Worsening of alcohol abuse disorder in a Spanish population during the first twelve months of the COVID-19 pandemic and associated factors: retrospective, ecological and community study.

PURPOSE: To analyse: (1) Changes in clinical parameters and in the use of social healthcare resources by patients with alcohol abuse disorder between the six months prior to the start of the pandemic and the first year of the pandemic. (2) The factors related to a worsening of clinical parameters among patients with alcohol abuse disorder. METHODS: A retrospective and observational study of a population who have been diagnosed with alcohol abuse disorders according to their primary health care (PHC) electronic medical records was performed. The total sample was made up of 11,384 patients. The variables (sociodemographic variables, chronic comorbidities, analytical parameters related to alcohol abuse disorder, COVID-19 infection, and use of healthcare resources) were collected in three different time periods: (i) six months before the onset of the strict lockdown, (ii) six months following the end of lockdown and (iii) from six to twelve months after the end of lockdown. Paired Student's T-test and a multivariate logistic regression were performed. RESULTS: Along the first year after the onset of the pandemic, between 44% and 54% of the patients suffered a decline in every clinical parameter. The number of PHC nursing, GP visits and social worker visits reduced significantly. As regards the associated factors related to deterioration of alcohol abuse disorder, being younger than 40 years old, having an income of over 18,000 euros/year and not having visited the social worker were associated with a worsening of the disorder. CONCLUSIONS: These results suggest that the impact of COVID-19 on this group has been high, and the social care offered to these patients plays a significant role in minimising the repercussions of the pandemic.

Self-rated health impact of COVID 19 confinement on inmates in Southeastern of Europe: a qualitative study.

INTRODUCTION: The COVID-19 pandemic necessitated the implementation of various measures within closed institutions like prisons to control the spread of the virus. Analyzing the impact of these measures on the health of inmates is crucial from a public health perspective. This study aimed to explore inmates' subjective perception of the COVID-19 lockdown, the implemented measures, their physical self-perception, and their views on the vaccination process. METHOD: Between April 2021 and January 2022, 27 semi-structured individual interviews and 1 focus group were conducted with inmates in a prison located in northwest Spain. The interviews were conducted in person and audio-recorded. Thematic content analysis was employed, utilizing methodological triangulation to enhance the coherence and rigor of the results. RESULTS: The analysis revealed two main themes and nine subthemes. The first theme focused on inmates' perception of the implementation of protective measures against COVID-19 within the prison and its impact on their well-being. The second theme explored the pandemic's emotional impact on inmates. All participants reported negative consequences on their health resulting from the measures implemented by the institution to contain the pandemic. However, they acknowledged that measures like lockdowns and mass vaccination helped mitigate the spread of the virus within the prison, contrary to initial expectations. CONCLUSION: COVID-19 and related measures have directly affected the health of inmates. To improve their health and minimize the impact of pandemic-induced changes, community participation and empowerment of individuals are essential tools, particularly within closed institutions such as prisons.

Use of health services and medication use, new comorbidities, and mortality in patients with chronic diseases who did not contract COVID-19 during the first year of the pandemic: a retrospective study and comparison by sex.

BACKGROUND: The restrictions introduced to stop the spread of the COVID-19 virus have also had a direct impact on people with chronic diseases and especially on diseases to which lifestyles are relevant in their control and management, such as diabetes, hypertension, chronic obstructive pulmonary disease (COPD), etc. The purpose of this paper is to conduct a longitudinal analysis of new comorbidities, mortality, medication use, and the use of health resources in patients with chronic diseases who did not contract COVID-19, comparing the six months before the strict lockdown to the 12 months following the end of the strict lockdown. METHOD: An observational real world data pre-post study of 668,974 people was undertaken. The patients studied were over 16 years of age, had been receiving care from the Aragon Health Service (Northeastern Spain), were diagnosed with one or more chronic diseases, and had not contracted COVID-19. Sociodemographic, comorbidity, pharmacological and health resource use variables were collected during the six months before the onset of the lockdown and during the six and 12 months following the end of the lockdown. The comparisons by sex were carried out using a Student T-test or chi-squared test to analyse differences. RESULTS: Dyslipidaemia (42.1%) followed by hypertension (35.1%) and anxiety and depression (34.6%) were the most prevalent chronic diseases among the study population. 78.% of patients had between one and four chronic illnesses. There was a decrease in new diagnoses of other chronic comorbidities in this population and a decrease in medications prescribed and the use of health services.  Although women received more diagnoses of chronic diseases, the number of medications dispensed was lower, but the use of health services was higher. These figures were maintained throughout the pandemic. CONCLUSION: Our results suggest an underdiagnosis of new chronic comorbidities and a decrease in mortality rates from causes unrelated to COVID-19 due to the closure of health centres in Aragón (Spain) during the lockdown. This trend was exacerbated in women. The underdiagnosis of new chronic comorbidities during confinement can cause the disease to worsen, with the consequent increase in symptoms and the worsening of chronic pathologies in patients with a severe evolution.

