Validity of the Penn Alcohol Craving Scale (PACS) for the Adolescent Colombian Population.

INTRODUCTION: Addiction behaviors are primary contributors to mental health issues among adolescents, often utilized as coping mechanisms or emotional regulation tools. This study aimed to establish the content validity of the Penn Alcohol Craving Scale (PACS) for Colombian adolescents, recognized for its representation of the cognitive-emotional aspects of craving. METHODOLOGY: This quantitative research focused on instrument validation. Seven subject matter experts evaluated the scale in terms of pertinence, relevance, usefulness, sufficiency, clarity, and appearance. Data analysis was conducted using SPSS version 22, calculating internal consistency and the Content Validity Index. Qualitative feedback from experts was compiled in an Excel matrix, facilitating grammatical and semantic adjustments to the instrument. RESULTS: Cronbach's Alpha values for each item and the scale exceeded 0.8. Content Validity Index scores exceeded 0.7 in four out of five evaluated criteria. These results supported retaining all scale items in the Colombian version. CONCLUSIONS: The content validation process yielded an instrument that satisfied expert opinion regarding conceptual constructs and explanatory power for the Colombian adolescent population.

Antithrombotic Use Patterns in COVID-19 Patients from Spain: A Real-World Data Study.

Antithrombotics have been widely used to treat and prevent COVID-19-related thrombosis; however, studies on their use at population levels are limited. We aimed to describe antithrombotic use patterns during the pandemic in Spanish primary care and hospital-admitted patients with COVID-19. Methods: A real-world data study was performed. Data were obtained from BIFAP's electronic health records. We investigated the antithrombotic prescriptions made within ±14 days after diagnosis between March 2020 and February 2022, divided their use into prior and new/naive groups, and reported their post-discharge use. Results: We included 882,540 individuals (53.4% women), of whom 78,499 were hospitalized. The median age was 44.7 (IQR 39-59). Antithrombotics were prescribed in 37,183 (4.6%) primary care subjects and 42,041 (53.6%) hospital-admitted patients, of whom 7505 (20.2%) and 20,300 (48.3%), respectively, were naive users. Prior users were older and had more comorbidities than new users. Enoxaparin was the most prescribed antithrombotic in hospitals, with higher prescription rates in new than prior users (2348.2, IQR 2390-3123.1 vs. 1378, IQR 1162-1751.6 prescriptions per 10,000 cases, p = 0.002). In primary care, acetylsalicylic acid was the most used antithrombotic, with higher use rates in prior than in naïve users. Post-discharge use occurred in 6686 (15.9%) subjects (median use = 10 days, IQR 9-30). Conclusions: Our study identified a consensus on prescribing antithrombotics in COVID-19 patients, but with low use rates in hospitals.

Lack of association between COVID-19 vaccines and miscarriage onset using a case-crossover design.

Pregnant women might have an increased risk of SARS-COV-2 infection. Although evidence towards the efficacy and safety of COVID-19 is growing still there is room for improvement on the knowledge towards pregnancy adverse events, such as miscarriage. We explored the association of COVID-19 vaccine with the risk of miscarriages using the Real-World. We identified a cohort of vaccinated pregnancies using the BIFAP database which contains systematically recorded data on care patients in Spain (N = 4054). We then restricted it to those women who had a miscarriage using a validated algorithm (N = 607). Among them, we performed a case-crossover design to evaluate the effect of intermittent exposures on the risk of miscarriage. Adjusted Odds Ratio with their confidence intervals were calculated using two analytical approaches: conditional logistic regression and Generalized Linear Mixed-Effects Models. A total of 225 (37.1%) were aged 35-39 years. The most common comorbidities were asthma, migraine, gastritis, and hypothyroidism. A total of 14.7% received only one dose of COVID-19 and 85.3% two doses, respectively. A total of 36.8% of women with one dose and 27.6% with two doses received the vaccine 7 days prior to the miscarriage. Corresponding adjusted estimates for the risk of miscarriage using the conditional logistic regression where as follows: 1.65 (95% CI 0.85-3.23) when using as the sum of 3 control moments among women with one dose, 1.02 (95% CI 0.72-1.46) among women with two doses and 1.03 (95% CI 0.72, 1.46) using the whole study population. Very similar results were obtained when conducting the Generalized Linear Mixed-Effects Models. There was no overall increased risk of miscarriage onset associated with COVID-19 vaccine although contradictory results were found according to the number of doses. Further studies are required with larger sample sizes to assess this association.

COVID-19 Distribution in Pregnancy, Drug Use Patterns and COVID-19 Medication during the Pandemic in Spain: Data from Real-World Electronic Health Records.

Although pregnant women were considered a risk population for COVID-19, little is known of their drug use during the pandemic. We aimed to investigate COVID-19 distribution, drug use patterns and COVID-19 medication. We conducted a retrospective cohort of validated pregnancies aged 15-49 years, from January 2020 to December 2022, using the BIFAP database. An identified cohort of pregnant women with COVID-19 was matched by age, gestational age, length of pregnancy and outcome to a cohort free of COVID-19 (8413 vs. 24,975). We performed a descriptive analysis on COVID-19 cases, estimated the drug use patterns and assessed COVID-19-specific drugs within the week prior/after diagnosis, stratified by pandemic wave and gestational week. The results showed that 72% of pregnant women with COVID-19 received at least one prescription vs. 66.6% of those free of COVID-19, with analgesics, antibiotics and thyroid hormones being the most prescribed drugs in both groups. In the COVID-19 group, they were antithrombotics (40 prescriptions per 100 women), analgesic/NSAIDs (19.64/6.29) and antibiotics (6.95). COVID-19 cases gradually increased, peaking at the fifth and second waves. Prescription rates were similar when compared to pre-pandemic studies. The use of drugs compatible with COVID-19 treatments was in line with recommendations.

