A comparison of four self-controlled study designs in an analysis of COVID-19 vaccines and myocarditis using five European databases.

INTRODUCTION: The aim of this study was to assess the possible extent of bias due to violation of a core assumption (event-dependent exposures) when using self-controlled designs to analyse the association between COVID-19 vaccines and myocarditis. METHODS: We used data from five European databases (Spain: BIFAP, FISABIO VID, and SIDIAP; Italy: ARS-Tuscany; England: CPRD Aurum) converted to the ConcePTION Common Data Model. Individuals who experienced both myocarditis and were vaccinated against COVID-19 between 1 September 2020 and the end of data availability in each country were included. We compared a self-controlled risk interval study (SCRI) using a pre-vaccination control window, an SCRI using a post-vaccination control window, a standard SCCS and an extension of the SCCS designed to handle violations of the assumption of event-dependent exposures. RESULTS: We included 1,757 cases of myocarditis. For analyses of the first dose of the Pfizer vaccine, to which all databases contributed information, we found results consistent with a null effect in both of the SCRI and extended SCCS, but some indication of a harmful effect in a standard SCCS. For the second dose, we found evidence of a harmful association for all study designs, with relatively similar effect sizes (SCRI pre = 1.99, 1.40 - 2.82; SCRI post 2.13, 95 %CI - 1.43, 3.18; standard SCCS 1.79, 95 %CI 1.31 - 2.44, extended SCCS 1.52, 95 %CI = 1.08 - 2.15). Adjustment for calendar time did not change these conclusions. Findings using all designs were also consistent with a harmful effect following a second dose of the Moderna vaccine. CONCLUSIONS: In the context of the known association between COVID-19 vaccines and myocarditis, we have demonstrated that two forms of SCRI and two forms of SCCS led to largely comparable results, possibly because of limited violation of the assumption of event-dependent exposures.

Online platform for cardiopulmonary resuscitation and automated external defibrillator training in a rural area: a community clinical trial protocol.

INTRODUCTION: Sudden death resulting from cardiorespiratory arrest carries a high mortality rate and frequently occurs out of hospital. Immediate initiation of cardiopulmonary resuscitation (CPR) by witnesses, combined with automated external defibrillator (AED) use, has proven to double survival rates. Recognising the challenges of timely emergency services in rural areas, the implementation of basic CPR training programmes can improve survival outcomes. This study aims to evaluate the effectiveness of online CPR-AED training among residents in a rural area of Tarragona, Spain. METHODS: Quasi-experimental design, comprising two phases. Phase 1 involves assessing the effectiveness of online CPR-AED training in terms of knowledge acquisition. Phase 2 focuses on evaluating participant proficiency in CPR-AED simulation manoeuvres at 1 and 6 months post training. The main variables include the score difference between pre-training and post-training test (phase 1) and the outcomes of the simulated test (pass/fail; phase 2). Continuous variables will be compared using Student's t-test or Mann-Whitney U test, depending on normality. Pearson's χ2 test will be applied for categorical variables. A multivariate analysis will be conducted to identify independent factors influencing the main variable. ETHICS AND DISSEMINATION: This study adheres to the tenets outlined in the Declaration of Helsinki and of Good Clinical Practice. It operated within the Smartwatch project, approved by the Clinical Research Ethics Committee of the Primary Care Research Institute IDIAP Jordi Gol i Gurina Foundation, code 23/081-P. Data confidentiality aligns with Spanish and European Commission laws for the protection of personal data. The study's findings will be published in peer-reviewed journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER: NCT05747495.

Protocol for a multicentre and prospective follow-up cohort study of early detection of atrial fibrillation, silent stroke and cognitive impairment in high-risk primary care patients: the PREFA-TE study.

