[Common Malignant Tumors in the Reproductive System of Chinese Women: Disease Burden During 1990-2019 and Prediction of Future Trend].

Objective To analyze the trends of disease burden of cervical cancer,uterine cancer,and ovarian cancer among Chinese women from 1990 to 2019,and to provide a basis for formulating precise prevention and control measures in China. Methods The global disease burden data in 2019 were used to describe the changes in indicators such as incidence,mortality,years of life lost due to premature mortality(YLL),years lived with disability(YLD),and disability-adjusted life year(DALY) of cervical,uterine,and ovarian cancers in China from 1990 to 2019.Furthermore,the Bayesian age-period-cohort model was adopted to predict the incidence and mortality of the cancers from 2020 to 2030. Results From 1990 to 2019,the incidence rates and mortality of cervical,uterine,and ovarian cancers in Chinese women showed an upward trend,and the age-standardized incidence rate of ovarian cancer increased the most(0.78%).In 2019,the incidence of cervical cancer and uterine cancer concentrated in the women of 55-59 years old,and ovarian cancer mainly occurred in the women of 70-74 years old.The DALY,YLL,and YLD of cervical,uterine,and ovarian cancers all presented varying degrees of growth at all ages.The Bayesian age-period-cohort model predicted that from 2020 to 2030,the incidence and mortality of cervical cancer in China showed a decreasing trend,while those of uterine cancer and ovarian cancer showed an increasing trend.There was no significant change in the age with high incidence of the three cancers. Conclusions From 1990 to 2019,the overall disease burden of cervical,uterine,and ovarian cancers in China increased,while the disease burden of cervical cancer decreased after 2020.It is recommended that the efforts should be doubled for the prevention and control of cervical,uterine,and ovarian cancers.

Generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study.

OBJECTIVE: Lamotrigine is a commonly prescribed antiepileptic drug. U.S. Food and Drug Administration (FDA)-funded clinical studies have demonstrated bioequivalence (BE) for generic lamotrigine immediate-release (IR) products in epilepsy patients with generic substitution. To address the potential concerns about the risk of generic-brand substitution of lamotrigine extended-release (ER) products, considering the complexity of controlled release systems and pharmacokinetic variations associated with possible within-subject variability (WSV), this prospective study assessed (1) BE of generic and brand lamotrigine ER products in a fully replicated BE study design in healthy subjects and (2) whether such fully replicated study design and WSV data can better support the approval of generic lamotrigine ER products. METHODS: This open-label, single-dose, two-treatment, four-period, two-sequence, fully replicated crossover BE study compared generic lamotrigine ER tablet to brand Lamictal XR (200 mg) in 30 healthy subjects under fed conditions. Pharmacokinetics (PK) profiles were generated based on intensive blood sampling up to 144 h. RESULTS: The two products showed comparable peak plasma concentration (Cmax ), area under the concentration-time curve (AUC) from time zero to the last measurable time point (AUC0-t ) and AUC extrapolated to infinity (AUC0-inf ), whereas median time to Cmax (Tmax ) values differed, that is, 10 h for generic and 22 h for brand products, respectively. WSVs for PK metrics were small (~8% of Cmax and ~6% of AUC) and similar between these two products. PK simulation predicted equivalent PK measurements of both products at steady state and after brand-to-generic switch, except the first day upon switching. No serious adverse events were reported. SIGNIFICANCE: The generic lamotrigine ER tablet product demonstrates BE to the brand product in a fully replicated BE study design with healthy subjects, supporting the adequacy of the two-way crossover study design to demonstrate BE and generic-brand substitution of lamotrigine ER products.

Estimation of disease burden and clinical severity of COVID-19 caused by Omicron BA.2 in Shanghai, February-June 2022.

