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.

Utility of PHQ-2, PHQ-8 and PHQ-9 for detecting major depression in primary health care: a validation study in Spain.

BACKGROUND: Primary health care (PHC) professionals may play a crucial role in improving early diagnosis of depressive disorders. However, only 50% of cases are detected in PHC. The most widely used screening instrument for major depression is the Patient Health Questionnaire (PHQ), including the two-, eight- and nine-item versions. Surprisingly, there is neither enough evidence about the validity of PHQ in PHC patients in Spain nor indications about how to interpret the total scores. This study aimed to gather validity evidence to support the use of the three PHQ versions to screen for major depression in PHC in Spain. Additionally, the present study provided information for helping professionals to choose the best PHQ version according to the context. METHODS: The sample was composed of 2579 participants from 22 Spanish PHC centers participating in the EIRA-3 study. The reliability and validity of the three PHQ versions for Spanish PHC patients were assessed based on responses to the questionnaire. RESULTS: The PHQ-8 and PHQ-9 showed high internal consistency. The results obtained confirm the theoretically expected relationship between PHQ results and anxiety, social support and health-related QoL. A single-factor solution was confirmed. Regarding to the level of agreement with the CIDI interview (used as the criterion), our results indicate that the PHQ has a good discrimination power. The optimal cut-off values were: ⩾2 for PHQ-2, ⩾7 for PHQ-8 and ⩾8 for PHQ-9. CONCLUSIONS: PHQ is a good and valuable tool for detecting major depression in PHC patients in Spain.

Effectiveness and safety of tetanus vaccine administration by intramuscular vs. subcutaneous route in anticoagulated patients: Randomized clinical trial in primary care.

Design: Prospective, double-blind clinical trial comparing tetanus-diphtheria vaccine administration routes, intramuscular (IM) vs. subcutaneous (SC) injection, in patients with oral anticoagulants. ISRCTN69942081. Study population: Patients treated with oral anticoagulants, 15 health centers, Vigo (Spain). Sample size, 117 in each group. Outcome variables: Safety analysis: systemic reactions and, at the vaccine administration site, erythematic, swelling, hematoma, granuloma, pain.Effectiveness analysis: differences in tetanus toxoid antibody titers.Independent variables: route, sex, age, baseline serology, number of doses administered. Analysis: Following the CONSORT guidelines, we performed an intention-to-treat analysis. We conducted a descriptive study of the variables included in both groups (117 in each group) and a bivariate analysis. Fewer than 5% of missing values. Imputation in baseline and final serology with the median was performed. Lost values were assumed to be values missing at random. We conducted a descriptive study of the variables and compared routes. For safety, multivariate logistic regression was applied, with each safety criterion as outcome and the independent variables. Odds ratios (ORs) were calculated. For effectiveness, a generalized additive mixed model, with the difference between final and initial antibody titers as outcome. Due to the bimodal distribution of the outcome, the normal mixture fitting with gamlssMX was used. All statistical analyses were performed with the gamlss.mx and texreg packages of the R free software environment. Results: A previously published protocol was used across the 6-year study period. The breakdown by sex and route showed: 102 women and 132 men; and 117 IM and 117 SC, with one dose administered in over 80% of participants. There were no differences between groups in any independent variable. The second and third doses administered were not analyzed, due to the low number of cases. In terms of safety, there were no severe general reactions. Locally, significant adjusted differences were observed: in pain, by sex (male, OR: 0.39) and route (SC, OR: 0.55); in erythema, by sex (male, OR: 0.34) and route (SC, OR: 5.21); and in swelling, by sex (male, OR: 0.37) and route (SC, OR: 2.75). In terms of effectiveness, the model selected was the one adjusted for baseline serology.

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 Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).

Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.

[Baseline characteristics and quality of life in patients with Diabetes Mellitus included in the EIRA randomized clinical trial.] / Características basales y calidad de vida de los pacientes con Diabetes mellitus incluidos en el ensayo clínico aleatorizado EIRA.