The impact of the COVID-19 lockdown on depression sufferers: a qualitative study from the province of Zaragoza, Spain.

BACKGROUND AND PURPOSE: The impact of COVID-19 and its control measures have exacerbated existing mental health conditions. Although the deleterious effects of mental health problems are well known, fewer studies have examined the links between the Social Determinants of Health (SDHs) and depression. This study provides insights into the relationship between SDHs and depression during the first strict lockdown in Spain, which lasted for a period of 7 weeks. METHODS: Fifty-two structured interviews were conducted with people diagnosed with depression during June 2020 in the province of Zaragoza (Spain). Interviews were conducted by telephone due to lockdown constraints. Inductive thematic content analysis was used to explore, develop, and define emergent categories of analysis, which were mapped against the SDH framework. RESULTS: Listening to people's experiences of living with depression during lockdown provided insights into their concerns and coping strategies, which are greatly influenced by the conditions in which they live, their job and their age. Examples of these factors include access to and quality of physical spaces, including housing conditions and public spaces for socialising, social support, adverse working conditions which include caring responsibilities, and access to digital technologies and healthcare services. CONCLUSION: SDHs have played a fundamental role in shaping people's health and well-being during the COVID-19 pandemic, and this study has shown that they have a considerable effect on depression outcomes. Governments should consider implementing social welfare programs to tackle both psychosocial problems and material need during crisis situations.

Evaluation of primary care responsiveness by people with mental illness in Spain.

BACKGROUND: The health system responsiveness is a concept developed by the World Health Organization that measures patients' expectations for the non-medical care they receive. The aim of this study is to assess primary care responsiveness as seen by people with mental illness and to analyse the factors associated with poor responsiveness. METHODS: Cross-sectional descriptive study on 426 people with mental illness who had attended primary care consultations at least once in the previous 12 months. The responsiveness of the health system was determined through the short questionnaire "Multi-country Survey Study on Health and Health Systems Responsiveness". Differences in responsiveness by sociodemographic characteristics were compared through the Chi-squared test. Logistic regression identified the factors associated with poor responsiveness. RESULTS: Overall responsiveness was measured as good by 77.4% of patients, being this probability higher in the domains: dignity, confidentiality, and communication. The most valued domains by people with mental illness were prompt attention (42.4%), dignity (30.1%), and communication (17%). Only prompt attention scored high importance and poor responsiveness. In patients with an income lower than 900 euros per month and low level of studies, the probability of poor confidentiality responsiveness was multiplied by 3 and 2.7 respectively. CONCLUSIONS: People with mental illness perceive good responsiveness from primary care in terms of dignity, confidentiality, and communication. Prompt attention, as the domain of greatest importance and worst valuation, should be prioritised through the implementation of organisational measures in health centres to reduce waiting times, especially in urban areas.

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".

Perception of the primary health care response capacity by patients with and without mental health problems, and health professionals: qualitative study.

BACKGROUND: The objective of this study is to deepen our understanding of perceptions towards Primary Health Care Response Capacity by specifically using patients with and without mental disorders, as well as family doctors and a manager, in order to compare and endorse perspectives. For it, a qualitative study was performed. In-depth interviews were conducted with 28 patients with and without mental health disorders and focus groups were held with 21 professionals and a manager. An inductive thematic content analysis was performed in order to explore, develop and define the emergent categories of analysis. RESULTS: The fundamental domains for patients are dignity, communication, and rapid service. People with mental health problems also highlight the domain of confidentiality as relevant, while patients who do not have a mental health problem prioritize the domain of autonomy. Patients with mental health disorders report a greater number of negative experiences in relation to the domain of dignity. Patients do not consider their negative experiences to be a structural problem of the system. These findings are also endorsed by health care professionals. CONCLUSIONS: It is necessary to take these results into account as responsive systems can improve service uptake, ensure adherence to treatment, and ultimately enhance patient welfare.

Mindfulness in primary care healthcare and teaching professionals and its relationship with stress at work: a multicentric cross-sectional study.

