus their counterfactual CI-AKI status. Specifically, CI-AKI patients above the predicted risk threshold for contrast-sparing were reassigned their no CI-AKI (counterfactual) outcomes. Expected event rates, resource use, and costs were estimated before and after those CI-AKI patients were reassigned their counterfactual outcomes. This entailed bootstrapped sampling of the full cohort., Results: Of the 542,813 patients in the study cohort, 5,802 (1.1%) had CI-AKI. The area under the receiver operating characteristic curve for the prediction model was 0.81. At a predicted risk threshold for CI-AKI of >2%, approximately 18.0% of PCI patients were assigned to contrast-sparing strategies, resulting in (/100,000 PCI patients) 121 fewer deaths, 58 fewer myocardial infarction readmissions, 4,303 fewer PCI hospital days, $11.3 million PCI cost savings, and $25.8 million total one-year cost savings, versus no contrast-sparing strategies., Limitations: Claims data may not fully capture disease burden and are subject to inherent limitations such as coding inaccuracies. Further, the dataset used reflects only individuals with fee-for-service Medicare, and the results may not be generalizable to Medicare Advantage or other patient populations., Conclusions: Assignment to contrast-sparing regimens at a predicted risk threshold close to the underlying incidence of CI-AKI is projected to result in significant clinical and economic benefits.

Background: Acute kidney injury (AKI), including contrast-induced AKI (CI-AKI), is an important complication of percutaneous coronary intervention (PCI), resulting in short- and long-term adverse clinical outcomes. While prior research has reported an increased cost burden to hospitals from CI-AKI, the incremental cost to payers remains unknown. Understanding this incremental cost may inform decisions and even policy in the future. The objective of this study was to estimate the short- and long-term cost to Medicare of AKI overall, and specifically CI-AKI, in PCI., Methods: Patients undergoing inpatient PCI between January 2017 and June 2020 were selected from Medicare 100% fee-for-service data. Baseline clinical characteristics, PCI lesion/procedural characteristics, and AKI/CI-AKI during the PCI admission, were identified from diagnosis and procedure codes. Poisson regression, generalized linear modelling, and longitudinal mixed effects modelling, in full and propensity-matched cohorts, were used to compare PCI admission length of stay (LOS) and cost (Medicare paid amount inflated to 2022 US$), as well as total costs during 1-year following PCI, between AKI and non-AKI patients., Results: The study cohort included 509,039 patients, of whom 104,033 (20.4%) were diagnosed with AKI and 9,691 (1.9%) with CI-AKI. In the full cohort, AKI was associated with +4.12 (95% confidence interval = 4.10, 4.15) days index PCI admission LOS, +$11,313 ($11,093, $11,534) index admission costs, and +$14,800 ($14,359, $15,241) total 1-year costs. CI-AKI was associated with +3.03 (2.97, 3.08) days LOS, +$6,566 ($6,148, $6,984) index admission costs, and +$13,381 ($12,118, $14,644) cumulative 1-year costs (all results are adjusted for baseline characteristics). Results from the propensity-matched analyses were similar., Conclusions: AKI, and specifically CI-AKI, during PCI is associated with significantly longer PCI admission LOS, PCI admission costs, and long-terms costs., Competing Interests: Conflict of interest RIG, RC, AMM, AB, LMH: Employee and shareholder. CAS: Consultant. APA: None., (Copyright © 2023. Published by Elsevier Inc.)

Background: Intensive care unit (ICU) utilization has increased among patients with Alzheimer disease and related dementia (ADRD), although outcomes are poor., Objectives: To compare ICU discharge location and subsequent mortality between patients with and patients without ADRD enrolled in Medicare Advantage., Methods: This observational study used Optum's Clinformatics Data Mart Database from years 2016 to 2019 and included adults aged >67 years with continuous Medicare Advantage coverage and a first ICU admission in 2018. Alzheimer disease and related dementia and comorbid conditions were identified from claims. Outcomes included discharge location (home vs other facilities) and mortality (within the same calendar month of discharge and within 12 months after discharge)., Results: A total of 145 342 adults met inclusion criteria; 10.5% had ADRD and were likely to be older, female, and have more comorbid conditions. Only 37.6% of patients with ADRD were discharged home versus 68.6% of patients who did not have ADRD (odds ratio [OR], 0.40; 95% CI, 0.38-0.41). Both death in the same month as discharge (19.9% vs 10.3%; OR, 1.54; 95% CI, 1.47-1.62) and death in the 12 months after discharge (50.8% vs 26.2%; OR, 1.95; 95% CI, 1.88-2.02) were twice as common among patients with ADRD., Conclusions: Patients with ADRD have lower home discharge rates and greater mortality after an ICU stay than patients without ADRD., (©2023 American Association of Critical-Care Nurses.)

Purpose: During the COVID-19 pandemic, telemedicine emerged as an important tool in primary care. Technology and policy-related challenges, however, revealed barriers to adoption and implementation. This report describes the findings from weekly and monthly surveys of primary care clinicians regarding telemedicine during the first 2 years of the pandemic., Methods: From March 2020 to March 2022, we conducted electronic surveys using convenience samples obtained through social networking and crowdsourcing. Unique tokens were used to confidentially track respondents over time. A multidisciplinary team conducted quantitative and qualitative analyses to identify key concepts and trends., Results: A total of 36 surveys resulted in an average of 937 respondents per survey, representing clinicians from all 50 states and multiple specialties. Initial responses indicated general difficulties in implementing telemedicine due to poor infrastructure and reimbursement mechanisms. Over time, attitudes toward telemedicine improved and respondents considered video and telephone-based care important tools for their practice, though not a replacement for in-person care., Conclusions: The implementation of telemedicine during COVID-19 identified barriers and opportunities for technology adoption and highlighted steps that could support primary care clinics' ability to learn, adapt, and implement technology., (© 2023 Annals of Family Medicine, Inc.)

Objective: To leverage electronic health record (EHR) data to explore the relationship between weight gain and antipsychotic adherence among patients with schizophrenia and bipolar disorder (BD)., Methods: EHR data were used to identify individuals with at least 60 days of continuous antipsychotic use between 2005 and 2019. Patients were diagnosed with schizophrenia, schizoaffective disorder, BD, or neither diagnosis (psychiatric controls). We examined the association of weight gain in the first 90 days with the proportion of days covered (PDC) with an antipsychotic and with the frequency of medication switching or stopping., Results: We identified 590 adults with schizophrenia or schizoaffective disorder, 819 adults with BD, and 642 psychiatric controls. In the first 90 days, the percentages of patients with a PDC ≥ 0.80 were 76.8% (schizophrenia), 77.1% (BD), and 70.7% (controls). Logistic regression models revealed that weight gain of ≥ 7% trended toward being significantly associated with greater adherence in the first 90 days (odds ratio = 1.29, P  = .077) and was significantly associated with an increased likelihood of a medication switch in the first 180 days (odds ratio = 1.60, P  = .003)., Discussion: Patients whose weight increased by 7% or more in the first 90 days were more adherent but were also more likely to switch medications during the first 180 days., (© Copyright 2023 Physicians Postgraduate Press, Inc.)

Objectives: To study the predictive validity of the CMS Practice Assessment Tool (PAT) among 632 primary care practices., Study Design: Retrospective observational study., Methods: The study included primary care physician practices recruited by the Great Lakes Practice Transformation Network (GLPTN), 1 of 29 CMS-awarded networks, and used data from 2015 to 2019. At enrollment, trained quality improvement advisers scored each of the PAT's 27 milestones by its degree of implementation based on interviews with staff, review of documents, direct observation of practice activity, and professional judgment. The GLPTN also tracked each practice's status regarding alternative payment model (APM) enrollment. Exploratory factor analysis (EFA) was used to identify summary scores; mixed-effects logistic regression was used to assess the relationship between derived scores with APM participation., Results: EFA revealed that the PAT's 27 milestones could be summed into 1 overall score and 5 secondary scores. By the end of the 4-year project, 38% of practices were enrolled in an APM. A baseline overall score and 3 secondary scores were associated with increased odds of joining an APM (overall score: odds ratio [OR], 1.06; 95% CI, 0.99-1.12; P = .061; data-driven care quality score: OR, 1.11; 95% CI, 1.00-1.22; P = .040; efficient care delivery score: OR, 1.08; 95% CI, 1.03-1.13; P = .003; collaborative engagement score: OR, 0.88; 95% CI, 0.80-0.96; P = .005)., Conclusions: These results demonstrate that the PAT has adequate predictive validity for APM participation.

