Patient Risk-Benefit Preferences for Transcatheter Versus Surgical Mitral Valve Repair.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) of mitral regurgitation is less invasive than surgery but has greater 5-year mortality and reintervention risks, and leads to smaller improvements in physical functioning. The study objective was to quantify patient preferences for risk-benefit trade-offs associated with TEER and surgery. METHODS AND RESULTS: A discrete choice experiment survey was administered to patients with mitral regurgitation. Attributes included procedure type; 30-day mortality risk; 5-year mortality risk and physical functioning for 5 years; number of hospitalizations in the next 5 years; and risk of additional surgery in the next 5 years. A mixed-logit regression model was fit to estimate preference weights. Two hundred one individuals completed the survey: 63% were female and mean age was 74 years. On average, respondents preferred TEER over surgery. To undergo a less invasive procedure (ie, TEER), respondents would accept up to a 13.3% (95% CI, 8.7%-18.5%) increase in reintervention risk above a baseline of 10%, 4.6 (95% CI, 3.1-6.2) more hospitalizations above a baseline of 1, a 10.7% (95% CI, 6.5%-14.5%) increase in 5-year mortality risk above a baseline of 20%, or more limited physical functioning representing nearly 1 New York Heart Association class (0.7 [95% CI, 0.4-1.1]) over 5 years. CONCLUSIONS: Patients in general preferred TEER over surgery. When holding constant all other factors, a functional improvement from New York Heart Association class III to class I maintained over 5 years would be needed, on average, for patients to prefer surgery over TEER.

Health Status After Transcatheter Tricuspid-Valve Repair in Patients With Severe Tricuspid Regurgitation.

BACKGROUND: In the TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated with the Tricuspid Valve Repair System Pivotal), tricuspid transcatheter edge-to-edge repair (T-TEER) reduced tricuspid regurgitation (TR) and improved health status compared with medical therapy alone with no benefit on heart failure hospitalizations or survival. OBJECTIVES: The purpose of this study was to better understand the health status benefits of T-TEER within the TRILUMINATE Pivotal trial. METHODS: TRILUMINATE randomized patients with severe TR to T-TEER (n = 175) or medical therapy (n = 175). Health status was assessed at baseline and at 1, 6, and 12 months with the Kansas City Cardiomyopathy Questionnaire (KCCQ) (range 0-100; higher = better), which was compared between treatment groups using mixed effects linear regression. Alive and well was defined as KCCQ overall summary score ≥60 and no decline from baseline of >10 points at 1 year. RESULTS: Compared with medical therapy, T-TEER significantly improved health status at 1 month (mean between-group difference in KCCQ overall summary score 9.4 points; 95% CI: 5.3-13.4 points), with a small additional improvement at 1 year (mean between-group difference 10.4 points; 95% CI: 6.3-14.6 points). T-TEER patients were more likely to be alive and well at 1 year (T-TEER vs medical therapy: 74.8% vs 45.9%; P < 0.001), with a number needed to treat of 3.5. Interaction analyses demonstrated that the benefit of T-TEER diminished as baseline KCCQ overall summary score increased (Pint < 0.001). Exploratory analyses suggested that much of the health status benefit of T-TEER could be explained by TR reduction and that improvement in health status after T-TEER was strongly correlated with reduced 1-year mortality and heart failure hospitalization. CONCLUSIONS: T-TEER with the TriClip system resulted in substantial and sustained health status improvement in patients with severe TR compared with medical therapy alone.

Prevalence of Malnutrition Risk and the Impact of Nutrition Risk on Hospital Outcomes: Results From nutritionDay in the U.S.

BACKGROUND: Malnutrition risk estimates vary greatly, and no robust data on the association between food intake and outcomes exist for hospitals in the United States (U.S.). This study aimed to determine the prevalence of malnutrition risk and to evaluate the impact of food intake on mortality using the nutritionDay in the U.S. dataset. METHODS: This study analyzed data from 2009 to 2015 for all adult patients from participating hospitals. Prevalence of malnutrition risk was determined by mapping self-reported nutritionDay survey questions to the Malnutrition Screening Tool (MST). Fine and Gray competing-risk analysis with clustering was used to evaluate the impact of nutrition risk and food intake on patients' 30-day in-hospital mortality, while controlling for age, mobility, and other disease-related factors. RESULTS: Analysis included data from 9959 adult patients from 601 wards. The overall prevalence of malnutrition risk (MST score ≥2) was 32.7%. On nutritionDay, 32.1% of patients ate a quarter of their meal or less. Hospital mortality hazard ratio was 3.24 (95% CI: [1.73, 6.07]; P-value < 0.001) for patients eating a quarter compared with those who ate all their meal and increased to 5.99 (95% CI: [3.03, 11.84]; P-value < 0.0001) for patients eating nothing despite being allowed to eat. CONCLUSION: This study provides the most robust estimate of malnutrition risk in U.S. hospitalized patients to date, finding that approximately 1 in 3 are at risk. Additionally, patients who have diminished meal intake experience increased mortality risk. These results highlight the ongoing issue of malnutrition in the hospital setting.

