Anemia Prevalence, Type, and Associated Risks in a Cohort of 5.0 Million Insured Patients in the United States by Level of Kidney Function.

RATIONALE & OBJECTIVE: Anemia is common in chronic kidney disease (CKD); although anemia is associated with adverse outcomes, the available treatments are not ideal. We characterized the burden, risk factors for, and risks associated with anemia by estimated glomerular filtration rate (eGFR) and hemoglobin level. STUDY DESIGN: Cross-sectional and prospective cohort study. SETTING & PARTICIPANTS: Outpatient data from 5,004,957 individuals across 57 health care centers in the United States from 2016 to 2019, extracted from the Optum Labs Data Warehouse. EXPOSURE: Severity of anemia, presence of low iron test results, eGFR. OUTCOME: Incident kidney failure with replacement therapy, cardiovascular disease, coronary heart disease, stroke, heart failure, death. ANALYTICAL APPROACH: The prevalences of anemia, low iron test results, vitamin B12 deficiency, and erythropoiesis-stimulating agent (ESA) use, stratified by sex and eGFR, were characterized. Polychotomous logistic regression was used to estimate the adjusted odds ratios of different hemoglobin levels across eGFR. Cox proportional hazards regression was used to calculate adjusted hazard ratios for adverse outcomes across hemoglobin level. RESULTS: The mean age was 54 years, and 42% were male. Lower eGFR was very strongly associated with increased prevalence of anemia, even after adjustment. Although iron studies were checked infrequently in patients with anemia, low iron test results were highly prevalent in those tested: 60.4% and 81.3% of men and women, respectively. ESA use was uncommon, with a prevalence of use of<4%. Lower hemoglobin was independently associated with increased risk of incident kidney failure with replacement therapy, cardiovascular disease, coronary heart disease, stroke, heart failure, and death. LIMITATIONS: Reliance on ICD codes for medical diagnoses, death information obtained from claims data, observational study. CONCLUSIONS: Severe anemia was common and strongly associated with lower eGFR and multiple adverse outcomes. Low-iron test results were highly prevalent in those tested despite iron studies being checked infrequently. ESA use in nondialysis CKD patients was uncommon.

Association of Rosuvastatin Use with Risk of Hematuria and Proteinuria.

BACKGROUND: Despite reports of hematuria and proteinuria with rosuvastatin use at the time of its approval by the US Food and Drug Association (FDA), little postmarketing surveillance exists to assess real-world risk. Current labeling suggests dose reduction (maximum daily dose of 10 mg) for patients with severe CKD. METHODS: Using deidentified electronic health record data, we analyzed 152,101 and 795,799 new users of rosuvastatin and atorvastatin, respectively, from 2011 to 2019. We estimated inverse probability of treatment-weighted hazard ratios (HRs) of hematuria, proteinuria, and kidney failure with replacement therapy (KFRT) associated with rosuvastatin. We reported the initial rosuvastatin dose across eGFR categories and evaluated for a dose effect on hematuria and proteinuria. RESULTS: Overall, we identified 2.9% of patients with hematuria and 1.0% with proteinuria during a median follow-up of 3.1 years. Compared with atorvastatin, rosuvastatin was associated with increased risk of hematuria (HR, 1.08; 95% confidence interval [95% CI], 1.04 to 1.11), proteinuria (HR, 1.17; 95% CI, 1.10 to 1.25), and KFRT (HR, 1.15; 95% CI, 1.02 to 1.30). A substantial share (44%) of patients with eGFR <30 ml/min per 1.73 m2 was prescribed high-dose rosuvastatin (20 or 40 mg daily). Risk was higher with higher rosuvastatin dose. CONCLUSIONS: Compared with atorvastatin, rosuvastatin was associated with increased risk of hematuria, proteinuria, and KFRT. Among patients with eGFR <30 ml/min per 1.73 m2, 44% were prescribed a rosuvastatin daily dose exceeding the FDA's recommended 10 mg daily dose. Our findings suggest the need for greater care in prescribing and monitoring rosuvastatin, particularly in patients who receive high doses or who have severe CKD.