Background: Non-adherence to psychotropic medications is common in schizophrenia and bipolar disorders (BDs) leading to adverse outcomes. We examined patterns of antipsychotic use in schizophrenia and BD and their impact on subsequent acute care utilization., Methods: We used electronic health record (EHR) data of 577 individuals with schizophrenia, 795 with BD, and 618 using antipsychotics without a diagnosis of either illness at two large health systems. We structured three antipsychotics exposure variables: the proportion of days covered (PDC) to measure adherence; medication switch as a new antipsychotic prescription that was different than the initial antipsychotic; and medication stoppage as the lack of an antipsychotic order or fill data in the EHR after the date when the previous supply would have been depleted. Outcome measures included the frequency of inpatient and emergency department (ED) visits up to 12 months after treatment initiation., Results: Approximately half of the study population were adherent to their antipsychotic medication (a PDC ≥ 0.80): 53.6% of those with schizophrenia, 52.4% of those with BD, and 50.3% of those without either diagnosis. Among schizophrenia patients, 22.5% switched medications and 15.1% stopped therapy. Switching and stopping occurred in 15.8% and 15.1% of BD patients and 7.4% and 20.1% of those without either diagnosis, respectively. Across the three cohorts, non-adherence, switching, and stopping therapy were all associated with increased acute care utilization, even after adjusting for baseline demographics, health insurance, past acute care utilization, and comorbidity., Conclusion: Non-continuous antipsychotic use is common and associated with high acute care utilization., (© 2023. The Author(s).)

Purpose: Care continuity is foundational to the clinician/patient relationship; however, little has been done to operationalize continuity of care (CoC) as a clinical quality measure. The American Board of Family Medicine developed the Primary Care CoC clinical quality measure as part of the Measures That Matter to Primary Care initiative., Methods: Using 12-month Optum Clinformatics Data Mart claims data, we calculated the Bice-Boxerman Continuity of Care Index for each patient, which we rolled up to create an aggregate, physician-level CoC score. The physician quality score is the percent of patients with a Bice-Boxerman Index ≥0.7 (70%). We tested validity in 2 ways. First, we explored the validity of using 0.7 as a threshold for patient CoC within the Optum claims database to validate its use for reflecting patient-level continuity. Second, we explored the validity of the physician CoC measure by examining its association with patient outcomes. We assessed reliability using signal-to-noise methodology., Results: Mean performance on the measure was 27.6%; performance ranged from 0% to 100% (n = 555,213 primary care physicians). Higher levels of CoC were associated with lower levels of care utilization. The measure indicated acceptable levels of validity and reliability., Conclusions: Continuity is associated with desirable health and cost outcomes as well as patient preference. The CoC clinical quality measure meets validity and reliability requirements for implementation in primary care payment and accountability. Care continuity is important and complementary to access to care, and prioritizing this measure could help shift physician and health system behavior to support continuity., (© 2022 Annals of Family Medicine, Inc.)

Objectives: Developing scalable strategies for the early identification of Alzheimer's disease and related dementia (ADRD) is important. We aimed to develop a passive digital signature for early identification of ADRD using electronic medical record (EMR) data., Design: A case-control study., Setting: The Indiana Network for Patient Care (INPC), a regional health information exchange in Indiana., Participants: Patients identified with ADRD and matched controls., Measurements: We used data from the INPC that includes structured and unstructured (visit notes, progress notes, medication notes) EMR data. Cases and controls were matched on age, race, and sex. The derivation sample consisted of 10 504 cases and 39 510 controls; the validation sample included 4500 cases and 16 952 controls. We constructed models to identify early 1- to 10-year, 3- to 10-year, and 5- to 10-year ADRD signatures. The analyses included 14 diagnostic risk variables and 10 drug classes in addition to new variables produced from unstructured data (eg, disorientation, confusion, wandering, apraxia, etc). The area under the receiver operating characteristics (AUROC) curve was used to determine the best models., Results: The AUROC curves for the validation samples for the 1- to 10-year, 3- to 10-year, and 5- to 10-year models that used only structured data were .689, .649, and .633, respectively. For the same samples and years, models that used both structured and unstructured data produced AUROC curves of .798, .748, and .704, respectively. Using a cutoff to maximize sensitivity and specificity, the 1- to 10-year, 3- to 10-year, and 5- to 10-year models had sensitivity that ranged from 51% to 62% and specificity that ranged from 80% to 89%., Conclusion: EMR-based data provide a targeted and scalable process for early identification of risk of ADRD as an alternative to traditional population screening. J Am Geriatr Soc 68:511-518, 2020., (© 2019 The American Geriatrics Society.)