Impact of a Nutrition-Focused Quality Improvement Intervention on Hospital Length of Stay.

BACKGROUND: Despite its high prevalence, malnutrition in hospitalized patients often goes unrecognized and undertreated. LOCAL PROBLEM: A hospital system sought to improve nutrition care by implementing a quality improvement initiative. Nurses screened patients upon admission using the Malnutrition Screening Tool and initiated oral nutrition supplements for patients at risk. METHODS: We retrospectively reviewed the medical records of 20 697 adult patients to determine whether early initiation of nutrition therapy had reduced hospital length of stay and 30-day readmission rates. RESULTS: We found the average time from hospital admission to oral nutrition supplement initiation was reduced by 20 hours (20.8%) after the quality improvement initiative was introduced (P < .01). Length of stay decreased 0.88 days (P < .05) more for patients at nutritional risk than patients not at nutritional risk; the probability of 30-day hospital readmission did not differ between groups. CONCLUSION: These results highlight the importance of adequate nutrition screening, diagnosis, and treatment for hospitalized patients.

Prevalence and predictors of malnutrition in elderly Chinese adults: results from the China Health and Retirement Longitudinal Study.

OBJECTIVE: China has the largest population of elderly citizens in the world, with 177 million adults aged 60 years or older. However, no national estimate of malnutrition in elderly Chinese adults exists. We estimated the prevalence and predictors of malnutrition in this population. DESIGN: Data from the second wave of the Chinese Health and Retirement Longitudinal Study (CHARLS) include interview and biomarker data for 6450 subjects aged 60 years or older from 448 different communities in twenty-eight provinces, allowing for nationally representative results. Malnutrition was identified based on the ESPEN (European Society of Parenteral and Enteral Nutrition and Metabolism) criteria. We used multivariable regression to investigate the predictors of malnutrition, including demographic factors, marital status, self-reported health status, self-reported standard of living, health insurance status and education. SETTING: China. SUBJECTS: Community-dwelling Chinese adults aged 60 years or older. RESULTS: The prevalence of malnutrition in elderly Chinese adults was 12·6 %. Malnutrition was most common among those who were older (OR=1·09; 95 % CI 1·07, 1·10), male (OR=1·41; 95 % CI 1·10, 1·79), lived in rural areas (v. urban: OR=0·75; 95 % CI 0·57, 1·00) or lacked health insurance (P<0·01). CONCLUSIONS: The burden of malnutrition on elderly Chinese adults is significant. Based on current population estimates, up to 20 million are malnourished. Malnutrition is strongly associated with demographic factors, shows a trend to association with health status and is not strongly associated with standard of living or education. A coordinated effort is needed to address malnutrition in this population.

Healthcare Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study.

