NIH funding and the pursuit of edge science.

The National Institutes of Health (NIH) plays a critical role in funding scientific endeavors in biomedicine. Funding innovative science is an essential element of the NIH's mission, but many have questioned the NIH's ability to fulfill this aim. Based on an analysis of a comprehensive corpus of published biomedical research articles, we measure whether the NIH succeeds in funding work with novel ideas, which we term edge science. We find that edge science is more often NIH funded than less novel science, but with a delay. Papers that build on very recent ideas are NIH funded less often than are papers that build on ideas that have had a chance to mature for at least 7 y. We have three further findings. First, the tendency to fund edge science is mostly limited to basic science. Papers that build on novel clinical ideas are not more often NIH funded than are papers that build on well-established clinical knowledge. Second, novel papers tend to be NIH funded more often because there are more NIH-funded papers in innovative areas of investigation, rather than because the NIH funds innovative papers within research areas. Third, the NIH's tendency to have funded papers that build on the most recent advances has declined over time. In this regard, NIH funding has become more conservative despite initiatives to increase funding for innovative projects. Given our focus on published papers, the results reflect both the funding preferences of the NIH and the composition of the applications it receives.

Assessing mandatory stay-at-home and business closure effects on the spread of COVID-19.

BACKGROUND AND AIMS: The most restrictive nonpharmaceutical interventions (NPIs) for controlling the spread of COVID-19 are mandatory stay-at-home and business closures. Given the consequences of these policies, it is important to assess their effects. We evaluate the effects on epidemic case growth of more restrictive NPIs (mrNPIs), above and beyond those of less-restrictive NPIs (lrNPIs). METHODS: We first estimate COVID-19 case growth in relation to any NPI implementation in subnational regions of 10 countries: England, France, Germany, Iran, Italy, Netherlands, Spain, South Korea, Sweden and the United States. Using first-difference models with fixed effects, we isolate the effects of mrNPIs by subtracting the combined effects of lrNPIs and epidemic dynamics from all NPIs. We use case growth in Sweden and South Korea, 2 countries that did not implement mandatory stay-at-home and business closures, as comparison countries for the other 8 countries (16 total comparisons). RESULTS: Implementing any NPIs was associated with significant reductions in case growth in 9 out of 10 study countries, including South Korea and Sweden that implemented only lrNPIs (Spain had a nonsignificant effect). After subtracting the epidemic and lrNPI effects, we find no clear, significant beneficial effect of mrNPIs on case growth in any country. In France, for example, the effect of mrNPIs was +7% (95% CI: -5%-19%) when compared with Sweden and + 13% (-12%-38%) when compared with South Korea (positive means pro-contagion). The 95% confidence intervals excluded 30% declines in all 16 comparisons and 15% declines in 11/16 comparisons. CONCLUSIONS: While small benefits cannot be excluded, we do not find significant benefits on case growth of more restrictive NPIs. Similar reductions in case growth may be achievable with less-restrictive interventions.

Racial and ethnic inequities in the early distribution of U.S. COVID-19 testing sites and mortality.

BACKGROUND: In 2020, early U.S. COVID-19 testing sites offered diagnostic capacity to patients and were important sources of epidemiological data about the spread of the novel pandemic disease. However, little research has comprehensively described American testing sites' distribution by race/ethnicity and sought to identify any relation to known disparities in COVID-19 outcomes. METHODS: Locations of U.S. COVID-19 testing sites were gathered from 16 April to 28 May 2020. Geographic testing disparities were evaluated with comparisons of the demographic makeup of zip codes around each testing site versus Monte Carlo simulations, aggregated to statewide and nationwide levels. State testing disparities were compared with statewide disparities in mortality observed one to 3 weeks later using multivariable regression, controlling for confounding disparities and characteristics. RESULTS: Nationwide, COVID-19 testing sites geographically overrepresented White residents on 7 May, underrepresented Hispanic residents on 16 April, 7 May and 28 May and overrepresented Black residents on 28 May compared with random distribution within counties, with new sites added over time exhibiting inconsistent disparities for Black and Hispanic populations. For every 1 percentage point increase in underrepresentation of Hispanic populations in zip codes with testing, mortality among the state's Hispanic population was 1.04 percentage points more over-representative (SE = 0.415, p = .01). CONCLUSIONS: American testing sites were not distributed equitably by race during this analysis, often underrepresenting minority populations who bear a disproportionate burden of COVID-19 cases and deaths. With an easy-to-implement measure of geographic disparity, these results provide empirical support for the consideration of access when distributing preventive resources.

