Perspectives on Fracture Liaison Service in Austria: clinical and economic considerations.

Osteoporosis is a widespread disease and affects over 500,000 people in Austria. Fragility fractures are associated with it and represent not only an individual problem for the patients, but also an enormous burden for the healthcare system. While trauma surgery care is well provided in Vienna, there is an enormous treatment gap in secondary prevention after osteoporotic fracture. Systematic approaches such as the Fracture Liaison Service (FLS) aim to identify patients with osteoporosis after fracture, to clarify diagnostically, to initiate specific therapy, and to check therapy adherence. The aim of this article is to describe the practical implementation and operational flow of an already established FLS in Vienna. This includes the identification of potential FLS inpatients, the diagnostic workup, and recommendations for an IT solution for baseline assessment and follow-up of FLS patients. We summarize the concept, benefits, and limitations of FLS and provide prospective as well as clinical and economic considerations for a city-wide FLS, managed from a central location. Future concepts of FLS should include artificial intelligence for vertebral fracture detection and simple IT tools for the implementation of FLS in the outpatient sector.

Long-Term Effects of an Intensive Prevention Program After Acute Myocardial Infarction.

Effective long-term prevention after myocardial infarction (MI) is crucial to reduce recurrent events. In this study the effects of a 12-months intensive prevention program (IPP), based on repetitive contacts between non-physician "prevention assistants" and patients, were evaluated. Patients after MI were randomly assigned to the IPP versus usual care (UC). Effects of IPP on risk factor control, clinical events and costs were investigated after 24 months. In a substudy efficacy of short reinterventions after more than 24 months ("Prevention Boosts") was analyzed. IPP was associated with a significantly better risk factor control compared to UC after 24 months and a trend towards less serious clinical events (12.5% vs 20.9%, log-rank p = 0.06). Economic analyses revealed that already after 24 months cost savings due to event reduction outweighted the costs of the prevention program (costs per patient 1,070 € in IPP vs 1,170 € in UC). Short reinterventions ("Prevention Boosts") more than 24 months after MI further improved risk factor control, such as LDL cholesterol and blood pressure lowering. In conclusion, IPP was associated with numerous beneficial effects on risk factor control, clinical events and costs. The study thereby demonstrates the efficacy of preventive long-term concepts after MI, based on repetitive contacts between non-physician coworkers and patients.

Single Visit Evaluation and Tympanostomy Tube Placement for the Treatment of Acute Otitis Media in Children.

OBJECTIVE: To review our experiences with development of a single visit surgery (SVS) program for children with recurrent acute otitis media (AOM) undergoing tympanostomy tube (TT) placement the same day as their otolaryngology surgical consultation. STUDY DESIGN: Retrospective cohort analysis. METHODS: Retrospective series of patients participating in SVS from inception March 1, 2014 to April 30, 2020 were analyzed, with attention to factors associated with increasing interest and participation in SVS and parent experiences/satisfaction. RESULTS: A total of 224 children had TT placed through SVS for AOM management. The average age of patients was 18.1 months (standard deviation 7.8 months), and 130 (58.0%) were male. The median interval between initial contact to schedule SVS, and the SVS date was 15 days (interquartile range 9-23 days). When analyzing year-over-year volumes from inception of SVS, notable increases were seen in 2016 and 2017 after a radio advertisement was played locally. A marked increase in volume was noted after implementation of a Decision Tree Scheduling (DTS) algorithm for children with recurrent AOM. Sixty-six (28.8%) procedures were performed after institution of DTS. A parent survey demonstrated high levels of satisfaction with the SVS experience. Estimations of savings to families in terms of time away from work demonstrated potential for indirect healthcare benefits. CONCLUSIONS: SVS for TT placement was a successful, alternative model of care for management of children with AOM. Marketing strategies regarding SVS, and the inclusion of SVS pathway in DTS platforms increased rates of interest and choice of this option. Parents of children undergoing TT through SVS were satisfied with the overall experience. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2823-2829, 2021.

Cost-Utility Analysis of the Ontario Fracture Screening and Prevention Program.

