Felipe Villalobos Martínez

The main research question is: What is the occurrence of safety events of interest, in particular, preterm birth, preterm delivery or any reduction in time between vaccination and live and non-live births, among all pregnant women who receive ABRYSVO (and their offspring) compared to a matched group of pregnant women who do not receive ABRYSVO during pregnancy (and their offspring)?

Primary objective
The primary study objective is to estimate the incidence, birth prevalence, prevalence ratios and risk ratios (depending on the specific outcome) and time between vaccination and birth (live or non-live) of the following adverse pregnancy, maternal and birth outcomes in women who receive ABRYSVO during pregnancy (and their offspring), compared with a matched group of pregnant women who do not receive ABRYSVO during pregnancy (and their offspring):
• Pregnancy outcomes
o Preterm delivery or birth (less than 37 weeks) among livebirths:
? Extremely preterm delivery or birth (less than 28 weeks)
? Very preterm delivery or birth (28 to less than 32 weeks)
? Moderate to late preterm delivery or birth (32 to less than 37 weeks)
o Time between vaccination and birth among live and non-live births (vaccination date for unvaccinated pregnant woman is the vaccination date of their matched vaccinated pregnant woman)
o Stillbirth among live and non-live births

• Maternal outcomes during pregnancy
o Hypertensive disorders of pregnancy
o Guillain-Barré Syndrome (GBS)
• Birth outcomes (at birth)
o Low birth weight among live births
o Small for gestational age among live births

Secondary objectives
The secondary objectives are:
1. To estimate the incidence, birth prevalence, prevalence ratios and risk ratios (depending on the specific outcome) of the above mentioned pregnancy, maternal and birth outcomes and time between vaccination and birth (live or non-live) in immunocompromised pregnant women or women with high-risk pregnancies who receive ABRYSVO during pregnancy (and their offspring), compared with a matched group of immunocompromised pregnant women or women with high-risk pregnancies who do not receive ABRYSVO during pregnancy (and their offspring).
2. To estimate the prevalence ratio of preterm delivery or birth and time between vaccination and birth (live or non-live) between pregnant women who receive ABRYSVO (and their offspring) compared with a matched group of pregnant women who do not receive ABRYSVO during pregnancy (and their offspring), by week of gestation of vaccination.

On 23 August 2023, PF-06928316 (hereafter ABRYSVO) was approved by the European Commission for active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV), a major cause of respiratory illness in older adults. This marketing authorization is valid in all 27 European Union (EU) member states plus Iceland, Liechtenstein, and Norway. On 31 May 2023, the Food and Drug Administration (FDA) approved ABRYSVO for active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older.
The EU marketing authorization for ABRYSVO in older adults is based on evidence from the pivotal Phase 3 clinical trial, RENOIR (C3671013, NCT05035212) which evaluated the efficacy, immunogenicity, and safety of a single 120 µg dose of PF-06928316 or prefusion F vaccine in adults 60 years or older.
As immunocompromised, renally and hepatically impaired older adults were not included in clinical trials that supported regulatory approvals, the safety profile of ABRYSVO in these populations is unknown.
This protocol describes a post-authorization safety study (PASS) to assess the safety of ABRYSVO in immunocompromised, or renally or hepatically impaired adults aged 60 and older in select European countries and in the UK, with data sources that can capture vaccine exposure in the target populations, and where outcomes and key covariates can be ascertained. This study is an additional pharmacovigilance activity (Category 3 study) in the approved EU risk management plan (RMP) for ABRYSVO.
Research question and objectives
The research question is: What is the incidence of safety events of interest among immunocompromised, or renally or hepatically impaired adults aged 60 years and older who receive ABRYSVO compared to a relevant comparator group who does not receive ABRYSVO?
The primary study objective is:
To estimate the incidence rates and rate ratios of safety events of interest in immunocompromised, or renally or hepatically impaired adults aged 60 years and older who receive ABRYSVO compared to a relevant comparator group who does not receive ABRYSVO (evaluated as separate populations and if appropriate, as a combined population).
Study design
This is a retrospective, comparative cohort study using data access providers of the Vaccine Monitoring Collaboration for Europe (VAC4EU) that meet fit-for-purpose criteria. If appropriate, based on the outcome of interest, the study will also use a self-controlled risk interval (SCRI) design.
Population
The target population will consist of individuals who are immunocompromised, or renally or hepatically impaired (evaluated as separate populations and if appropriate, as a combined population) who are at least 60 years of age on the date of vaccination (i.e, index date for the vaccinated cohort) or on the matched index date (for the unvaccinated cohort), and who have at least 12 months of medical history in one of the data sources with no record of RSV vaccination in that 12 month period and who have at least one day of post-index follow up. Immunocompromised or renally impaired or hepatically impaired status will be ascertained via coded diagnoses, treatments, procedures, and/or laboratory values, as appropriate, at index date or in the 12-month baseline period prior to the index date.
Variables
The exposure of interest is ABRYSVO vaccination, which will be obtained from pharmacy dispensing records, general practice records, immunization registers, vaccination records, medical records, or other secondary data sources. Outcomes will be identified in participating databases with algorithms based on codes for diagnoses, procedures, and treatments. Standard algorithms for each outcome definition will be applied to participant data sources, based on the results of the ACCESS project, and will be tailored to the data source. Potential covariates may include the following information, as available in each data source: demographics; personal lifestyle characteristics; and clinical characteristics including comorbidities, comedication use, healthcare utilisation descriptors, other vaccinations, and surrogates of frailty. Covariates will be identified on the index date (or during the 12-month baseline period prior to the index date). These variables will be used to further characterize the patient populations of interest and/or to control for confounding.
Data sources
The study will utilise data from the following selected data sources: Clinical Practice Research Datalink (CPRD) Aurum (UK), Valencia Health System Integrated Database (VID) (ES), Sistema d’Informació per el Desenvolupament de la Investigació en Atenció Primària (SIDIAP) [Information System for the Improvement of Research in Primary Care] (ES), EpiChron Research Group on Chronic Diseases at the Aragon Health Sciences Institute (EpiChron) (ES), and Système National des Données de Santé (SNDS) (FR).
Study size
All individuals who meet the eligibility criteria during the study period in the select data sources will be included. The sample size will depend on the number of individuals administered ABRYSVO identified within the data sources during the study period, which will increase over time. The relative increases in rates to be detected will vary across outcomes of interest. For example, analyses using a comparative cohort design will have sufficient power (80%) to detect a 2-fold and 3-fold increased rate of arrhythmia associated with ABRYSVO, with a sample size of 1,178 and 393 individuals per cohort, respectively, assuming a baseline rate of 2,000 arrhythmia events per 100,000 person-years and equal numbers of individuals in the vaccinated and unvaccinated cohorts.
Data analysis
Baseline demographics and clinical characteristics for ABRYSVO vaccinated and unvaccinated individuals will be summarized using descriptive statistics. Descriptive statistics will also be used to summarize ABRYSVO uptake characteristics. Incidence rates per 1,000 patient years (and corresponding 95% CIs) will be calculated for all outcomes of interest in the ARBYSVO vaccinated and unvaccinated cohorts separately.
For the comparative cohort design, outcome specific incidence rates in the ABRYSVO vaccinated cohort will be compared to incidence rates in the unvaccinated cohort. Average treatment effect for the treated (ATT) weighting based on the propensity scores (PS) will be used to ensure baseline comparability between the vaccinated and unvaccinated cohorts. Stabilized inverse probability of censoring weighting (IPCW) will also be used if informative censoring between the cohorts is observed. After weighting, the distribution of baseline characteristics will be evaluated between the vaccinated cohort and the unvaccinated cohort, and variables that are inadequately balanced (standardized difference >10%) between the two cohorts will be included as regression model covariates in a doubly robust approach. Weighted Poisson regression models will be conducted, and incidence rate ratios and corresponding 95% confidence intervals (CIs) will be summarized.
For the SCRI design, the study population will include individuals who have received ABRYSVO, and experienced the specific outcomes of interest during the post-vaccination risk or control interval. Individuals who experienced a prespecified outcome following ABRYSVO vaccination serve as their own control by comparing the incidence of the outcome in the post-vaccination risk interval to the incidence of the outcome in a post-vaccination control interval using a conditional Poisson regression model. From this model, incidence rate ratios and 95% CIs will be reported.
Meta-analysis: Using the main estimates from each data source, appropriate random-effects meta-analytic methods may be used to obtain a combined effect estimate within each population of interest for both the comparative cohort and SCRI design analyses.

