Although animal studies have shown that the immunomodulator ipilimumab causes inflammation of the myocardium, clinically significant myocarditis has been observed only infrequently. We report a case of suspected acute coronary syndrome without a culprit lesion on cardiac angiography and takotsubo cardiomyopathy (TC)-like appearance on echocardiography in a patient with metastatic melanoma who received four standard doses of ipilimumab. Apical ballooning, hyperdynamic basal wall motion, systolic anterior motion of the mitral valve, and associated severe left ventricular outflow tract obstruction were present. Restaging with positron emission tomography-computed tomography done soon after discharge incidentally revealed increased fludeoxyglucose uptake in the apex. This case illustrates that a TC-like syndrome might be caused by autoimmune myocarditis after ipilimumab treatment although this was not biopsy-confirmed. Post-marketing surveillance should capture cardiac events occurring in patients treated with ipilimumab to better document and clarify a relationship to the drug, and biopsies should be considered. Physicians utilizing this novel agent should be aware of the potential for immune-related adverse events.
BACKGROUND: Non-pharmacological treatment programmes are being developed, in which specialised nurses take care of heart failure (HF) patients. Such disease management programmes might increase survival and quality of life in HF patients, but evidence on their cost-effectiveness remains limited.
METHODS AND RESULTS: A prospective economic evaluation piggy-backed onto the randomised controlled Interdisciplinary Network for Heart Failure (INH) Study weighted costs of the intervention HeartNetCare -HF™ (HNC) regarding effectiveness, mortality and quality-adjusted life years (QALYs). To consider uncertainty sensitivity analyses were performed. Compared to usual care (UC), HNC revealed 8,284 per death avoided within the 6 month study follow-up period. The cost-utility analysis showed additional costs of 49,335 per QALY.
CONCLUSION: Although HNC did not reduce short-term re-admission rates of HF patients hospitalised for cardiac decompensation within the first 180 days after discharge, HNC might reduce mortality and increase quality of life in these patients at reasonable costs. Therefore, long-term HNC-effects deserve further evaluation.
OBJECTIVES: To study the economic impact on payers and providers of the four main endovascular strategies for the treatment of infrainguinal peripheral artery disease.
BACKGROUND: Bare metal stents (BMS), drug-eluting stents (DES), and drug-coated balloons (DCB) are associated with lower target lesion revascularization (TLR) probabilities than percutaneous transluminal angioplasty (PTA), but the economic impact is unknown.
METHODS: In December 2012, PubMed and Embase were systematically searched for studies with TLR as an endpoint. The 24-month probability of TLR for each treatment was weighted by sample size. A decision-analytic Markov model was used to assess the budget impact from payers' and facility-providers' perspectives of the four index procedure strategies (BMS, DES, DCB, and PTA). Base cases were developed for U.S. Medicare and the German statutory sickness fund perspectives using current 2013 reimbursement rates.
RESULTS: Thirteen studies with 2,406 subjects were included. The reported probability of TLR in the identified studies varied widely, particularly following treatment with PTA or BMS. The pooled 24-month probabilities were 14.3%, 19.3%, 28.1%, and 40.3% for DCB, DES, BMS, and PTA, respectively. The drug-eluting strategies had a lower projected budget impact over 24 months compared to BMS and PTA in both the U.S. Medicare (DCB: $10,214; DES: $12,904; uncoated balloons $13,114; BMS $13,802) and German public health care systems (DCB €3,619; DES €3,632; BMS €4,026; PTA €4,290).
CONCLUSIONS: DCB and DES, compared to BMS and PTA, are associated with lower probabilities of target lesion revascularization and cost savings for U.S. and German payers.
OBJECTIVES: The purpose of this study was to assess cost-effectiveness and long-term clinical benefits of renal denervation in resistant hypertensive patients.
BACKGROUND: Resistant hypertension affects 12% of hypertensive persons. In the Symplicity HTN-2 randomized controlled trial, catheter-based renal denervation (RDN) lowered systolic blood pressure by 32 ± 23 mm Hg from 178 ± 18 mm Hg at baseline.