Information and Communication Technologies for promotion of physical activity

Background: information and communication technologies have produced lifestyle changes, especially in physical activity. Therefore, it is important to promote the use of those resources through innovative processes to improve the quality of life. Objective: to analyze the scientific evidence on the information and communication technologies used for the promotion of physical activity. Method: a bibliographic search of publications in scientific journals between 2013 and 2019 was carried out. The descriptors technology, physical activity, innovation and their equivalences in English were used. The analyzed elements were title, abstract, publication year, language, country and publication source. From the complete text, the variables technology, population group, activities or strategies and results were analyzed. Results: 32 full articles that met the inclusion criteria were analyzed. The most used technologies for the promotion of physical activity in the different groups were PPPs and mobile phones; the evidence concludes that their use generates adherence and contributes to life quality. Conclusion: the need for the use of information and communication technologies was evidenced, therefore, innovative physical activity practice in different populations is encouraged. The challenge for professionals who work on the area is to take such technologies and start their implementation.

Antecedentes: las tecnologías de la información y la comunicación han configurado cambios en los estilos de vida de los sujetos, especialmente aquellos relacionados con la actividad física, por ello, es importante que a través de procesos innovadores se promueva la utilización de las mismas, que permitan el aprovechamiento de este recurso para la mejora de la calidad de vida. Objetivo: analizar la evidencia científica sobre la utilización de las tecnologías de la información y la comunicación para el fomento de la actividad física. Método: se realizó una búsqueda bibliográfica de publicaciones en revistas científicas, entre los años 2013 y 2019. Se utilizaron los descriptores tecnología, actividad física, innovación y sus correspondientes en inglés. Los artículos fueron analizados a partir del título, resumen, año de publicación, idioma, país y fuente de publicación. A partir del texto completo se analizaron las variables tecnología utilizada, grupo poblacional, actividades o estrategias y resultados. Resultados: fueron revisados para el análisis 32 artículos en texto completo que cumplieron criterios de inclusión, las tecnologías más utilizadas para el fomento de la actividad física en los diferentes grupos fueron las APP y los teléfonos móviles, la evidencia concluye que su uso genera adherencia y aporta para la calidad de vida. Conclusión: se evidenció la necesidad de la utilización de las tecnologías de la información y la comunicación para que de manera innovadora se fomente la práctica de la actividad física en diferentes poblaciones, el reto para los profesionales que trabajan el tema es apropiarlas e iniciar su implementación.

Antecedentes: as tecnologias da informação e a comunicação tem configurado câmbios nos estilos de vida dos sujeitos, especialmente aqueles relacionados com a atividade física, por isto, é importante que a través de processos inovadores se promove a utilização das mesmas, que permitam o aproveitamento destes recursos para a melhora da qualidade de vida. Objetivo: analisar a evidencia científica sobre a utilização das tecnologias da informação e a comunicação para a promoção da atividade física. Método: Realizou-se uma busca bibliográfica de publicações em revistas científicas, entre os anos 2013 e 2019. Utilizaram-se os descritores tecnologia, atividade física, inovação e seus correspondentes em inglês. Os artigos foram analisados a partir do título, resumo, ano de publicação, idioma, país e fonte de publicação. A partir do texto completo se analisaram as variáveis, tecnologia utilizada, grupo populacional, atividades as estratégias e resultados. Resultados: foram revisados para a análise 32 artigos em texto completo que cumpriram critérios de inclusão, as tecnologias mais utilizadas para o aumento da atividade física nos diferentes grupos foram as APP e os telefones móveis, a evidencia conclui que seu uso gera aderência e contribui para a qualidade de vida. Conclusão: Evidenciou-se a necessidade da utilização das tecnologias da informação e a comunicação para que de maneira inovadora se fomente a prática da atividade física em diferentes povoações, o reto para os profissionais que trabalham o tema é apropria-las e iniciar sua implementação.

Diseño y validez de contenido del cuestionario continuidad del cuidado entre niveles asistenciales / Design and content validity of the Continuity of Care Across Levels of Care Questionnaire

Introducción: La falta de continuidad del cuidado puede ocasionar omisiones o duplicaciones en las acciones dirigidas al cuidado de usuarios con Enfermedades Crónicas No Transmisibles (ECNT), generando un posible deterioro de su salud. Particularmente, en México y Colombia no existe un instrumento que evalúe la continuidad del cuidado que incluya sus tres elementos esenciales. Objetivos: Diseñar un instrumento que evalúe la continuidad del cuidado entre niveles asistenciales en usuarios con ECNT en México y Colombia; y validar el contenido del cuestionario por medio de un juicio de expertos en versiones adaptadas al contexto mexicano y colombiano. Materiales y Métodos: Se diseñó el cuestionario Continuidad del Cuidado entre Niveles Asistenciales. Se realizó el proceso de validación de contenido por expertos usando el método Delphi. Se seleccionaron 16 jueces expertos (8 por país). Los ítems del cuestionario fueron evaluados bajo cuatro categorías: suficiencia, claridad, coherencia y relevancia. Se realizaron dos rondas de evaluación para determinar el grado de concordancia entre jueces. Resultados: El cuestionario obtuvo un Coeficiente de Validez de Contenido General "Excelente" para ambos países (0,97). La versión final quedó conformada por 85 ítems divididos en tres secciones. Discusión: Este instrumento, a diferencia de otros, evalúa desde la experiencia de los usuarios con ECNT la continuidad del cuidado de forma multidisciplinaria en los tres niveles de atención. Conclusión: El cuestionario alcanzó una validez de contenido esperada usando el método Delphi, para evaluar la continuidad del cuidado entre niveles asistenciales en usuarios con ECNT según el contexto mexicano y colombiano.