Challenging Assumptions of Outcomes and Costs Comparing Peritoneal and Hemodialysis.

OBJECTIVES: Policy makers have suggested increasing peritoneal dialysis (PD) would improve end-stage kidney disease (ESKD) outcomes and reduce Medicare spending compared with hemodialysis (HD). We compared mortality, hospitalizations, and Medicare spending between PD and HD among uninsured adults with incident ESKD. METHODS: Using an instrumental variable design, we exploited a natural experiment encouraging PD among the uninsured. Uninsured patients usually receive Medicare at dialysis month 4. For those initiating PD, Medicare covers the first 3 dialysis months, including predialysis services in the calendar month when dialysis started. Starting dialysis later in a calendar month increases predialysis coverage that is essential for PD catheter placements. The policy encourages PD incrementally when ESKD develops later in the month. Dialysis start day appears to be unrelated to patient characteristics and effectively "randomizes patients" to dialysis modality, mitigating selection bias. RESULTS: Starting dialysis later in the month was associated with an increased PD uptake: every week later in the month was associated with an absolute increase of 0.8% (95% confidence interval [CI] 0.6%-0.9%) at dialysis day 1 and 0.5% (95% CI 0.3%-0.7%) at dialysis month 12. We observed no significant absolute difference between PD and HD for 12-month mortality (-0.9%, 95% CI -3.3% to 0.8%), hospitalizations during months 7 to 12 (-0.05, 95% CI -0.20 to 0.07), and Medicare spending during months 7 to 12 (-$702, 95% CI -$4004 to $2909). CONCLUSIONS: In an instrumental variable analysis, PD did not result in improved outcomes or lower costs than HD.

Consolidation of primary care physicians and its impact on healthcare utilization.

We use administrative data from Medicare to document the massive consolidation of primary care physicians over the last decade and its impact on patient healthcare utilization. We first document that primary care organizations have consolidated all over the United States between 2008 and 2014. We then show that regions that experienced greater consolidation are associated with greater decline in overall healthcare spending. Finally, in our primary exercise, we exploit transitions of patients across organizations that are driven by changes in the organizational affiliations of their primary care physicians to study the impact of organizational size on overall spending. Our preferred specification suggests that patients switching from small to large physician organizations reduce their overall healthcare spending by 16%, and that this reduction is primarily driven by a 13% reduction in primary care visits and 0.09 (21%) fewer inpatient admissions per year.

Future projection of the health and functional status of older people in Japan: A multistate transition microsimulation model with repeated cross-sectional data.

Accurate future projections of population health are imperative to plan for the future healthcare needs of a rapidly aging population. Multistate-transition microsimulation models, such as the U.S. Future Elderly Model, address this need but require high-quality panel data for calibration. We develop an alternative method that relaxes this data requirement, using repeated cross-sectional representative surveys to estimate multistate-transition contingency tables applied to Japan's population. We calculate the birth cohort sex-specific prevalence of comorbidities using five waves of the governmental health surveys. Combining estimated comorbidity prevalence with death record information, we determine the transition probabilities of health statuses. We then construct a virtual Japanese population aged 60 and older as of 2013 and perform a microsimulation to project disease distributions to 2046. Our estimates replicate governmental projections of population pyramids and match the actual prevalence trends of comorbidities and the disease incidence rates reported in epidemiological studies in the past decade. Our future projections of cardiovascular diseases indicate lower prevalence than expected from static models, reflecting recent declining trends in disease incidence and fatality.

