The impact of vaccination and outpatient treatment on the economic burden of Covid-19 in the United States omicron era: a systematic literature review.

AIMS: To identify and synthesize evidence regarding how coronavirus disease 2019 (COVID-19) interventions, including vaccines and outpatient treatments, have impacted healthcare resource use (HCRU) and costs in the United States (US) during the Omicron era. MATERIALS AND METHODS: A systematic literature review (SLR) was performed to identify articles published between 1 January 2021 and 10 March 2023 that assessed the impact of vaccination and outpatient treatment on costs and HCRU outcomes associated with COVID-19. Screening was performed by two independent researchers using predefined inclusion/exclusion criteria. RESULTS: Fifty-eight unique studies were included in the SLR, of which all reported HCRU outcomes, and one reported costs. Overall, there was a significant reduction in the risk of COVID-19-related hospitalization for patients who received an original monovalent primary series vaccine plus booster dose vs. no vaccination. Moreover, receipt of a booster vaccine was associated with a lower risk of hospitalization vs. primary series vaccination. Evidence also indicated a significantly reduced risk of hospitalizations among recipients of nirmatrelvir/ritonavir (NMV/r), remdesivir, sotrovimab, and molnupiravir compared to non-recipients. Treated and/or vaccinated patients also experienced reductions in intensive care unit (ICU) admissions, length of stay, and emergency department (ED)/urgent care clinic encounters. LIMITATIONS: The identified studies may not represent unique patient populations as many utilized the same regional/national data sources. Synthesis of the evidence was also limited by differences in populations, outcome definitions, and varying duration of follow-up across studies. Additionally, significant gaps, including HCRU associated with long COVID and various high-risk populations and cost data, were observed. CONCLUSIONS: Despite evidence gaps, findings from the SLR highlight the significant positive impact that vaccination and outpatient treatment have had on HCRU in the US, including periods of Omicron predominance. Continued research is needed to inform clinical and policy decision-making in the US as COVID-19 continues to evolve as an endemic disease.

Accounting for the relationship between per diem cost and LOS when estimating hospitalization costs.

BACKGROUND: Hospitalization costs in clinical trials are typically derived by multiplying the length of stay (LOS) by an average per-diem (PD) cost from external sources. This assumes that PD costs are independent of LOS. Resource utilization in early days of the stay is usually more intense, however, and thus, the PD cost for a short hospitalization may be higher than for longer stays. The shape of this relationship is unlikely to be linear, as PD costs would be expected to gradually plateau. This paper describes how to model the relationship between PD cost and LOS using flexible statistical modelling techniques. METHODS: An example based on a clinical study of clevidipine for the treatment of peri-operative hypertension during hospitalizations for cardiac surgery is used to illustrate how inferences about cost-savings associated with good blood pressure (BP) control during the stay can be affected by the approach used to derive hospitalization costs.Data on the cost and LOS of hospitalizations for coronary artery bypass grafting (CABG) from the Massachusetts Acute Hospital Case Mix Database (the MA Case Mix Database) were analyzed to link LOS to PD cost, factoring in complications that may have occurred during the hospitalization or post-discharge. The shape of the relationship between LOS and PD costs in the MA Case Mix was explored graphically in a regression framework. A series of statistical models including those based on simple logarithmic transformation of LOS to more flexible models using LOcally wEighted Scatterplot Smoothing (LOESS) techniques were considered. A final model was selected, using simplicity and parsimony as guiding principles in addition traditional fit statistics (like Akaike's Information Criterion, or AIC). This mapping was applied in ECLIPSE to predict an LOS-specific PD cost, and then a total cost of hospitalization. These were then compared for patients who had good vs. poor peri-operative blood-pressure control. RESULTS: The MA Case Mix dataset included data from over 10,000 patients. Visual inspection of PD vs. LOS revealed a non-linear relationship. A logarithmic model and a series of LOESS and piecewise-linear models with varying connection points were tested. The logarithmic model was ultimately favoured for its fit and simplicity. Using this mapping in the ECLIPSE trials, we found that good peri-operative BP control was associated with a cost savings of $5,366 when costs were derived using the mapping, compared with savings of $7,666 obtained using the traditional approach of calculating the cost. CONCLUSIONS: PD costs vary systematically with LOS, with short stays being associated with high PD costs that drop gradually and level off. The shape of the relationship may differ in other settings. It is important to assess this and model the observed pattern, as this may have an impact on conclusions based on derived hospitalization costs.

