Rationale and background: The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), has resulted in a global pandemic. The Pfizer-BioNTech COVID-19 vaccine, Comirnaty® (tozinameran), a novel mRNA-based vaccine, has been authorised for use in the European Union (EU) for the prevention of COVID-19. Efficient and timely monitoring of the safety of the vaccine is needed in European countries. The safety of the Pfizer-BioNTech COVID-19 vaccine is being investigated in clinical and epidemiological studies conducted worldwide.
The Centers for Disease Control and Prevention (CDC) in the United States (US) issued a statement indicating a possible link between vaccination to prevent COVID-19 and myocarditis for both the Pfizer-BioNTech COVID-19 vaccine and the mRNA-1273 vaccine produced by Moderna. Several researchers have reported an increase in risk of myocarditis and/or pericarditis within 42 days of receiving the vaccination, compared with the risk among unexposed persons, particularly after the second dose and among young male recipients. European Medicines Agency (EMA)’s safety committee (Pharmacovigilance Risk Assessment Committee [PRAC]) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax (i.e., trade names for the Pfizer-BioNTech and Moderna COVID-19 vaccines, respectively). The outcome of the review confirms the risk of myocarditis and pericarditis, which is already reflected in the product information for these 2 vaccines.
To further examine the risk of myocarditis and pericarditis with the Pfizer-BioNTech COVID-19 vaccine, Pfizer and Vaccine monitoring Collaboration for Europe (VAC4EU) are conducting this study. This study is nested in the EUPAS41623 cohort study, titled Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine, which estimates the incidence rates of prespecified adverse events of special interest (AESIs) in 5 European countries among individuals who receive at least 1 dose of the Pfizer-BioNTech COVID 19 vaccine and among unvaccinated individuals.
Research question and objectives: This study will address the following research question, «»What is the clinical course of myocarditis and pericarditis cases after being vaccinated with the Pfizer-BioNTech COVID-19 vaccine in European countries?»»
Primary study objective
? To describe the clinical course (treatment, survival, hospitalisations, long-term cardiac outcomes) of myocarditis or pericarditis among individuals diagnosed with myocarditis and/or pericarditis after receiving at least 1 dose of the Pfizer-BioNTech COVID-19 vaccine and among individuals diagnosed with myocarditis and/or pericarditis who had no prior COVID-19 vaccination, using a cohort study design.
Secondary study objective
? To examine and identify potential risk factors for myocarditis and pericarditis, such as age, sex, Pfizer-BioNTech COVID-19 vaccination status, vaccine doses received (e.g., first, second, third, and booster doses), and history of COVID-19, using a cohort study design
Study design: This cohort study is nested in the ongoing retrospective cohort study (EUPAS41623) titled Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine. The parent study includes individuals across 5 European countries who receive at least 1 dose of the Pfizer-BioNTech COVID 19 vaccine, as well as individuals who did not receive a COVID-19 vaccine.
For the primary objective (natural history), the study will be conducted in the cohort of cases of myocarditis and of pericarditis identified in the full population of the parent study.
In the parent study component comparing risk of AESIs in vaccinated and unvaccinated individuals, the 2 groups are matched 1:1 on date of vaccination in the vaccinated group and date of study eligibility in the unvaccinated group. Individuals are also matched on age, sex, history of COVID-19, place of residence, history of influenza vaccination, pregnancy status, immunocompromised status, presence of pre-existing medical conditions, and socioeconomic status/education level. This matched population constitutes the cohort in which risk factors for myocarditis and pericarditis will be evaluated (secondary objective). The matching variables, vaccination status, and other baseline variables to be identified in a review of the medical literature will be considered as potential risk factors for the development of myocarditis and of pericarditis.
Population: The source population will comprise all individuals across 5 European countries (i.e., the Netherlands [NL], United Kingdom [UK], Italy [IT], Norway [NO], and Spain [ES]) who are registered in the health care database(s) used in the study and who are eligible to receive the Pfizer-BioNTech COVID-19 vaccine. The study period starts on the date of conditional approval of the Pfizer-BioNTech COVID 19 vaccine in each country: 01 December 2020 in UK and 21 December 2020 in NL, IT, ES, and NO. The study period will end on 31 December 2023, however, the end date may be earlier in some data sources depending on the latest date of data availability at that time.
Variables:
Exposure to vaccines will be assessed in each data source based on recorded prescription, dispensing, or administration of the Pfizer-BioNTech COVID-19 vaccine. Vaccine administration and date of vaccination will be obtained from all possible sources that capture COVID-19 vaccination.