An outbreak of COVID-19 caused by the SARS-CoV-2 Omicron BA.2 sublineage occurred in Shanghai, China from February 26 to June 30, 2022. We use official reported data retrieved from Shanghai municipal Health Commissions to estimate the incidence of infections, severe/critical infections, and deaths to assess the disease burden. By adjusting for right censoring and RT-PCR sensitivity, we provide estimates of clinical severity, including the infection fatality ratio, symptomatic case fatality ratio, and risk of developing severe/critical disease upon infection. The overall infection rate, severe/critical infection rate, and mortality rate were 2.74 (95% CI: 2.73-2.74) per 100 individuals, 6.34 (95% CI: 6.02-6.66) per 100,000 individuals and 2.42 (95% CI: 2.23-2.62) per 100,000 individuals, respectively. The severe/critical infection rate and mortality rate increased with age, noted in individuals aged 80 years or older. The overall fatality ratio and risk of developing severe/critical disease upon infection were 0.09% (95% CI: 0.09-0.10%) and 0.27% (95% CI: 0.24-0.29%), respectively. Having received at least one vaccine dose led to a 10-fold reduction in the risk of death for infected individuals aged 80 years or older. Under the repeated population-based screenings and strict intervention policies implemented in Shanghai, our results found a lower disease burden and mortality of the outbreak compared to other settings and countries, showing the impact of the successful outbreak containment in Shanghai. The estimated low clinical severity of this Omicron BA.2 epidemic in Shanghai highlight the key contribution of vaccination and availability of hospital beds to reduce the risk of death.

The Occurrence, Pathways, and Risk Assessment of Heavy Metals in Raw Milk from Industrial Areas in China.

This study evaluated chromium (Cr), arsenic (As), cadmium (Cd), and lead (Pb) contamination in raw milk from industrial areas in China, identified the possible pathways of heavy metals from the environment to raw milk, and made a risk assessment of the consumption of heavy metals from milk consumption. The Cr, As, Cd, and Pb concentrations in raw milk, water and silage were analyzed using inductively coupled plasma mass spectrometry. The Cr and As in soil were analyzed by flame atomic absorption spectrometry and atomic fluorescence spectrometry, respectively. Cd and Pb in soil were determined by a Graphite furnace atomic absorption spectrophotometer. The Cr and As concentrations in milk from industrial areas were 2.41 ± 2.12 and 0.44 ± 0.31 µg/kg, respectively, which were significantly higher (p < 0.01) than those from non-industrial areas, which had levels of 1.10 ± 0.15 and 0.25 ± 0.09 µg/kg, respectively. Chromium was mainly transferred through the soil-silage-milk pathway, As was transferred through the water-silage-milk pathway, while Cd was mainly transferred through the soil (water)-silage-milk pathway. The contributions of each metal to the overall hazard index (HI) followed a descending order of As, Cr, Pb, and Cd, with values of 46.64%, 25.54%, 24.30%, and 3.52%, respectively. Children were at higher risk than adults.

Heavy Metals in Raw Milk and Dietary Exposure Assessment in the Vicinity of Leather-Processing Plants.

The objective of this study was to assess the contamination levels of arsenic (As), lead (Pb), chromium (Cr), and cadmium (Cd) in raw milk and the subsequent potential health risk to local consumers close to leather-processing plants in China. The As and Pb concentrations in milk from contaminated areas were 0.43 ± 0.21 and 2.86 ± 0.96 µg/L, respectively, which were significantly higher than in milk from unpolluted farm, with values of 0.20 ± 0.05 and 2.32 ± 0.78 µg/L, respectively. The Cr and Cd levels in milk from contaminated areas were 1.21 ± 1.57 and 0.15 ± 0.04 µg/L, respectively, which were slightly higher than in milk from unpolluted farm, with values of 0.87 ± 0.61 and 0.13 ± 0.04 µg/L, respectively, (P > 0.05). Target hazard quotient (THQ) and hazard index (HI) values for As, Pb, Cr, and Cd from milk consumption were calculated for individuals aged 3 to 69. The THQ followed a descending order of As > Pb > Cr > Cd, with values of 0.0066-0.0441, 0.0033-0.0220, 0.0019-0.0124, and 0.0007-0.0046, respectively. The HI values (0.0124-0.0832) were far below the threshold of 1.

