Effectiveness of a multiple health-behaviour-change intervention in increasing adherence to the Mediterranean Diet in adults (EIRA study): a randomized controlled hybrid trial.

BACKGROUND: The present study describes the effectiveness of a complex intervention that addresses multiple lifestyles to promote healthy behaviours in increasing adherence to the Mediterranean diet (MD).  METHODS: Cluster-randomised, hybrid clinical trial controlled with two parallel groups. The study was carried out in 26 primary Spanish healthcare centres. People aged 45-75 years who presented at least two of the following criteria were included: smoker, low adherence to the MD or insufficient level of physical activity. The intervention group (IG) had three different levels of action: individual, group, and community, with the aim of acting on the behaviours related to smoking, diet and physical activity at the same time. The individual intervention included personalised recommendations and agreements on the objectives to attain. Group sessions were adapted to the context of each healthcare centre. The community intervention was focused on the social prescription of resources and activities performed in the environment of the community of each healthcare centre. Control group (CG) received brief advice given in the usual visits to the doctor's office. The primary outcome was the change, after 12 months, in the number of participants in each group with good adherence to the MD pattern. Secondary outcomes included the change in the total score of the MD adherence score (MEDAS) and the change in some cardiovascular risk factors. RESULTS: Three thousand sixty-two participants were included (IG = 1,481, CG = 1,581). Low adherence to the MD was present in 1,384 (93.5%) participants, of whom 1,233 initiated the intervention and conducted at least one individual visit with a healthcare professional. A greater increase (13.7%; 95% CI, 9.9-17.5; p < 0.001) was obtained by IG in the number of participants who reached 9 points or more (good adherence) in the MEDAS at the final visit. Moreover, the effect attributable to the intervention obtained a greater increase (0.50 points; 95% CI, 0.35 to 0.66; p < 0.001) in IG. CONCLUSIONS: A complex intervention modelled and carried out by primary healthcare professionals, within a real clinical healthcare context, achieved a global increase in the adherence to the MD compared to the brief advice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03136211. Retrospectively registered on 02/05/2017 https://clinicaltrials.gov/ct2/show/NCT03136211.

Cost-effectiveness analysis of a multiple health behaviour change intervention in people aged between 45 and 75 years: a cluster randomized controlled trial in primary care (EIRA study).

BACKGROUND: Multiple health behaviour change (MHBC) interventions that promote healthy lifestyles may be an efficient approach in the prevention or treatment of chronic diseases in primary care. This study aims to evaluate the cost-utility and cost-effectiveness of the health promotion EIRA intervention in terms of MHBC and cardiovascular reduction. METHODS: An economic evaluation alongside a 12-month cluster-randomised (1:1) controlled trial conducted between 2017 and 2018 in 25 primary healthcare centres from seven Spanish regions. The study took societal and healthcare provider perspectives. Patients included were between 45 and 75 years old and had any two of these three behaviours: smoking, insufficient physical activity or low adherence to Mediterranean dietary pattern. Intervention duration was 12 months and combined three action levels (individual, group and community). MHBC, defined as a change in at least two health risk behaviours, and cardiovascular risk (expressed in % points) were the outcomes used to calculate incremental cost-effectiveness ratios (ICER). Quality-adjusted life-years (QALYs) were estimated and used to calculate incremental cost-utility ratios (ICUR). Missing data was imputed and bootstrapping with 1000 replications was used to handle uncertainty in the modelling results. RESULTS: The study included 3062 participants. Intervention costs were €295 higher than usual care costs. Five per-cent additional patients in the intervention group did a MHBC compared to usual care patients. Differences in QALYS or cardiovascular risk between-group were close to 0 (- 0.01 and 0.04 respectively). The ICER was €5598 per extra health behaviour change in one patient and €6926 per one-point reduction in cardiovascular risk from a societal perspective. The cost-utility analysis showed that the intervention increased costs and has no effect, in terms of QALYs, compared to usual care from a societal perspective. Cost-utility planes showed high uncertainty surrounding the ICUR. Sensitivity analysis showed results in line with the main analysis. CONCLUSION: The efficiency of EIRA intervention cannot be fully established and its recommendation should be conditioned by results on medium-long term effects. TRIAL REGISTRATION: Clinicaltrials.gov NCT03136211 . Registered 02 May 2017 - Retrospectively registered.