BACKGROUND: The MOMENTUM 3 trial compares the centrifugal HeartMate 3 (HM3) with the axial HeartMate II (HMII) continuous-flow left ventricular assist system in patients with advanced heart failure, irrespective of the intended goal of therapy. The trial's 2-year clinical outcome (n=366) demonstrated superiority of the HM3 for the primary end point (survival free of a disabling stroke or reoperation to replace or remove a malfunctioning pump). This analysis evaluates health resource use and cost implications of the observed differences between the 2 devices while patients were enrolled in the trial. METHODS: We analyzed all hospitalizations and their associated costs occurring after discharge from the implant hospitalization until censoring (study withdrawal, heart transplantation, and pump exchange with a nonstudy device or death). Each adjudicated episode of hospital-based care was used to calculate costs (device-attributable and non-device-attributable event costs), estimated by using trial data and payer administrative claims databases. Cost savings stratified by subgroups (study outcome [transplant, death, or ongoing on device], intended goal of therapy, type of insurance, or sex) were also assessed. RESULTS: In 366 randomly assigned patients, 361 comprised the as-treated group (189 in the HM3 group and 172 in the HMII group), of whom 337 (177 in the HM3 group and 160 in the HMII group) were successfully discharged following implantation. The HM3 arm experienced fewer total hospitalizations per patient-year (HM3: 2.1±0.2 versus HMII: 2.7±0.2; P=0.015) and 8.3 fewer hospital days per patient-year on average (HM3: 17.1 days versus HMII: 25.5 days; P=0.003). These differences were driven by patients hospitalized for suspected pump thrombosis (HM3: 0.6% versus HMII: 12.5%; P<0.001) and stroke (HM3: 2.8% versus HMII: 11.3%; P=0.002). Controlled for time spent in the study (average cumulative cost per patient-year), postdischarge HM3 arm costs were 51% lower than with the HMII (HM3: $37 685±4251 versus HMII: $76 599±11 889, P<0.001) and similar in either bridge to transplant or destination therapy intent. CONCLUSIONS: In this 2-year outcome economic analysis of the MOMENTUM 3 trial, the HM3 demonstrated a reduction in rehospitalizations, hospital days spent during rehospitalizations, and a significant cost savings following discharge in comparison with the HMII left ventricular assist system, irrespective of the intended goal of therapy. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02224755.

Impact of malnutrition on survival and healthcare utilization in Medicare beneficiaries with diabetes: a retrospective cohort analysis.

OBJECTIVE: The aim of this study was to examine the impact of pre-existing malnutrition on survival and economic implications in elderly patients with diabetes. RESEARCH DESIGN AND METHODS: A retrospective observational study was conducted to examine the impact of malnutrition with or without other significant health conditions on survival time and healthcare costs using the Centers for Medicare and Medicaid Services (CMS) data from 1999 to 2014 for beneficiaries with a confirmed first date of initial diagnosis of diabetes (n=15 121 131). The primary outcome was survival time, which was analyzed using all available data and after propensity score matching. Healthcare utilization cost was a secondary outcome. RESULTS: A total of 801 272 beneficiaries were diagnosed with malnutrition. The analysis on propensity score-matched data for the effect of common conditions on survival showed that the risk for death in beneficiaries with diabetes increased by 69% in malnourished versus normo-nourished (HR, 1.69; 99.9% CI 1.64 to 1.75; P<0.0001) beneficiaries. Malnutrition increased the risk for death within each of the common comorbid conditions including ischemic heart disease (1.63; 1.58 to 1.68), chronic obstructive pulmonary disorder (1.60; 1.55 to 1.65), stroke or transient ischemic attack (1.57; 1.53 to 1.62), heart failure (1.54; 1.50 to 1.59), chronic kidney disease (1.50; 1.46 to 1.55), and acute myocardial infarction (1.47; 1.43 to 1.52). In addition, the annual total spending for the malnourished beneficiaries was significantly greater than that for the normo-nourished beneficiaries ($36 079 vs 20 787; P<0.0001). CONCLUSIONS: Malnutrition is a significant comorbidity affecting survival and healthcare costs in CMS beneficiaries with diabetes. Evidence-based clinical decision pathways need to be developed and implemented for appropriate screening, assessment, diagnosis and treatment of malnourished patients, and to prevent malnutrition in normo-nourished patients with diabetes.

Cost-Effectiveness of a Specialized Oral Nutritional Supplementation for Malnourished Older Adult Patients in Spain.

Malnutrition has been related to prolonged hospital stays, and to increases in readmission and mortality rates. In the NOURISH (Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients) study, administering a high protein oral nutritional supplement (ONS) containing beta-hydroxy-beta-methylbutyrate (HP-HMB) to hospitalised older adult patients led to a significant improvement in survival compared with a placebo treatment. The aim of this study was to determine whether HP-HMB would be cost-effective in Spain. We performed a cost-effectiveness analysis from the perspective of the Spanish National Health System using time horizons of 90 days, 180 days, 1 year, 2 years, 5 years and lifetime. The difference in cost between patients treated with HP-HMB and placebo was €332.75. With the 90 days time horizon, the difference in life years gained (LYG) between both groups was 0.0096, resulting in an incremental cost-effectiveness ratio (ICER) of €34,700.62/LYG. With time horizons of 180 days, 1 year, 2 years, 5 years and lifetime, the respective ICERs were €13,711.68, €3377.96, €2253.32, €1127.34 and €563.84/LYG. This analysis suggests that administering HP-HMB to older adult patients admitted to Spanish hospitals during hospitalisation and after discharge could be a cost-effective intervention that would improve survival with a reduced marginal cost.