BACKGROUND: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Future estimations suggest an increase in global burden of AF greater than 60% by 2050. Numerous studies provide growing evidence that AF is not only associated with stroke but also with cognitive impairment and dementia. AIM: The main goal is to assess the impact of the combined use of cardiac rhythm monitoring devices, echocardiography, biomarkers and neuroimaging on the early diagnosis of AF, silent strokes and cognitive decline, in subjects at high risk of AF. METHODS AND ANALYSIS: Two-year follow-up of a cohort of individuals aged 65-85 years at high risk for AF, with no prior diagnosis of either stroke or dementia. The study involves baseline echocardiography, biomarkers, and neuroimaging, yearly cardiac monitoring, and semiannual clinical assessments. Different parameters from these tests will be analysed as independent variables. Throughout the study period, primary outcomes: new diagnoses of AF, stroke and cognitive impairment, along with any clinical and therapeutic changes, will be registered. A first descriptive and bivariate statistical analysis, appropriate to the types of variables, will be done. The information obtained from the data analysis will encompass adjusted risk estimates along with 95% confidence intervals. Event risk predictions will rely on multivariate Cox proportional hazards regression models. The predictive value of the model will be evaluated through the utilisation of receiver operating characteristic curves for area under the curve calculation. Additionally, time-to-event analysis will be performed using Kaplan-Meier curves. ETHICS AND DISSEMINATION: This study protocol has been reviewed and approved by the Independent Ethics Committee of the Foundation University Institute for Primary Health Care Research-IDIAP Jordi Gol (expedient file 22/090-P). The authors plan to disseminate the study results to the general public through various scientific events. Publication in open-access journals and presentations at scientific congresses, seminars and meetings is also foreseen. TRIAL REGISTRATION NUMBER: NCT05772806.

Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial.

BACKGROUND: The effectiveness of providing feedback on spirometry results for smoking cessation remains inconclusive according to the current evidence. OBJECTIVES: To assess the effectiveness of a motivational intervention based on spirometry results in achieving prolonged smoking abstinence (12 months post-intervention). DESIGN AND SETTING: A randomised, controlled, observer-blinded, multicentre clinical trial was conducted (from January 2012 to December 2015) in 20 primary healthcare centres in the Tarragona province, Spain. METHODS: Participants, active smokers aged 35-70 without known respiratory disease, were recruited from primary healthcare centres by family doctors and nurses. They were randomly assigned to either the intervention group (IG = 308) or the control group (CG = 306). Both groups received brief smoking cessation counselling. Additionally, the IG underwent spirometry and received detailed information about the results, including lung age. The primary outcome was prolonged abstinence, defined as lasting at least 12 months and validated through cotinine measurement in urine. RESULTS: The prolonged abstinence rate was 7.8% in the IG, compared to 2.6% in the CG (p = 0.004). At 12 months, in the multivariate analysis, the intervention was identified as an independent factor for smoking cessation (OR 2.8; 95%CI 1.2 to 7.7), a trend maintained throughout the follow-up (HR 2.74; 95%CI 1.13 to 6.62). Moreover, according to the Prochaska and DiClemente model, the preparation or action phase to quit was also associated with smoking cessation (HR 2.55, 95%CI 1.07 to 6.09). CONCLUSION: A primary care-delivered intervention involving brief counselling and detailed spirometry information proves effective in increasing abstinence rates among active smokers without known respiratory disease. Additionally, smoking cessation is also influenced by the individual's stage of change. TRIAL REGISTRATION: ClinicatTrials.gov NCT02153047.

Short and long-term predictors of pain severity and interference in primary care patients with chronic musculoskeletal pain and depression.

BACKGROUND: Chronic pain and depression are frequent comorbidities in primary care. Depression among other psychosocial factors play a role in the clinical course of chronic pain. OBJECTIVE: To study the short and long-term predictive factors of severity and interference of chronic pain in primary care patients with chronic musculoskeletal pain and major depression. METHODS: Longitudinal study of a cohort of 317 patients. The outcomes are severity and functional interference of pain (Brief Pain Inventory) measured at 3 and 12 months. We performed multivariate linear regression models to estimate the effects the explanatory baseline variables on the outcomes. RESULTS: 83% participants were women; average age was 60.3 years (SD = 10.2). In multivariate models, baseline pain severity predicted pain severity at 3 months (ß = 0.53; 95% CI = 0.37-0.68) and at 12 months (ß = 0.48; 95% CI = 0.29-0.67). Also, pain > 2 years of evolution predicted long term pain severity (ß = 0.91; CI95%=0.11-1.71). Baseline pain interference predicted interference at 3 and 12 months (ß = 0.27; 95%CI = 0.11-0.43 and ß = 0.21; 95%CI = 0.03-0.40, respectively). Baseline pain severity predicted interference at 3 and 12 months (ß = 0.26; 95%CI = 0.10-0.42 and ß = 0.20; 95%CI = 0.02-0.39, respectively). Pain > 2 years predicted greater severity and greater interference at 12 months (ß = 0.91; CI95%=0.11-1.71, and ß = 1.23; CI95%=0.41-2.04). Depression severity predicted more interference at 12 months (ß = 0.58; CI95%=0.04-1.11). Occupational status as active worker predicted less interference throughout the follow-up (ß=-0.74; CI95%=-1.36 to -0.13 and ß=-0.96; CI95%=-1.71 to -0.21, at 3 and 12 months). Currently working also predicts less pain severity at 12 months (ß=-0.77; CI95%=1.52 - 0.02). With regard to the psychological variables, pain catastrophizing predicted pain severity and interference at three months (ß = 0.03; 95% CI = 0.00-0.05 and ß = 0.03; 95% CI = 0.00-0.05), but not at long term. CONCLUSION: In a sample of adults with chronic pain and depression, this primary care study has identified prognostic factors that independently predict the severity and functional interference of pain. If confirmed in new studies, these factors should be targeted for individualized interventions. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02605278), registered 16/11/2015.

