Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.

The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties. PLEG is thus part of the continuum of evidence development for a medicinal product, complementing earlier evidence, facilitating further elucidation of a product's benefit/risk profile, value proposition, and/or exploring broader aspects of disease management and provision of healthcare. PLEG plays a role in regulatory decision making, not only in the European Union but also in other jurisdictions including the USA and Japan. PLEG is also relevant for downstream decision-making by health technology assessment bodies and payers. PLEG comprises studies of different designs, based on data collected in observational or experimental settings. Experience to date in the European Union has indicated a need for improvements in PLEG. Improvements in design and research efficiency of PLEG could be addressed through more systematic pursuance of Scientific Advice on PLEG with single or multiple decision makers. To date, limited information has been available on the rationale, process or timing for seeking PLEG advice from regulators or health technology assessment bodies. This article sets out to address these issues and to encourage further uptake of PLEG advice.

El circuito asistencial de la fibrilación auricular en pacientes ambulatorios: estudio observacional Audit fibrilación auricular en el Baix Ebre / The management of atrial fibrillation and characteristics of its current care in outpatients. AFABE observational study

OBJETIVO: Conocer el circuito asistencial de la fibrilación auricular (FA): diagnóstico, tratamiento y seguimiento en el contexto asistencial del sistema sanitario público. DISEÑO: AFABE es un estudio observacional, multicéntrico y descriptivo, con datos retrospectivos relacionados con el diagnóstico, tratamiento y seguimiento de una cohorte de pacientes ambulatorios con FA en el contexto de la atención primaria, servicios de urgencias y cardiología referentes. Emplazamiento: Atención primaria y especializada. Comarca del Baix Ebre. Tarragona. España. Participantes: Muestra representativa de pacientes con FA > 60 años, seleccionados aleatoriamente entre los pacientes registrados en los 22 centros de atención primaria existentes en el territorio del estudio. Mediciones principales: Datos demográficos, comorbilidades, valor CHA2DS2-VASc y HAS_BLED, y patrones asistenciales resultantes entre la atención primaria y servicios referentes. RESULTADOS: Se incluyeron 182 pacientes, de 78,5; DE:7,3 años, y el 50% mujeres. En atención primaria (AP) se realizó el primer contacto en el 68,3% (IC 95% 60,3-76,3) de los casos de FA, de los que un 56,3% (IC 95% 45,2-66,0) fueron enviados al servicio de urgencias del hospital referente. El 72,7% (IC 95% 63,5-79,0) de los tratamientos anticoagulantes orales y el 58,44% (IC 95% 49,4-66,9) de los tratamientos antiarrítmicos se iniciaron en el servicio de urgencias referente. Un 55,9% (IC 95% 47,2-64,7) de los pacientes son seguidos por el servicio de cardiología referente. CONCLUSIONES: El médico de AP realiza el primer contacto de la mayoría de FA y deriva el 55% de los casos al servicio de urgencias hospitalario donde se inician la mayoría de tratamientos específicos de la FA

AIM: To provide insights into the characteristics and management of outpatients when their atrial fibrillation (AF) was first detected: diagnosis, treatment and follow-up in the context of the public health system. DESIGN: AFABE is an observational, multicentre descriptive study with retrospective data collection relating to the practice patterns, management and initial strategies of treatment of patients with diagnosed AF in the context of primary care, emergency and cardiologists of the public health system. Setting: Primary and Specialist care. Baix Ebre region. Tarragona. Spain. Subjects: A representative sample of 182 subjects > 60-year-old with AF who have been randomized, recruited among the registered patients with AF in 22 primary care centres in the area of the study. Mesurements: Demographic data, comorbidities (AF), CHA2DS2-VASc and HAS BLED scores, and practice patterns results between Primary Care and referral services. RESULTS: A total of 182 patients were included (mean age 78.5 SD: 7.3 years; 50% women). Most patients (68.3% 95%CI; 60.3-76.3) had the first contact in Primary Care, of which 56.3% (95%CI;45.2-66.0) were sent to Hospital Emergency Department where 72.7% (95%CI: 63.5-79.0) of the oral anticoagulation and 58.4% (95%CI: 49.4-66.9) of antiarrhytmic treatments were started. More than half (55.9%:95%CI; 47.2-64.7, of patients with permanent AF were followed-up by the Cardiology department. CONCLUSIONS: Most patients with newly diagnosed AF made a first contact with Primary Care, but around half were sent to Hospital Emergency departments, where they were treated with an antiarrhythmic and/or oral anticoagulation

