BACKGROUND: The safety profile of COVID-19 vaccines in immunocompromised patients has not been comprehensively evaluated. AIM: To measure the frequency of patient-reported adverse drug reactions (ADRs) related to the first/second/booster dose of COVID-19 vaccine in immunocompromised subject versus matched cohort. As a secondary objective, the time course, evaluated as time to onset (TTO) and time to recovery (TTR), of COVID-19 vaccine-related ADRs was explored. METHODS: A prospective cohort study, based on electronic questionnaires filled by vaccinees from 11 European countries in the period February 2021 to February 2023 was conducted. All immunocompromised vaccinees who provided informed consent and registered to the project’s web-app within 48 h after first/booster vaccine dose administration of any EMA-authorised COVID-19 vaccine were recruited. Participants filled baseline and up to six follow-up questionnaires (FU-Qs) over 6 months from vaccination, collecting information on suspected COVID-19 vaccine-related ADRs. As a control group, non-immunocompromised vaccinees from the same source population were 1:4 matched by sex, age, vaccine dose, and brand. A descriptive analysis of demographic/clinical characteristics of vaccinees was conducted. Heatmaps of the frequency of solicited ADRs, stratified by gender and vaccine brand, were generated. Median TTO/TTR of reported ADRs were visualised using violin/box-plots. RESULTS: A total of 773 immunocompromised vaccines were included in the analyses. Most participants were females (F/M ratio: 2.1 and 1.6) with a median age of 56 (43-74) and 51 (41-60) years, at the first vaccination cycle and booster dose, respectively. Injection-site pain and fatigue were the most frequently reported ADRs in immunocompromised vaccinees with higher frequency than matched control, especially after the first dose (41.2% vs 37.8% and 38.2% vs 32.9%, respectively). For both cohorts, all solicited ADRs were more frequently reported in females than males, and in those who had received a first dose of the Vaxzevria vaccine. Dizziness was the most frequently reported unsolicited ADR after the first dose in both groups (immunocompromised subjects: 2.5% and matched controls: 2.1%). At the booster dose, lymphadenopathy (3.9%) and lymphadenitis (1.8%) were the most reported unsolicited ADRs for immunocompromised subjects and matched controls, respectively. A very low number of subjects reported adverse event of special interest (AESI) (2 immunocompromised, 3 matched controls) and serious ADRs (5 immunocompromised, 5 matched controls). A statistically significant difference among study cohorts was observed for median TTO after the booster dose, and for median TTR after the first vaccination cycle and booster dose (p < 0.001). CONCLUSION: The overall safety profile of COVID-19 vaccines in immunocompromised people was favourable, with minor differences as compared to non-immunocompromised vaccinees. Participants mostly experienced mild ADRs, mainly reported after the first dose of Vaxzevria and Jcovden vaccines. Serious ADRs and AESI were rare.

Background: Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs. those without a history of allergy. Methods: From February 2021 to February 2023, a web-based prospective study gathered vaccinee-reported outcomes using electronic questionnaires across eleven European countries. Baseline and up to six follow-up questionnaires captured data on vaccinee demographics, as well as both solicited and unsolicited adverse reactions. Results: Overall, 3476 vaccinees with a history of allergy were matched with 13,872 vaccinees from the general population at the first vaccination cycle and were included in the analysis. A total of 825 vaccinees with a history of allergy who had received a booster dose, matched to 3297 vaccinees from the general population, were included in the analysis. Higher rates of ADRs occurred after the first vaccination cycle compared to after the booster dose (64-91% vs. 56-79%). However, most reported ADRs were solicited and not serious, and no case of anaphylaxis was reported. Women and vaccinees with a history of allergy reported ADRs more frequently than men and the matched controls, respectively. Compared to other COVID-19 vaccines, a higher proportion of vaccinees experiencing at least one ADR following their first vaccination cycle was observed with Comirnaty and Vaxzevria. Statistically significant differences were observed among the study cohorts for median TTO after the second dose, and for median TTR following the first vaccination cycle and booster dose (p < 0.001). Conclusions: Typically, any drug or vaccine use carries a risk of severe allergic reactions, yet the benefits of vaccination generally outweigh these potential risks, as shown with the COVID-19 vaccines.