Missing Care: the Initial Impact of the COVID-19 Pandemic on CKD Care Delivery.

BACKGROUND: Chronic kidney disease (CKD) is a common condition with adverse health outcomes addressable by early disease management. The impact of the COVID-19 pandemic on care utilization for the CKD population is unknown. OBJECTIVE: To examine pandemic CKD care and identify factors associated with a high care deficit. DESIGN: Retrospective observational study PARTICIPANTS: 248,898 insured individuals (95% Medicare Advantage, 5% commercial) with stage G3-G4 CKD in 2018 MAIN MEASURES: Predicted (based on the pre-pandemic period of January 1, 2019-February 28, 2020) to observed per-member monthly face-to-face and telehealth encounters, laboratory testing, and proportion of days covered (PDC) for medications, evaluated during the early (March 1, 2020-June 30, 2020), pre-vaccine (July 1, 2020-December 31, 2020), and late (January 2021-August 2021) periods and overall. KEY RESULTS: In-person encounters fell by 24.1% during the pandemic overall; this was mitigated by a 14.2% increase in telehealth encounters, resulting in a cumulative observed utilization deficit of 10% relative to predicted. These reductions were greatest in the early pandemic period, with a 19.8% cumulative deficit. PDC progressively decreased during the pandemic (range 9-20% overall reduction), with the greatest reductions in hypertension and diabetes medicines. CKD laboratory monitoring was also reduced (range 11.8-43.3%). Individuals of younger age (OR 1.63, 95% CI 1.16, 2.28), with commercial insurance (1.43, 95% CI 1.25, 1.63), residing in the Southern US (OR 1.17, 95% CI 1.14, 1.21), and with stage G4 CKD (OR 1.21, 95% CI 1.17, 1.26) had greater odds of a higher care deficit overall. CONCLUSIONS: The early COVID-19 pandemic resulted in a marked decline of healthcare services for individuals with CKD, with an incomplete recovery during the later pandemic. Increased telehealth use partially compensated for this deficit. The downstream impact of CKD care reduction on health outcomes requires further study, as does evaluation of effective care delivery models for this population.

The FDA Metformin Label Change and Racial and Sex Disparities in Metformin Prescription among Patients with CKD.

BACKGROUND: In 2016, the Food and Drug Administration (FDA) changed labeling regarding metformin contraindications in patients with diabetes and CKD from using serum creatinine-based thresholds to using eGFR-based thresholds. Because race and sex affect serum creatinine levels independently of GFR, the earlier creatinine-based contraindication may have inadvertently caused racial and sex disparities in metformin prescription among patients with low eGFR. METHODS: In an analysis of 15,946 Black and White primary care patients with diabetes and eGFR≥30 ml/min per 1.73 m2 in a large health system (the primary cohort), we assessed the association of race and sex with metformin prescription across eGFR level before and after the FDA label change. For a replication cohort, we meta-analyzed data from 36 cohorts with 1,051,723 patients from OptumLabs Data Warehouse. RESULTS: In the primary cohort, before the label change, Black patients with eGFR of 30-44 ml/min per 1.73 m2 were prescribed metformin less often than White counterparts (adjusted prevalence ratio [aPR], 0.65; 95% confidence interval [95% CI], 0.52 to 0.82); this disparity was significantly attenuated after the label change (aPR, 0.90; 95% CI, 0.74 to 1.09; P value for interaction by period =0.04). Results were consistent in the replication cohorts. Men with eGFR of 30-44 ml/min per 1.73 m2 received metformin prescriptions less often than women counterparts before the label change; this was nonsignificantly attenuated after the label change, but we found significant attenuation in the replication cohorts (aPRpre-label change, 0.76; 95% CI, 0.73 to 0.79; aPRpost-label change, 0.85; 95% CI, 0.83 to 0.88; P value for interaction by period <0.001). CONCLUSIONS: The metformin label change to an eGFR-based contraindication may have reduced racial and sex disparities in metformin prescription in moderate kidney dysfunction.