Content and Dietary Exposure Assessment of Toxic Elements in Infant Formulas from the Chinese Market.

In this study, the content of chromium (Cr), arsenic (As), cadmium (Cd) and lead (Pb) in domestic and imported infant formulas from Beijing, China were analyzed using inductively coupled plasma mass spectrometry. The content of Cr, As, Cd and Pb was 2.51-83.80, 0.89-7.87, 0.13-3.58 and 0.36-5.57 µg/kg, respectively. Even though there were no significant differences in toxic elements content between domestic and imported infant formulas, Cd content was slightly lower in domestic samples. The estimated daily intake (EDI), target hazard quotient (THQ) and hazard index (HI) were calculated for infants between 0.5 and 5 y of age. The EDIs were lower than the oral reference doses. THQ of As, Cr, Cd and Pb was 0.027-0.103, 0.024-0.093, 0.0025-0.0090 and 0.0015-0.0046, respectively. HI values were 0.055-0.192 for boys and 0.056-0.209 for girls and were inversely associated with age with a threshold < 1. The non-carcinogenic risk value were in the safe range, indicating that exposure of As, Pb, Cr and Cd from infant formulas do not represent a health risk in China.

Have Hospice Costs Increased After Implementation of the Hospice Quality-Reporting Program?

CONTEXT: The Centers for Medicare & Medicaid Services Hospice Quality-Reporting Program introduced the requirement that hospices nationwide begin collecting and submitting standardized patient-level quality data on July 1, 2014. OBJECTIVES: This study examined whether this requirement has increased hospice total costs, general costs, and visiting services costs. METHODS: We conducted a cross-sectional study using data from the 2012 and 2014 Medicare hospice cost reports linked to hospice claims. We measured total costs per patient day (PPD), general costs PPD, and visiting services costs PPD for freestanding hospices. We estimated the incremental costs of operating in 2014 vs. 2012 using hierarchical random effects models and adjusting for year, wage index, care volume, case-mix, and hospice and market characteristics, stratified by hospice ownership type. RESULTS: Both for-profit and nonprofit hospices reported higher total costs PPD and general services costs PPD in 2014 than 2012. Nonprofit hospices also reported higher general costs PPD in 2014 than 2012. In adjusted models, the total costs PPD in 2014 were $10.55 higher than in 2012 for nonprofit hospices and $6.43 higher for for-profit hospices. The increase in general costs PPD and visiting services costs PPD ranged from $3.15 to $5.87 by ownership and type of costs. Both for-profit and nonprofit hospices showed lower costs PPD for all types associated with more patients and longer length of stay. CONCLUSION: Hospice costs increased after the Centers for Medicare & Medicaid Services Hospice Quality-Reporting Program quality data collection/submission requirement. Complementary studies need to understand whether increased costs brought additional benefits.

Nursing Facilities Can Reduce Avoidable Hospitalizations Without Increasing Mortality Risk For Residents.

Implementation of the Centers for Medicare and Medicaid Services' Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents reflected recognition of the adverse impacts of excess hospitalizations on the cost of care and the well-being of long-stay residents. Prior studies of the initiative have found favorable effects on reducing hospitalizations and costs, but were these accompanied by unintended consequences for well-being? We tracked all-cause mortality rates in each year for the period 2014-16 among long-stay residents at nursing facilities in seven states that participated in the initiative, and we found no evidence of excess mortality. The initiative's effects on mortality rates were small-ranging from a reduction of 0.8 percentage points to an increase of 1.5 percentage points, relative to changes in mortality rates at comparison-group facilities-and none of the effects was significant. This suggests that efforts to reduce unnecessary hospitalizations among nursing facility residents can succeed without increasing mortality rates.

High-quality assembly of the reference genome for scarlet sage, Salvia splendens, an economically important ornamental plant.