BACKGROUND: The Fracture Screening and Prevention Program (FSPP), a fracture liaison service (FLS), was implemented in the province of Ontario, Canada, in 2007 to prevent recurrent fragility fractures and to improve post-fracture care. The objective of this analysis was to determine the cost-effectiveness of the current model of the FSPP compared with usual care (no program) from the perspective of the universal public health-care payer (Ontario Ministry of Health and Long-Term Care [MOHLTC]), over the lifetime of older adults who presented with a fragility fracture of the proximal part of the femur, the proximal part of the humerus, or the distal part of the radius and were not taking medications to prevent or slow bone loss and reduce the risk of fracture (bone active medications). METHODS: We developed a state-transition (Markov) model to conduct a cost-effectiveness analysis of the FSPP in comparison with usual care. The model simulated a cohort of patients with a fragility fracture starting at 71 years of age. Model parameters were obtained from published literature and from the FSPP. Quality-adjusted life-years (QALYs) and costs in 2018 Canadian dollars were predicted over a lifetime horizon using a 1.5% annual discount rate. Health outcomes included subsequent proximal femoral, vertebral, proximal humeral, and distal radial fractures. Scenario and subgroup analyses were reported. RESULTS: The FSPP had lower expected costs ($277 less) and higher expected effectiveness (by 0.018 QALY) than usual care over the lifetime horizon. Ninety-four percent of the 10,000 Monte Carlo simulated incremental cost-effectiveness ratios (ICERs) demonstrated lower costs and higher effectiveness of the FSPP. CONCLUSIONS: The FSPP appears to be cost-effective compared with usual care over a lifetime for patients with fragility fracture. This information may help to quantify the value of the FSPP and to assist policy-makers in deciding whether to expand the FSPP to additional hospitals or to initiate similar programs where none exist. LEVEL OF EVIDENCE: Economic and Decision Analysis Level II. See Instructions for Authors for a complete description of levels of evidence.

A fast and effective solution for ingrown toenail: Creation of a 2-mm space between tissue and nail by sutureless lateral longitudinal excision.

Nails have both functional and aesthetic importance. Undertreatments cause frequent recurrences affecting its functionality, while over-treatment spoils the aesthetic view. To describe the most practical and aesthetic method to treat ingrown toenail. All patients with ingrown toenail who applied to outpatient clinics of General Surgery Department between 2013 and 2019 were enrolled. A 2-mm space between tissue and nail by lateral longitudinal excision was created with only minimal matricectomy, under local anaesthesia. A total of 2334 surgical procedures were performed in 2118 patients. Recurrence rate was 1.7% during 36-month follow-up, most (70.7%) in younger men (22 years). The location of the lesions (right/left, medial/lateral or bilateral) did not show difference (p > 0.05 for each). Predisposing factors were tight-fitting footwear (4.5%), incorrect nail-trimming (3%), genetic tendency (2.8%), obesity (2.1%) and trauma (0.75%); but each was p > 0.05. Mean operation time was 3 min. There was no important complication, except hematoma (0.89%) and infection (0.68%). Mean healing time was 10 days and patients returned to daily activities in 3 days. Longitudinal excision with minimal matricectomy technique provides all dead tissue and diseased parts of nail and soft tissue to be removed. It is simple, cost-effective, satisfactory and aesthetic. SBU/23.01.2019/B.10.1.TKH.4.34.H.GP.0.01/7 (retrospectively registered).

Cost-effective analysis of clopidogrel versus aspirin for high risk patients with established peripheral arterial disease in China.

Objective: To assess the cost-effectiveness of clopidogrel versus aspirin for high risk patients (pre-existing symptomatic atherosclerosis or multi-vascular territory involvement) with established peripheral arterial disease (PAD) for secondary prevention of atherothrombotic events in a Chinese setting.Methods: A Markov model with a lifetime horizon was developed from the perspective of the national healthcare system in China. The primary outputs are quality adjusted life years (QALYs), direct medical costs, and the incremental cost-effectiveness ratios (ICERs). Clinical efficacy data were obtained from the CAPRIE trial. Drug acquisition cost, other direct medical costs, and utilities were from pricing records and the literature. One-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were conducted to test the robustness of the model on all parameters.Results: In patients with pre-existing atherosclerosis, 2 years of treatment with clopidogrel and aspirin would yield total QALYs of 8.776 and 8.576 at associated costs of ¥18,777 ($2,838) and ¥12,302 ($1,859), respectively, resulting in an ICER of ¥32,382 ($4,893) per QALY gained. In patients with PVD, secondary prevention with the same drugs would expect to lead to total QALYs of 8.836 and 8.632 at associated costs of ¥18,518 ($2,798) and ¥12,041 ($1,820), respectively, resulting in a corresponding ICER of ¥31,743 ($4,797) per QALY gained. The results were most sensitive to the discount rate for future outcomes and costs. The PSA indicated that the probability of clopidogrel being cost-effective was 100% at the willingness-to-pay threshold of 3-times GDP.Conclusions: Secondary prevention with clopidogrel is an attractive cost-effective option compared with aspirin for high risk patients with established PAD from the perspective of the national healthcare system in Chinese settings.