What's Happening at Home: A Claims-based Approach to Better Understand Home Clinical Care Received by Older Adults.

BACKGROUND: Home clinical care (HCC) includes home-based medical care (HBMC-medical visits in the home) and skilled home health care (skilled nursing or therapy visits). Over 7 million older adults would benefit from HCC; however, we know surprisingly little about homebound older adults and HCC. OBJECTIVE: To describe HCC received by older adults using claims data within the OptumLabs Data Warehouse. RESEARCH DESIGN: Using administrative claims data for commercial and Medicare Advantage enrollees, we describe morbidity profiles, health service use, and care coordination (operationalized as care plan oversight [CPO]) for people receiving HCC and the subgroup receiving HBMC. PARTICIPANTS: Three million adults (3,027,247) age ≥65 with 12 months of continuous enrollment 2013-2014. MEASURES: CPT or HCPCS codes delineated HCC, HBMC, and CPO recipients and care site, frequency, and provider type. Other measures included demographic characteristics, clinical characteristics, and health care utilization. RESULTS: Overall, 5% of the study population (n=161,801) received 2+ months of HCC visits; of these, 46% also received 2+ HBMC visits (n=73,638) while 54% received only skilled home health (n=88,163 HCC but no HBMC). HBMC-recipients had high comorbidity burden (Charlson score 4.3), dementia (35%), and ambulance trips (58%), but few nursing facility admissions (4.9%). Evidence of care coordination (CPO claims) occurred in 30% of the HCC population, 46% of HBMC, and 17% of the skilled home health care only. CONCLUSIONS: Approximately 1 of 20 older adults in this study received HCC; 30% or less have a claim for care coordination by their primary care provider.

Development of Risk Prediction Equations for Incident Chronic Kidney Disease.

Importance: Early identification of individuals at elevated risk of developing chronic kidney disease (CKD) could improve clinical care through enhanced surveillance and better management of underlying health conditions. Objective: To develop assessment tools to identify individuals at increased risk of CKD, defined by reduced estimated glomerular filtration rate (eGFR). Design, Setting, and Participants: Individual-level data analysis of 34 multinational cohorts from the CKD Prognosis Consortium including 5 222 711 individuals from 28 countries. Data were collected from April 1970 through January 2017. A 2-stage analysis was performed, with each study first analyzed individually and summarized overall using a weighted average. Because clinical variables were often differentially available by diabetes status, models were developed separately for participants with diabetes and without diabetes. Discrimination and calibration were also tested in 9 external cohorts (n = 2 253 540). Exposures: Demographic and clinical factors. Main Outcomes and Measures: Incident eGFR of less than 60 mL/min/1.73 m2. Results: Among 4 441 084 participants without diabetes (mean age, 54 years, 38% women), 660 856 incident cases (14.9%) of reduced eGFR occurred during a mean follow-up of 4.2 years. Of 781 627 participants with diabetes (mean age, 62 years, 13% women), 313 646 incident cases (40%) occurred during a mean follow-up of 3.9 years. Equations for the 5-year risk of reduced eGFR included age, sex, race/ethnicity, eGFR, history of cardiovascular disease, ever smoker, hypertension, body mass index, and albuminuria concentration. For participants with diabetes, the models also included diabetes medications, hemoglobin A1c, and the interaction between the 2. The risk equations had a median C statistic for the 5-year predicted probability of 0.845 (interquartile range [IQR], 0.789-0.890) in the cohorts without diabetes and 0.801 (IQR, 0.750-0.819) in the cohorts with diabetes. Calibration analysis showed that 9 of 13 study populations (69%) had a slope of observed to predicted risk between 0.80 and 1.25. Discrimination was similar in 18 study populations in 9 external validation cohorts; calibration showed that 16 of 18 (89%) had a slope of observed to predicted risk between 0.80 and 1.25. Conclusions and Relevance: Equations for predicting risk of incident chronic kidney disease developed from more than 5 million individuals from 34 multinational cohorts demonstrated high discrimination and variable calibration in diverse populations. Further study is needed to determine whether use of these equations to identify individuals at risk of developing chronic kidney disease will improve clinical care and patient outcomes.