Multiple health behaviour change primary care intervention for smoking cessation, physical activity and healthy diet in adults 45 to 75 years old (EIRA study): a hybrid effectiveness-implementation cluster randomised trial.

BACKGROUND: This study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45-75 years compared to usual care; and b) an implementation strategy. METHODS: A cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success. RESULTS: 14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain. CONCLUSIONS: Compared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control.

BACKGROUND: The management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. The strategy to broaden the knowledge base of primary care professionals to improve health care has mainly been prompted by the current reality of limited resources and access to specialized care. The main objective of this study is to assess the effectiveness of comprehensive interventions focused on treatment intensification, decrease clinical inertia and reduce possible barriers to treatment adherence in patients with poorly controlled diabetes in a primary care setting. METHODS: This is a two-phase mixed method study, whose aims are the development of complex interventions and the assessment of their effectiveness. The main study outcome is a change in glycated haemoglobin (HbA1c) levels. The INTEGRA study is divided into two phases. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews with the objective of determining the factors related to the participants and health care professionals that influence the development and implementation of a specific intervention strategy aimed at patients with poor glycaemic control of T2DM in primary care. Phase 2: Exploratory intervention study to be conducted in Primary Health Care Centres in Catalonia (Spain), including 3 specific health care areas. The intervention study has two arms: Intervention Group 1 and 2. Each intervention group will recruit 216 participants (the same as in the control group) between the ages of 30 and 80 years with deficient glycaemic control (HbA1c > 9%). The control group will be established based on a randomized selection from the large SIDIAP (Sistema d'Informació per al desenvolupament de la Investigació en Atenció Primària) database of patients with comparable socio-demographic and clinical characteristics from the three provinces. DISCUSSION: This study is a comprehensive, pragmatic intervention based on glycaemic treatment intensification and the control of other cardiovascular risk factors. It is also aimed at improving treatment adherence and reducing clinical inertia, which could lead to improved glycaemic control and could likewise be feasible for implementation in the actual clinical practice of primary care. TRIAL REGISTRATION: Clinicaltrials.gov . registration number. NCT02663245; January 25, 2016.

Correction to: Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.

It has been highlighted the original article (1) contained a typesetting mistake in the authorship, and that author Caterine Vicens was omitted.

Complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in primary health care (EIRA study): study protocol for a hybrid trial.

BACKGROUND: Health promotion is a key process of current health systems. Primary Health Care (PHC) is the ideal setting for health promotion but multifaceted barriers make its integration difficult in the usual care. The majority of the adult population engages two or more risk behaviours, that is why a multiple intervention might be more effective and efficient. The primary objectives are to evaluate the effectiveness, the cost-effectiveness and an implementation strategy of a complex multiple risk intervention to promote healthy behaviours in people between 45 to 75 years attended in PHC. METHODS: This study is a cluster randomised controlled hybrid type 2 trial with two parallel groups comparing a complex multiple risk behaviour intervention with usual care. It will be carried out in 26 PHC centres in Spain. The study focuses on people between 45 and 75 years who carry out two or more of the following unhealthy behaviours: tobacco use, low adherence to the Mediterranean dietary pattern or insufficient physical activity level. The intervention is based on the Transtheoretical Model and it will be made by physicians and nurses in the routine care of PHC practices according to the conceptual framework of the "5A's". It will have a maximum duration of 12 months and it will be carried out to three different levels (individual, group and community). Incremental cost per quality-adjusted life year gained measured by the tariffs of the EuroQol-5D questionnaire will be estimated. The implementation strategy is based on the "Consolidated Framework for Implementation Research", a set of discrete implementation strategies and an evaluation framework. DISCUSSION: EIRA study will determine the effectiveness and cost-effectiveness of a complex multiple risk intervention and will provide a better understanding of implementation processes of health promotion interventions in PHC setting. It may contribute to increase knowledge about the individual and structural barriers that affect implementation of these interventions and to quantify the contextual factors that moderate the effectiveness of implementation. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03136211 .Retrospectively registered on May 2, 2017.