Cost-effectiveness and Clinical Outcomes of Early Anti-Tumor Necrosis Factor-α Intervention in Pediatric Crohn's Disease.

BACKGROUND: Anti-tumor necrosis factor-α (anti-TNF-α) treatments are increasingly used to treat pediatric Crohn's disease, even without a prior trial of immunomodulators, but the cost-effectiveness of such treatment algorithms has not been formally examined. Drug plan decision-makers require evidence of cost-effectiveness to inform funding decisions. The objective was to assess the incremental cost-effectiveness of early intervention with anti-TNF-α treatment vs a conventional step-up strategy per steroid-free remission-week gained from public health care and societal payer perspectives over 3 years. METHODS: A probabilistic microsimulation model was constructed for children with newly diagnosed moderate to severe Crohn's disease receiving anti-TNF-α treatment and concomitant treatments within the first 3 months of diagnosis compared with children receiving standard care consisting of steroids and/or immunomodulators with the possibility of anti-TNF-α treatment after 3 months of diagnosis. A North American multicenter observational study with 360 patients provided input into clinical outcomes and health care resource use. RESULTS: Early intervention with anti-TNF-α treatment was more costly, with an incremental cost of CAD$31,112 (95% confidence interval [CI], $2939-$91,715), and more effective, with 11.3 more weeks in steroid-free remission (95% CI, 10.6-11.6) compared with standard care, resulting in an incremental cost per steroid-free remission-week gained of CAD$2756 from an Ontario public health care perspective and CAD$2968 from a societal perspective. The incremental cost-effectiveness ratio was sensitive to the price of infliximab. CONCLUSIONS: The results suggest that although early anti-TNF-α was not cost-effective, it was clinically beneficial. These findings, along with other randomized controlled trial evidence, may inform formulary decision-making.

Primary surgical management of anterior pelvic organ prolapse: a systematic review, network meta-analysis and cost-effectiveness analysis.

BACKGROUND: Anterior compartment prolapse is the most common pelvic organ prolapse (POP) with a range of surgical treatment options available. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of surgical treatments for the repair of anterior POP. METHODS: We conducted a systematic review of randomised controlled trials comparing surgical treatments for women with POP. Network meta-analysis was possible for anterior POP, same-site recurrence outcome. A Markov model was used to compare the cost-utility of surgical treatments for the primary repair of anterior POP from a UK National Health Service perspective. MAIN RESULTS: We identified 27 eligible trials for the network meta-analysis involving eight surgical treatments tested on 3194 women. Synthetic mesh was the most effective in preventing recurrence at the same site. There was no evidence to suggest a difference between synthetic non-absorbable mesh, synthetic partially absorbable mesh, and biological mesh. The cost-utility analysis, which incorporated effectiveness, complications and cost data, found non-mesh repair to have the highest probability of being cost-effective. The conclusions were robust to model inputs including effectiveness, costs and utility values. CONCLUSIONS: Anterior colporrhaphy augmented with mesh appeared to be cost-ineffective in women requiring primary repair of anterior POP. There is a need for further research on long-term effectiveness and the safety of mesh products to establish their relative cost-effectiveness with a greater certainty. TWEETABLE ABSTRACT: New study finds mesh cost-ineffective in women with anterior pelvic organ prolapse.

Cost-Benefit Limitations of Extended, Outpatient Venous Thromboembolism Prophylaxis Following Surgery for Crohn's Disease.

