Clinical value of a tool for managing oral anticoagulation in nonvalvular atrial fibrillation in primary health care. Randomized clinical trial.

INTRODUCTION AND OBJECTIVES: The management of atrial fibrillation is complex and requires improvement at strategic points, such as in the control of patients treated with vitamin K antagonists. The aim of this study was to evaluate the impact on health outcomes of a nonvalvular atrial fibrillation decision support tool based on visualization of the time in therapeutic range in primary care. METHODS: The present randomized clinical trial was conducted in 2018 with a 1-year follow-up in 325 primary care centers in Catalonia. In the intervention centers, the decision support tool was installed to control the time in therapeutic range of patients treated with vitamin K antagonists. The tool was not visualized in the control group. This clinical trial was registered with ClinicalTrials.gov (NCT03367325). RESULTS: In total, 44 556 patients were studied. The intervention protected against admission for stroke (adjusted odds ratio [OR], 0.70; 95% confidence interval [95%CI], 0.55-0.88). The number needed to treat was 3502 (95%CI, 3305-3725) while the number of admissions for stroke avoided was 12.63 (95%CI, 11.88-13.38). The intervention also protected against mortality (adjusted OR, 0.78; 95%CI, 0.67-0.90), with a number needed to treat of 13 687 (95%CI, 10 789-18 714) and number of deaths avoided of 3.23 (95%CI, 2.36-4.10). CONCLUSIONS: The decision support tool was associated with slight reductions in the numbers of admissions for ischemic stroke and mortality. Although the follow-up time was short and the effect of the intervention was small, the results are valuable and could improve implementation of the tool.

Concordance between the Clinical Diagnosis of Influenza in Primary Care and Epidemiological Surveillance Systems (PREVIGrip Study).

INTRODUCTION: Health authorities use different systems of influenza surveillance. Sentinel networks, which are recommended by the World Health Organization, provide information on weekly influenza incidence in a monitored population, based on laboratory-confirmed cases. In Catalonia there is a public website, DiagnostiCat, that publishes the number of weekly clinical diagnoses at the end of each week of disease registration, while the sentinel network publishes its reports later. The objective of this study was to determine whether there is concordance between the number of cases of clinical diagnoses and the number of confirmed cases of influenza, in order to evaluate the predictive potential of a clinical diagnosis-based system. METHODS: Population-based ecological time series study in Catalonia. The period runs from the 2010-2011 to the 2018-2019 season. The concordance between the clinical diagnostic cases and the confirmed cases was evaluated. The degree of agreement and the concordance were analysed using Bland-Altman graphs and intraclass correlation coefficients. RESULTS: There was greater concordance between the clinical diagnoses and the sum of the cases confirmed outside and within the sentinel network than between the diagnoses and the confirmed sentinel cases. The degree of agreement was higher when influenza rates were low. CONCLUSIONS: There is concordance between the clinical diagnosis and the confirmed cases of influenza. Registered clinical diagnostic cases could provide a good alternative to traditional surveillance, based on case confirmation. Cases of clinical diagnosis of influenza may have the potential to predict the onset of annual influenza epidemics.

Gender and Socioeconomic Inequality in the Prescription of Direct Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation in Primary Care in Catalonia (Fantas-TIC Study).

BACKGROUND: Evidence points to unequal access to direct oral anticoagulant (DOAC) therapy, to the detriment of the most socioeconomically disadvantaged patients in different geographic areas; however, few studies have focused on people with atrial fibrillation. This study aimed to assess gender-based and socioeconomic differences in the prescriptions of anticoagulants in people with non-valvular atrial fibrillation who attended Primary Care. METHOD: A cross-sectional study with real-world data from patients treated in Primary Care in Catalonia (Spain). Data were obtained from the SIDIAP database, covering 287 Primary Care centers in 2018. Results were presented as descriptive statistics and odds ratios estimated by multivariable logistic regression. RESULTS: A total of 60,978 patients on anticoagulants for non-valvular atrial fibrillation were identified: 41,430 (68%) were taking vitamin K antagonists and 19,548 (32%), DOACs. Women had higher odds of treatment with DOAC (adjusted odds ratio [ORadj] 1.12), while lower DOAC prescription rates affected patients from Primary Care centers located in high-deprivation urban centers (ORadj 0.58) and rural areas (ORadj 0.34). CONCLUSIONS: DOAC prescription patterns differ by population. Women are more likely to receive it than men, while people living in rural areas and deprived urban areas are less likely to receive this therapy. Following clinical management guidelines could help to minimize the inequality.