Myocarditis/pericarditis: Standard algorithms for myocarditis and for pericarditis will be applied to participant data sources to identify potential cases. The potential cases of myocarditis or pericarditis will be validated against information available for each data source and classified based on the definitions of the Brighton Collaboration. Cardiac symptoms for myocarditis and pericarditis are acute chest pain or pressure; dyspnoea after exercise, at rest, or lying down; fatigue; diaphoresis; and sudden death. Other non-specific symptoms in adults are palpitations, abdominal pain, dizziness, syncope and cardiogenic shock, fatigue, oedema, and cough. In infants or young children, symptoms include irritability, vomiting, poor feeding, and sweating. The detection of these signs and symptoms during the validation process will be used to determine levels of certainty of the diagnosis.
Potential risk factors for myocarditis and pericarditis are demographics (such as male sex, young ages); status of Pfizer-BioNTech COVID-19 vaccination and non-COVID vaccinations; vaccine doses received (e.g., first, second, third, and booster doses); post-vaccination risk window of 1 14 days; history of COVID-19 and other infectious diseases; status of immunocompromising conditions and systemic immune-mediated diseases; and comedication use (prescriptions or dispensings only) during the year before time zero (defined as date of vaccination, or matched index date for comparator).
Treatments for myocarditis based on clinical presentation of mild symptoms include paracetamol and antivirals for viral myocarditis; immunosuppression treatment for autoimmune myocarditis; heart failure therapy (i.e., beta-blockers, diuretics, angiotensin-converting enzyme [ACE] inhibitors or angiotensin-II receptor blockers [ARBs], aldosterone agonists, cardiac glycosides or calcium-channel blockers); and procedures (i.e., pacemaker, implantable cardiac defibrillator, mechanical circulatory support, and heart transplantation).
Treatments for pericarditis include antimicrobial treatment (for pericarditis of proven infectious origin); anti-inflammatory treatment (non-steroidal anti-inflammatory drugs [NSAIDs] and colchicine [for recurrent pericarditis]); and procedures (i.e., intrapericardial administration of steroids; pericardioscopy for direct instillation of treatments into the pericardial space; pericardial drainage; subdiaphragmatic laparoscopic technique, video-assisted thoracoscopic technique, and pericardioscopy for easy drainage of effusion; pericardiocentesis; cardiac catheterisation during pericardiocentesis; balloon pericardial window formation; instillation of sclerosing agents or fibrinolytic agents; and pericardiectomy).
Potential outcomes for myocarditis that will be evaluated are recovery, survival, hospitalisations, sudden cardiac death, heart failure, cardiogenic shock, fulminant myocarditis, inflammatory cardiomyopathy, heart transplant, and arrhythmia.
Potential outcomes for pericarditis that will be evaluated are recovery, survival, hospitalisations, and chronic, restrictive, and recurrent pericarditis.
Data sources: The study will be performed using the following data sources: PHARMO (PHARMO Institute for Drug Outcomes Research) (NL), ARS Toscana (Agenzia Regionale di Sanità della Toscana) (IT), Pedianet/Health Search Database (HSD) (IT), EpiChron (EpiChron Research Group on Chronic Diseases) (ES), CPRD (Clinical Practice Research Datalink) (UK), the Norwegian health registers (NO), and SIDIAP (Sistema d’Informació per el Desenvolupament de la Investigació en Atenció Primària) [Information System for the Improvement of Research in Primary Care] (ES).
Study size: The study will be conducted in a source population of 38.9 million individuals captured across the electronic healthcare data sources. The 42-day risk of myocarditis has been reported to be 2.13 cases per 100,000 vaccinated individuals and about one-third of this in unvaccinated individuals. Therefore, we expect to identify approximately 469 cases of myocarditis among vaccinated individuals and 150 cases among unvaccinated individuals.
Data analysis:
Natural history of myocarditis and pericarditis (primary objective): Individuals will be followed through recovery, death, or end of study period, whichever occurs first. The distributions of vaccination status and other baseline characteristics will be described. For continuous variables, means, standard deviations and quartiles will be estimated. For categorical variables, counts and proportions will be estimated. The missingness of variables will also be described. The occurrence of the different treatments and outcomes during follow-up will be described using counts and proportions. Continuous variables (e.g., length of stay) will be described using means, standard deviations and quartiles. When appropriate, the occurrence of time-to-event outcomes (e.g., death) will be described using the Kaplan-Meier estimator or curve.
Analysis will be performed overall by sex and age, COVID-19 history, vaccination status, and time since vaccination.
Risk factors for myocarditis and pericarditis (secondary objective): All individuals in the matched cohort of the parent study will be followed from the date of matching (i.e., the date of vaccination for those in the vaccinated group and a matched calendar date in the unvaccinated group) until the earliest occurrence of the following:
? Diagnosis of myocarditis or pericarditis
? Death
? Administrative end of follow-up
? Receipt of a non-Pfizer-BioNTech COVID-19 vaccine
? Unvaccinated member of the pair is vaccinated with the Pfizer-BioNTech COVID-19 (both the unvaccinated and vaccinated individuals of the pair will be censored).
All baseline variables, including vaccination status, will be treated as potential risk factors or effect modifiers for the development of myocarditis and/or pericarditis. A regression-based predictive analysis will be conducted to identify the variables that better predict the diagnoses. The strength of the association between the risk factors and a diagnosis of myocarditis or pericarditis will be estimated via odds ratios or hazard ratios, as appropriate.