Smoking, life expectancy, and chronic disease in South Korea, Singapore, and the United States: A microsimulation model.

The substantial social and economic burden attributable to smoking is well-known, with heavy smokers at higher risk of chronic disease and premature mortality than light smokers and nonsmokers. In aging societies with high rates of male smoking such as in East Asia, smoking is a leading preventable risk factor for extending lives (including work-lives) and healthy aging. However, little is known about whether smoking interventions targeted at heavy smokers relative to light smokers lead to disproportionately larger improvements in life expectancy and prevalence of chronic diseases and how the effects vary across populations. Using a microsimulation model, we examined the health effects of smoking reduction by simulating an elimination of smoking among subgroups of smokers in South Korea, Singapore, and the United States. We found that life expectancy would increase by 0.2 to 1.5 years among light smokers and 2.5 to 3.7 years among heavy smokers. Whereas both interventions led to an increased life expectancy and decreased the prevalence of chronic diseases in all three countries, the life-extension benefits were greatest for those who would otherwise have been heavy smokers. Our findings illustrate how smoking interventions may have significant economic and social benefits, especially for life extension, that vary across countries.

Technological Progress and Health Convergence: The Case of Penicillin in Postwar Italy.

Throughout history, technological progress has transformed population health, but the distributional effects of these gains are unclear. New substitutes for older, more expensive health technologies can produce convergence in population health outcomes but may also be prone to elite capture and thus divergence. We study the case of penicillin using detailed historical mortality statistics and exploiting its abruptly timed introduction in Italy after WWII. We find that penicillin reduced both the mean and standard deviation of infectious disease mortality, leading to substantial convergence across disparate regions of Italy. Our results do not appear to be driven by competing risks or confounded by mortality patterns associated with WWII.

Safety-Net Care for Maintenance Dialysis in the United States.

BACKGROUND: Although most American patients with ESKD become eligible for Medicare by their fourth month of dialysis, some never do. Information about where patients with limited health insurance receive maintenance dialysis has been lacking. METHODS: We identified patients initiating maintenance dialysis (2008-2015) from the US Renal Data System, defining patients as "safety-net reliant" if they were uninsured or had only Medicaid coverage at dialysis onset and had not qualified for Medicare by the fourth dialysis month. We examined four dialysis facility ownership categories according to for-profit/nonprofit status and ownership (chain versus independent). We assessed whether patients who were safety-net reliant were more likely to initiate dialysis at certain facility types. We also examined hospital-based affiliation. RESULTS: The proportion of patients <65 years initiating dialysis who were safety-net reliant increased significantly over time, from 11% to 14%; 73% of such patients started dialysis at for-profit/chain-owned facilities compared to 76% of all patients starting dialysis. Patients who were safety-net reliant had a 30% higher relative risk of initiating dialysis at nonprofit/independently owned versus for-profit/independently owned facilities (odds ratio, 1.30; 95% CI, 1.24 to 1.36); they had slightly lower relative risks of initiating dialysis at for-profit and non-profit chain-owned facilities, and were more likely to receive dialysis at hospital-based facilities. These findings primarily reflect increased likelihood of dialysis among patients without insurance at certain facility types. CONCLUSIONS: Although most patients who were safety-net reliant received care at for-profit/chain-owned facilities, they were disproportionately cared for at nonprofit/independently owned and hospital-based facilities. Ongoing loss of market share of nonprofit/independently owned outpatient dialysis facilities may affect safety net-reliant populations.

Early Delays in Insurance Coverage and Long-term Use of Home-based Peritoneal Dialysis.

