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.

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 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).

[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.

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.

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.