Non-specific protection against severe COVID-19 associated to typhoid fever and DTP vaccination.

Trained immunity (TRAIM) or the enhanced non-specific immune response after primary stimulation by infection or vaccination is a recent but well-recognized concept. To verify its predictions, our objective was to determine the effects of two bacterial vaccines, typhoid fever (TFV) and diphtheria-tetanus-pertussis (DTP) on the infection, hospitalization and death frequencies associated to COVID-19 in a retrospective study on subjects vaccinated or not with TFV and DTP in the 4 years prior to the start of COVID-19 pandemia in the Basque Country (Spain). The studied outcome records were split into two periods according to COVID-19 vaccination, the pre-vaccination (ACV) from March to December 2020 and the post-vaccination (PCV) from September 2021 to June 2022). In total, 13,673 subjects were vaccinated against TFV and 42,997 against DTP. A total of 2,005,084 individual records were studied in the ACV period and 1,436,693 in the PCV period. The proportion of infection, hospitalization and death associated to COVID-19 among controls in ACV was 4.97 %, 7.14 % and 3.54 %, respectively vs. 7.20 %, 2.24 % and 0.10 % among TFV subjects. Regarding DTP, the proportions were 4.97 %, 7.12 % and 3.58 % for controls and 5.79 %, 5.79 % and 0.80 % for vaccinees. In the PCV period, the proportion of infection, hospitalization and death among controls was 21.89 %, 2.62 % and 0.92 %, respectively vs. 31.19 %, 0.76 %, 0.00 % among TFV. For DTP, infection, hospitalization and death proportions were 21.89 %, 2.62 % and 0.92 %, respectively, among controls vs. 32.03 %, 1.85 % and 0.24 % among vaccinated subjects. The corresponding combined ACV and PCV odds ratios (OR) for SARS-CoV2 infection were 1.505 (95%CI 1.455-1.558; p < 0.0001; reduction -41.85 %) and 1.633 (95%CI 1.603-1.662; p < 0.0001; reduction -51.74 %), for TFV and DTP, respectively. Regarding COVID-19 associated hospitalization, the OR were 0.295 (95%CI 0.220-0.396; p = 0.0001; reduction 69.74 %) and 0.667 (95%CI 0.601-0.741; p = 0.0001; reduction 32.44 %), for TFV and DTP, respectively). COVID-19 associated death OR were 0.016 (95%CI 0.002-0.113, p < 0.0001; reduction 98.38 %) and 0.212 (95%CI 0.161-0.280; p = 0.0001; reduction 78.52 %), for TFV and DTP, respectively. We conclude that TRAIM effects by TFV and DTP vaccination in the four years prior to the pandemic SARS-CoV2 were supported by slightly increased infection rates, but strongly reduced COVID-19 associated hospitalization and death rates.

Development of Continuous Assessment of Muscle Quality and Frailty in Older Patients Using Multiparametric Combinations of Ultrasound and Blood Biomarkers: Protocol for the ECOFRAIL Study.