Import en USD!!

This proposal presents a framework for vaccine safety monitoring by leveraging the data, human resources, expertise, methods, and infrastructures that are available in the VAC4EU and EU PE&PV networks.
For this specific purpose, we included 10 pre-selected data sources from 7 countries whose data quality will be characterized using available INSIGHT tools (level 1-3 quality checks) that operate on the ConcePTION CDM structure. The source population comprises 68,300,000 persons. Fitness for purpose will subsequently be assessed using the data feasibility assessment tool by Gatto et al., and public external benchmarks of incidence and vaccination coverage, in compliance with the EMA data quality framework.
A selection of immune-mediated events will be agreed with EMA from a comprehensive list that we propose. Background incidence and prevalence rates of these events and their flares will be calculated, based on detailed algorithms and analysis of the contribution of single components of information to the overall risk estimates.
A case study to investigate the association between RSV vaccines and Guillain Barré Syndrome in a comparative cohort study, using a target trial emulation is proposed as an example of an optional service.
Studies will be conducted under the ENCePP code of conduct. Protocols, reports, code lists, clinical definition forms and phenotype algorithms, results and programs will be made publicly available with digital object identifiers in line with FAIR principles.
Data access providers for the optional service will be chosen based on fitness for purpose assessments and lag times to ensure at least 5 data sources, 2 of which with short lag times.
Objective 1: To provide and describe a network of real-world data sources for the evaluation of vaccine safety signals, and to assess its fitness-for-purpose.
Objective 2: To provide an estimation of the occurrence of flares of selected pre-existing chronic diseases using electronic healthcare data sources.
Objective 3: To provide (i) a critical review of existing case definitions for immunocompromised populations, and (ii) a consolidated approach to identify and characterise such populations in real-world data sources.

Rationale and background: In November 2021, World Health Organization (WHO) designated the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant B.1.1.529 a variant of concern and named it Omicron. The Omicron variant, and its descendant sub-lineages, such as BA.4-5, have since spread to become the dominant variant of the virus circulating worldwide. The Omicron variant has greatly increased transmissibility and immune-evasion capacity compared with prior circulating variants. In addition, there is evidence that the original mRNA vaccines provide lower protection against the Omicron variant.
Bivalent formulations (Comirnaty Original/Omicron BA.1 (bivalent BA.1) and Comirnaty Original/Omicron BA.4-5 (bivalent BA.4-5)) of Pfizer-BioNTech’s Coronavirus Disease 2019 (COVID-19) mRNA-based vaccine were authorised as booster doses in the European Union (EU) on 01 September 2022 and 12 September 2022, respectively. On 06 December 2022, the Emergency Task Force of the European Medicines Agency (EMA) concluded that “bivalent BA.4-5 may be used as a primary vaccination series in adult and children” who have not been previously vaccinated against SARS-CoV-2″.[1] Pfizer and Vaccine monitoring Collaboration for Europe (VAC4EU) are conducting this study to monitor the safety of these bivalent formulations in European countries.
Research question and objectives: Is there an increased risk of pre-specified adverse events of special interest (AESIs) after vaccination with bivalent BA.1 or bivalent BA.4-5 compared with no vaccination against COVID-19 among individuals with comparable vaccination histories?
Primary study objective To determine whether there is an increased risk of pre-specified AESIs following the administration bivalent BA.1 or bivalent BA.4-5 compared with not receiving any COVID-19 vaccine during follow-up.
Study design: A retrospective cohort design will be used to estimate the incidence of AESIs after receiving a Pfizer-BioNTech COVID-19 bivalent vaccine, and these incidences will be compared with those in a comparator group that did not receive any COVID-19 vaccine during follow-up. Exposed individuals will be matched to unexposed individuals using relevant individual characteristics listed below. For selected AESIs a self-controlled risk interval (SCRI) study design will also be used, when appropriate.
Population: The source population will comprise all individuals registered in each of the health care data sources who are eligible to receive bivalent BA.1 or bivalent BA.4-5. The study period will start on the date of availability of the bivalent BA.1, which was the first bivalent vaccine to receive authorisation in the EU (on 01 September 2022), in each participating country and will end on 31 August 2024 or the date of the latest data availability. BA.4-5 received authorisation in the EU on 12 September 2022.
Individuals will be evaluated for eligibility and time zero will be determined as the date of exposure (vaccination with bivalent BA.1 or bivalent BA.4-5. Matching will occur at time zero and follow-up will begin at time zero. Individuals who have received at least one dose of bivalent BA.1 or bivalent BA.4-5 will be included in the exposed cohort. Individuals who have not received a dose of any COVID-19 vaccine at time zero will be included in the unexposed cohort.
Variables: Exposure will be based on recorded prescription, dispensing, or administration of the bivalent BA.1 and bivalent BA.4-5 vaccines. Outcomes will be based on the AESIs proposed by the European Medicines Agency (EMA)-sponsored ACCESS project (vACcine COVID-19 monitoring readinESS) and also, for consistency, those included in the ongoing post-authorisation safety study of the Pfizer BioNTech COVID-19 monovalent vaccine (EUPAS41623). Clinical validation, using individual health records, will be carried out for specific AESIs. This manual review will be conducted by clinicians blinded to COVID-19 vaccine exposure. Confirmation of the certainty of an event diagnosis will be classified using available Brighton Collaboration case definitions and, those from other organisations, if Brighton Collaboration case definitions are not available.
Data sources: The study will be performed within the following selected data sources: Pedianet (IT), PHARMO Institute for Drug Outcomes Research (PHARMO) (NL), the Norwegian health registers (NHR) (NO), EpiChron Research Group on Chronic Diseases at the Aragon Health Sciences Institute (EpiChron) (ES), Sistema d’Informació per el Desenvolupament de la Investigació en Atenció Primària ( SIDIAP) [Information System for the Improvement of Research in Primary Care] (ES), and Clinical Practice Research Datalink (CPRD) (UK).
Study size: The sample size will be determined by the uptake of bivalent BA.1 and bivalent BA.4-5 during the study period.
Data analysis: Data from the matched cohort design will be analysed as follows:
• Conditional exchangeability: The pairs will be matched using several variables considered as potential confounders to ensure conditional exchangeability. Additional standard epidemiological methods, based on propensity scores, will be used to improve adjustment for confounding, if necessary.
• The effect estimates will be reported as risk ratios and risk differences (and their corresponding 95% CIs) for those exposed to a Pfizer-BioNTech COVID-19 bivalent vaccine compared with those not exposed to any COVID-19 vaccine during follow-up.
• Appropriate data analysis models will be used to estimate the incidence rate ratios of AESIs in the risk and the control windows in the SCRI study.

