Software educativo para la asignatura Estratificación de Riesgos Medioambientales

Se realizó una investigación relacionada con la innovación tecnológica, en la Facultad de Enfermería-Tecnología de la Salud de Santiago de Cuba, durante el curso escolar 2019-2020, con el objetivo de diseñar un software educativo para la asignatura Estratificación de Riesgos Medioambientales, dirigido a los estudiantes de técnico medio en Vigilancia y Lucha Antivectorial. Se utilizaron los métodos teóricos: análisis-síntesis, histórico-lógico, modelación, sistémico-estructural e inductivo-deductivo; y empíricos: observación y análisis documental. La muestra fue de 44 estudiantes y 6 profesores escogidos al azar. Se concluye que el software propuesto es factible, pertinente y necesario como medio de enseñanza; proporciona información actualizada, su navegación es fácil y amena, y permite la autoevaluación de los estudiantes al interactuar con él mismo, lo que contribuye a mejorar el trabajo independiente.

An investigation related to the technological innovation was carried out in the Health Nursing-Technology Faculty from Santiago de Cuba, during the school course 2019-2020, aimed at designing an educational software for the subject Stratification of Environmental Risks, directed to medium technician students in Surveillance and Vector Control. The theoretical methods used were: analysis-synthesis, historical-logical, modelation, systemic-structural and inductive-deductive; and the empiric methods were: observation and documental analysis. The sample had 44 students and 6 professors chosen at random. It was concluded that the proposed software is feasible, pertinent and necessary as teaching aid; provides up-to-date information, it is easy and interesting to surf internet, and allows the self-appraisal of students in the interaction with themselves, what contributes to improve the independent work.

Regulating ethical experimentation: Impacts of the breakthrough therapy designation on drug R&D.

This article investigates patterns of pharmaceutical development activity around the 2012 creation of the FDA's Breakthrough Therapy Designation (BTD). The BTD introduced regulatory flexibility and support to avoid ethical challenges created by experimental therapies of exceptional performance in early stage clinical trials. We argue that the program's design indirectly created substantial incentives for the industry to pursue the designation. Consistent with this hypothesis, our evidence links the creation of the program with a substantial increase in the number of new drug indications entering the clinical trial process. This surge in introductions has resulted in a discernible increase in approvals, which has manifested with a lag and may strengthen in the future. Countering theoretical predictions, BTD incentives have not led to increased risk taking in project selection.

Leveraging the E-commerce footprint for the surveillance of healthcare utilization.

The utilization of healthcare services serves as a barometer for current and future health outcomes. Even in countries with modern healthcare IT infrastructure, however, fragmentation and interoperability issues hinder the (short-term) monitoring of utilization, forcing policymakers to rely on secondary data sources, such as surveys. This deficiency may be particularly problematic during public health crises, when ensuring proper and timely access to healthcare acquires special importance. We show that, in specific contexts, online pharmacies' digital footprint data may contain a strong signal of healthcare utilization. As such, online pharmacy data may enable utilization surveillance, i.e., the monitoring of short-term changes in utilization levels in the population. Our analysis takes advantage of the scenario created by the first wave of the Covid-19 pandemic in Mainland China, where the virus' spread lead to pervasive and deep reductions of healthcare service utilization. Relying on a large sample of online pharmacy transactions with full national coverage, we first detect variation that is strongly consistent with utilization reductions across geographies and over time. We then validate our claims by contrasting online pharmacy variation against credit-card transactions for medical services. Using machine learning methods, we show that incorporating online pharmacy data into the models significantly improves the accuracy of utilization surveillance estimates.

COVID-19 unemployment and access to statin medications in the United States.

Objective: To quantify the effect of the unemployment created by COVID-19 on access to (sales of) statin drugs in the United States population. Methods: Approximately half a billion transactions for statin drugs in the United States between January 2018 and September 2020 are analyzed. We studied the potential causal relation between abnormal levels of unemployment during the first wave of COVID-19 in the U.S. and abnormal levels of sales of statin products (both variables defined at the state/week level). Variables are analyzed using the Two-Stage Least Squares (2SLS) method, which exploits comparisons of statin sales between states where, given the occupational distribution of their workforce, unemployment was more structurally vulnerable to mobility restrictions derived from COVID-19 against states where it was less structurally vulnerable. Results: While we do not find unemployment effects on statin sales on most of the population, our estimates link COVID-fueled unemployment with a sharp sales reduction among Medicaid-insured populations, particularly those in working age. For the period between March and August of 2020, these estimates imply a 31% drop of statin sales among this population. Discussion: COVID-fueled unemployment may have had a negative and significant effect on access to statin populations among Medicaid-insured populations.

Association between universal health coverage and the disease burden of acute illness and injury at the global level.