BACKGROUND: Frailty resulting from the loss of muscle quality can potentially be delayed through early detection and physical exercise interventions. There is a demand for cost-effective tools for the objective evaluation of muscle quality, in both cross-sectional and longitudinal assessments. Literature suggests that quantitative analysis of ultrasound data captures morphometric, compositional, and microstructural muscle properties, while biological assays derived from blood samples are associated with functional information. OBJECTIVE: This study aims to assess multiparametric combinations of ultrasound and blood-based biomarkers to offer a cross-sectional evaluation of the patient frailty phenotype and to track changes in muscle quality associated with supervised exercise programs. METHODS: This prospective observational multicenter study will include patients aged 70 years and older who are capable of providing informed consent. We aim to recruit 100 patients from hospital environments and 100 from primary care facilities. Each patient will undergo at least two examinations (baseline and follow-up), totaling a minimum of 400 examinations. In hospital environments, 50 patients will be measured before/after a 16-week individualized and supervised exercise program, while another 50 patients will be followed up after the same period without intervention. Primary care patients will undergo a 1-year follow-up evaluation. The primary objective is to compare cross-sectional evaluations of physical performance, functional capacity, body composition, and derived scales of sarcopenia and frailty with biomarker combinations obtained from muscle ultrasound and blood-based assays. We will analyze ultrasound raw data obtained with a point-of-care device, along with a set of biomarkers previously associated with frailty, using quantitative real-time polymerase chain reaction and enzyme-linked immunosorbent assay. Additionally, we will examine the sensitivity of these biomarkers to detect short-term muscle quality changes and functional improvement after a supervised exercise intervention compared with usual care. RESULTS: At the time of manuscript submission, the enrollment of volunteers is ongoing. Recruitment started on March 1, 2022, and ends on June 30, 2024. CONCLUSIONS: The outlined study protocol will integrate portable technologies, using quantitative muscle ultrasound and blood biomarkers, to facilitate an objective cross-sectional assessment of muscle quality in both hospital and primary care settings. The primary objective is to generate data that can be used to explore associations between biomarker combinations and the cross-sectional clinical assessment of frailty and sarcopenia. Additionally, the study aims to investigate musculoskeletal changes following multicomponent physical exercise programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294757; https://clinicaltrials.gov/ct2/show/NCT05294757. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50325.

Physical Interventions Restore Physical Frailty and the Expression of CXCL-10 and IL-1ß Inflammatory Biomarkers in Old Individuals and Mice.

BACKGROUND: Frailty is a geriatric syndrome associated with negative health outcomes that represents a dynamic condition with a potential of reversibility after physical exercise interventions. Typically, inflammatory and senescence markers are increased in frail individuals. However, the impact that physical exercise exerts on inflammatory and senescence biomarkers remains unknown. We assessed the effect of physical intervention in old individuals and mice and determined the expression of inflammatory and senescence markers. METHODS: Twelve elderly individuals were enrolled from a primary care setting to a 3-month intervention. Frailty was measured by SPPB and the expression of biomarkers by cytokine array and RT-qPCR. In addition, 12 aged C57BL/6 mice completed an intervention, and inflammation and senescence markers were studied. RESULTS: The physical intervention improved the SPPB score, reducing frail and pre-frail individuals. This was correlated with a reduction in several pro-inflammatory biomarkers such as IL-6, CXCL-1, CXCL-10, IL-1ß, IL-7, GM-CSF as well as p16INK4a and p21CIP1 senescence markers. Otherwise, the levels of anti-inflammatory biomarker IL-4 were significantly increased. Moreover, the physical intervention in mice also improved their functional capacity and restored the expression of inflammatory (Il-1ß, Cxcl-10, Il-6, and Cxcl-1) and senescence (p21Cip1) markers. Additionally, PLSDA and ROC curve analysis revealed CXCL-10 and IL-1ß to be the biomarkers of functional improvement in both cohorts. CONCLUSIONS: Our results showed that a physical intervention improves physical frailty, and reverses inflammation and senescence biomarkers comprising CXCL-10 and IL-1ß.

Essential steps in primary care management of older people with Type 2 diabetes: an executive summary on behalf of the European geriatric medicine society (EuGMS) and the European diabetes working party for older people (EDWPOP) collaboration.

We present an executive summary of a guideline for management of type 2 diabetes mellitus in primary care written by the European Geriatric Medicine Society, the European Diabetes Working Party for Older People with contributions from primary care practitioners and participation of a patient's advocate. This consensus document relies where possible on evidence-based recommendations and expert opinions in the fields where evidences are lacking. The full text includes 4 parts: a general strategy based on comprehensive assessment to enhance quality and individualised care plan, treatments decision guidance, management of complications, and care in case of special conditions. Screening for frailty and cognitive impairment is recommended as well as a comprehensive assessment all health conditions are concerned, including end of life situations. The full text is available online at the following address: essential_steps_inprimary_care_in_older_people_with_diabetes_-_EuGMS-EDWPOP___3_.pdf.