BACKGROUND: Work stress is a common problem among the health personnel of the Spanish National Health System. The objective of this paper is to assess the state of mindfulness among Spanish primary care providers and to evaluate its potential relationship with work stress and basic labor and sociodemographic characteristics. METHODS: Cross-sectional, multi-centric study. Primary care nurses, teachers, teaching collaborators and residents assigned to six Spanish Family Medicine/Family and Community Care Departments were invited to participate (n = 475). A template was designed in Google Forms, including sociodemographic and work-related variables. The state of mindfulness was measured with the Five Facet Mindfulness Questionnaire (FFMQ), while work-related stress was measured using an ordinal scale ranging from 0 to 10 points. Descriptive and inferential statistical analyses were carried out, as well as bivariate and multivariate statistics. RESULTS: The mean age of participants was 40,14 ± 13.12 (range:23-65 years); 66.9% were women, 42.5% internal medicine residents, 29.3% family physicians, and 20.2% nurses. More than half (54.5%) knew about mindfulness, with 24.0% have received training on it, and 22.5% were usual practitioners. The average level of mindfulness was 127.18 ± 15.45 (range: 89-177). The average score of stress at work was 6.00 ± 2.44; 49.9% (range: 0-10). 49.9% of participants scored 7 or more on the stress at work scale. There was an inverse correlation between the levels of mindfulness (FFMQ total score) and work-related stress (Spearman's r = - 0.155, p = 0.003). Significant relationships between the mindfulness practice and the level of mindfulness (F = 29.80, p < 0.001), as well as between the mindfulness practice and the level of work-related stress (F = 9.68, p = 0.042), were also found. CONCLUSIONS: Levels of mindfulness in primary care health providers were in line with those levels observed in other groups of health professionals. Half of all of the primary care providers suffered from a high degree of stress. Although weak, inverse relationships were observed between levels of mindfulness and stress at work, with lower values of stress at work among those who practiced mindfulness. TRIAL REGISTRATION: NCT03629457 .

Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial.

BACKGROUND: Breast cancer (BC) is a major public health issue. More than one out of five women treated for breast cancer will develop lymphedema in an upper extremity. Current evidence advocates transdisciplinary oncological rehabilitation. Therefore, research in this area is necessary since limited consensus having been reached with regard to the basic essential components of this rehabilitation. Consensus has, however, been reached on the use of decongestive lymphedema therapy (DLT), but due to a lack of tests, the necessary dosages are unknown and its level is moderately strong. This study attempts to verify both the efficacy of activity-oriented proprioceptive antiedema therapy (TAPA), as compared to conventional treatments such as DLT or Complex Physical Therapy (CPT), as well as its efficiency in terms of cost-effectiveness, for patients affected by breast cancer-related arm lymphedema. METHODS: Controlled, randomized clinical trial with dual stratification, two parallel arms, longitudinal and single blind. 64 women with breast cancer-related arm lymphedema will take part in the study. The experimental group intervention will be the same for stage I and II, and will consist of neuro-dynamic exercises oriented to the activity, proprioceptive neuromuscular facilitation activities and proprioceptive anti-edema bandaging. The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II). RESULTS: Sociodemographic and clinical variables will be collected for the measurement of edema volume and ADL performance. Statistical analysis will be performed on intent to treat. DISCUSSION: It has been recommended that patient training be added to DLT, as well as a re-designing of patient lifestyles and the promotion of health-related aspects. In addition, clinical trials should be undertaken to assess neural mobilization techniques and proprioceptive neuromuscular facilitation should be included in the therapy. Cohesive bandaging will also be performed as an early form of pressotherapy. The proposed study combines all of these aspects in order to increased comfort and promote the participation of individuals with lymphedema in everyday situations. LIMITATIONS: The authors have proposed the assessment of the experimental treatment for stages I and II. One possible limitation is the lack of awareness of whether or not this treatment would be effective for other stages as well as the concern for proper hand cleansing during use of bandages, given the current COVID-19 pandemic situation. TRIAL REGISTRATION: This trial was registered in ClinicalTrials.gov ( NCT03762044 ). Date of registration: 23 November 2018. Prospectively Registered.

Imported malaria cases: the connection with the European ex-colonies.