Rationale & Objective: Prior studies suggesting that medical therapy is inferior to percutaneous (percutaneous coronary intervention [PCI]) or surgical (coronary artery bypass grafting [CABG]) coronary revascularization in chronic kidney disease (CKD) have not adequately considered medication optimization or baseline cardiovascular risk and have infrequently evaluated progression to kidney failure. We compared, separately, the risks for kidney failure and death after treatment with PCI, CABG, or optimized medical therapy for coronary disease among patients with CKD stratified by cardiovascular disease risk., Study Design: Retrospective cohort study., Setting & Participants: 34,385 individuals with CKD identified from a national 20% Medicare sample who underwent angiography or diagnostic stress testing without (low risk) or with (medium risk) prior cardiovascular disease or who presented with acute coronary syndrome (high risk)., Exposures: PCI, CABG, or optimized medical therapy (defined by the addition of cardiovascular medications in the absence of coronary revascularization)., Outcomes: Death, kidney failure, composite outcome of death or kidney failure., Analytical Approach: Adjusted relative rates of death, kidney failure, and the composite of death or kidney failure estimated from Cox proportional hazards models., Results: Among low-risk patients, 960 underwent PCI, 391 underwent CABG, and 6,426 received medical therapy alone; among medium-risk patients, 1,812 underwent PCI, 512 underwent CABG, and 9,984 received medical therapy alone; and among high-risk patients, 4,608 underwent PCI, 1,330 underwent CABG, and 8,362 received medical therapy alone. Among low- and medium-risk patients, neither CABG (HRs of 1.22 [95% CI, 0.96-1.53] and 1.08 [95% CI, 0.91-1.29] for low- and medium-risk patients, respectively) nor PCI (HRs of 1.14 [95% CI, 0.98-1.33] and 1.02 [95% CI, 0.93-1.12], respectively) were associated with reduced mortality compared with medical therapy, but in low-risk patients, CABG was associated with a higher rate of the composite, death or kidney failure (HR, 1.25; 95% CI, 1.02-1.53). In high-risk patients, CABG and PCI were associated with lower mortality (HRs of 0.57 [95% CI, 0.51-0.63] and 0.70 [95% CI, 0.66-0.74], respectively). Also, in high-risk patients, CABG was associated with a higher rate of kidney failure (HR, 1.40; 95% CI, 1.16-1.69)., Limitations: Possible residual confounding; lack of data for coronary angiography or left ventricular ejection fraction; possible differences in decreased kidney function severity between therapy groups., Conclusions: Outcomes associated with cardiovascular therapies among patients with CKD differed by baseline cardiovascular risk. Coronary revascularization was not associated with improved survival in low-risk patients, but was associated with improved survival in high-risk patients despite a greater observed rate of kidney failure. These findings may inform clinical decision making in the care of patients with both CKD and cardiovascular disease., (Copyright © 2019 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Mobile phone and tablet ownership have increased in the United States over the last decade, contributing to the growing use of mobile health (mHealth) interventions to help patients manage chronic health conditions like diabetes. However, few studies have characterized mobile device ownership and the presence of health-related apps on mobile devices in people with a self-reported history of hypertension., Objective: This study aimed to describe the prevalence of smartphone, tablet, and basic mobile phone ownership and the presence of health apps by sociodemographic factors and self-reported hypertension status (ie, history) in a nationally representative sample of US adults, and to describe whether mobile devices are associated with health goal achievement, medical decision making, and patient-provider communication., Methods: Data from 3285 respondents from the 2017 Health Information National Trends Survey were analyzed. Participants were asked if they owned a smartphone, tablet, or basic mobile phone and if they had health apps on a smartphone or tablet. Participants were also asked if their smartphones or tablets helped them achieve a health-related goal like losing weight, make a decision about how to treat an illness, or talk with their health care providers. Chi-square analyses were conducted to test for differences in mobile device ownership, health app presence, and app helpfulness by patient characteristics., Results: Approximately 1460 (37.6% weighted prevalence) participants reported a history of hypertension. Tablet and smartphone ownership were lower in participants with a history of hypertension than in those without a history of hypertension (55% vs 66%, P=.001, and 86% vs 68%, P<.001, respectively). Participants with a history of hypertension were more likely to own a basic mobile phone only as compared to those without a history of hypertension (16% vs 9%, P<.001). Among those with a history of hypertension exclusively, basic mobile phone, smartphone, and tablet ownership were associated with age and education, but not race or sex. Older adults were more likely to report having a basic mobile phone only, whereas those with higher education were more likely to report owning a tablet or smartphone. Compared to those without a history of hypertension, participants with a history of hypertension were less likely to have health-related apps on their smartphones or tablets (45% vs 30%, P<.001) and report that mobile devices helped them achieve a health-related goal (72% vs 63%, P=.01)., Conclusions: Despite the increasing use of smartphones, tablets, and health-related apps, these tools are used less among people with a self-reported history of hypertension. To reach the widest cross-section of patients, a mix of novel mHealth interventions and traditional health communication strategies (eg, print, web based, and in person) are needed to support the diverse needs of people with a history of hypertension., (©Aisha T Langford, Craig A Solid, Ebony Scott, Meeki Lad, Eli Maayan, Stephen K Williams, Azizi A Seixas. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 14.01.2019.)

Background: Central line-associated bloodstream infections (CLABSIs) are among the most common hospital-acquired infections and can lead to increased patient morbidity and mortality rates. Implementation of practice guidelines and recommended prevention bundles has historically been suboptimal, suggesting that improvements in implementation methods could further reductions in CLABSI rates. In this article, we describe the agile implementation methodology and present details of how it was successfully used to reduce CLABSI., Methods: We conducted an observational study of patients with central line catheters at 2 adult tertiary care hospitals in Indianapolis from January 2015 to June 2017., Results: The intervention successfully reduced the CLABSI rate from 1.76 infections per 1,000 central line days to 1.24 (rate ratio = 0.70; P = .011). We also observed reductions in the rates of Clostridium difficile and surgical site infections, whereas catheter-associated urinary tract infections remained stable., Conclusions: Using the AI model, we were able to successfully implement evidence-based practices to reduce the rate of CLABSIs at our facility., (Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)

The current US system of reimbursement for dementia care does not support the complex biospychosocial needs of families living with Alzheimer disease and related dementias. We propose an alternative payment system for dementia care that would provide insurance coverage for evidence-based, collaborative dementia care models. This payment model involves a per member per month payment for care management services that would target community-dwelling beneficiaries living with dementia and evidence-based education and support programs for unpaid caregivers. This payment model has the potential to align the incentives of payers and providers and create market demand for the implementation of collaborative dementia care models across the nation.

Objective: To describe behavioral and genetic beliefs about developing hypertension (HTN) by sociodemographic factors and self-reported HTN status, and among those with a history of HTN, evaluate associations between HTN-related causal beliefs and behavior change attempts., Method: Data from the 2014 Health Information National Trends Survey were evaluated. HTN causal beliefs questions included (a) "How much do you think health behaviors like diet, exercise, and smoking determine whether or not a person will develop high blood pressure/HTN?"; and (b) "How much do you think genetics, that is characteristics passed from one generation to the next, determine whether or not a person will develop high blood pressure/HTN?" Multivariate logistic regressions evaluated associations between HTN causal beliefs and behavior change attempts including diet, exercise, and weight management., Results: Approximately 1,602 out of 3,555 respondents with nonmissing data (33% weighted) reported ever having HTN. In logistic regression models, results show that the more strongly people believed in the impact of behavior on developing HTN, the higher their odds for behavior change attempts. Beliefs about genetic causes of HTN were not associated with behavior change attempts. Women had higher odds of attempts to increase fruit and vegetable intake, reduce soda intake, and lose weight compared to men. Blacks and Hispanics were significantly more likely than Whites to report attempts to lose weight., Conclusions: Beliefs about behavioral causes of HTN, but not genetic, were associated with behavior change attempts. Health messages that incorporate behavioral beliefs and sociodemographic factors may enhance future prohealth behavior changes. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Objectives: To describe the essential components of an Agile Implementation (AI) process, which rapidly and effectively implements evidence-based healthcare solutions, and present a case study demonstrating its utility., Design: Case demonstration study., Setting: Integrated, safety net healthcare delivery system in Indianapolis., Participants: Interdisciplinary team of clinicians and administrators., Measurements: Reduction in dementia symptoms and caregiver burden; inpatient and outpatient care expenditures., Results: Implementation scientists were able to implement a collaborative care model for dementia care and sustain it for more than 9 years. The model was implemented and sustained by using the elements of the AI process: proactive surveillance and confirmation of clinical opportunities, selection of the right evidence-based healthcare solution, localization (i.e., tailoring to the local environment) of the selected solution, development of an evaluation plan and performance feedback loop, development of a minimally standardized operation manual, and updating such manual annually., Conclusion: The AI process provides an effective model to implement and sustain evidence-based healthcare solutions., (© 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.)

Background: Diabetes is an important risk factor for ischemic stroke in non-valvular atrial fibrillation (AF). The aim of the present study was to evaluate temporal trends in ischemic stroke and warfarin use among US Medicare patients with and without diabetes., Methods: In this retrospective cohort study, 1-year cohorts of patients with Medicare as the primary payer over the period 1992-2010 were created using the Medicare 5% sample (excluding patients with valvular disease and end-stage renal disease). International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes were used to identify AF, ischemic and hemorrhagic stroke, and diabetes; three or more consecutive prothrombin time claims were used to identify warfarin use., Results: Demographic characteristics of subjects in 1992 (n = 40 255) and 2010 (n = 80 314), respectively, were as follows: age 65-74 years, 37% and 32%; age >85 years, 20% and 25%; White, 94% and 93%; hypertension, 46% and 80%; diabetes, 20% and 32%; and chronic kidney disease, 5% and 18%. Among Medicare AF patients with diabetes, ischemic stroke decreased by 71% (1992-2010) from 65 to 19 per 1000 patient-years; warfarin use increased from 28% to 62%. Among patients without diabetes, ischemic stroke decreased by 68% from 44 to 14 per 1000 patient-years, whereas warfarin use increased from 26% to 59%. Approximately 38% of Medicare AF patients with diabetes did not receive anticoagulation in 2010., Conclusions: Ischemic stroke declined and warfarin use increased similarly in Medicare patients with and without diabetes. Ischemic stroke rates were consistently higher in diabetes patients, validating the inclusion of diabetes in risk calculators. The population of Medicare patients with diabetes who did not receive warfarin deserves future attention., (© 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.)