Effect of comprehensive smoke-free legislation on asthma and coronary disease trends in Spanish primary care patients.

Background: To examine the impact of comprehensive smoke-free legislation (SFL) (Law 42/2010) on the incidence and prevalence of adult asthma and coronary disease in primary health care (PHC) patients from three Spanish regions, overall and stratified by sex. Methods: Longitudinal observational study conducted between 2007 and 2013 in the population over 15 years of age assigned to 66 PHC teams in Catalonia, Navarre and the Balearic Islands. Crude rates and age-standardized (truncated: asthma ≥ 16 years and coronary disease ≥ 35 years) incidence and prevalence rates using the direct method based on the European Standard Population were estimated based on data from PHC electronic health records. Joinpoint analysis was used to analyse the trends of age-standardized incidence and prevalence rates. Trends were expressed as annual percentage change and average annual percent change (AAPC). Results: The standardized asthma incidence rate showed a non-significant downward trend and the standardized prevalence rates rose significantly in the three regions. Standardized coronary disease incidence and prevalence rates were considerably higher for men than for women in all regions. The standardized coronary disease incidence rates in Catalonia (AAPC: -8.00%, 95% CI: -10.46; -5.47) and Navarre (AAPC: -3.66%, 95% CI: -4.95;-2.35) showed a significant downward trend from 2007 to 2013, overall and by sex. The standardized coronary disease prevalence trend rate increased significantly in the whole period in Catalonia and the Balearic Islands, although a non-significant downward trend was observed from 2010 in Catalonia. Conclusion: No changes in the trends of adult asthma and coronary disease in PHC Spanish patients were detected after the introduction of comprehensive SFL.

Effectiveness and safety of drugs used for stroke prevention in a cohort of non-valvular atrial fibrillation patients from a primary care electronic database.

PURPOSE: The aim of this study was to assess effectiveness and safety of antithrombotics for stroke prevention in non-valvular atrial fibrillation in real-use conditions. METHODS: We used a population-based retrospective cohort study. Information emerges from SIDIAP, a database containing anonymized information from electronic health records from 274 primary healthcare centres of the Catalan Health Institute, Catalonia (Spain), with a reference population of 5 835 000 people. Population includes all adults with a new diagnosis of non-valvular atrial fibrillation registered in SIDIAP from 2007 to 2012. The main outcome of antithrombotics' effectiveness was stroke. The main outcomes of safety were cerebral and gastrointestinal haemorrhages. We also estimated all-cause mortality. We used multivariable Cox proportional hazard models to examine association between antithrombotic treatment and main outcomes. RESULTS: We included 22 205 subjects with non-valvular atrial fibrillation; 40.8% initiated on vitamin K antagonists (VKA), 33.4% on antiplatelets and 25.8% untreated. We found stroke-risk reduction with VKA, hazard ratio (HR) 0.72 (95% confidence interval (CI), 0.58-0.91), also seen in patients with CHADS2 ≥ 2, HR 0.65 (95%CI, 0.49-0.86), and CHA2 DS2 -VASc ≥ 2, HR 0.66 (95%CI, 0.52-0.84). We observed a higher risk of digestive bleeding with antiplatelets, HR 1.32 (95%CI, 1.01-1.73). Both VKA and antiplatelets were associated with reduction of all-cause mortality risk; HR 0.55 (95%CI, 0.49-0.62) and HR 0.89 (95%CI, 0.80-0.97), respectively. CONCLUSIONS: This study found a stroke-risk reduction associated with VKA and an increased risk of gastrointestinal bleeding associated with platelet-aggregation inhibitors in comparison with untreated patients. Both antithrombotic groups showed a reduction in all-cause mortality. Copyright © 2016 John Wiley & Sons, Ltd.

Variability in screening prevention activities in primary care in Spain: a multilevel analysis.