Blood RNA-Seq profiling reveals a set of circular RNAs differentially expressed in frail individuals.

BACKGROUND: Frailty is an intermediate and reversible geriatric syndrome that often precedes dependence. Therefore, its identification is essential to prevent dependence. Several molecules have been proposed as biomarkers of frailty, but none of them have reached clinical practice. Recently, circular RNAs have emerged as new non-coding RNAs. Their regulatory role together with their high stability in biofluids makes them good candidates as biomarkers for various processes, but, to date, no study has characterized the expression of circRNA in frailty. RESULTS: We studied RNA from leukocytes of 35 frails and 35 robust individuals. After RNA-Sequencing, circRNA detection was performed by CIRI2 and Circexplorer2 and differential expression analysis by DESeq2. Validation was performed by Quantitative-PCR. Linear Discriminant Analysis was performed to determine the best circRNA combination to discriminate frail from robust. In addition, CircRNA candidates were studied in 13 additional elder donors before and after a 3-month physical intervention. We found 89 differentially expressed circRNAs (p-value<0.05, FC>|1.5|) with frailty. Upregulation of hsa_circ_0007817, hsa_circ_0101802 and hsa_circ_0060527 in frail individuals was validated. The combination of hsa_circ_0079284, hsa_circ_0007817 and hsa_circ_0075737 levels showed a great biomarker value with a 95.9% probability of correctly classifying frail and robust individuals. Moreover, hsa_circ_0079284 levels decreased after physical intervention in concordance with an improvement in frailty scores. CONCLUSIONS: This work describes for the first time a different expression pattern of circular RNA (circRNAs) between frail and robust individuals. Moreover, the level of some circRNAs is modulated after a physical intervention. These results suggest that they could be used as minimally invasive biomarkers of frailty.

Environmental health knowledge of healthcare professionals: Instrument development and validation using the Rasch model.

INTRODUCTION: environmental risk factors constitute a major public health issue, calling for preventive actions and interventions at multiple levels. An important step in this direction is increasing the environmental health (EH) knowledge of the healthcare professionals. In this context, tools designed to measure such knowledge are of imperative importance. The aim of the present study was to develop an EH knowledge tool for healthcare professionals. METHODS: a group of experts defined the knowledge areas of the EH tool and their corresponding items. An online pilot and a validation study were performed. Internal consistency reliability was measured with the Kuder-Richardson 20 (KR-20) estimate, the construct validity and uni-dimensionality of the tool were assessed with the Rasch model. Known-groups validity was analysed with the two-sample t-test. RESULTS: a total of n = 151 and n = 444 healthcare professionals and end-year medical and nursing students, participated in the pilot and the validation study, respectively. The resulting 33-item EH knowledge questionnaire for healthcare professionals (EHKQ-HP) obtained a KR-20 = 0.82. The scale is uni-dimensional. Its construct validity was verified, and its items cover a wide range of difficulties. Separation statistics were adequate and known-groups behaved as hypothesized. CONCLUSIONS: the EHKQ-HP is a valuable resource for measuring the EH knowledge of the healthcare professionals. As such it will be useful in detecting EH knowledge gaps, and helping public health agents in making informed decisions when developing interventions for increasing this very knowledge. This would consequently help in improving the health of the general population.

Assessment of the Effectiveness, Socio-Economic Impact and Implementation of a Digital Solution for Patients with Advanced Chronic Diseases: The ADLIFE Study Protocol.