Debido al aniversario de los acontecimientos ocurridos hace un año con la explosión de la empresa Industrias Químicas del Óxido de Etileno que tuvo lugar en Tarragona, el 14 de enero de 2020, se ha vuelto a poner el foco en la preocupación por los posibles efectos adversos en la salud de la población que vive en las inmediaciones de los complejos petroquímicos. Varios estudios epidemiológicos demuestran una relación entre las emisiones de complejos petroquímicos y el aumento de sufrir enfermedades respiratorias y cáncer. Los biomarcadores son sustancias químicas indicadores de un estado o condición biológica utilizados en el diagnóstico, pronóstico y/o tratamiento de varias patologías o enfermedades. con la experiencia que tiene el grupo de TecnATox en la investigación del impacto en la salud de la industria petroquímica del Camp de Tarragona, proyecto se basa en la siguiente hipótesis: los residentes de El Morell y La Pobla que viven cerca del complejo petroquímico (grupo expuesto) tendrán elevados tanto los biomarcadores de respuesta como de efecto a la contaminación provocada por los complejos petroquímicos, en comparación con los residentes de Tortosa (Grupo Control). Este conocimiento beneficiará a la comunidad científica y a otras partes implicadas (público, autoridades, legisladores, etc.).

«Objetivo principal: Evaluar la efectividad de la intervención SinergiAPS (intervención de auditoría/ retroalimentación centrada en el paciente) en la reducción de hospitalizaciones evitables, y explorar los factores que afectan a su implementación.

Diseño: Ensayo clínico híbrido tipo 1, pragmático, múlticéntrico, abierto, con seguimiento a los 24 meses.

