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.

[Narratives on changes in health-related behaviours during lockdown in Spain according to gender]. / Narrativas sobre cambios de conductas en salud durante el confinamiento en España según género.

OBJECTIVE: To explore experiences related to health-oriented behaviours during lockdown in the Spanish resident population from a gender perspective. METHOD: Qualitative research with a critical and feminist approach. Twenty-nine semi-structured interviews (17 women and 12 men) were conducted between June and July 2020 via telephone with people who had previously answered an online survey. The interviews were transcribed and a thematic content analysis was carried out, differentiating between the experiences of women and men. The data were triangulated by the research team. RESULTS: Among women, greater diversity emerged in terms of health behaviours. Among them, the difficult experiences related to COVID-19, the complexity of living together and doing unpaid care work, as well as the importance of support networks, stood out. Among men, there were different attitudes towards sport, self-care and having time for healthy eating were positively valued, and there was a good assessment of coexistence and organisation in household chores. In both men and women, work overload and economic problems were related to emotional distress and difficulties in carrying out healthy activities. CONCLUSIONS: Health-oriented behaviours during lockdown differed according to gender. They were mostly limited to COVID-19 experiences, socio-economic conditions and burden of care. It is essential to tailor public health and primary care programmes according to people's life moments, taking into account their social context and questioning traditional gender roles.

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.

Association between metabolic syndrome and 13 types of cancer in Catalonia: A matched case-control study.

BACKGROUND: Metabolic syndrome (MS) is the simultaneous occurrence of a cluster of predefined cardiovascular risk factors. Although individual MS components are associated with increased risk of cancer, it is still unclear whether the association between MS and cancer differs from the association between individual MS components and cancer. The aim of this matched case-control study was to estimate the association of 13 types of cancer with (1) MS and (2) the diagnosis of 0, 1 or 2 individual MS components. METHODS: Cases included 183,248 patients ≥40 years from the SIDIAP database with incident cancer diagnosed between January 2008-December 2017. Each case was matched to four controls by inclusion date, sex and age. Adjusted conditional logistic regression models were used to evaluate the association between MS and cancer risk, comparing the effect of global MS versus having one or two individual components of MS. RESULTS: MS was associated with an increased risk of the following cancers: colorectal (OR: 1.28, 95%CI: 1.23-1.32), liver (OR: 1.93, 95%CI: 1.74-2.14), pancreas (OR: 1.79, 95%CI: 1.63-1.98), post-menopausal breast (OR: 1.10, 95%CI: 1.06-1.15), pre-menopausal endometrial (OR: 2.14, 95%CI: 1.74-2.65), post-menopausal endometrial (OR: 2.46, 95%CI: 2.20-2.74), bladder (OR: 1.41, 95%CI: 1.34-1.48), kidney (OR: 1.84, 95%CI: 1.69-2.00), non-Hodgkin lymphoma (OR: 1.23, 95%CI: 1.10-1.38), leukaemia (OR: 1.42, 95%CI: 1.31-1.54), lung (OR: 1.11, 95%CI: 1.05-1.16) and thyroid (OR: 1.71, 95%CI: 1.50-1.95). Except for prostate, pre-menopause breast cancer and Hodgkin and non-Hodgkin lymphoma, MS is associated with a higher risk of cancer than 1 or 2 individual MS components. Estimates were significantly higher in men than in women for colorectal and lung cancer, and in smokers than in non-smokers for lung cancer. CONCLUSION: MS is associated with a higher risk of developing 11 types of common cancer, with a positive correlation between number of MS components and risk of cancer.

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".

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.

Medication-Related Problems in Older People with Multimorbidity in Catalonia: A Real-World Data Study with 5 Years' Follow-Up.

Aging, multimorbidity, and polypharmacy are associated with medication-related problems (MRPs). This study aimed to assess the association that multimorbidity and mortality have with MRPs in older people over time. We followed multimorbid, older (65-99 years) people in Catalonia from 2012 to 2016, using longitudinal data and Cox models to estimate adjusted hazard ratios (HR). We reviewed electronic health records to collect explanatory variables and MRPs (duplicate therapy, drug-drug interactions, potentially inappropriate medications (PIM), and contraindicated drugs in chronic kidney disease (CKD) or liver disease). There were 723,016 people (median age: 74 years; 58.9% women) who completed follow-up. We observed a significant (p < 0.001) increase in the proportion with at least one MRP (2012: 66.9% to 2016: 75.5%); contraindicated drugs in CKD (11.1 to 18.5%) and liver disease (3.9 to 5.3%); and PIMs (62.5 to 71.1%), especially drugs increasing fall risk (67.5%). People with ≥10 diseases had more MRPs (in 2016: PIMs, 89.6%; contraindicated drugs in CKD, 34.4%; and in liver disease, 9.3%). All MRPs were independently associated with mortality, from duplicate therapy (HR 1.06; 95% confidence interval (CI) 1.04-1.08) to interactions (HR 1.60; 95% CI 1.54-1.66). Ensuring safe pharmacological treatment in elderly, multimorbid patient remains a challenge for healthcare systems.