[The management of atrial fibrillation and characteristics of its current care in outpatients. AFABE observational study]. / El circuito asistencial de la fibrilación auricular en pacientes ambulatorios: estudio observacional Audit fibrilación auricular en el Baix Ebre.

AIM: To provide insights into the characteristics and management of outpatients when their atrial fibrillation (AF) was first detected: diagnosis, treatment and follow-up in the context of the public health system. DESIGN: AFABE is an observational, multicentre descriptive study with retrospective data collection relating to the practice patterns, management and initial strategies of treatment of patients with diagnosed AF in the context of primary care, emergency and cardiologists of the public health system. SETTING: Primary and Specialist care. Baix Ebre region. Tarragona. Spain. SUBJECTS: A representative sample of 182 subjects > 60-year-old with AF who have been randomized, recruited among the registered patients with AF in 22 primary care centres in the area of the study. MESUREMENTS: Demographic data, comorbidities (AF), CHA2DS2-VASc and HAS_BLED scores, and practice patterns results between Primary Care and referral services. RESULTS: A total of 182 patients were included (mean age 78.5 SD:7.3 years; 50% women). Most patients (68.3% 95%CI; 60.3-76.3) had the first contact in Primary Care, of which 56.3% (95%CI; 45.2-66.0) were sent to Hospital Emergency Department where 72.7% (95%CI: 63.5-79.0) of the oral anticoagulation and 58.4% (95%CI: 49.4-66.9) of antiarrhytmic treatments were started. More than half (55.9%:95%CI; 47.2-64.7, of patients with permanent AF were followed-up by the Cardiology department. CONCLUSIONS: Most patients with newly diagnosed AF made a first contact with Primary Care, but around half were sent to Hospital Emergency departments, where they were treated with an antiarrhythmic and/or oral anticoagulation.

Prevalencia de la fibrilación auricular desconocida y la no tratada con anticoagulantes. Estudio AFABE / Prevalence of undiagnosed atrial fibrillation and of that not being treated with anticoagulant drugs: the AFABE study

Introducción y objetivos. La fibrilación auricular significa un grave problema de salud pública por sus complicaciones, por lo que su manejo debería incluir no sólo su tratamiento, sino también la prevención de las complicaciones tromboembólicas. El objetivo principal es conocer las proporciones de la fibrilación auricular desconocida y la no tratada con anticoagulantes. Métodos. Estudio observacional, transversal, retrospectivo, de base poblacional y multicéntrico. Se seleccionó aleatoriamente a 1.043 sujetos mayores de 60 años para realizarles un electrocardiograma en visita concertada. Se registraron variables sociodemográficas, valores en las escalas CHA2DS2-VASc y HAS-BLED, razón internacional normalizada y motivos de no recibir tratamiento anticoagulante oral. Resultados. La prevalencia total de fibrilación auricular fue del 10,9% (intervalo de confianza del 95%, 9,1-12,8%), de la que el 20,1% era desconocida. De la fibrilación auricular conocida, el 23,5% con un valor de CHA2DS2-VASc ≥ 2 no recibía tratamiento anticoagulante y el 47,9% tenía un valor HAS-BLED ≥ 3. La odds ratio de no recibir tratamiento anticoagulante fue 2,04 (intervalo de confianza del 95%, 1,11-3,77) para las mujeres, 1,10 (intervalo de confianza del 95%, 1,05-1,15) para la mayor edad de diagnóstico y 8,61 (intervalo de confianza del 95%, 2,38-31,0) si el valor de CHA2DS2-VASc es < 2. El deterioro cognitivo (15,2%) fue el motivo principal de no recibir tratamiento anticoagulante. Conclusiones. El 20,1% de las fibrilaciones auriculares de pacientes mayores de 60 años son desconocidas previamente y no se trata con anticoagulantes al 23,5% del total (AU)

