PCV39 THE EFFECT OF GENDER ON HEALTH-RELATED QUALITY OF LIFE AFTER CORONARY STENT IMPLANTATION

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Ablation of Left Atrial Tachycardia following Catheter Ablation of Atrial Fibrillation: 12-Month Success Rates

The treatment of atrial tachycardia following catheter ablation of atrial fibrillation is often challenging. Electrophysiological studies using high-resolution 3D mapping systems have contributed significantly to their understanding, and new ablation approaches have shown high rates of acute terminations with low recurrences for the clinical AT. However, patient populations are very heterogeneous, and long-term data of the freedom from any atrial tachycardia or any arrhythmia are still sparse. To evaluate long-term success, a unified patient population and predefined ablation strategies are preferred. In this study, we present 12-month success and mean 30 month follow-up data of catheter ablation of left atrial tachycardia. All 35 patients had a history of pulmonary vein isolation (PVI), 71% of which had a previous substrate modification. A total of 54 ATs, with a mean cycle length 297 ± 86 ms, 31 macro-reentries, and 4 localized reentries, were targeted. The ablation strategy to be used was given by the study protocol, depending on the type of reentry and the number of critical isthmuses. All available ablation strategies were included: standard (anatomical) lines, individual lines, critical isthmuses, and focal ablation. All ATs were terminated by ablation. A total of 91% terminated upon the first ablation strategy. Freedom from any AT after 12 months was 82%, and from any arrhythmia, it was 77%. The multi-procedure success after 30 months was 65% for any AT and 55% for any arrhythmia. In conclusion, individual ablation strategies based on the reentry mechanism and the number of critical isthmuses seems promising and demonstrates a high long-term clinical success. Tachycardia comprising a single critical isthmus can be ablated by critical isthmus ablation only. These patients present with the highest 12-month and long-term success rates

Economic analysis based on multinational studies: methods for adapting findings to national contexts

Background: Health economic parameters are increasingly considered as variables in health care decisions, but decision makers are interested in country-specific evaluations. However, a large number of studies are performed in foreign countries or in a multinational setting, which limits the transferability to a single nation’s context. Objective: The present analysis summarises several of the most common international methods for generating health economic analyses based on clinical studies from different settings. Methods: A narrative literature review was performed to identify potential reasons for limited transferability of health economic evaluation results from one country to another. Based on these results, we searched the methodological literature for analytic approaches to handle the restrictions. Additionally we describe the possibility of transferring foreign economic study results to the country of interest by matching trial data with routine data of national databases. Results: The main factors for limited transferability of health economic findings were found in country-specific differences in resource consumption and the resulting costs. These differences are affected by a number of influencing cofactors (demography, epidemiology and individual patient’s factors) and the overall health care system structures (e.g. payment systems, health provider incentives). However, despite the limitations country-specific health economic assessments could be realised using the pooled/ split analyses approach, some statistical approaches and modelling approaches. Conclusion: A variety of methods for identifying and adjusting country-specific differences in costs, effects and cost-effectiveness was established during the past decades. Multinational studies will continue to play a crucial role in the evaluation of cost-effectiveness at national levels. It seems likely that the growing interest in multinational studies will lead to continued developments in adaptation methods

Identification of patients with atrial fibrillation in UK community pharmacy: an evaluation of a new service

Background: Many patients with atrial fibrillation (AF) are asymptomatic and diagnosed via opportunistic screening. Community pharmacy has been advocated as a potential resource for opportunistic screening and lifestyle interventions.  Objective: The objective of this evaluation is to describe the outcomes from an AF service, in terms of referrals and interventions provided to patients identified as not at risk.  Method: Eligibility was assessed from pharmacy records and the completion of a short questionnaire. Once consented, patients were screened for AF and their blood pressure was measured.  Results: Of 594 patients screened, nine were identified as at risk of having AF and were referred to their GP. The service also identified 109 patients with undiagnosed hypertension, 176 patients with a Body Mass Index (BMI) > 30, 131 with an Audit-C score > 5 and 59 smokers. Pharmacists provided 413 interventions in 326 patients aimed at weight reduction (239), alcohol consumption (123) and smoking cessation (51).  Conclusion: This evaluation characterises the interventions provided to, not only those identified with the target condition - in this case AF - but also those without it. The true outcome of these additional interventions, along with appropriate follow-up, should be the focus of future studies.Impact of findings on patients or practice •Patients are willing to be screened for AF through community pharmacies•Screening can provide opportunities to identify other healthcare problems such a hypertension or poor lifestyle •Community pharmacists are able to provide brief advice to patients as a result of this opportunistic screenin

