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

Mobile application; Primary public health; Tobacco smoking cessationAplicación móvil; Atención primaria de salud pública; Dejar de fumar tabacoAplicació mòbil; Salut pública primària; Cessament del consum de tabacBackground: 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

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

Mediterranean diet; Lung function; SmokingDieta mediterrània; Funció pulmonar; FumarDieta mediterránea; Función pulmonar; FumarBackground: 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

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

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

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

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

AbstractBackground 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 NCT0215304

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&ndash;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&ndash;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 &micro;g/L vs. 60.3 &micro;g/L; p &lt; 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&ndash;4 were 1.00 (reference), 0.95 (95% CI = 0.85&ndash;1.06), 1.18 (95% CI = 1.65&ndash;1.31) and 1.51 (95% CI = 1.36&ndash;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

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&ndash;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 &ge;3). Associated independent risk factors were age &ge;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

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.This work was supported by the 2017 call for proposals within the Strategic Plan of Research and Innovation in Health (PERIS) 2016–2020 for Primary Care Research Projects from the Health Department of the Generalitat de Catalunya, with reference P17/084, and the official Spanish Institutions for funding scientific biomedical research, CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN) and Instituto de Salud Carlos III (ISCIII), through the Fondo de Investigación para la Salud (FIS), which is cofunded by the European Regional Development Fund (four coordinated FIS projects led by J.S.-S., including the following projects: PI13/01123, PI13/00462, PI13/00233, PI13/02184, PI14/00728, PI16/01094, PI16/00501, PI16/00381, PI17/00215, PI19/01226, P119/00017, PI19/00576, and PI19/01032), the Especial Action Project entitled Implementación y evaluación de una intervención intensiva sobre la actividad física, Cohorte PREDIMED-Plus grant to J.S.-S.; the European Research Council (Advanced Research Grant 2014–2019; agreement #340918) granted to M.Á.M.-G.; the Recercaixa (number 2013ACUP00194) grant to J.S.-S. J.S.-S. gratefully acknowledges the financial support of ICREA under the ICREA Academia program. I.P.-G. receives a grant from the Spanish Ministry of Education, Culture and Sports (FPU 17/01925). None of the funding sources took part in the design, collection, analysis, interpretation of the data, or the writing of the report, or in the decision to submit the manuscript for publication

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 (β: 1.36; 95% CI 0.35; 2.3; p = 0.009), and this increase was maintained after adjusting for age and sex (β: 1.15; 95% CI 0.05; 2.2; p = 0.040) and after adjusting for various sociodemographic, lifestyle and anthropometric variables (β: 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