Introduction and objectives. Atrial fibrillation constitutes a serious public health problem because it can lead to complications. Thus, the management of this arrhythmia must include not only its treatment, but antithrombotic therapy as well. The main goal is to determine the proportion of cases of undiagnosed atrial fibrillation and the proportion of patients not being treated with oral anticoagulants. Methods. A multicenter, population-based, retrospective, cross-sectional, observational study. In all, 1043 participants over 60 years of age were randomly selected to undergo an electrocardiogram in a prearranged appointment. Demographic data, CHA2DS2-VASc and HAS-BLED scores, international normalized ratio results, and reasons for not receiving oral anticoagulant therapy were recorded. Results. The overall prevalence of atrial fibrillation was 10.9% (95% confidence interval, 9.1%-12.8%), 20.1% of which had not been diagnosed previously. In the group with known atrial fibrillation, 23.5% of those with CHA2DS2-VASc≥2 were not receiving oral anticoagulant therapy, and 47.9% had a HAS-BLED score≥3. The odds ratio for not being treated with oral anticoagulation was 2.04 (95% confidence interval, 1.11-3.77) for women, 1.10 (95% confidence interval, 1.05-1.15) for more advanced age at diagnosis, and 8.61 (95% confidence interval 2.38-31.0) for a CHA2DS2-VASc score<2. Cognitive impairment (15.2%) was the main reason for not receiving oral anticoagulant therapy. Conclusions. The prevalence of previously undiagnosed atrial fibrillation in individuals over 60 years of age is 20.1%, and 23.5% of those who have been diagnosed receive no treatment with oral anticoagulants (AU)

Prevalence of undiagnosed atrial fibrillation and of that not being treated with anticoagulant drugs: the AFABE study.

INTRODUCTION AND OBJECTIVES: Atrial fibrillation constitutes a serious public health problem because it can lead to complications. Thus, the management of this arrhythmia must include not only its treatment, but antithrombotic therapy as well. The main goal is to determine the proportion of cases of undiagnosed atrial fibrillation and the proportion of patients not being treated with oral anticoagulants. METHODS: A multicenter, population-based, retrospective, cross-sectional, observational study. In all, 1043 participants over 60 years of age were randomly selected to undergo an electrocardiogram in a prearranged appointment. Demographic data, CHA2DS2-VASc and HAS-BLED scores, international normalized ratio results, and reasons for not receiving oral anticoagulant therapy were recorded. RESULTS: The overall prevalence of atrial fibrillation was 10.9% (95% confidence interval, 9.1%-12.8%), 20.1% of which had not been diagnosed previously. In the group with known atrial fibrillation, 23.5% of those with CHA2DS2-VASc≥2 were not receiving oral anticoagulant therapy, and 47.9% had a HAS-BLED score≥3. The odds ratio for not being treated with oral anticoagulation was 2.04 (95% confidence interval, 1.11-3.77) for women, 1.10 (95% confidence interval, 1.05-1.15) for more advanced age at diagnosis, and 8.61 (95% confidence interval 2.38-31.0) for a CHA2DS2-VASc score<2. Cognitive impairment (15.2%) was the main reason for not receiving oral anticoagulant therapy. CONCLUSIONS: The prevalence of previously undiagnosed atrial fibrillation in individuals over 60 years of age is 20.1%, and 23.5% of those who have been diagnosed receive no treatment with oral anticoagulants.