Intensive care unit improves dialysis care quality while reducing costs.

AIMS AND BACKGROUND: The current report details transition of outsourced conventional dialysis therapy in the ICU services to an in-house prolonged intermittent renal replacement therapy (PIRRT) service model as a quality improvement project using the Tablo Hemodialysis System, Outset Medical, Inc. The goals were aimed at maintaining or improving clinical outcomes, while also reducing dialysis-related nursing staff burden and dialysis-related treatment costs. METHODS: A descriptive comparative analysis was conducted of renal replacement therapy (RRT) of ≥6 hours in duration performed in the 1 year prior and 1 year after the ICU's in-house program launch using a PIRRT model including sequential 24-h treatments when medically necessary. RESULTS: Overall, there were 145 intensive care unit (ICU) stays among 145 patients with 13,641 h of conventional ICU dialysis in the year prior to program transition. In the year post, there were 116 ICU stays among 116 patients with 5,098 h of PIRRT. By employing a PIRRT and sequential 24-h treatment strategy vs. the prior outsourced model, the mean dialysis treatment hours per patient were reduced (Pre, 94.1 h with 214 treatment starts; Post, 43.9 h with 370 treatment starts), increasing ICU nurse productivity by 50.2 h per patient. Overall, ICU length of stay and ICU mortality declined post-service transition by 4.8 days and 9.8 percentage points (pp), respectively, overall, and in the non-COVID subset by 1.6 days and 3.1 pp, respectively. CONCLUSIONS: Insourcing RRT with an innovative technology that can provide both PIRRT and 24-h sequential treatments can maintain or improve clinical outcomes in critically ill patients requiring RRT in the ICU, while reducing dialysis-related costs.

Comparison of methodologies to define hemodialysis patients hyporesponsive to epoetin and impact on counts and characteristics.

BACKGROUND: Some hemodialysis patients require large doses of erythropoiesis-stimulating agents (ESAs) to manage anemia. These patients, termed "ESA hyporesponsive," have been characterized using various definitions. We applied three definitions of hyporesponsiveness to a large, national cohort of hemodialysis patients to assess the impact of definition on counts and on characteristics associated with hyporesponsiveness. METHODS: We studied point-prevalent hemodialysis patients on May 1, 2008, with Medicare as primary payer, who survived through December 31, 2008. Included patients received recombinant human erythropoietin (EPO) in each month, August-December. Hyporesponsiveness definitions were: above the ninetieth percentile of total monthly EPO dose; above the ninetieth percentile of total monthly EPO dose divided by weight in kg; above the ninetieth percentile of total monthly EPO dose divided by hemoglobin level. Hyporesponsiveness was further classified as chronic, acute, or other. Comorbid conditions were assessed before and concurrent with the hyporesponsive period. RESULTS: Women, African Americans, and patients aged <40 years, with cause of renal failure other than diabetes or hypertension, or longer dialysis duration, were more likely to be hyporesponsive. Antecedent comorbid conditions most predictive of any subsequent hyporesponsiveness were congestive heart failure, peripheral vascular disease, other cardiac disease, gastrointestinal bleeding, and cancer. Concurrent comorbid conditions most strongly associated with any hyporesponsiveness were gastrointestinal bleeding and cancer. All conditions were somewhat more likely when ascertained concurrently. Comorbidity burdens were lowest for non-hyporesponsive patients. CONCLUSIONS: As associations were similar between patient characteristics and three methods of characterizing EPO hyporesponsiveness, the simplest definition using EPO dose can be used.

Prevalence of use and characteristics of users of home-based medical care in Medicare Advantage.