BACKGROUND: Patients with Crohn's disease are at increased risk of postoperative venous thromboembolism. Historically, extended outpatient prophylaxis has not met conventional measures of societal cost-benefit advantage. However, extended prophylaxis for patients with Crohn's disease may be more cost-effective because of the patients' high thrombotic risk and long life expectancy. OBJECTIVE: This study aimed to assess the cost-effectiveness of extended prophylaxis in patients with Crohn's disease after abdominal surgery. DESIGN: A decision tree model was used to assess the incremental cost-effectiveness and cost per case averted with extended-duration venous thromboembolism prophylaxis following abdominal surgery. SETTING: The risk of a postdischarge thrombotic event, age at surgery, type of thrombotic event, prophylaxis risk reduction, bleeding complications, and mortality were estimated by using existing published sources. PATIENTS: Studied were patients with Crohn's disease versus routine care. INTERVENTION: We constructed a decision analysis to compare costs and outcomes in patients with Crohn's disease postoperatively with and without extended prophylaxis over a lifetime horizon. MAIN OUTCOME MEASURES: Productivity costs ($) and benefits (quality-adjusted life-year) were used to reflect a societal perspective and were time discounted at 3%. Multivariable probabilistic sensitivity analysis accounted for uncertainty in probabilities, costs, and utility weights. RESULTS: With the use of reference parameters, the individual expected societal total cost of care was $399.83 without and $1387.95 with prophylaxis. Preventing a single mortality with prophylaxis would cost $43.00 million (number needed to treat: 39,839 individuals). The incremental cost was $1.90 million per quality-adjusted life-year. Adjusting across a range of scenarios upheld these conclusions 88% of the time. With further sensitivity testing, subpopulations with postdischarge thrombosis rates greater than 4.9% favors postoperative extended-duration venous thromboembolism prophylaxis. LIMITATIONS: Further investigation is needed to determine if specific high-risk individuals can be preemptively identified in the Crohn's surgical population for targeted prophylaxis. CONCLUSION: Extended prophylaxis in patients with Crohn's disease postoperatively is not cost-effective when the cumulative incidence of posthospital thrombosis remains less than 4.9%. These findings are driven by the low absolute risk of thrombosis in this population and the considerable cost of universal treatment. See Video Abstract at http://links.lww.com/DCR/A998. LIMITACIONES DE COSTO-BENEFICIO DE LA PROFILAXIS AMBULATORIA PROLONGADA DEL TROMBOEMBOLISMO VENOSO DESPUÉS DE CIRUGÍA EN CASOS DE ENFERMEDAD DE CROHN:: Los pacientes con enfermedad de Crohn tienen un mayor riesgo de tromboembolismo venoso postoperatorio. Históricamente, la profilaxis ambulatoria prolongada no ha cumplido con las medidas convencionales de ventajas en costo-beneficio para la sociedad. Sin embargo, la profilaxis prolongada en los pacientes con Crohn puede ser más rentable debido al alto riesgo trombótico y a una larga esperanza de vida en estos pacientes.Evaluar la rentabilidad de la profilaxis prolongada en pacientes postoperados de un Crohn.Se utilizó un modelo de árbol de decisión para evaluar el incremento de rentabilidad y el costo por cada caso evitado con la profilaxis prolongada de tromboembolismo venoso después de cirugía abdominal.Se calcularon utilizando fuentes publicadas el riesgo de evento trombótico posterior al alta, la edad del paciente al momento de la cirugía, el tipo de evento trombótico, la reducción del riesgo de profilaxis, las complicaciones hemorrágicas y la mortalidad.Se estudiaron los pacientes de atención rutinaria versus aquellos portadores de Crohn.Construimos un arbol de análisis decisional para comparar costos y resultados de pacientes portadores de Crohn, con y sin profilaxis prolongada en el postoperatorio en un horizonte de por vida.Los costos de productividad ($) y los beneficios (año de vida ajustado por calidad) se utilizaron para reflejar la perspectiva social y se descontaron en el tiempo de un 3%. El análisis de sensibilidad probabilística multivariable dió cuenta de la incertidumbre en las probabilidades, costos y peso de utilidades.Usando parámetros de referencia, el costo total social esperado de la atención individual fue de $ 399.83 sin y $ 1,387.95 con profilaxis. La prevención del deceso de un paciente con profilaxis costaría $ 43.00 millones (valor requerido para tratar: 39,839 individuos). El costo incrementado fue de $ 1.90 millones por año de vida ajustado por la calidad. El ajuste a través de una gama de escenarios confirmó estas conclusiones el 88% del tiempo. Con pruebas de sensibilidad adicionales, las subpoblaciones con tasas de trombosis posteriores al alta fueron superiores al 4,9% y favorecían la profilaxis prolongada del tromboembolismo venoso en el postoperatorio.Se necesita más investigación para determinar si se puede identificar de manera preventiva los individuos específicos de alto riesgo en la población quirúrgica de Crohn en casos de profilaxis dirigida.La profilaxis prolongada en pacientes postoperados de un Crohn no es rentable cuando la incidencia acumulada de trombosis posthospitalaria sigue siendo inferior al 4,9%. Estos hallazgos son impulsados por el bajo riesgo absoluto de trombosis en esta población y el costo considerable del tratamiento universal. Vea el resumen del video en http://links.lww.com/DCR/A998.