Background: Salvia splendens Ker-Gawler, scarlet or tropical sage, is a tender herbaceous perennial widely introduced and seen in public gardens all over the world. With few molecular resources, breeding is still restricted to traditional phenotypic selection, and the genetic mechanisms underlying phenotypic variation remain unknown. Hence, a high-quality reference genome will be very valuable for marker-assisted breeding, genome editing, and molecular genetics. Findings: We generated 66 Gb and 37 Gb of raw DNA sequences, respectively, from whole-genome sequencing of a largely homozygous scarlet sage inbred line using Pacific Biosciences (PacBio) single-molecule real-time and Illumina HiSeq sequencing platforms. The PacBio de novo assembly yielded a final genome with a scaffold N50 size of 3.12 Mb and a total length of 808 Mb. The repetitive sequences identified accounted for 57.52% of the genome sequence, and 54,008 protein-coding genes were predicted collectively with ab initio and homology-based gene prediction from the masked genome. The divergence time between S. splendens and Salvia miltiorrhiza was estimated at 28.21 million years ago (Mya). Moreover, 3,797 species-specific genes and 1,187 expanded gene families were identified for the scarlet sage genome. Conclusions: We provide the first genome sequence and gene annotation for the scarlet sage. The availability of these resources will be of great importance for further breeding strategies, genome editing, and comparative genomics among related species.

Analysis and Risk Assessment of Seven Toxic Element Residues in Raw Bovine Milk in China.

The object of this study is to analyze the levels of seven toxic elements residues in raw bovine milk in China and assess the potential health risk of those residues. The 178 raw bovine milk samples were collected from eight main milk-producing provinces and from three types of milk stations in China, and were analyzed for arsenic (As), lead (Pb), cadmium (Cd), chromium (Cr), mercury (Hg), aluminum (Al), and nickel (Ni) using inductively coupled plasma-mass spectrometry (ICP-MS). Al, Pb, Hg, Ni, Cr, and As were detected in 47.8, 29.2, 28.1, 23.6, 12.4, and 9.0% of total milk samples, respectively, and Cd were not detected in all samples. The raw bovine milk samples with high levels of toxic elements were found in industrial areas, such as Heilongjiang and Shanxi. Nemerow pollution index analysis showed that the levels were lower in the samples from the processing plants than that from the large-scale farms and small farm cooperatives. The margin of exposure (MOE) values suggest that the levels of As, Pb, Hg, Cr, Al, and Ni in the raw milk samples are not causing a health risk for Chinese consumers, including adults and children. Nevertheless, the risk of Pb for infant and young children was more serious than adult.

Nationwide Quality of Hospice Care: Findings From the Centers for Medicare & Medicaid Services Hospice Quality Reporting Program.

CONTEXT: With increasing use of the Medicare hospice benefit, policymakers recognize the need for quality measurement to assure that terminally ill patients receive high-quality care and have the information they need when selecting a hospice. Toward these goals, Centers for Medicare & Medicaid Services has been collecting standardized patient-level quality data via the Hospice Item Set (HIS) since July 1, 2014. OBJECTIVE: This article presents a first look at the national hospice HIS quality data. METHODS: We calculated seven quality measures using the HIS data. These measures are endorsed by the National Quality Forum and focus on important care processes hospice providers are required to perform at admission, including discussion of patient preferences regarding life-sustaining treatments, care for spiritual and existential concerns, and symptom management (pain, opioid-induced constipation, and dyspnea). RESULTS: Our sample included 1,218,786 hospice patients discharged from 3922 hospices from October 1, 2014 to September 30, 2015. More than 90% of patients received screenings and assessments captured by six of the seven quality measures. The only exception was pain assessment, for which the national mean score was 78.2%. A small number of hospices (156, 4.0%) had perfect scores for all seven quality measures. CONCLUSIONS: Most hospices conduct critical assessments and discuss treatment preferences with patients at admission, although few hospices have perfect scores.

How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

Initiative To Reduce Avoidable Hospitalizations Among Nursing Facility Residents Shows Promising Results.