BACKGROUND/OBJECTIVES: Home-based medical care (HBMC) is longitudinal medical care provided by physicians, advanced practice providers, and, often, inter-professional care teams to patients in their homes. Our objective is to determine the prevalence of HBMC among older adults (≥65) insured by a Medicare Advantage (MA) plan and compare characteristics of those who receive HBMC to those who do not. METHODS: Study used de-identified medical claims and enrollment records for MA beneficiaries during calendar years 2017 and 2018 linked with socioeconomic status data in the OptumLabs Data Warehouse. We defined a cohort of MA beneficiaries age ≥65 receiving HBMC for at least 2 months during 2017-2018, described the cohort using demographic, utilization, and comorbidity data and compared it to a 5% random sample of a population of MA beneficiaries age ≥65 not receiving HBMC (No HBMC). RESULTS: Overall, 1.45% of the study cohort age ≥65 received HBMC. Compared to No HBMC (n = 132,147), those receiving HBMC (n = 38,800) were more likely to be: older (46.6% vs. 11.9% age 85+); female (70.8% vs. 58.5%); Black (12.3% vs. 11.3%); urban (90.3% vs. 81.3%); experience hospitalization (38.0% vs. 13.3%), emergency department visit (58.3% vs. 26.9%), ambulance trip (44.1% vs. 9.6%), skilled nursing facility (37.6% vs. 6.4%), or hospice care admission (21.1% vs. 3.5%). They also were more likely to experience a wide range of chronic conditions including dementia (58.1% vs. 5.2%), morbidity burden (Charlson score 3.4 vs. 1.8), and serious illness (77.1% vs. 29.5%). All comparisons p < 0.0001. CONCLUSIONS: MA beneficiaries who received HBMC are older, experience greater chronic and serious illness burden, and higher levels of facility-based care than those who did not receive HBMC. MA plans need strategies to identify patients that would benefit from HBMC and develop approaches to deliver such care to this impactful, often invisible population.

Health care costs associated with unrecognized progression to late-stage kidney disease.

OBJECTIVES: Many individuals with chronic kidney disease (CKD) are undiagnosed or unaware of the disease and at risk of not receiving services to manage their condition and of "crashing" into dialysis. Past studies report higher health care costs among patients with delayed nephrology care and suboptimal dialysis initiation, but they are limited because they focused on patients undergoing dialysis and did not evaluate costs associated with unrecognized disease for patients "upstream," or patients with late-stage CKD. We compared costs for patients with unrecognized progression to late-stage (stages G4 and G5) CKD and end-stage kidney disease (ESKD) with costs for individuals with prior CKD recognition. STUDY DESIGN: Retrospective study of commercial, Medicare Advantage, and Medicare fee-for-service enrollees 40 years and older. METHODS: Using deidentified claims data, we identified 2 groups of patients with late-stage CKD or ESKD, one group with prior evidence of CKD diagnosis and the other without, and compared total and CKD-related costs in the first year following late-stage diagnosis between the 2 groups. We used generalized linear models to determine the association between prior recognition and costs and used recycled predictions to calculate predicted costs. RESULTS: Total and CKD-related costs were 26% and 19% higher, respectively, for patients without prior diagnosis compared with those with prior recognition. Total costs were higher both for unrecognized patients with ESKD and unrecognized patients with late-stage disease. CONCLUSIONS: Our findings indicate that costs associated with undiagnosed CKD extend to patients not yet requiring dialysis and highlight potential savings from earlier disease detection and management.

Fulfillment and Validity of the Kidney Health Evaluation Measure for People with Diabetes.