The SAFETY-VAC project assesses the feasibility of participating data sources to participate in vaccine safety studies using electronic healthcare databases in European countries. The primary objective is this specific study is i) to estimate the incidence rates and 6- and 12-month risks of flares of Graves´ disease, Hashimoto´s thyroiditis, polyarteritis nodosa, autoimmune hepatitis, rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, erythema nodosum, lupus erythematosus and ulcerative colitis using electronic healthcare data sources. The secondary objectives are i) to assess the contribution of different provenances of data to the incidence rates of flares, and ii) to estimate the incidence of flares of selected auto-immune diseases in selected subgroups, including pregnancy.

«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.»

Antecedents: La mort sobtada per aturada cardiopulmonar (ACP) fora de l’àmbit hospitalari esdevé un problema major de salut pública, essent una de les primeres causes de mortalitat a Espanya. Les actuals guies de reanimació cardiopulmonar (RCP) diuen que la implementació precoç de les pautes de RCP abans de l’arribada de l’equip del Servei d’Emergències Mèdiques (SEM) augmenta la supervivència les persones amb ACP. Per aquest motiu, l’actuació de les persones que presencien un cas d’ACP esdevé un factor clau. No obstant, la població general desconeix la realització de les maniobres de RCP i l’ús del desfibril·lador extern automatitzat (DEA). Un estudi previ de l’equip va comprovar l’eficàcia dels cursos presencials sobre RCP-DEA a una mostra de població general i va detectar un gran interès social. L’ús de noves tecnologies ha permès l’extensió de la informació i de les formacions virtuals, sent una eina eficaç en aprenentatge.
Hipòtesis: La formació online en maniobres de RCP-DEA és una eina eficaç per augmentar els coneixement i les competències en RCP-DEA a la població general.
Objectiu: Avaluar l’eficàcia de la formació online en RCP-DEA realitzada per participants del Camp de Tarragona.
Metodologia: Aquest estudi es desenvoluparà en 2 fases: Fase 1) Avaluació de l’eficàcia de la formació online en els coneixements en RCP-DEA; Fase 2) Avaluació de l’eficàcia de la formació online en maniobres RCP-DEA en simulació. Es recolliran dades mitjançat un qüestionari a l’inici de la formació online i al final d’aquesta, s’avaluarà presencialment la competència en RCP-DEA mitjançant un checklist realitzat per un professional. La variable principal serà la diferència de puntuació entre el test pre- i post-formació (fase 1) i la superació o no (apte/ no apte) de la prova simulada en maniquins (fase 2).
Es realitza una anàlisis descriptiva de la diferència de puntuació pre- i post formació online i del percentatge de participants aptes i no aptes en la simulació a curt i mig termini. Les variables contínues es compararan mitjançant la prova t de Student o la prova U-Man Whitney (segons normalitat). Per a les variables categòriques, s’utilitzarà la prova de Chi quadrat de Pearson. Es farà una anàlisi multivariada per determinar quins factors influeixen de manera independent a la variable principal.
Resultats esperats: S’espera que la formació online sobre RCP-DEA sigui eficaç per millorar els seus coneixements i competències en RCP-DEA a curt i mig termini.
Aplicabilitat i Rellevància: La valoració de l’eficàcia d’aquest curs permetrà que sigui estès a diferents territoris de la comunitat, contribuint en l’expansió de coneixement de les maniobres RCP-DEA.

Research question and objectives:
Research question: Is there a difference in the risk of selected adverse events of special interest (AESIs) after vaccination with BIMERVAX® compared with vaccination by other vaccines for the same indication?
Primary objectives:
?? To characterise recipients of BIMERVAX® in relation to demographics and clinical characteristics at the time of vaccination, including the following: pregnancy status, age of childbearing potential, immunocompromised status, comorbidities, presence of
autoimmune and inflammatory disorders, and interaction with other vaccines (influenza).
?? To estimate the risk ratio and risk difference of prespecified AESIs comparing recipients of BIMERVAX® with recipients of other COVID-19 vaccines with the same indication, using a cohort design.
?? To estimate the incidence rate ratio of selected AESIs comparing a prespecified risk interval following BIMERVAX® vaccination with a later post-risk interval, using a selfcontrolled risk interval (SCRI) design.
Secondary objectives (study size allowing):
?? To estimate the risk ratio and risk difference of prespecified AESIs comparing recipients of BIMERVAX® with recipients of other COVID-19 vaccines with the same indication, using a cohort design in subgroups defined by the following baseline variables:
pregnancy status, immunocompromised status, frailty due to comorbidities, presence of autoimmune or inflammatory disorders, prior use of influenza vaccine and calendar time.
?? To estimate the incidence rate ratio of selected AESIs comparing a prespecified risk interval following BIMERVAX® vaccination with a later post-risk interval, using an SCRI design in subgroups defined by the following baseline variables: immunocompromised status, frailty due to comorbidities, presence of autoimmune or inflammatory disorders, prior use of influenza vaccine and calendar time.Study design:
The study will comprise:
?? A vaccine utilisation study component, which will use a descriptive study design to characterise individuals at the time of vaccination
?? A component on comparative safety studies, including:
– A cohort design to estimate the incidence of AESIs after receiving a BIMERVAX® vaccine dose compared with the incidence in a comparator group vaccinated by other COVID-19 vaccines.
– A self-controlled risk interval design to evaluate the risk of AESIs in a time interval following the receipt of a BIMERVAX® vaccine (the risk interval) compared with the risk of the same AESI during a subsequent post-risk time interval (the control
interval).
Population: The eligible population for the vaccine utilisation study will be all individuals actively enrolled in each of the selected European health data sources for at least 12 months before receiving a dose of the BIMERVAX® vaccine within the study period. For the comparative safety studies, the main eligibility criterion will be receiving BIMERVAX® or other COVID-19 vaccine at baseline (matched cohort design) or receiving BIMERVAX® and have experienced an AESI during the risk or control interval (self-controlled risk interval design). The study period will begin from the date of first availability of the BIMERVAX® original vaccine in each participating data source/country and will end 36 months (48 months for pregnancy outcomes) after the start of data collection. The start of data collection will be anchored on the threshold of a total of 4,000 BIMERVAX® doses administered across the participating data sources.
Variables:
?? In the vaccine utilisation study, the following variables will be measured at the time of vaccination: demographics; pregnancy status and trimester of pregnancy, as feasible; immunocompromised status; comorbidities that may determine frailty; autoimmunity,
and inflammatory conditions; prior COVID-19 vaccination (brand, doses); prior use of other vaccines (influenza); comedications; and COVID-19 history.
?? In the comparative safety studies, exposures will be based on recorded prescription, dispensing, or administration of COVID-19 vaccines during the study period. The outcomes will be based on the BIMERVAX® risk management plan that included AESIs
proposed by the ACCESS project for a cohort and an SCRI study design. Key confounders will include demographics, COVID-19 history, vaccinations, personal lifestyle characteristics, comorbidities, comedications, immunocompromising conditions,
and others. Subgroups will be defined by baseline variables, such as immunocompromised status, vaccinations, and others.
Data sources: The planned data sources for this study, pending confirmation of vaccine rollout, are EpiChron (Spain), Information System for Research in Primary Care (SIDIAP) (Spain), and Valencia Health System Integrated Database (VID) (Spain). Rollout in other European countries will be monitored to evaluate other potential data sources.
Study size: The study size for both the vaccine utilisation study and the comparative safety studies will be determined by the uptake of BIMERVAX® in the participating data sources during the study period.
Data analysis: The vaccine utilisation study will summarise the variables of interest at the time of vaccination using standard measures of central tendency and of dispersion for continuous variables as well as counts and percentages for categorical variables.
The comparative safety cohort study will use matching and inverse probability weighting to adjust for the measured baseline confounders. Outcomes will be treated as time-to-event variables and will be analysed accordingly. Effect estimates will be provided as risk ratios and as risk differences scales.
The SCRI study will compare the risk of each AESI during a prespecified period following the index date (the “risk interval” during which there is a hypothesised increased risk of the outcome) with that of a self-matched “control interval,” used to assess the baseline risk of the outcome.