Mediterranean Diet and Lung Function in Adults Current Smokers: A Cross-Sectional Analysis in the MEDISTAR Project.

BACKGROUND: Previous studies have shown that adherence to the Mediterranean Diet (MeDi) has a positive impact on lung function in subjects with lung disease. In subjects free of respiratory diseases, but at risk, this association is not yet well established. METHODS: Based on the reference data from the MEDISTAR clinical trial (Mediterranean Diet and Smoking in Tarragona and Reus; ISRCTN 03.362.372), an observational study was conducted with 403 middle-aged smokers without lung disease, treated at 20 centres of primary care in Tarragona (Catalonia, Spain). The degree of MeDi adherence was evaluated according to a 14-item questionnaire, and adherence was defined in three groups (low, medium, and high). Lung function were assessed by forced spirometry. Logistic regression and linear regression models were used to analyse the association between adherence to the MeDi and the presence of ventilatory defects. RESULTS: Globally, the pulmonary alteration prevalence (impaired FEV1 and/or FVC) was 28.8%, although it was lower in participants with medium and high adherence to the MeDi, compared to those with a low score (24.2% and 27.4% vs. 38.5%, p = 0.004). Logistic regression models showed a significant and independent association between medium and high adherence to the MeDi and the presence of altered lung patterns (OR 0.467 [95%CI 0.266, 0.820] and 0.552 [95%CI 0.313, 0.973], respectively). CONCLUSIONS: MeDi adherence is inversely associated with the risk impaired lung function. These results indicate that healthy diet behaviours can be modifiable risk factors to protect lung function and reinforce the possibility of a nutritional intervention to increase adherence to MeDi, in addition to promoting smoking cessation.

[Influence of gender and place of residence differences on the evolution and mortality of ischemic cardiopathy in Catalonia: a population-based study.] / Influencia del género y el lugar de residencia sobre la evolución y mortalidad de la cardiopatía isquémica en Cataluña: un estudio de base poblacional.

OBJECTIVE: Some bibliography supports a diagnostic and therapeutic delay in women with high cardiovascular risk. The objective of this paper was to know the incidence of cardiovascular disease (CVD) and mortality in a cohort with Metabolic Syndrome (MetS); analyze possible differences in gender and place of residence, regarding the performance of primary angioplasties in patients with ischemic heart disease (IHD). METHODS: Population cohort study, with SIDIAP database (Sistema de Información para la Investigación en Atención Primaria), in primary care in Catalonia. We selected people of both sexes, between 35-75 years old, exempt from CVD at the beginning (2009), fulfilling MetS criteria (NCEP-ATPIII-National Cholesterol Education Program-Adult Treatment Panel III- criteria diagnoses). We performed descriptive statistics, and ANOVA and Chi-square test to evaluate differences between variables. RESULTS: 167,673 people met MetS criteria (5.2% of the population), 105,969 men (63.2%). 22% of the population belonged to rural areas. Those urban areas with the most socioeconomic differences (urban-1 and urban-5) exhibited the highest incidences of CVD and IHD. We registered 51,129 CVD (30.7%) of which 8,889 were acute myocardial infarctions (AMI) (5,3%) and 24,284 were IHD (14,5%). 1.758 primary angioplasties procedures were performed, 1,467 in men and 291 in women, representing, respectively, 4.4% and 0.9% (p<0.005). CONCLUSIONS: The incidence of IHD and AMI in subjects with MetS is high in Catalonia. There is a difference in the angioplasties performed, according to sex and place of residence. Probably a practical implication would be to detect IHD in time in women with MetS, so that they can benefit from revascularization therapy in the same way as men.