Nursing facility residents are frequently admitted to the hospital, and these hospital stays are often potentially avoidable. Such hospitalizations are detrimental to patients and costly to Medicare and Medicaid. In 2012 the Centers for Medicare and Medicaid Services launched the Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents, using evidence-based clinical and educational interventions among long-stay residents in 143 facilities in seven states. In state-specific analyses, we estimated net reductions in 2015 of 2.2-9.3 percentage points in the probability of an all-cause hospitalization and 1.4-7.2 percentage points in the probability of a potentially avoidable hospitalization for participating facility residents, relative to comparison-group members. In that year, average per resident Medicare expenditures were reduced by $60-$2,248 for all-cause hospitalizations and by $98-$577 for potentially avoidable hospitalizations. The effects for over half of the outcomes in these analyses were significant. Variability in implementation and engagement across the nursing facilities and organizations that customized and implemented the initiative helps explain the variability in the estimated effects. Initiative models that included registered nurses or nurse practitioners who provided consistent clinical care for residents demonstrated higher staff engagement and more positive outcomes, compared to models providing only education or intermittent clinical care. These results provide promising evidence of an effective approach for reducing avoidable hospitalizations among nursing facility residents.

Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials.

In the past few decades, the development of medicine at the nanoscale has been applied to oral and parenteral dosage forms in a wide range of therapeutic areas to enhance drug delivery and reduce toxicity. An obvious response to these benefits is reflected in higher market shares of complex drug products containing nanomaterials than that of conventional formulations containing the same active ingredient. The surging market interest has encouraged the pharmaceutical industry to develop cost-effective generic versions of complex drug products based on nanotechnology when the associated patent and exclusivity on the reference products have expired. Due to their complex nature, nanotechnology-based drugs present unique challenges in determining equivalence standards between generic and innovator products. This manuscript attempts to provide the scientific rationales and regulatory considerations of key equivalence standards (e.g., in vivo studies and in vitro physicochemical characterization) for oral drugs containing nanomaterials, iron-carbohydrate complexes, liposomes, protein-bound drugs, nanotube-forming drugs, and nano emulsions. It also presents active research studies in bridging regulatory and scientific gaps for establishing equivalence of complex products containing nanomaterials. We hope that open communication among industry, academia, and regulatory agencies will accelerate the development and approval processes of generic complex products based on nanotechnology.

Access to Care for Medicare-Medicaid Dually Eligible Beneficiaries: The Role of State Medicaid Payment Policies.

STUDY OBJECTIVES: Medicaid programs are not required to pay the full Medicare coinsurance and deductibles for Medicare-Medicaid dually eligible beneficiaries. We examined the association between the percentage of Medicare cost sharing paid by Medicaid and the likelihood that a dually eligible beneficiary used evaluation and management (E&M) services and safety net provider services. DATA SOURCES: Medicare and Medicaid Analytic eXtract enrollment and claims data for 2009. STUDY DESIGN: Multivariate analyses used fee-for-service dually eligible and Medicare-only beneficiaries in 20 states. A comparison group of Medicare-only beneficiaries controlled for state factors that might influence utilization. PRINCIPAL FINDINGS: Paying 100 percent of the Medicare cost sharing compared to 20 percent increased the likelihood (relative to Medicare-only) that a dually eligible beneficiary had any E&M visit by 6.4 percent. This difference in the percentage of cost sharing paid decreased the likelihood of using safety net providers, by 37.7 percent for federally qualified health centers and rural health centers, and by 19.8 percent for hospital outpatient departments. CONCLUSIONS: Reimbursing the full Medicare cost-sharing amount would improve access for dually eligible beneficiaries, although the magnitude of the effect will vary by state and type of service.

Use of Therapeutic Drug Monitoring, Electronic Health Record Data, and Pharmacokinetic Modeling to Determine the Therapeutic Index of Phenytoin and Lamotrigine.