Medication-related problems in older people in Catalonia: A real-world data study.

PURPOSE: The aim of this study was to determine medication-related problems (MRPs) in primary care patients over 65 years of age. METHODS: Cross-sectional study based on the electronic health records of patients (65-99 years of age) visited in 284 primary health care centers during 2012 in Catalonia. VARIABLES: age, sex, sociodemographic variables, number of drugs, kidney and liver function and MRPs (duplicate therapy, drug-drug interactions, potentially inappropriate medications [PIMs] and drugs contraindicated in chronic kidney disease and in liver diseases). Unconditional logistic regression models were used to identify the factors associated with MRPs in patients with multimorbidity. RESULTS: 916 619 older people were included and 853 085 of them met the criteria for multimorbidity. Median age was 75 years and 57.7% of them were women. High percentages of MRPs were observed: PIMs (62.8%), contraindicated drugs in chronic kidney disease (12.1%), duplicate therapy (11.1%), contraindicated drugs in liver diseases (4.2%), and drug-drug interactions (1.0%). These numbers were higher in the subgroup of patients with ≥10 diseases. The most common PIMs were connected to drugs that increase the risk of fall (66.8%), antiulcer agents without criteria for gastroprotection (40.6%), and the combination of drugs with anticholinergic effects (39.7%). In the multivariate analysis, the variables associated with all MRPs among the patients with multimorbidity were the number of drugs and the number of visits. CONCLUSIONS: The coexistence of multimorbidity and polypharmacy is associated with an elevated risk of MRPs in older people. Medication safety for older patients constitutes a pressing concern for health services.

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.

Metabolic syndrome and risk of cancer: a study protocol of case-control study using data from the Information System for the Development of Research in Primary Care (SIDIAP) in Catalonia.

BACKGROUND: Metabolic syndrome (MS) is defined by the clustering of specific metabolic disorders in one subject. MS is highly prevalent globally and currently considered a growing public health concern. MS comprises obesity, hypertension, dyslipidaemia and insulin resistance. Mechanisms linking MS with cancer are poorly understood, and it is as yet unknown if MS confers a greater risk than the risk entailed by each of its separate components. The main objective of this study is to compare the association between MS and 14 site-specific cancer against the association between one or two individual components of MS and cancer. The secondary objective is to evaluate the time elapsed since the diagnosis of MS and the subsequent onset of cancer within the 2006-2017 period by sex. METHODS AND ANALYSIS: A case-control study will be conducted for the main objective and a cohort of patients with MS will be followed for the evaluation of the second objective. Incident cases of fourteen types of cancer in patients ≥40 years of age diagnosed prospectively will be selected from electronic primary care records in the Information System for Research in Primary Care (SIDIAP database; www.sidiap.org). The SIDIAP database includes anonymous data from 6 million people (80% of the Catalan population) registered in 286 primary healthcare centres. Each matched control (four controls for each case) will have the same inclusion date, the same sex and age (±1 year) than the paired case. Logistic regression and a descriptive analysis and Kaplan-Meier analysis will be performed, in accordance with the objectives. ETHICS AND DISSEMINATION: The protocol of the study was approved by the IDIAP Jordi Gol Clinical Research Ethics Committee (protocol P17/212). The study's findings will be published in a peer-reviewed journal and disseminated at national and international conferences and oral presentations to researchers, clinicians and policy makers.

Medication patterns in older adults with multimorbidity: a cluster analysis of primary care patients.