Els hàbits dietètics són reconeguts factors de riscs de diverses patologies respiratòries cròniques.[1]
Ambtot, l’impacte de la dieta en la preservació pulmonar no està ben establert.[2]
Amb l’objectiu de demostrar els beneficis de la dieta mediterrània (DieMet) sobre la funció
pulmonar, es va dissenyar un assaig clínic multicèntric en Atenció Primària.[3] L’equip investigador va
estar format per professionals sanitaris dels 20 CAPs que gestiona l’ICS a Tarragona, investigadors
de la Unitat de Recerca de l’IDIAPJGol i del Departament de Medicina de la URV.
Es van incloure pacients fumadors de 25-75 anys sense malaltia respiratòria coneguda, que van ser
assignats aleatòriament a grup control o intervenció (1:1). Al grup intervenció van rebre educació
nutricional para augmentat l’adherència a la DieMet mitjançant visites personalitzades, reforç
telefònic i accés a un blog d’informació dietètica. Al grup control van seguir la seva dieta habitual.
Tots els participants van rebre consell sanitari per deixar de fumar.
En una fase pilot (l’estudi DIET), es va demostrar que la intervenció proposada millorava els hàbits
dietètics, augmentant 2 punts l’adherència a la DieMet.[4] En una segona fase (l’estudi MEDIS-TAR),
es comparen els canvis entre grups respecte a la funció pulmonar (mesurada per espirometria) i
l’adherència a la DieMet (qüestionari validat de 14 ítems i determinacions bioquímiques).[5] Els
primers anàlisis mostren menor prevalença d’alteracions pulmonars dels participants amb més
adherència a la DieMet (reducció del 14,3%; p=0,004) i associació inversa entre la DieMet i la
presencia d’alteració pulmonar (OR:0,47-0,55).
Aquests resultats indican que comportaments dietètics saludables poden protegir el deteriorament
de la funció pulmonar i reforcen els beneficis de la seva promoció, conjuntament amb el
abandonament del tabac.

Antecedents:
Els centres d’atenció primària (AP) a Catalunya tenen experiència en la realització de projectes
comunitaris. No obstant, amb l’actual crisi ocasionada per la COVID-19 aquestes iniciatives
s’han vist limitades, debilitant la participació comunitària i allunyant als professionals de
salut de la comunitat. Aquest fet, ha tingut un major impacte als col?lectius més vulnerables i
ha augmentat entre d’altres, les desigualtats econòmiques, sent necessari establir mecanismes de
participació comunitària, l’aplicació de polítiques i intervencions sensibles localment atenent
a la diversitat dels contextos. Tot i que Catalunya, en comparació amb altres comunitats
autonòmiques, és pionera en la realització d’activitats comunitàries, encara és necessària la
participació de manera activa tant per part de la població com dels professionals d’AP. Això
permetrà reforçar la prescripció social i així pugui respondre a les particularitats i
necessitats locals i millorar la salut de les persones.
Mont-roig del camp té una població de 12460 habitants amb una població que ha augmentat els
darrers 5 anys i amb algunes peculiaritats: existeix més d’un grup urbà de població conferint
una dispersió poblacional, el 49% de la població és forana de Catalunya, té una població
estacional superior al 30% i aproximadament el 10% de la població viu sola, a més de tenir molts
serveis duplicats en els dos grups urbans més importants (Mont-roig i Miami). L’equip d’atenció
primària de Mont-roig del camp, amb amplia experiència en projectes comunitaris, pren el
lideratge mitjançant un treball col?laboratiu amb l’Ajuntament i altres entitats socials per
millorar la salut i el benestar de la població a la que atén.
Hipòtesis: Una plataforma digital en salut interactiva nodrida entre els residents i les
diferents entitats d’una població serà viable i identificarà actius socials i sanitaris que
permetrà fomentar activitats comunitàries per la millora de la seva salut i benestar.
Objectiu: Estudiar la viabilitat d’una plataforma digital en salut interactiva entre la població
i les seves entitats, que incorpori activitats comunitàries per fomentar la salut i benestar
d’aquesta població.
Metodologia: Es proposa un enfocament metodològic mixt convergent que combinen metodologia
qualitativa i quantitativa. La metodologia qualitativa inclou un treball de camp amb entrevistes
semiestructurades i grups focals que permeten l’obtenció d’informació i contextualització.
D’aquesta manera es podran identificar els actius socials i sanitaris per ser posteriorment
pilotats a la plataforma digital en salut per a l’avaluació i l’efecte de la població. La
metodologia quantitativa inclou l’avaluació dels principals indicadors de salut abans i després
de la utilització de la plataforma per mitjà de l’avaluació de la historia informatitzada i la
realització de qüestionaris; i dades sobre l’ús i identificació dels actius socials i sanitaris
de la plataforma l’estudi de i d’aquesta manera s’avaluarà l’impacte d’aquesta.
Resultats esperats: El principal resultat d’aquesta proposta és el disseny i implementació d’una
plataforma digital en salut mitjançant un esquema innovador contribuint a construir polítiques
més sensibles cap a les necessitats de la ciutadania, de les persones i col?lectius implicats,
que incorpora la participació ciutadana en la gestió i manteniment de les comunitats més fortes
i cohesionades. Aquest estudi permetrà comprovar la viabilitat d’una eina innovadora en salut
així com el seu efecte en el benestar i la salut d’una població. La seva avaluació permetrà
identificar noves necessitats, que contribuiran a una millor planificació de les polítiques
sanitàries.

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.

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.

