There is an increasing prevalence of psychological issues in childhood. Lifestyle factors during pregnancy, including maternal nutrition, have been linked to children’s behavioural development. This study aims to assess the impact of adherence to the Mediterranean diet during pregnancy on the behavioural problems of children at the age of 4. A total of 231 mother-child pairs were assessed. Maternal adherence to the Mediterranean diet during pregnancy was estimated using a relative Mediterranean Diet Score (rMED). Behavioural outcomes were evaluated through the Child Behaviour Checklist 1 1/2–5, Teacher’s Report Form 1 1/2 -5, and Behaviour Rating Inventory of Executive Function-Preschool Version questionnaires. The results indicated that a higher rMED score during pregnancy was associated with a reduced probability of obtaining a clinical score for total problems (OR = 0.42; 95% IC from 0.21 to 0.85), including externalising (OR = 0.29; 95% IC from 0.14 to 0.62), attention problems (OR = 0.32; 95%IC from 0.15 to 0.70), attention-deficit/hyperactivity problems (OR = 0.36; 95% IC from 0.15 to 0.87), oppositional defiant problems (OR = 0.06; 95% IC from 0.06 to 0.75), and depressive problems (OR = 0.38; 95% IC from 0.15 to 0.96). This study highlights the importance of maternal diet, especially Mediterranean diet, during gestation for proper child development.
A high adherence to a Mediterranean diet during pregnancy has been associated with a reduction in behavioural problems in children at the age of 4, particularly in externalising problems such as attention-deficit/hyperactivity problems and depressive symptoms. These results highlight the critical role of prenatal nutrition for optimal child development. image
Maternal nutrition during pregnancy has a significant impact on children’s development. Previous studies showed that prenatal adherence to the Mediterranean diet is associated with beneficial outcomes for both mother and foetus and in children’s development outcomes. Adhering to a Mediterranean diet during pregnancy is related to lower behavioural problems, especially externalising and attention-deficit hyperactivity disorder, and psychological problems such as depression, in children at 4 years of age. Attention should be directed towards maternal nutrition during the prenatal period to ensure proper child neurodevelopment, encouraging mothers to follow healthy nutritional habits.

The initial APEAS study, conducted in June 2007, examined adverse events (AEs) in Spanish Primary Healthcare (PHC). Since then, significant changes have occurred in healthcare systems. To evaluate these changes, a study was conducted in the Camp de Tarragona PHC region (CTPHC) in June 2019. This cross-sectional study aimed to identify AEs in 20 PHC centres in Camp de Tarragona. Data collection used an online questionnaire adapted from APEAS-2007, and a comparative statistical analysis between APEAS-2007 and CTPHC-2019 was performed. The results revealed an increase in nursing notifications and a decrease in notifications from family doctors. Furthermore, fewer AEs were reported overall, particularly in medication-related incidents and healthcare-associated infections, with an increase noted in no-harm incidents. However, AEs related to worsened clinical outcomes, communication issues, care management, and administrative errors increased. Concerning severity, there was a decrease in severe AEs, coupled with an increase in moderate AEs. Despite family doctors perceiving a reduction in medication-related incidents, the overall preventability of AEs remained unchanged. In conclusion, the reporting patterns, nature, and causal factors of AEs in Spanish PHC have evolved over time. While there has been a decrease in medication-related incidents and severe AEs, challenges persist in communication, care management, and clinical outcomes. Although professionals reported reduced severity, the perception of preventability remains an area that requires attention.

OBJECTIVE: We studied whether the use of hydroxychloroquine (HCQ) for COVID-19 resulted in supply shortages for patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). METHODS: We used US claims data (IQVIA PHARMETRICS® Plus for Academics [PHARMETRICS]) and hospital electronic records from Spain (Institut Municipal d’Assistència Sanitària Information System [IMASIS]) to estimate monthly rates of HCQ use between January 2019 and March 2022, in the general population and in patients with RA and SLE. Methotrexate (MTX) use was estimated as a control. RESULTS: More than 13.5 million individuals (13,311,811 PHARMETRICS, 207,646 IMASIS) were included in the general population cohort. RA and SLE cohorts enrolled 135,259 and 39,295 patients, respectively, in PHARMETRICS. Incidence of MTX and HCQ were stable before March 2020. On March 2020, the incidence of HCQ increased by 9- and 67-fold in PHARMETRICS and IMASIS, respectively, and decreased in May 2020. Usage rates of HCQ went back to prepandemic trends in Spain but remained high in the United States, mimicking waves of COVID-19. No significant changes in HCQ use were noted among patients with RA and SLE. MTX use rates decreased during HCQ approval period for COVID-19 treatment. CONCLUSION: Use of HCQ increased dramatically in the general population in both Spain and the United States during March and April 2020. Whereas Spain returned to prepandemic rates after the first wave, use of HCQ remained high and followed waves of COVID-19 in the United States. However, we found no evidence of general shortages in the use of HCQ for both RA and SLE in the United States.

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.