OBJETIVO: Existe bibliografía que apoya un retraso diagnóstico y terapéutico en mujeres con alto riesgo cardiovascular. El objetivo de este trabajo fue conocer la incidencia de la enfermedad cardiovascular (ECV) y la mortalidad en una cohorte con Síndrome Metabólico (SM), así como analizar posibles diferencias de género y lugar de residencia, respecto a la realización de angioplastias primarias en pacientes con cardiopatía isquémica (CI). METODOS: Se realizó un estudio de cohorte poblacional apoyándonos en la base de datos SIDIAP (Sistema de Información para la Investigación en Atención Primaria), en Atención Primaria de Cataluña. Seleccionamos personas de ambos sexos, entre 35-75 años, exentos de ECV al inicio (2009), cumpliendo criterios de SM (diagnósticos NCEP-ATPIII [National Cholesterol Education Program-Adult Treatment Panel III]). La variable resultado fue la incidencia a 10 años de ECV y la mortalidad global por toda causa. Registramos variables sociodemográficas (edad, sexo, fenotipo SM, índice socioeconómico MEDEA) y reperfusión coronaria. Se realizó estadística descriptiva, ANOVA y prueba de chi-cuadrado para verificar la diferencia entre variables. RESULTADOS: 167.673 personas cumplieron criterios de SM (5,2% de la población), de las cuales había 105.969 hombres (63,2%). El 22% de población pertenecía a áreas rurales. Aquellas áreas urbanas más dispares socioeconómicamente (urbana-1 y urbana-5), exhibieron las mayores incidencias de ECV y CI. Registramos 51.129 ECV (30,7%) de los cuales 8.889 fueron infartos agudos de miocardio (IAM; 5,3%) y 24.284 fueron CI (14,5%). Se realizaron 1.758 procedimientos de angioplastia primaria, 1.467 en hombres y 291 en mujeres, representando respectivamente un 4,4% y un 0,9% (p<0.005). CONCLUSIONES: La incidencia de IAM y CI en sujetos con SM es alta en Cataluña. Existe diferencia estadísticamente significativa en las angioplastias realizadas, según sexo y lugar de residencia. Probablemente una implicación práctica sería detectar a tiempo la CI en mujeres con SM, para que puedan beneficiarse de la terapia revascularizadora igual que los hombres.

Influencia del género y el lugar de residencia sobre la evolución y mortalidad de la cardiopatía isquémica en Cataluña: un estudio de base poblacional / Influence of gender and place of residence differences on the evolution and mortality of ischemic cardiopathy in Catalonia: a population-based study

FUNDAMENTOS: Existe bibliografía que apoya un retraso diagnóstico y terapéutico en mujeres con alto riesgo cardiovascular. El objetivo de este trabajo fue conocer la incidencia de la enfermedad cardiovascular (ECV) y la mortalidad en una cohorte con Síndrome Metabólico (SM), así como analizar posibles diferencias de género y lugar de residencia, respecto a la realización de angioplastias primarias en pacientes con cardiopatía isquémica (CI). MÉTODOS: Información para la Investigación en Atención Primaria), en Atención Primaria de Cataluña. Seleccionamos personas de ambos sexos, entre 35-75 años, exentos de ECV al inicio (2009), cumpliendo criterios de SM (diagnósticos NCEP-ATPIII [National Cholesterol Education Program-Adult Treatment Panel III]). La variable resultado fue la incidencia a 10 años de ECV y la mortalidad global por toda causa. Registramos variables sociodemográficas (edad, sexo, fenotipo SM, índice socioeconómico MEDEA) y reperfusión coronaria. Se realizó estadística descriptiva, ANOVA y prueba de chi-cuadrado para verificar la diferencia entre variables. RESULTADOS: 167.673 personas cumplieron criterios de SM (5,2% de la población), de las cuales había 105.969 hombres (63,2%). El 22% de población pertenecía a áreas rurales. Aquellas áreas urbanas más dispares socioeconómicamente (urbana-1 y urbana-5), exhibieron las mayores incidencias de ECV y CI. Registramos 51.129 ECV (30,7%) de los cuales 8.889 fueron infartos agudos de miocardio (IAM; 5,3%) y 24.284 fueron CI (14,5%). Se realizaron 1.758 procedimientos de angioplastia primaria, 1.467 en hombres y 291 en mujeres, representando respectivamente un 4,4% y un 0,9% (p<0.005). CONCLUSIONES: La incidencia de IAM y CI en sujetos con SM es alta en Cataluña. Existe diferencia estadísticamente significativa en las angioplastias realizadas, según sexo y lugar de residencia...(AU)