Background/aims: Few studies explore the magnitude of the disease burden and health care utilization imposed by renal disease among patients with hepatitis C virus (HCV). We aimed to describe the characteristics, outcomes, and health care utilization and costs of patients with HCV with and without renal impairment., Methods: This retrospective analysis used 2 administrative claims databases: the US commercially insured population in Truven Health MarketScan® data (aged 20-64 years), and the US Medicare fee-for-service population in the Medicare 20% sample (aged ≥65 years). Baseline characteristics and comorbid conditions were identified from claims during 2011; patients were followed for up to 1 year (beginning January 1, 2012) to identify health outcomes of interest and health care utilization and costs., Results: In the MarketScan and Medicare databases, 35,965 and 10,608 patients with HCV were identified, 8.5 and 26.5% with evidence of renal disease (chronic kidney disease [CKD] or end-stage renal disease [ESRD]). Most comorbid conditions and unadjusted outcome rates increased across groups from patients with no evidence of renal disease to non-ESRD CKD to ESRD. Health care utilization followed a similar pattern, as did the costs., Conclusions: Our findings suggest that HCV patients with concurrent renal disease have significantly more comorbidity, a higher likelihood of negative health outcomes, and higher health care utilization and costs., (© 2017 S. Karger AG, Basel.)

Aims: We sought to evaluate survival of dialysis (chronic kidney disease (CKD) stage 5D) patients undergoing coronary revascularization procedures in the context of acute coronary syndrome (ACS) compared with absence of ACS., Methods and Results: CKD 5D patients undergoing coronary revascularization, 2004-2009 (n = 23,033), were identified from the United States Renal Data System. Long-term survival was estimated by the Kaplan-Meier method and independent predictors of mortality using a comorbidity-adjusted Cox proportional hazards model. Among ACS patients (n = 12,473; 54%), revascularization procedures were coronary artery bypass grafting (CABG, n = 2910), drug-eluting stents (DESs, n = 6566), and bare metal stents (BMSs, n = 2997). All-cause survival rates following these procedures, respectively, were: in-hospital 90%, 96%, 93%; one-year: 66%, 67%, 58%; two-year: 53%, 48%, 43%. Among non-ACS patients (n = 10,560; 46%), procedures were CABG (n = 3268), DESs (n = 5278), and BMSs (n = 2014). Survival rates following these procedures, respectively, were: in-hospital 94%, 99%, 98%; one year: 73%, 77%, 70%; two year: 61%, 59%, 55%. DESs (versus CABG) independently predicted mortality among ACS (hazard ratio 1.08; 95% confidence interval 1.02-1.15) but not non-ACS patients (1.01, 0.95-1.07); BMSs (versus CABG) independently predicted mortality among ACS (1.30, 1.21-1.38) and non-ACS (1.13, 1.05-1.22) patients., Conclusions: Among CKD 5D patients, survival was lower for ACS versus non-ACS indications following all revascularization strategies. CABG (versus DESs) was associated with higher long-term survival in the context of ACS; in the absence of ACS, long-term survival was similar after CABG or DESs. BMSs were consistently associated with worse outcomes., (© The European Society of Cardiology 2015.)

Background: The 2011 expanded Prospective Payment System (PPS) and contemporaneous Food and Drug Administration label revision for erythropoiesis-stimulating agents (ESAs) were associated with changes in ESA use and mean hemoglobin levels among patients receiving maintenance dialysis. We aimed to investigate whether these changes coincided with increased red blood cell transfusions or changes to Medicare-incurred costs or sites of anemia management care in the period immediately before and after the introduction of the PPS, 2009-2011., Methods: From US Medicare end-stage renal disease (ESRD) data (Parts A and B claims), maintenance hemodialysis patients from facilities that initially enrolled 100 % into the ESRD PPS were identified. Dialysis and anemia-related costs per-patient-per-month (PPPM) were calculated at the facility level, and transfusion rates were calculated overall and by site of care (outpatient, inpatient, emergency department, observation stay)., Results: More than 4100 facilities were included. Transfusions in both the inpatient and outpatient environments increased. In the inpatient environment, PPPM use increased by 11-17 % per facility in each quarter of 2011 compared with 2009; in the outpatient environment, PPPM use increased overall by 5.0 %. Site of care for transfusions appeared to have shifted. Transfusions occurring in emergency departments or during observation stays increased 13.9 % and 26.4 %, respectively, over 2 years., Conclusions: Inpatient- and emergency-department-administered transfusions increased, providing some evidence for a partial shift in the cost and site of care for anemia management from dialysis facilities to hospitals. Further exploration into the economic implications of this increase is necessary.

Although management of multiple myeloma has changed substantially in the last decade, it is unknown whether the burden of ESRD due to multiple myeloma has changed, or whether survival of patients with multiple myeloma on RRT has improved. Regarding ESRD due to multiple myeloma necessitating RRT in the United States, we evaluated temporal trends between 2001 and 2010 for demography-adjusted incidence ratios, relative to rates in 2001-2002, and mortality hazards from RRT initiation, relative to hazards in 2001-2002. In this retrospective cohort study, we used the US Renal Data System database (n=1,069,343), 2001-2010, to identify patients with ESRD due to multiple myeloma treated with RRT (n=12,703). Demography-adjusted incidence ratios of ESRD from multiple myeloma decreased between 2001-2002 and 2009-2010 in the overall population (demography-adjusted incidence ratio 0.82; 95% confidence interval, 0.79 to 0.86) and in most demographic subgroups examined. Mortality rates were 86.7, 41.4, and 34.4 per 100 person-years in the first 3 years of RRT, respectively, compared with 32.3, 20.6, and 21.3 in matched controls without multiple myeloma. Unadjusted mortality hazards ratios declined monotonically after 2004 to a value of 0.72; 95% confidence interval, 0.67 to 0.77 in 2009-2010, and declines between 2001-2002 and 2008-2009 were observed (P<0.05) in most demographic subgroups examined. Findings were similar when adjustment was made for demographic characteristics, comorbidity markers, and laboratory test values. These data suggest the incidence of RRT from multiple myeloma in the United States has decreased in the last decade, and clinically meaningful increases in survival have occurred for these patients., (Copyright © 2016 by the American Society of Nephrology.)

Management of hemolytic uremic syndrome (HUS) has evolved rapidly, and optimal treatment strategies are controversial. However, it is unknown whether the burden of end-stage renal disease (ESRD) from HUS has changed, and outcomes on dialysis in the United States are not well described. We retrospectively examined data for patients initiating maintenance renal replacement therapy (RRT) (n = 1,557,117), 1995-2010, to define standardized incidence ratios (SIRs) and outcomes of ESRD from HUS) (n = 2241). Overall ESRD rates from HUS in 2001-2002 were 0.5 cases/million per year and were higher for patients characterized by age 40-64 years (0.6), ≥65 years (0.7), female sex (0.6), and non-Hispanic African American race (0.7). Standardized incidence ratios remained unchanged (P ≥ 0.05) between 2001-2002 and 2009-2010 in the overall population. Compared with patients with ESRD from other causes, patients with HUS were more likely to be younger, female, white, and non-Hispanic. Over 5.4 years of follow-up, HUS patients differed from matched controls with ESRD from other causes by lower rates of death (8.3 per 100 person-years in cases vs. 10.4 in controls, P < 0.001), listing for renal transplant (7.6 vs. 8.6 per 100 person-years, P = 0.04), and undergoing transplant (6.9 vs. 9 per 100 person-years, P < 0.001). The incidence of ESRD from HUS appears not to have risen substantially in the last decade. However, given that HUS subtypes could not be determined in this study, these findings should be interpreted with caution., (© 2015 International Society for Hemodialysis.)