Anticoagulation Control with Acenocoumarol or Warfarin in Non-Valvular Atrial Fibrillation in Primary Care (Fantas-TIC Study).

Introduction: The use of vitamin K antagonists (VKAs) in non-valvular atrial fibrillation (NVAF) is complicated due to the narrow therapeutic margin they present and their unpredictable dose-response relationship. Most studies are based on warfarin, with the results being extrapolated to acenocoumarol. However, studies comparing the two treatments in terms of the degree of anticoagulation control are scarce, justifying the present study. Main factors associated with poor control of time in therapeutic range (TTR) of anticoagulated patients are also studied. Methods: Cross-sectional study, with real-world data from patients treated in primary care (PC). Data were obtained from the System for the Improvement of Research in PC (SIDIAP) database, covering 60,978 NVAF-anticoagulated patients from 287 PC centres in 2018. Descriptive statistics were derived, and odds ratios were estimated by multivariate logistic regression. Results: 41,430 patients were considered: 93% were being treated with acenocoumarol and 7% with warfarin. There was no difference in poor control of TTR between the two types of VKA treatment, acenocoumarol and warfarin (38.9 vs. 38.4; p = 0.610). Poor anticoagulation control was mainly associated with advanced alcoholism (OR = 1.38), liver failure (OR = 1.37) and intracranial haemorrhage (OR = 1.35) as well as female sex, age < 60 years, cardiovascular history, diabetes mellitus and other variables. Conclusions: There is no association between poor anticoagulation control and the type of VKA treatment administered. Factors associated with poor control of TTR must be considered in clinical practice to improve control and decision-making.

Oral Anticoagulant Adequacy in Non-Valvular Atrial Fibrillation in Primary Care: A Cross-Sectional Study Using Real-World Data (Fantas-TIC Study).

Background: Oral anticoagulants (OAs) are the treatment to prevent stroke in atrial fibrillation (AF). Anticoagulant treatment choice in non-valvular atrial fibrillation (NVAF) must be individualized, taking current guidelines into account. Adequacy of anticoagulant therapy under the current criteria for NVAF in real-world primary care is presented. Methods: Cross-sectional study, with real-world data from patients treated in primary care (PC). Data were obtained from the System for the Improvement of Research in Primary Care (SIDIAP) database, covering 60,978 NVAF-anticoagulated patients from 287 PC centers in 2018. Results: In total, 41,430 (68%) were treated with vitamin K antagonists (VKAs) and 19,548 (32%) NVAF with direct-acting oral anticoagulants (DOACs). Inadequate prescription was estimated to be 36.0% and 67.6%, respectively. Most DOAC inadequacy (77.3%) was due to it being prescribed as a first-line anticoagulant when there was no history of thromboembolic events or intracranial hemorrhage (ICH). A total of 22.1% had missing estimated glomerular filtration rate (eGFR) values. Common causes of inadequate VKA prescription were poor control of time in therapeutic range (TTR) (98.8%) and ICH (2.2%). Conclusions: Poor adequacy to current criteria was observed, being inadequacy higher in DOACs than in VKAs. TTR and GFR should be routinely calculated in electronic health records (EHR) to facilitate decision-making and patient safety.

Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation: A study protocol using Real-World Data from Catalonia (FantasTIC Study).

BACKGROUND: Anticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut. METHODS: Population-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis. DISCUSSION: We hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.

Ten-Year Follow-Up of Clinical Governance Implementation in Primary Care: Improving Screening, Diagnosis and Control of Cardiovascular Risk Factors.

Current improvement strategies for the control of cardiovascular risk factors (CRFs) in Europe are based on quality management policies. With the aim of understanding the effect of interventions delivered by primary healthcare systems, we evaluated the impact of clinical governance on cardiovascular health after ten years of implementation in Catalonia. A cohort study that included 1878 patients was conducted in 19 primary care centres (PCCs). Audits that comprised 13 cardiovascular health indicators were performed and general practitioners received periodic (annual, biannual or monthly) feedback about their clinical practice. We evaluated improvement in screening, diagnosis and control of the main CRFs and the effects of the feedback on cardiovascular risk (CR), incidence of cardiovascular disease (CVD) and mortality, comparing baseline data with data at the end of the study (after a 10-year follow-up). The impact of the intervention was assessed globally and with respect to feedback frequency. General improvement was observed in screening, percentage of diagnoses and control of CRFs. At the end of the study, few clinically significant differences in CRFs were observed between groups. However, the reduction in CR was greater in the group receiving high frequency feedback, specifically in relation to smoking and control of diabetes and cholesterol (Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL)). A protective effect of having a cardiovascular event (hazard ratio (HR) = 0.64, 95% confidence interval (CI) = 0.44-0.94) or death (HR = 0.55, 95% CI = 0.35-0.88) was observed in patients from centres where general practitioners received high frequency feedback. Additionally, these PCCs presented improved cardiovascular health indicators and lower incidence and mortality by CVD, illustrating the impact of this intervention.