Objective: To evaluate the fulfillment and validity of the kidney health evaluation for people with diabetes (KED) Healthcare Effectiveness Data Information Set (HEDIS) measure. Patients and Methods: Optum Labs Data Warehouse (OLDW) was used to identify the nationally distributed US population aged 18 years and older, with diabetes, between January 1, 2017, and December 31, 2017. The OLDW includes deidentified medical, pharmacy, laboratory, and electronic health record (EHR) data. The KED fulfillment was defined in 2017 as both estimated glomerular filtration rate (eGFR) and urinary albumin-creatinine ratio testing within the measurement year. The KED validity was assessed using bivariate analyses of KED fulfillment with diabetes care measures in 2017 and chronic kidney disease (CKD) diagnosis and evidence-based kidney protective interventions in 2018. Results: Among eligible 5,635,619 Medicare fee-for-service beneficiaries, 736,875 Medicare advantage (MA) beneficiaries, and 660,987 commercial patients, KED fulfillment was 32.2%, 38.7%, and 37.7%, respectively. Albuminuria testing limited KED fulfillment with urinary albumin-creatinine ratio testing (<40%) and eGFR testing (>90%). The KED fulfillment was positively associated with receipt of diabetes care in 2017, CKD diagnosis in 2018, and evidence-based kidney protective interventions in 2018. The KED fulfillment trended lower for Black race, Medicare-Medicaid dual eligibility status, low neighborhood income, and low education status. Conclusion: Less than 40% of adults with diabetes received guideline-recommended testing for CKD in 2017. Routine KED was associated with diabetes care and evidence-based CKD interventions. Increasing guideline-recommended testing for CKD among people with diabetes should lead to timely and equitable CKD detection and treatment.

Estimating Kidney Failure Risk Using Electronic Medical Records.

Background: The four-variable kidney failure risk equation (KFRE) is a well-validated tool for patients with GFR <60 ml/min per 1.73 m2 and incorporates age, sex, GFR, and urine albumin-creatinine ratio (ACR) to forecast individual risk of kidney failure. Implementing the KFRE in electronic medical records is challenging, however, due to low ACR testing in clinical practice. The aim of this study was to determine, when ACR is missing, whether to impute ACR from protein-to-creatinine ratio (PCR) or dipstick protein for use in the four-variable KFRE, or to use the three-variable KFRE, which does not require ACR. Methods: Using electronic health records from OptumLabs Data Warehouse, patients with eGFR <60 ml/min per 1.73 m2 were categorized on the basis of the availability of ACR testing within the previous 3 years. For patients missing ACR, we extracted urine PCR and dipstick protein results, comparing the discrimination of the three-variable KFRE (age, sex, GFR) with the four-variable KFRE estimated using imputed ACR from PCR and dipstick protein levels. Results: There were 976,299 patients in 39 health care organizations; 59% were women, the mean age was 72 years, and mean eGFR was 47 ml/min per 1.73 m2. The proportion with ACR testing was 19% within the previous 3 years. An additional 2% had an available PCR and 36% had a dipstick protein; the remaining 43% had no form of albuminuria testing. The four-variable KFRE had significantly better discrimination than the three-variable KFRE among patients with ACR testing, PCR testing, and urine dipstick protein levels, even with imputed ACR for the latter two groups. Calibration of the four-variable KFRE was acceptable in each group, but the three-variable equation showed systematic bias in the groups that lacked ACR or PCR testing. Conclusions: Implementation of the KFRE in electronic medical records should incorporate ACR, even if only imputed from PCR or urine dipstick protein levels.

The Serious Illness Population: Ascertainment via Electronic Health Record or Claims Data.

CONTEXT: Palliative care can improve the lives of people with serious illness, yet clear operational definitions of this population do not exist. Prior efforts to identify this population have not focused on Medicare Advantage (MA) and commercial health plan enrollees. OBJECTIVES: We aimed to operationalize our conceptual definition of serious illness to identify those with serious medical conditions (SMC) among commercial insurance and MA enrollees, and to compare the populations identified through electronic health record (EHR) or claims data sources. METHODS: We used de-identified claims and EHR data from the OptumLabs Data Warehouse (2016-2017), to identify adults age ≥18 with SMC and examine their utilization and mortality. Within the subset found in both data sources, we compared the performance of claims and EHR data. RESULTS: Within claims, SMC was identified among 10% of those aged ≥18 (5.4% ages 18-64, 27% age ≥65). Within EHR, SMC was identified among 9% of those aged ≥18 (5.6% ages 18-64, 21% ages ≥65). Hospital, emergency department and mortality rates were similar between the EHR and claims-based groups. Only 50% of people identified as having SMC were recognized by both data sources. CONCLUSION: These results demonstrate the feasibility of identifying adults with SMC in a commercially insured population, including MA enrollees; yet separate use of EHR or claims result in populations that differ. Future research should examine methods to combine these data sources to optimize identification and support population management, quality measurement, and research to improve the care of those living with serious illness.