A history of trauma is common in refugee populations and appropriate treatment is frequently avoided. Using a convenience sample of 64 patients in a Somali primary care clinic, a culture and trauma specific intervention was developed to address retention into appropriate treatment. One goal of the intervention was to improve the rate of engagement in psychotherapy after a mental health referral and to test the effect of psychotherapy on health care utilization using a staged primary care clinical tool. Forty-eight percent of patients given a mental health referral engaged in psychotherapy. Patients engaging in psychotherapy had higher baseline utilization and over 12 months trended towards less emergency room use and more primary care. Our findings suggest that the intervention improved referral and retention in mental health therapy for East African refugee women.

Background: Bending the cost curve in medical expenses is a high national priority. The relationship between cost and kidney allograft failure has not been fully investigated in the United States., Methods: Using Medicare claims from the United States Renal Data System, we determined costs for all adults with Medicare coverage who underwent kidney transplant January 1, 2007, to June 30, 2009. We compared relative cost (observed/expected payment) for year 1 after transplantation for all transplant centers, adjusting for recipient, donor, and transplant characteristics, region, and local wage index. Using program-specific reports from the Scientific Registry of Transplant Recipients, we correlated relative cost with observed/expected allograft failure between centers, excluding small centers., Results: Among 19,603 transplants at 166 centers, mean observed cost per patient per center was $65,366 (interquartile range, $55,094-$71,624). Mean relative cost was 0.99 (± 0.20); mean observed/expected allograft failure was 1.03 (± 0.46). Overall, there was no correlation between relative cost and observed/expected allograft failure (r = 0.096, P = 0.22). Comparing centers with higher than expected costs and allograft failure rates (lower performing) and centers with lower than expected costs and failure rates (higher-performing) showed differences in donor and recipient characteristics. As these characteristics were accounted for in the adjusted cost and allograft failure models, they are unlikely to explain the differences between higher- and lower-performing centers., Conclusions: Further investigations are needed to determine specific cost-effective practices of higher- and lower-performing centers to reduce costs and incidence of allograft failure.

Background/aims: Few published data describe survival rates for pediatric end-stage renal disease (ESRD) patients. We aimed to describe one-year mortality rates for US pediatric ESRD patients over a 15-year period., Methods: In this retrospective cohort study, we used the US Renal Data System database to identify period-prevalent cohorts of patients aged younger than 19 for each year during the period 1995-2010. Yearly cohorts averaged approximately 1,200 maintenance dialysis patients (60% hemodialysis, 40% peritoneal dialysis) and 1,100 transplant recipients. Patients were followed for up to 1 year and censored at change in modality, loss to follow-up, or death. We calculated the unadjusted model-based mortality rates per time at risk, within each cohort year, by treatment modality (hemodialysis, peritoneal dialysis, transplant) and patient characteristics; percentage of deaths by cause; and overall adjusted odds of mortality by characteristics and modality., Results: Approximately 50% of patients were in the age group 15-18, 55% were male, and 45% were female. The most common causes of ESRD were congenital/reflux/obstructive causes (55%) and glomerulonephritis (30%). One-year mortality rates showed evidence of a decrease in the number of peritoneal dialysis patients (6.03 per 100 patient-years, 1995; 2.43, 2010; p = 0.0263). Mortality rates for transplant recipients (average 0.68 per 100 patient-years) were consistently lower than the rates for all dialysis patients (average 4.36 per 100 patient-years)., Conclusions: One-year mortality rates differ by treatment modality in pediatric ESRD patients.

This work proposes a frailty model that accounts for non-random treatment assignment in survival analysis. Using Monte Carlo simulation, we found that estimated treatment parameters from our proposed endogenous selection survival model (esSurv) closely parallel the consistent two-stage residual inclusion (2SRI) results, while offering computational and interpretive advantages. The esSurv method greatly enhances computational speed relative to 2SRI by eliminating the need for bootstrapped standard errors and generally results in smaller standard errors than those estimated by 2SRI. In addition, esSurv explicitly estimates the correlation of unobservable factors contributing to both treatment assignment and the outcome of interest, providing an interpretive advantage over the residual parameter estimate in the 2SRI method. Comparisons with commonly used propensity score methods and with a model that does not account for non-random treatment assignment show clear bias in these methods, which is not mitigated by increased sample size. We illustrate using actual dialysis patient data comparing mortality of patients with mature arteriovenous grafts for venous access to mortality of patients with grafts placed but not yet ready for use at the initiation of dialysis. We find strong evidence of endogeneity (with estimate of correlation in unobserved factors ρ^=0.55) and estimate a mature-graft hazard ratio of 0.197 in our proposed method, with a similar 0.173 hazard ratio using 2SRI. The 0.630 hazard ratio from a frailty model without a correction for the non-random nature of treatment assignment illustrates the importance of accounting for endogeneity., (Copyright © 2014 John Wiley & Sons, Ltd.)

Objective: The Brief Cognitive Symptoms Inventory (BCSI) is a short, self-report scale designed to measure cognitive symptomatology in patients with rheumatic disease. To facilitate research and clinical practice, we tested the internal consistency and validity of the BCSI in patients with Sjögren syndrome (SS)., Methods: Patients who met the American-European Consensus Group criteria for SS and healthy controls completed a questionnaire assessing symptoms including cognitive complaints. We calculated Cronbach's alpha to assess internal consistency and Pearson correlation coefficients to test for association between BCSI, symptoms, and demographic variables. Total score distribution was analyzed to establish cutoff criteria for differentiation of case versus non-case. We compared neuropsychological outcomes of patients with SS above and below the threshold BCSI score to assess the association of cognitive symptoms with objective cognitive deficits., Results: Complete data were available on 144 patients with SS and 35 controls. Internal consistency of the BCSI was good. Scores were similar in all patient groups and patients reported more cognitive symptoms than controls (p < 0.0001). BCSI scores correlated moderately with pain, depression, anxiety, fatigue, and health quality. High scores for cognitive dysfunction were reported by 20% of the patients with SS and only 3% of controls. Patients with cognitive scores > 50 had more depression, fatigue, pain (effect size all > 1), and worse performance on multiple cognitive domains., Conclusion: The BCSI should be a useful tool for the study of cognitive symptoms in SS. Both self-report and standardized tests should be considered in screening for cognitive disorders in SS.

