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".

Effectiveness of a psychoeducation group intervention conducted by primary healthcare nurses in patients with depression and physical comorbidity: study protocol for a randomized, controlled trial.

BACKGROUND: Depressive disorders are the third leading cause of consultation in primary care, mainly in patients with chronic physical illnesses. Studies have shown the effectiveness of group psychoeducation in reducing symptoms in depressive individuals. Our primary aim is to evaluate the effectiveness of an intervention based on a psychoeducational program, carried out by primary care nurses, to improve the remission/response rate of depression in patients with chronic physical illness. Secondarily, to assess the cost-effectiveness of the intervention, its impact on improving control of the physical pathology and quality of life, and intervention feasibility. METHODS/DESIGN: A multicenter, randomized, clinical trial, with two groups and one-year follow-up evaluation. Economic evaluation study. SUBJECTS: We will assess 504 patients (252 in each group) aged > 50 years assigned to 25 primary healthcare centers (PHC) from Catalonia (urban, semi-urban, and rural). Participants suffer from major depression (Beck depression inventory: BDI-II 13-28) and at least one of the following: type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, and/or ischemic cardiopathy. Patients with moderate/severe suicide risk or severe mental disorders are excluded. Participants will be distributed randomly into the intervention group (IG) and control (CG). INTERVENTION: The IG will participate in the psychoeducational intervention: 12 sessions of 90 min, once a week led by two Primary Care (PC) nurses. The sessions will consist of health education regarding chronic physical illness and depressive symptoms. MAIN MEASUREMENTS: Clinical remission of depression and/or response to intervention (BDI-II). SECONDARY MEASUREMENTS: Improvement in control of chronic diseases (blood test and physical parameters), drug compliance (Morinsky-Green test and number of containers returned), quality of life (EQ-5D), medical service utilization (appointments and hospital admissions due to complications), and feasibility of the intervention (satisfaction and compliance). Evaluations will be blinded, and conducted at baseline, post-intervention, and 12 months follow-up. DISCUSSION: Results could be informative for efforts to prevent depression in patients with a chronic physical illness. TRIAL REGISTRATION: NCT03243799 (registration date August 9, 2017).

Effectiveness of a multidisciplinary BIOPSYCHOSOCIAL intervention for non-specific SUBACUTE low back pain in a working population: a cluster randomized clinical trial.

BACKGROUND: Low back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally. Current guidelines for the treatment of LBP recommend pharmacological and non-pharmacological strategies. The aim of this study was to compare usual clinical practice with the effectiveness of a biopsychosocial multidisciplinary intervention in reducing disability, severity of pain and improving quality of life in a working population of patients with subacute (2-12 weeks), non-specific LBP. METHODS: Longitudinal cluster randomized clinical trial conducted in 39 Primary Health Care Centres (PHCC) of Barcelona, with patients aged 18-65 years (n = 501; control group = 239; 26 PHCC, intervention group = 262; 13 PHCC). The control group received usual clinical care. The intervention group received usual clinical care plus a biopsychosocial multidisciplinary intervention, which consisted of physiotherapy, cognitive-behavioural therapy and medication. The main outcomes were changes in the Roland Morris Disability Questionnaire (RMDQ), and the minimal clinically important differences. Secondary outcomes were changes in the McGill Pain (MGPQ) and Quality of Life (SF-12) questionnaires. Assessment was conducted at baseline, 3 and 12 months. Analysis was by intention-to-treat and analyst-blinded. Multiple imputations were used. RESULTS: Of the 501 enrolled patients, 421 (84%) provided data at 3 months, and 387 (77.2%) at 12 months. Mean age was 46.8 years (SD: 11.5) and 64.7% were women. In the adjusted analysis of the RMDQ outcome, only the intervention group showed significant changes at 3 months (- 1.33 points, p = 0.005) and at 12 months (- 1.11 points, p = 0.027), but minimal clinically important difference were detected in both groups. In the adjusted analysis of the RMDQ outcome, the intervention group improvement more than the control group at 3 months (- 1.33 points, p = 0.005) and at 12 months (- 1.11 points, p = 0.027). The intervention group presented a significant difference. Both groups presented a minimal clinically important difference, but more difference in the intervention group. The intervention group presented significant differences in the MGPQ scales of current pain intensity and VAS scores at 3 months. No statistically significant differences were found in the physical and mental domains of the SF-12. CONCLUSIONS: A multidisciplinary biopsychosocial intervention in a working population with non-specific subacute LBP has a small positive impact on disability, and on the level of pain, mainly at short-term, but no difference on quality of life. TRIAL REGISTRATION: ISRCTN21392091 (17 oct 2018) (Prospectively registred).

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.

Cost-effectiveness and cost-utility study of a psychoeducational group intervention for people with depression and physical comorbidity in primary care.