The strong case for government funding of a polypill for the secondary prevention of cardiovascular disease in New Zealand.

Wald and Law, who popularised the term 'polypill' in 2003, proposed giving everyone above a certain age a polypill to reduce the burden of cardiovascular disease (CVD). A more compelling potential application, proposed in 2001 by the World Health Organization, is to use a polypill containing antiplatelet, statin and blood pressure-lowering therapy among people with established CVD, in whom the components are already indicated but in whom guideline implementation and adherence are suboptimal. This article outlines relevant international and New Zealand evidence on the likely benefits and harms of a polypill for the secondary prevention of CVD. The evidence indicates that the benefits are likely to outweigh the harms, particularly given the persistence of substantial treatment gaps and inequities in the management of and outcomes in CVD. The time is long overdue for the polypill to be funded for the secondary prevention of CVD.

Health and Economic Impact of Intensive Surveillance for Distant Recurrence After Curative Treatment of Colon Cancer: A Mathematical Modeling Study.

BACKGROUND: Intensive surveillance strategies are currently recommended for patients after curative treatment of colon cancer, with the aim of secondary prevention of recurrence. Yet, intensive surveillance has not yielded improvements in overall patient survival compared with minimal follow-up, and more intensive surveillance may be costlier. OBJECTIVE: The purpose of this study was to estimate the quality-adjusted life-years, economic costs, and cost-effectiveness of various surveillance strategies after curative treatment of colon cancer. DESIGN: A Markov model was calibrated to reflect the natural history of colon cancer recurrence and used to estimate surveillance costs and outcomes. SETTINGS: This was a decision-analytic model. PATIENTS: Individuals entered the model at age 60 years after curative treatment for stage I, II, or III colon cancer. Other initial age groups were assessed in secondary analyses. MAIN OUTCOME MEASURES: We estimated the gains in quality-adjusted life-years achieved by early detection and treatment of recurrence, as well as the economic costs of surveillance under various strategies. RESULTS: Cost-effective strategies for patients with stage I colon cancer improved quality-adjusted life-expectancy by 0.02 to 0.06 quality-adjusted life-years at an incremental cost of $1702 to $13,019. For stage II, they improved quality-adjusted life expectancy by 0.03 to 0.09 quality-adjusted life-years at a cost of $2300 to $14,363. For stage III, they improved quality-adjusted life expectancy by 0.03 to 0.17 quality-adjusted life-years for a cost of $1416 to $17,631. At a commonly cited willingness-to-pay threshold of $100,000 per quality-adjusted life-year, the most cost-effective strategy for patients with a history of stage I or II colon cancer was liver ultrasound and chest x-ray annually. For those with a history of stage III colon cancer, the optimal strategy was liver ultrasound and chest x-ray every 6 months with CEA measurement every 6 months. LIMITATIONS: The study was limited by model structure assumptions and uncertainty around the values of the model's parameters. CONCLUSIONS: Given currently available data and within the limitations of a model-based decision-analytic approach, the effectiveness of routine intensive surveillance for patients after treatment of colon cancer appears, on average, to be small. Compared with testing using lower cost imaging, currently recommended strategies are associated with cost-effectiveness ratios that indicate low value according to well-accepted willingness-to-pay thresholds in the United States. See Video Abstract at http://links.lww.com/DCR/A921.

Modeling the cost effectiveness and budgetary impact of Polypills for secondary prevention of cardiovascular disease in the United States.

BACKGROUND: There is underutilization of appropriate medications for secondary prevention of cardiovascular disease (CVD). METHODS: Usual care (UC) was compared to polypill-based care with 3 versions using a validated micro-simulation model in the NHANES population with prior CVD. UC included individual prescription of up to 4 drug classes (antiplatelet agents, beta-blockers, renin-angiotensin-aldosterone inhibitors and statins). The polypills modeled were aspirin 81 mg, atenolol 50 mg, ramipril 5 mg, and either simvastatin 40 mg (Polypill I), atorvastatin 80 mg (Polypill II), or rosuvastatin 40 mg (Polypill III). Baseline medication use and adherence came from United Healthcare claims data. RESULTS: When compared to UC, there were annual reductions of 130,000 to 178,000 myocardial infarctions and 54,000 to 74,000 strokes using Polypill I and II, respectively. From a health sector perspective, in incremental analysis the ICERs for Polypill I and II were $20,073/QALY and $21,818/QALY respectively; Polypill III was dominated but had a similar cost-effectiveness ratio to Polypill II when compared directly to usual care. From a societal perspective, Polypill II was cost-saving and dominated all strategies. Over a 5-year period, those taking Polypill I and II compared to UC saved approximately $12 and $6 per-patient-per-year alive, respectively. Polypill II was the preferred strategy in 98% of runs at a willingness to pay of $50,000 in the probability sensitivity analysis. CONCLUSIONS: Use of a polypill has a favorable cost profile for secondary CVD prevention in the United States. Reductions in CVD-related healthcare costs outweighed medication cost increases on a per-patient-per-year basis, suggesting that a polypill would be economically advantageous to both patients and payers.