Positive Behavior Support Systems in a Rural West Texas Middle School

Positive Behavior Support (PBS) programs are being implemented in schools in the United States to support faculty, staff, and students. The purpose of this study was to evaluate a PBS system at a rural west Texas middle school to discover what improvements are necessary for district-wide implementation and sustainability. The study drew on Bandura\u27s social learning theory, which posits that people learn from each other through observation, imitation, and modeling. PBS systems provide the framework for exhibiting specific behavior expectations so students and teachers can get the most from their educational experiences. A program evaluation was completed using discipline data from 2008-2012 from the middle school, observations at the middle school, and archival campus improvement plan results from the campus needs assessment from 2012. The research instrument used to assess the information was a pre-established PBS evaluation system called the School-Wide Evaluation Tool (SET) designed for programmatic assessment. The SET assessment tool guided the evaluation of information gathered from 100 students, 15 teachers, and an administrative team survey to highlight the strengths and weaknesses of the PBS program in the school and district, identify necessary changes to improve its effectiveness, and determine how to best implement the system district-wide. These findings were used to inform a white paper outlining how to implement a successful program and how to maintain the program over time. This evaluation provided specific steps to strengthen each component of a PBS program to ensure school-wide application and sustainability. A positive social change is experienced by students, teachers, and parents by the enhancement of a PBS system that improves student behavior in the school and district

Antithrombotic management and outcomes of patients with atrial fibrillation treated with NOACs early at the time of market introduction:Main results from the PREFER in AF Prolongation Registry

International audienceAbstract The management of patients with atrial fibrillation (AF) has rapidly changed with increasing use of non-vitamin K antagonist oral anticoagulants (NOACs) and changes in the use of rhythm control therapy. The prevention of thromboembolic events European Registry in Atrial Fibrillation Prolongation Registry (PREFER Prolongation) enrolled consecutive patients with AF on NOACs between 2014 and 2016 in a multicentre, prospective, observational study with one-year follow-up, focusing on the time of introduction of NOACs. Overall, 3783 patients were enrolled, with follow-up information available in 3223 (85%). Mean age was 72.2 ± 9.4 years, 40% were women, mean CHA 2 DS 2 VASc score was 3.4 ± 1.6, and 2587 (88.6%) had a CHA 2 DS 2 VASc score ≥ 2. Rivaroxaban was used in half of patients, and dabigatran and apixaban were used in about a quarter of patients each; edoxaban was not available for use in Europe at the time. Major cardiovascular event rate was low: serious events occurred in 74 patients (84 events, 2%), including 24 strokes (1%), 62 major bleeds (2%), of which 30 were life-threatening (1%) and 3 intracranial (0.1%), and 28 acute coronary syndromes (1%). Mortality was 2%. Antiarrhythmic drugs were used in about 50% of patients, catheter ablation in 5%. Adverse events were low in this contemporary European cohort of unselected AF patients treated with NOACs already at the time of their first introduction, despite high thromboembolic risk

Tip of the Iceberg: Assessing the Global Socioeconomic Costs of Alzheimer's Disease and Related Dementias and Strategic Implications for Stakeholders

