Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study

BackgroundThe use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting.MethodsMulticenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024.DiscussionThe scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript.Trial registrationNCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021

Role of age and comorbidities in mortality of patients with infective endocarditis

[Purpose]: The aim of this study was to analyse the characteristics of patients with IE in three groups of age and to assess the ability of age and the Charlson Comorbidity Index (CCI) to predict mortality. [Methods]: Prospective cohort study of all patients with IE included in the GAMES Spanish database between 2008 and 2015.Patients were stratified into three age groups:<65 years,65 to 80 years,and ≥ 80 years.The area under the receiver-operating characteristic (AUROC) curve was calculated to quantify the diagnostic accuracy of the CCI to predict mortality risk. [Results]: A total of 3120 patients with IE (1327 < 65 years;1291 65-80 years;502 ≥ 80 years) were enrolled.Fever and heart failure were the most common presentations of IE, with no differences among age groups.Patients ≥80 years who underwent surgery were significantly lower compared with other age groups (14.3%,65 years; 20.5%,65-79 years; 31.3%,≥80 years). In-hospital mortality was lower in the <65-year group (20.3%,<65 years;30.1%,65-79 years;34.7%,≥80 years;p < 0.001) as well as 1-year mortality (3.2%, <65 years; 5.5%, 65-80 years;7.6%,≥80 years; p = 0.003).Independent predictors of mortality were age ≥ 80 years (hazard ratio [HR]:2.78;95% confidence interval [CI]:2.32–3.34), CCI ≥ 3 (HR:1.62; 95% CI:1.39–1.88),and non-performed surgery (HR:1.64;95% CI:11.16–1.58).When the three age groups were compared,the AUROC curve for CCI was significantly larger for patients aged <65 years(p < 0.001) for both in-hospital and 1-year mortality. [Conclusion]: There were no differences in the clinical presentation of IE between the groups. Age ≥ 80 years, high comorbidity (measured by CCI),and non-performance of surgery were independent predictors of mortality in patients with IE.CCI could help to identify those patients with IE and surgical indication who present a lower risk of in-hospital and 1-year mortality after surgery, especially in the <65-year group

Treatment with tocilizumab or corticosteroids for COVID-19 patients with hyperinflammatory state: a multicentre cohort study (SAM-COVID-19)

Objectives: The objective of this study was to estimate the association between tocilizumab or corticosteroids and the risk of intubation or death in patients with coronavirus disease 19 (COVID-19) with a hyperinflammatory state according to clinical and laboratory parameters. Methods: A cohort study was performed in 60 Spanish hospitals including 778 patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state. Treatment was mainly with tocilizumab, an intermediate-high dose of corticosteroids (IHDC), a pulse dose of corticosteroids (PDC), combination therapy, or no treatment. Primary outcome was intubation or death; follow-up was 21 days. Propensity score-adjusted estimations using Cox regression (logistic regression if needed) were calculated. Propensity scores were used as confounders, matching variables and for the inverse probability of treatment weights (IPTWs). Results: In all, 88, 117, 78 and 151 patients treated with tocilizumab, IHDC, PDC, and combination therapy, respectively, were compared with 344 untreated patients. The primary endpoint occurred in 10 (11.4%), 27 (23.1%), 12 (15.4%), 40 (25.6%) and 69 (21.1%), respectively. The IPTW-based hazard ratios (odds ratio for combination therapy) for the primary endpoint were 0.32 (95%CI 0.22-0.47; p < 0.001) for tocilizumab, 0.82 (0.71-1.30; p 0.82) for IHDC, 0.61 (0.43-0.86; p 0.006) for PDC, and 1.17 (0.86-1.58; p 0.30) for combination therapy. Other applications of the propensity score provided similar results, but were not significant for PDC. Tocilizumab was also associated with lower hazard of death alone in IPTW analysis (0.07; 0.02-0.17; p < 0.001). Conclusions: Tocilizumab might be useful in COVID-19 patients with a hyperinflammatory state and should be prioritized for randomized trials in this situatio

CIBERER : Spanish national network for research on rare diseases: A highly productive collaborative initiative

Altres ajuts: Instituto de Salud Carlos III (ISCIII); Ministerio de Ciencia e Innovación.CIBER (Center for Biomedical Network Research; Centro de Investigación Biomédica En Red) is a public national consortium created in 2006 under the umbrella of the Spanish National Institute of Health Carlos III (ISCIII). This innovative research structure comprises 11 different specific areas dedicated to the main public health priorities in the National Health System. CIBERER, the thematic area of CIBER focused on rare diseases (RDs) currently consists of 75 research groups belonging to universities, research centers, and hospitals of the entire country. CIBERER's mission is to be a center prioritizing and favoring collaboration and cooperation between biomedical and clinical research groups, with special emphasis on the aspects of genetic, molecular, biochemical, and cellular research of RDs. This research is the basis for providing new tools for the diagnosis and therapy of low-prevalence diseases, in line with the International Rare Diseases Research Consortium (IRDiRC) objectives, thus favoring translational research between the scientific environment of the laboratory and the clinical setting of health centers. In this article, we intend to review CIBERER's 15-year journey and summarize the main results obtained in terms of internationalization, scientific production, contributions toward the discovery of new therapies and novel genes associated to diseases, cooperation with patients' associations and many other topics related to RD research