BackgroundMental health problems often begin in early childhood and could predict psychiatric and behavioral outcomes. Prenatal factors such as maternal nutrition have an impact on neurodevelopment. This study aims to investigate the association between maternal dietary patterns and emotional and behavioral problems in 4-year-old children.MethodsWithin a cohort of 205 mother-child pairs, three maternal dietary patterns were identified: ‘Sweet and Superfluous’, ‘Fish and Vegetables’ and ‘Meat and Cereals’. Child behavior was evaluated by means of the Child Behavior Checklist 1.5-5 (CBCL 1.5-5), the Teacher’s Report Form 1.5-5 (TRF 1.5-5), and the Behavior Rating Inventory of Executive Function – Preschool Version (BRIEF-P). Multivariable analysis determined associations between maternal dietary patterns and their children’s behavior.ResultsMaternal adherence to the ‘Sweet and Superfluous’ pattern was positively associated with externalizing and depressive problems in children. The ‘Meat and Cereals’ pattern was linked to a higher risk for attention, hyperactivity and depressive problems as somatic complaints. Conversely, the ‘Fish and Vegetables’ pattern was associated with a reduced risk of hyperactivity problems. All these associations were more pronounced in girls than in boys.ConclusionsMaternal diet during pregnancy is associated with the emotional and behavioral development of children at 4 years of age.ImpactPrevious research on prenatal dietary patterns and children’s behavior is inconclusive.In our study, children of mothers who had higher intakes of sugar and processed foods during pregnancy were more likely to have emotional and behavioral problems at age 4, especially girls.A high-quality diet characterized by fish and vegetable consumption during pregnancy was associated with reduced anxiety and hyperactivity problems in girls.Our findings highlight the importance of prenatal nutrition for child neurodevelopment.

OBJECTIVE: To evaluate the impact of a pharmaceutical intervention on treatment optimization in patients with type 2 diabetes mellitus. DESIGN: Before-after intervention study. SITE: Health centers of the Primary Care Department of Camp de Tarragona. PARTICIPANTS: Patients aged = 18 years, diagnosed with type 2 diabetes mellitus and under treatment with antidiabetic drugs. INTERVENTIONS: Review of pharmacological treatment for type 2 diabetes mellitus and issuance of proposals for its adequacy. MAIN MEASUREMENTS: Demographic and clinical variables were collected to assess the adequacy of antidiabetic treatment. A consensus meeting was arranged with the patients’ primary care physician to evaluate the proposals for improvement. The implementation of the proposals and the variation in postintervention glycemic control were assessed. RESULTS: A total of 907 patients (59% men) were included. A total of 782 proposals for intervention were made in 65.8% of the patients reviewed. Of the proposals, 43.5% corresponded to drug discontinuation, 16% to intensification of dosing and 12.6% to exchange for a therapeutic equivalent. Of the consensual proposals, 54.7% were implemented. HbA1c was reduced by 0.2% after the intervention (7.4 vs 7.2%). CONCLUSIONS: Review of the pharmacological treatment of patients with type 2 diabetes mellitus by a pharmacist or pharmacologist facilitates its optimization.

During the rapid development of COVID-19 vaccines, concerns emerged about potential adverse effects on menstrual health. This study examines the association between COVID-19 vaccination-considering the number of doses and vaccine type-and menstrual disorders, specifically heavy menstrual bleeding (HMB) and amenorrhea (AM). Utilizing electronic health records from the Sistema d’Informació per al Desenvolupament de la Investigació en Atenció Primària (SIDIAP) database in Catalonia, Spain, the retrospective cohort included 1,172,621 vaccinated women aged 12-55 with no prior menstrual disorders observed from 27 December 2020 to 30 June 2023. The incidence rate of HMB and AM increased with the second and third doses of the vaccine. Notably, the AstraZeneca(®) and Janssen(®) vaccines were associated with higher odds of HMB (OR: 1.765, CI: 1.527-2.033; OR: 2.155, CI: 1.873-2.476, respectively) and AM (OR: 1.623, CI: 1.416-1.854; OR: 1.989, CI: 1.740-2.269, respectively) from the first to the second dose compared to Pfizer/BioNTech(®). Conversely, the Moderna(®) vaccine appeared to offer a protective effect against HMB (OR: 0.852, CI: 0.771-0.939) and AM (OR: 0.861, CI: 0.790-0.937) between the second and third doses. These results were adjusted for potential confounders, such as age, previous COVID-19 infection, and other relevant covariates.