While it is generally understood that Alzheimer's disease (AD) and related dementias (ADRD) is one of the costliest diseases to society, there is widespread concern that researchers and policymakers are not comprehensively capturing and describing the full scope and magnitude of the socioeconomic burden of ADRD. This review aimed to 1) catalogue the different types of AD-related socioeconomic costs described in the literature; 2) assess the challenges and gaps of existing approaches to measuring these costs; and 3) analyze and discuss the implications for stakeholders including policymakers, healthcare systems, associations, advocacy groups, clinicians, and researchers looking to improve the ability to generate reliable data that can guide evidence-based decision making. A centrally emergent theme from this review is that it is challenging to gauge the true value of policies, programs, or interventions in the ADRD arena given the long-term, progressive nature of the disease, its insidious socioeconomic impact beyond the patient and the formal healthcare system, and the complexities and current deficiencies (in measures and real-world data) in accurately calculating the full costs to society. There is therefore an urgent need for all stakeholders to establish a common understanding of the challenges in evaluating the full cost of ADRD and define approaches that allow us to measure these costs more accurately, with a view to prioritizing evidence-based solutions to mitigate this looming public health crisis.This article is freely available via Open Access. Click on the Publisher URL to access it via the publisher's site.This work was partially sponsored by F. Hoffman La Roche Ltd (see below). We would like to thank Jean Georges (Executive Director Alzheimer Europe) for his suggestions and feedback on early drafts of this manuscript. Shift Health consults with organizations across the health and life sciences sector, including F. Hoffman La Roche Ltd. Authors from Shift Health (REW, CPK, YEH, RD) were employed under contract with Hoffman-La Roche Ltd. for the purposes of this work. Authors not employed by Shift Health (CB, ARE, MK, JLM, MN, and AA) did not receive support or remuneration related to this work. Authors’ disclosures available online (https://www.j-alz.com/manuscript-disclosures/19-0426)published version, accepted version, submitted versio

