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.
...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.
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.
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.
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.
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.
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).
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.
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.
This work did not receive specific funding.
BackgroundAtrial 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.AimThe 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 analysisTwo-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 disseminationThis 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 numberNCT05772806.
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.
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.
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.
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 (β = 0.53; 95% CI = 0.37-0.68) and at 12 months (β = 0.48; 95% CI = 0.29-0.67). Also, pain > 2 years of evolution predicted long term pain severity (β = 0.91; CI95%=0.11-1.71). Baseline pain interference predicted interference at 3 and 12 months (β = 0.27; 95%CI = 0.11-0.43 and β = 0.21; 95%CI = 0.03-0.40, respectively). Baseline pain severity predicted interference at 3 and 12 months (β = 0.26; 95%CI = 0.10-0.42 and β = 0.20; 95%CI = 0.02-0.39, respectively). Pain > 2 years predicted greater severity and greater interference at 12 months (β = 0.91; CI95%=0.11-1.71, and β = 1.23; CI95%=0.41-2.04). Depression severity predicted more interference at 12 months (β = 0.58; CI95%=0.04-1.11). Occupational status as active worker predicted less interference throughout the follow-up (β=-0.74; CI95%=-1.36 to -0.13 and β=-0.96; CI95%=-1.71 to -0.21, at 3 and 12 months). Currently working also predicts less pain severity at 12 months (β=-0.77; CI95%=1.52 - 0.02). With regard to the psychological variables, pain catastrophizing predicted pain severity and interference at three months (β = 0.03; 95% CI = 0.00-0.05 and β = 0.03; 95% CI = 0.00-0.05), but not at long term.
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.
ClinicalTrials.gov (NCT02605278), registered 16/11/2015.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
IntroductionSudden 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.MethodsQuasi-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 disseminationThis 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 numberNCT05747495.
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;
< 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.
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.
BackgroundThe effectiveness of providing feedback on spirometry results for smoking cessation remains inconclusive according to the current evidence.ObjectivesTo assess the effectiveness of a ...motivational intervention based on spirometry results in achieving prolonged smoking abstinence (12 months post-intervention).Design and SettingA 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.MethodsParticipants, 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.ResultsThe 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).ConclusionA 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 RegistrationClinicatTrials.gov NCT02153047
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.
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.
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.
Clinicaltrials.gov ID NCT05222958 . Trial registered 3 February 2022.
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