BACKGROUND: Some bibliography supports a diagnostic and therapeutic delay in women with high cardiovascular risk. The objective of this paper was to know the incidence of cardiovascular disease (CVD) and mortality in a cohort with Metabolic Syndrome (MetS); analyze possible differences in gender and place of residence, regarding the performance of primary angioplasties in patients with ischemic heart disease (IHD). METHODS: Population cohort study, with SIDIAP database (Sistema de Información para la Investigación en Atención Primaria), in primary care in Catalonia. We selected people of both sexes, between 35-75 years old, exempt from CVD at the beginning (2009), fulfilling MetS criteria (NCEP-ATPIII-National Cholesterol Education Program-Adult Treatment Panel III- criteria diagnoses). We performed descriptive statistics, and ANOVA and Chi-square test to evaluate differences between variables. RESULTS: 167,673 people met MetS criteria (5.2% of the population), 105,969 men (63.2%). 22% of the population belonged to rural areas. Those urban areas with the most socioeconomic differences (urban-1 and urban-5) exhibited the highest incidences of CVD and IHD. We registered 51,129 CVD (30.7%) of which 8,889 were acute myocardial infarctions (AMI) (5,3%) and 24,284 were IHD (14,5%). 1.758 primary angioplasties procedures were performed, 1,467 in men and 291 in women, representing, respectively, 4.4% and 0.9% (p<0.005). CONCLUSIONS: The incidence of IHD and AMI in subjects with MetS is high in Catalonia. There is a difference in the angioplasties performed, according to sex and place of residence. Probably a practical implication would be to detect IHD in time in women with MetS, so that they can benefit from revascularization therapy in the same way as men.

Myocarditis and pericarditis associated with SARS-CoV-2 vaccines: A population-based descriptive cohort and a nested self-controlled risk interval study using electronic health care data from four European countries.

Background: Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity of events, especially in age- and sex-stratified analyses. Methods: Population-based cohort study with nested self-controlled risk interval (SCRI) using healthcare data from five European databases. Individuals were followed from 01/01/2020 until end of data availability (31/12/2021 latest). Outcome was first myo-/pericarditis diagnosis. Exposures were first and second dose of Pfizer, AstraZeneca, Moderna, and Janssen COVID-19 vaccines. Baseline incidence rates (IRs), and vaccine- and dose-specific IRs and rate differences were calculated from the cohort The SCRI calculated calendar time-adjusted IR ratios (IRR), using a 60-day pre-vaccination control period and dose-specific 28-day risk windows. IRRs were pooled using random effects meta-analysis. Findings: Over 35 million individuals (49·2% women, median age 39-49 years) were included, of which 57·4% received at least one COVID-19 vaccine dose. Baseline incidence of myocarditis was low. Myocarditis IRRs were elevated after vaccination in those aged < 30 years, after both Pfizer vaccine doses (IRR = 3·3, 95%CI 1·2-9.4; 7·8, 95%CI 2·6-23·5, respectively) and Moderna vaccine dose 2 (IRR = 6·1, 95%CI 1·1-33·5). An effect of AstraZeneca vaccine dose 2 could not be excluded (IRR = 2·42, 95%CI 0·96-6·07). Pericarditis was not associated with vaccination. Interpretation: mRNA-based COVID-19 vaccines and potentially AstraZeneca are associated with increased myocarditis risk in younger individuals, although absolute incidence remains low. More data on children (≤ 11 years) are needed.

Effectiveness of an App for tobacco cessation in pregnant smokers (TOBBGEST): study protocol.

BACKGROUND: Tobacco consumption during pregnancy is one of the most modifiable causes of morbidity and mortality for both pregnant smokers and their foetus. Even though pregnant smokers are conscious about the negative effects of tobacco consumption, they also had barriers for smoking cessation and most of them continue smoking, being a major public health problem. The aim of this study is to determine the effectiveness of an application (App) for mobile devices, designed with a gamification strategy, in order to help pregnant smokers to quit smoking during pregnancy and in the long term. METHODS: This study is a multicentre randomized community intervention trial. It will recruit pregnant smokers (200 participants/group), aged more than 18 years, with sporadically or daily smoking habit in the last 30 days and who follow-up their pregnancy in the Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Departments. All the participants will have the usual clinical practice intervention for smoking cessation, whereas the intervention group will also have access to the App. The outcome measure will be prolonged abstinence at 12 months after the intervention, as confirmed by expired-carbon monoxide and urinary cotinine tests. Results will be analysed based on intention to treat. Prolonged abstinence rates will be compared, and the determining factors will be evaluated using multivariate statistical analysis. DISCUSSION: The results of this study will offer evidence about the effectiveness of an intervention using a mobile App in smoking cessation for pregnant smokers, to decrease comorbidity associated with long-term smoking. If this technology is proven effective, it could be readily incorporated into primary care intervention for all pregnant smokers. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT05222958 . Trial registered 3 February 2022.