Ámbito, muestra y aleatorización: 118 centros de atención primaria de diversas CCAA de España serán aleatoriamente asignados (ratio 1:1) a dos grupos (control e intervención). El grupo intervención recibirá dos auditorías (basal e intermedia a los 12 meses). Dichas auditorías consistirán en la administración del cuestionario PREOS-PC (que mide la seguridad del paciente en base a las experiencias de los pacientes) a una muestra de 150 pacientes por centro. El grupo intervención recibirá informes de los resultados de ambas auditorías, junto a recursos dirigidos a facilitar el diseño e implementación de planes de acción. La intervención se desplegará a través de la herramienta web SinergiAPS, desarrollada y validada en proyectos previos. El grupo control tendrá acceso a la intervención tras la finalización del ensayo clínico (waitlist).

Variables resultado: Variable principal: tasa de hospitalizaciones evitables (extraída a través de CMBD). Secundarias: seguridad percibida por pacientes (PREOS-PC); cultura de seguridad del paciente percibida por los profesionales (cuestionario MOSPC); eventos adversos experimentados por los sanitarios (cuestionario ad hoc); número de acciones de mejora de seguridad (cuestionario ad hoc). Se realizarán dos evaluaciones: basal, y a los 24 meses.

Evaluación de la implementación: Utilizando como base el modelo CFIR, combinaremos técnicas de investigación cualitativa (30 entrevistas individuales, cuadernos de registro de implementación) y cuantitativa (cuestionarios a profesionales de centros intervención,
nivel de uso de la herramienta web SinergiAPS) para evaluar la implementación de SinergiAPS.
«

El tabaquisme és un problema de salut pública de primer ordre a nivell mundial. Diverses estratègies per deixar de fumar han demostrat efectivitat. Amb tot, deixar el tabac no és fàcil.
El treball presentat descriu l’eficàcia d’una intervenció personalitzada per deixar de fumar basada en subministrar informació personalitzada dels resultats d’una espirometria, afegida al consell sanitari habitual.
Es tracta d’un assaig clínic aleatoritzat, paral·lel, controlat i multicèntric (registre ClinicalTrial NCT01194596), on van participar 12 CAPs de l’ICS-Camp de Tarragona. Els participants eren fumadors actius, d’entre 35-70 anys, sense malaltia respiratòria coneguda. Tots van rebre consell per deixar de fumar i avaluació de la funció pulmonar mitjançant espirometria. Posteriorment van ser aleatoritzats a intervenció (IG; van rebre informació detallada de l’espirometria), o control (CG; simplement es va informar dels resultats dins de valors normals). La variable principal d’estudi va ser l’abstinència prolongada (12 mesos) confirmada per COoximetria. Es van comparar 286 participants del IG amb 285 del CG, sense diferències significatives entre grups. L’abstinència prolongada va ser superior al IG en comparació al CG (5,6% vs. 2,1%; p=0,03). L’abstinència acumulada es va associar de forma significativa a la intervenció (HR=1,98; IC95%=1,29-3,04) després d’ajustar per diverses variables de confusió.
En conclusió, la intervenció amb espirometria va millorar l’efectivitat del consell sanitari habitual per deixar de fumar, duplicant la probabilitat d’abstinència a llarg termini. Aquests resultats afegeixen evidències al coneixement científic actual sobre les intervencions contra el tabac, i recolzen una estratègia senzilla d’implementar com activitat preventiva de salut pública a l’Atenció Primària