OBJECTIVE: To evaluate the cost-effectiveness and cost-utility of a psychoeducational group intervention led by primary care (PC) nurses in relation to customary care to prevent the depression and improve quality of life in patients with physical comorbidity. DESIGN: Economic evaluation based on data from randomized, multicenter clinical trial with blind response variables and a one-year follow-up, carried in the context of the PSICODEP study. LOCATION: 7 PC teams from Catalonia. PARTICIPANTS: >50 year-old patients with depression and some physical comorbidity: diabetes mellitus type 2, ischemic heart disease, chronic obstructive pulmonary disease, and/or asthma. INTERVENTION: 12 psychoeducational group sessions, 1 per week, led by 2 PC nurses with prior training. MEASUREMENTS: Effectiveness: depression-free days (DFD) calculated from the BDI-II and quality-adjusted life years (QALYs) from the Euroqol-5D. Direct costs: PC visits, mental health, emergencies and hospitalizations, drugs. Indirect costs: days of temporary disability (TD). The incremental cost-effectiveness ratios (ICER), cost-effectiveness (ΔCost/ΔDLD) and cost-utility (ΔCost/ΔQALY) were estimated. RESULTS: The study includes 380 patients (intervention group [IG] = 204; control group [CG] = 176). 81.6% women; mean age 68.4 (SD = 8.8). The IG had a higher mean cost of visits, less of hospitalizations and less TD than the CG. The difference in costs between the IG and the CG was -357.95€ (95% CI: -2026.96 to 1311.06) at one year of follow-up. There was a mean of 11.95 (95% CI: -15.98 to 39.88) more DFD in the IG than in the CG. QALYs were similar (difference -0.01, 95% CI -0.04 to 0.05). The ICERs were 29.95€/DLD and 35,795€/QALY. CONCLUSIONS: Psychoeducational intervention is associated with an improvement in DFD, as well as a reduction in costs at 12 months, although not significantly. QALYs were very similar between groups.

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.

Physical and mental health impact of the COVID-19 pandemic at first year in a Spanish adult cohort.

The COVID-19 pandemic and the political and health measures have profoundly affected the health of our populations. However, very few studies have been published assessing its impact using a prospective cohort. The aim of this study is to describe the impact on physical and mental health due to the COVID-19 pandemic in the general population in Spain, and according to COVID-19 clinical status, during the first year of the pandemic. A longitudinal cohort study with two online surveys were performed on a representative sample of the adult Spanish population before (N = 2005, October/November 2019) and during the pandemic (N = 1357, November/December 2020). We assessed disability using the World Health Organisation Disability Assessment Schedule (WHODAS), major depressive episode (MDE) and suicidal thoughts and behaviours (STB), using an adapted version of the Composite International Diagnostic Interview (CIDI 3.0); generalised anxiety disorder (GAD) using the GAD-7 scale; post-traumatic stress disorder (PTSD) symptoms using the PTSD checklist for DSM-5 (PCL-5). For physical health, there was a statistically significant loss of weight (mean/SD) (T0, 73.22/15.56 vs. T1, 71.21/11.94), less use of tobacco (T0, 11.4% vs. T1, 9.0%) and decreased disability (mean/SD) (T0, 21.52/9.22 vs. T1, 19.03/7.32). For mental health, there was a significant increase in MDE (T0, 6.5% vs. T1, 8.8%) and in the prevalence of GAD (T0, 13.7% vs. T1, 17.7%). The prevalence of STB (T0, 15.1% vs. T1, 7.1%) significantly decreased. Individuals who declared they had been diagnosed with COVID-19 (3.6%) showed a worsening in physical health and an increase in mental health problems and PTSD symptoms. Although suicide risk during the first year of the pandemic was significantly less, many suicide risk factors increased: such as the incidence and persistence of MDE and GAD, the presence of PTSD symptoms in those diagnosed with COVID-19, and a worsening in self-assessed health status. We expect an increase in STB in the population in the long-term. Future research should gather information about the long-term impact of the pandemic.

A multiple health behaviour change intervention to prevent depression: A randomized controlled trial.