RATIONALE AND BACKGGROUND: The novel coronavirus SARS-CoV-2, the cause of COVID-19, has resulted in a global pandemic. The Pfizer-BioNTech COVID-19 vaccine, tozinameran (Comirnaty®) 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.
RESEARCH QUESTION AND OBJECTIVES:
Is there an increased risk of select adverse events of special interest (AESI) after being vaccinated with the Pfizer-BioNTech COVID-19 vaccine?
OBJECTIVES
Primary study objective
To determine whether an increased risk of prespecified AESI exists following the administration of at least one dose the Pfizer-BioNTech COVID 19 vaccine using two approaches: (a) a cohort design comparing risk in vaccinated and non-vaccinated individuals and (b) a self-controlled risk interval (SCRI) design.
Secondary study objectives
— To estimate the incidence rates of prespecified AESI among individuals who receive at least one dose of the Pfizer-BioNTech COVID 19 vaccine using a cohort study design.
— To describe the incidence rates and determine whether an increased risk of prespecified AESI exists following the administration of at least one dose the Pfizer-BioNTech COVID 19 vaccine compared with a matched comparator group with no COVID 19 vaccination within subcohorts of interest (i.e., individuals who are immunocompromised, individuals who are frail and have comorbidities, individuals diagnosed with previous COVID 19 infection, and age-specific groups) in Europe using a cohort study design and/or a SCRI design.
— To determine whether an increased risk of prespecified AESI exists following the administration of at least one dose of the Pfizer-BioNTech COVID 19 vaccine compared with no COVID-19 vaccination, in pregnant people and their neonates using a cohort study design.
— To characterise utilisation patterns of Pfizer-BioNTech COVID 19 vaccine among individuals within Europe, including estimating the proportion of individuals receiving the vaccine; two-dose vaccine completion rate and distribution of time gaps between the first and second doses; and demographics and clinical characteristics of recipients, overall and among subcohorts of interest, such as individuals who are immunocompromised, elderly, or have specific comorbidities.
STUDY DESIGN: A retrospective cohort design will be used to estimate the incidence of AESI after receiving vaccine doses and compare this incidence with that occurring in an unvaccinated comparator group matched on relevant individual characteristics (e.g., age, comorbidities). Where appropriate, the study will also use a SCRI design.
Population: The source population will comprise all individuals registered in each of the health care data sources who are eligible to receive the Pfizer-BioNTech COVID-19 vaccine. The study period will start on the date of launch of the Pfizer-BioNTech COVID-19 vaccine and will end on the date of the latest data availability or 31 Dec 2023. It is expected that follow-up will last for 2 years for AESI. People who are pregnant at time of vaccination or who become pregnant within two years of study start and their live born infants will be followed for an additional 12 months to collect information about birth outcomes and linked infant outcomes.
VARIABLES: Exposure will be based on recorded prescription, dispensing, or administration of the Pfizer-BioNTech COVID-19 vaccine. Vaccine administration and date of vaccination should be obtained from all possible sources that capture COVID-19 vaccination. The outcomes will be based on the AESI proposed by the European Medicines Agency (EMA) sponsored ACCESS project (vACcine COVID-19 monitoring readinESS). AESI will be identified based on patient profile review of electronic records by health care professionals. In addition, manual review of patient charts conducted by clinicians blinded to COVID-19 vaccine exposure will be performed. Confirmation of an event diagnosis will be classified against existing definitions of the Brighton Collaboration and those currently being developed. Key covariates include demographics; COVID-19 history, as available in each data source (will be used to define a subgroup of interest); personal lifestyle characteristics; comorbidities; immunocompromising conditions (will be used to define subgroups for secondary analyses); comedication use during the year before time zero (prescriptions or dispensing, no over-the-counter medication use); health care utilisation descriptors; other vaccinations; and surrogates of frailty.
Data sources: The study will be performed within the following selected data sources: PHARMO (PHARMO Institute for Drug Outcomes Research) (NL), ARS Toscana (Agenzia Regionale di Sanita’ della Toscana) (IT), Pedianet/Health Search Database (HSD) (IT), EpiChron (EpiChron Research Group on Chronic Diseases at the Aragon Health Sciences Institute) (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).
DATA ANALYSIS: The distributions of baseline characteristics at time zero by exposure group will be calculated to describe the study cohort and illustrate differences between the groups. For safety outcomes, the risk over specific time period(s), incidence rates and their corresponding 95% confidence intervals (CIs) will be computed after the receipt of a first dose and similarly after the receipt of a second dose. Crude risks, cumulative incidence over different time periods, and measures of association (risk differences and risk ratios) for each AESI after vaccination will be estimated in the entire population overall across both doses and separately by dose. Subgroup analyses will be conducted by subgroups defined by demographic and clinical characteristics as well as other covariates of interest. Individuals following each vaccination category under study (vaccination with at least one dose of the Pfizer-BioNTech vaccine vs. no vaccination) may have different characteristics that may determine their risk of AESI. To account for such potential confounding, propensity score methods will be used to estimate the adjusted risk ratios and 95% CIs. Using the main estimates from each data source, appropriate random-effects meta-analytic methods will be used to obtain a combined effect estimate. Where appropriate, the study will also use a SCRI design.

Rationale and background:
The global rapid spread of COVID-19 caused by the SARS-CoV2 triggered the need for developing vaccines to control for this pandemic. This study will create readiness and allows for rapid assessment of the association of adverse events of special interest (AESI) following COVID-19 vaccination.

Research question and objectives:
Readiness
The readiness phase will include the following objectives:
?To provide an overview of the methods for identification of COVID-19 vaccine exposure in the datasources
?To monitor the number of individuals exposed to any COVID-19 vaccine and to compare this to COVID-19 vaccine exposure (benchmark: https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab)
?To quantitatively evaluate different algorithms to identify adverse events by provenance in electronic health care data
?To conduct time-to-onset analyses for the AESI with respect to time since vaccination
?To assess the association between negative control events and the vaccines of interest using the SCRI to estimate systematic bias
?To test the impact of different comparators in the cohort design, using the negative control design
?To generate information for testing of methodological questions around misclassification of events/exposure

Rapid assessment studies
Primary objective
The primary objective for this rapid assessment study is to assess the potential association between the occurrence of specific AESIs and vaccination with COVID-19 vaccines within disease-specific risk periods in individuals exposed to the COVID-19 vaccines compared to other COVID-19 vaccine exposed individuals, or compared to a control window within the same individual.

Secondary objectives
The secondary objectives for the rapid assessments studies are:
?To assess the potential association between the occurrence of specific AESIs and vaccination with COVID-19 vaccines in the following subgroups
*immunocompromised persons
opersons with presence of co-morbidities elevating the risk of serious COVID-19
opersons with a history of diagnosed COVID-19 disease
opregnant women
oage groups (<18 , 18-64, 65 years and more) opatients with a prior history (ever) of that event more than a year before. Study design: A retrospective, multi-database, self-controlled risk interval or cohort study, conducted during the study period ranging from December 1, 2020 to latest availability of data. The self-controlled study will compare against non-vaccinated, and the cohort analysis against another COVID-19 vaccine. As part of the methods development work in the CVM project we will explore implementation of the use of an active comparator in the SCRI allowing comparison with the estimates from the cohort analysis , and different comparators for the cohort design. This will first be tested using the negative control events in the readiness phase and results may inform sensitivity analyses for the rapid evaluation studies. For death, the SCRI design will be adapted, and start at date of vaccination, with comparison of in different intervals of the postvaccination window. For events with high fatality rate a sensitivity analyses will be conducted with those that survive both the control and vaccination risk window Population: All subjects in the source population in the participating data sources who were in follow-up for at least 365 days on December 1, 2020 or were born into the cohort during the study period, and for whom vaccination data would be able to be obtained/linked. Variables: Variables of interest will be: ?Person-time: birth and death dates as well as periods of observation. ?Events: dates of medical and/or procedure and/or prescription/dispensing codes to identify AESI, COVID-19 and at-risk medical conditions. ?Vaccines: vaccine brands Data sources: The study will include data from 9 electronic health care data sources in 5 European countries (Italy, Netherlands, Spain, Norway, United Kingdom) that can link event data to vaccination data. Data sources will capture outcomes from hospitalization and/or general practice Study size: The source population will comprise approximately 40 million individuals Data analysis: In the readiness phase we will use negative control outcomes to assess the impact of misclassification of outcome and exposure, confounding and choice of comparators. Relative risks of specific AESI will be estimated for each specific brand of COVID-19 vaccine in comparison to non-vaccinated individuals (prior to vaccination or in non-vaccinated) and between different Covid-19 vaccines. For secondary analysis stratified analyses will be conducted.