METHODS: A state-transition model was used to predict the effect of RDN and standard of care on 10-year and lifetime probabilities of stroke, myocardial infarction, all coronary heart disease, heart failure, end-stage renal disease, and median survival. We adopted a societal perspective and estimated an incremental cost-effectiveness ratio in U.S. dollars per quality-adjusted life-year, both discounted at 3% per year. Robustness and uncertainty were evaluated using deterministic and probabilistic sensitivity analyses.
RESULTS: Renal denervation substantially reduced event probabilities (10-year/lifetime relative risks: stroke 0.70/0.83; myocardial infarction 0.68/0.85; all coronary heart disease 0.78/0.90; heart failure 0.79/0.92; end-stage renal disease 0.72/0.81). Median survival was 18.4 years for RDN versus 17.1 years for standard of care. The discounted lifetime incremental cost-effectiveness ratio was $3,071 per quality-adjusted life-year. Findings were relatively insensitive to variations in input parameters except for systolic blood pressure reduction, baseline systolic blood pressure, and effect duration. The 95% credible interval for incremental cost-effectiveness ratio was cost-saving to $31,460 per quality-adjusted life-year.
CONCLUSIONS: The model suggests that catheter-based renal denervation, over a wide range of assumptions, is a cost-effective strategy for resistant hypertension that might result in lower cardiovascular morbidity and mortality.
BACKGROUND: The World Health Assembly recently adopted a resolution to urge improved competency in the provision of injury care through medical education. This survey sought to investigate trauma education experience and competency among final year medical students worldwide.
METHODS: An Internet survey was distributed to medical students and conducted from March 2008 to January 2009. Demographic data and questions pertaining to both instruction and attainment of specific skills in burn and trauma care were assessed.
RESULTS: There were 776 responses from final year medical students in 77 countries, with at least 10 countries from each economic stratum. Over 93% of final year students reported receiving some form of trauma or burn training, with 79% reporting a minimum compulsory requirement. Students received theoretical instruction without practical exposure. Few felt prepared to undertake basic procedures, such as laceration repair (19%), vascular access (8%), or endotracheal intubation (21%). Over 99% agreed that trauma education should be mandatory, but only half felt prepared to provide basic care. Those from low income and low middle income countries felt better prepared to provide trauma care than students from high middle and high income countries.
CONCLUSIONS: Trauma education and experience varies among medical students in different countries. Many critical concepts are not formally taught and practical experience with many basic procedures is often lacking. The present study confirms that the trauma care training received by medical students needs to be strengthened in countries at all economic levels.
Chronic heart failure (CHF) is a critical public health issue with increasing effect on the healthcare budgets of developed countries. Various decision-analytic modelling approaches exist to estimate the cost effectiveness of health technologies for CHF. We sought to systematically identify these models and describe their structures. We performed a systematic literature review in MEDLINE/PreMEDLINE, EMBASE, EconLit and the Cost-Effectiveness Analysis Registry using a combination of search terms for CHF and decision-analytic models. The inclusion criterion required 'use of a mathematical model evaluating both costs and health consequences for CHF management strategies'. Studies that were only economic evaluations alongside a clinical trial or that were purely descriptive studies were excluded. We identified 34 modelling studies investigating different interventions including screening (n = 1), diagnostics (n = 1), pharmaceuticals (n = 15), devices (n = 13), disease management programmes (n = 3) and cardiac transplantation (n = 1) in CHF. The identified models primarily focused on middle-aged to elderly patients with stable but progressed heart failure with systolic left ventricular dysfunction. Modelling approaches varied substantially and included 27 Markov models, three discrete-event simulation models and four mathematical equation sets models; 19 studies reported QALYs. Three models were externally validated. In addition to a detailed description of study characteristics, the model structure and output, the manuscript also contains a synthesis and critical appraisal for each of the modelling approaches. Well designed decision models are available for the evaluation of different CHF health technologies. Most models depend on New York Heart Association (NYHA) classes or number of hospitalizations as proxy for disease severity and progression. As the diagnostics and biomarkers evolve, there is the hope for better intermediate endpoints for modelling disease progression as those that are currently in use all have limitations.