OBJECTIVE: To examine the effectiveness of a 12-month MHBC intervention in the prevention of onset depression in primary health care (PHC). METHODS: Twenty-two PHC centres took part in the cluster-randomized controlled trial. Patients were randomized to receive either usual care or an MHBC intervention. The endpoints were onset of major depression and reduction of depressive symptoms in participants without baseline depression at a 12-month follow-up. RESULTS: 2531 patients agreed and were eligible to participate. At baseline, around 43% were smokers, 82% were non-adherent to the Mediterranean diet and 55% did not perform enough physical activity. The intervention group exhibited a greater positive change in two or more behaviours (OR 1.75 [95%CI: 1.17 to 2.62]; p = 0.006); any behaviour (OR 1.58 [95%CI: 1.13 to 2.20]; p = 0.007); and adherence to the Mediterranean diet (OR 1.94 [95%CI: 1.29 to 2.94]; p = 0.002), while this increase was not statistically significant for smoking and physical activity. The intervention was not effective in preventing major depression (OR 1.17; [95% CI 0.53 to 2.59)]; p = 0.690) or reducing depressive symptoms (Mean difference: 0.30; [95% CI -0.77 to 1.36]; p = 0.726) during follow-up. CONCLUSIONS: As compared to usual care, the MHBC intervention provided a non-significant reduction in the incidence of major depression. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03136211.

Low Resilience Was a Risk Factor of Mental Health Problems during the COVID-19 Pandemic but Not in Individuals Exposed to COVID-19: A Cohort Study in Spanish Adult General Population.

BACKGROUND: The aim is to analyze whether people with low resilience are at higher risk of mental health problems during the COVID-19 pandemic in Spanish adults. METHODS: a longitudinal cohort study was carried out. Resilience was measured with the CD-RISC. Mental health problems that were assessed included: Major Depressive Episode (MDE), Generalized Anxiety Disorder (GAD), Suicidal Thoughts and Behaviors (STB), and Posttraumatic Stress Disorder (PTSD) symptoms. RESULTS: we found statistically significant differences between groups and resilience scores in MDE [F (3; 48.40) = 19.55], GAD [F (3; 19.63) = 6.45] and STB [F (3; 111.74) = 31.94]. Multivariable analyses showed individuals with very low resilience were at a 5-fold risk of Incidence of MDE and a 4-fold risk of STB. Persistent group presented a 21-fold risk of MDE and 54-fold risk of STB. No evidence of higher risk was found for GAD. Individuals with low resilience and exposed to COVID-19 were not at higher risk. Individuals with low resilience were at higher risk of PTSD in general population [ß(95% CI) = -3.25 (-3.969 to -2.54)], but not for individuals with COVID-19. CONCLUSIONS: in the general population, having low or very low resilience increases the risk of suffering MDE, STB, and PTSD, but not GAD during the COVID-19 pandemic, and not in the population with COVID-19.

Socio-economic and psychological impact of COVID-19 pandemic in a Spanish cohort BIOVAL-D-COVID-19 study protocol.

OBJECTIVE: SARS-CoV-2 outbreak has a negative psychological impact among general population. Data comparing mental health status before and during the outbreak is needed. The BIOVAL-D-COVID-19 study assess the socio-economic and psychological impact of the COVID-19 pandemic and lockdown in a representative sample of non-institutionalized Spanish adult population, and estimate the incidence of mental health disorders, including suicidal behaviours, and possible related factors. METHOD: Observational longitudinal study including two online surveys: baseline survey (T0) performed during 2019 and follow-up survey (T1) conducted 12-month later. The latter included nine sections: socio-demographic, health status, mental health, employment conditions and status, material deprivation, use of healthcare services, intimate partner violence and resilience. Four of the nine sections are administered in T0 and T1 assessments. Longitudinal data analyses will estimate adjusted incidence rates of mental health disorders using Poisson regression models. Risk and protective factors will be analysed through multiple logistic regression models.

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.

Validation and Psychometric Properties of the Spanish Version of the Hopkins Symptom Checklist-25 Scale for Depression Detection in Primary Care.

Depression constitutes a major public health problem due to its high prevalence and difficulty in diagnosis. The Hopkins Symptom Checklist-25 (HSCL-25) scale has been identified as valid, reproducible, effective, and easy to use in primary care (PC). The purpose of the study was to assess the psychometric properties of the HSCL-25 and validate its Spanish version. A multicenter cross-sectional study was carried out at six PC centers in Spain. Validity and reliability were assessed against the structured Composite International Diagnostic Interview (CIDI). Out of the 790 patients, 769 completed the HSCL-25; 738 answered all the items. Global Cronbach's alpha was 0.92 (0.88 as calculated for the depression dimension and 0.83 for the anxiety one). Confirmatory factor analysis (CFA) showed one global factor and two correlated factors with a correlation of 0.84. Area under the curve (AUC) was 0.89 (CI 95%, 0.86-0.93%). For a 1.75 cutoff point, sensibility was 88.1% (CI 95%, 77.1-95.1%) and specificity was 76.7% (CI 95%, 73.3-79.8%). The Spanish version of the HSCL-25 has a high response percentage, validity, and reliability and is well-accepted by PC patients.

Geographic Factors Associated with Poorer Outcomes in Patients Diagnosed with COVID-19 in Primary Health Care.

