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.

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study.

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.

Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study.

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.

Incident use of hydroxychloroquine for the treatment of rheumatoid arthritis and systemic lupus erythematosus during the COVID-19 pandemic.

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 (IMASIS) to estimate monthly rates of HCQ use between January 2019 and March 2022, in the general population, and in RA and SLE patients. Methotrexate (MTX) was use was estimated as a control. RESULTS: Over 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, to decrease in May 2020. Usage rates of HCQ went back to pre-pandemic trends in Spain, but remained high in the US, 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. CONCLUSIONS: Use of HCQ increased dramatically in the general population in both Spain and the US during March and April 2020. While Spain returned to pre-pandemic rates after the first wave, use of HCQ remained high and followed waves of COVID-19 in the US. However, we found no evidence of general shortages in the use of HCQ for both RA and SLE in the US. This article is protected by copyright. All rights reserved.

Impact of perceived discrimination and coping strategies on well-being and mental health in newly-arrived migrants in Spain.

OBJECTIVES: To explore how perceived discrimination impacts the emotional well-being and mental health of newly-arrived migrants in Spain; and to identify the coping strategies and behavioral changes used to deal with perceived discrimination. DESIGN: 102 individual audio-recorded in-depth qualitative interviews were conducted. The interviews were transcribed and analyzed through content analysis. RESULTS: Negative emotions related to perceived discrimination included disgust, sadness, fear, loneliness, humiliation, sense of injustice, rage, feeling undervalued or vulnerable, and mixed emotions. Change in behaviors due to perceived discrimination comprised westernization or cultural assimilation, creating a good image, avoiding going out or leaving alone, hypervigilance, stop participating in politics, self-sufficiency, a positive adaptation, and paradoxically, becoming an oppressor. The identified coping strategies to deal with perceived discrimination were ignoring or not responding, isolation, self-medication, engagement in intellectual activities, leisure and sport, talking or insulting the oppressor, denouncement, physical fight or revenge, seeking comfort, increasing solidarity with others, crying, or using humor. Discrimination-related stress and related mental health problems were conveyed, as challenges related to substance abuse and addictive behaviors, mood, and anxiety. CONCLUSIONS: Findings establish initial evidence of the great impact of perceived discrimination on the health, emotional well-being, and behavior of newly-arrived migrants in Spain, alerting to the need for targeted policies and services to address the effects of discrimination in this population. Further research is needed to explore more closely the causes and effects of perceived discrimination on mental health, to develop more targeted and effective interventions.

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.

Effectiveness of homologous/heterologous booster COVID-19 vaccination schedules against severe illness in general population and clinical subgroups in three European countries.

Using 4 data-sources (Spain, Italy, United Kingdom) data and a 1:1 matched cohort study, we aimed to estimate vaccine effectiveness (VE) in preventing SARS-CoV-2 infections with hospitalisations (±30 days) and death (±56 days) in general population and clinical subgroups with homologous/heterologous booster schedules (Comirnaty-BNT and Spikevax-MOD original COVID-19 vaccines) by comparison with unboosted individuals, during Delta and beginning of Omicron variants. Hazard Ratio (HR, by Cox models) and VE ([1-HR]*100) were calculated by inverse probability weights. Between December 2020-February 2022, in adults without prior SARS-CoV-2 infection, we matched 5.5 million people (>1 million with immunodeficiency, 343,727 with cancer) with a booster (3rd) dose by considering doses 1 and 2 vaccine brands and calendar time, age, sex, region, and comorbidities (immunodeficiency, cancer, severe renal disease, transplant recipient, Down Syndrome). We studied booster doses of BNT and MOD administered after doses 1 and 2 with BNT, MOD, or Oxford-AstraZeneca during a median follow-up between 9 and 16 weeks. BNT or MOD showed VE ranging from 70 to 86% across data sources as heterologous 3rd doses, whereas it was 42-88% as homologous 3rd doses. Depending on the severity and available follow-up, 3rd-dose effectiveness lasted between 1 and 5 months. In people with immunodeficiency and cancer, protection across data sources was detected with both heterologous (VE = 54-83%) and homologous (VE = 49-80%) 3rd doses. Overall, both heterologous and homologous 3rd doses with BTN or MOD showed additional protection against the severe effects of SARS-CoV-2 infections for the general population and for patients at potentially high risk of severe COVID-19 (elderly, people with immunodeficiency and cancer) in comparison with two doses schemes during Delta or early Omicron periods. The early VE after vaccination may be due to less testing among vaccinated pairs and unknown confounders, deserving cautious interpretation. The VE wane over time needs further in-depth research to properly envisage when or whether a booster of those vaccines should be administered.

Extraordinary Control of Photosensitized Singlet Oxygen Generation by Acyclic Cucurbituril-like Containers.