BACKGROUND: Observation care is a core component of emergency care delivery, yet, the prevalence of emergency department (ED) observation units (OUs) and use of observation care after ED visits is unknown. Our objective was to describe the 1) prevalence of OUs in United States (US) hospitals, 2) clinical conditions most frequently evaluated with observation, and 3) patient and hospital characteristics associated with use of observation.
METHODS: Retrospective analysis of the proportion of hospitals with dedicated OUs and patient disposition after ED visit (discharge, inpatient admission or observation evaluation) using the National Hospital Ambulatory Medical Care Survey (NHAMCS) from 2001 to 2008. NHAMCS is an annual, national probability sample of ED visits to US hospitals conducted by the Center for Disease Control and Prevention. Logistic regression was used to assess hospital-level predictors of OU presence and polytomous logistic regression was used for patient-level predictors of visit disposition, each adjusted for multi-level sampling data. OU analysis was limited to 2007-2008.
RESULTS: In 2007-2008, 34.1% of all EDs had a dedicated OU, of which 56.1% were under ED administrative control (EDOU). Between 2001 and 2008, ED visits resulting in a disposition to observation increased from 642,000 (0.60% of ED visits) to 2,318,000 (1.87%, p<.05). Chest pain was the most common reason for ED visit resulting in observation and the most common observation discharge diagnosis (19.1% and 17.1% of observation evaluations, respectively). In hospital-level adjusted analysis, hospital ownership status (non-profit or government), non-teaching status, and longer ED length of visit (>3.6 h) were predictive of OU presence. After patient-level adjustment, EDOU presence was associated with increased disposition to observation (OR 2.19).
CONCLUSIONS: One-third of US hospitals have dedicated OUs and observation care is increasingly used for a range of clinical conditions. Further research is warranted to understand the quality, cost and efficiency of observation care.
OBJECTIVES: : Health-related quality-of-life estimates currently available for urinary incontinence have largely been derived from population-based studies without physician confirmation of diagnosis. The purpose of this study was to compare the health state utility values for urinary incontinence in women derived from EQ-5D questionnaires and visual analog scale (VAS) with the economic gold standard method, the Standard Gamble (SG) interview.
METHODS: : Subjects were approached for study participation after a diagnosis of stress or urge urinary incontinence was made by the attending urogynecologist. Twenty-eight patients completed the Sandvik Severity Index (SSI), EQ-5D, and VAS. They then participated in the SG conversation.
RESULTS: : The median utility (interquartile range) for stress incontinence varied based on the methods: EQ-5D, 0.83 (0.23); VAS, 0.85 (0.15); and SG, 1.00 (0.01). There was a statistically significant difference between the SG assessment and the other 2 methods of assessing utility values, the EQ-5D and VAS in women with urodynamically demonstrated stress urinary incontinence (P = 0.0003 and P < 0.0001, respectively). In the combined group of women with urodynamically proven stress, urge, and mixed urinary incontinence, there was also a statistically significant difference between the SG and the generic methods of assessing utility values, the EQ-5D and VAS (P < 0.0001). Mean SSI scores were similar in women with stress incontinence (6.6 [23.5]) and in the combined group (7.9 [3.8]).
CONCLUSIONS: : Previous studies may have underestimated the health-related quality of life of urinary incontinence.
BACKGROUND: Policymakers advocate universal electronic medical records (EMRs) and propose incentives for "meaningful use" of EMRs. Though emergency departments (EDs) are particularly sensitive to the benefits and unintended consequences of EMR adoption, surveillance has been limited. We analyze data from a nationally representative sample of US EDs to ascertain the adoption of various EMR functionalities.
METHODOLOGY/PRINCIPAL FINDINGS: We analyzed data from the National Hospital Ambulatory Medical Care Survey, after pooling data from 2005 and 2006, reporting proportions with 95% confidence intervals (95% CI). In addition to reporting adoption of various EMR functionalities, we used logistic regression to ascertain patient and hospital characteristics predicting "meaningful use," defined as a "basic" system (managing demographic information, computerized provider order entry, and lab and imaging results). We found that 46% (95% CI 39-53%) of US EDs reported having adopted EMRs. Computerized provider order entry was present in 21% (95% CI 16-27%), and only 15% (95% CI 10-20%) had warnings for drug interactions or contraindications. The "basic" definition of "meaningful use" was met by 17% (95% CI 13-21%) of EDs. Rural EDs were substantially less likely to have a "basic" EMR system than urban EDs (odds ratio 0.19, 95% CI 0.06-0.57, p = 0.003), and Midwestern (odds ratio 0.37, 95% CI 0.16-0.84, p = 0.018) and Southern (odds ratio 0.47, 95% CI 0.26-0.84, p = 0.011) EDs were substantially less likely than Northeastern EDs to have a "basic" system.