Background: Autosomal dominant polycystic kidney disease (ADPKD) is amenable to early detection and specialty care. Thus, while important to patients with the condition, end-stage renal disease (ESRD) from ADPKD also may be an indicator of the overall state of nephrology care., Study Design: Retrospective cohort study of temporal trends in ESRD from ADPKD and pre-renal replacement therapy (RRT) nephrologist care, 2001-2010 (n = 23,772)., Setting & Participants: US patients who initiated maintenance RRT from 2001 through 2010 (n = 1,069,343) from US Renal Data System data., Predictor: ESRD from ADPKD versus from other causes for baseline characteristics and clinical outcomes; interval 2001-2005 versus 2006-2010 for comparisons of cohort of patients with ESRD from ADPKD., Outcomes: Death, wait-listing for kidney transplant, kidney transplantation., Measurements: US census data were used as population denominators. Poisson distribution was used to compute incidence rates (IRs). Incidence ratios were standardized to rates in 2001-2002 for age, sex, and race/ethnicity. Patients with and without ADPKD were matched to compare clinical outcomes. Poisson regression was used to calculate IRs and adjusted HRs for clinical events after inception of RRT., Results: General population incidence ratios in 2009-2010 were unchanged from 2001-2002 (incidence ratio, 1.02). Of patients with ADPKD, 48.1% received more than 12 months of nephrology care before RRT; preemptive transplantation was the initial RRT in 14.3% and fistula was the initial hemodialysis access in 35.8%. During 4.9 years of follow-up, patients with ADPKD were more likely to be listed for transplantation (IR, 11.7 [95% CI, 11.5-12.0] vs 8.4 [95% CI, 8.2-8.7] per 100 person-years) and to undergo transplantation (IR, 9.8 [95% CI, 9.5-10.0] vs 4.8 [95% CI, 4.7-5.0] per 100 person-years) and less likely to die (IR, 5.6 [95% CI, 5.4-5.7] vs 15.5 [95% CI, 15.3-15.8] per 100 person-years) than matched controls without ADPKD., Limitations: Retrospective nonexperimental registry-based study of associations; cause-and-effect relationships cannot be determined., Conclusions: Although outcomes on dialysis therapy are better for patients with ADPKD than for those without ADPKD, access to predialysis nephrology care and nondeclining ESRD rates may be a cause for concern., (Copyright © 2014 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Clinical experience suggests a heightened risk associated with the transition to maintenance dialysis but few national studies have systematically examined early mortality trajectories. Here we calculated weekly mortality rates in the first year of treatment for 498,566 adults initiating maintenance dialysis in the United States (2005-2009). Mortality rates were initially unexpectedly low, peaked at 37.0 per 100 person-years in week 6, and declined steadily to 14.8 by week 51. In both early (weeks 7-12) and later (weeks 13-51) time frames, multivariate mortality associations included older age, female, Caucasian, non-Hispanic ethnicity, end-stage renal disease (ESRD) from hypertension and acute tubular necrosis, ischemic heart disease, estimated glomerular filtration rate of 15 ml/min per 1.73 m(2) or more, shorter duration of nephrologist care, and hemodialysis, especially with a catheter. For early mortality risk, adjusted hazard ratios of 2 or more were seen with age over 65 (5.80 vs. under 40 years), hemodialysis with a catheter (2.73 vs. fistula), and age 40-64 (2.33). For later mortality risk, adjusted hazard ratios of 2 or more were seen with age over 65 (4.32 vs. under 40 years), hemodialysis with a catheter (2.10 vs. fistula), and age 40-64 (2.00). Thus, low initial mortality rates question the accuracy of data collected and are consistent with deaths occurring in the early weeks after starting dialysis not being registered with the United States Renal Data System.

Background: Calciphylaxis, a rare disease seen in chronic dialysis patients, is associated with significant morbidity and mortality. As is the case with other rare diseases, the precise epidemiology of calciphylaxis remains unknown. Absence of a unique International Classification of Diseases (ICD) code impedes its identification in large administrative databases such as the United States Renal Data System (USRDS) and hinders patient-oriented research. This study was designed to develop an algorithm to accurately identify cases of calciphylaxis and to examine its incidence and mortality., Design, Participants, and Main Measures: Along with many other diagnoses, calciphylaxis is included in ICD-9 code 275.49, Other Disorders of Calcium Metabolism. Since calciphylaxis is the only disorder listed under this code that requires a skin biopsy for diagnosis, we theorized that simultaneous application of code 275.49 and skin biopsy procedure codes would accurately identify calciphylaxis cases. This novel algorithm was developed using the Partners Research Patient Data Registry (RPDR) (n = 11,451 chronic hemodialysis patients over study period January 2002 to December 2011) using natural language processing and review of medical and pathology records (the gold-standard strategy). We then applied this algorithm to the USRDS to investigate calciphylaxis incidence and mortality., Key Results: Comparison of our novel research strategy against the gold standard yielded: sensitivity 89.2%, specificity 99.9%, positive likelihood ratio 3,382.3, negative likelihood ratio 0.11, and area under the curve 0.96. Application of the algorithm to the USRDS identified 649 incident calciphylaxis cases over the study period. Although calciphylaxis is rare, its incidence has been increasing, with a major inflection point during 2006-2007, which corresponded with specific addition of calciphylaxis under code 275.49 in October 2006. Calciphylaxis incidence continued to rise even after limiting the study period to 2007 onwards (from 3.7 to 5.7 per 10,000 chronic hemodialysis patients; r = 0.91, p = 0.02). Mortality rates among calciphylaxis patients were noted to be 2.5-3 times higher than average mortality rates for chronic hemodialysis patients., Conclusions: By developing and successfully applying a novel algorithm, we observed a significant increase in calciphylaxis incidence. Because calciphylaxis is associated with extremely high mortality, our study provides valuable information for future patient-oriented calciphylaxis research, and also serves as a template for investigating other rare diseases.

Background: We evaluated temporal trends in ischemic stroke and warfarin use among demographic subsets of the US Medicare population that are not well represented in randomized trials of warfarin for stroke prevention in nonvalvular atrial fibrillation (AF)., Methods and Results: One-year cohorts of Medicare-primary payer patients (1992-2010) were created using the Medicare 5% sample. International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify AF and ischemic and hemorrhagic stroke; ≥ 3 consecutive prothrombin time claims were used to identify warfarin use. Ischemic stroke rates (per 1000 patient-years) decreased markedly from 1992 to 2010. Among women, rates decreased from 37.1 to 13.6 for ages 65 to 74 years, from 55.2 to 16.5 for ages 74 to 84, and from 66.9 to 22.9 for age ≥ 85; warfarin use increased 31% to 59%, 27% to 63%, and 15% to 49%, respectively. Among men, rates decreased from 33.8 to 11.7 for ages 65 to 74 years, from 49.2 to 13.8 for ages 75 to 84, and from 51.5 to 18.0 for age ≥ 85; warfarin use increased 34% to 63%, 28% to 66%, and 15% to 55%, respectively. Rates decreased from 47.0 to 14.8 for whites and 73.0 to 29.3 for blacks; warfarin use increased 27% to 61% and 19% to 52%, respectively. In all age categories, the thromboembolic risk (CHADS [congestive heart failure, hypertension, age ≥ 75 years, diabetes, stroke]) score was significantly higher among women (versus men) and blacks (versus whites)., Conclusions: Ischemic stroke rates among Medicare AF patients decreased significantly in all demographic subpopulations from 1992-2010, coincident with increasing warfarin use. Ischemic stroke rates remained higher and warfarin use rates remained lower for women and blacks with AF, groups whose baseline CHADS scores were higher., (© 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Purpose: Febrile neutropenia (FN) is a common and serious complication of myelosuppressive chemotherapy. Guidelines recommend primary granulocyte colony-stimulating factors (G-CSF) prophylaxis (PPG) in patients with a high risk (HR, >20 %) of developing FN. We performed a retrospective analysis using a subset of the Medicare 5 % database to assess patterns of G-CSF use and FN occurrence among elderly cancer patients receiving myelosuppressive chemotherapy., Methods: Chemotherapy courses for patients aged 65+ years were identified; only the first course was used for this analysis. Using clinical guidelines, chemotherapy regimens were classified as HR or intermediate risk (IR) for FN. The first administration of G-CSF was classified as either PPG (within the first 5 days of the first cycle), secondary prophylaxis, or reactive., Results: Twelve thousand seven hundred seven courses across five tumor types were classified as having a HR or IR regimen. G-CSF was used in 24.5-73.8 % of patients receiving a HR FN regimen, with the highest use in breast cancer or NHL. Except for breast cancer (where PPG was used in 52.1 %), PPG was given in less than half of patients receiving a HR regimen. Depending on the tumor type, 4.8-22.6 % of patients with a HR regimen had a neutropenia-related hospitalization., Conclusions: Guidelines recommend PPG with HR FN regimens and older age (>65 years), an important risk factor for developing severe neutropenic complications. However, our results show that in this elderly population, PPG was not routinely used (range 4.8-52.1 %) in patients receiving HR FN regimens. Careful attention to FN risk factors, including chemotherapy regimen and patient age, is needed when planning treatment strategies.