Introduction: In the absence of continuity of care, actions aimed at the care of users with chronic non-communicable diseases (NCDs) may be omitted or duplicated, which can potentially worsen users' health. In Mexico and Colombia, in particular, there is no instrument for assessing continuity of care that includes its three essential elements. Objective: To develop an instrument to assess care continuity across levels of care for users with NCDs in Mexico and Colombia and validate the content of the questionnaire through expert judgment of versions adapted to the Mexican and Colombian contexts. Materials and Methods: The Continuity of Care across Levels of Care Questionnaire was designed. The content validation process was carried out by experts using the Delphi technique. Sixteen experts were selected (8 per country). Questionnaire items were assessed in four categories: sufficiency, clarity, coherence, and relevance. Two assessment rounds were conducted to determine the level of experts' agreement. Results: The questionnaire obtained an 'Excellent' overall Content Validity Coefficient in both countries (0.97). Discussion: This instrument, unlike others, assesses the continuity of care in a multidisciplinary manner across the three levels of care from the experience of users with NCDs. Conclusion: The questionnaire achieved the expected content validity using the Delphi technique to assess care continuity across levels of care for users with NCDs, according to the Mexican and Colombian contexts.

Introdução: A falta de continuidade do cuidado pode ocasionar omissões ou duplicidades nas ações voltadas para o atendimento aos usuários com Doenças Crônicas Não Transmissíveis (DCNT), gerando um possível agravamento de sua saúde. Particularmente, no México e na Colômbia não existe um instrumento que avalie a continuidade do cuidado que inclua seus três elementos essenciais. Objetivo: Desenhar um instrumento que avalie a continuidade do cuidado entre os níveis de atenção em usuários com DCNT no México e na Colômbia; e validar o conteúdo do questionário por meio de julgamento de especialistas em versões adaptadas ao contexto mexicano e colombiano. Materiais e Métodos: Foi elaborado o questionário de Continuidade de Cuidados entre os Níveis de Cuidados. O processo de validação de conteúdo foi realizado por especialistas por meio do método Delphi. Foram selecionados 16 juízes especialistas (8 por país). Os itens do questionário foram avaliados em quatro categorias: suficiência, clareza, coerência e relevância. Duas rodadas de avaliação foram realizadas para determinar o grau de concordância entre os juízes. Resultados: O questionário obteve um Coeficiente de Validade de Conteúdo Geral "Excelente" para ambos os países (0,97). A versão final foi composta por 85 itens divididos em três seções. Discussão: Este instrumento, diferente de outros, avalia a partir da experiência dos usuários com DCNT a continuidade do cuidado de forma multidisciplinar nos três níveis de atenção. Conclusão: O questionário atingiu a validade de conteúdo esperada usando o método Delphi, para avaliar a continuidade do cuidado entre níveis de atenção em usuários com DCNT de acordo com o contexto mexicano e colombiano.

A Clinical Prediction Rule for Thrombosis in Critically Ill COVID-19 Patients: Step 1 Results of the Thromcco Study.

The incidence of thrombosis in COVID-19 patients is exceptionally high among intensive care unit (ICU)-admitted individuals. We aimed to develop a clinical prediction rule for thrombosis in hospitalized COVID-19 patients. Data were taken from the Thromcco study (TS) database, which contains information on consecutive adults (aged ≥ 18) admitted to eight Spanish ICUs between March 2020 and October 2021. Diverse logistic regression model analysis, including demographic data, pre-existing conditions, and blood tests collected during the first 24 h of hospitalization, was performed to build a model that predicted thrombosis. Once obtained, the numeric and categorical variables considered were converted to factor variables giving them a score. Out of 2055 patients included in the TS database, 299 subjects with a median age of 62.4 years (IQR 51.5-70) (79% men) were considered in the final model (SE = 83%, SP = 62%, accuracy = 77%). Seven variables with assigned scores were delineated as age 25-40 and ≥70 = 12, age 41-70 = 13, male = 1, D-dimer ≥ 500 ng/mL = 13, leukocytes ≥ 10 × 103/µL = 1, interleukin-6 ≥ 10 pg/mL = 1, and C-reactive protein (CRP) ≥ 50 mg/L = 1. Score values ≥28 had a sensitivity of 88% and specificity of 29% for thrombosis. This score could be helpful in recognizing patients at higher risk for thrombosis, but further research is needed.

The Risk of SARS-CoV-2 Infection in Pregnant Women: An Observational Cohort Study Using the BIFAP Database.