BACKGROUND: Uninsured patients with end-stage renal disease face barriers to peritoneal dialysis (PD), a type of home dialysis that is associated with improved quality of life and reduced Medicare costs. Although uninsured patients using PD at dialysis start receive retroactive Medicare coverage for required predialysis services, coverage only applies for the calendar month of dialysis start. Thus, initiating dialysis later in the month yields longer retroactive coverage. OBJECTIVES: To examine whether differences in retroactive Medicare were associated with decreased long-term PD use. RESEARCH DESIGN: We exploited the dialysis start date using a regression discontinuity design on a national cohort from the US Renal Data System. SUBJECTS: 36,256 uninsured adults starting dialysis between January 1, 2006 and December 31, 2014. MEASURES: PD use at dialysis days 1, 90, 180, and 360. RESULTS: Starting dialysis on the first versus last day of the calendar month was associated with an absolute decrease in PD use of 2.7% [95% confidence interval (CI), 1.5%-3.9%], or a relative decrease of 20% (95% CI, 12%-27%) at dialysis day 360. The absolute decrease was 5.5% (95% CI, 3.5%-7.2%) after Medicare established provider incentives for PD in 2011 and 7.2% (95% CI, 2.5%-11.9%) after Medicaid expansion in 2014. Patients were unlikely to switch from hemodialysis to PD after the first month of dialysis (probability of 6.9% in month 1, 1.5% in month 2, and 0.9% in month 4). CONCLUSIONS: Extending retroactive coverage for preparatory dialysis services could increase PD use and reduce overall Medicare spending in the uninsured.

Trends in EMR for nonmalignant colorectal polyps in the United States.

BACKGROUND AND AIMS: Although most large nonpedunculated colorectal lesions can be safely and efficaciously removed using EMR, the use of colectomy for benign colorectal lesions appears to be increasing. The reason(s) is unclear. We aimed to determine the use and adverse events of EMR in the United States. METHODS: We used Optum's de-identified Clinformatics Data Mart Database (2003-2016), a database from a large national insurance provider, to identify all colonoscopies performed with either EMR or simple polypectomy on adult patients from January 1, 2011 to December 31, 2015. We measured time trends, regional variation, and adverse event rates. We assessed risk factors for adverse events using multivariate logistic regression. RESULTS: The rate of EMR use in the US increased from 1.62% of all colonoscopies in 2011 to 2.48% of colonoscopies in 2015 (P < .001). There were, however, significant regional differences in the use of EMRs, from 2.4% of colonoscopies in the western United States to 2.0% of colonoscopies in the southern United States. Between 2011 and 2015, we found stable rates of perforation, GI bleeding (GIB), infections, and cardiac adverse events and decreasing rates of admissions after EMR. In our multivariate model, EMR was an independent risk factor for adverse events, albeit the rates of adverse events were low (1.35% GIB, .22% perforation). CONCLUSIONS: Use of EMR is rising in the United States, although there is significant regional variation. The rates of adverse events after EMR and polypectomies were low and stable, confirming the continued safety of EMR procedures. A better understanding of the regional barriers and facilitators may improve the use of EMR as the standard management for benign colorectal lesions throughout the United States.

Racial disparities in knowledge, attitudes and practices related to COVID-19 in the USA.

BACKGROUND: Recent reports indicate racial disparities in the rates of infection and mortality from the 2019 novel coronavirus (coronavirus disease 2019 [COVID-19]). The aim of this study was to determine whether disparities exist in the levels of knowledge, attitudes and practices (KAPs) related to COVID-19. METHODS: We analyzed data from 1216 adults in the March 2020 Kaiser Family Foundation 'Coronavirus Poll', to determine levels of KAPs across different groups. Univariate and multivariate regression analysis was used to identify predictors of KAPs. RESULTS: In contrast to White respondents, Non-White respondents were more likely to have low knowledge (58% versus 30%; P < 0.001) and low attitude scores (52% versus 27%; P < 0.001), but high practice scores (81% versus 59%; P < 0.001). By multivariate regression, White race (odds ratio [OR] 3.06; 95% confidence interval [CI]: 1.70-5.50), higher level of education (OR 1.80; 95% CI: 1.46-2.23) and higher income (OR 2.06; 95% CI: 1.58-2.70) were associated with high knowledge of COVID-19. Race, sex, education, income, health insurance status and political views were all associated with KAPs. CONCLUSIONS: Racial and socioeconomic disparity exists in the levels of KAPs related to COVID-19. More work is needed to identify educational tools that tailor to specific racial and socioeconomic groups.