Background: The choice of vascular access type is an important aspect of care for incident hemodialysis patients. However, data from the Centers for Medicare & Medicaid Services (CMS) Medical Evidence Report (form CMS-2728) identifying the first access for incident patients have not previously been validated. Medicare began requiring that vascular access type be reported on claims in July 2010. We aimed to determine the agreement between the reported vascular access at initiation from form CMS-2728 and from Medicare claims., Methods: This retrospective study used a cohort of 9777 patients who initiated dialysis in the latter half of 2010 and were eligible for Medicare at the start of renal replacement therapy to compare the vascular access type reported on form CMS-2728 with the type reported on Medicare outpatient dialysis claims for the same patients. For each patient, the reported access from each data source was compiled; the percent agreement represented the percent of patients for whom the access was the same. Multivariate logistic analysis was performed to identify characteristics associated with the agreement of reported access., Results: The two data sources agreed for 94% of patients, with a Kappa statistic of 0.83, indicating an excellent level of agreement. Further, we found no evidence to suggest that agreement was associated with the patient characteristics of age, sex, race, or primary cause of renal failure., Conclusion: These results suggest that vascular access data as reported on form CMS-2728 are valid and reliable for use in research studies.

Anemia management in hemodialysis patients is of primary importance for clinicians and dialysis providers. Through a retrospective claims analysis, we studied prevalent US hemodialysis patients 1998-2009, and examined patterns of hemoglobin levels and erythropoiesis-stimulating agent (ESA, epoetin [EPO], and darbepoetin [DPO] ) doses surrounding hospitalization events. Medicare outpatient claims were used to determine monthly ESA doses and associated hemoglobin levels. ESA dose trajectories were defined with repeated measures models incorporating an autoregressive covariance matrix that compared subsequent measurements with the index month of hospitalization, with variance component covariance matrices chosen for pair-wise comparisons. Regarding prehospitalization hemoglobin levels, a biphasic pattern occurred in both the EPO (1998-2009, n = 161,242) and DPO (2004-2009, n = 4391) populations; levels rose from 1998 to 2004, fell thereafter in the EPO population, and fell after 2006 or 2007 in the DPO population. In the EPO population, the proportions of patients with hemoglobin less than 10 g/dL were 30.1% in 1998, 14.5% in 2004, and 28.3% in 2009; corresponding values for the DPO population were 21.0% in 2004 and 31.6% in 2009. While some degree of year-to-year variability occurred, EPO dose trends were less pronounced, with an apparent peak in 2004 followed by a modest decline; trends were similar for DPO. Trends in EPO dose trajectories did not completely parallel those for hemoglobin level; while EPO doses increased yearly up to 2004, doses stabilized, but did not materially decrease after 2004. No definite annual trends for DPO dose trajectories were apparent., (© 2013 International Society for Hemodialysis.)

The incidence of stroke is substantially higher among hemodialysis patients than among patients with earlier stages of CKD, but to what extent the initiation of dialysis accelerates the risk for stroke is not well understood. In this cohort study, we analyzed data from incident hemodialysis and peritoneal dialysis patients in 2009 who were at least 67 years old and had Medicare as primary payer. We noted whether each of the 20,979 hemodialysis patients initiated dialysis as an outpatient (47%) or inpatient (53%). One year before initiation, the baseline stroke rate was 0.15%-0.20% of patients per month (ppm) for both outpatient and inpatient initiators. Among outpatient initiators, stroke rates began rising approximately 90 days before initiation, reached 0.5% ppm during the 30 days before initiation, and peaked at 0.7% ppm (8.4% per patient-year) during the 30 days after initiation. The pattern was similar among inpatient initiators, but the stroke rate peaked at 1.5% ppm (18% per patient-year). For both hemodialysis groups, stroke rates rapidly declined by 1-2 months after initiation, fluctuated, and stabilized at approximately twice the baseline rate by 1 year. Among the 620 peritoneal dialysis patients, stroke rates were slightly lower and variable, but approximately doubled after initiation. In conclusion, these data suggest that the process of initiating dialysis may cause strokes. Further studies should evaluate methods to mitigate the risk for stroke during this high-risk period.

Background: Few published data describe long-term survival of dialysis patients undergoing surgical versus percutaneous coronary revascularization in the era of drug-eluting stents (DES)., Methods and Results: Using United States Renal Data System data, we identified 23 033 dialysis patients who underwent coronary revascularization (6178 coronary artery bypass grafting, 5011 bare metal stents, 11 844 DES) from 2004 to 2009. Revascularization procedures decreased from 4347 in 2004 to 3344 in 2009. DES use decreased by 41% and bare metal stent use increased by 85% from 2006 to 2007. Long-term survival was estimated by the Kaplan-Meier method, and independent predictors of mortality were examined in a comorbidity-adjusted Cox model. In-hospital mortality for coronary artery bypass grafting patients was 8.2%; all-cause survival at 1, 2, and 5 years was 70%, 57%, and 28%, respectively. In-hospital mortality for DES patients was 2.7%; 1-, 2-, and 5-year survival was 71%, 53%, and 24%, respectively. Independent predictors of mortality were similar in both cohorts: age >65 years, white race, dialysis duration, peritoneal dialysis, and congestive heart failure, but not diabetes mellitus. Survival was significantly higher for coronary artery bypass grafting patients who received internal mammary grafts (hazard ratio, 0.83; P<0.0001). The probability of repeat revascularization accounting for the competing risk of death was 18% with bare metal stents, 19% with DES, and 6% with coronary artery bypass grafting at 1 year., Conclusions: Among dialysis patients undergoing coronary revascularization, in-hospital mortality was higher after coronary artery bypass grafting, but long-term survival was superior with internal mammary grafts. In-hospital mortality was lower for DES patients, but the probability of repeat revascularization was higher and comparable to that in patients receiving a bare metal stent. Revascularization decisions for dialysis patients should be individualized.

The new prospective payment system, or bundled payment plan, for dialysis treatments presents dialysis providers with the potential for clinical and economic risk and opportunity, depending on the modality of dialysis therapy used and the frequency and doses of injectable drugs administered. Under the bundle, some financial incentives may encourage starting incident patients on home dialysis, either home hemodialysis or peritoneal dialysis. Administration of injectable medications such as vitamin D and iron, which are no longer separately billable, may require providers to consider oral equivalents or slightly different dosing patterns. Treatment of anemia with erythropoiesis-stimulating agents will also require careful consideration, as will use of oral medications when they are added to the bundle in 2016. These factors are already playing out in the marketplace, and going forward providers will need to balance changes in utilization with patient care.

Background/aims: Data describing real-world use and effectiveness of cinacalcet are limited. We aimed to characterize predictors of treatment and changes in secondary hyperparathyroidism (SHPT) biochemistry after cinacalcet initiation., Methods: We studied 25,250 in-center hemodialysis patients from a large dialysis provider, alive through November 2004, with no prior cinacalcet prescription. Patients were followed until initiation of cinacalcet, censoring, death, or July 31, 2007. Initiators were further followed for dose titration and discontinuation. Predictors of these events were evaluated using Cox proportional hazards modeling. Biochemical parameters and other SHPT medication use were compared between baseline, pre-initiation, and post-initiation time points., Results: Over an average of 1.25 years of follow-up, 30% of patients initiated cinacalcet therapy. Between baseline and initiation (mean of 386 days), parathyroid hormone (PTH) and phosphorus levels increased 78 and 7%, respectively, in these patients. After adjustment, cinacalcet initiation was associated with higher SHPT severity, younger age, African-American race, higher phosphorus levels, and more comorbidity. Within 1 month of initiation, median PTH was reduced by 15-30% and phosphorus by 3-5%. Reductions were sustained or increased over 12 months, depending on initiating PTH level and whether dose up-titration occurred. Discontinuation was common, although many patients reinitiated., Conclusions: A substantial proportion of patients experienced SHPT progression and initiated cinacalcet treatment. Reductions in biochemistry varied by disease severity and whether doses were titrated., (Copyright © 2013 S. Karger AG, Basel.)