Cost-Effectiveness and Burden of Disease for Adjuvanted Quadrivalent Influenza Vaccines Compared to High-Dose Quadrivalent Influenza Vaccines in Elderly Patients in Spain.

Influenza is a contagious respiratory disease that causes severe illness and death, particularly in elderly populations. Two enhanced formulations of quadrivalent influenza vaccine (QIV) are available in Spain. Adjuvanted QIV (aQIV) is available for those aged 65+ and high-dose QIV (HD-QIV) for those aged 60+. In this study, we used a health economic model to assess the costs and outcomes associated with using aQIV or HD-QIV in subjects aged 65+. Using aQIV instead of HD-QIV to vaccinate an estimated 5,126,343 elderly people results in reductions of 5405 symptomatic cases, 760 primary care visits, 171 emergency room visits, 442 hospitalizations, and 26 deaths in Spain each year. Life-years (LYs) and quality-adjusted LYs (QALYs) increases by 260 and 206, respectively, each year. Savings from a direct medical payer perspective are EUR 63.6 million, driven by the lower aQIV vaccine price and a minor advantage in effectiveness. From a societal perspective, savings increase to EUR 64.2 million. Results are supported by scenario and sensitivity analyses. When vaccine prices are assumed equal, aQIV remains dominant compared to HD-QIV. Potential savings are estimated at over EUR 61 million in vaccine costs alone. Therefore, aQIV provides a highly cost-effective alternative to HD-QIV for people aged 65+ in Spain.

An Economic Evaluation of the Adjuvanted Quadrivalent Influenza Vaccine Compared with Standard-Dose Quadrivalent Influenza Vaccine in the Spanish Older Adult Population.

Standard-dose quadrivalent influenza vaccines (QIV) are designed to provide protection against all four influenza strains. Adjuvanted QIV (aQIV), indicated for individuals aged 65+ years, combines MF59® adjuvant (an oil-in-water emulsion of squalene oil) with a standard dose of antigen, and is designed to produce stronger and longer immune response, especially in the elderly where immunosenescence reduces vaccine effectiveness. This study evaluated the cost-effectiveness of aQIV vs. egg-based standard-dose QIV (QIVe) in the elderly population, from the payer and societal perspective in Spain. A dynamic transmission model, which accounts for herd protection, was used to predict the number of medically attended infections in Spain. A decision tree structure was used to forecast influenza-related costs and benefits. Influenza-related probabilities of outpatient visit, hospitalization, work absenteeism, mortality, and associated utilities and costs were extracted from Spanish and European published literature. Relative vaccine effectiveness (rVE) was sourced from two different meta-analyses: the first meta-analysis was informed by laboratory-confirmed influenza studies only, resulting in a rVE = 34.6% (CI95% 2-66%) in favor of aQIV; the second meta-analysis included real world evidence influenza-related medical encounters outcomes, resulting in a rVE = 13.9% (CI95% 4.2-23.5%) in benefit of aQIV. All costs were expressed in 2021 euros. Results indicate that replacing QIVe with aQIV in the Spanish elderly population would prevent on average 43,664 influenza complicated cases, 1111 hospitalizations, and 569 deaths (with a rVE = 34.6%) or 19,104 influenza complicated cases, 486 hospitalizations, and 252 deaths (with a rVE = 13.9%). When the rVE of aQIV vs. QIVe is 34.6%, the incremental cost per quality adjusted life years (QALY) gained was €2240 from the payer; from the societal perspective, aQIV was cost saving compared with QIVe. If the rVE was 13.9%, the incremental cost per QALY was €6694 and €3936 from the payer and societal perspective, respectively. Sensitivity analyses validated the robustness of these findings. Results indicate that replacing QIVe with aQIV in the Spanish elderly population is a cost-effective strategy for the Spanish healthcare system.

Estimated cost-effectiveness and burden of disease associated with quadrivalent cell-based and egg-based influenza vaccines in Spain.