BACKGROUND: It has been suggested that women experiencing during pregnancy several physiological and immunological changes that might increase the risk of any infection including the SARS-CoV-2. OBJECTIVE: We aimed to quantify the risk of SARS-CoV-2 infection during pregnancy compared with women with no pregnancies. METHODS: We used data from the BIFAP database and a published algorithm to identify all pregnancies during 2020. Pregnancies were matched (1:4) by age region, and length of pregnancy with a cohort of women of childbearing age. All women with SARS-CoV-2 infection before entering the study were discarded. We estimated incidence rates of SARS-CoV-2 with 95% confidence intervals (CIs) expressed by 1000 person-months as well as Kaplan-Meier figures overall and also stratified according to pregnancy period: during pregnancy, at puerperium (from end of pregnancy up to 42 days) and after pregnancy. (from 43 days after pregnancy up to end pf study period (i.e., June 2021). We conducted a Cox regression to assess risk factors for SARS-COV infection. The incidence rate of SARS-CoV-2 infection expressed by 1000 person-months were. RESULTS: There was a total of 103,185 pregnancies and 412,740 matched women at childbearing, with a mean age of 32.3 years. The corresponding incidence rates of SARS-CoV-2 infection according to cohorts were: 2.44 cases per 1000 person-months (confidence interval (CI) 95%: 2.40-2.50) and 4.29 (95% CI: 4.15-4.43) for comparison cohort. The incidence rate ratio (IRR) of SARS-CoV-2 was 1.76 (95% CI: 1.69-1.83). When analyzing according to pregnancy period, the IRRs were 1.30 (95% CI: 11.20-1.41) during the puerperium and 1.19 (95% CI: 41.15-1.23) after pregnancy. In addition to pregnancy itself, other important risk factors were obesity (1.33 (95% CI: 1.23-1.44)) and diabetes (1.23 (95% CI: 11.00-1.50). CONCLUSION: Pregnant women are at increased risk of SARS-CoV-2 infection compared with women of childbearing age not pregnant. Nevertheless, there is a trend towards reverting during puerperium and after pregnancy.

Measuring the social determinants of health: an integrative literature review / Medición de los determinantes sociales de la salud: revisión documental integrativa / Medindo os determinantes sociais da saúde: uma revisão integrativa da literature

AВSTRАСT Introduction: The Social Determinants of Health are those conditions that directly or indirectly influence the life course, the health of individuals and inequalities. Objective: to analyze the scientific evidence on instruments used to measure the Social Determinants of Health. Method: integrative documentary review of publications on this topic in 27 scientific articles, analyzed in ATLAS.ti software. Results: 2019 was the year with the highest number of studies related to Social Determinants of Health, English the predominant language; the United States is the most prolific country in publications; the most evaluated were the health system (70%), education (63%), economic income and housing (55%). Age, gender and ethnicity were assessed in 41%, socioeconomic stratum was not directly assessed. The measurement has been focused on the structural. Conclusion: according to scientific evidence, there is no homogeneity to include in instruments the fundamental Social Determinants of Health that explain inequalities and inequities and the design of generic instruments is an international need to evaluate the structural and intermediate determinants.

RESUMEN Introducción: los Determinantes Sociales de la Salud son aquellas condiciones que directa o indirectamente influyen en el curso de vida, la salubridad de los individuos y las desigualdades. Objetivo: analizar la evidencia científica sobre instrumentos utilizados para la medición de los Determinantes Sociales de la Salud. Material y método: revisión documental integrativa de publicaciones referentes a este tema en 27 artículos científicos, analizados en software ATLAS.ti. Resultados: el ano 2019 fue el de mayor número de estudios relacionados con Determinantes Sociales de la Salud, inglés el idioma predominante; Estados Unidos es el país más prolífico en publicaciones; los mayormente evaluados fueron el sistema de salud (70%), educación (63%), ingresos económicos y vivienda (55%). La edad, género y etnia se evaluaron en un 41%, el estrato socioeconómico no se evaluó directamente. La medición se ha centrado en lo estructural. Conclusión: según la evidencia científica no existe homogeneidad para incluir en instrumentos los Determinantes Sociales de la Salud fundamentales que explican las desigualdades e inequidades y el diseno de instrumentos genéricos es una necesidad internacional para evaluar los determinantes estructurales e intermedios.

RESUMO Introdução: os Determinantes Dociais da Daúde são as condições que influenciam directa ou indirectamente o curso da vida, a saúde dos indivíduos e as desigualdades. Objectivo: analisar as provas científicas sobre os instrumentos utilizados para medir os Determinantes Dociais da Daúde. Método: revisão documental integrativa de publicações sobre este tema em 27 artigos científicos, utilizando o software de análise estatística ATLAS.ti. Resultados: 2019 foi o ano com o maior número de estudos relacionados com Determinantes Sociais da Saúde, sendo o inglês a língua predominante; os Estados Unidos são o país mais prolífico em publicações. Entre as variáveis mais avaliadas estão o sistema de saúde (70%), educação (63%) e rendimento económico e habitação (55%). A idade, género e etnia foram avaliados em 41%, o estrato socioeconómico não foi directamente avaliado. A medição centra-se nos aspectos estruturais. Conclusão: de acordo com provas científicas não existe homogeneidade para incluir nos instrumentos os determinantes sociais da saúde, que são fundamentais para explicar as desigualdades e as desigualdades. Do mesmo modo, a concepção de instrumentos genéricos é uma necessidade internacional de avaliar determinantes estruturais e intermediários.