BACKGROUND: Older adults suffer from various chronic conditions which make them particularly vulnerable. The proper management of multiple drug use is therefore crucial. The aim of our study was to describe drug prescription and medication patterns in this population. METHODS: A cross-sectional study in Barcelona (Spain) using electronic health records from 50 primary healthcare centres. Participants were aged 65 to 94 years, presenting multimorbidity (≥2 chronic diseases), and had been prescribed at least 1 drug for 6 months or longer during 2009. We calculated the prevalence of prescribed drugs and identified medication patterns using multiple correspondence analysis and k-means clustering. Analyses were stratified by sex and age (65-79, 80-94 years). RESULTS: We studied 164,513 patients (66.8% women) prescribed a median of 4 drugs (interquartile range [IQR] = 3-7) in the 65-79 age-group and 6 drugs (IQR = 4-8) in the 80-94 age-group. A minimum of 45.9% of patients aged 65-79 years, and 61.8% of those aged 80-94 years, were prescribed 5 or more drugs. We identified 6 medication patterns, a non-specific one and 5 encompassing 8 anatomical groups (alimentary tract and metabolism, blood, cardiovascular, dermatological, musculo-skeletal, neurological, respiratory, and sensory organ). CONCLUSIONS: Drug prescription is widespread among the elderly. Six medication patterns were identified, 5 of which were related to one or more anatomical group, with associations among drugs from different systems. Overall, guidelines do not accurately reflect the situation of the elderly multimorbid, new strategies for managing multiple drug uses are needed to optimize prescribing in these patients.

Effect of the comprehensive smoke-free law on time trends in smoking behaviour in primary healthcare patients in Spain: a longitudinal observational study.

OBJECTIVE: This study aimed to analyse the impact of comprehensive smoke-free legislation (SFL) on the prevalence and incidence of adult smoking in primary healthcare (PHC) patients from three Spanish regions, overall and stratified by sex. DESIGN: Longitudinal observational study conducted between 2008 and 2013. SETTING: 66 PHC teams in Catalonia, Navarre and the Balearic Islands (Spain). PARTICIPANTS: Population over 15 years of age assigned to PHC teams. PRIMARY AND SECONDARY OUTCOMES MEASURES: Quarterly age-standardised prevalence of non-smoker, smoker and ex-smoker and incidence of new smoker, new ex-smoker and ex-smoker relapse rates were estimated with data retrieved from PHC electronic health records. Joinpoint analysis was used to analyse the trends of age-standardised prevalence and incidence rates. Trends were expressed as annual percentage change and average annual percent change. RESULTS: The overall standardised smoker prevalence rate showed a significant downward trend (higher in men than women) and the overall standardised ex-smoker prevalence rate showed a significant increased trend (higher in women than men) in the three regions. Standardised smoker and ex-smoker prevalence rates were higher for men than women in all regions. With regard to overall trends of incidence rates, new smokers decreased significantly in Catalonia and Navarre and similarly in men and women, new ex-smokers decreased significantly and more in men in Catalonia and the Balearic Islands, and ex-smoker relapse increased in Catalonia (particularly in women) and decreased in Navarre. CONCLUSIONS: Trends in smoking behaviour in PHC patients remain unchanged after the implementation of comprehensive SFL. The impact of the comprehensive SFL might have been lessened by the effect of the preceding partial SFL.

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.

Pharmacological control of diabetes and hypertension comorbidity in the elderly: A study of "real world" data.

AIMS: The study aimed to determine which drug combinations achieve better control in comorbid diabetes and hypertension in a pragmatic sample of primary health care patients. METHODS: Cross-sectional study. SETTING: 251 primary health care centres in Catalonia, Spain. PARTICIPANTS: individuals ≥65 years old with a dual diagnosis of hypertension and diabetes. MAIN OUTCOME MEASURES: good control criteria were established as glycated haemoglobin ≤7% and blood pressure <140/90mmHg. Antihypertensive and hypoglycaemic drugs and treatment adherence were analysed in relation to their association with good control. RESULTS: 27,637 patients (58.0% women) had hypertension and diabetes and met selection criteria. Mean age was 75.9 years (standard deviation [SD]: 6.7). Both diseases were well controlled simultaneously in 34.2% of patients. The combination of biguanides and diuretics achieved the highest association with good control. Adherence to pharmacological treatment was more difficult in diabetes than in hypertension. Lack of control was associated significantly with non-adherence to treatment, 0-12 PHC visits, obesity and increasing number of diabetes prescriptions. CONCLUSIONS: Good control of diabetes and hypertension comorbidity with pharmacological treatment in elderly patients is challenging. Some drug combinations achieved better control than others. The greatest effort should focus on improving the low adherence to diabetes treatment.