Due to population ageing and medical advances, people with advanced chronic diseases (ACD) live longer. Such patients are even more likely to face either temporary or permanent reduced functional reserve, which typically further increases their healthcare resource use and the burden of care on their caregiver(s). Accordingly, these patients and their caregiver(s) may benefit from integrated supportive care provided via digitally supported interventions. This approach may either maintain or improve their quality of life, increase their independence, and optimize the healthcare resource use from early stages. ADLIFE is an EU-funded project, aiming to improve the quality of life of older people with ACD by providing integrated personalized care via a digitally enabled toolbox. Indeed, the ADLIFE toolbox is a digital solution which provides patients, caregivers, and health professionals with digitally enabled, integrated, and personalized care, supporting clinical decisions, and encouraging independence and self-management. Here we present the protocol of the ADLIFE study, which is designed to provide robust scientific evidence on the assessment of the effectiveness, socio-economic, implementation, and technology acceptance aspects of the ADLIFE intervention compared to the current standard of care (SoC) when applied in real-life settings of seven different pilot sites across six countries. A quasi-experimental trial following a multicenter, non-randomized, non-concurrent, unblinded, and controlled design will be implemented. Patients in the intervention group will receive the ADLIFE intervention, while patients in the control group will receive SoC. The assessment of the ADLIFE intervention will be conducted using a mixed-methods approach.

Use of health care services according to functional performance in community-dwelling older adults in Spain. An approach using GAMLSS models.

Functional performance in older adults is a predictor of survival and other health outcomes and its measurement is highly recommended in primary care settings. Functional performance and frailty are closely related concepts, and frailty status is associated with the use of health care services. However, there is insufficient evidence on the utilization of services profile according to the functional performance of older adults. The aim of this study was to assess the relationship between functional performance and the use of a wide range of health services in community-dwelling older adults. Generalized additive models for location, scale and shape were used to study these complex data of services utilization, from primary to hospital care. A total of 749 participants from two Spanish regions were followed up for 2 years. Of those, 276 (37%) presented low functional performance and 473 (63%) normal performance according to the Timed Up and Go test. The results showed that even after adjusting for burden of comorbidity and polypharmacy, participants with low functional performance used primary and secondary care health services more intensively, visited emergency rooms more often, and were hospitalized more frequently and for longer periods of time. A negative binomial distribution and a variant thereof were found to be the best models to describe health service utilization data. In conclusion, functionality should be considered as an important health indicator for tailoring the provision of health services for older adults.

Immune response and reactogenicity after immunization with two-doses of an experimental COVID-19 vaccine (CVnCOV) followed by a third-fourth shot with a standard mRNA vaccine (BNT162b2): RescueVacs multicenter cohort study.

Background: There is no evidence to date on immunogenic response among individuals who participated in clinical trials of COVID-19 experimental vaccines redirected to standard national vaccination regimens. Methods: This multicentre, prospective controlled cohort study included subjects who received a COVID-19 experimental vaccine (CVnCoV)(test group, TG) - and unvaccinated subjects (control group, CG), selected among individuals to be vaccinated according to the Spanish vaccination program. All study subjects received BNT162b2 as a standard national vaccination schedule, except 8 (from CG) who received mRNA-1273 and were excluded from immunogenicity analyses. Anti-RBD antibodies level and neutralising titres (NT50) against G614, Beta, Mu, Delta and Omicron variants were analysed. Reactogenicity was also assessed. Findings: 130 participants (TG:92; CG:38) completed standard vaccination. In TG, median (IQR) of anti-RBD antibodies after first BNT162b2 dose were 10740·0 BAU/mL (4466·0-12500) compared to 29·8 BAU/mL (14·5-47·8) in CG (p <0·0001). Median NT50 (IQR) of G614 was 2674·0 (1865·0-3997·0) in TG and 63·0 (16·0-123·1) in CG (p <0·0001). After second BNT162b2 dose, anti-RBD levels increased to ≥12500 BAU/mL (11625·0-12500) in TG compared to 1859·0 BAU/mL (915·4-3820·0) in CG (p <0·0001). NT50 was 2626·5 (1756·0-5472·0) and 850·4 (525·1-1608·0), respectively (p <0·0001). Variant-specific (Beta, Mu, Omicron) response was also assessed. Most frequent adverse reactions were headache, myalgia, and local pain. No severe AEs were reported. Interpretation: Heterologous BNT162b2 as third and fourth doses in previously suboptimal immunized individuals elicit stronger immune response than that obtained with two doses of BNT162b2. This apparent benefit was also observed in variant-specific response. No safety concerns arose. Funding: Partly funded by the Institute of Health Carlos-III and COVID-19 Fund, co-financed by the European Regional Development Fund (FEDER) "A way to make Europe".