Influenza is a viral respiratory disease that causes significant clinical and economic burden globally. Quadrivalent influenza vaccine (QIV) is frequently used to protect people who have a high-risk of developing influenza complications due to comorbidities. QIV offers protection against influenza A (A/H1N1 and H3N2) and B (B/Victoria, and B/Yamagata) strains. The European Medicines Agency has recently approved a cell-based QIV (QIVc) in people aged over 9 years old. QIVc has been shown to be more effective at preventing influenza than traditional egg-based QIV (QIVe). In this study, we use a health economic model adapted to Spain to assess the costs and outcomes associated with using QIVc instead of QIVe in people aged 9-64 at high-risk of complications. Observed vaccine coverage of 32% in the 9-17 age group, 17% in those aged 18-59, and 22% for ages 60-64 was used in the analysis. In total, 2.5 million people were vaccinated in the simulations. Using QIVc instead of QIVe was associated with 16,221fewer symptomatic cases, 4,522 fewer primary care visits, 1,015 fewer emergency room visits and 88 fewer hospitalizations. From a societal perspective, QIVc was more effective and less expensive compared to QIVe, leading to a cost-saving of €3.4 million. From a public payer perspective, the incremental cost-effectiveness ratio for QIVc vs QIVe was €12,852 per QALY gained. In conclusion, QIVc offers a cost-effective alternative to QIVe and should be considered as an alternative vaccine to QIVe for people aged 9-64 at high-risk of influenza complications in Spain.

Social Physique Anxiety and Intention to Be Physically Active: A Self-Determination Theory Approach.

PURPOSE: Based on self-determination theory, the purpose of this study was to analyze the relationship between social physique anxiety and intention to be physically active, while taking into account the mediating effects of the basic psychological needs and behavioral regulations in exercise. METHOD: Having obtained parents' prior consent, 390 students in secondary school (218 boys, 172 girls; Mage = 15.10 years, SD = 1.94 years) completed a self-administered questionnaire during physical education class that assessed the target variables. Preliminary analyses included means, standard deviations, and bivariate correlations among the target variables. Next, a path analysis was performed using the maximum likelihood estimation method with the bootstrapping procedure in the statistical package AMOS 19. RESULTS: Analysis revealed that social physique anxiety negatively predicted intention to be physically active through mediation of the basic psychological needs and the 3 autonomous forms of motivation (i.e., intrinsic motivation, integrated regulation, and identified regulation). CONCLUSION: The results suggest that social physique anxiety is an internal source of controlling influence that hinders basic psychological need satisfaction and autonomous motivation in exercise, and interventions aimed at reducing social physique anxiety could promote future exercise.

Direct medical costs of complications of diabetes in the United States: estimates for event-year and annual state costs (USD 2012).

OBJECTIVE: To estimate the direct medical costs associated with managing complications, hypoglycemia episodes, and infections associated with type 2 diabetes expressed in 2012 United States dollars (USD). METHODS: Direct data analysis and microcosting were used to estimate the costs for an event leading to either a hospital admission or outpatient care, and the post-acute care associated with managing macrovascular and microvascular complications, hypoglycemia episodes, and infections. Data were obtained from many sources, including inpatient and emergency department databases, national physician and laboratory fee schedules, government reports, and literature. Event-year costs reflect the resource use during an acute care episode (initial management in an inpatient or outpatient setting) and any subsequent care provided in the first year. State costs reflect annual resource use required beyond the first year for the ongoing management of complications and other conditions. Costs were assessed from the perspective of a comprehensive US healthcare payer and expressed in 2012 USD. RESULTS: Event-year costs (and state costs) for macrovascular complications were as follows: myocardial infarction $56,445 ($1904); ischemic stroke $42,119 ($15,541); congestive heart failure $23,758 ($1904); ischemic heart disease $21,406 ($1904); and transient ischemic attack $7388 ($179). For two microvascular complications the event-year and state costs were assumed the same: $71,714 for end stage renal disease, and $2862 blindness. The event-year cost was $9041 for lower extremity amputations, and $2147 for diabetic foot ulcers. Costs were also determined for managing hypoglycemic episodes: $176-$16,478 (depending on treatment required), and infections: vulvovaginal candidiasis $111, lower urinary tract infection $105. CONCLUSIONS: This study, which provides up-to-date cost estimates per patient, found that managing macrovascular and microvascular complications results in substantial costs to the healthcare system. This study facilitates conduct of other research studies such as modeling the management of diabetes and estimating the economic burden associated with complications.