Prior Hospitalization Burden and the Relatedness of 30-Day Readmissions in Patients Receiving Hemodialysis.

BACKGROUND: Thirty-day readmissions are common in patients receiving hemodialysis and costly to Medicare. Because patients on hemodialysis have a high background hospitalization rate, 30-day readmissions might be less likely related to the index hospitalization than in patients with other conditions. METHODS: In adults with Medicare receiving hemodialysis in the United States, we used multinomial logistic regression to evaluate whether prior hospitalization burden was associated with increased 30-day readmissions unrelated to index hospitalizations with a discharge date from January 1, 2013 to December 31, 2014. We categorized a hospitalization, 30-day readmission pair as "related" if the principal diagnoses came from the same organ system. RESULTS: The adjusted probability of unrelated 30-day readmission after any index hospitalization was 19.1% (95% confidence interval [95% CI] 18.9% to 19.3%), 22.6% (95% CI, 22.4% to 22.8%), and 31.2% (95% CI, 30.8% to 31.5%) in patients with 0-1, 2-4, and ≥5 hospitalizations, respectively. Cardiovascular index hospitalizations had the highest adjusted probability of related 30-day readmission: 10.4% (95% CI, 10.2% to 10.7%), 13.6% (95% CI, 13.4% to 13.9%), and 20.8% (95% CI, 20.2% to 21.4%), respectively. Renal index hospitalizations had the lowest adjusted probability of related 30-day readmission: 2.0% (95% CI, 1.8% to 2.3%), 3.9% (95% CI, 3.4% to 4.4%), and 5.1% (95% CI, 4.3% to 5.9%), respectively. CONCLUSIONS: High prior hospitalization burden increases the likelihood that patients receiving hemodialysis experience a 30-day readmission unrelated to the index hospitalization. Health care payers such as Medicare should consider incorporating clinical relatedness into 30-day readmission quality measures.

Visualizing the invisible: The effect of asymptomatic transmission on the outbreak dynamics of COVID-19.

Understanding the outbreak dynamics of the COVID-19 pandemic has important implications for successful containment and mitigation strategies. Recent studies suggest that the population prevalence of SARS-CoV-2 antibodies, a proxy for the number of asymptomatic cases, could be an order of magnitude larger than expected from the number of reported symptomatic cases. Knowing the precise prevalence and contagiousness of asymptomatic transmission is critical to estimate the overall dimension and pandemic potential of COVID-19. However, at this stage, the effect of the asymptomatic population, its size, and its outbreak dynamics remain largely unknown. Here we use reported symptomatic case data in conjunction with antibody seroprevalence studies, a mathematical epidemiology model, and a Bayesian framework to infer the epidemiological characteristics of COVID-19. Our model computes, in real time, the time-varying contact rate of the outbreak, and projects the temporal evolution and credible intervals of the effective reproduction number and the symptomatic, asymptomatic, and recovered populations. Our study quantifies the sensitivity of the outbreak dynamics of COVID-19 to three parameters: the effective reproduction number, the ratio between the symptomatic and asymptomatic populations, and the infectious periods of both groups. For nine distinct locations, our model estimates the fraction of the population that has been infected and recovered by Jun 15, 2020 to 24.15% (95% CI: 20.48%-28.14%) for Heinsberg (NRW, Germany), 2.40% (95% CI: 2.09%-2.76%) for Ada County (ID, USA), 46.19% (95% CI: 45.81%-46.60%) for New York City (NY, USA), 11.26% (95% CI: 7.21%-16.03%) for Santa Clara County (CA, USA), 3.09% (95% CI: 2.27%-4.03%) for Denmark, 12.35% (95% CI: 10.03%-15.18%) for Geneva Canton (Switzerland), 5.24% (95% CI: 4.84%-5.70%) for the Netherlands, 1.53% (95% CI: 0.76%-2.62%) for Rio Grande do Sul (Brazil), and 5.32% (95% CI: 4.77%-5.93%) for Belgium. Our method traces the initial outbreak date in Santa Clara County back to January 20, 2020 (95% CI: December 29, 2019-February 13, 2020). Our results could significantly change our understanding and management of the COVID-19 pandemic: A large asymptomatic population will make isolation, containment, and tracing of individual cases challenging. Instead, managing community transmission through increasing population awareness, promoting physical distancing, and encouraging behavioral changes could become more relevant.