Bioseguridad y autocuidado: prioridad en la formación universitaria en momentos de pandemia / Biosafety and self-care: a priority in university training during pandemic times

Introducción: La bioseguridad y el autocuidado son dos prácticas importantes en el proceso de formación. Estas deben reforzarse permanentemente, ya que se relacionan de manera directa no solo con el riesgo de infecciones, sino con la calidad de la atención. Objetivo: Identificar la evidencia científica sobre los procesos de formación en bioseguridad y autocuidado en el marco de la pandemia. Métodos: Se hizo una revisión de la literatura científica publicada entre 2016 y 2020 sobre medidas de bioseguridad y autocuidado. La búsqueda se realizó en español, inglés y portugués, en la Biblioteca Virtual en Salud, Pubmed, Science Direct y el motor de búsqueda de Google Académico. Se aplicó la metodología PRISMA y se evaluaron en total 25 artículos científicos. Resultados: El año 2020 tuvo mayor frecuencia. La generalidad de los estudios se realizó en el contexto universitario en programas de salud. La higiene de las manos y el uso de guantes fueron las medidas de bioseguridad más informadas; mientras que las medidas de precaución se conocen e implementan. Las publicaciones denotan moderado conocimiento en cuanto a prevención de factores de riesgos biológicos, especialmente en prácticas clínicas. Conclusiones: En los procesos de formación debe tenerse en cuenta la relevancia de reforzar las medidas de bioseguridad y autocuidado para favorecer el ejercicio profesional. Es importante diseñar y repensar estos procesos, tanto en docentes como estudiantes, a través de nuevos métodos y cambios curriculares. La salud mental puede verse afectada no solo por la situación, sino por desconocimiento, miedo a infectarse y sobrecarga laboral(AU)

Introduction: Biosafety and self-care are two important practices in the training process. These should be permanently reinforced, since they are directly related not only to the risk of infections, but also to the quality of care. Objective: To identify the scientific evidence on the biosafety and self-care training processes in the context of the pandemic. Methods: A review of the scientific literature published between 2016 and 2020 on biosafety and self-care measures was carried out. The search was performed in Spanish, English and Portuguese, in the Virtual Health Library, PubMed, Science Direct, and the Google Scholar search engine. The PRISMA methodology was applied and a total of 25 scientific articles were assessed. Results: The year 2020 had the highest frequency. Most of the studies were carried out in the university context in health programs. Hand hygiene and glove-wearing were the most reported biosafety measures, while warning measures are known and implemented. The publications are indicative of moderate knowledge regarding prevention of biological risk factors, especially in clinical practices. Conclusions: The relevance of reinforcing biosafety and self-care measures to favor professional practice should be taken into account in training processes. It is important to design and rethink these processes, both in professors and students, through new methods and curricular changes. Mental health may be affected not only by the situation, but also by ignorance, fear of infection and work overload(AU)

[Non-inferiority studies efficacy and safety: review of methodological and statistical aspects in clinical trials and non-interventional studies with medicinal products.] / Estudios de no inferioridad de eficacia y seguridad: revisión e interpretación de aspectos metodológicos y estadísticos en ensayos clínicos y estudios observacionales con medicamentos.

Non-inferiority studies are increasingly more common for introducing new medicines in the market. Despite being situations where the use of this study design is justified, there is not a common analytical approach on how to conduct them. Pursuing a rigorous methodology, both in the study conduction and in its disseminations, is critical to ensure robust results to enable regulatory agencies and clinicians to reach valid conclusions and decisions which ultimately will benefit clinical practice. Most of the published reviews focus on the efficacy outcomes of non-inferiority clinical trials. We are unaware of other reviews that goes beyond and includes specific aspects for non-interventional designs and for studies focused on safety. Moreover, this review provides a simple and practical perspective with a minimum mathematical content on this complex type of studies.

Los estudios de no inferioridad son cada vez más frecuentes para introducir nuevos medicamentos en el mercado. Aunque existen situaciones en las que su uso está justificado, no existe un enfoque analítico único y conservador. Para arrojar resultados fiables y de calidad, deben seguir una estricta metodología, tanto en la ejecución como en la difusión de los resultados, la cual permita, tanto a las agencias reguladoras como a los clínicos, establecer conclusiones válidas y decisiones que repercutan en beneficio de la práctica clínica. La mayor parte de las revisiones publicadas se centran en los ensayos clínicos de no inferioridad de eficacia. En esta revisión se contemplan, además, los diseños observacionales y los aspectos específicos de los estudios de seguridad. Todo ello desde un punto de vista práctico y sencillo, con un contenido matemático mínimo.

Student Attitudes Contribute to the Effectiveness of a Genomics CURE.

The Genomics Education Partnership (GEP) engages students in a course-based undergraduate research experience (CURE). To better understand the student attributes that support success in this CURE, we asked students about their attitudes using previously published scales that measure epistemic beliefs about work and science, interest in science, and grit. We found, in general, that the attitudes students bring with them into the classroom contribute to two outcome measures, namely, learning as assessed by a pre- and postquiz and perceived self-reported benefits. While the GEP CURE produces positive outcomes overall, the students with more positive attitudes toward science, particularly with respect to epistemic beliefs, showed greater gains. The findings indicate the importance of a student's epistemic beliefs to achieving positive learning outcomes.

Estudios de no inferioridadde eficacia y seguridad: revisión e interpretación de aspectosmetodológicos y estadísticosen ensayos clínicos y estudiosobservacionales con medicamentos / Non-inferiority studies efficacy and safety: review of methodological and statistical aspects in clinical trials and non-interventional studies with medicinal products

Los estudios de no inferioridad son cada vez más frecuentes para introducir nuevos medicamentos en el mercado. Aunque existensituaciones en las que su uso está justificado, no existe un enfoque analítico único y conservador. Para arrojar resultados fiables y decalidad, deben seguir una estricta metodología, tanto en la ejecución como en la difusión de los resultados, la cual permita, tanto alas agencias reguladoras como a los clínicos, establecer conclusiones válidas y decisiones que repercutan en beneficio de la prácticaclínica. La mayor parte de las revisiones publicadas se centran en los ensayos clínicos de no inferioridad de eficacia. En esta revisiónse contemplan, además, los diseños observacionales y los aspectos específicos de los estudios de seguridad. Todo ello desde unpunto de vista práctico y sencillo, con un contenido matemático mínimo.(AU)