Hospital economic impact from hemostatic matrix usage in cardiac surgery.

OBJECTIVE: Improved health outcomes can result in economic savings for hospitals and payers. While effectiveness of topical hemostatic agents in cardiac surgery has been demonstrated, evaluations of their economic benefit are limited. This study quantifies the cost consequences to hospitals, based on clinical outcomes, from using a flowable hemostatic matrix vs non-flowable topical hemostatic agents in cardiac surgery. RESEARCH DESIGN AND METHODS: Applying clinical outcomes from a prospective randomized clinical trial, a cost consequence framework was utilized to model the economic impact of comparator groups. From that study, clinical outcomes were obtained and analyzed for a flowable hemostatic matrix (FLOSEAL, Baxter Healthcare Corporation) vs non-flowable topical hemostats (SURGICEL Nu-Knit, Ethicon-Johnson & Johnson; GELFOAM, Pfizer). Costing analyses focused on the following outcomes: complications, blood transfusions, surgical revisions, and operating room (OR) time. Cardiac surgery costs were analyzed and expressed in 2012 US dollars based on available literature searches and US data. Comparator group variability in cost consequences (i.e., cost savings) was calculated based on annualized impact and scenario testing. RESULTS: RESULTS suggest that if a flowable hemostatic matrix (rather than a non-flowable hemostat) was utilized exclusively in 600 mixed cardiac surgeries annually, a hospital could improve patient outcomes by a reduction of 33 major complications, 76 minor complications, 54 surgical revisions, 194 transfusions, and 242 h of OR time. These outcomes correspond to a net annualized cost consequence savings of $5.38 million, with complication avoidance as the largest contributor. CONCLUSIONS: This cost consequence framework and supportive modeling was used to evaluate the hospital economic impact of outcomes resulting from the usage of various hemostatic agents. These analyses support that cost savings can be achieved from routine use of a flowable hemostatic matrix, rather than a non-flowable topical hemostat, in cardiac surgery.

Psychometric properties of the Social Physique Anxiety Scale (SPAS-7) in Spanish adolescents.

The purpose of this study was to validate the Spanish version of Motl and Conroy's model of the Social Physique Anxiety Scale (SPAS-7). To achieve this goal, a sample of 398 secondary school students was used, and the psychometric properties of the SPAS-7 were examined through different analyses. The results supported the seven-item model, although the item 5 did not show any significant correlation with two items from this model and had a lower factor loading than the rest of items. The structure of the model was invariant across gender and Body Mass Index (BMI). Alpha value over .70 and suitable levels of temporal stability were obtained. Girls and students classified according to the BMI as overweight and obese had higher scores in social physique anxiety than boys and the group classified as underweight and normal range. The findings of this study provided reliability and validity for the SPAS-7 in a Spanish adolescent sample.

Improved perioperative blood pressure control leads to reduced hospital costs.

BACKGROUND: Perioperative hypertension affects 80% of cardiac surgery patients and is associated with an increased risk of complications. OBJECTIVE: To determine the relationship between perioperative blood pressure (BP) control and hospital costs for cardiac surgery in the United States (US) and estimate the potential cost reductions associated with effective therapies. METHODS: The analysis estimated hospitalization costs (2011 US dollars (USD)) for cardiac surgery when BP was controlled with intravenous (IV) antihypertensives. Patient characteristics, hospital length of stay, and clinical event rates during the initial hospitalization and post-discharge 30 days after study drug infusion were based on the ECLIPSE (Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events) trials. These clinical trial data were combined with data from the Massachusetts Acute Hospital Case Mix Database 2007 - 2009 (MA Case Mix Database) to estimate total hospitalization costs. RESULTS: Effective perioperative BP control in patients requiring IV antihypertensives was associated with a 7% decrease in hospital costs compared with less effective BP control. Reductions in total hospital costs associated with clevidipine versus other IV antihypertensives averaged $394 per patient overall. Cost savings with clevidipine exceeded $500 per patient versus sodium nitroprusside and nitroglycerin, but only $22 compared to nicardipine. CONCLUSION: Improved perioperative BP control may reduce hospital costs. Given the low cost of IV antihypertensives, the total hospital cost reductions may offset any incremental cost increases associated with newer, more effective therapies.

