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.

[The Research Network on Preventive Activities and Health Promotion (redIAPP): a reference network and promoter of primary care research]. / La Red de Investigación en Actividades Preventivas y Promoción de la Salud (redIAPP): una red de referencia e impulsora de la investigación en atención primaria.

The Research Network on Preventive Activities and Health Promotion (redIAPP), a reference network and promoter of primary care research was created in 2003 thanks to the program Thematic Networks for Cooperative Research in Health (RETICS) of the Instituto de Salud Carlos III (ISCIII). Its creation has meant a radical change in the situation of research in primary care. Throughout its 19 years (2003-2021), different research groups and autonomous communities have participated, and different lines of research have been developed with numerous projects and publications. Despite the difficulties suffered, it has created a collaborative research experience between different autonomous communities with great vitality and with important results for primary care. The redIAPP, therefore, has been a great reference for research in primary care and for the deepening of its area of knowledge. Several lines of improvement are suggested for the future of primary care research.

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.

Sex Differences in Clinical Parameters, Pharmacological and Health-Resource Utilization in a Population With Hypertension Without a Diagnosis of COVID-19.

Objectives: Determine the changes in clinical, pharmacological and healthcare resource use parameters, between the 6 months prior to the lockdown and the 6 months following its end, in a population with hypertension who did not have a diagnosis of COVID-19. Methods: Real world data observational study of 245,979 persons aged >16 years with hypertension in Aragon (Spain). Clinical (systolic-diastolic blood pressure, estimated glomerular filtration rate (eGFR), blood creatinine, cholesterol, triglycerides and anthropometric measures); pharmacological (diuretics, calcium channel antagonists, and ACE inhibitors); and utilization of healthcare resources were considered. We performed the Student's T-test for matched samples (quantitative) and the Chi-squared test (qualitative) to analyze differences between periods. Results: SBP, DBP, parameters of renal function and triglycerides displayed a significant, albeit clinically irrelevant, worsening in women. In men only DBP and eGFR showed a worsening, although to a lesser extent than in women. Certain antihypertensive drugs and health-resource utilization remained below pre-pandemic levels across the 6 months post-lockdown. Conclusion: Changes in lifestyles, along with difficulties in access to routine care has not substantially compromised the health and quality of life of patients with hypertension.

Analysis of Clinical Parameters, Drug Consumption and Use of Health Resources in a Southern European Population with Diabetes That Did Not Contract COVID-19: A Longitudinal Big Data Study.

The lockdown measures imposed to stop the spread of the virus have affected the general population, but particularly people with chronic diseases such as diabetes. An observational real world data pre-post study of 86,615 individuals over the age of 16, having a medical history in the Aragon (Spain) Health Service and diagnosed with diabetes, without COVID-19 infection was undertaken. Clinical, pharmacological and health resource use variables were collected during the six months prior to the onset of the lockdown and during the six months after the lockdown ended. The Student's t-test was used to analyse differences in means. Our study does not show clinically relevant changes six months following the end of the strict lockdown. The consumption, by these patients, of hypoglycaemic drugs and the use of health resources continue at below pre-pandemic levels, six months later. The interruption in care for these patients and the lifestyle change resulting from the pandemic do not appear to have had a significant impact on the health of the diabetic population.

Analysis of Drug and Health Resource Use Before and After COVID-19 Lockdown in a Population Undergoing Treatment for Depression or Anxiety.

Introduction: The arrival of the COVID-19 pandemic modified the functions of Primary Care (PC) teams, which were forced to focus their resources on the diagnosis and treatment of SARS-CoV-2 infected patients. The disrupted healthcare of individuals with pre-existing mental disorders (depression or anxiety), as well as the psychological decompensation resulting from the lockdown caused by the COVID-19 pandemic, may have modified the use of drugs and health resources by these patients. The aim of this study is to determine the changes in these parameters, between the 6 months prior to the lockdown (09/14/2019 to 03/15/2020) and the 6 months following its end (05/03/2020 to 11/04/2020), in a population undergoing active treatment for depression or anxiety, according to the electronic clinical record. Materials and Methods: Real world data observational study of 110,694 individuals aged >16 years suffering from active or undergoing treatment for depression or anxiety according to the electronic medical records of the Aragon Regional Health Service (Spain). Pharmacological variables [daily dose per inhabitant (DHD) dispensed by pharmacies of: anxiolytics, hypnotics/sedatives, and antidepressants] and variables related to the use of healthcare resources (number of primary and specialized healthcare visits) were considered. Student's T-tests for paired samples were performed to analyze differences between periods (pre-post). The level of significance was established at 5% (p < 0.05). Results: The use of anxiolytic drugs increased as compared to its use over the 6 months prior to the lockdown. In contrast, the consumption of antidepressants was found to decrease. The use of health resources continued to be below pre-pandemic levels, 6 months post-lockdown end. Conclusion: Changes in the use of health resources could have a negative impact on the parameters of these diseases. The increase in drug use, especially benzodiazepines, may suggest a worsening of the symptoms during the lockdown and in the subsequent months. It is a worrying sign, which points to the growth of this public health problem and the need for its prevention.