Non-inferiority studies are increasingly more common for introducing new medicines in the market. Despite being situations wherethe use of this study design is justified, there is not a common analytical approach on how to conduct them. Pursuing a rigorousmethodology, both in the study conduction and in its disseminations, is critical to ensure robust results to enable regulatory agenciesand clinicians to reach valid conclusions and decisions which ultimately will benefit clinical practice. Most of the published reviewsfocus on the efficacy outcomes of non-inferiority clinical trials. We are unaware of other reviews that goes beyond and includes spe-cific aspects for non-interventional designs and for studies focused on safety. Moreover, this review provides a simple and practicalperspective with a minimum mathematical content on this complex type of studies.(AU)

Sentido de coherencia en universitarios: recurso para el cuidado en tiempos de pandemia / The sense of coherence among university students: A resource for care in times of pandemic / Senso de coerência nos estudantes universitários: um recurso para o cuidado em tempos de pandemias

Introducción: El constructo Sentido de Coherencia derivado del modelo salutogénico, permite afrontar factores estresantes a través de activos para mantener una buena salud. Objetivo: Describir el Sentido de Coherencia (SOC-29) en estudiantes universitarios de la ciudad de Manizales como recurso de cuidado en tiempos de pandemia. Materiales y métodos: Se realizó un estudio cuantitativo, descriptivo con una fase asociativa y comparativa, con 566 estudiantes matriculados en universidades públicas y privadas de la ciudad de Manizales, Caldas (Colombia), durante el primer período académico del 2021. La técnica de recolección fue la encuesta online. Para el análisis univariado se realizó distribución de frecuencias, medidas de tendencia central y dispersión, y para el bivariado U de Mann Whitney, H de Kruskal-Wallis y Chi-cuadrado. Resultados: El valor del Sentido de Coherencia osciló entre 58 y 185 puntos, promedio 133.6 ± 24,4 puntos, un 27% de los participantes informó la pandemia afectó negativamente su vida, se encontró asociación estadísticamente significativa p<0,05 entre el cambio en las condiciones de vida y todos los ítems de la escala. Conclusión: La consolidación del Sentido de Coherencia como parte integral de la salud mental de los universitarios los prepara para afrontar cambios en sus condiciones de vida y hace factible direccionar acciones de cuidado en el contexto social, familiar y académico.

Introduction:The construct of the sense of coherence, derived from the salutogenic model, allows people to cope with stressors through resources to maintain good health. Objective: To describe the sense of coherence (SOC-29) among university students in the city of Manizales as a care resource in times of pandemic. Materials and Methods: A quantitative and descriptive study with an associative-comparative phase was conducted with 566 students enrolled in public and private universities in Manizales, Caldas, (Colombia), during the first semester of 2021. The data collection technique was online surveys. For the univariate analysis, frequency distribution and central tendency and dispersion measures were determined. For bivariate analysis, the Mann-Whitney U test, Kruskal-Wallis H test, and Chi-square test were used. Results:The SOC-29 score ranged from 58 to 185 points (mean 133.6 ± 24.4 points), and 27% of the participants reported that the pandemic negatively affected their life, a statistically significant association (p<0.05) was found between the change in living conditions and all the items of the scale. Conclusions: Consolidating the sense of coherence as an integral part of university students' mental health prepares them to cope with changes in their living conditions and makes it feasible to direct care actions in social, family, and academic settings.

Introdução: A construção Sentido de Coerência derivada do modelo salutogênico, permite lidar com os estressores através de ativos para manter a boa saúde. Objetivo: Descrever o Sentido de Coerência (SOC-29) em estudantes universitários da cidade de Manizales, Caldas (Colômbia), como um recurso para o cuidado em tempos de pandemia. Materiais e Métodos: Foi realizado um estudo quantitativo, descritivo com uma fase associativa e comparativa com 566 estudantes matriculados em universidades públicas e privadas na cidade de Manizales, Caldas (Colômbia), durante o primeiro período acadêmico de 2021. A técnica de coleta foi a pesquisa on-line. Para a análise univariada, foram utilizadas a distribuição de frequência, medidas de tendência central e dispersão, e para a análise bivariada foram utilizadas Mann Whitney U, Kruskal-Wallis H e Chi-quadrado. Resultados: O valor de senso de coerência variou de 58 a 185 pontos, média 133,6 ± 24,4 pontos, 27% dos participantes relataram que a pandemia afetou negativamente suas vidas, associação estatisticamente significativa p<0,05 foi encontrada entre mudança nas condições de vida e todos os itens da escala. Conclusões: A consolidação do Senso de Coerência como parte integrante da saúde mental dos estudantes universitários os prepara para enfrentar mudanças em suas condições de vida e torna viável a abordagem de ações de cuidado no contexto social, familiar e acadêmico.

Thromboembolic Events in a Socio-Economically Disadvantaged Population with COVID-19 Admitted to a Medicalized Hotel in Madrid.