Cost-benefit analysis of primary prevention of sudden cardiac death with an implantable cardioverter defibrillator versus amiodarone in Canada.

BACKGROUND: Clinical trials have shown that implantable cardioverter defibrillators are effective in primary prevention of sudden cardiac death (SCD) in patients with high risk profiles. OBJECTIVES: To conduct a cost-benefit assessment of prevention of sudden cardiac death with an implantable cardioverter defibrillator (ICD) vs. amiodarone from the Canadian health-care system perspective. METHODS: A simulation model that estimates the patient's course following an implantation with an ICD or initiation of amiodarone treatment was created. A thousand pairs of patients with identical characteristics in each treatment group, with similar demographic profiles as observed in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) were simulated. Based on the simulated individual patient characteristics, the model estimated the timing of severe arrhythmic events and deaths due to other causes and implemented the consequences at the time of the events. Patients might die at the time of severe arrhythmia (sudden cardiac death) or survive and become secondary prevention cases and be exposed to a higher risk of severe arrhythmia for the following 6 months. The rates of arrhythmia and death due to other causes were assumed to be the same, whereas the cases of fatality from severe arrhythmia differed between treatments. During the course of the simulation, the clinical (i.e., deaths) and economic outcomes were tallied for both treatment groups. All model parameters were obtained from the literature. The primary data source for clinical inputs was the published results of the SCD-HeFT trial which investigated the impact of ICDs on patients' survival in primary prevention of sudden cardiac deaths compared to amiodarone and conventional therapy. The value of a statistical life (CND$ 5.8 million) was obtained from an analysis previously performed by Health Canada. The direct medical costs and monetary value of lives saved were estimated over 5 years. Sensitivity analyses on key parameters were carried out. The most important study limitation was using two different sources to derive the age dependent clinical risks. This issue was resolved by calibrating the derived risks to account for the population differences. RESULTS: The model predicted that the overall mortality would be reduced by 19.1% (7.1% absolute reduction) with ICD compared to amiodarone over 5 years. The incremental benefit with ICD was estimated at CND$526,700 and additional cost at CND$28,300, which translated into a 0.05 cost: benefit ratio--around 1: 20 return of investment. CONCLUSION: In Canada, ICDs are a worthwhile alternative to amiodarone in the primary prevention of sudden cardiac death.

Hematomas espinales / Spinal Hematomas

Los hematomas espinales constituyen una entidad neurológica rara y potencialmente grave. Si no se tratan adecuadamente, puede dar lugar a déficit neurológico permanente o muerte. Su diagnóstico temprano es vital para asegurar el éxito del tratamiento. Entre sus causas se encuentran: sangrado espontáneo, trauma, coagulopatías, terapia anticoagulante, malformaciones vasculares, hemorragia iatrogénica durante la punción lumbar, anestesia epidural y cirugía de la columna vertebral. Independientemente de su localización, los hematomas espinales se pueden presentar con signos de compresión de la médula o de la cauda equina. Debido al amplio grupo de diagnósticos diferenciales, es indispensable su caracterización imaginológica, ya sea con tomografía (TC) o idealmente con resonancia magnética (RM).

Spinal hematomas are potentially serious but rare neurological entities that can lead to permanent neurological deficit or death, if not treated properly. Early diagnosis is vital to ensure the success of treatment. Its causes include: spontaneous bleeding, trauma, coagulopathies, anticoagulant therapy, vascular malformations, iatrogenic bleeding during lumbar puncture, epidural anesthesia and spinal surgery. Regardless of their location, they can present with signs of spinal cord or cauda equina compression. Imaging characterization is essential by computed tomography (CT) or ideally by magnetic resonance (MR) due to the wide range of differential diagnoses.