BACKGROUND: Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic drug monitoring and electronic health record (EHR) data with pharmacokinetic (PK) modeling. This approach was first tested on phenytoin, which has a known TI, and then applied to lamotrigine, which lacks a defined TI. METHODS: Retrospective EHR data from patients in a tertiary hospital were used to develop phenytoin and lamotrigine population PK models and to identify adverse events (anemia, thrombocytopenia, and leukopenia) and efficacy outcomes (seizure-free). Phenytoin and lamotrigine concentrations were simulated for each day with an adverse event or seizure. Relationships between simulated concentrations and adverse events and efficacy outcomes were used to calculate the TI for phenytoin and lamotrigine. RESULTS: For phenytoin, 93 patients with 270 total and 174 free concentrations were identified. A de novo 1-compartment PK model with Michaelis-Menten kinetics described the data well. Simulated average total and free concentrations of 10-15 and 1.0-1.5 mcg/mL were associated with both adverse events and efficacy in 50% of patients, resulting in a TI of 0.7-1.5. For lamotrigine, 45 patients with 53 concentrations were identified. A published 1-compartment model was adapted to characterize the PK data. No relationships between simulated lamotrigine concentrations and safety or efficacy endpoints were seen; therefore, the TI could not be calculated. CONCLUSIONS: This approach correctly determined the TI of phenytoin but was unable to determine the TI of lamotrigine due to a limited sample size. The use of therapeutic drug monitoring and EHR data to aid in narrow TI drug classification is promising, but it requires an adequate sample size and accurate characterization of concentration-response relationships.

Therapeutic Drug Monitoring, Electronic Health Records, and Pharmacokinetic Modeling to Evaluate Sirolimus Drug Exposure-Response Relationships in Renal Transplant Patients.

BACKGROUND: Sirolimus, an immunosuppressive agent used in renal transplantation, can prevent allograft rejection. Identification of the therapeutic index (the ratio of minimum toxic concentration to minimum therapeutic concentration) for immunosuppresants is necessary to optimize the care of patients and set standards for bioequivalence evaluation of sirolimus products. However, the therapeutic index for sirolimus has been inconsistently defined, potentially because of inconsistencies in sirolimus exposure-response relationships. METHODS: The authors used retrospective therapeutic drug monitoring data from the electronic health records of patients treated in a tertiary health care system from 2008 to 2014 to (1) develop a population pharmacokinetic (PK) model, (2) use the model to simulate sirolimus concentrations, and (3) characterize the exposure-response relationship. Using Wilcoxon rank-sum and Fisher exact tests, the authors determined relationships between sirolimus exposure and adverse events (AEs) (anemia, leukopenia, thrombocytopenia, hyperlipidemia, and decline in renal function) and the composite efficacy end point of graft loss or rejection. RESULTS: The developed 2-compartment population PK model showed appropriate goodness of fit. In a late-phase (>12 months), postrenal transplant population of 27 inpatients, the authors identified statistically significant relationships between 83 simulated peak and trough sirolimus concentrations and outcomes: graft loss or rejection (P = 0.018) and decline in renal function (P = 0.006), respectively. CONCLUSIONS: Use of therapeutic drug monitoring results and PK modeling permitted correlation of sirolimus concentrations with graft loss or rejection and decline in renal function. However, the method was limited in its assessment of other AEs. To better evaluate sirolimus exposure-response relationships, the method should be applied to a larger sample of newly transplanted patients with a higher propensity toward AEs or efficacy failure.

The effect of hospice on hospitalizations of nursing home residents.