Health Economic Analyses and Decision-Making in Healthcare

Ziel der vorliegenden Habilitationsschrift ist es, am Beispiel ausgewählter Arbeiten die Anwendung von gesundheitsökonomischen Analysen im Rahmen von Entscheidungsprozessen im Gesundheitswesen darzustellen, sowie die aktuellen Umsetzungs- und Entwicklungsmöglichkeiten im deutschen Gesundheitswesen aufzuzeigen. Gesundheitsökonomische Modelle dienen dem Verständnis der Kostenstruktur ausgewählter Erkrankungen und helfen, die kurz- und langfristigen Effekte und Kosten einer Technologie abzubilden. Modellierungen kommen insbesondere in Situationen mit nicht ausreichender Datenlage zum Einsatz und liegen überwiegend als Entscheidungsbaumverfahren bzw. Markov- Modelle vor. Sie unterstützen die Synthese von Kurz- und Langzeitergebnissen, helfen den Transfer von Studien in Alltagsbedingungen zu modellieren oder werden im Rahmen der Evaluation eingesetzt. Mit Hilfe der Versorgungsforschung können reale setting-bezogenen Daten in die entscheidungsunterstützende Modellierung integriert werden. Die Analyse detaillierter Kostenstrukturen wurde am Beispiel der überaktiven Blase (OAB) aufgezeigt. Auf Basis epidemiologischer Studien belaufen sich die direkten OAB-bezogenen Kosten auf € 3,98 Mio., wovon die gesetzliche Krankenversicherung € 1,76 Mio. tragen muss. € 1,8 Mio. entstehen im Rahmen der Leistungen der Pflegeversicherung und € 0,41 Mio. werden von den Patienten selbst getragen. Der größte Kostenblock der OAB sind die Aufwendungen für pflegerische Maßnahmen. Krankheitskosten- Analysen helfen Kostenstrukturen aufzudecken und erste Hinweise für Größenordnungen von gesundheitlichen Problemen zu geben. In der zweiten vorgestellten Arbeit wurden die langfristigen Konsequenzen einer einjährigen Gabe von Clopidogrel bei Patienten mit akutem Koronarsyndrom ohne ST- Streckenhebung betrachtet. Mit Gesamt-Kosten in der Clopidogrel Gruppe von € 8.953 pro Patient und in der ASS-Gruppe von € 8.548, konnte auf Basis der Zulassungsstudien ein Kosten-Nutzen-Verhältnis von € 3.113 pro gewonnenen Lebensjahr ermittelt werden. Das Kosten-Nutzen-Verhältnis aus Sicht der Krankenversicherung liegt international im mittleren Bereich. Alle Analysen basierten auf einer Markov-Modellierung, die den langfristigen Verlauf der Erkrankung beschreibt. Die dritte Publikation berichtet über den Kostenvergleich eines flexiblen Asthmatherapieregimes gegenüber einer starren Dosierung bei der Anwendung fixer Budesonid/Formoterol-Kombinations- Inhalatoren. Asthmabezogene Gesamtkosten (€ 277 vs. € 340), direkte Kosten (€ 221 vs. € 292) und Kosten durch Studienmedikation (€ 162 vs. € 234) waren für das flexible Regime niedriger als bei konventioneller Behandlung. Die Kostenstruktur wurde im Versorgungsalltag erhoben, was aus Sicht der Krankenversicherungen als Bewertungsansatz bedeutsam ist. Die Kosten der Versorgung von Patienten mit Knieknorpelläsionen in den ersten fünf Jahren nach Operation werden in der vierten Publikation dargestellt. Die direkten Kosten betrugen in Jahr eins bis fünf € 782, € 398, € 420, € 272 und € 361. Die Höhe der Folgetherapiekosten, sowie die trotz umfangreicher Behandlungen nachhaltig reduzierte Lebensqualität der Patienten machen deutlich, dass ein großes Potential zu Verbesserung des Nutzens sowie des Kosten-Nutzen- Verhältnisses in der Patientenversorgung besteht. Ökonomische Evaluationen können auch auf Basis vorhandener Primärdaten erstellt wer-den, was in der vierten Arbeit am Beispiel der BASS Studie gezeigt wurde. Durchschnittliche direkte Schlaganfall-Kosten pro Patient mit Vorhofflimmern waren höher als die Kosten von Patienten ohne Vorhofflimmern (€ 11.799 vs. € 8.817). Auch nach Adjustierung blieb die signifikante Differenz in Bezug auf die akuten Hospitalisierungskosten bestehen. Die medizinische Versorgung von Schlaganfall-Patienten mit Vorhofflimmern erfordert einen höheren Ressourcenverbrauch. In der letzten Arbeit wurde die Einführung einer Technologie am Beispiel der Sirolimus-freisetzenden Stents (SES) mit Hilfe eines sequentiellen Kontrolldesigns untersucht. Die SES-Patienten verursachten im Vergleich zu unbeschichteten Stents (BMS) über 18 Monate aufgrund der höheren Stentpreise höhere Gesamtkosten (SES € 13.950 versus BMS € 12.273). Die Ergebnisse der allgemeinen und krankheitsspezifischen Lebensqualität zeig- ten nach Implantation eines SES verbesserte Werte. Die Ergebnisse der Studie können als Grundlage für Entscheidungen bezüglich der Leistungsplanung und -erstattung dienen. Gesundheitsökonomische Evaluationen sollten sektor- und budgetübergreifend durchgeführt werden. Um eine Vergleichbarkeit von Publikationen zu erreichen, ist bei der Erhebung der Kostendaten ein standardisierter Ansatz zu fordern. Kosten-Nutzen-Bewertungen können zum Einführungszeitpunkt eines neuen Verfahrens noch nicht über Nutzen- und Kosteneffekte im Versorgungsalltag verfügen. Daher wäre eine zunächst befristete bzw. probatorische Erstattungszusage aus ökonomischer Sicht sinnvoll. Parallel zur Einführung der Kosten-Nutzen-Bewertung sollte eine gesellschaftliche Wertediskussion im Sinne einer Priorisierung von Leistungen öffentlich und transparent geführt werden, da der wissenschaftliche Nutzenbeleg und die Kosten-Nutzen-Bewertung allein nicht zu einer Entscheidungsfindung ausreichen.The objective of this cumulative summary for a postdoctoral qualification as lecturer is to outline the use of health economic analyses in decision-making processes, exemplified by six previously published articles of the author. Furthermore, current implementation and development opportunities concerning health economic