Educational attainment and cardiovascular disease in the United States: A quasi-experimental instrumental variables analysis.

BACKGROUND: There is ongoing debate about whether education or socioeconomic status (SES) should be inputs into cardiovascular disease (CVD) prediction algorithms and clinical risk adjustment models. It is also unclear whether intervening on education will affect CVD, in part because there is controversy regarding whether education is a determinant of CVD or merely correlated due to confounding or reverse causation. We took advantage of a natural experiment to estimate the population-level effects of educational attainment on CVD and related risk factors. METHODS AND FINDINGS: We took advantage of variation in United States state-level compulsory schooling laws (CSLs), a natural experiment that was associated with geographic and temporal differences in the minimum number of years that children were required to attend school. We linked census data on educational attainment (N = approximately 5.4 million) during childhood with outcomes in adulthood, using cohort data from the 1992-2012 waves of the Health and Retirement Study (HRS; N = 30,853) and serial cross-sectional data from 1971-2012 waves of the National Health and Nutrition Examination Survey (NHANES; N = 44,732). We examined self-reported CVD outcomes and related risk factors, as well as relevant serum biomarkers. Using instrumental variables (IV) analysis, we found that increased educational attainment was associated with reduced smoking (HRS ß -0.036, 95%CI: -0.06, -0.02, p < 0.01; NHANES ß -0.032, 95%CI: -0.05, -0.02, p < 0.01), depression (HRS ß -0.049, 95%CI: -0.07, -0.03, p < 0.01), triglycerides (NHANES ß -0.039, 95%CI: -0.06, -0.01, p < 0.01), and heart disease (HRS ß -0.025, 95%CI: -0.04, -0.002, p = 0.01), and improvements in high-density lipoprotein (HDL) cholesterol (HRS ß 1.50, 95%CI: 0.34, 2.49, p < 0.01; NHANES ß 0.86, 95%CI: 0.32, 1.48, p < 0.01), but increased BMI (HRS ß 0.20, 95%CI: 0.002, 0.40, p = 0.05; NHANES ß 0.13, 95%CI: 0.01, 0.32, p = 0.05) and total cholesterol (HRS ß 2.73, 95%CI: 0.09, 4.97, p = 0.03). While most findings were cross-validated across both data sets, they were not robust to the inclusion of state fixed effects. Limitations included residual confounding, use of self-reported outcomes for some analyses, and possibly limited generalizability to more recent cohorts. CONCLUSIONS: This study provides rigorous population-level estimates of the association of educational attainment with CVD. These findings may guide future implementation of interventions to address the social determinants of CVD and strengthen the argument for including educational attainment in prediction algorithms and primary prevention guidelines for CVD.

Patients Prescribed Direct-Acting Oral Anticoagulants Have Low Risk of Postpolypectomy Complications.