Fármacos biológicos y biosimilares: aclarando conceptos / Biological and biosimilar drugs: Clarifying concepts

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A new clinical decision support tool for improving the adequacy of anticoagulant therapy and reducing the incidence of stroke in nonvalvular atrial fibrillation: A randomized clinical trial in primary care.

INTRODUCTION: Atrial fibrillation (AF) is the most common cardiac arrhythmia and increases the risk of ischemic stroke 4 to 5-fold. The first choice of anticoagulant therapy (AT) is the vitamin K antagonist (VKA). Contraindication to VKA or poor control of the International Normalized Ratio leads to the administration of direct-acting oral anticoagulants. There is a trend toward inadequate AT in nonvalvular AF (NVAF) patients. AIM: To evaluate the impact of the implementation of a decision support tool linked to the digital clinical history on the adequacy of AT, the incidence of complications, and the mortality in patients with NVAF in primary care centers (PCCs) of the Catalan Institute of Health (ICS). METHODS AND ANALYSIS: Randomized clinical trial in 287 PCCs, formed by 2 groups (intervention and control). POPULATION: patients controlled in PCCs, diagnosed with NVAF 1 year before the implementation of the decision support tool and with VKA treatment over a minimum of 1 year. A simple randomization method will be performed at a sector level. The decision support tool will be available for 1 year. The time in therapeutic range (TTR) will be available in the digital clinical history only to professionals of the intervention group. The information system for primary care research development database will be used for the data extraction. Statistical analysis will be done at 3 time points: before the implementation of the tool, at 1 year, and at 2 years after the beginning of the intervention. Multilevel (patient and professional levels) logistic regression models will be used to estimate the effect of the intervention. ETHICS AND DISSEMINATION: This study protocol was approved by the Ethical Committee of Clinical Investigation of the Institut Universitari d'Investigació en Atenció Primària Jordi Gol (code P17/091). Articles will be published in scientific journals. TRIAL REGISTRATION: Clinical-Trials.gov: NCT03367325.

Biosimilares: una realidad presente, ¿un futuro prometedor? / Biosimilars: current reality, promising future?

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Utilización de antivíricos en las pandemias gripales / No disponible

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Tratamiento médico de la insuficiencia cardíaca basado en la evidencia / Evidence Based Treatment of Heart Failure

Introducción y objetivos. Se han elaborado unas recomendaciones de tratamiento de la insuficiencia cardíaca a partir de la revisión sistemática de la evidencia disponible sobre los distintos tratamientos farmacológicos. Material y métodos. La revisión se ha centrado en el tratamiento de la insuficiencia cardíaca crónica y sistólica. Se identificaron todos los estudios publicados en inglés sobre los tratamientos farmacológicos de la insuficiencia cardíaca. Para cada tratamiento se clasificaron las evidencias en función de: a) variables de eficacia (reducción de la mortalidad y de los ingresos hospitalarios, mejoría de la clase funcional, fracción de eyección y de la tolerancia al ejercicio), y b) nivel de calidad de la evidencia según una escala de evaluación. También se revisaron las evidencias sobre las comparaciones y las combinaciones de los tratamientos, y sobre su toxicidad y costes. Resultados. Las pautas de tratamiento han sido definidas en función de la clase funcional de la NYHA y se han clasificado en las categorías A, B o C según el nivel de calidad de la evidencia disponible. Las evidencias de mortalidad se han considerado las más importantes. Se han tenido en cuenta los fármacos de primera elección, las alternativas y otros posibles tratamientos. Conclusiones. Se dispone de suficiente información para elaborar recomendaciones terapéuticas en todas las fases de la insuficiencia cardíaca basadas en evidencias sobre variables, como la reducción de la mortalidad o de los ingresos hospitalarios. Esto pone de manifiesto el interés y la prioridad de utilizarlas en el proceso de evaluación y mejora de resultados en este proceso patológico (AU)