Protocol for a trial assessing the efficacy of a universal school-based prevention program for addictive behaviors

Background: “Juego de Llaves” [Set of Keys] is a universal school-based prevention program for adolescents aged 12-15. It is aimed at reducing drug use and other addictive behaviors. This paper describes the full protocol for the evaluation design, instruments, randomization procedure, follow-ups, and primary outcomes. Method: Non-Randomized Control Cluster Trial in a set of Spanish secondary schools, with follow-ups at 12-, 24- and 36-months. Participants will be allocated to an experimental or control group. Using a digital application designed for the study, a battery of instruments will be used to assess addictive behaviors, sociodemographic variables, school climate and other transdiagnostic psychological variables. Results: A pilot test will be carried out to test the implementation protocol and to calculate the sample size needed for outcome evaluation. After implementing the program, longitudinal statistical approaches will be used to report intervention efficacy and potential moderators and mediators. Conclusions: There is a lack of assessments on the effectiveness of school prevention programs, and this paper is expected to improve monitoring and ongoing evaluation in prevention

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Does dispositional mindfulness mediate the relationship between anxiety and exam performance?

Anxiety affects students’ performance in exams. Dispositional mindfulness (DM), the ability to be aware of one’s own feelings and thoughts while not react to them, is associated with better cognitive performance under anxiety conditions. However, none study has addressed if DM mediates between anxiety and students’ performance in test taking. The aim was to study DM as a mediator of the effect of anxiety over exam performance in a college sample. 240 students driven from the same course and subject participated. Data was gathered before exam started. Measures entailed a sociodemographic questionnaire; the State-Trait Anxiety Inventory (STAI); the Five-Facets Mindfulness Questionnaire (FFMQ); and final marks from the exam. Mediational analyses were performed for each STAI dimension, setting each FFMQ factor as mediator, and marks from the final exam as outcome. Twenty-nine participants were excluded due to prior experience in meditation. Direct effect model showed that final exam score was significantly predicted by STAI-State (R2=,145, p<,001, b=-,536, 95% CI [-,719, -353]). A significant indirect effect was detected (t=-3,937, p<,001) for STAI-State through FFMQ-Non-Reactivity (b=-,06, 95% CI [-,095, -,032]). Data suggest that anxiety negatively affects performance in final exams, but this effect is ameliorated by DM.La ansiedad afecta al rendimiento de los estudiantes en los exámenes. El Mindfulnes Disposicional (MD) está relacionado con un mejor rendimiento cognitivo bajo condiciones de ansiedad. Sin embargo, ningún estudio ha investigado si el MD media el efecto de la ansiedad sobre el rendimiento en exámenes en estudiantes de universidad. El objetivo del estudio fue estudiar este posible papel mediador del MD. 240 estudiantes del mismo curso y materia participaron. Las medidas fueron un cuestionario sociodemográfico, el Inventario de Ansiedad Estado-Rasgo (STAI); el cuestionario Five-Facets Mindfulness Questionnaire (FFMQ), y la nota del examen final. Se realizaron análisis mediacionales para cada dimensión del STAI, con cada factor de la FFMQ como mediador, y la nota del examen como resultado. Veintinueve estudiantes fueron excluidos de los análisis por tener experiencia previa con meditación. La nota final era predicha por STAI-Estado (R2=,145, p<,001, b=-,536, 95% CI [-,719, -353]). Se encontró un efecto indirecto significativo (t=-3,937, p<,001) para la relación STAI-Estado a través de las puntuaciones de FFMQ-Non-Reactivity  (b=-,06, 95% CI [-,095, -,032]). Los datos sugieren que la ansiedad afecta negativamente a la ejecución en el examen final, pero que este efecto es reducido por el MD