Racial and socioeconomic disparities in adherence to preventive health services for ovarian cancer survivors.

PURPOSE: To examine ovarian cancer survivors' adherence to evidence-based guidelines for preventive health care. METHODS: A case-control, retrospective study of Medicare fee-for-service beneficiaries diagnosed with stage I, II, or III epithelial ovarian cancer from 2001 to 2010 using the Surveillance, Epidemiology, and End Results-Medicare database. Survivors were matched 1:1 to non-cancer controls from the 5% Medicare Beneficiary file on age, race, state of residence, and follow-up time. Receipt of flu vaccination, mammography, and bone density tests were examined in accordance with national guidelines. Adherence was assessed starting 1 year after cancer diagnosis, across 2 years of claims. Interaction with the health care system, including outpatient and cancer surveillance visits, was tested as a potential mechanism for receipt of services. RESULTS: 2437 survivors met the eligibility criteria (mean age, 75; 90% white). Ovarian cancer survivors were more likely to be adherent to flu vaccination (5 percentage points (pp); < 0.001) and mammography guidelines (10 pp.; < 0.001) compared to non-cancer controls, but no differences were found for bone density test guidelines (- 1 pp.; NS). Black women were less likely to be adherent to flu vaccination and bone density tests compared with white women. Women dually eligible for Medicare and Medicaid were less likely to be adherent compared to those without such support. Adherence was not influenced by measures of outpatient visits. CONCLUSION: Ovarian cancer survivors are receiving preventive services with the same or better adherence than their matched counterparts. Minority and dual-eligible survivors received preventive services at a lower rate than white survivors and those with higher income. The number of outpatient visits was not associated with increased preventive health visits. IMPLICATIONS FOR CANCER SURVIVORS: Ovarian cancer survivors are receiving adequate follow-up care to be adherent to preventive health measures. Efforts to improve care coordination post-treatment may help reduce minority and low SES disparities.

Effectiveness and cost-effectiveness of a Yoga-based Cardiac Rehabilitation (Yoga-CaRe) program following acute myocardial infarction: Study rationale and design of a multi-center randomized controlled trial.

BACKGROUND: Cardiac rehabilitation (CR) is a standard treatment for secondary prevention of acute myocardial infarction (AMI) in high income countries (HICs), but it is inaccessible to most patients in India due to high costs and skills required for multidisciplinary CR teams. We developed a low-cost and scalable CR program based on culturally-acceptable practice of yoga (Yoga-CaRe). In this paper, we report the rationale and design for evaluation of its effectiveness and cost-effectiveness. METHODS: This is a multi-center, single-blind, two-arm parallel-group randomized controlled trial across 22 cardiac care hospitals in India. Four thousand patients aged 18-80 years with AMI will be recruited and randomized 1:1 to receive Yoga-CaRe program (13 sessions supervised by an instructor and encouragement to self-practice daily) or enhanced standard care (3 sessions of health education) delivered over a period of three months. Participants will be followed 3-monthly till the end of the trial. The co-primary outcomes are a) time to occurrence of first cardiovascular event (composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and emergency cardiovascular hospitalization), and b) quality of life (Euro-QoL-5L) at 12 weeks. Secondary outcomes include need for revascularization procedures, return to pre-infarct activities, tobacco cessation, medication adherence, and cost-effectiveness of the intervention. CONCLUSION: This trial will alone contribute >20% participants to existing meta-analyses of randomized trials of CR worldwide. If Yoga-CaRe is found to be effective, it has the potential to save millions of lives and transform care of AMI patients in India and other low and middle income country settings.