Evolving mortality and clinical outcomes of hospitalized subjects during successive COVID-19 waves in Catalonia, Spain.

BACKGROUND: The changes in shield strategies, treatments, emergence variants, and healthcare pathways might shift the profile and outcome of patients hospitalized with COVID-19 in successive waves of the outbreak. METHODS: We retrospectively analysed the characteristics and in-hospital outcomes of all patients admitted with COVID-19 in eight university hospitals of Catalonia (North-East Spain) between Feb 28, 2020 and Feb 28, 2021. Using a 7-joinpoint regression analysis, we split admissions into four waves. The main hospital outcomes included 30-day mortality and admission to intensive care unit (ICU). FINDINGS: The analysis included 17,027 subjects admitted during the first wave (6800; 39.9%), summer wave (1807; 10.6%), second wave (3804; 22.3%), and third wave (4616; 27.1%). The highest 30-day mortality rate was reported during the first wave (17%) and decreased afterwards, remaining stable at 13% in the second and third waves (overall 30% reduction); the lowest mortality was reported during the summer wave (8%, 50% reduction). ICU admission became progressively more frequent during successive waves. In Cox regression analysis, the main factors contributing to differences in 30-day mortality were the epidemic wave, followed by gender, age, diabetes, chronic kidney disease, and neoplasms. INTERPRETATION: Although in-hospital COVID-19 mortality remains high, it decreased substantially after the first wave and is highly dependent of patient's characteristics and ICU availability. Highest mortality reductions occurred during a wave characterized by younger individuals, an increasingly frequent scenario as vaccination campaigns progress. FUNDING: This work did not receive specific funding.

Prenatal folic acid supplementation and folate status in early pregnancy: ECLIPSES study.

This research evaluates the prevalence of inadequate folate status in early pregnancy, the pattern of prenatal folic acid (FA) supplementation and associated factors in Spanish pregnant women from the ECLIPSES study, which included 791 participants prior gestational week 12. A cross-sectional evaluation of erythrocyte folate levels was performed at recruitment and used to calculate the prevalence of folate deficiency (erythrocyte folate < 340 nmol/l) and insufficiency (erythrocyte folate < 906 nmol/l). Sociodemographic and lifestyle data as well as information on prenatal FA supplementation were recorded. Descriptive and multivariate statistical analyses were performed. The prevalence of folate deficiency and insufficiency were 9·6 % and 86·5 %, respectively. Most of women used prenatal FA supplements, but only 6·3 % did so as recommended. Supplementation with FA during the periconceptional period abolished folate deficiency and reduced folate insufficiency. Prenatal FA supplementation with ≥1000 µg/d in periconceptional time and pregnancy planning increased erythrocyte folate levels. The main risk factor for folate insufficiency in early pregnancy was getting prenatal FA supplementation out of the periconceptional time (OR 3·32, 95 % CI 1·02, 15·36), while for folate deficiency they were young age (OR 2·02, 95 % CI 1·05, 3·99), and smoking (OR 2·39, 95 % CI 1·30, 4·37). In addition, social and ethnic differences according to folate status were also identified. As conclusion, periconceptional FA use is crucial for achieving optimal folate levels in early pregnancy. Pregnancy planning should focus on young women, smokers, those with low consumption of folate-rich foods, low socio-economic status or from ethnic minorities.

Adjusted Morbidity Groups and Intracerebral Haemorrhage: A Retrospective Primary Care Cohort Study.