Antecedentes
La pandemia por SARS-CoV-2 condicionó una serie de cambios organizativos en las consultas que afectaron profundamente al seguimiento habitual de los pacientes crónicos en Atención Primaria (AP), entre estos, aquellos con enfermedad pulmonar obstructiva crónica (EPOC). A pesar de la carga de morbilidad potencial de esta enfermedad, un buen número de pacientes con EPOC no fueron diagnosticados o seguidos adecuadamente durante las sucesivas olas de COVID-19. En el momento actual, se proponen estrategias para retomar y mejorar su manejo.
Para diagnosticar EPOC es indispensable la realización de una espirometría forzada. Además, el deterioro de la función pulmonar se ha sugerido como una variable fundamental en la evaluación pronostica de la EPOC. Sin embargo, la espirometría de seguimiento no está bien implementada en AP. Aunque la mayoría de médicos de familia reconocen su utilidad, la dificultad para realizarla durante la consulta supone una barrera importante. Actualmente están disponibles pequeños espirómetros portátiles que permiten valorar de forma rápida y básica la función pulmonar. Estos aparatos son baratos y fáciles de usar, así que podrían integrarse en la consulta habitual de los pacientes EPOC.
Hipótesis
Una estrategia de mejora de la atención de los pacientes con EPOC, basada en las guías de práctica clínica actuales y que incorpora la medición de la función pulmonar, es útil, factible y efectiva para mejorar el control clínico en AP.
Objetivos
Evaluar una estrategia de mejora de la atención sanitaria de los pacientes con EPOC a partir de su identificación, programación y realización de visitas de seguimiento, de acuerdo con las recomendaciones de la guía GesEPOC y la valoración de la función pulmonar con el microespirómetro Vitalograph-COPD-6.
Diseño y ámbito
Proyecto de mejora de la calidad de la asistencia de los pacientes EPOC a partir de una intervención de diseño cuasi-experimental (sin grupo control) y con seguimiento prospectivo, en un entorno de práctica clínica real en diez centros de AP repartidos por toda Catalunya.
Intervenciones
Se implementará una estrategia para mejorar el seguimiento de los pacientes con EPOC, validada por el grupo de trabajo de Patología Respiratoria de la CAMFIC. Incluirá la formación de los participantes en el seguimiento de la EPOC y la evaluación funcional respiratoria. Los pacientes diagnosticados de EPOC que acepten participar (consentimiento firmado) serán citados para valoración basal clínica (propuesta GesEPOC) y de función pulmonar (microespirómetro Vitalograph-COPD-6), y para seguimiento prospectivo a los 3-6 meses.
Variables y análisis estadístico Se analizarán (por medio de test estadísticos habituales) indicadores de proceso de la intervención
de mejora realizada (número de pacientes evaluados, tiempo medio de consulta, número de pacientes en buen/mal control clínico/funcional y cambios introducidos en el tratamiento) y de seguimiento de los pacientes evaluados (número de pacientes que han mantenido un buen control o que han mejorado su grado de control, aparición de exacerbaciones y utilización adicional de recursos asistenciales). Resultados esperados e implicaciones en la práctica clínica Se espera que los resultados obtenidos confirmen que la estrategia de formación, identificación y seguimiento de la EPOC que incluye el uso de un microespirómetro mejora el grado de control de los pacientes y optimizar el uso de la espirometría en AP.
Palabras clave (keywords): Enfermedad Pulmonar Obstructiva Crónica –EPOC (Pulmonary Disease,
Chronic Obstructive); Estudios de Seguimiento (Follow-up Studies); Mediciones del Volumen Pulmonar (Lung Volume Measurements)