Analysis of Clinical Parameters, Drug Consumption and Use of Health Resources in a Southern European Population with Alcohol Abuse Disorder during COVID-19 Pandemic.

The disruption in healthcare attention to people with alcohol dependence, along with psychological decompensation as a consequence of lockdown derived from the COVID-19 pandemic could have a negative impact on people who suffer from alcohol abuse disorder. Observational real world data pre-post study included 9966 men aged >16 years registered as having the diagnosis of alcohol abuse disorder in the electronic medical records (EMR) of the Aragon Regional Health Service (Spain). Clinical (Glutamate-oxaloacetate -GOT-, Glutamate pyruvate -GPT-, creatinine, glomerular filtration, systolic blood pressure -SBP-, diastolic blood pressure -DBP-, total cholesterol, LDL, HDL, triglycerides, and body mass index -BMI-), pharmacological (dose per inhabitant per day, DHD, of drugs used in addictive disorders, benzodiazepines and antidepressants) and health resource use variables (primary and specialized care) were considered. A Student's t-test for matched samples was performed to analyze the changes in clinical variables between alcohol abuse disorder patients with and without COVID-19. Only creatinine and LDL showed a significant but clinically irrelevant change six months after the end of the strict lockdown. The total number of DHDs for all drugs included in the study (except for benzodiazepines), decreased. In the same way, the use of health services by these patients also decreased. The impact of COVID-19 among this group of patients has been moderate. The reorganization of health and social services after the declaration of the state of alarm in our country made possible the maintenance of care for this vulnerable population.

Interrupted Time Series Analysis of Pediatric Infectious Diseases and the Consumption of Antibiotics in an Atlantic European Region during the SARS-CoV-2 Pandemic.

The increasing concern about bacterial resistance has made the rational prescription of antibiotics even more urgent. The non-pharmacological measures established to reduce the impact of the SARS-CoV-2 pandemic have modified the epidemiology of pediatric infections and, consequently, the use of antibiotics. Interrupted time series (ITS) analyses are quasi-experimental studies that allow for the estimation of causal effects with observational data in "natural experiments", such as changes in health policies or pandemics. The effect of the SARS-CoV-2 pandemic on the incidence of infectious diseases and the use of antibiotics between 2018 and 2020 in the Health Area of Vigo (Galicia, Spain) was quantified and analyzed. This paper outlines a real-world data study with administrative records from primary care services provided for the pediatric population. The records were related to episodes classified as infectious by the International Classification of Primary Care (ICPC-2) and oral medication in the therapeutic subgroup J01, corresponding to antibiotics for systemic use, according to the World Health Organization's Anatomical Therapeutic Chemical (ATC) classification system. The records were classified according to incident episodes, age, dose per inhabitant, and year. Segmented regression models were applied using an algorithm that automatically identifies the number and position of the change points. During the SARS-CoV-2 pandemic, the number of infectious diseases being transmitted between individuals, through the air and through the fecal-oral route, significantly decreased, and a slight decrease in infections transmitted via other mechanisms (urinary tract infections) was also found. In parallel, during the months of the pandemic, there has been a marked and significant reduction in antibacterial agent utilization, mainly of penicillins, cephalosporins, and macrolides.

Analysis of the impact of social determinants and primary care morbidity on population health outcomes by combining big data: A research protocol.