BACKGROUND & AIMS: Use of direct-acting oral anticoagulants (DOACs) is increasing, but little is known about the associated risks in patients undergoing colonoscopy with polypectomy. We aimed to determine the risk of post-polypectomy complications in patients prescribed DOACs. METHODS: We performed a retrospective analysis using Optum's de-identified Clinformatics Data Mart Database (2003-2016) (a de-identified administrative database from a large national insurance provider) to identify adults who underwent colonoscopy with polypectomy or endoscopic mucosal resection (EMR) from January 1, 2011, through December 31, 2015. We collected data from 11,504 patients prescribed antithrombotic agents (1590 DOAC, 3471 warfarin, and 6443 clopidogrel) and 599,983 patients not prescribed antithrombotics of interest (controls). We compared 30-day post-polypectomy complications, including gastrointestinal bleeding (GIB), cerebrovascular accident (CVA), myocardial infarction (MI), and hospital admissions, of patients prescribed DOACs, warfarin, or clopidogrel vs controls. RESULTS: Post-polypectomy complications were uncommon but occurred in a significantly higher proportion of patients receiving any antithrombotic vs controls (P < .001). The percentage of patients in the DOAC group with GIB was 0.63% (95% CI, 0.3%-1.2%) vs 0.2% (95% CI, 0.2%-0.3%) in controls. The percentage of patients with CVA in the DOAC group was 0.06% (95% CI, 0.01%-0.35%) vs 0.04% (95% CI, 0.04%-0.05%) in controls. After we adjusted for bridge anticoagulation, EMR, Charlson comorbidity index (CCI), and CHADS2 (congestive heart failure, hypertension, age over 75, diabetes, stroke [double weight]) score, patients prescribed DOACs no longer had a statistically significant increase in the odds of GIB (odds ratio [OR], 0.90; 95% CI, 0.44-1.85), CVA (OR, 0.45; 95% CI, 0.06-3.28), MI (OR, 1.07; 95% CI, 0.14-7.72), or hospital admission (OR, 0.86; 95% CI, 0.64-1.16). Clopidogrel, warfarin, bridge anticoagulation, higher CHADS2, CCI, and EMR were associated with increased odds of complications. CONCLUSION: In our retrospective analysis of a large national dataset, we found that patients prescribed DOACs did not have significantly increased adjusted odds of post-polypectomy GIB, MI, CVA, or hospital admission. Bridge anticoagulation, higher CHADS2 score, CCI, and EMR were risk factors for GIB, MI, CVA, and hospital admissions. Studies are needed to determine the optimal peri-procedural dose for high-risk patients.

Market Consolidation and Mortality in Patients Initiating Hemodialysis.

BACKGROUND: It is uncertain whether consolidation in health care markets affects the quality of care provided and health outcomes. OBJECTIVES: To examine whether changes in market competition resulting from acquisitions by two large national for-profit dialysis chains were associated with patient mortality. METHODS: We identified patients initiating in-center hemodialysis between 2001 and 2009 from a registry of patients with end-stage renal disease in the United States. We considered two scenarios when evaluating consolidation from dialysis facility acquisitions: one in which we considered only those patients receiving dialysis in markets that became substantially more concentrated to have been affected by consolidation, and the other in which all patients living in hospital service areas where a facility was acquired were potentially affected. We used a difference-in-differences study design to examine the associations between market consolidation and changes in mortality rates. RESULTS: When we considered the 12,065 patients living in areas that became substantially more consolidated to have been affected by consolidation, we found a nominally significant (8%; 95% confidence interval 0%-17%) increase in likelihood of death after consolidation. Nevertheless, when we considered all 186,158 patients living in areas where an acquisition occurred to have been affected by consolidation, there was no observable effect of market consolidation on mortality. CONCLUSIONS: Decreased market competition may have led to increased mortality among a relatively small subset of patients initiating in-center hemodialysis in areas that became substantially more concentrated after two large dialysis acquisitions, but not for most of the patients living in affected areas.

The Timing of Early Antibiotics and Hospital Mortality in Sepsis.