Cost-Effectiveness Analysis of Bezlotoxumab Added to Standard of Care Versus Standard of Care Alone for the Prevention of Recurrent Clostridium difficile Infection in High-Risk Patients in Spain.

INTRODUCTION: Clostridium difficile infection (CDI) is the major cause of infectious nosocomial diarrhoea and is associated with considerable morbidity, mortality and economic impact. Bezlotoxumab administered in combination with standard of care (SoC) antibiotic therapy prevents recurrent CDI. This study assessed the cost-effectiveness of bezlotoxumab added to SoC, compared to SoC alone, to prevent the recurrence of CDI in high-risk patients from the Spanish National Health System perspective. METHODS: A Markov model was used to simulate the natural history of CDI over a lifetime horizon in five populations of patients at high risk of CDI recurrence according to MODIFY trials: (1) ≥ 65 years old; (2) severe CDI; (3) immunocompromised; (4) ≥ 1 CDI episode in the previous 6 months; and (5) ≥ 65 years old and with ≥ 1 CDI episode in the previous 6 months. The incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained was calculated. Deterministic (DSA) and probabilistic sensitivity analyses (PSA) were performed. RESULTS: In all patient populations (from 1 to 5), bezlotoxumab added to SoC reduced CDI recurrence compared to SoC alone by 26.4, 19.5, 21.2, 26.6 and 39.7%, respectively. The resulting ICERs for the respective subgroups were €12,724, €17,495, €9545, €7386, and €4378. The model parameters with highest impact on the ICER were recurrence rate (first), mortality, and utility values. The probability that bezlotoxumab was cost-effective at a willingness-to-pay threshold of €21,000/QALY was 85.5%, 54.1%, 86.0%, 94.5%, 99.6%, respectively. CONCLUSION: The results suggest that bezlotoxumab added to SoC compared to SoC alone is a cost-effective treatment to prevent the recurrence of CDI in high-risk patients. The influence of changes in model parameters on DSA results was higher in patients ≥ 65 years old, with severe CDI and immunocompromised. Additionally, PSA estimated that the probability of cost-effectiveness exceeded 85% in most subgroups. FUNDING: Merck Sharp & Dohme Corp.

Cost-effectiveness of a fixed dose combination (polypill) in secondary prevention of cardiovascular diseases in India: Within-trial cost-effectiveness analysis of the UMPIRE trial.

BACKGROUND: The Use of Multidrug Pill In Reducing cardiovascular Events (UMPIRE) trial, showed that access to a cardiovascular polypill (aspirin, statin and two blood pressure lowering drugs) significantly improved adherence, lowered systolic blood pressure (SBP) and low-density lipoprotein cholesterol (LDLc) in patients with or at high risk of cardiovascular disease (CVD). We aimed to analyze the within-trial cost-effectiveness of the polypill strategy versus usual care in India. METHODS: Relative effectiveness and costs of polypill versus usual care groups in UMPIRE were estimated from the health sector perspective. Only direct medical costs were considered. The effectiveness of the polypill was reported as a percentage increase in adherence and mean reductions in SBP, and LDL-c, over the 15-month trial period. Healthcare resource utilization and costs were collected for each patient during the trial. Polypill price was constructed using a range of scenarios: $0.06-$0.94/day. The cost-effectiveness of the polypill was measured as the additional cost for 10% increase in adherence, and per unit reduction in SBP and LDL-c. RESULTS: Overall, the mean cost per patient was significantly lower with the polypill strategy (-$203 per person, (95% CI: -286, -119, p < 0.01). In scenario analyses that varied polypill price assumptions, incremental cost-effectiveness ratios for a polypill strategy ranged between cost-saving to $75 per 10% increase in adherence for polypill price of $0.94 per day. CONCLUSIONS: The polypill strategy was cost-saving compared to usual care among patients with or at high risk of CVD in India.

Cost-effectiveness of percutaneous patent foramen ovale closure as secondary stroke prevention.