Background: The prognosis of older age COVID-19 patients with comorbidities is associated with a more severe course and higher fatality rates but no analysis has yet included factors related to the geographical area/municipality in which the affected patients live, so the objective of this study was to analyse the prognosis of patients with COVID-19 in terms of sex, age, comorbidities, and geographic variables. Methods: A retrospective cohort of 6286 patients diagnosed with COVID-19 was analysed, considering demographic data, previous comorbidities and geographic variables. The main study variables were hospital admission, intensive care unit (ICU) admission and death due to worsening symptoms; and the secondary variables were sex, age, comorbidities and geographic variables (size of the area of residence, distance to the hospital and the driving time to the hospital). A comparison analysis and a multivariate Cox model were performed. Results: The multivariate Cox model showed that women had a better prognosis in any type of analysed prognosis. Most of the comorbidities studied were related to a poorer prognosis except for dementia, which is related to lower admissions and higher mortality. Suburban areas were associated with greater mortality and with less hospital or ICU admission. Distance to the hospital was also associated with hospital admission. Conclusions: Factors such as type of municipality and distance to hospital act as social health determinants. This fact must be taken account in order to stablish specifics prevention measures and treatment protocols.

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.

Effectiveness of a Psychoeducational Group Intervention Carried Out by Nurses for Patients with Depression and Physical Comorbidity in Primary Care: Randomized Clinical Trial.

The association between physical illness and depression implies a poorer management of chronic disease and a lower response to antidepressant treatments. Our study evaluates the effectiveness of a psychoeducational group intervention led by Primary Care (PC) nurses, aimed at patients of this kind. It is a randomized, multicenter clinical trial with intervention (IG) and control groups (CG), blind response variables, and a one year follow-up. The study included 380 patients ≥50 years of age from 18 PC teams. The participants presented depression (BDI-II > 12) and a physical comorbidity: diabetes mellitus type 2, ischemic heart disease, chronic obstructive pulmonary disease, and/or asthma. The IG (n = 204) received the psychoeducational intervention (12 weekly sessions of 90 min), and the CG (n = 176) had standard care. The patients were evaluated at baseline, and at 4 and 12 months. The main outcome measures were clinical remission of depressive symptoms (BDI-II ≤ 13) and therapeutic response (reduction of depressive symptoms by 50%). Remission was not significant at four months. At 12 months it was 53.9% in the IG and 41.5% in the CG. (OR = 0.61, 95% CI, 0.49-0.76). At 4 months the response in the IG (OR = 0.59, 95% CI, 0.44-0.78) was significant, but not at 12 months. The psychoeducational group intervention led by PC nurses for individuals with depression and physical comorbidity has been shown to be effective for remission at long-term and for therapeutic response at short-term.

Health status, lifestyle habits, and perceived social support in long-term cancer survivors: a cross-sectional study.

OBJECTIVE: To compare the presence of comorbidities and self-perceived health and social support between long-term cancer survivors and people without a history of cancer from a clinical trial examining the effects of a multiple risk behavior intervention. RESULTS: Of the 4259 people studied, 190 (4.46%) were cancer survivors. They had a mean ± SD age of 62.8 ± 7 years vs. 58.7 ± 8 years (P < 0.01) for non-cancer people and were more likely to be on long-term sick leave (11.9 vs. 3.5%, P < 0.001). No differences were observed for smoking, adherence to the Mediterranean diet, physical activity, obesity, or social support. Cancer survivors were more likely to have worse self-perceived health (OR 1.82; 95% CI 1.02-2.75), more comorbidities (OR 1.68; 95% CI 1.18-2.39), COPD (OR 2.17; 95% CI 1.25-3.78), and depression (OR 1.65; 95% CI 1.06-2.57). Older age and worse self-perceived health were independent predictors of survivorship in the adjusted analysis.

Economic Evaluations Informed Exclusively by Real World Data: A Systematic Review.

Economic evaluations using Real World Data (RWD) has been increasing in the very recent years, however, this source of information has several advantages and limitations. The aim of this review was to assess the quality of full economic evaluations (EE) developed using RWD. A systematic review was carried out through articles from the following databases: PubMed, Embase, Web of Science and Centre for Reviews and Dissemination. Included were studies that employed RWD for both costs and effectiveness. Methodological quality of the studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Of the 14,011 studies identified, 93 were included. Roughly half of the studies were carried out in a hospital setting. The most frequently assessed illnesses were neoplasms while the most evaluated interventions were pharmacological. The main source of costs and effects of RWD were information systems. The most frequent clinical outcome was survival. Some 47% of studies met at least 80% of CHEERS criteria. Studies were conducted with samples of 100-1000 patients or more, were randomized, and those that reported bias controls were those that fulfilled most CHEERS criteria. In conclusion, fewer than half the studies met 80% of the CHEERS checklist criteria.