BACKGROUND: Despite evidence of the benefits of prevention activities, studies have reported only partial integration and great variability of screening in daily clinical practice. The study objectives were: 1) To describe Primary Health Care (PHC) screening for arterial hypertension, dyslipidaemia, obesity, tobacco use, and excessive alcohol consumption in 2008 in 2 regions of Spain, based on electronic health records, and 2) To assess and quantify variability in screening, and identify factors (of patient, general practitioners and PHC team) associated with being screened, that are common throughout the PHC population. METHODS: Multicentre, cross-sectional study of individuals aged ≥ 16 years (N = 468,940) who visited the 426 general practitioners (GPs) in 44 PHC teams in Catalonia and Navarre in 2008. OUTCOMES: screening for hypertension, dyslipidaemia, obesity, tobacco use, and excessive alcohol consumption. Other variables were considered at the individual (sociodemographics, visits, health problems), GP and PHC team (region among others). Individual and contextual factors associated with the odds of being screened and the variance attributable to each level were identified using the SAS PROC GLIMMIX macro. RESULTS: The most prevalent screenings were for dyslipidaemia (64.4%) and hypertension (50.8%); the least prevalent was tobacco use (36.6%). Overall, the odds of being screened were higher for women, older patients, those with more comorbidities, more cardiovascular risk factors, and more frequent office visits, and those assigned to a female GP, a GP with a lower patient load, or a PHC team with a lower percentage of patients older than 65 years. On average, individuals in Navarre were less likely to be screened than those in Catalonia. Hypertension and dyslipidaemia screenings had the least unexplained variability between PHC teams and GPs, respectively, after adjusting for individual and contextual factors. CONCLUSIONS: Of the studied screenings, those for obesity, tobacco, and alcohol use were the least prevalent. Attention to screening, especially for tobacco and alcohol, can be greatly improved in the PHC setting.

[Prevalence of nasal carriage of Staphylococcus aureus and Streptococcus pneumoniae in Primary Care and factors associated with colonization]. / Prevalencia de portadores nasales de Staphylococcus aureus y Streptococcus pneumoniae en atención primaria y factores asociados a la colonización.

OBJECTIVE: To determine (i) the prevalence of Staphylococcus aureus (S.aureus) and Streptococcus pneumoniae (S.pneumoniae) nasal carriage in Primary Health Care patients in area of Barcelona, and (ii) the factors associated with S.aureus and S.pneumoniae colonization. METHODS: Multi-center cross-sectional study conducted in 2010-2011 with the participation of 27 Primary Health Care professionals. Nasopharyngeal swabs were obtained from 3,969 patients over 4 years of age who did not present with any sign of infection. DEPENDENT VARIABLES: S.aureus and/or S.pneumoniae carrier state. INDEPENDENT VARIABLES: socio-demographic characteristics, health status, vaccination status, occupation, and living with children. A descriptive analysis was performed. The prevalence of carriers of S.aureus and/or S.pneumoniae was calculated and logistic regression models were adjusted by age. RESULTS: In children from 4 to 14 years old, the prevalence of S.aureus carriers was 35.7%, of S.pneumoniae 27.1%, and 5.8% were co-colonized. In adults older than 14 years old, the prevalence was 17.8%, 3.5%, and 0.5%, respectively. In children, S.aureus carrier state was inversely associated with S.pneumoniae carrier state; S.pneumoniae was associated with younger age, and inversely associated with S.aureus carrier state. In adults, being a carrier of S.aureus was associated with male gender, younger age, and a health-related occupation, whereas S.pneumoniae carrier state was associated with living with children under 6 years of age. The proportion of co-colonized carriers was low (1.0%). CONCLUSIONS: The proportion of S.aureus and S.pneumoniae carriers was higher in children than in adults. Age was the only factor associated with healthy carrier status for S.aureus and for S.pneumoniae.

Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial.