(1) Background: Although DR screening is effective, one of its most significant problems is a lack of attendance. The aim of the present study was to demonstrate the effectiveness of our algorithm in predicting the development of any type of DR and referable DR. (2) Methods: A retrospective study with an 11-year follow-up of a population of 120,389 T2DM patients was undertaken. (3) Results: Applying the results of the algorithm showed an AUC of 0.93 (95% CI, 0.92-0.94) for any DR and 0.90 (95% CI, 0.89-0.91) for referable DR. Therefore, we achieved a promising level of agreement when applying our algorithm. (4) Conclusions: The algorithm is useful for predicting which patients may develop referable forms of DR and also any type of DR. This would allow a personalized screening plan to be drawn up for each patient.

INTRODUCTION: During the COVID-19 pandemic, EMA set-up a large-scale cohort event monitoring (CEM) system to estimate incidence rates of patient-reported adverse drug reactions (ADRs) of different COVID-19 vaccines across the participating countries. This study aims to give an up to date and in-depth analysis of the frequency of patient-reported ADRs after the 1st, 2nd, and booster vaccination, to identify potential predictors in developing ADRs and to describe time-to-onset (TTO) and time-to-recovery (TTR) of ADRs. METHODS: A CEM study was rolled out in a period ranging from February 2021 to February 2023 across multiple European countries; The Netherlands, Belgium, France, the United Kingdom, Italy, Portugal, Romania, Slovakia and Spain. Analysis consisted of a descriptive analyses of frequencies of COVID-19 vaccine-related ADRs for 1st, 2nd and booster vaccination, analysis of potential predictors in developing ADRs with a generalized linear mixed-effects model, analysis of TTO and TTR of ADRs and a sensitivity analysis for loss to follow-up (L2FU). RESULTS: A total of 29,837 participants completed at least the baseline and the first follow-up questionnaire for 1st and 2nd vaccination and 7,250 participants for the booster. The percentage of participants who reported at least one ADR is 74.32% (95%CI 73.82-74.81). Solicited ADRs, including injection site reactions, are very common across vaccination moments. Potential predictors for these reactions are the brand of vaccine used, the patient’s age, sex and prior SARS-CoV-2 infection. The percentage of serious ADRs in the study is low for 1st and 2nd vaccination (0.24%, 95%CI 0.19–0.31) and booster (0.26%, 95%CI 0.15, 0.41). The TTO was 14 h (median) for dose 1 and slightly longer for dose 2 and booster dose. TTR is generally also within a few days. The effect of L2FU on estimations of frequency is limited. CONCLUSION: Despite some limitations due to study design and study-roll out, CEM studies can allow prompt and almost real-time observations of the safety of medications directly from a patient-centered perspective, which can play a crucial role for regulatory bodies during an emergency setting such as the COVID-19 pandemic.

Background: The study of thoracic injuries and biomechanics during CPR requires detailed studies that are very scarce. The role of the heart in CPR biomechanics has not been determined. This study aimed to determine the risk factors importance for serious ribcage damage due to CPR. Methods: Data were collected from a prospective registry of out-of-hospital cardiac arrest between April 2014 and April 2017. This study included consecutive out-of-hospital CPR attempts undergoing an autopsy study focused on CPR injuries. Cardiac mass ratio was defined as the ratio of real to expected heart mass. Pearson’s correlation coefficient was used to select clinically relevant variables and subsequently classification tree models were built. The Gini index was used to determine the importance of the associated serious ribcage damage factors. The LUCAS (R) chest compressions device forces and the cardiac mass were analyzed by linear regression. Results: Two hundred CPR attempts were included (133 manual CPR and 67 mechanical CPR). The mean age of the sample was 60.4 +/- 13.5, and 56 (28%) were women. In all, 65.0% of the patients presented serious ribcage damage. From the classification tree build with the clinically relevant variables, age (0.44), cardiac mass ratio (0.26), CPR time (0.22), and mechanical CPR (0.07), in that order, were the most influential factors on serious ribcage damage. The chest compression forces were greater in subjects with higher cardiac mass. Conclusions: The heart plays a key role in CPR biomechanics being cardiac mass ratio the second most important risk factor for CPR injuries.

In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVID-19 vaccination cycle, as well as the administration of booster doses of different vaccine brands, in people with prior SARS-CoV-2 infection, as compared to prior infection-free matched cohorts of vaccinees. A web-based prospective study was conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries in the period February 2021-February 2023. A baseline questionnaire and up to six follow-up questionnaires collected data on the vaccinee’s characteristics, as well as solicited and unsolicited adverse reactions. Overall, 3886 and 902 vaccinees with prior SARS-CoV-2 infection and having received the first dose or a booster dose, respectively, were included in the analysis. After the first dose or booster dose, vaccinees with prior SARS-CoV-2 infection reported at least one ADR at a higher frequency than those matched without prior infection (3470 [89.6%] vs. 2916 [75.3%], and 614 [68.2%] vs. 546 [60.6%], respectively). On the contrary side, after the second dose, vaccinees with a history of SARS-CoV-2 infection reported at least one ADR at a lower frequency, compared to matched controls (1443 [85.0%] vs. 1543 [90.9%]). The median time to onset and the median time to recovery were similar across all doses and cohorts. The frequency of adverse reactions was higher in individuals with prior SARS-CoV-2 infection who received Vaxzevria as the first dose and Spikevax as the second and booster doses. The frequency of serious ADRs was low for all doses and cohorts. Data from this large-scale prospective study of COVID-19 vaccinees could be used to inform people as to the likelihood of adverse effects based on their history of SARS-CoV-2 infection, age, sex, and the type of vaccine administered. In line with pivotal trials, the safety profile of COVID-19 vaccines was also confirmed in people with prior SARS-CoV-2 infection.