Trends in patient characteristics and first-year medical costs of older incident hemodialysis patients, 1995-2005.

BACKGROUND: Characteristics of patients with chronic kidney disease who survive to end-stage renal disease may change over time, affecting subsequent outcomes and costs. We examined trends in older incident hemodialysis patient characteristics and analyzed first-year post-dialysis therapy initiation medical costs. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: All US incident hemodialysis patients aged > or =67 years at dialysis therapy initiation from January 1, 1995, to December 31, 2005, with Medicare Part A and Part B in the prior 2 years. PREDICTOR: Year of dialysis therapy initiation. OUTCOMES: Changes in patient characteristics and first-year costs. MEASUREMENTS: Mean and median values for continuous variables and percentages of categorical variables; first-year total medical costs measured per person per year. Observed costs were adjusted using Medicare Price Indices and patient case-mix. RESULTS: Median age at dialysis therapy initiation increased from 74.9 to 77.0 years from 1995 (n = 19,044) to 2005 (n = 31,796; P < 0.001). Diabetes prevalence increased from 54.2% to 64.1% (P < 0.001). Median estimated glomerular filtration rate increased from 8.0 to 11.2 mL/min/1.73 m(2), and median hemoglobin level increased from 9.4 to 10.2 g/dL. Obesity increased from 8.9% to 22.9% (P < 0.001). First-year observed costs increased by 37.9%; however, inflation-adjusted and case-mix-inflation-adjusted costs were stable. Important adjusters for costs are inability to ambulate/transfer, baseline serum albumin level, primary end-stage renal disease cause, comorbid peripheral vascular disease, and baseline hospital days. LIMITATIONS: Population aged > or =67 years at dialysis therapy initiation and results may not generalize to the overall hemodialysis population. CONCLUSIONS: From 1995 to 2005, incident hemodialysis patients aged > or =67 years became older, sicker, and more obese with significantly increased estimated glomerular filtration rates and hemoglobin levels at dialysis therapy initiation. Increased first-year post-dialysis therapy initiation costs became stable over time after adjustment for price inflation; case-mix-inflation-adjusted costs remained constant, possibly because of mixed changes in patient characteristics.

Mortality from cancer among US hemodialysis patients, 1995-2005.

BACKGROUND/AIMS: Concern has emerged that erythropoiesis-stimulating agents (ESAs) may decrease survival for cancer patients; many patients beginning dialysis have previous cancer diagnoses. As ESA doses have more than tripled in the USA since ESAs were introduced, we aimed to compare annual trends in cancer-specific mortality rates among incident maintenance hemodialysis patients. METHODS: This national, retrospective, incident cohort study included 873,493 patients aged > or =20 years who initiated hemodialysis between 1995 and 2005. Cancer-specific mortality rates were adjusted for baseline characteristics, determined from the Centers for Medicare & Medicaid Services (CMS) Medical Evidence Report (form CMS-2728). Follow-up extended to December 31, 2006. Cause of death was ascertained from the Death Notification (form CMS-2746). RESULTS: Crude first-year cancer-specific mortality rates, per 1,000 patient-years, 1995-2005, were as follows: 13.8, 13.7, 14.2, 14.9, 13.8, 15.4, 15.4, 16.5, 16.4, 15.8, 15.2. Mortality rates remained stable year to year within subsequent follow-up intervals; for the first and last annual cohorts, mortality rates by follow-up interval were: year 2, 9.1 and 8.7; year 3, 8.6 and 8.3; years 4-5, 7.9 and 6.8. Annual comparisons were similar after adjustment for patient characteristics at dialysis initiation. CONCLUSION: Cancer-specific mortality rates remained stable among US hemodialysis patients between 1995 and 2005.

Association between cancer-specific adverse event triggers and mortality: A validation study.