Background/aims: African-Americans with end-stage renal disease receiving dialysis have more severe secondary hyperparathyroidism than Whites. We aimed to assess racial differences in clinical use of cinacalcet., Methods: This retrospective cohort study used data from DaVita, Inc., for 45,589 prevalent hemodialysis patients, August 2004, linked to Centers for Medicare & Medicaid Services data, with follow-up through July 2007. Patients with Medicare as primary payer, intravenous vitamin D use, or weighted mean parathyroid hormone (PTH) level >150 pg/ml at baseline (August 1-October 31, 2004) were included. Cox proportional hazard modeling was used to evaluate race and other demographic and clinical characteristics as predictors of cinacalcet initiation, titration, and discontinuation., Results: Of 16,897 included patients, 7,674 (45.4%) were African-American and 9,223 (54.6%) were white; 53.2% of cinacalcet users were African-American. Cinacalcet was prescribed for 47.7% of African-Americans and 34.5% of Whites, and for a greater percentage of African-Americans at higher doses at each PTH strata. After covariate adjustment, African-Americans were more likely than Whites to receive cinacalcet prescriptions (hazard ratio 1.17, p < 0.001). The direction and magnitude of this effect appeared to vary by age, baseline PTH, and calcium, and by elemental calcium use. African-Americans were less likely than Whites to have prescriptions discontinued and slightly more likely to undergo uptitration (hazard ratio 1.09, 95% confidence interval 0.995-1.188), but this relationship lacked statistical significance., Conclusion: Cinacalcet is prescribed more commonly and at higher initial doses for African-Americans than for Whites to manage secondary hyperparathyroidism.

Background: Osmotherapy has been the cornerstone in the management of patients with elevated intracranial pressure (ICP) following traumatic brain injury (TBI). Several studies have demonstrated that hypertonic saline (HTS) is a safe and effective osmotherapy agent. This study evaluated the effectiveness of HTS in reducing intracranial hypertension in the presence of a wide range of serum and cerebrospinal fluid (CSF) osmolalities., Methods: Forty-two doses of 23.4% saline boluses for treatment of refractory intracranial hypertension were reviewed retrospectively. Thirty milliliters of 23.4% NaCl was infused over 15 min for intracranial hypertension, defined as ICP >20 mmHg. The CSF and serum osmolalities from frozen stored samples were measured with an osmometer. The values of serum sodium, hourly ICP, blood urea nitrogen (BUN), and creatinine were obtained directly from the medical records., Results: The serum and CSF osmolalities correlated very closely to serum sodium (r > 0.9, P < 0.0001). The reduction in ICP from the baseline (measured from either the mean ICP or the lowest ICP measurement in the first 6 h after bolus HTS treatment) was statistically significant regardless of serum osmolality. The mean reduction from baseline to follow-up values was 8.8 mm Hg (P < 0.0001). The decrease in ICP was as evident with serum osmolalities >320 as it was at ≤320., Conclusion: This study demonstrates that 23.4% HTS bolus is effective for the reduction of elevated ICP in patients with severe TBI even in the presence of high serum and CSF osmolalities.

Background/aims: Arteriovenous fistulas (AVFs) appear to be clinically superior to catheters as vascular access for maintenance hemodialysis, but higher insertion costs and high disease burden and mortality obscure the issue of whether AVF placement before hemodialysis initiation represents a net cost savings. We aimed to investigate Medicare costs for patients beginning maintenance hemodialysis, as related to timing of AVF placement., Methods: Data were from Medicare claims for incident hemodialysis patients aged ≥67 years in 2006. The study period extended from 2 years before to 1 year after dialysis initiation. Patients identified as having AVFs were categorized by timing of placement (mature AVF at dialysis initiation, maturing AVF at initiation, postinitiation AVF placement). Because timing may be influenced by factors that also influence overall costs, the model accounted for this nonrandom treatment assignment. An ordered probit extension of the classic Heckman correction was employed after identifying an appropriate instrumental variable. A cohort with Medicare coverage before and after dialysis initiation was identified, and Medicare claims were used to identify comorbid conditions and treatment costs., Results: Principal findings are that earlier AVF placement leads to lower costs, with the potential for about USD 500 million in savings. Additionally, the effect of nonrandom treatment assignment is real and significant. In our data, the impact of AVF placement timing was understated when treatment selection was ignored., Conclusions: For appropriate AVF candidates, having a mature AVF in place at the time of dialysis initiation appears to confer cost savings., (Copyright © 2012 S. Karger AG, Basel.)

Background: Cardiac disease is a significant cause of morbidity and mortality in children with end-stage renal disease (ESRD). This study aimed to report the frequency of cardiac disease diagnostic methods used in US pediatric maintenance hemodialysis patients., Methods: A cross-sectional analysis of all US pediatric (ages 0.7-18 years, n = 656) maintenance hemodialysis patients was performed using data from the Centers for Medicare and Medicaid Services ESRD Clinical Performance Measures Project. Clinical and laboratory information was collected in 2001. Results were analysed by age, sex, race, Hispanic ethnicity, dialysis duration, body mass index (BMI), primary ESRD cause and laboratory data., Results: Ninety-two percent of the patients had a cardiovascular risk factor (63% hypertension, 38% anemia, 11% BMI > 94th percentile, 63% serum phosphorus > 5.5 mg/dL and 55% calcium-phosphorus product ≥ 55 mg(2)/dL(2)). A diagnosis of cardiac disease was reported in 24% (n = 155) of all patients: left ventricular hypertrophy/enlargement 17%, congestive heart failure/pulmonary edema 8%, cardiomyopathy 2% and decreased left ventricular function 2%. Thirty-one percent of patients were not tested. Of those tested, the diagnostic methods used were chest X-rays in 60%, echocardiograms in 35% and electrocardiograms in 33%; left ventricular hypertrophy/enlargement was diagnosed using echocardiogram (72%), chest X-ray (20%) and electrocardiogram (15%)., Conclusions: Although 92% of patients had cardiovascular risk factors, an echocardiography was performed in only one-third of the patients. Our study raises the question of why echocardiography, considered the gold standard for cardiac disease diagnosis, has been infrequently used in pediatric maintenance dialysis patients, a high-risk patient population.

Objective: Hypertonic saline is emerging as a potentially effective single osmotic agent for control of acute elevations in intracranial pressure (ICP) caused by severe traumatic brain injury. This study examines its effect on ICP, cerebral perfusion pressure (CPP), and brain tissue oxygen tension (PbtO2)., Methods: Twenty-five consecutive patients with severe traumatic brain injury who were treated with 23.4% NaCl for elevated ICP were evaluated. Bolt catheter probes were placed in the noninjured hemisphere, and hourly ICP, mean arterial pressure, CPP, and PbtO2 values were recorded. Thirty milliliters of 23.4% NaCl was infused over 15 minutes for intracranial hypertension, defined as ICP greater than 20 mm Hg. Twenty-one male patients and 4 female patients aged 16 to 64 years were included. The mean presenting Glasgow Coma Scale score was 5.7., Results: Mean pretreatment values included an ICP level of 25.9 mm Hg and a PbtO2 value of 32 mm Hg. The posttreatment ICP level was decreased by a mean of 8.3 mm Hg (P < 0.0001), and there was an improvement in PbtO2 of 3.1 mm Hg (P < 0.01). ICP of more than 31 mm Hg decreased by 14.2 mm Hg. Pretreatment CPP values of less than 70 mm Hg increased by a mean of 6 mm Hg (P < 0.0001). No complications occurred from this treatment, with the exception of electrolyte and chemistry abnormalities. At 6 months postinjury, the mortality rate was 28%, with 48% of patients achieving a favorable outcome by the dichotomized Glasgow Outcome Scale., Conclusion: Hypertonic saline as a single osmotic agent decreased ICP while improving CPP and PbtO2 in patients with severe traumatic brain injury. Patients with higher baseline ICP and lower CPP levels responded to hypertonic saline more significantly.