evaluations in the German healthcare setting will be highlighted. Health economic models provide an understanding of cost structures of diseases, as well as short and long-term impact of interventions on costs and outcomes. Modelling is applied particularly in complex situations with restricted or not yet available evidence from studies, with decision trees and Markov models being the predominant technologies utilised. These economic models support the synthesis of short and long-term results, simulating the transfer of study results into real life settings which can then be applied to compare treatment strategies. Data from health services research can further strengthen decision-supporting modelling by addressing setting-related issues. The burden of disease study of overactive bladder (OAB) provides an example for the analysis of detailed cost structures. Based on German epidemiological data, OAB-related costs accrue to € 3,98 mill. with € 1,76 mill. to be borne by the statutory health insurance (SHI). € 1,8 mill. arise due to nursing care services whereas € 0,41 mill. are out of pocket payments of patients. The major cost component is costs related to nursing care. Cost of disease analyses help understand cost structures and provide a initial indication of the magnitude of healthcare resource spending in selected health issues. The second publication presents long-term consequences of a one-year administration of Clopidogrel in addition to aspirin (ASA) compared to ASA monotherapy in patients with acute coronary syndrome without ST-segment elevation. Patients receiving Clopidogrel plus ASA or ASA alone accrued cumulative costs of € 8,953 and € 8,548 per patient respectively. Based on the clinical approval study, a cost-efficacy ratio of € 3,113 per life-year saved was calculated. In an international context the cost-efficacy ratio from a sickfund perspective ranks a medium-range position. Analyses were based on a Markov model, which allowed depiction of the long-term course of disease, related costs and potential treatment impact. The third study highlights the contribution of real healthcare data to modelling by a cost comparison of an adjustable maintenance treatment of asthma with budesonide/formoterol in a single inhaler versus fixed treatment over 12 weeks. Both asthma-related total costs (€ 277 vs. € 340), direct costs (€ 221 vs. € 292), as well as costs due to study medication (€ 162 vs. € 234) were lower for the adjustable regime compared to fixed treatment. The fact that costs were based on a real-life setting was of particular importance from a third party payer perspective. The cost of care of patients with cartilage lesions of the knee after a first surgical intervention are described in the fourth publication selected. From the first to the fifth post-operative year, the respective annual direct costs totalled € 782, € 398, € 420, € 272 and € 361. These substantial follow-up costs of patients occurred despite intensive treatment efforts and demonstrate the broad potential to improve patient outcomes and related cost-efficacy ratios when delivering care for patients with knee cartilage lesions. Primary study data might also serve as a sound basis for economic evaluations, as illustrated in the fifth study using data from the German Berlin Acute Stroke Study (BASS). Average direct stroke- related costs per patient with atrial fibrillation were higher compared to those in patients without atrial fibrillation (€ 11,799 vs. € 8,817). After adjusting for confounders, necessary due to the real-life nature of the study, the difference between acute hospitalisation costs remained significant. Delivering healthcare to stroke patients with atrial fibrillation induces higher resource consumption and costs. With the last selected study, the author exemplifies the economic evaluation of a newly launched medical technology using the example of sirolimus-eluting stents (SES) in patients with coronary disease. The total costs of SES implantation were compared to bare metal stents (BMS) applying a sequential control design. In comparison to patients with BMS, SES patients incurred higher total costs (SES € 13,950 versus BMS € 12,273) during the follow-up period of 18 months, primarily due to the higher SES price. After implantation of SES, both generic and disease- specific quality of life data showed better outcomes compared to BMS. With the incorporation of real-life evidence into new health technology appraisals by German decision-making bodies, these study results could serve as a basis for resource planning and reimbursement allocation. Health economic evaluations should incorporate all relevant sectors and budgets along the course of the disease. With regard to obtaining unit costs, crucial in guaranteeing comparability of results and publications, a standardised official costing data set has yet to be established for Germany. Additionally, cost-benefit assessments of medical technologies at market launch can not yet incorporate real-life data with regard to long-term costs and clinical outcomes. Hence, from an economic perspective, a conditional and restricted reimbursement approval would be recommendable until these data become available. In parallel to introducing cost-benefit assessments a transparent and public discussion on societal values for priorisation of healthcare services should be conducted, as these are essential elements of the complex allocation decisions in healthcare. As such, scientific clinical evidence and cost-benefit assessment are vital but are not the only criteria sufficient for decision-making in healthcare