The Cost-Effectiveness of Oral Nutrition Supplementation for Malnourished Older Hospital Patients.

BACKGROUND: Malnutrition, which is associated with increased medical complications in older hospitalized patients, can be attenuated by providing nutritional supplements. OBJECTIVE: This study evaluates the cost effectiveness of a specialized oral nutritional supplement (ONS) in malnourished older hospitalized patients. METHODS: We conducted an economic evaluation alongside a multicenter, randomized, controlled clinical trial (NOURISH Study). The target population was malnourished older hospitalized patients in the USA. We used 90-day (base case) and lifetime (sensitivity analysis) time horizons. The study compared a nutrient-dense ONS, containing high protein and ß-hydroxy-ß-methylbutyrate to placebo. Outcomes included health-care costs, measured as the product of resource use and per unit cost; quality-adjusted life-years (QALYs) (90-day time horizon); life-years (LYs) saved (lifetime time horizon); and the incremental cost-effectiveness ratio (ICER). All costs were inflated to 2015 US dollars. RESULTS: In the base-case analysis, 90-day treatment group costs averaged US$22,506 per person, compared to US$22,133 for the control group. Treatment group patients gained 0.011 more QALYs than control group subjects, reflecting the treatment group's significantly greater probability of survival through 90 days' follow-up, as reported by the clinical trial. Hence, the 90-day follow-up period ICER was US$33,818/QALY. Assuming a lifetime time horizon, estimated treatment group life expectancy exceeded control group life expectancy by 0.71 years. Hence, the lifetime ICER was US$524/LY. The follow-up period for the trial was relatively short. Some of the patients were lost to follow-up, thus reducing collection of health-care utilization data during the clinical trial. CONCLUSION: Our findings suggest that the investigative ONS cost-effectively extends the lives of malnourished hospitalized patients.

Economic Burden of Disease-Associated Malnutrition at the State Level.

BACKGROUND: Disease-associated malnutrition has been identified as a prevalent condition, particularly for the elderly, which has often been overlooked in the U.S. healthcare system. The state-level burden of community-based disease-associated malnutrition is unknown and there have been limited efforts by state policy makers to identify, quantify, and address malnutrition. The objective of this study was to examine and quantify the state-level economic burden of disease-associated malnutrition. METHODS: Direct medical costs of disease-associated malnutrition were calculated for 8 diseases: Stroke, Chronic Obstructive Pulmonary Disease, Coronary Heart Failure, Breast Cancer, Dementia, Musculoskeletal Disorders, Depression, and Colorectal Cancer. National disease and malnutrition prevalence rates were estimated for subgroups defined by age, race, and sex using the National Health and Nutrition Examination Survey and the National Health Interview Survey. State prevalence of disease-associated malnutrition was estimated by combining national prevalence estimates with states' demographic data from the U.S. Census. Direct medical cost for each state was estimated as the increased expenditures incurred as a result of malnutrition. PRINCIPAL FINDINGS: Direct medical costs attributable to disease-associated malnutrition vary among states from an annual cost of $36 per capita in Utah to $65 per capita in Washington, D.C. Nationally the annual cost of disease-associated malnutrition is over $15.5 billion. The elderly bear a disproportionate share of this cost on both the state and national level. CONCLUSIONS: Additional action is needed to reduce the economic impact of disease-associated malnutrition, particularly at the state level. Nutrition may be a cost-effective way to help address high health care costs.

Health System Quality Improvement: Impact of Prompt Nutrition Care on Patient Outcomes and Health Care Costs.

Among hospitalized patients, malnutrition is prevalent yet often overlooked and undertreated. We implemented a quality improvement program that positioned early nutritional care into the nursing workflow. Nurses screened for malnutrition risk at patient admission and then immediately ordered oral nutritional supplements for those at risk. Supplements were given as regular medications, guided and monitored by medication administration records. Post-quality improvement program, pressure ulcer incidence, length of stay, 30-day readmissions, and costs of care were reduced.

A cost-effectiveness analysis of the first federally funded antismoking campaign.