«The overarching goal of this study is to characterize the clinical course, outcomes and risk factors for myocarditis and pericarditis associated with Elasomeran vaccination. We want to investigate the natural course in terms of morbidity and to identify the relevant prognostic factors using the following study objectives:
Primary objectives:
1. To identify possible risk factors for post Elasomeran vaccine myocarditis and pericarditis including demographic characteristics, lifestyle factors, medical history, and vaccination characteristics
2. To characterize the clinical course of myocarditis and pericarditis of varying origin, including Elasomeran-associated myocarditis and pericarditis, and myocarditis or pericarditis not associated with COVID-19 vaccines, and to identify prognostic factors in the course of myocarditis and pericarditis.
Secondary objectives:
1. To identify whether there are differences in the clinical course or risk factor profile between Elasomeran-associated myocarditis and pericarditis, and myocarditis and pericarditis not associated with COVID-19 vaccines
2. If severe cases or cases with sequelae are identified, identify risk factors for severe Elasomeran-associated myocarditis and pericarditis
Study design:
The study will include two distinct designs to answer the primary and secondary objectives.
Case Cohort: To assess risk factors for development of post-vaccine myocarditis and pericarditis, a case-cohort of Elasomeran recipients will be defined in each participating database. This set will be used for the first primary objective.
VARIABLES:
Exposures: The main goal of interest is vaccination with any dose of Elasomeran.
Outcomes: Myocarditis and pericarditis cases will be confirmed based on adjudication criteria similar to the US CDC case definition; Probable and Definite cases will be included.
DATA SOURCES: This study is planned as analysis of routinely collected health data in five secondary automated electronic data sources in four countries (Denmark, Norway, Spain, and the UK).
STUDY SIZE: Considering the type of investigation, a traditional sample size calculation cannot be provided.
DATA ANALYSIS: In the Elasomeran-exposed case-cohort study, all cases of myocarditis, pericarditis and the control population will be described with respect to demographic characteristics, lifestyle factors or proxy variables of lifestyle factors (depending on the availability in each database), medical history and vaccination characteristics.»

Implementation of the study ind IDIAP Jordi Gol include three stages:
*Stage One: Identification of cases
-We will use the Myocarditis and Pericarditis case identification data dictionary to identify cases using the ICD10CM codes provided.
-We will also collect demographic and the exposure variable (COVID-19 Vaccine) guided by the data dictionary.
*Stage Two: Case confirmation via chart review/review of clinical records
-Once we finish stage one, we will collect the information and fill the Myocarditis and Pericarditis case confirmation form in REDCap platform for the second stage which includes:
– Confirmation of cases via chart review/review of clinical records using Brighton Collaboration standards, in our case we will you use free text (MEAP).
-Additional data collection for association and descriptive analysis.
*Stage Three: Data analysis and submission of results o after data collection is complete, IDIAPJGol will send aggregate results trought DRE platform.
– R-scripts will be sent to IDIAP JGol research group to run and create the results.
– Results will be uploaded to DRE platform.
-All data will be and stored at local level.

Implementation of the study ind IDIAP Jordi Gol include three stages:
*Stage One: Identification of cases
-We will use the VITT case identification data dictionary to identify cases using the ICD10CM codes provided.
-We will also collect demographic and the exposure variable (COVID-19 Vaccine) guided by the data dictionary.
*Stage Two: Case confirmation via chart review/review of clinical records
-Once we finish stage one, we will collect the information and fill the VITT case confirmation form in REDCap platform for the second stage which includes:
– Confirmation of cases via chart review/review of clinical records using Brighton Collaboration standards, in our case we will you use free text (MEAP).
-Additional data collection for association and descriptive analysis.
*Stage Three: Data analysis and submission of results o after data collection is complete, IDIAPJGol will send aggregate results trought DRE platform.
– R-scripts will be sent to IDIAP JGol research group to run and create the results.
– Results will be uploaded to DRE platform.
-All data will be and stored at local level.

Implementation of the study ind IDIAP Jordi Gol include three stages:
*Stage One: Identification of cases
-We will use the GBS case identification data dictionary to identify cases using the ICD10CM codes provided.
-We will also collect demographic and the exposure variable (COVID-19 Vaccine) guided by the data dictionary.
*Stage Two: Case confirmation via chart review/review of clinical records
-Once we finish stage one, we will collect the information and fill the GBS case confirmation form in REDCap platform for the second stage which includes:
– Confirmation of cases via chart review/review of clinical records using Brighton Collaboration standards, in our case we will you use free text (MEAP).
-Additional data collection for association and descriptive analysis.
*Stage Three: Data analysis and submission of results o after data collection is complete, IDIAPJGol will send aggregate results trought DRE platform.
– R-scripts will be sent to IDIAP JGol research group to run and create the results.
– Results will be uploaded to DRE platform.
-All data will be and stored at local level.