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.

BackgroundATDOM is the Catalan home healthcare program at primary care level. Patients in the home care program are usually frail, elderly people with multiple comorbidities. They are often polymedicated, leading to a high risk of drug-related problems (DRPs). Our hypothesis is that the pharmacist-led individualized review of the pharmacotherapeutic plans of ATDOM patients will be effective in improving the quality of treatments by reducing DRPs in terms of indication, adequacy, effectiveness, and safety.MethodsAim: To compare the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients with usual management practice.Design: Pragmatic randomized clinical trial with a comparable control group, with prospective follow-up regarding the intervention on the adequacy of the pharmacological treatment of patients in the ATDOM program.Setting: Primary care teams in the Camp de Tarragona Primary Care Area, Tarragona, Spain.Participants: Four hundred and thirty-two ATDOM patients will be recruited, those who are over 65 years old and who are currently undergoing pharmacological treatment.Measures: Effectiveness of a six-month long intervention in reducing DRPs per patient and polypharmacy. Additionally, in the intervention group we will evaluate the implementation of the proposals for change or improvement made by the responsible physician.Analysis: The outcomes will be analyzed on an intent-to-treat basis and the analysis units will be the individual patients. Logistic regression and linear regression models will be used to evaluate the effects of the intervention on dichotomous and continuous variables versus the control arm.Ethics: The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAPJGol), Barcelona, (19/141-P).MethodsAim: To compare the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients with usual management practice.Design: Pragmatic randomized clinical trial with a comparable control group, with prospective follow-up regarding the intervention on the adequacy of the pharmacological treatment of patients in the ATDOM program.Setting: Primary care teams in the Camp de Tarragona Primary Care Area, Tarragona, Spain.Participants: Four hundred and thirty-two ATDOM patients will be recruited, those who are over 65 years old and who are currently undergoing pharmacological treatment.Measures: Effectiveness of a six-month long intervention in reducing DRPs per patient and polypharmacy. Additionally, in the intervention group we will evaluate the implementation of the proposals for change or improvement made by the responsible physician.Analysis: The outcomes will be analyzed on an intent-to-treat basis and the analysis units will be the individual patients. Logistic regression and linear regression models will be used to evaluate the effects of the intervention on dichotomous and continuous variables versus the control arm.Ethics: The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAPJGol), Barcelona, (19/141-P).MethodsAim: To compare the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients with usual management practice.
Design: Pragmatic randomized clinical trial with a comparable control group, with prospective follow-up regarding the intervention on the adequacy of the pharmacological treatment of patients in the ATDOM program.Setting: Primary care teams in the Camp de Tarragona Primary Care Area, Tarragona, Spain.Participants: Four hundred and thirty-two ATDOM patients will be recruited, those who are over 65 years old and who are currently undergoing pharmacological treatment.Measures: Effectiveness of a six-month long intervention in reducing DRPs per patient and polypharmacy. Additionally, in the intervention group we will evaluate the implementation of the proposals for change or improvement made by the responsible physician.Analysis: The outcomes will be analyzed on an intent-to-treat basis and the analysis units will be the individual patients. Logistic regression and linear regression models will be used to evaluate the effects of the intervention on dichotomous and continuous variables versus the control arm.Ethics: The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAPJGol), Barcelona, (19/141-P).MethodsAim: To compare the effectiveness of a standardized pharmaceutical intervention for the review and optimization of pharmacological treatments in ATDOM patients with usual management practice.Design: Pragmatic randomized clinical trial with a comparable control group, with prospective follow-up regarding the intervention on the adequacy of the pharmacological treatment of patients in the ATDOM program.Setting: Primary care teams in the Camp de Tarragona Primary Care Area, Tarragona, Spain.Participants: Four hundred and thirty-two ATDOM patients will be recruited, those who are over 65 years old and who are currently undergoing pharmacological treatment.Measures: Effectiveness of a six-month long intervention in reducing DRPs per patient and polypharmacy. Additionally, in the intervention group we will evaluate the implementation of the proposals for change or improvement made by the responsible physician.Analysis: The outcomes will be analyzed on an intent-to-treat basis and the analysis units will be the individual patients. Logistic regression and linear regression models will be used to evaluate the effects of the intervention on dichotomous and continuous variables versus the control arm.Ethics: The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAPJGol), Barcelona, (19/141-P).MethodsAim: To c