OBJECTIVE: The EIRA study is a randomized clinical multicenter trial that aims to evaluate the effectiveness of a complex multi-risk intervention aimed at people aged 45-75 in Primary Care. The objectives of this work were to describe the baseline characteristics of patients with Diabetes Mellitus included in phase III of the EIRA study and analyze the relationship that different independent variables may have with the quality of life. METHODS: The data of all patients with Diabetes Mellitus that were included in phase III of EIRA study collected at baseline were analyzed. Patients with at least two or more of unhealthy lifestyles were selected: smoking, low adherence to the Mediterranean diet and/or low level of physical activity. The quality of life was measured with the EQ-5D-5L questionnaire. A descriptive and bivariate study was performed. The variables did not follow a normal distribution. Non-parametric statistical tests were used. For the multivariate analysis of the quality of life, automated linear regression was used with SPSS v19. RESULTS: 694 were patients included with Diabetes Mellitus (356 controls, 338 in intervention, without significant differences between both groups). Control: 37.64% women, age (median) 60 years. Intervention: 37.87% women, age (median) 60 years. Most prevalent risk behaviors in descending order: low adherence to the Mediterranean diet, low level of physical activity and smoking. The variables that significantly influenced quality of life were: GAD-7, work activity, HbA1c and CIDI. CONCLUSIONS: There are no significant differences motivated by the study design. The influence of mental health on the EQ-5D-5L is remarkable.

OBJETIVO: El estudio EIRA es un ensayo clínico aleatorizado multicéntrico que pretende evaluar la efectividad de una intervención compleja multirriesgo dirigida a personas de 45-75 años atendidas en Atención Primaria. Los objetivos de este trabajo fueron describir las características basales de los pacientes con Diabetes Mellitus incluidos en la fase III del estudio EIRA, y analizar la relación que puedan tener las diferentes variables independientes con la calidad de vida. METODOS: Se analizaron los datos recogidos al inicio del estudio de todos los pacientes con Diabetes Mellitus que se incluyeron en la fase III del estudio EIRA. Se seleccionaron pacientes con dos o más estilos de vida no saludables: tabaquismo, baja adherencia a dieta mediterránea y/o bajo nivel de actividad física. La calidad de vida se midió con el cuestionario EQ-5D-5L. Se realizó un estudio descriptivo y bivariante. Las variables no siguieron una distribución normal. Se utilizaron test estadísticos no paramétricos. Para identificar factores influyentes en la calidad de vida, se utilizó regresión lineal automatizada con SPSS v19. RESULTADOS: Se incluyeron 694 pacientes con Diabetes Mellitus (356 controles, 338 en intervención, sin diferencias significativas entre ambos grupos). Control: 37,64% mujeres, edad (mediana) 60 años. Intervención: 37,87% mujeres, edad (mediana) 60 años. Comportamientos de riesgo más prevalentes en orden descendente: baja adherencia a dieta mediterránea, bajo nivel de actividad física y tabaquismo. Las variables que influyeron significativamente en la calidad de vida fueron: GAD-7, actividad laboral, HbA1c y CIDI. CONCLUSIONES: No existen diferencias significativas motivadas por el diseño del estudio. Es destacable la influencia de la salud mental en el EQ-5D-5L.

Multiple risk behaviour intervention to prevent depression in primary care.

BACKGROUND: Primary care is the ideal setting for promotion and prevention intervention. Multiple risk behaviour interventions present several advantages over single-risk lifestyle interventions. Multiple risk behaviour interventions could be easily implemented in primary care to prevent non-communicable disease and depression. AIM: To test the effectiveness of a multiple risk behaviour intervention to promote Mediterranean diet, physical activity, and/or smoking cessation in people attending Spanish primary health care with incidence of depression and symptoms of depression. METHOD: This was a secondary analysis of the EIRA study that aims to test the effectiveness of a multiple risk behaviour intervention to promote healthy lifestyles. Twenty-six primary care centres were randomised to receive multiple risk behaviour intervention or usual care. The multiple risk behaviour intervention included individual sessions, group sessions, communitarian activities, and SMS reception. Participants were followed for 10-14 months. The primary outcomes of this study were incidence of depression and reductions of depressive symptoms. RESULTS: Three thousand and sixty-seven participants were included. Females accounted for 45.13% and 93.88% were Spanish. Age varied between 45 and 75 years old. The effectiveness of the intervention will be calculated using the Patient Health Questionnaire (PHQ-9) and the Composite International Diagnostic Interview ( CIDI) depression section. Linear and logistic regression will be used to create predictive models. CONCLUSION: Primary care is the most accessible service in the health system for patients. Hence primary care is the ideal setting for health education, promotion, and prevention interventions. This study will provide high-quality evidence about the effectiveness of multiple risk behaviour interventions over depression prevention.