Conducta suicida y periodo perinatal: entre el tabú y la incomprensión

El suicidio es la primera causa de muerte de las mujeres durante el periodo perinatal, que comprende desde el embarazo hasta un año después del parto. Hay apoyo empírico suficiente para afirmar que las mujeres embarazadas tienen mayor ideación suicida que su correspondiente grupo de comparación en la población general. A pesar de estos datos, este tipo de problemas no suelen ni prevenirse ni reconocerse adecuadamente. Sin embargo, si las disonancias y dilemas asociados a la maternidad, así como los problemas de salud mental, no se previenen o se abordan adecuadamente, éstos pueden afectar al bienestar de las mujeres, al de sus hijos y al de otros miembros de la familia. Se exponen los factores implicados en la conducta suicida de este grupo de mujeres, así como algunas directrices generales de actuación. Se reclama la necesaria puesta en marcha de estrategias de prevención.Suicide is the leading cause of death for women during the perinatal period, which commences in pregnancy and finishes one year after delivery. Empirical evidence from previous studies shows that pregnant women have greater suicidal ideation than their comparison group in the general population. However, there is a tendency for these problems to be neither prevented nor adequately recognized. Nevertheless, if the dissonances and dilemmas associated with motherhood, as well as mental health problems, are not prevented or adequately addressed, they can affect the well-being of women, their children, and other family members. Risk and protective factors for suicidal behavior in this group of women are discussed, as well as general principles of action. The need for the implementation of prevention strategies is highlighted

The Time of Ambulatory Assessment

Ambulatory assessment brings together a set of methods that make it possible to evaluate, through mobile devices, and at multiple moments in time, the behavior of people in their natural environment and daily context. It allows a more precise, dynamic, contextual, and idiographic evaluation than the classical approaches, opening new horizons with clear implications for psychological intervention. The main goal of this paper is to provide an introduction to ambulatory assessment. First, a conceptual delimitation is made and the issues to be solved are discussed, as well as their possible benefits. Second, aspects related to the methodology are exposed, addressing the designs, data types, and a general evaluation protocol. Third, some of the main limitations are discussed, and the most relevant applications are presented. Finally, some recommendations for the application of this type of methodology are discussed, and some challenges and future perspectives are analyzed

La hora de la evaluación ambulatoria

Ambulatory assessment brings together a set of methods that make it possible to evaluate, through mobile devices, and at multiple moments in time, the behavior of people in their natural environment and daily context. It allows a more precise, dynamic, contextual, and ideographic evaluation than the classical approaches, opening new horizons with clear implications for psychological intervention. The main goal of this paper is to provide an introduction to ambulatory assessment. First, a conceptual delimitation is made and the issues to be solved are discussed, as well as their possible benefits. Second, aspects related to the methodology are exposed, addressing the designs, data types, and a general evaluation protocol. Third, some of the main limitations are discussed, and the most relevant applications are presented. Finally, some recommendations for the application of this type of methodology are discussed, and some challenges and future perspectives are analyzed.La evaluación ambulatoria aglutina un conjunto de métodos que permiten evaluar mediante dispositivos móviles, y en múltiples momentos temporales, el comportamiento de las personas en su entorno natural y contexto diario. Permite una evaluación más precisa, dinámica, contextual e ideográfica que los métodos clásicos, abriendo nuevos horizontes con claras implicaciones para el diagnóstico y la intervención psicológica. El objetivo de este trabajo es realizar una introducción a la evaluación ambulatoria. En primer lugar, se realiza una delimitación conceptual y se comentan las cuestiones que viene a solucionar y sus posibles beneficios. En segundo lugar, se exponen aspectos relacionados con la metodología, abordando los diseños, los tipos de datos y un protocolo general de evaluación. En tercer lugar, se comentan algunas de las principales limitaciones, y se exponen las aplicaciones más relevantes. Finalmente, se comentan algunas recomendaciones para la aplicación de este tipo de metodología, y se analizan los retos y perspectivas futuras

Recuperación natural del abuso de alcohol y drogas ilegales en una muestra española

La recuperación natural es la vía preferente de salida de las adicciones entre los que abandonan o reducen el consumo de alcohol y otras sustancias, aunque se desconoce si dicha mejoría presenta diferencias relevantes en función de la sustancia consumida o del contexto cultural de los adictos. El objetivo de este estudio ex post facto fue investigar las posibles variaciones tanto en el proceso como en los determinantes del autocambio entre dos grupos de autocambiadores españoles. Utilizando fundamentalmente anuncios de prensa, se reclutaron 29 autocambiadores que llevaban al menos 1 año recuperados, de los cuales 17 lo eran de alcohol y 12 de drogas ilegales. A todos ellos se les evaluó en una única sesión en aspectos relacionados con la adicción y la recuperación. Los resultados mostraron diferencias significativas en variables relacionadas con el proceso adictivo como son la gravedad de la dependencia o el policonsumo y en algunas de las razones que motivaron el cambio y las estrategias de mantenimiento. A la vista de los resultados se concluyó que el estudio de las diferencias entre grupos de autocambiadores con problemas de adicción a varias sustancias puede ser muy útil para la mejora y especialización de las estrategias terapéuticas para cada tipo de problema adictivo