BACKGROUND: Imported malaria is increasing in non-endemic areas due to the increment of international travels, migration and, probably, other unknown factors. The objective of this study was to describe the epidemiological and clinical characteristics of malaria cases in a region of Spain; analyse the possible association between the variables of interest; compare this series with others; and evaluate the characteristics of imported malaria cases according to the country of origin, particularly cases from Equatorial Guinea (Spanish ex-colony) and from the rest of sub-Saharan Africa. METHODS: A descriptive observational study was carried out with a retrospective data collection of cases of malaria reported in Aragon from 1996 to 2017. Univariate and bivariate analysis of clinical-epidemiological variables was performed. In addition, an analysis of cases from sub-Saharan Africa was carried out using logistic regression, calculating odds ratio with its 95% confidence interval. RESULTS: 609 cases of malaria were recorded in Aragon from 1996 to 2017. An autochthonous case in 2010. 50.33% were between 15 and 39 years old. 45.65% of the cases were notified of the 4-weeks 9 to 12. 82.6% reside in the main province, urban area, of which 65.4% were VFR (Visiting Friends and Relatives), 23.8% new immigrants and 10.9% travellers. The infectious Plasmodium species par excellence was Plasmodium falciparum (88%). Analysing the cases from sub-Saharan Africa (95.2% of the total), 48.1% were from Equatorial Guinea. Comparing these with the cases from the rest of sub-Saharan Africa, it was observed that the cases from the Spanish ex-colony have association with the female gender, being under 5 years old, residing in the main province (urban area) and being a new immigrant. CONCLUSIONS: The epidemiological profile of imported malaria cases can be defined as VFR between 15 and 39 years old, coming from sub-Saharan Africa, particularly from Equatorial Guinea. Immigrants education about the importance of chemoprophylaxis when travelling to visit friends and relatives, emphasizing on those who are originally from the ex-colonies of destination country, is necessary; as well as to raise awareness among health professionals to make advice in consultations, specially before summer vacations.

Prevalence of celiac disease in primary care: the need for its own code.

BACKGROUND: Celiac disease (CD) is an autoimmune chronic enteropathy of the small intestine caused by exposure to gluten in genetically predisposed individuals. CD is not easy to diagnose due to its unspecific symptomatology, especially in adults, a diagnosed/undiagnosed ratio of 1:7 is estimated. CD does not have its own code in the International Classification of Primary Care (ICPC) but it is coded under code D99 "Disease digestive system, other", which hinders diagnosis, intervention and research. The aim of this study is to investigate the prevalence of CD in Aragón, Spain, using the information available from Primary Care, as well as to discuss the difficulties involved in determining prevalence of CD from data collected at this level of medical intervention. METHODS: We designed an epidemiological cross-sectional study and analysed 26,964 electronic clinical records from the Aragonese Health Service under code ICPC D99 collected up to December 31st, 2016. The clinical records were classified by their editable field "descriptor" according to their probability of being related to CD. Analyses of gender, age, age at diagnosis, province and health sector were carried out. RESULTS: We found 4534 clinical records under 293 different descriptors with a high probability of referring to CD. Prevalence in Aragón was estimated to be 0.35% ranging from 0.24 to 0.81% with important differences among health sectors. CONCLUSIONS: The prevalence of 0.35% is a long way from the generally accepted 1% but within the usually considered ratio 1:7 of diagnosed:undiagnosed cases. Differences among sectors should be carefully analysed. Lacking its own ICPC code, diagnosis of CD in Primary Care Services is not included in a single category, but it is distributed under several descriptors, which makes it difficult to offer any firm diagnosis for treatment and hinders research. Finally, the high prevalence of CD justifies its own ICPC code and the need to withdraw CD from the generic D99 code "Disease digestive system other".

Controlled clinical trial comparing the effectiveness of a mindfulness and self-compassion 4-session programme versus an 8-session programme to reduce work stress and burnout in family and community medicine physicians and nurses: MINDUUDD study protocol.