BACKGROUND: In 2012, CDC launched the first federally funded national mass media antismoking campaign. The Tips From Former Smokers (Tips) campaign resulted in a 12% relative increase in population-level quit attempts. PURPOSE: Cost-effectiveness analysis was conducted in 2013 to evaluate Tips from a funding agency's perspective. METHODS: Estimates of sustained cessations; premature deaths averted; undiscounted life years (LYs) saved; and quality-adjusted life years (QALYs) gained by Tips were estimated. RESULTS: Tips saved about 179,099 QALYs and prevented 17,109 premature deaths in the U.S. With the campaign cost of roughly $48 million, Tips spent approximately $480 per quitter, $2,819 per premature death averted, $393 per LY saved, and $268 per QALY gained. CONCLUSIONS: Tips was not only successful at reducing smoking-attributable morbidity and mortality but also was a highly cost-effective mass media intervention.

CDC central-line bloodstream infection prevention efforts produced net benefits of at least $640 Million during 1990-2008.

The prevention of central line-associated bloodstream infections in patients in hospital critical care units has been a target of efforts by the Centers for Disease Control and Prevention (CDC) since the 1960s. We developed a historical economic model to measure the net economic benefits of preventing these infections in Medicare and Medicaid patients in critical care units for the period 1990-2008-a time when reductions attributable to federal investment resulted primarily from CDC efforts-using the cost perspective of the federal government as a third-party payer. The estimated net economic benefits ranged from $640 million to $1.8 billion, with the corresponding net benefits per case averted ranging from $15,780 to $24,391. The per dollar rate of return on the CDC's investments ranged from $3.88 to $23.85. These findings suggest that investments in CDC programs targeting other health care-associated infections also have the potential to produce savings by lowering Medicare and Medicaid reimbursements.

State-based Medicaid costs for pediatric asthma emergency department visits.

INTRODUCTION: The prevalence of childhood asthma in the United States increased from 8.7% in 2001 to 9.5% in 2011. This increased prevalence adds to the costs incurred by state Medicaid programs. We provide state-based cost estimates of pediatric asthma emergency department (ED) visits and highlight an opportunity for states to reduce these costs through a recently changed Centers for Medicare and Medicaid Services (CMS) regulation. METHODS: We used a cross-sectional design across multiple data sets to produce state-based cost estimates for asthma-related ED visits among children younger than 18, where Medicaid/CHIP (Children's Health Insurance Program) was the primary payer. RESULTS: There were approximately 629,000 ED visits for pediatric asthma for Medicaid/CHIP enrollees, which cost $272 million in 2010. The average cost per visit was $433. Costs ranged from $282,000 in Alaska to more than $25 million in California. CONCLUSIONS: Costs to states for pediatric asthma ED visits vary widely. Effective January 1, 2014, the CMS rule expanded which type of providers can be reimbursed for providing preventive services to Medicaid/CHIP beneficiaries. This rule change, in combination with existing flexibility for states to define practice setting, allows state Medicaid programs to reimburse for asthma interventions that use nontraditional providers (such as community health workers or certified asthma educators) in a nonclinical setting, as long as the service was initially recommended by a physician or other licensed practitioner. The rule change may help states reduce Medicaid costs of asthma treatment and the severity of pediatric asthma.

Participation in Universal Prevention Programs.

We analyze family decisions to participate in community-based universal substance-abuse prevention programs through the framework of expected utility theory. Family functioning, which has been shown to be a good indicator of child risk for substance abuse, provides a useful reference point for family decision making. Our results show that well-functioning families (with children at low risk for substance use) should have the lowest incentive to participate, but that high-risk families may also opt out of prevention programs. For programs that are most effective for high-risk youth, this could be a problem. Using data from the Strengthening Families Program and the Washington Healthy Youth Survey, we empirically test the implications of our model and find that at least for one measure of family functioning those families with children most likely to be at risk for substance use are opting out of the program.

Detecting selection effects in community implementations of family-based substance abuse prevention programs.

To calculate valid estimates of the costs and benefits of substance abuse prevention programs, selection effects must be identified and corrected. A supplemental comparison sample is typically used for this purpose, but in community-based program implementations, such a sample is often not available. We present an evaluation design and analytic approach that can be used in program evaluations of real-world implementations to identify selection effects, which in turn can help inform recruitment strategies, pinpoint possible selection influences on measured program outcomes, and refine estimates of program costs and benefits. We illustrate our approach with data from a multisite implementation of a popular substance abuse prevention program. Our results indicate that the program's participants differed significantly from the population at large.