Background: In recent years, different tools have been developed to facilitate analysis of social determinants of health (SDH) and apply this to health policy. The possibility of generating predictive models of health outcomes which combine a wide range of socioeconomic indicators with health problems is an approach that is receiving increasing attention. Our objectives are twofold: (1) to predict population health outcomes measured as hospital morbidity, taking primary care (PC) morbidity adjusted for SDH as predictors; and (2) to analyze the geographic variability of the impact of SDH-adjusted PC morbidity on hospital morbidity, by combining data sourced from electronic health records and selected operations of the National Statistics Institute (Instituto Nacional de Estadística/INE). Methods: The following will be conducted: a qualitative study to select socio-health indicators using RAND methodology in accordance with SDH frameworks, based on indicators published by the INE in selected operations; and a quantitative study combining two large databases drawn from different Spain's Autonomous Regions (ARs) to enable hospital morbidity to be ascertained, i.e., PC electronic health records and the minimum basic data set (MBDS) for hospital discharges. These will be linked to socioeconomic indicators, previously selected by geographic unit. The outcome variable will be hospital morbidity, and the independent variables will be age, sex, PC morbidity, geographic unit, and socioeconomic indicators. Analysis: To achieve the first objective, predictive models will be used, with a test-and-training technique, fitting multiple logistic regression models. In the analysis of geographic variability, penalized mixed models will be used, with geographic units considered as random effects and independent predictors as fixed effects. Discussion: This study seeks to show the relationship between SDH and population health, and the geographic differences determined by such determinants. The main limitations are posed by the collection of data for healthcare as opposed to research purposes, and the time lag between collection and publication of data, sampling errors and missing data in registries and surveys. The main strength lies in the project's multidisciplinary nature (family medicine, pediatrics, public health, nursing, psychology, engineering, geography).

Measuring depression in Primary Health Care in Spain: Psychometric properties and diagnostic accuracy of HSCL-5 and HSCL-10.

Background: Depression has a high prevalence among European countries. Several instruments have been designed to assess its symptoms in different populations. The Hopkins Symptom Checklist 25 (HSCL-25) scale has been identified as valid, reproducible, effective, and easy to use. There are short versions of this scale that could be useful in Primary Care (PC) settings, but their psychometric properties are unknown. Aim: To assess in PC patients the psychometric properties and diagnostic accuracy of the Spanish version of the HSCL-10 and the HSCL-5 consisting of 10 and 5 items, respectively. Methods: A multicenter, cross-sectional study was carried out at six PC centers in Spain. The HSCL-25 was administered to outpatients aged 45-75 who also participated in the structured Composite International Diagnostic Interview (CIDI). HSCL-10 and HSCL-5 were assessed and compared to HSCL-25 regarding total score correlation, internal consistency, and criterion validity against the gold-standard CIDI. This is a methodological study from a secondary data analysis and the primary data has been previously published. Results: Out of 790 patients, 767 completed the HSCL-25 and 736 the CIDI interview (96.0%). Cronbach's Alpha was 0.84 for HSCL-10 and 0.77 for HSCL-5. The known-group method and confirmatory factor analysis were acceptable for the establishment of construct validity. Sensitivity was 79.7% (CI95%, 67.7-88.0%) for HSCL-10, and 78.0% (CI95%, 65.9-86.6%) for HSCL-5, whereas specificity was 83% (CI95%, 80.0-85.7%) for HSCL-10, and 72.8% (CI95%, 69.3-76.0%) for HSCL-5. Area under the curve against CIDI was 0.88 (CI95%, 0.84-0.92%) for HSCL-10, and 0.85 (CI95%, 0.81-0.89%) for HSCL-5. Optimum cutoff point calculated with Youden Index was 1.90 for the HSCL-10 and 1.80 for the HSCL-5. Conclusion: HSCL-10 and HSCL-5 are reliable and valid tools to detect depression symptoms and can be used in PC settings.

General practitioners' perceptions of using virtual primary care during the COVID-19 pandemic: An international cross-sectional survey study.

With the onset of COVID-19, general practitioners (GPs) and patients worldwide swiftly transitioned from face-to-face to digital remote consultations. There is a need to evaluate how this global shift has impacted patient care, healthcare providers, patient and carer experience, and health systems. We explored GPs' perspectives on the main benefits and challenges of using digital virtual care. GPs across 20 countries completed an online questionnaire between June-September 2020. GPs' perceptions of main barriers and challenges were explored using free-text questions. Thematic analysis was used to analyse the data. A total of 1,605 respondents participated in our survey. The benefits identified included reducing COVID-19 transmission risks, guaranteeing access and continuity of care, improved efficiency, faster access to care, improved convenience and communication with patients, greater work flexibility for providers, and hastening the digital transformation of primary care and accompanying legal frameworks. Main challenges included patients' preference for face-to-face consultations, digital exclusion, lack of physical examinations, clinical uncertainty, delays in diagnosis and treatment, overuse and misuse of digital virtual care, and unsuitability for certain types of consultations. Other challenges include the lack of formal guidance, higher workloads, remuneration issues, organisational culture, technical difficulties, implementation and financial issues, and regulatory weaknesses. At the frontline of care delivery, GPs can provide important insights on what worked well, why, and how during the pandemic. Lessons learned can be used to inform the adoption of improved virtual care solutions and support the long-term development of platforms that are more technologically robust and secure.