BACKGROUND: Health personnel are susceptible to high levels of work stress and burnout due to the psychological and emotional demands of their work, as well as to other aspects related to the organisation of that work. This paper describes the rationale and design of the MINDUUDD study, the aim of which is to evaluate the effectiveness of a mindfulness and self-compassion 4-session programme versus the standard 8-session programme to reduce work stress and burnout in Family and Community Medicine and Nursing tutors and residents. METHODS: The MINDUDD study is a multicentre cluster randomised controlled trial with three parallel arms. Six Teaching Units will be randomised to one of the three study groups: 1) Experimental Group-8 (EG8); 2) Experimental Group-4 (EG4) Control group (CG). At least 132 subjects will participate (66 tutors/66 residents), 44 in the EG8, 44 in the EG4, and 44 in the CG. Interventions will be based on the Mindfulness-Based Stress Reduction (MBSR) program, including some self-compassion practices of the Mindful Self-Compassion (MSC) programme. The EG8 intervention will be implemented during 8 weekly face-to-face sessions of 2.5 h each, while the EG4 intervention will consist of 4 sessions of 2.5 h each. The participants will have to practice at home for 30 min/day in the EG8 and 15 min/day in the EG4. The Five Facet Mindfulness Questionnaire (FFMQ), Self-Compassion Scale (SCS), Perceived Stress Questionnaire (PSQ), Maslach Burnout Inventory (MBI), Jefferson Scale of Physician Empathy (JSPE), and Goldberg Anxiety-Depression Scale (GADS) will be administered. Measurements will be taken at baseline, at the end of the programs, and at three months after completion. The effect of the interventions will be evaluated by bivariate and multivariate analyses (Multiple Linear Regression). DISCUSSION: If the abbreviated mindfulness programme is at least as effective as the standard program, its incorporation into the curriculum and training plans will be easier and more appropriate. It will also be more easily applied and accepted by primary care professionals because of the reduced resources and means required for its implementation, and it may also extend beyond care settings to academic and teaching environments as well. TRIAL REGISTRATION: The study has been registered at ClinicalTrials.gov ( NCT03629457 ; date of registration: 13.08.2018).

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.

External validation of multidimensional prognostic indices (ADO, BODEx and DOSE) in a primary care international cohort (PROEPOC/COPD cohort).

BACKGROUND: Due to the heterogeneous and systemic nature of the chronic obstructive pulmonary disease (COPD), the new guidelines are oriented toward individualized attention. Multidimensional scales could facilitate its proper clinical and prognostic assessment, but not all of them were validated in an international primary care cohort, different from the original ones used for model development. Therefore, our main aim is to assess the prognostic capacity of the ADO, BODEx and DOSE indices in primary care for predicting mortality in COPD patients and to validate the models obtained in subgroups of patients, classified by revised Global Initiative for Chronic Obstructive Lung Disease (2011) and updated Spanish Guideline (2014). Besides, we want to confirm that the prognostic capacity of all indices increases if the number of exacerbations is substituted by the interval between them and to assess the impact on health of the patient's lifestyle, social network and adherence to treatment. METHODS: Design: External validation of scales, open and prospective cohort study in primary care. SETTING: 36 health centres in 6 European high, medium and low income countries. SUBJECTS: 477 patients diagnosed with COPD, captured in clinical visit by their General Practitioner/Nurse. PREDICTORS: Detailed patient history, exacerbations, lung function test and questionnaires at baseline. OUTCOMES: Exacerbations, all-cause mortality and specific mortality, within 5 years of recruitment. ANALYSIS: Multivariate logistic regression and Cox regression will be used. Possible non-linear effect of the indices will be studied by using Structured Additive Regression models with penalised splines. Subsequently, we will assess different aspects of the regression models: discrimination, calibration and diagnostic precision. Clinical variables modulated in primary care and the interval between exacerbations will be considered and incorporated into the analysis. DISCUSSION: The Research Agenda for General Practice/Family Medicine highlights that the evidence on predictive values of prognostic indices in primary care is scarce. A prospective cohort like that of PROEPOC/COPD provides good opportunities for research into COPD and make communication easier between family practitioners, nursing staff, pneumologists and other professionals, supporting a multi-disciplinary approach to the treatment of these patients. TRIAL REGISTRATION: ISRCTN52402811 . Date: 15/01/2015. Prospectively registered.

Transcultural adaptation and validation of the Celiac Dietary Adherence Test. A simple questionnaire to measure adherence to a gluten-free diet.

BACKGROUND AND AIMS: A gluten-free diet is to date the only treatment available to celiac disease sufferers. However, systematic reviews indicate that, depending on the method of evaluation used, only 42% to 91% of patients adhere to the diet strictly. Transculturally adapted tools that evaluate adherence beyond simple self-informed questions or invasive analyses are, therefore, of importance. The aim is to obtain a Spanish transcultural adaption and validation of Leffler's Celiac Dietary Adherence Test. METHODS: A two-stage observational transversal study: translation and back translation by four qualified translators followed by a validation stage in which the questionnaire was administered to 306 celiac disease patients aged between 12 and 72 years and resident in Aragon. Factorial structure, criteria validity and internal consistency were evaluated. RESULTS: The Spanish version maintained the 7 items in a 3-factor structure. Reliability was very high in all the questions answered and the floor and ceiling effects were very low (4.3% and 1%, respectively). The Spearman correlation with the self-efficacy and life quality scales and the self-informed question were statistically significant (p < 0.01). According to the questionnaire criteria, adherence was 72.3%. CONCLUSION: The Spanish version of the Celiac Dietary Adherence Test shows appropriate psychometric properties and is, therefore, suitable for studying adherence to a gluten-free diet in clinical and research environments.