Tobacco use during pregnancy is the main avoidable cause of morbidity and mortality both for pregnant women and their offspring. Between 12 and 22% of pregnant women in industrialized countries smoke during pregnancy, and 13% are unable to stop smoking. Pregnancy is considered an ideal opportunity to intervene and control tobacco use among smokers and their families. However, pregnant women experience barriers to quitting smoking, including social stigma and fear of being judged. Thus, it is necessary to develop interventions for smoking cessation adapted for pregnant women. This paper presents a qualitative study protocol to assess the barriers and facilitators of smoking cessation during pregnancy that female smokers encounter or perceive. It consists of a series of focus groups and individual interviews with female smokers who have been pregnant within the last five years. Participants will be recruited from the Sexual and Reproductive Health Care Services of the Camp de Tarragona. A group of 5-10 women who have been pregnant and tried to quit smoking over the last 5 years will be selected. The data will be collected by means of semistructured interviews. All interviews will be transcribed verbatim, coded and synthesized into categories and main themes. Thematic analysis will be conducted employing an iterative and reflexive approach. The results of this study will offer new perspectives on smoking interventions for pregnant women and enhance our comprehension of the main barriers to and facilitators of smoking cessation during pregnancy. This will contribute to the adaptation of the Tobbstop app, originally designed for the general public, to suit the needs of pregnant women. Consequently, the creation of targeted interventions will positively influence the health outcomes of both pregnant women and newborns.Trial registration: Clinicaltrials.gov ID: NCT05222958. The trial was registered 3 February 2022, at https://clinicaltrials.gov/ct2/show/NCT05222958.

Patient safety reporting and learning systems (PSRLS) are tools to promote patient safety culture in healthcare organisations (HCO). Many PRSLS are locally developed. WHO Global Action Plan on Patient Safety 2021-2030 urges governments to deploy policies for healthcare risk management including PSRLS. The Ministry of Health of Catalonia (MHC) faced challenges in addressing quality and patient safety (Q&PS) issues due to disparate information systems. To address these challenges, the MHC developed a territorial PSRLS and embedded it in the Quality and Patient Safety Strategic Plan of Catalonia 2023-2027 (QPSS Plan Cat).Methods Four-step process: (1) creation of a governance model, a web platform and reporting forms for a PSRLS in Catalonia (SNiSP Cat); (2) SNiSP Cat roll out; (3) embed SNiSP Cat information in the accreditation model for HCO and the PS scorecard; (4) Development of SNiSP Cat within the QPSS Plan Cat 2023-2027.Results The SNiSP Cat is in use by 63/64 acute care hospital (ACH), 376/376 primary healthcare teams (PCT) and 17/98 long-term care facilities (LTCF). 1335/109 273 professionals were trained. Until 2022, 127 051 incidents have been migrated and reported (2013-2022). The system has generated three comprehensive risk maps for HCO: one for ACH, including patients’ falls, medication, clinical process and procedures; second for PCT, including clinical process and procedures, clinical administration and medication; and a third for LTCF, included patients’ falls, medication, digital/analogical documentation. SNiSP Cat provided information to support 53 standards out of 1312 of the ACH accreditation model and 14 standards out of 379 of PCT one. Regarding the MHC patient safety scorecard, 14 indicators out of 147 of ACH and 4 out of 41 of PCT are supported by SNiSP Cat data.Conclusions The availability of a territorial PSRLS (SNiSP Cat) allows MHC leads the Q&PS policy with direct information, risk maps and data support to the standards for the Catalan accreditation models and PS scorecard linked to incentivisation, turning the SNiSP Cat into a driven tool to implement the Quality and Patient Safety Strategic Plan of Catalonia 2023-2027.