Relevance of well-being, resilience, and health-related quality of life to mental health profiles of European adolescents: results from a cross-sectional analysis of the school-based multinational UPRIGHT project.

PURPOSE: The existing evidence suggests that a complete evaluation of mental health should incorporate both psychopathology and mental well-being indicators. However, few studies categorize European adolescents into subgroups based on such complete mental health data. This study used the data on mental well-being and symptoms of mental and behavioral disorders to explore the mental health profiles of adolescents in Europe. METHODS: Data collected from adolescents (N = 3767; mean age 12.4 [SD = 0.9]) from five European countries supplied the information on their mental well-being (personal resilience, school resilience, quality of life, and mental well-being) and mental and behavioral disorder symptoms (anxiety, depression, stress, bullying, cyber-bullying, and use of tobacco, alcohol, or cannabis). Multiple correspondence analysis and cluster analysis were combined to classify the youths into mental health profiles. RESULTS: Adolescents were categorized into three mental health profiles. The "poor mental health" profile (6%) was characterized by low levels of well-being and moderate symptoms of mental disorders. The "good mental health" profile group (26%) showed high well-being and few symptoms of mental disorders, and the "intermediate mental health" profile (68%) was characterized by average well-being and mild-to-moderate symptoms of mental disorders. Groups with higher levels of well-being and fewer symptoms of mental disorders showed lower rates of behavioral problems. Mental well-being indicators strongly contributed to this classification. CONCLUSION: Adolescents with the "intermediate" or "poor" mental health profiles may benefit from interventions to improve mental health. Implications for school-based interventions are discussed. TRIAL REGISTRATION NUMBER (TRN) AND DATE OF REGISTRATION: ClinicalTrials.gov Identifier: NCT03951376. Registered 15 May 2019.

Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial.