BACKGROUND: Although hypercholesterolemia is considered a cardiovascular risk factor, in isolation it is not necessarily sufficient cause for a cardiovascular event. To improve event prediction, cardiovascular risk calculators have been developed; the REGICOR calculator has been validated for use in our population. The objective of this project is to develop an intervention with general practitioners (GPs) and evaluate its impact on prescription adequacy of cholesterol-lowering drugs in primary prevention of cardiovascular disease and in controlling the costs associated with this disease. METHODS: This nonblinded, cluster-randomized clinical trial analyzes data from primary care electronic medical records (ECAP) and other databases. Inclusion criteria are patients aged 35 to 74 years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the 2-year study period. Dependent variables include the following: RETIRA, defined as new cholesterol-lowering drugs initiated during the year preceding the intervention, considered inadequate, and withdrawn during the study period; EVITA, defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate; COST, defined as the total cost of inadequate new treatments prescribed; and REGISTER, defined as the recording of cardiovascular risk factors. Independent variables include the GP's quality-of-care indicators and randomly assigned study group (intervention vs control), patient demographics, and clinical variables. Aggregated descriptive analysis will be done at the GP level and multilevel analysis will be performed to estimate the intervention effect, adjusted for individual and GP variables. DISCUSSION: The study objective is to generate evidence about the effectiveness of implementing feedback information programs directed to GPs in the context of Primary Care. The goal is to improve the prescription adequacy of lipid-lowering therapies for primary prevention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01997671. November 28, 2013.

Examining the influence of mental health and structural determinants of health on the stage of motivational readiness for health behaviour changes: A path analysis study.

This study explores the influence of mental health and structural determinants of health on motivational readiness for health behaviour change in 1462 Spanish primary healthcare users. Chi-square test and structural equation modelling were performed. Results showed that depression and anxiety were negatively associated with being in the action stages of motivational readiness for a healthy diet and physical activity. This association was statistically significant only for motivational readiness for a healthy diet and depression (ß=-0.076;p=0.046). Furthermore, women and workers were more likely to be in the action stages of motivational readiness for a healthy diet while older adults and adults with higher health-related quality of life were more likely to be in the action stages of motivational readiness for physical activity. The present study suggests that structural (being older, being a woman and being employed) and intermediary (suffering from depression and higher health-related quality of life) determinants of health influence motivational readiness for health behaviour changes.

Comparison of the information provided by electronic health records data and a population health survey to estimate prevalence of selected health conditions and multimorbidity.

BACKGROUND: Health surveys (HS) are a well-established methodology for measuring the health status of a population. The relative merit of using information based on HS versus electronic health records (EHR) to measure multimorbidity has not been established. Our study had two objectives: 1) to measure and compare the prevalence and distribution of multimorbidity in HS and EHR data, and 2) to test specific hypotheses about potential differences between HS and EHR reporting of diseases with a symptoms-based diagnosis and those requiring diagnostic testing. METHODS: Cross-sectional study using data from a periodic HS conducted by the Catalan government and from EHR covering 80% of the Catalan population aged 15 years and older. We determined the prevalence of 27 selected health conditions in both data sources, calculated the prevalence and distribution of multimorbidity (defined as the presence of ≥2 of the selected conditions), and determined multimorbidity patterns. We tested two hypotheses: a) health conditions requiring diagnostic tests for their diagnosis and management would be more prevalent in the EHR; and b) symptoms-based health problems would be more prevalent in the HS data. RESULTS: We analysed 15,926 HS interviews and 1,597,258 EHRs. The profile of the EHR sample was 52% women, average age 47 years (standard deviation: 18.8), and 68% having at least one of the selected health conditions, the 3 most prevalent being hypertension (20%), depression or anxiety (16%) and mental disorders (15%). Multimorbidity was higher in HS than in EHR data (60% vs. 43%, respectively, for ages 15-75+, P <0.001, and 91% vs. 83% in participants aged ≥65 years, P <0.001). The most prevalent multimorbidity cluster was cardiovascular. Circulation disorders (other than varicose veins), chronic allergies, neck pain, haemorrhoids, migraine or frequent headaches and chronic constipation were more prevalent in the HS. Most symptomatic conditions (71%) had a higher prevalence in the HS, while less than a third of conditions requiring diagnostic tests were more prevalent in EHR. CONCLUSIONS: Prevalence of multimorbidity varies depending on age and the source of information. The prevalence of self-reported multimorbidity was significantly higher in HS data among younger patients; prevalence was similar in both data sources for elderly patients. Self-report appears to be more sensitive to identifying symptoms-based conditions. A comprehensive approach to the study of multimorbidity should take into account the patient perspective.