BACKGROUND: Intracerebral haemorrhage rates are increasing among highly complex, elderly patients. The main objective of this study was to identify modifiable risk factors of intracerebral haemorrhage. METHODS: Multicentre, retrospective, community-based cohort study was conducted, including patients in the Adjusted Morbidity Group 4 with no history of intracerebral haemorrhage. Cases were obtained from electronic clinical records of the Catalan Institute of Health and were followed up for five years. The primary outcome was the occurrence of intracerebral haemorrhage during the study period. Demographic, clinical and pharmacological variables were included. Logistic regression analyses were carried out to detect prognostic variables for intracerebral haemorrhage. RESULTS: 4686 subjects were included; 170 (3.6%) suffered an intracerebral haemorrhage (85.8/10,000 person-year [95% CI 85.4 to 86.2]). The HAS-BLED score for intracerebral haemorrhage risk detection obtained the best AUC (0.7) when used in the highest complexity level (cut-off point ≥3). Associated independent risk factors were age ≥80 years, high complexity and use of antiplatelet agents. CONCLUSIONS: The Adjusted Morbidity Group 4 is associated with a high risk of intracerebral haemorrhage, particularly for highly complex patients and the use of antiplatelet agents. The risk of bleeding in these patients must be closely monitored.

Effectiveness of a Motivational Nutritional Intervention through Social Networks 2.0 to Increase Adherence to the Mediterranean Diet and Improve Lung Function in Active Smokers: The DIET Study, a Randomized, Controlled and Parallel Clinical Trial in Primary Care.

BACKGROUND: Diet can help preserve lung function in smokers, as well as aid individuals who avoid smoking. This study aimed to evaluate the effectiveness of a nutritional intervention, using the Social Networks 2.0 tool, to increase adherence to the Mediterranean diet (MD) and improve lung function in smokers without prior respiratory disease. METHODS: A randomized controlled parallel design was used. The participants were assigned to either the intervention or control group. Data from representative smokers without respiratory disease (n = 77) aged 18-70 years were analyzed. The participants completed a validated semi-quantitative food-frequency questionnaire, and their adherence to the diet was evaluated by using the questionnaire called the Mediterranean Diet Adherence Score (MEDAS, with 14 items), which considers ≥9 points to indicate high adherence. The lung function was assessed by spirometry. Associations among variables were determined by logistic regression. RESULTS: A comparison of the variables at the end of the study between the control and intervention groups showed that the intervention significantly increased adherence to the MD based on the MEDAS questionnaire (0.69 (2.1) vs. 2.05 (2.03); p = 0.009). Specifically, the consumption of fruits was increased after two years in both groups; however, a more significant increase was detected in the intervention group (121 (178) vs. 12.7 (167) in the control group; p-value = 0.008). In the unadjusted analysis, the intervention only showed a statistical significant increase in the score of adherence to the MD (ß: 1.36; 95% CI 0.35; 2.3; p = 0.009), and this increase was maintained after adjusting for age and sex (ß: 1.15; 95% CI 0.05; 2.2; p = 0.040) and after adjusting for various sociodemographic, lifestyle and anthropometric variables (ß: 1.17; 95% CI 0.02; 2.31; p = 0.046). The pulmonary function parameters improved more in the intervention group; however, no significant differences were observed between the two groups. CONCLUSIONS: A nutritional intervention based on a dietetic-nutritional education program resulted in a significant increase in adherence to the MD. However, some evidence suggests that an MD dietary intervention can improve lung function, but in our study, we were not able to demonstrate this. Further research is needed to obtain more robust data and confirm a possible benefit of the program before it can be extended to general practice.

Deprivation Index and Lifestyle: Baseline Cross-Sectional Analysis of the PREDIMED-Plus Catalonia Study.

This baseline cross-sectional analysis from data acquired in a sub-sample of the PREDIMED-Plus study participants aimed to evaluate the relation between the Composite Socioeconomic Index (CSI) and lifestyle (diet and physical activity). This study involved 1512 participants (759 (52.2%) women) between 55 and 80 years with overweight/obesity and metabolic syndrome assigned to 137 primary healthcare centers in Catalonia, Spain. CSI and lifestyle (diet and physical activity) were assessed. Multiple linear regression or multinomial regression were applied to the data. Cluster analysis was performed to identify dietary patterns. The multiple linear regression model showed that a high deprivation index was related to a higher consumption of refined cereals (11.98 g/d, p-value = 0.001) and potatoes (6.68 g/d, p-value = 0.001), and to a lower consumption of fruits (-17.52 g/d, p-value = 0.036), and coffee and tea (-8.03 g/d, p-value = 0.013). Two a posteriori dietary patterns were identified by cluster analysis and labeled as "healthy" and "unhealthy". In addition, the multinomial regression model showed that a high deprivation index was related to an unhealthy dietary pattern and low physical activity (OR 1.42 [95% CI 1.06-1.89]; p-value < 0.05). In conclusion, a high deprivation index was related to an unhealthy lifestyle (diet and physical activity) in PREDIMED-Plus study participants.