OBJECTIVE: Compared to medical therapy alone, percutaneous closure of patent foramen ovale (PFO) further reduces risk of recurrent ischemic strokes in carefully selected young to middle-aged patients with a recent cryptogenic ischemic stroke. The objective of this study was to evaluate the cost-effectiveness of this therapy in the context of the United Kingdom (UK) healthcare system. METHODS: A Markov cohort model consisting of four health states (Stable after index stroke, Post-Minor Recurrent Stroke, Post-Moderate Recurrent Stroke, and Death) was developed to simulate the economic outcomes of device-based PFO closure compared to medical therapy. Recurrent stroke event rates were extracted from a randomized clinical trial (RESPECT) with a median of 5.9-year follow-up. Health utilities and costs were obtained from published sources. One-way and probabilistic sensitivity analyses (PSA) were performed to assess robustness. The model was discounted at 3.5% and reported in 2016 Pounds Sterling. RESULTS: Compared with medical therapy alone and using a willingness-to-pay (WTP) threshold of £20,000, PFO closure reached cost-effectiveness at 4.2 years. Cost-effectiveness ratios (ICERs) at 4, 10, and 20 years were £20,951, £6,887, and £2,158, respectively. PFO closure was cost-effective for 89% of PSA iterations at year 10. Sensitivity analyses showed that the model was robust. CONCLUSIONS: Considering the UK healthcare system perspective, percutaneous PFO closure in cryptogenic ischemic stroke patients is a cost-effective stroke prevention strategy compared to medical therapy alone. Its cost-effectiveness was driven by substantial reduction in recurrent strokes and patients' improved health-related quality-of-life.

Polypill: an affordable strategy for cardiovascular disease prevention in low-medium-income countries.

The simplification of fixed dose medications by using a single 'polypill' is an attractive strategy to improve adherence to medications which has shown benefit to cardiovascular risk factor control and cardiovascular disease prevention or delay in the progression of these diseases. We review the evidence obtained from a series of clinical trials demonstrating an improvement in adherence to the polypill compared to the use of each compound separately, and found similar or better control of the classical cardiovascular risk factors and a similar safety profile. These results suggest that the use of the polypill could have a beneficial impact in cardiovascular morbidity and mortality. Furthermore, the polypill has the potential to improve cost effectiveness and is simple to use. However, before recommending the implementation of the polypill in programs aimed at primary and secondary cardiovascular prevention, we are awaiting the results of several current clinical trials aimed at measuring the impact on the frequency of major cardiovascular outcomes, particularly in low-medium-income countries.

Considerations for Secondary Prevention of Nutritional Deficiencies in High-Risk Groups in High-Income Countries.

Surveys in high-income countries show that inadequacies and deficiencies can be common for some nutrients, particularly in vulnerable subgroups of the population. Inadequate intakes, high requirements for rapid growth and development, or age- or disease-related impairments in nutrient intake, digestion, absorption, or increased nutrient losses can lead to micronutrient deficiencies. The consequent subclinical conditions are difficult to recognize if not screened for and often go unnoticed. Nutrient deficiencies can be persistent despite primary nutrition interventions that are aimed at improving dietary intakes. Secondary prevention that targets groups at high risk of inadequacy or deficiency, such as in the primary care setting, can be a useful complementary approach to address persistent nutritional gaps. However, this strategy is often underestimated and overlooked as potentially cost-effective means to prevent future health care costs and to improve the health and quality of life of individuals. In this paper, the authors discuss key appraisal criteria to consider when evaluating the benefits and disadvantages of a secondary prevention of nutrient deficiencies through screening.

The use of adjuncts to reduce seroma in open incisional hernia repair: a systematic review.

BACKGROUND: Seroma formation remains a common complication after an incisional hernia repair. The use of surgical drains is widespread, but evidence for their use and other adjuncts is limited. Our aim was to perform a systematic review of the literature on techniques used to reduce the incidence of post-operative seroma formation. METHODS: A systematic search of PubMed and Embase databases was conducted using terms including "incisional hernia" and "seroma". All studies on adults undergoing open incisional hernia repair with at least one intervention designed to reduce seroma formation were included. RESULTS: Of the 1093 studies identified, 9 met the inclusion criteria. Medical talc: one cohort study of 74 patients undergoing talc application following pre-peritoneal mesh placement found a significantly decreased rate of seroma formation of 20.8 versus 2.7% (p < 0.001), but a retrospective study including 21 patients with onlay mesh found an increased rate of 76% seroma formation from 9.5% (p = 0.001). Fibrin glue: one comparative study including 60 patients found a reduction in seroma formation from 53 to 10% (p = 0.003), whereas a retrospective study of 250 patients found no difference (11 vs. 4.9% p = 0.07). Negative pressure wound therapy: four retrospective studies including a total of 358 patients found no difference in seroma outcome. Others: one randomised study of 42 patients undergoing either suction drainage or "quilting" sutures found no difference in seroma formation. CONCLUSIONS: There is currently insufficient quality evidence to recommend any of the investigated methods, some of which incur significant additional cost.