BACKGROUND: As there are few validated measures of patient safety in clinical oncology, creating an efficient measurement instrument would create significant value. Accordingly, we sought to assess the validity of a novel patient safety measure by examining the association of oncology-specific triggers and mortality using administrative claims data. METHODS: We examined a retrospective cohort of 322 887 adult cancer patients enrolled in commercial or Medicare Advantage products for one year after an initial diagnosis of breast, colorectal, lung, or prostate cancer in 2008-2014. We used diagnosis and procedure codes to calculate the prevalence of 16 cancer-specific "triggers"-events that signify a potential adverse event. We compared one-year mortality rates among patients with and without triggers by cancer type and metastatic status using logistic regression models. RESULTS: Trigger events affected 19% of patients and were most common among patients with metastatic colorectal (41%) and lung (50%) cancers. There was increased one-year mortality among patients with triggers compared to patients without triggers across all cancer types in unadjusted and multivariate analyses. The increased mortality rate among patients with trigger events was particularly striking for nonmetastatic prostate cancer (1.3% vs 7.5%, adjusted odds ratio 1.96 [95% CI 1.49-2.57]) and nonmetastatic colorectal cancer (4.1% vs 11.7%, 1.44 [1.19-1.75]). CONCLUSIONS: The association between adverse event triggers and poor survival among a cohort of cancer patients supports the validity of a cancer-specific, administrative claims-based trigger tool.

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data.

BACKGROUND: As there are few validated tools to identify treatment-related adverse events across cancer care settings, we sought to develop oncology-specific "triggers" to flag potential adverse events among cancer patients using claims data. METHODS: 322 887 adult patients undergoing an initial course of cancer-directed therapy for breast, colorectal, lung, or prostate cancer from 2008 to 2014 were drawn from a large commercial claims database. We defined 16 oncology-specific triggers using diagnosis and procedure codes. To distinguish treatment-related complications from comorbidities, we required a logical and temporal relationship between a treatment and the associated trigger. We tabulated the prevalence of triggers by cancer type and metastatic status during 1-year of follow-up, and examined cancer trigger risk factors. RESULTS: Cancer-specific trigger events affected 19% of patients over the initial treatment year. The trigger burden varied by disease and metastatic status, from 6% of patients with nonmetastatic prostate cancer to 41% and 50% of those with metastatic colorectal and lung cancers, respectively. The most prevalent triggers were abnormal serum bicarbonate, blood transfusion, non-contrast chest CT scan following radiation therapy, and hypoxemia. Among patients with metastatic disease, 10% had one trigger event and 29% had two or more. Triggers were more common among older patients, women, non-whites, patients with low family incomes, and those without a college education. CONCLUSIONS: Oncology-specific triggers offer a promising method for identifying potential patient safety events among patients across cancer care settings.

Exceeding hemoglobin target levels in US hemodialysis patients receiving epoetin, 1999 to 2002.

Despite emerging concerns that exceeding anemia targets with erythropoiesis stimulating agents may be risky for hemodialysis patients, the magnitude of and risk factors for the problem have received little attention, particularly regarding year-to-year comparisons. We studied monthly hemoglobin and epoetin levels in 41,101 patients aged at least 65 years who initiated hemodialysis between 1999 and 2002, with upper targets defined by hemoglobin levels of 120 and 130 g/L, respectively. While baseline hemoglobin values and epoetin doses rose from year to year, their rates of change during follow-up declined (p<0.0001). Similar patterns were seen after reaching hemoglobin levels of 110 g/L; comparing 1999 to 2002, the proportions reaching 120 and 130 g/L in the ensuing 9 months increased from 90% to 96% (p<0.0001) and from 56% to 69%, respectively (p<0.0001). Multivariate analysis showed that, while more recent years of dialysis inception and initial epoetin dose were associated with all 3 outcomes, higher baseline hemoglobin levels were associated with reaching levels of 110 and 120 g/L, but not 130 g/L. Exceeding hemoglobin level targets has become widespread in the United States and is associated with changes in epoetin dosing practices.