BACKGROUND: Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate. METHODS: HERALD is a randomised, observer-blinded, placebo-controlled, phase 2b/3 clinical trial conducted in 47 centres in ten countries in Europe and Latin America. By use of an interactive web response system and stratification by country and age group (18-60 years and ≥61 years), adults with no history of virologically confirmed COVID-19 were randomly assigned (1:1) to receive intramuscularly either two 0·6 mL doses of CVnCoV containing 12 µg of mRNA or two 0·6 mL doses of 0·9% NaCl (placebo) on days 1 and 29. The primary efficacy endpoint was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose. For the primary endpoint, the trial was considered successful if the lower limit of the CI was greater than 30%. Key secondary endpoints were the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity by age group. Primary safety outcomes were solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events within 28 days after each dose in phase 2b participants, and serious adverse events and adverse events of special interest up to 1 year after the second dose in phase 2b and phase 3 participants. Here, we report data up to June 18, 2021. The study is registered at ClinicalTrials.gov, NCT04652102, and EudraCT, 2020-003998-22, and is ongoing. FINDINGS: Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48·2 days (SE 0·2), 83 cases of COVID-19 occurred in the CVnCoV group (n=12 851) in 1735·29 person-years and 145 cases occurred in the placebo group (n=12 211) in 1569·87 person-years, resulting in an overall vaccine efficacy against symptomatic COVID-19 of 48·2% (95·826% CI 31·0-61·4; p=0·016). Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (95% CI 42·5-86·1; CVnCoV 12 cases in 1735·29 person-years, placebo 37 cases in 1569·87 person-years). In participants aged 18-60 years, vaccine efficacy against symptomatic disease was 52·5% (95% CI 36·2-64·8; CVnCoV 71 cases in 1591·47 person-years, placebo, 136 cases in 1449·23 person-years). Too few cases occurred in participants aged 61 years or older (CVnCoV 12, placebo nine) to allow meaningful assessment of vaccine efficacy. Solicited adverse events, which were mostly systemic, were more common in CVnCoV recipients (1933 [96·5%] of 2003) than in placebo recipients (1344 [67·9%] of 1978), with 542 (27·1%) CVnCoV recipients and 61 (3·1%) placebo recipients reporting grade 3 solicited adverse events. The most frequently reported local reaction after any dose in the CVnCoV group was injection-site pain (1678 [83·6%] of 2007), with 22 grade 3 reactions, and the most frequently reported systematic reactions were fatigue (1603 [80·0%] of 2003) and headache (1541 [76·9%] of 2003). 82 (0·4%) of 19 783 CVnCoV recipients reported 100 serious adverse events and 66 (0·3%) of 19 746 placebo recipients reported 76 serious adverse events. Eight serious adverse events in five CVnCoV recipients and two serious adverse events in two placebo recipients were considered vaccination-related. None of the fatal serious adverse events reported (eight in the CVnCoV group and six in the placebo group) were considered to be related to study vaccination. Adverse events of special interest were reported for 38 (0·2%) participants in the CVnCoV group and 31 (0·2%) participants in the placebo group. These events were considered to be related to the trial vaccine for 14 (<0·1%) participants in the CVnCoV group and for five (<0·1%) participants in the placebo group. INTERPRETATION: CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile. Taking into account the changing environment, including the emergence of SARS-CoV-2 variants, and timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the development of next-generation vaccine candidates. FUNDING: German Federal Ministry of Education and Research and CureVac.

Abordaje de factores de riesgo de diabetes tipo 2 en adolescentes: estudio PRE-STARt Euskadi / Tackling risk factors for type 2 diabetes in adolescents: PRE-STARt study in Euskadi

Introducción: La obesidad en la población pediátrica y su efecto en la génesis de las enfermedades metabólicas constituye un gran problema de salud pública. Uno de los objetivos del estudio de ámbito europeo PRE-STARt en Euskadi es evaluar la efectividad de un programa de promoción de la salud, dirigido a adolescentes con factores de riesgo asociados al desarrollo de diabetes mellitus tipo 2 (DMT2).Pacientes y métodos: Ensayo clínico con doble grupo aleatorizado de adolescentes de 12 a 14 años con exceso ponderal. El grupo intervención recibió un programa multidisciplinar durante 24 meses, de 11 sesiones grupales (ocho al inicio, tres de refuerzo) junto con sus tutores. El grupo control continuó el seguimiento habitual por los equipos de pediatría de Atención Primaria. Se plantean modelos longitudinales para estudiar la evolución de medidas antropométricas y hábitos de vida desde el momento basal, a los 3, 6, 12 y 24 meses.Resultados: Participaron 92 personas en el estudio, igualmente distribuidas por grupo. Se observaron mejoras estadísticamente significativas en varios resultados: evolución del índice de masa corporal; aumento del consumo de frutas y verduras; disminución del consumo de snacks y de bebidas azucaradas; y aumento del número de días por semana en los que realizan más de una hora de ejercicio físico.Conclusiones: Los resultados confirman la efectividad del programa multidisciplinar, tanto en la evolución del índice de masa corporal como en la mejora de los hábitos alimentarios y de actividad física, todos ellos factores de riesgo en la génesis de enfermedades metabólicas futuras, como la DMT2. (AU)