Correlation between diagnosis of depression and symptoms present in primary care patients.

Depression is a chronic disease with a high prevalence that normally is episodic and an average episodic duration of 16 weeks. No analyses that evaluate the correlation between the evolution of the episode and its appearance have been found. The aim of this study is to analyze the correlation between symptomatic progression (appearance, maintenance, remission of different symptoms) and the evolution of the diagnosis of depression (onset, maintenance, and remission) in a cohort of patients diagnosed with and without major depression. A prospective cohort study was performed with a one year follow-up in which a random sample of 741 subjects attending primary care was interviewed. Diagnosis of depression was made according to DSM-IV criteria and symptoms presented were analyzed. These subjects were reevaluated at 6 months and 12 months. Depressed mood state, decreased interest or anhedonia and symptoms related to sleep (insomnia or hypersomnia), agitation, feeling of guilt, fatigue or energy loss, are consistent with the diagnosis. The rest of the symptoms display an evolution independent of the diagnostic trends. In Primary Care, it is important to know which are the key symptoms in the evolution of the diagnosis in order to achieve full remission of depression and avoid maintenance of residual symptoms that can become prodromal.

Opinions and beliefs held by Spanish teenagers regarding tobacco and alcohol consumption: a descriptive study.

BACKGROUND: Preventive strategies are the most effective approach for dealing with issues of substance abuse, particularly in teenagers. Such strategies adapt well to this target population. Our objective was to reveal the opinions and beliefs held by teenagers about tobacco and alcohol as types of drugs, and their effects on health. METHODS: In this cross-sectional study, participants completed a self-administered questionnaire based on the World Health Organization "Health Behaviour of School-aged Children" study. Our sample included 1,005 schoolchildren aged between 11 and 13 years, resident in the province of Córdoba in Spain. Descriptive and univariate analyses were performed using a chi-squared test. RESULTS: Of respondents, 25% (95% confidence interval [CI]: 22.2-27.6%) and 61% (95% CI: 58.0-64.1%), respectively, did not consider tobacco or alcohol to be drugs. No relationship was found between tobacco and alcohol use, and the belief that these are drugs (p = 0.477 and p = 0.217, respectively). A total 98.2% of adolescents surveyed (95% CI: 97.3-99.1%) believed that tobacco causes physical damage, mainly to the lungs, heart, and to the developing fetus. Additionally, 92.4% (95% CI: 90.6-94.0%) believed that alcohol is detrimental to health and identified the liver as the organ most frequently damaged by alcohol consumption. The media was identified as the main source of information about these substances by 78.0% of respondents (95% CI: 75.4-80.6%). CONCLUSIONS: Teenagers possess an acceptable level of knowledge and information about the negative effects of tobacco and alcohol on health; however, many of them do not consider these substances to be drugs.

Pilot study of an online brief mindfulness-based intervention to improve the well-being of managers and reduce their stress at work.

Objectives. The COVID-19 pandemic, remote work and new technologies have heightened workplace pressures. Effective response and essential organizational changes require business leaders to be more adaptable, with managers' presence playing a pivotal role in successful implementation. The study assesses a brief mindfulness-based emotional regulation for managers (MBERM) intervention, to reduce workplace stress and enhance managerial well-being. Methods. An 8-week non-randomized controlled trial was conducted with a waiting list control group and an intervention group. Pre-post differences were measured by Student's t test or Wilcoxon test, and effect size calculated using the Hedge's g formula. The sample included 23 managers (17 men and six women) with average age 50 years. The study assessed anxiety and depressive symptoms, psychological flexibility, perceived self-efficacy, general work-related well-being, perceived stress and mindfulness. Results. Statistically significant changes were observed in the intervention group in depression, anxiety, work-related acceptance and action, general self-efficacy, exhaustion, alienation, stress and non-reactivity. The control group showed no statistically significant changes in any of the variables. Conclusion. The MBERM intervention could improve the emotional and work-related well-being of managers and reduce stress levels and burnout. Further study of this intervention is needed to promote adherence and ensure a long-term improvement.