OBJECTIVES: Hospice enrollment is known to reduce risk of hospitalizations for nursing home residents who use it. We examined whether residing in facilities with a higher hospice penetration: (1) reduces hospitalization risk for nonhospice residents; and (2) decreases hospice-enrolled residents' hospitalization risk relative to hospice-enrolled residents in facilities with a lower hospice penetration. METHODS: Medicare Beneficiary File, Inpatient and Hospice Claims, Minimum Data Set Version 2.0, Provider of Services File, and Area Resource File. Retrospective analysis of long-stay nursing home residents who died during 2005-2007. Overall, 505,851 nonhospice (67.66%) and 241,790 hospice-enrolled (32.34%) residents in 14,030 facilities nationwide were included. We fit models predicting the probability of hospitalization conditional on hospice penetration and resident and facility characteristics. We used instrumental variable method to address the potential endogeneity between hospice penetration and hospitalization. Distance between each nursing home and the closest hospice was the instrumental variable. RESULTS: In the last 30 days of life, 37.63% of nonhospice and 23.18% of hospice residents were hospitalized. Every 10% increase in hospice penetration leads to a reduction in hospitalization risk of 5.1% for nonhospice residents and 4.8% for hospice-enrolled residents. CONCLUSIONS: Higher facility-level hospice penetration reduces hospitalization risk for both nonhospice and hospice-enrolled residents. The findings shed light on nursing home end-of-life care delivery, collaboration among providers, and cost benefit analysis of hospice care.

Hospices' use of electronic medical records for quality assessment and performance improvement programs.

CONTEXT: Electronic medical records (EMRs) are increasingly viewed as essential tools for quality assurance and improvement in many care settings, but little is known about the use of EMRs by hospices in their quality assessment and performance improvement (QAPI) programs. OBJECTIVES: To examine the data sources hospices use to create quality indicators (QIs) used in their QAPI programs and to examine the domains of EMR-based QIs. METHODS: We used self-reported QIs (description, numerator, and denominator) from 911 hospices nationwide that participated in the Centers for Medicare & Medicaid Services nationwide hospice voluntary reporting period. The data reflected QIs that hospices used for their internal QAPI programs between October 1 and December 31, 2011. We used the primary data sources for QIs reported by hospices and analyzed EMR-based QIs in terms of the quality domains and themes addressed. RESULTS: EMRs were the most frequent data source for the QIs reported, followed by family survey and paper medical record. Physical symptom management was the largest quality domain--included in 51.5% of the reported EMR-based QIs--followed by patient safety and structure and process of care. CONCLUSION: Most participating hospices use EMRs for retrieving items needed for QI calculations. EMR-based QIs address various quality domains and themes. Our findings present opportunities for potential future reporting of EMR-based quality data.

Site of death among nursing home residents in the United States: changing patterns, 2003-2007.

CONTEXT: The proportion of US deaths occurring in nursing homes (NHs) has been increasing in the past 2 decades and is expected to reach 40% by 2020. Despite being recognized as an important setting in the provision of end-of-life (EOL) care, little is known about the quality of care provided to dying NH residents. There has been some, but largely anecdotal evidence suggesting that many US NHs transfer dying residents to hospitals, in part to avoid incurring the cost of providing intensive on-site care, and in part because they lack resources to appropriately serve the dying residents. We assessed longitudinal trends and geographic variations in place of death among NH residents, and examined the association between residents' characteristics, treatment preferences, and the probability of dying in hospitals. METHODS: We used the Minimum Data Set (NH assessment records), Medicare denominator (eligibility) file, and Medicare inpatient and hospice claims to identify decedent NH residents. In CY2003-2007, there were 2,992,261 Medicare-eligible NH decedents from 16,872 US Medicare- and/or Medicaid-certified NHs. Our outcome of interest was death in NH or in a hospital. The analytical strategy included descriptive analyses and multiple logistic regression models, with facility fixed effects, to examine risk-adjusted temporal trends in place of death. FINDINGS: Slightly more than 20% of decedent NH residents died in hospitals each year. Controlling for individual-level risk factors and for facility fixed effects, the likelihood of residents dying in hospitals has increased significantly each year between 2003 through 2007. CONCLUSIONS: This study fills a significant gap in the current literature on EOL care in US nursing homes by identifying frequent facility-to-hospital transfers and an increasing trend of in-hospital deaths. These findings suggest a need to rethink how best to provide care to EOL nursing home residents.