Supramolecular control of singlet oxygen generation is incredibly valuable for several fields with broad applications and thus still challenging. However, macrocyclic inclusion complexes inherently restrict the interaction of photosensitizers with surrounding oxygen in the media. To circumvent this issue, we turned our attention in this work to acyclic cucurbituril-like containers and uncover their properties as supramolecular hosts for photosensitizers with extraordinary control of their photophysics, including singlet oxygen generation. Thermodynamic and photophysical studies were carried out showing that these acyclic containers compare very favorably to benchmark macrocycles such as cucurbiturils and cyclodextrins in terms of their binding affinities and supramolecular control of singlet oxygen generation. Acyclic container with terminal naphthalene walls offers a similar cavity to cucurbit[7]uril and the same carbonyl-lined portals for a tight binding of phenothiazinium dye methylene blue and stabilizing its singlet and triplet excited states. Thus, generation of singlet oxygen for this container is higher than for other macrocycles and even higher than the free photosensitizer. While the acyclic container with smaller terminal benzene walls, stacks over the dye through sulfur-π and π-π interactions deactivating the singlet and triplet excited states, thus showing the lowest generation of singlet oxygen out of all of the studied systems. Due to the great water solubility and biocompatibility of these systems, they possess great potential for novel applications in photocatalysis, synthesis, and biomedical fields, among others.

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials.

BACKGROUND AND OBJECTIVES: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. METHODS: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. RESULTS: The CVM study enrolled 658 first-dose vaccinees (children aged 5-11 years; n = 250 and adolescents aged 12-17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. CONCLUSIONS: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

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.

Hypoalbuminemia Predicts Adverse Events following Unicompartmental Knee Arthroplasty.

Hypoalbuminemia is a potentially modifiable risk factor associated with adverse events following total knee arthroplasty. The present study aimed to evaluate whether hypoalbuminemia similarly predisposes to adverse events following unicompartmental knee arthroplasty (UKA). Patients who underwent UKA during 2006-2018 were identified through the American College of Surgeons National Surgical Quality Improvement Program. Only patients with preoperative serum albumin concentration were included. Outcomes were compared between patients with and without hypoalbuminemia (serum albumin concentration < 3.5 g/dL). All associations were adjusted for demographic, comorbidity, and laboratory differences between populations. A total of 11,342 patients were identified, of whom 6,049 (53.3%) had preoperative serum albumin laboratory values available for analysis. After adjustment for potential confounders, patients with hypoalbuminemia had a greater than 2-fold increased probability for occurrence of any complication (7.02% vs. 2.23%, p = 0.009) and a 4-fold increased probability of receiving a blood transfusion (1.81% vs. 0.25%, p = 0.045). Among procedures performed as inpatients, mean postoperative length of stay (LOS) was longer in patients with hypoalbuminemia (2.2 vs. 1.8 days; p = 0.031). Hypoalbuminemia is independently associated with complications and increased LOS following UKA and a marker for patients at higher risk of postoperative complications. Patients should be screened for hypoalbuminemia and nutritional deficiencies addressed prior to UKA.

Validity of the Espiro Mobile Application in the Interpretation of Spirometric Patterns: An App Accuracy Study.

Spirometry is a pulmonary function test where correct interpretation of the results is crucial for accurate diagnosis of disease. There are online tools to assist in the interpretation of spirometry results; however, as yet none are validated. We evaluated the interpretation accuracy of the Espiro app using pulmonologist interpretations as the gold standard. This is an observational descriptive study in which 118 spirometry results were interpreted by the Espiro app, two pulmonologists, two primary care physicians, and two residents of a primary care training program. We determined the interpretation accuracy of the Espiro app and the concordance of the pattern and severity interpretation between the Espiro app and each of the observers using Cohen's kappa coefficient (k). We obtained a sensitivity and specificity for the Espiro app of 97.5% (95% confidence interval (CI): 86.8-99.9%) and 94.9% (95%CI: 87.4-98.6%) with pulmonologist 1 and 100% (95%CI: 91.6-100%) and 98.7% (95%CI: 92.9-99.9%) with pulmonologist 2. The concordance for the pattern interpretation was greater than k 0.907, representing almost perfect agreement. The concordance of the severity interpretation was greater than k 0.807, representing substantial to almost perfect agreement. We concluded that the Espiro app is a valid tool for spirometry interpretation.

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.

Factors Associated with Depression and Anxiety Symptoms among Migrant Population in Spain during the COVID-19 Pandemic.