Percepção de adolescentes sobre o consumo de redes sociais

Adolescents participate in social networks on a regular basis as a new space for leisure and entertainment among this group, with little awareness of responsible use. The purpose of this study was to analyse the consumption of digital media and social networks in young people, as well as to assess their influence on the family and socio-educational environment. The research, of a cross-sectional, descriptive and correlational nature, was carried out with the participation of 104 students of Compulsory Secondary Education (ESO) from an educational centre in the Autonomous Community of the Region of Murcia, by means of the completion of a Likert scale questionnaire. From the results obtained, it is evident that there are significant differences in the use of social networks, according to gender and that there is a evidence of a relationship between their perception of digital competence and participation in social networks; on the other hand, adolescents do not perceive risky behaviour, as well as the possibility of having conflicts in their socio-family environment due to their participation in social networks.Los adolescentes participan en las redes sociales de forma habitual como un nuevo espacio de ocio y entretenimiento entre este colectivo, siendo escasa la sensibilización de un uso responsable. El propósito de este estudio fue analizar el consumo de medios digitales y redes sociales en los jóvenes, así como valorar su influencia en el entorno familiar y socioeducativo. La investigación, de carácter transversal, descriptiva y correlacional, se llevó a cabo con la participación de 104 estudiantes de Educación Secundaria Obligatoria (ESO) de un centro educativo de la Comunidad Autónoma de la Región de Murcia, mediante la cumplimentación de un cuestionario tipo escala Likert. De los resultados obtenidos se evidencia que existen diferencias significativas en el uso de las redes sociales, según el género y que existe relación entre su percepción de la competencia digital y la participación en las redes sociales; por el contrario, los adolescentes no consideran que lleven a cabo conductas de riesgo, ni creen que el origen de los conflictos en su entorno sociofamiliar pueda ser el uso de las mismas.Os adolescentes participam regularmente das redes sociais como um novo espaço de lazer e entretenimento desse grupo, com pouca consciência do uso responsável. O objetivo deste estudo foi analisar o consumo de mídias digitais e redes sociais em jovens, bem como avaliar sua influência no ambiente familiar e socioeducativo. A pesquisa, de natureza transversal, descritiva e correlacional, foi realizada com a participação de 104 alunos do Ensino Secundário Obrigatório (ESO) de um centro educativo da Comunidade Autónoma da Região de Múrcia, através do preenchimento de uma escala tipo questionário Likert. A partir dos resultados obtidos, evidencia-se que existem diferenças significativas na utilização das redes sociais, de acordo com o género e que existe uma relação entre a sua percepção da competência digital e a participação nas redes sociais; Ao contrário, os adolescentes não consideram que realizam comportamentos de risco, nem acreditam que a origem dos conflitos em seu ambiente sociofamiliar possa ser seu uso

Aula abierta

Resumen basado en el de la publicaciónA pesar de la migración de los niños y jóvenes a pantallas y dispositivos más modernos, la televisión tradicional o en abierto sigue siendo la más consumida en el hogar durante la infancia. Se exponen los resultados de una investigación desarrollada entre alumnado de Educación Primaria, con el objetivo de analizar, desde la perspectiva de los alumnos, la influencia que la familia ejerce en el consumo, visionado de programas, así como en el proceso de elección y recepción de contenidos televisivos de sus hijos. El estudio se engloba dentro de un enfoque cuantitativo, de diseño no experimental, siendo el instrumento de recogida de datos un cuestionario. Los resultados muestran, entre otros aspectos, que ante el consumo televisivo los escolares revelan preferencias de sus progenitores al seleccionar la programación televisiva y se constata cómo influye el nivel formativo y modelo familiar en el tiempo de consumo. Como conclusión se destaca el importante papel que la familia tiene en el uso y tipo de consumo televisivo de los escolares.ES

Predictive inpatient falls risk model using Machine Learning

Aim: To create a model that detects the population at risk of falls taking into account fall prevention variable and to know the effect on the model´s performance when not considering it. Background: Traditionally, instruments for detecting fall risk are based on risk factors, not mitigating factors. Machine learning (ML), which allows working with a wider range of variables, could improve patient risk identification. Methods: The sample was composed of adult patients admitted to the Internal Medicine service (total, n=22515; training, n=11134; validation, n=11381). A retrospective cohort design was used and we applied ML technics. Variables were extracted from electronic medical records (EMR). Results: The Two-Class Bayes Point Machine algorithm was selected. Model-A (with fall prevention variable) obtained better results than Model-B (without it) in sensitivity (0.74 vs 0.71), specificity (0.82 vs 0.74) and AUC (0.82 vs 0.78). Conclusions: Fall prevention was a key variable. The model that included it detected the risk of falls better than the model without it. Implications for Nursing Management: We created a decision-making support tool that helps nurses to identify patients at risk of falling. When it´s integrated in the EMR, it decreases nurses’ workloads by not having to collect information manually

Predictive Modeling of Pressure Injury Risk in Patients Admitted to an Intensive Care Unit

Background Pressure injuries are an important problem in hospital care. Detecting the population at risk for pressure injuries is the first step in any preventive strategy. Available tools such as the Norton and Braden scales do not take into account all of the relevant risk factors. Data mining and machine learning techniques have the potential to overcome this limitation. Objectives To build a model to detect pressure injury risk in intensive care unit patients and to put the model into production in a real environment. Methods The sample comprised adult patients admitted to an intensive care unit (N = 6694) at University Hospital of Torrevieja and University Hospital of Vinalopó. A retrospective design was used to train (n = 2508) and test (n = 1769) the model and then a prospective design was used to test the model in a real environment (n = 2417). Data mining was used to extract variables from electronic medical records and a predictive model was built with machine learning techniques. The sensitivity, specificity, area under the curve, and accuracy of the model were evaluated. Results The final model used logistic regression and incorporated 23 variables. The model had sensitivity of 0.90, specificity of 0.74, and area under the curve of 0.89 during the initial test, and thus it outperformed the Norton scale. The model performed well 1 year later in a real environment. Conclusions The model effectively predicts risk of pressure injury. This allows nurses to focus on patients at high risk for pressure injury without increasing workload