RATIONALE: Prior sepsis studies evaluating antibiotic timing have shown mixed results. OBJECTIVES: To evaluate the association between antibiotic timing and mortality among patients with sepsis receiving antibiotics within 6 hours of emergency department registration. METHODS: Retrospective study of 35,000 randomly selected inpatients with sepsis treated at 21 emergency departments between 2010 and 2013 in Northern California. The primary exposure was antibiotics given within 6 hours of emergency department registration. The primary outcome was adjusted in-hospital mortality. We used detailed physiologic data to quantify severity of illness within 1 hour of registration and logistic regression to estimate the odds of hospital mortality based on antibiotic timing and patient factors. MEASUREMENTS AND MAIN RESULTS: The median time to antibiotic administration was 2.1 hours (interquartile range, 1.4-3.1 h). The adjusted odds ratio for hospital mortality based on each hour of delay in antibiotics after registration was 1.09 (95% confidence interval [CI], 1.05-1.13) for each elapsed hour between registration and antibiotic administration. The increase in absolute mortality associated with an hour's delay in antibiotic administration was 0.3% (95% CI, 0.01-0.6%; P = 0.04) for sepsis, 0.4% (95% CI, 0.1-0.8%; P = 0.02) for severe sepsis, and 1.8% (95% CI, 0.8-3.0%; P = 0.001) for shock. CONCLUSIONS: In a large, contemporary, and multicenter sample of patients with sepsis in the emergency department, hourly delays in antibiotic administration were associated with increased odds of hospital mortality even among patients who received antibiotics within 6 hours. The odds increased within each sepsis severity strata, and the increased odds of mortality were greatest in septic shock.

The Medicare Access and CHIP Reauthorization Act: Implications for Nephrology.

In response to rising Medicare costs, Congress passed the Medicare Access and Children's Health Insurance Program Reauthorization Act in 2015. The law fundamentally changes the way that health care providers are reimbursed by implementing a pay for performance system that rewards providers for high-value health care. As of the beginning of 2017, providers will be evaluated on quality and in later years, cost as well. High-quality, cost-efficient providers will receive bonuses in reimbursement, and low-quality, expensive providers will be penalized financially. The Centers for Medicare and Medicaid Services will evaluate provider costs through episodes of care, which are currently in development, and alternative payment models. Although dialysis-specific alternative payment models have already been implemented, current models do not address the transition of patients from CKD to ESRD, a particularly vulnerable time for patients. Nephrology providers have an opportunity to develop cost-efficient ways to care for patients during these transitions. Efforts like these, if successful, will help ensure that Medicare remains solvent in coming years.

Hemodialysis Hospitalizations and Readmissions: The Effects of Payment Reform.

BACKGROUND: In 2004, the Centers for Medicare & Medicaid Services changed reimbursement for physicians and advanced practitioners caring for patients receiving hemodialysis from a capitated to a tiered fee-for-service system, encouraging increased face-to-face visits. This early version of a pay-for-performance initiative targeted a care process: more frequent provider visits in hemodialysis. Although more frequent provider visits in hemodialysis are associated with fewer hospitalizations and rehospitalizations, it is unknown whether encouraging more frequent visits through reimbursement policy also yielded these benefits. STUDY DESIGN: We used a retrospective cohort interrupted time-series study design to examine whether the 2004 nephrologist reimbursement reform led to reduced hospitalizations and rehospitalizations. We also used published data to estimate a range of annual economic costs associated with more frequent visits. SETTING & PARTICIPANTS: Medicare beneficiaries in the United States receiving hemodialysis in the 2 years prior to and following reimbursement reform. PREDICTOR: The 2 years following nephrologist reimbursement reform. OUTCOMES: Odds of hospitalization and 30-day hospital readmission for all causes and fluid overload; US dollars. RESULTS: We found no significant change in all-cause hospitalization or rehospitalization and slight reductions in fluid overload hospitalization and rehospitalization following reimbursement reform; the estimated economic cost associated with additional visits ranged from $13 to $87 million per year, depending on who (physicians or advanced practitioners) spent additional time visiting patients and how much additional effort was involved. LIMITATIONS: Due to limited information about how much additional time providers spent seeing patients after reimbursement reform, we could only examine a range of potential economic costs associated with the reform. CONCLUSIONS: A Medicare reimbursement policy designed to encourage more frequent visits during outpatient hemodialysis may have been costly. The policy was associated with fewer hospitalizations and rehospitalizations for fluid overload, but had no effect on all-cause hospitalizations or rehospitalizations.