Rationale and background: The novel coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the cause of coronavirus disease 2019 (COVID-19), has led to a global pandemic. AZD1222 is a vaccine developed to prevent COVID-19. Now known as COVID-19 Vaccine AstraZeneca, the vaccine has received emergency use authorisation in the United Kingdom (UK) and conditional approval by the European Commission. Several important potential risks have been identified based on the experience of other non-COVID-19 vaccines. The clinical development programme also had limited enrolment of certain patient populations, including pregnant or breastfeeding women, individuals who are immunocompromised, frail persons with comorbidities, those with autoimmune or inflammatory disorders, and use with other vaccines such as an influenza vaccine.
Research question and objectives: What are the incidence rates (IRs) of safety events of interest (based on adverse events of special interest [AESIs]) among individuals vaccinated with AZD1222 and in individuals who have not received any vaccination for COVID-19, overall and in subpopulations of interest, within selected European data sources? How do the IRs compare with one another? What are the baseline characteristics of individuals who received at least one dose of AZD1222? How many of them received a second dose of a COVID-19 vaccine, which vaccine did they receive, and when did they receive it?
Study design: A multi-country, retrospective cohort design will be used to estimate the incidence of AESIs after receiving AZD1222 and will compare this incidence with that occurring in an unvaccinated comparator group. Where appropriate, the study will also use a self-controlled risk interval (SCRI) design. The study period will start on 04 January 2021, when the vaccine was first used in the UK, and will end approximately 24 months after it is introduced in the last country among participating data sources.
Population: The source population will comprise all individuals registered in each of the health care data sources. An exposed cohort will be identified based on first vaccination with AZD1222 (index date). A concurrent comparator population will be identified among subjects who have not received any vaccination for COVID-19 matched on the vaccinee’s index date, age, and gender.
Variables: Receipt of AZD1222, other SARS-CoV-2 vaccines, and dates of vaccination will be obtained from all possible sources that capture COVID-19 vaccination, such as pharmacy dispensing records, general practice records, and immunisation registers. Safety outcomes include safety concerns and other AESIs. These outcomes will be identified using algorithms based on codes for diagnoses, procedures, and treatments in electronic data, and they will be defined uniformly across the data sources to the fullest extent possible. Operational case definitions from the ACCESS (vACcine Covid-19 monitoring readinESS) project will be implemented for the AESIs for which they have been developed.

RATIONALES AND BACKGROUND
The novel coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) causes coronavirus disease 2019 (COVID-19) and has led to a global pandemic. A mass vaccination campaign is currently underway in Europe. The mRNA-1273 vaccine, currently known as Spikevax,1 combines Moderna’s mRNA (messenger ribonucleic acid) delivery platform with the stabilised SARS-CoV-2 spike immunogen.

RESEARCH QUESTION AND OBJECTIVES
The overarching research question of this study: Is the occurrence of each adverse event of special interest (AESI) among persons vaccinated with Spikevax in Europe higher than the occurrence of that AESI that would have been expected in the same population in the absence of Spikevax?
Primary objective:
? To assess whether vaccination with Spikevax (by dose number where feasible and for any dose) is associated with increased rates of the AESI compared with the expected rates overall and stratified by country, sex, and age group.
Secondary objective:
? To assess whether vaccination with Spikevax is associated with increased rates of the AESI compared with the expected rates in subpopulations of interest: women of childbearing age, patients who are immunocompromised, patients previously diagnosed with COVID-19 infection, patients with unstable health conditions and morbidities, and patients with autoimmune or inflammatory disorders

STUDY DESIGN
This study will proceed in two phases: signal detection and signal evaluation.
For the signal detection stage, population-based, country-specific historical general population background rates of the AESI estimated in the participating databases/countries from 2017-2019 will be used as estimates of the expected rates in the unvaccinated. Rates in Spikevax recipients will be compared with the historical pre-pandemic rates. All comparisons will be conducted stratified by country, and within each country further stratified on sex, and age groups.
For the signal evaluation stage, conducted as needed based on findings from signal detection, analytic approaches will be selected based on the best methodologic fit for a given AESI. It is anticipated that a combination of self-controlled designs and cohort designs using either historical or concurrent unexposed comparators will be utilised.

POPULATION
Recipients of Spikevax will be identified between 6 January 2021 (date of the earliest approval of Spikevax in Europe) and 31 December 2022 and members of the database source population selected for each study design, including persons providing historical rates from 2017-2019, will be eligible for inclusion in the study and will constitute the overall cohort. Subgroups of interest will include adolescents, adults, elderly individuals, patients who are immunocompromised, patients previously diagnosed with COVID-19 infection, patients with unstable health conditions and morbidities, and patients with autoimmune or inflammatory disorders (defined below). Individuals receiving more than one type of COVID-19 vaccine will be excluded.

VARIABLES
Cohort members will be described with respect to available demographic characteristics, medical history, medication use, and receipt of other vaccines.
Outcomes of interest will include AESI primarily based on the list defined by the Safety Platform for Emergency vACcines (SPEAC) and endorsed for COVID-19 vaccine safety assessment by the WHO Global Advisory Committee for Vaccine Safety, by the EMA and by the US CDC. Other AESI may be considered if relevant signals appear during the study conduct or additional outcomes are added to the ACCESS protocol.

DATA SOURCES
This study is planned as analysis of routinely collected health data in secondary automated electronic data sources in Denmark, Italy, Norway, Spain, and the UK, selected based on availability of the required routinely collected data, including information on vaccine brand and frequency of data updates.

STUDY SIZE
As of 1 June 2021, it is estimated that the participating databases together will be able to identify at least 431,216 recipients of Spikevax.
For signal detection, incidence rates among Spikevax vaccinees will be computed and compared using relative or absolute measures of association against appropriate (e.g., age- sex- country-specific) general population background AESI rates.
For signal evaluation using self-controlled designs, the ratio between the incidence rate estimate in the risk period and the incidence rate estimate in the control period (incidence rate ratio) will be computed using conditional Poisson regression. For parallel cohort designs, appropriate contrasts will be estimated in exposed vs. unexposed cohorts, while controlling for measured confounding. Whenever appropriate incidence rate ratios (IRRs) will be estimated with appropriate 95% confidence intervals (CIs).

MILESTONES
Data collection will continue through 31 March 2023 with a final study report planned by December 2023.