CONCLUSIONS/SIGNIFICANCE: EMRs are becoming more prevalent in US EDs, though only a minority use EMRs in a "meaningful" way, no matter how "meaningful" is defined. Rural EDs are less likely to have an EMR than metropolitan EDs, and Midwestern and Southern EDs are less likely to have an EMR than Northeastern EDs. We discuss the nuances of how to define "meaningful use," and the importance of considering not only adoption, but also full implementation and consequences.
PURPOSE: This paper's aim is to identify existing and developing new concepts of organization, management, and leadership at a large European university hospital; and to evaluate whether mixed qualitative-quantitative methods with both internal and external input can provide helpful views of the possible future of large health care providers.
DESIGN/METHODOLOGY/APPROACH: Using the Delphi method in semi-structured, semi-quantitative interviews, with managers and employees as experts, the authors performed a vertical and a horizontal internal analysis. In addition, input from innovative faculties in other countries was obtained through structured power questions. These two sources were used to create three final scenarios, which evaluated using traditional strategic planning methods.
FINDINGS: There is found a collaboration scenario in which faculty and hospital are separated; a split scenario which divides the organization into three independent hospitals; and a corporation scenario in which corporate activities are bundled in three separate entities.
PRACTICAL IMPLICATIONS: In complex mergers of knowledge-driven organizations, the employees of the own organization (in addition to external consultants) might be tapped as a knowledge resource to successful future business models.
ORIGINALITY/VALUE: The paper uses a real world consulting case to present a new set of methods for strategic planning in large health care provider organizations.
IMPORTANCE OF THE FIELD: Prevalence of chronic heart failure (CHF) is increasing, and despite improvements in the past decade the prognosis in terms of mortality and health-related quality of life remains poor. Anemia is often found concomitantly in CHF patients.
AREAS COVERED IN THIS REVIEW: Erythropoiesis-stimulating agents (ESAs) are a new treatment option for these anemic CHF patients, promising to decrease mortality and hospitalizations, and increase health-related quality of life.
WHAT THE READER WILL GAIN: CHF epidemiology is briefly discussed. Currently available clinical efficacy and safety data are critically appraised. Health care utilization by CHF patients, particularly hospitalizations, are reviewed in order predict cost-effectiveness of ESAs.
TAKE HOME MESSAGES: The efficacy for the most pertinent endpoints has not been proven by a pivotal trial or a meta-analysis free of bias, and there might be increased cardiovascular events and cancer incidence rates above a currently unknown target value or with multiple doses. However, subgroups should be identified in which ESAs might prove to be more efficacious and as safe as usual care and either cost-saving or cost-effective. Nevertheless, depending on the subgroup, the budget effect for payors might be dramatic due to the large number of CHF patients.
OBJECTIVES: Monte Carlo microsimulations have gained increasing popularity in decision-analytic modeling because they can incorporate discrete events. Although deterministic sensitivity analyses are essential for interpretation of results, it remains difficult to combine these alongside Monte Carlo simulations in standard modeling packages without enormous time investment. Our purpose was to facilitate one-way deterministic sensitivity analysis of TreeAge Markov state-transition models requiring first-order Monte Carlo simulations.
METHODS AND RESULTS: Using TreeAge Pro Suite 2007 and Microsoft Visual Basic for EXCEL, we constructed a generic script that enables one to perform automated deterministic one-way sensitivity analyses in EXCEL employing microsimulation models. In addition, we constructed a generic EXCEL-worksheet that allows for use of the script with little programming knowledge.
CONCLUSIONS: Linking TreeAge Pro Suite 2007 and Visual Basic enables the performance of deterministic sensitivity analyses of first-order Monte Carlo simulations. There are other potentially interesting applications for automated analysis.