Association between Iron Status and Incident Type 2 Diabetes: A Population-Based Cohort Study.

Type 2 diabetes poses a major public health challenge. Here, we conducted a cohort study with a large sample size to determine the association of baseline serum ferritin (SF), a marker of iron status, with incident type 2 diabetes in primary healthcare patients in Catalonia, a western Mediterranean region. A total of 206,115 patients aged 35-75 years without diabetes and with available baseline SF measurements were eligible. The variables analyzed included sociodemographic characteristics, anthropometry, lifestyle, morbidity and iron status (SF, serum iron and hemoglobin). Incident type 2 diabetes during follow-up (2006-2016) was ascertained using the International Classification of Diseases, 10th edition. Cox proportional-hazards models adjusted for multiple baseline confounders/mediators were used to estimate hazard ratios (HRs). Over a median follow-up of 8.4 years, 12,371 new cases of type 2 diabetes were diagnosed, representing an incidence rate of 7.5 cases/1000 persons/year. Since at baseline, the median SF concentration was higher in subjects who developed type 2 diabetes (107.0 µg/L vs. 60.3 µg/L; p < 0.001), SF was considered an independent risk predictor for type 2 diabetes; the multivariable-adjusted HRs for incident type 2 diabetes across SF quartiles 1-4 were 1.00 (reference), 0.95 (95% CI = 0.85-1.06), 1.18 (95% CI = 1.65-1.31) and 1.51 (95% CI = 1.36-1.65), respectively. Our study suggested that higher baseline SF was significantly associated with an increased risk of new-onset type 2 diabetes in Catalan primary healthcare users, supporting the relevance of monitoring iron stores in order to improve the diagnosis and management of diabetes in clinical practice.

Association between the Potential Influence of a Lifestyle Intervention in Older Individuals with Excess Weight and Metabolic Syndrome on Untreated Household Cohabitants and Their Family Support: The PREDIMED-Plus Study.

This cross-sectional study aims to evaluate the association between the PREDIMED-Plus study lifestyle intervention and (i) adherence to the Mediterranean diet (MedDiet) and (ii) physical activity of cohabiting study participants, and to define the related social characteristics of the household members. Participants were a subsample of 541 cohabitants of the PREDIMED-Plus study. Adherence to the MedDiet, physical activity, anthropometric measurements, family function, and social support were assessed. Multiple linear regressions were applied to the data. Partners of the PREDIMED-Plus participants had higher adherence to the MedDiet compared to their sons/daughters (9.0 vs. 6.9 points). In comparison to partners with low adherence to the MedDiet, partners with high adherence were older, practiced more physical activity, ate more frequently with the PREDIMED-Plus participants, and had better family function (adaptability item). Compared to physically active partners, very active ones were older, more likely to be women, and had lower BMI and higher adherence to the MedDiet. In addition, they ate more frequently with the PREDIMED-Plus participants and had better family function. Using multiple lineal regressions, an increase in the adherence to the MedDiet of the PREDIMED-Plus participant, and better family function, were positively associated with their partner's adherence to the MedDiet. The PREDIMED-Plus intervention showed a positive association with adherence to the MedDiet of the study participants' partners. In addition, this association was influenced by the social characteristics of the household members.

Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial.

BACKGROUND: Mobile apps provide an accessible way to test new health-related methodologies. Tobacco is still the primary preventable cause of death in industrialized countries, constituting an important public health issue. New technologies provide novel opportunities that are effective in the cessation of smoking tobacco. OBJECTIVE: This paper aims to evaluate the efficacy and usage of a mobile app for assisting adult smokers to quit smoking. METHODS: We conducted a cluster randomized clinical trial. We included smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app. We carried out follow-up visits at 15, 30, and 45 days, and at 2, 3, 6, and 12 months. Participants of the intervention group had access to the Tobbstop mobile app designed by the research team. The primary outcomes were continuous smoking abstinence at 3 and 12 months. RESULTS: A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day. Of participants in the intervention group, 34.15% (97/284) did not use the app. The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01). Participants in the intervention group who used the app regularly and correctly had a higher probability of not being smokers at 12 months (OR 7.20, 95% CI 2.14-24.20; P=.001) than the participants of the CG. CONCLUSIONS: Regular use of an app for smoking cessation is effective in comparison with standard clinical practice. TRIAL REGISTRATION: Clinicaltrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421.