RATIONALE AND BACKGROUND: Intensive monitoring of adverse reactions following immunization (AEFI) with COVID19 vaccines or cohort event monitoring has been performed on (sub)national levels. However, the exact data collection and analysis methods, study populations, and vaccines monitored varied. For the already marketed and upcoming COVID-19 vaccines, a pan-European cohort monitoring system is an important addition to existing spontaneous reporting systems for signal detection. This is of particular importance in fragile populations (e.g. immunocompromised) who may be at higher risk of developing vaccine-related adverse reactions as well as in those patients’ categories that have not been included in COVID-19 vaccine premarketing clinical studies (e.g. pregnant and lactating women, children and adolescents). This will enable the collection of patient-reported safety data to generate incidence rates of vaccine-related adverse reactions in those special cohorts.
OBJECTIVES
* Primary aim
– To generate and compare incidence rates of patient-reported adverse reactions of different COVID-19 vaccines across the participating countries in pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection
* Secondary aim
– Within each special cohort of vaccinees to identify potential predictors of the most frequently reported adverse reactions related to different COVID-19 vaccines.
STUDY DESIGN: Prospective cohort study in special populations (pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection). In different countries, on the national level, data will be prospectively collected, directly from a cohort of vaccine recipients. The common core data from different countries will be pooled, stratified by special cohort and analysed at the European level. The study is set up as a cohort monitoring for a duration of up until 6 months from the first dose vaccination date (except for pregnant women who will be followed up until 1.5 month after the pregnancy end).
* Vaccine recipients should be asked to fill in questionnaires at baseline, and 1 and 3 weeks after the first dose (and eventually the second dose), and 3 and 6 months after first dose vaccination. The exact timing of the sending of the third questionnaire will depend on the vaccination interval between two doses. As regards pregnant women a specific «»End of Pregnancy»» questionnaire will be additionally sent within 1.5 months from the estimated delivery to collect information on outcomes related to pregnancy and new-born.
STUDY POPULATION: Pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection who received COVID-19 vaccines first dose within 48 hours, consenting to participate and with a baseline questionnaire as well as questionnaires filled out after vaccination at multiple time points. Participants will be recruited before or at the moment of vaccination (as mentioned earlier within 48 hours from first dose vaccination at latest), which may differ per country and target group. There is the possibility of recruiting participants receiving a COVID-19 vaccine booster in the future, namely those who have already received a complete cycle of vaccination.
? Variables: Vaccine brand and batch number, ADRs, age, sex, height and weight, geographical area, medical history including information on comorbidities and concomitant diseases (e.g. diseases or drugs affecting the immune system, history of allergy and SARS-CoV-2 prior infection, etc.). In addition, for pregnant women: baseline variables for pregnancy (e.g., gestity, parity, previous pregnancy complications, ongoing pregnancy due date, etc.) and outcomes of pregnancy and new-born (pregnancy complications, end of pregnancy week, delivery mode, pregnancy outcomes and neonatal outcomes).
? ADRs: Suspected short- and medium/long-term adverse reactions that are reported after each dose of COVID-19 vaccination (as both solicited and unsolicited events) by the participant. All serious adverse reactions will be assessed by a qualified assessor, taking into account all information including possible uploads of documents by participants or comments on these events. When consent has been given by a participant, follow-up will be requested by e-mail for verification and upgrading of the clinical documentation grade. Otherwise, serious ADR assessment will be carried out by regional center of pharmacovigilance or local pharmacovigilance responsible person, in agreement with national pharmacovigilance legislation. Outcomes of pregnancy and new-born will also be explored in pregnant women.
DATA SOURCES: Safety data can be directly reported by vaccine recipients in their local language using the Lareb Intensive Monitoring (LIM) web app or the ResearchOnline web app, which have been both built specifically for patient-reported outcomes using exactly the same structure. As regards pregnancy monitoring, only ResearchOnline will be used as collecting additionally information on pregnancy. Collected data from European countries using LIM/ResearchOnline web app can be stored in dedicated central databases.
STUDY SIZE: We aim to include overall up to 60,000 vaccine recipients belonging to the special cohorts from 9 European countries, with a maximum of up to 30,000 pregnant and lactating women, up to 10,000 children, up to 20,000 immunocompromised, up to 10,000 persons with history of SARS-CoV-2 infection, and up to 5,000 with a history of allergies.
DATA ANALYSIS: For each special cohort, adverse reaction incidence rates will be reported overall and stratified and compared across different vaccine brands, gender, age groups, and countries.

RATIONALE AND BACKGROUND
The novel coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) causes coronavirus disease 2019 (COVID-19) and has led to a global pandemic. A mass vaccination campaign is currently underway in Europe. The mRNA-1273 vaccine, currently known as Spikevax,1 combines Moderna’s mRNA (messenger ribonucleic acid) delivery platform with the stabilized SARS-CoV-2 spike immunogen, developed by NIAID.

RESEARCH QUESTION AND OBJECTIVES
The overarching research question is: is there a greater risk or prevalence of pregnancy complications, adverse pregnancy outcomes, or adverse neonatal outcomes following pregnancies exposed to Spikevax compared with pregnancies unexposed to Spikevax?
Primary objectives:
? To determine whether exposure to the Spikevax during pregnancy is associated with an increased risk of:
a. Pregnancy complications
b. Adverse pregnancy outcomes
c. Major congenital malformations in the offspring (overall and organ-specific if feasible)
d. Adverse neonatal outcomes
Secondary objectives
?To describe utilization of Spikevax in pregnancy

STUDY DESIGN
The maternal and pregnancy outcomes will be addressed using the prevalence study design; neonatal outcomes and pregnancy related death in the cohort design. In the routinely collected data, pregnancies are typically identifiable on the date of pregnancy end, either in a birth or in an abortive outcome. All identifiable pregnancies will be included, and their start and end dates will be determined based on the LMP or gestational age at end, depending on data availability. Outcomes examined in this design include gestational diabetes, hypertensive disorders of pregnancy, pregnancy-related death, fetal growth restriction/small for gestational age, spontaneous abortion, stillbirth, preterm birth, major congenital malformations, microcephaly, neonatal death, and termination of pregnancy for foetal anomaly (TOPFA).

POPULATION
This study will be multi-database, utilizing routinely collected health data of various types in five European countries: Denmark, Italy, Norway, Spain, and the United Kingdom. Pregnancies ending between 6 January 2021 (date of the earliest approval of the COVID-19 Moderna Vaccine in Europe) and 31 December 2022 will be identified and classified according to the exposure to the COVID-19 Moderna Vaccine, overall and according to the trimester of exposure. The study period may be extended if the size of the study population is insufficient to study specific outcomes of interest.
The study population will encompass all pregnancies, identifiable in the databases, ending in a live or still birth, a spontaneous abortion, or an induced abortion, as identifiable in the participating databases. In Denmark and Norway, all pregnancies ending in a live or still birth, as well as pregnancies leading to a hospital encounter due to termination will be identifiable.

VARIABLES
Members of the analysis populations (pregnancies, births, depending on the outcome) will be described with respect to available demographic characteristics, medical history, medication use, receipt of other vaccines, and characteristics of the exposed pregnancy. Pregnancies and births will be classified according to the exposure status Spikevax, overall and by trimester.
The outcomes of interest will include pregnancy complications, adverse pregnancy outcomes, and adverse neonatal outcomes.
Covariates will include maternal pre-pregnancy demographic and clinical characteristics, such as age, smoking, body mass index, chronic morbidities and medication use.

DATA SORUCES
This study is planned as analysis of routinely collected health data in secondary automated electronic data sources in Denmark, Italy, Norway, Spain, and the UK, selected based on availability of the required routinely collected data, including information on vaccine brand and frequency of data updates.

STUDY SIZE
It is estimated that the number of live births available for analysis will range between 20,000 to 100,000 depending on a data source.