Introduction: Obesity in the child population and its effect in the development of metabolic diseases are a public health issue. One of the aims of the European Project PRE-STARt in Euskadi, is the evaluation of the effectiveness of a multidisciplinary health promotion program directed at adolescents with risk factors associated with the development of type 2 Diabetes Mellitus (T2DM).Patients and methods: Randomised clinical trial with two groups of 12-14 year-old overweight adolescents. The intervention group took part in a multidisciplinary program for 24 months. This program was based on 11 group sessions (8 main sessions and 3 additional support ones) for adolescents and their guardians. The control group received usual care at primary care level. Longitudinal regression models were adjusted to assess the evolution of anthropometric measures and living habits at baseline, 3, 6, 12, and 24 months in both groups.Results: There were 92 participants, equally distributed by group. Statistically significant differences were observed between intervention and control groups in several results: evolution of the body mass index; increase in the consumption of fruits and vegetables; decrease in the consumption of snacks and sweetened drinks; and increase in the number of days per week with more than one hour of physical activity.Conclusions:The results confirm the effectiveness of this multidisciplinary program, both in the evolution of the body mass index, and in the improvement of the eating and physical activity habits, all of them risk factors for the future development of metabolic diseases, such as T2DM. (AU)

Tackling risk factors for type 2 diabetes in adolescents: PRE-STARt study in Euskadi.

INTRODUCTION: Obesity in the child population and its effect in the development of metabolic diseases are a public health issue. One of the aims of the European Project in a health system, is the evaluation of the effectiveness of a multidisciplinary health promotion program directed at adolescents with risk factors associated with the development of type 2 Diabetes Mellitus (T2DM). PATIENTS AND METHODS: Randomised clinical trial with two groups of 12-14 year-old overweight adolescents. The intervention group took part in a multidisciplinary program for 24 months. This program was based on 11 group sessions (8 main sessions and 3 additional support ones) for adolescents and their guardians. The control group received usual care at primary care level. Longitudinal regression models were adjusted to assess the evolution of anthropometric measures and living habits at baseline, 3, 6, 12, and 24 months in both groups. RESULTS: There were 92 participants, equally distributed by group. Statistically significant differences were observed between intervention and control groups in several results: evolution of the body mass index; increase in the consumption of fruits and vegetables; decrease in the consumption of snacks and sweetened drinks; and increase in the number of days per week with more than one hour of physical activity. CONCLUSIONS: The results confirm the effectiveness of this multidisciplinary program, both in the evolution of the body mass index, and in the improvement of the eating and physical activity habits, all of them risk factors for the future development of metabolic diseases, such as T2DM.

Variables associated with COVID-19 severity: an observational study of non-paediatric confirmed cases from the general population of the Basque Country, Spain.

OBJECTIVES: To investigate which were the most relevant sociodemographic and clinical variables associated with COVID-19 severity, and uncover how their inter-relations may have affected such severity. DESIGN: A retrospective observational study based on electronic health record data. PARTICIPANTS: Individuals ≥14 years old with a positive PCR or serology test, between 28 February and 31 May 2020, belonging to the Basque Country (Spain) public health system. Institutionalised and individuals admitted to a hospital at home unit were excluded from the study. MAIN OUTCOME MEASURE: Three severity categories were established: primary care, hospital/intensive care unit admission and death. RESULTS: A total of n=14 197 cases fulfilled the inclusion criteria. Most variables presented statistically significant associations with the outcome (p<0.0001). The Classification and Regression Trees recursive partitioning methodology (based on n=13 792) suggested that among all associations, those with, age, sex, stratification of patient healthcare complexity, chronic consumption of blood and blood-forming organ, and nervous system drugs, as well as the total number of chronic Anatomical Therapeutic Chemical types were the most relevant. Psychosis also emerged as a potential factor. CONCLUSIONS: Older cases are more likely to experience more severe outcomes. However, the sex, underlying health status and chronic drug consumption may interfere and alter the ageing effect. Understanding the factors related to the outcome severity is of key importance when designing and promoting public health intervention plans for the COVID-19 pandemic.

Inflammaging markers characteristic of advanced age show similar levels with frailty and dependency.