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".

Nine Forward-Backward Translations of the Hopkins Symptom Checklist-25 With Cultural Checks.

Introduction: The Hopkins Symptom Checklist-25 (HSCL-25) is an effective, reliable, and ergonomic tool that can be used for depression diagnosis and monitoring in daily practice. To allow its broad use by family practice physicians (FPs), it was translated from English into nine European languages (Greek, Polish, Bulgarian, Croatian, Catalan, Galician, Spanish, Italian, and French) and the translation homogeneity was confirmed. This study describes this process. Methods: First, two translators (an academic translator and an FP researcher) were recruited for the forward translation (FT). A panel of English-speaking FPs that included at least 15 experts (researchers, teachers, and practitioners) was organized in each country to finalize the FT using a Delphi procedure. Results: One or two Delphi procedure rounds were sufficient for each translation. Then, a different translator, who did not know the original version of the HSCL-25, performed a backward translation in English. An expert panel of linguists compared the two English versions. Differences were listed and a multicultural consensus group determined whether they were due to linguistic problems or to cultural differences. All versions underwent cultural check. Conclusion: All nine translations were finalized without altering the original meaning.

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 mobile applications in diabetic patients' healthy lifestyles: A review of systematic reviews.

OBJECTIVE: (1) Examine the mobile applications that address lifestyles to improve the metabolic control of adult patients with diabetes mellitus. (2) Describe the characteristics of the used mobile applications, identify the healthy lifestyles they target, and describe any of their adverse effects. METHODS: Review systematic reviews. We included studies that used any mobile application to help patients improve diabetes mellitus self-management by focusing on healthy lifestyles. Studies needed to include a control group receiving regular care with no mobile devices. In May 2018, Medline, Embase, Cochrane, LILACS, PsychINFO, Cinahl and Science Direct were searched, updated in June 2021. The methodological quality of the studies was assessed by the Amstar-2 tool. RESULTS: First 804 articles were analyzed to select 17 systematic reviews, of which the methodological quality of seven was high or moderate. Interventions lasted 1-12 months. Twenty-three different mobile applications were identified that were all related to eating and physical activity. Significant changes were noted in HbA1c values. No clear improvement was observed for weight/BMI, lipid profile, quality of life or blood pressure. No adverse effects were found. CONCLUSIONS: Managing the lifestyle of patients with diabetes using mobile applications improves short-term glycemic control, but the long-term results are not conclusive. The identified mobile applications focus on food and physical activity. Most are free. No adverse effects caused by using them were identified. PROSPERO REGISTER: CRD42019133685.

Evaluating the Impact of COVID-19 on the Adoption of Virtual Care in General Practice in 20 Countries (inSIGHT): Protocol and Rationale Study.

BACKGROUND: In recent decades, virtual care has emerged as a promising option to support primary care delivery. However, despite the potential, adoption rates remained low. With the outbreak of COVID-19, it has suddenly been pushed to the forefront of care delivery. As we progress into the second year of the COVID-19 pandemic, there is a need and opportunity to review the impact remote care had in primary care settings and reassess its potential future role. OBJECTIVE: This study aims to explore the perspectives of general practitioners (GPs) and family doctors on the (1) use of virtual care during the COVID-19 pandemic, (2) perceived impact on quality and safety of care, and (3) essential factors for high-quality and sustainable use of virtual care in the future. METHODS: This study used an online cross-sectional questionnaire completed by GPs distributed across 20 countries. The survey was hosted in Qualtrics and distributed using email, social media, and the researchers' personal contact networks. GPs were eligible for the survey if they were working mainly in primary care during the period of the COVID-19 pandemic. Descriptive statistical analysis will be performed for quantitative variables, and relationships between the use of virtual care and perceptions on impact on quality and safety of care and participants' characteristics may be explored. Qualitative data (free-text responses) will be analyzed using framework analysis. RESULTS: Data collection took place from June 2020 to September 2020. As of this manuscript's submission, a total of 1605 GP respondents participated in the questionnaire. Further data analysis is currently ongoing. CONCLUSIONS: The study will provide a comprehensive overview of the availability of virtual care technologies, perceived impact on quality and safety of care, and essential factors for high-quality future use. In addition, a description of the underlying factors that influence this adoption and perceptions, in both individual GP and family doctor characteristics and the context in which they work, will be provided. While the COVID-19 pandemic may prove the first great stress test of the capabilities, capacity, and robustness of digital systems currently in use, remote care will likely remain an increasingly common approach in the future. There is an imperative to identify the main lessons from this unexpected transformation and use them to inform policy decisions and health service design. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30099.

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.