Background: The social determinants of health (SDOH) of patients with COVID-19-related thrombosis have been scarcely explored. Our objective was to investigate the cases of thrombosis in a group of socially disadvantaged populations with COVID-19. Methods: We investigated the thrombotic events that occurred in a cohort of migrant and Spanish patients with COVID-19 that were admitted to a medicalized hotel in Madrid. Demographic data, past medical history, and socio-economic backgrounds, such as monthly household income, level of education, and living conditions, were explored to determine the factors related to thrombosis. Results: A cohort of 383 subjects (mean age 55.4 ± 14.6 years old, 69% male), of which 58% were migrants, was studied. Fourteen (3.6%) cases of thrombosis were reported. Thrombosis was more frequent in Spanish than in migrant individuals (OR 5.3, 95%CI 1.4-19.5, p = 0.005). Neither a low monthly household income nor a low education level showed a statistical association with thrombosis (p ≥ 0.05). History of venous thromboembolism (OR 8.1, 95%CI 2.2-28.6) and being a current smoker (OR 4.7, 95%CI 1.3-16.0) were factors associated with thrombosis. Conclusions: The SDOH studied were not associated with thrombosis; however, further investigation must be performed to investigate the socio-economic conditions of subjects with COVID-19 with adverse outcomes such as thrombotic events.

Atención primaria social en Colombia: una mirada desde una experiencia exitosa / Social primary care in Colombia: A look from a successful experience

Resumen Introducción: La estrategia de Atención Primaria Social ha sido valorada por la Organización Panamericana de la Salud como una experiencia exitosa. Objetivo: Analizar la experiencia de Atención Primaria Social en el departamento de Caldas en el marco de un proceso de sistematización. Materiales y métodos: Estudio de sistematización de experiencias, las unidades de análisis y de trabajo fueron documentos municipales y departamentales, información del Observatorio Social de Caldas y relatos de diferentes actores. Técnicas: 71 entrevistas a profundidad a informantes claves, 27 grupos focales, 11 diarios de campo y revisión documental. La información fue recolectada en 6 fases y luego analizada en el software ATLAS.ti 8.0. Resultados: La estrategia tuvo un recorrido histórico bajo lineamientos nacionales e internacionales desde los años 80 hasta la actualidad, fue modificada en 2013 al articular actores y sectores público-privados para convertirla en "Atención Primaria Social". El modelo operativo se cimienta en la transectorialidad y educación interdisciplinar, bienestar y salud familiar, y participación social y comunitaria, cuyo eje central son los actores, familias y comunidades. Se destacan actividades como caracterización familiar, intervenciones a familias priorizadas y unidades de análisis para apoyo, monitoreo y seguimiento. Conclusiones: Han participado diferentes actores en la comprensión de la mirada y el abordaje de la salud desde lo "social", un actor relevante ha sido la comunidad, acompañada de sus líderes y la academia. La voluntad política del gobierno nacional, departamental y municipal es relevante para el éxito de la estrategia. Los indicadores en salud han sido impactados por el avance en la implementación de la estrategia de Atención Primaria Social.

Abstract Introduction: The Social Primary Care strategy has been evaluated by the Pan American Health Organization as a successful experience. Objective: To analyze the experience of Primary Social Care in the department of Caldas within the framework of a systematization process. Methods: Systematization study of experiences, the units of analysis and work were municipal and departmental documents, information from the Social Observatory of Caldas and accounts of different actors. Techniques: 71 in-depth interviews with key informants, 27 focus groups, 11 field diaries and documentary review, the information was collected in 6 phases and then analyzed in ATLAS. ti 8.0 software. Results: The strategy had a historical trajectory under national and international guidelines from the 1980s to the present, it was modified in 2013 by articulating actors and public-private sectors to turn it into "Social Primary Care". The operational model is based on trans-sectoriality and interdisciplinary education, family wellbeing and health, and social and community participation, whose central axis are the actors, families, and communities. Activities include family characterization, interventions for prioritized families and units of analysis for support, monitoring and follow-up. Conclusions: Different actors have participated in the understanding of the "social" approach to health, a relevant actor has been the community accompanied by its leaders and academia. The political will of the national, departmental and municipal governments is relevant for the success of the strategy. Health indicators have been impacted by the progress in the implementation of the Social Primary Health Care strategy.

Effect of regulatory interventions on agomelatine use in Spain: A multiple intervention time-series analysis in a nationwide electronic healthcare record database.

BACKGROUND: Liver injury is an important identified risk for agomelatine and several measures were put in place to prevent and minimize such risk. The study aims to assess the impact of four interventions on the incidence of agomelatine use, particularly among patients aged ≥75 in Spain between 2011 and 2018. METHODS: Quasi-experimental interrupted time-series analysis to examine data from a nationwide electronic healthcare record database (BIFAP). Quarterly cumulative incidence of agomelatine use per 100 000 patients was calculated and the impact of four regulatory interventions was quantified. RESULTS: The incidence of agomelatine use decreased by 85% and 87% from first quarter 2011 to last quarter 2018 in patients below and above 75 years old, respectively. Regulatory actions taken were not associated with an immediate and significant falling level of use or slope. The incidence was less than expected 6 months after the first and third intervention for patients below and above 75 years old, and more than expected after the second and fourth intervention for both populations, though these analyses were underpowered to observe significant results. The downward trend became less pronounced, reaching a residual level of use, which remained stable in the last segment of the study period. CONCLUSION: New users of agomelatine decreased throughout the study period, starting before interventions took place. The effect of specific interventions might be masked by the progressive decrease tendency, constant over the study period. The effects of external factors that might overlap, unintended consequences, and issues concerning statistical modeling in situations where rates are already falling, should be considered when interpreting the results.

Flecainide and risk of skin neoplasms: Results of a large nested case-control study in Spain and Denmark.