Migrants are likely to experience mental health conditions, being one of the most vulnerable groups during the COVID-19 pandemic. The present study aims to: (1) estimate the prevalence of depressive and anxious symptoms and (2) examine the impact of risk and protective factors on this symptomatology. A sample of 129 migrants living in Spain during the COVID-19 pandemic completed an anonymous online survey, including information on sociodemographic and individual characteristics, migration, basic needs, social environment and perceived health domains. Multiple Poisson regression models analysed the effects of risk and protective factors on depression and anxiety symptoms. The prevalence of depressive and anxiety symptoms was 22.3% and 21.4%, respectively. Risk factors such as living in a rented house and previous mental health conditions were associated with higher depression symptoms, whereas unemployment was related to anxiety symptoms. Conversely, older age, better self-esteem, and higher levels of social support were associated with fewer depression symptoms. Older age and better quality of life were related to fewer anxiety symptoms. These findings addressing risk and protective factors (e.g., social support, self-esteem) help to design culturally effective programs, particularly in migrants with pre-existing mental health conditions, adjusting the organisation of mental healthcare services in difficult times in Spain.

Binding of toluidine blue-myristic acid derivative to cucurbit[7]uril and human serum albumin: computational and biophysical insights towards a biosupramolecular assembly.

A new toluidine blue-myristic acid photosensitizer derivate (TBOMyr) was investigated as a design molecule to bind simultaneously to cucurbit[7]uril (CB[7]) and human serum albumin (HSA) with the aim of constructing a biosupramolecular assembly. Molecular docking and dynamics calculations revealed the main supramolecular and bio-molecular interactions of TBOMyr with the macrocycle or the protein, respectively. The addition of the negatively charged myristic acid-like tail resulted in a unique conformation of the CB[7] complex where the phenothiazine core was included in the cavity of CB[7], leaving the fatty acid portion free to interact with the protein. A favorable ternary interaction between TBOMyr, CB[7] and HSA was suggested by the calculations, and an experimental binding affinity in the order of 105 M-1 was determined for the TBOMyr@CB[7] complex with HSA. The new TBOMyr derivative could find applications in photodynamic therapy benefiting from the biosupramolecular interactions as a transport system.

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.

Biosupramolecular complexes of amphiphilic photosensitizers with human serum albumin and cucurbit[7]uril as carriers for photodynamic therapy.

In the present work, we evaluated the supramolecular interactions between three photosensitizers, namely toluidine blue O (TBO, positively charged) and two fatty acid conjugates of 6 and 14 carbon atoms chain lengths (TBOC6 and TBOC14), with human serum albumin (HSA) and the macrocycle cucurbit[7]uril (CB[7]), alone or in combination within a biosupramolecular system as potential carriers of photosensitizers for Photodynamic therapy (PDT). Binding studies were carried out using photophysical and calorimetric techniques and accompanied with molecular docking simulations. Amphiphilic photosensitizers, particularly TBOC14, showed stronger binding to HSA and (CB[7]). Comparing the different delivery systems, (CB[7]) had a marginal effect on cell uptake and phototoxicity in HeLa cells, while HSA showed enhanced cell uptake with phototoxicities that depended on the photosensitizer. Despite low cell uptake, the combination of both (CB[7]) and HSA was the most phototoxic, which illustrates the potential of combining these systems for PDT applications.

Effectiveness of a motivational intervention based on spirometry results to achieve smoking cessation in primary healthcare patients: randomised, parallel, controlled multicentre study.

OBJECTIVE: This 12-month study in a primary healthcare network aimed to assess the effectiveness of usual smoking cessation advice compared with personalised information about the spirometry results. DESIGN: Randomised, parallel, controlled, multicentre clinical trial. SETTING: This study involved 12 primary healthcare centres (Tarragona, Spain). PARTICIPANTS: Active smokers aged 35-70 years, without known respiratory disease. Each participant received brief smoking cessation advice along with a spirometry assessment. Participants with normal results were randomised to the intervention group (IG), including detailed spirometry information at baseline and 6-month follow-up or control group (CG), which was simply informed that their spirometry values were within normal parameters. MAIN OUTCOME: Prolonged abstinence (12 months) validated by expired-CO testing. RESULTS: Spirometry was normal in 571 patients in 571 patients (45.9% male), 286 allocated to IG and 285 to CG. Baseline characteristics were comparable between the groups. Mean age was 49.8 (SD ±7.78) years and mean cumulative smoking exposure was 29.2 (±18.7) pack-years. Prolonged abstinence was 5.6% (16/286) in the IG, compared with 2.1% (6/285) in the CG (p=0.03); the cumulative abstinence curve was favourable in the IG (HR 1.98; 95% CI 1.29 to 3.04). CONCLUSIONS: In active smokers without known respiratory disease, brief advice plus detailed spirometry information doubled prolonged abstinence rates, compared with brief advice alone, in 12-month follow-up, suggesting a more effective intervention to achieve smoking cessation in primary healthcare. TRIAL REGISTRATION NUMBER: NCT01194596.

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.