The improvement of life quality and medical advances has resulted in increased life expectancy. Despite this, health status commonly worsens in the last years of life. Frailty is an intermediate and reversible state that often precedes dependency and therefore, its identification may be essential to prevent dependency. However, there is no consensus on the best tools to identify frailty. In this sense, diverse molecules have been proposed as potential biomarkers. Some investigations pointed to an increased chronic inflammation or inflammaging with frailty, while others did not report such differences. In this work, we evaluated the circulating concentration of the inflammaging markers in adults and older adults (aged over 70 years) by ELISA and Luminex techniques. The Barthel Index was applied for the evaluation of dependency and Timed up-and-go, Gait Speed, Short Physical Performance Battery, Tilburg Frailty Indicator and Gerontopole Frailty Screening Tool were used for the identification of frailty. CRP, TNF-α, IL-6 and albumin concentrations were measured, and we found that elevated inflammation is present in older adults, while no differences with frailty and dependency were reported. Our results were consistent for all the evaluated frailty scales, highlighting the need to reconsider increased inflammation as a biomarker of frailty.

Development of an Interactive Lifestyle Programme for Adolescents at Risk of Developing Type 2 Diabetes: PRE-STARt.

BACKGROUND: Type 2 diabetes (T2D) is increasing in young people. Reporting on the processes used when developing prevention interventions is needed. We present the development of a family-based interactive lifestyle intervention for adolescents with risk factors for T2D in the future. METHOD: A multidisciplinary team in the UK site led the intervention development process with sites in Portugal, Greece, Germany and Spain. Potential programme topics and underpinning theory were gathered from literature and stakeholders. A theoretical framework based on self-efficacy theory and the COM-B (capability, opportunity, motivation, behaviour) model was developed. Sessions and supporting resources were developed and refined via two iterative cycles of session and resource piloting, feedback, reflection and refinement. Decision on delivery and content were made by stakeholders (young people, teachers, parents, paediatricians) and all sites. Materials were translated to local languages. Site-specific adaptations to the language, content and supporting resources were made. RESULTS: The "PRE-STARt" programme is eight 90-min interactive sessions with supporting curriculum and resources. Iterative development work provided valuable feedback on programme content and delivery. CONCLUSION: Reporting on the intervention development process, which includes stakeholder input, could yield a flexible approach for use in this emerging 'at risk' groups and their families.

Nursing Home Survey on Patient Safety Culture: Cross-cultural Validation Data From Spanish Nursing Homes.

OBJECTIVES: Developing an adequate patient safety culture is a relevant objective for all health care levels. The Nursing Home Survey on Patient Safety Culture (NHSOPS) is a 12-dimension tool assessing safety culture in nursing homes (NH) for elder people. The psychometric properties of its Spanish adaptation are evaluated in this study. METHODS: Nursing homes with 15 beds or more, located in the Basque Country (North Spain), were invited in the study. All staff types were allowed to participate. Internal consistency was tested with Cronbach's α. Convergent and divergent validity with Spearman's correlations. Two-sample t test was used for known-groups validity. The NHSOPS dimensionality was tested with confirmatory factor analysis (CFA), and its stability in consecutive administrations (test-retest) was explored. RESULTS: Five hundred fifty-three valid baseline and 83 retest replies were received. The data suggest that the NHSOPS can be represented by a 10-factor model. Two items (A6 and A10) had loadings of less than 0.12. The rest survey items obtained loadings of greater than 0.40. Estimated correlations supported the convergent and divergent validity of the survey. Managers and administrators, as well as staff considering their NH to be a safe place for residents, obtained higher NHSOPS scores, suggesting acceptable known-groups validity. On the other hand, test-retest variation was considerable. CONCLUSIONS: The current data support a simpler model, similar to that of the Norwegian NHSOPS validation. The stability of the scale should be further assessed in a bigger sample. Test-retest reliability and developing an adequate scoring scheme are issues worth of further study.