Relationship between efficiency and clinical effectiveness indicators in an adjusted model of resource consumption: a cross-sectional study.

BACKGROUND: Adjusted clinical groups (ACG®) have been widely used to adjust resource distribution; however, the relationship with effectiveness has been questioned. The purpose of the study was to measure the relationship between efficiency assessed by ACG® and a clinical effectiveness indicator in adults attended in Primary Health Care Centres (PHCs). RESEARCH DESIGN: cross-sectional study. SUBJECTS: 196, 593 patients aged >14 years in 13 PHCs in Catalonia (Spain). MEASURES: Age, sex, PHC, basic care team (BCT), visits, episodes (diagnoses), and total direct costs of PHC care and co-morbidity as measured by ACG® indicators: Efficiency indices for costs, visits, and episodes (costs EI, visits EI, episodes EI); a complexity or risk index (RI); and effectiveness measured by a general synthetic index (SI). The relationship between EI, RI, and SI in each PHC and BCT was measured by multiple correlation coefficients (r). RESULTS: In total, 56 of the 106 defined ACG® were present in the study population, with five corresponding to 44.5% of the patients, 11 to 68.0% of patients, and 30 present in less than 0.5% of the sample. The RI in each PHC ranged from 0.9 to 1.1. Costs, visits, and episodes had similar trends for efficiency in six PHCs. There was moderate correlation between costs EI and visits EI (r = 0.59). SI correlation with episodes EI and costs EI was moderate (r = 0.48 and r = -0.34, respectively) and was r = -0.14 for visits EI. Correlation between RI and SI was r = 0.29. CONCLUSIONS: The Efficiency and Effectiveness ACG® indicators permit a comparison of primary care processes between PHCs. Acceptable correlation exists between effectiveness and indicators of efficiency in episodes and costs.

[Cigarette smoking prevalence and associated factors in secondary school children in Catalunya]. / Prevalencia y factores asociados al consumo de tabaco en alumnos de enseñanza secundaria de Cataluña.

OBJECTIVE: The aim of this study was to analyze those factors associated with cigarette smoking in adolescent school children, in order to plan future school interventions for promoting good health strategies developed by the schools and Primary Health Care professionals. DESIGN: Cross-sectional study with a two-stage cluster sampling. SETTING: The study included 97 schools, and was carried out in 2005-06 in Catalonia (Spain). PARTICIPANTS: 14-16 year-old secondary school children. MAIN MEASURES: The survey was based on a self-administered paper-based questionnaire that collected sociodemographic variables, academic level, health status, family variables, sexual relations, addictive substances, mood state, and variables related to opinions on cigarette smoking The association between these variables and smoker/non-smoker variable was analyzed, as well as factors that could increase the probability of becoming a smoker using multilevel models. RESULTS: A total of 9340 completed questionnaires, including 4653 from males, were received from the pupils, with a mean age of 15.2 years. The results showed that 71.1% of pupils were non-smokers, 75% of whom were males and 67.3% of females. The following factors increased the probability of becoming a smoker (OR and 95%CI): being a female 0.60 (0.53-0.68), being in the 4(th) year 1.27 (1.12-1.43), low academic performance 3.38 (2.74-4.17), self-reported regular/poor health status 2.81 (2.21-3.58), smoking parents 1.68 (1.45-1.95), alcohol consumption 5.05 (4.35-5.86), having 3 or more problems of mood state 1.22 (1.05-1.41), living without parents 1.59 (1.07-2.38), agreeing with tobacco industry advertising 1.64 (1.45-1.85) and believing that tobacco acts as a relaxant 3.57 (3.23-4.17). CONCLUSIONS: Although the majority of pupils were non-smokers, smoking was more prevalent among females. The factors associated with cigarette smoking in the adolescents included sociodemographic, sociocultural, and personal environmental factors, as well as their opinions on the habit.

Role of personal aptitudes as determinants of incident morbidity, lifestyles, quality of life, use of health services, and mortality (DESVELA cohort): quantitative study protocol for a prospective cohort study in a hybrid analysis.