DATA ANALYSIS
Counts and percentages will be presented for categorical variables (woman’s age at conception in categories). Means, standard deviations, medians and interquartile ranges will be presented for continuous variables (woman’s age at conception). The proportion of missing data will be described when appropriate. For pregnancy complications and adverse pregnancy outcomes, pregnancy will be the unit of observation; for neonatal outcomes, a newborn will be the unit of observation. For the outcomes of congenital malformations and stillbirth, the number at risk will be the total number of live or stillborn children.
Prevalence of each outcome will be computed as number of observations with a given outcome divided by the total number of observations at risk. Prevalence of each outcome will be compared for exposed vs. unexposed pregnancies according to predefined exposure categories and using, whenever necessary, plausible exposure risk windows. For example, for assessing the outcome of congenital malformations, maternal gestational diabetes and hypertensive disorders, births or pregnancies will be classified based on their exposure in the first (or second, if relevant) trimester. For all other neonatal outcomes, exposure any time in pregnancy and per trimester may be considered.
For neonatal deaths, 28-day mortality risks will be computed and compared among live-born neonates. For pregnancy-related death, maternal mortality will be evaluated at any time while pregnant or up to 1 year after pregnancy end.
All relevant analyses will be stratified by country, maternal age, sex, calendar time, trimester and seasonality if applicable.

MILESTONES
Data collection will continue through 31 March 2023 with a final study report planned by December 2023.

Objetivos:
Evaluar la efectividad de una aplicación (app) para la abstinencia tabáquica en mujeres gestantes fumadoras. Objetivos específicos: 1)Determinar la efectividad de la intervención sobre la deshabituación del tabaco durante el embarazo, 2)Determinar la efectividad de la intervención a largo plazo (12 meses post intervención) y 3)Determinar la efectividad de la intervención sobre la reducción del tabaquismo en las embarazadas que continúen fumando.
Diseño:
Ensayo aleatorizado, multicéntrico de intervención comunitaria.
Ámbito:
Servicios de Atención a la Salud Sexual y Reproductiva de los Centros de Atención Primaria del Camp de Tarragona y Cataluña Central.
Población de estudio:
mujeres embarazadas que consulten por cualquier motivo, refieran haber fumado los 30 días previos y acepten participar.
Intervención:
todas las participantes recibirán la atención clínica habitual para dejar de fumar, el grupo intervención (GI) además tendrá acceso a una app para dejar de fumar basada en la gamificación. Variable resultado principal: abstinencia autoinformada prolongada, durante el embarazo y tras 12 meses de la intervención, se comprobará mediante coximetria durante el seguimiento y se verificara con test de cotinina al finalizarlo.
Análisis:
de grupos «»por intención de tratar»» se compararán tasas de abstinencia y se evaluarán los factores determinantes mediante estadística multivariante. Resultados esperados: La abstinencia en el GI será >5%, comparado con la práctica habitua

Research question and objectives:
Co-primary:
– To estimate the incidence rates of adverse events of special interest (AESI) in the general population by calendar year and data source over the period 2017 to 2020.
– To estimate the incidence of pregnancy outcomes among pregnant women aged between 12 to 55 years old by calendar year and data source over the period 2017 to 2020.
– To estimate the weekly and monthly incidence rates of COVID-19 (overall and by severity level) in 2020 by data source.
– To estimate the monthly incidence rates of multisystem inflammatory syndrome in children (MIS-C) aged between 0 to 19 years old in 2020 by data source.
Secondary:
– To estimate the incidence rates of AESI in the general population by calendar year, sex, age group, and data source over the period 2017 to 2020.
– To estimate the incidence rates of AESI in the general population by month, sex, age group, and data source over the period 2017 to 2020.
– To estimate the incidence rates of multisystem inflammatory syndrome (MIS-C) in children in 2020 by month, sex, age group, and data source.
– To estimate the prevalence of high-risk medical conditions for developing severe COVID-19 by year and data source over the period 2017 to 2020.
– To estimate the incidence rates of AESI in the at-risk population for developing severe COVID-19 by calendar year, sex, age group, and data source over the period 2017 to 2020.

Study design: A retrospective multi-database dynamic cohort study, conducted during the years 2017 to 2020, including the period of SARS-CoV-2 circulation in Europe until the date of last data availability for each data source.

Population: The study population will include all individuals observed in one of the participating data sources for at least one day during the study period (01 January 2017 – last data availability) and who has at least 1 year of data availability before cohort entry, except for individuals with data available since birth.

Variables:
– Person-time: birth and death dates as well as periods of observation.
– Events: dates of medical and/or procedure and/or prescription/dispensing codes to identify AESI, pregnancy outcomes and at-risk medical conditions.

L’obesitat és una malaltia crònica multifactorial de gran transcendència sociosanitària i econòmica. L’obesitat posseeix una important agregació familiar, pel que s’ha de tractar com un problema de salut familiar. Així són necessàries estratègies per fomentar l’expansió (efecte «»halo»») dels tractaments individuals a nivell de l’estil de vida en el context de l’entorn familiar.

Objectius
1. – Estudi longitudinal de l’efecte halo produït per intervencions de canvis d’estil de vida:
1.1 – Analitzar canvis antropomètrics, d’hàbits dietètics, d’adherència a DMed, i d’activitat física observats en el nucli familiar dels pacients obesos/sobrepès que reben una intervenció de canvis d’estil de vida.
1.2. – Analitzar diferències en l’efecte halo en funció del tipus d’intervenció (intensiva amb DMed hipocalòrica i activitat física versus recomanacions de DMed) comparant canvis antropomètrics, de conducta alimetària, d’hàbits dietètics, d’adherència a la DMed i d’activitat física.
1.3. – Analitzar l’associació dels canvis antropomètrics, conducta alimentària, d’adherència a DMed i d’activitat física de l’entorn familiar amb els canvis del participant.
1.4. – Estudiar si els canvis observats en l’entorn familiar estan associats al grau de parentiu, situació ponderal inicial dels familiars, patrons inicials de conducta alimentària i magnitud del pes perdut dels participants independentment del grup d’intervenció.
2. – Estudiar l’agregació familiar dels pacients amb sobrepès/obesitat, analitzant l’associació entre familiars i pacients de l’estatus ponderal, conducta alimentària, adherència a la DMed i activitat física en un estudi transversal.
3. – Analitzar les característiques dels entorns familiars que s’associen a una major o menor resposta dels pacients tractats a les intervencions, en un estudi transversal.

Mètodes:
En el marc de l’Estudi PREDIMEDpIus, un assaig clínic aleatoritzat, controlat i multicèntric en pacients amb sobrepès/obesitat i síndrome metabòlica, amb una intervenció intensiva sobre l’estil de vida (dieta mediterrània hipocalòrica i d’activitat física) versus grup control, es realitzaran dos sub-estudis als familiars: a/ estudi longitudinal amb 188 familiars (94 a cada grup) i b/ estudi transversal amb 1400 familiars (750 a cada grup). Es realitzaran mesures antropomètriques i es determinarà l’adherència a la dieta mediterrània, hàbits alimentaris, freqüència de consum d’aliments, qüestionaris de conducta alimentària i hàbits de pràctica d’activitat física.

Resultats esperats:
S’observaran canvis antropomètrics i en els hàbits d’estil de vida envers un patró més cardio- saludable, en els familiars de participants d’un assaig sobre estil de vida. I aquests canvis seran, així mateix, semblants als soferts pel seus parents.

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