[Early detection of the problematic Internet use in adolescents, in pediatrics of primary care.] / Detección precoz del uso problemático de Internet en adolescentes, en pediatría de atención primaria.

OBJECTIVE: Use of the Internet has grown exponentially and adolescents are considered one of the most vulnerable groups in this new environment. Hence the problematic use of the Internet (PIU) at this stage has become a concern for a growing number of researchers. Taking into account the interest that this issue has generated at many levels, the aim of this paper is to find the prevalence of PIU among adolescents in the health area of Vigo (Spain). METHODS: Cross-sectional descriptive study. The PIU validated scale was applied to children between 10 and 16 years old, captured by systematic sampling with replacement in the primary care consultations of four health centers. A descriptive and bivariate analysis was performed. RESULTS: The questionnaire was applaid to 165 children, 51.2% men. Problematic Internet use was observed in 38.8% (95% CI: 31.7-46.4), higher in women (46.3%) than in men (31.8%), with no significant differences (p 0.07). By age groups, the positive rate on the scale reached 36.8% in the 13-14 year range and 48.6% in the 15-16 range. The item that reached the highest score was "When I am online, I feel that time flies and hours pass without me realizing it" (60.6%). CONCLUSIONS: The prevalence of UPI in children / adolescents is similar to that observed in Asian adolescents. This study is the first to apply a scale validated and adapted to the Spanish cultural context in the daily practice of Primary Care consultations. Its use would allow to identify the PIU in this context and intervene if necessary.

OBJETIVO: El uso de Internet ha crecido exponencialmente y los adolescentes son considerados uno de los grupos más vulnerables en este nuevo contexto. De ahí que el uso problemático de Internet (UPI) en esta etapa se haya convertido en una preocupación para un número creciente de investigadores. Teniendo en cuenta el interés que este tema ha generado en muchos niveles, el objetivo de este trabajo fue conocer la prevalencia del uso problemático de Internet entre los niños/adolescentes del área sanitaria de Vigo (España). METODOS: Se realizó un estudio descriptivo transversal. Se aplicó la escala validada EUPI-a a niños entre 10 y 16 años, captados por muestreo sistemático con reposición en las consultas de atención primaria de cuatro centros de salud. Se elaboró posteriormente un análisis descriptivo y bivariante. RESULTADOS: Se entregó el cuestionario a 165 niños, de los que el 51,2% eran varones. Se objetivó un uso problemático de Internet en el 38,8% (IC 95%: 31,7-46,4), mayor en mujeres (46,3%) que en varones (31,8%), aunque no se constataron diferencias estadísticamente significativas (p=0,07). Por grupos de edad, la tasa de positivos en la escala alcanzó un 36,8% en la franja de 13-14 años y un 48,6% en la de 15-16 años. El ítem que alcanzó mayor puntuación fue "Cuando me conecto siento que el tiempo vuela y pasan las horas sin darme cuenta" (60,6%). CONCLUSIONES: La prevalencia de UPI en niños/adolescentes es similar a la observada en adolescentes asiáticos. Este estudio es el primero en aplicar una escala validada y adaptada al contexto cultural español en la práctica diaria de una consulta de atención primaria. Su utilización en este entorno permitiría identificar el UPI e intervenir si fuera preciso.

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.

[The health basket in primary care: an emperor without clothes. SESPAS Report 2012]. / La cartera de servicios en atención primaria: un rey sin camisa. Informe SESPAS 2012.

Despite the apparent stagnation, the development of primary care in response to social changes in recent decades is undeniable, both in figures and in the perception of those providing or using primary care. The traditional difficulties of defining roles and allocating resources among levels of care should be reassessed. A model is required that adjusts the health basket in primary care to today's society, to citizen's new needs and demands, and to the legitimate progress of health professionals, while maintaining the comprehensiveness of this level of care. A model with new resource allocation would increase decision-making in primary health care, thereby improving efficiency in this setting. With a view to equity, because of economies of scale, these changes should be agreed on by the Interregional Council, as the representative of the autonomous communities. The support of the Network of Agencies for Health Technology Assessment, the Institute for Health Information, the GuíaSalud Project and the participation of civil society in its many forms, can offer knowledge and experience for the design, implementation and evaluation of actions designed both to improve clinical practice and enhance the organizational and economic infrastructure necessary to support it.