Introduction: The healthcare and well-being of the population depend on multiple factors and should adapt to societal changes. The opposite is also occurring; society has evolved concerning the individuals' approach to their care, which includes participation in decision-making processes. In this scenario, health promotion and prevention become crucial to provide an integrated perspective in the organization and management of the health systems.Health status and well-being depend on many aspects, determinants of health, which in turn may be modulated by individual behavior. Certain models and frameworks try to study the determinants of health and individual human behaviors, separately. However, the interrelation between these two aspects has not been examined in our population.Our main objective is to analyze whether personal aptitudes related to behaviors are independently associated with the incidence of morbidity. A secondary objective will enquire whether these personal aptitudes are independently associated with lower all-cause mortality, enhanced adoption of healthy lifestyles, higher quality of life, and lower utilization of health services during follow-up. Methods: This protocol addresses the quantitative branch of a multicenter project (10 teams) for the creation of a cohort of at least 3,083 persons aged 35 to 74 years from 9 Autonomous Communities (AACC). The personal variables to evaluate are self-efficacy, activation, health literacy, resilience, locus of control, and personality traits. Socio-demographic covariates and social capital will be recorded. A physical examination, blood analysis, and cognitive evaluation will be carried out.Several sets of six Cox models (one for each independent variable) will analyze the incidence of morbidity (objective 1); all-cause mortality and the rest of the dependent variables (objective 2). The models will be adjusted for the indicated covariates, and random effects will estimate Potential heterogeneity between AACC. Discussion: The analysis of the association of certain behavioral patterns and determinants of health is essential and will contribute to improving health promotion and prevention strategies. The description of the individual elements and interrelated aspects that modulate the onset and persistence of diseases will allow the evaluation of their role as prognostic factors and contribute to the development of patient-tailored preventive measures and healthcare.Clinical Trial Registration: ClinicalTrials.gov, NCT04386135. Registered on April 30, 2020.

Rationale and design of the PREDICE project: cost-effectiveness of type 2 diabetes prevention among high-risk Spanish individuals following lifestyle intervention in real-life primary care setting.

BACKGROUND: Type 2 diabetes is an important preventable disease and a growing public health problem. Based on information provided by clinical trials, we know that Type 2 diabetes can be prevented or delayed by lifestyle intervention. In view of translating the findings of diabetes prevention research into real-life it is necessary to carry out community-based evaluations so as to learn about the feasibility and effectiveness of locally designed and implemented programmes. The aim of this project was to assess the effectiveness of an active real-life primary care strategy in high-risk individuals for developing diabetes, and then evaluate its efficiency. METHODS/DESIGN: Cost-Effectiveness analysis of the DE-PLAN (Diabetes in Europe - Prevention using Lifestyle, physical Activity and Nutritional intervention) project when applied to a Mediterranean population in Catalonia (DE-PLAN-CAT). Multicenter, longitudinal cohort assessment (4 years) conducted in 18 primary health-care centres (Catalan Health Institute). Individuals without diabetes aged 45-75 years were screened using the Finnish Diabetes Risk Score - FINDRISC - questionnaire and a 2-h oral glucose tolerance test. All high risk tested individuals were invited to participate in either a usual care intervention (information on diet and cardiovascular health without individualized programme), or the intensive DE-PLAN educational program (individualized or group) periodically reinforced. Oral glucose tolerance test was repeated yearly to determine diabetes incidence. Besides measuring the accumulated incidence of diabetes, information was collected on economic impact of the interventions in both cohorts (using direct and indirect cost questionnaires) and information on utility measures (Quality Adjusted Life Years). A cost-utility and a cost-effectiveness analysis will be performed and data will be modelled to predict long-term cost-effectiveness. DISCUSSION: The project was intended to evidence that a substantial reduction in Type 2 diabetes incidence can be obtained at a reasonable cost-effectiveness ratio in real-life primary health care setting by an intensive lifestyle intervention. As far as we know, the DE-PLAN-CAT/PREDICE project represents the first assessment of long-term effectiveness and cost-effectiveness of a public healthcare strategy to prevent diabetes within a European primary care setting.

Construction and validation of a scoring system for the selection of high-quality data in a Spanish population primary care database (SIDIAP).