Background: A previous study in Denmark suggested an increased melanoma risk associated with the use of flecainide. Objective: To study the association between flecainide use and the risk of melanoma and non-melanoma skin cancer in Spain and Denmark. Methods: We conducted a multi-database case-control study in (database/study period) Spain (SIDIAP/2005-2017 and BIFAP/2007-2017) and Denmark (Danish registries/2001-2018). We included incident cases of melanoma or non-melanoma skin cancer (NMSC) aged ≥18 with ≥2 years of previous data (≥10 years for Denmark) before the skin cancer and matched them to controls (10:1 by age and sex). We excluded persons with immunosuppression or previous cancer. We defined ever-use as any prescription fill and high-use as a cumulative dose of at least 200 g (reference: never-use). We categorized a cumulative dose for a dose-response assessment. We used conditional logistic regression to compute ORs (95% CI) adjusted for photosensitizing, anti-neoplastic, disease-specific drugs and comorbidities. Results: The total numbers of melanoma/NMSC cases included were 7,809/64,230 in SIDIAP, 4,661/31,063 in BIFAP, and 27,978/152,821 in Denmark. In Denmark, high-use of flecainide was associated with increased adjusted ORs of skin cancer compared with never-use [melanoma: OR 1.97 (1.38-2.81); NMSC: OR 1.34 (1.15-1.56)]. In Spain, an association between high-use of flecainide and NMSC was also observed [BIFAP: OR 1.42 (1.04-1.93); SIDIAP: OR 1.19 (0.95-1.48)]. There was a non-significant dose-response pattern for melanoma in Denmark and no apparent dose-response pattern for NMSC in any of the three databases. We found similar results for ever-use of flecainide. Conclusion: Flecainide use was associated with an increased risk of melanoma (Denmark only) and NMSC (Denmark and Spain) but without substantial evidence of dose-response patterns. Further studies are needed to assess for possible unmeasured confounders.

Validación de contenido y adaptación de la escala de sentido de coherencia 29 para la población colombiana / Content validation and adaptation of the 29-item Sense of Coherence scale for the Colombian population / Validação de conteúdo e adaptação da escala senso de coerência (soc-29) para a população colombiana

Resumen Objetivo: Validar el contenido de la escala de sentido de coherencia 29 para la población colombiana, la cual mide la capacidad de las personas para aprovechar los recursos materiales e inmateriales que dispone para enfrentar los estímulos presentes a lo largo de la vida. Metodología: Investigación del tipo validación de instrumentos, realizada bajo la técnica de juicio de expertos. El procedimiento contiene cinco pasos: preparación de instrucciones y planilla, selección de expertos, explicación del contexto, discusión y establecimiento de acuerdos. Los criterios de calidad valorados para la validación de contenido fueron: "pertinencia", "relevancia", "utilidad", "suficiencia", "claridad" y "apariencia". Se contó con el consentimiento informado de los participantes. Resultados: La escala de sentido de coherencia fue adaptada acorde con ciertos términos desde el punto de vista semántico y sintáctico, y según las pruebas realizadas, posee buena consistencia interna, con un Alfa de Cronbach de 0,838 y un valor global del índice de validez de contenido considerado como esencial de 0,83. Conclusiones: Los hallazgos cuantitativos y cualitativos del proceso de validación confirman que la escala en versión español puede ser aplicada en población colombiana, con el fin de medir el sentido de coherencia, entendido como la capacidad de aprovechar los recursos para enfrentar los estímulos.

Abstract Objective: To validate, for the Colombian population, the content of the 29-item Sense of Coherence scale, which measures the ability of people to take advantage of material and immaterial resources available for them to face the stimuli present throughout life. Methodology: Instrument validation research, carried out under the expert judgment technique. The procedure contains five steps: preparation of instructions and worksheet, selection of experts, explanation of the context, discussion, and establishment of agreements. The quality criteria assessed for content validation were: "pertinence," "relevance," "usefulness," "sufficiency," "clarity," and "appearance." Informed consent was obtained from all the participants. Results: The Sense of Coherence scale was adapted according to certain terms from the semantic and syntactic point of view, and according to the tests carried out, it has good internal consistency, with a Cronbach's alpha of 0.838 and a global value of the content validity index considered as essential of 0.83. Conclusions: The quantitative and qualitative findings of the validation process confirm that the scale version in Spanish can be applied in the Colombian population with the aim of measuring the sense of coherence, understood as the ability to take advantage of resources to face stimuli.

Resumo Objetivo: Validar o conteúdo da escala senso de coerência 29 para a população colombiana, a qual mede a capacidade das pessoas para aproveitar os recursos materiais e imateriais disponíveis para enfrentar os estímulos presentes ao longo da vida. Metodologia: Estudo do tipo validação de instrumentos, realizado com a técnica de julgamento de especialistas. O procedimento está composto por cinco passos: preparação de instruções e planilha, seleção de especialistas, explicação do contexto, discussão e estabelecimento de acordos. Os critérios de qualidade analisados para a validação de conteúdo foram: "pertinência", "relevância", "utilidade", "suficiência", "clareza" e "aparência". Contou-se com o consentimento informado dos participantes. Resultados: A escala senso de coerência foi adaptada de acordo com certos termos partindo do ponto de vista semântico e sintático, e de acordo com os testes realizados, possui boa consistência interna, com um Alfa de Cronbach de 0,838 e um valor global de índice de validade de conteúdo considerado como essencial de 0,83. Conclusões: As descobertas quantitativas e qualitativas do processo de validação confirmam que a escala na versão em espanhol pode ser aplicada na população colombiana, com o objetivo de medir o sentido de coerência, entendido como a capacidade de aproveitar os recursos para enfrentar os estímulos.