BACKGROUND: Computerised databases of primary care clinical records are widely used for epidemiological research. In Catalonia, the Information System for the Development of Research in Primary Care (SIDIAP) aims to promote the development of research based on high-quality validated data from primary care electronic medical records. OBJECTIVE: The purpose of this study is to create and validate a scoring system (Registry Quality Score, RQS) that will enable all primary care practices (PCPs) to be selected as providers of researchusable data based on the completeness of their registers. METHODS: Diseases that were likely to be representative of common diagnoses seen in primary care were selected for RQS calculations. The observed/expected cases ratio was calculated for each disease. Once we had obtained an estimated value for this ratio for each of the selected conditions we added up the ratios calculated for each condition to obtain a final RQS. Rate comparisons between observed and published prevalences of diseases not included in the RQS calculations (atrial fibrillation, diabetes, obesity, schizophrenia, stroke, urinary incontinence and Crohn's disease) were used to set the RQS cutoff which will enable researchers to select PCPs with research-usable data. RESULTS: Apart from Crohn's disease, all prevalences were the same as those published from the RQS fourth quintile (60th percentile) onwards. This RQS cut-off provided a total population of 1 936 443 (39.6% of the total SIDIAP population). CONCLUSIONS: SIDIAP is highly representative of the population of Catalonia in terms of geographical, age and sex distributions. We report the usefulness of rate comparison as a valid method to establish research-usable data within primary care electronic medical records.

Implementation of the EIRA 3 Intervention by Targeting Primary Health Care Practitioners: Effectiveness in Increasing Physical Activity.

The World Health Organization (WHO) estimated that physical inactivity (PI) is responsible for 20 to 30% of all non-communicable diseases. We aimed to analyze the effectiveness of a multiple health behavior change (MHBC) intervention to increase physical activity (PA) in patients 45 to 75 years old who had at least 2 of 3 unhealthy behaviors (tobacco use, reduced fruit and vegetable consumption, and insufficient PA). The MHBC intervention is based on the Transtheoretical Model and the conceptual framework of the "5 A's" and includes an individually tailored intervention, group sessions, and the use of community resources. We included 3062 participants, 1481 in the intervention group and 1581 in the control group. After 12 months, there were no differences in PA intensity measured by metabolic_equivalent_of_task_minutes/week (adjusted mean difference: 284.093, 95% CI: -298.24, 866.42) nor in the proportion of participants who increased PA levels to moderate or high (OR: 1.02, 95% CI: 0.85, 1.23; p = 0.822), and no differences in blood pressure, weight loss, or waist circumference. We found an increased proportion of patients in the intervention group who followed the WHO recommendations for PA (OR: 1.29; 95% CI: 1.04, 1.60; p = 0.02). We concluded that the intervention did not lead to a significant increase in PA.

The Relationship between Adherence to the Mediterranean Diet, Intake of Specific Foods and Depression in an Adult Population (45-75 Years) in Primary Health Care. A Cross-Sectional Descriptive Study.

BACKGROUND: The relationship between the quality of the diet and the adherence to the Mediterranean diet with the presence of persistent or recurrent depressive symptoms have been described. The objective of this study is to analyze the relationship between adherence to the Mediterranean diet and the intake of specific foods in primary care patients aged 45 to 75, having subclinical or major depression. The study also specifically analyzes this relationship in individuals suffering from chronic diseases. METHODS: A cross-sectional descriptive study was conducted. 3062 subjects met the inclusion criteria from the EIRA study. Sociodemographic variables, clinical morbidity, depression symptomatology (PHQ-9) and adherence to Mediterranean diet (MEDAS) were collected. RESULTS: Being female, younger, with a higher BMI, consuming more than 1 serving of red meat a day and drinking more than one carbonated or sugary drink daily, not consuming 3 servings of nuts a week and not eating 2 vegetables cooked in olive oil a week are predictors of having higher depressive symptomatology. CONCLUSIONS: Assessing the type of diet of patients presenting depressive symptoms and promoting adherence to a healthy diet is important, especially in patients with chronic diseases. However, depression is a very complex issue and the relationship between nutrition and depression must be further examined.