BACKGROUND: This study examines the relationship between universal health coverage (UHC) and the burden of emergency diseases at a global level. METHODS: Data on Disability-Adjusted Life Years (DALYs) from emergency conditions were extracted from the Institute for Health Metrics and Evaluation (IHME) database for the years 2015 and 2019. Data on UHC, measured using two variables 1) coverage of essential health services and 2) proportion of the population spending more than 10% of household income on out-of-pocket health care expenditure, were extracted from the World Bank Database for years preceding our outcome of interest. A linear regression was used to analyze the association between UHC variables and DALYs for emergency diseases, controlling for other variables. RESULTS: A total of 132 countries were included. The median national coverage of essential health services index was 67.5/100, while the median national prevalence of catastrophic spending in the sample was 6.74% of households. There was a strong significant relationship between health service coverage and the burden of emergency diseases, with an 11.5-point reduction in DALYs of emergency medical diseases (95% CI -9.5, -14.8) for every point increase in the coverage of essential health services index. There was no statistically significant relationship between catastrophic expenditures and the burden of emergency diseases, which may be indicative of inelastic demand in seeking services for health emergencies. CONCLUSION: Increasing the coverage of essential health services, as measured by the essential health services index, is strongly correlated with a reduction in the burden of emergency conditions. In addition, data affirms that financial protection remains inadequate in many parts of the globe, with large numbers of households experiencing significant economic duress related to seeking healthcare. This evidence supports a strategy of strengthening UHC as a means of combating death and disability from health emergencies, as well as extending protection against impoverishment related to healthcare expenses.

Software educativo sobre algunas enfermedades transmisibles por vectores / Educative software about some vector-borne diseases

Introducción: Los vectores constituyen organismos vivos que pueden transmitir patógenos infecciosos entre personas, o de animales a personas. Muchos de esos vectores son insectos hematófagos que ingieren los microorganismos patógenos junto con la sangre de un portador infectado y, posteriormente, los transmiten a un nuevo portador, una vez replicado el patógeno. Objetivo: Diseñar un software educativo sobre enfermedades transmisibles por vectores, para favorecer el conocimiento de los estudiantes de la Facultad de Enfermería-Tecnología de la Salud en Santiago de Cuba. Métodos: Se realizó una investigación de desarrollo e innovación tecnológica con el programa CrheaSoft versión 3.3.3. De un universo de 327 estudiantes, se seleccionó una muestra de 130 de ellos, mediante el muestreo aleatorio simple. Se utilizaron los métodos teóricos, análisis-síntesis, histórico-lógico y sistémico-estructural. Resultados: Las valoraciones de docente y estudiantes fueron favorables, por facilitar la adquisición de nuevos conocimientos y ampliar los existentes, lo que demuestra la utilidad y necesidad del producto. Conclusiones: El software resultó pertinente para su utilización en la práctica, según criterios mayoritarios de docentes y estudiantes. Este constituye un material de consulta y de apoyo a la docencia, que puede utilizarse por los estudiantes de las carreras a la que van dirigidos y por el personal que labora en la Atención Primaria de Salud(AU)

Introduction: Vectors are living organisms that can transmit infectious pathogens between humans, or from animals to humans. Many of these vectors are hematophagous insects that ingest pathogenic microorganisms along with the blood of an infected carrier and subsequently transmit them to a new carrier, once the pathogen has replicated. Objective: To design an educative software about vector-borne diseases, in order to increase the knowledge of students from the School of Nursing and Health Technology in Santiago de Cuba. Methods: A technological development and innovation research was carried out with the CrheaSoft software, version 3.3.3. From a study universe of 327 students, a sample of 130 was selected by simple random sampling. The theoretical, analysis-synthesis, historical-logical and systemic-structural methods were used. Results: The evaluations provided by professors and students were favorable, since the acquisition of new knowledge was facilitated and the existing knowledge was expanded, which demonstrates the usefulness and necessity of the product. Conclusions: The software was suitable to be used in practice, according to the prevailing criteria provided by professors and students. It is a material for consultation and teaching support, which can be used by students of the majors for whom it has been designed and by the primary healthcare personnel(AU)

Prospective adverse event risk evaluation in clinical trials.

Proactive and objective regulatory risk management of ongoing clinical trials is limited, especially when it involves the safety of the trial. We seek to prospectively evaluate the risk of facing adverse outcomes from standardized and routinely collected protocol data. We conducted a retrospective cohort study of 2860 Phase 2 and Phase 3 trials that were started and completed between 1993 and 2017 and documented in ClinicalTrials.gov. Adverse outcomes considered in our work include Serious or Non-Serious as per the ClinicalTrials.gov definition. Random-forest-based prediction models were created to determine a trial's risk of adverse outcomes based on protocol data that is available before the start of a trial enrollment. A trial's risk is defined by dichotomic (classification) and continuous (log-odds) risk scores. The classification-based prediction models had an area under the curve (AUC) ranging from 0.865 to 0.971 and the continuous-score based models indicate a rank correlation of 0.6-0.66 (with p-values < 0.001), thereby demonstrating improved identification of risk of adverse outcomes. Whereas related frameworks highlight the prediction benefits of incorporating data that is highly context-specific, our results indicate that Adverse Event (AE) risks can be reliably predicted through a framework of mild data requirements. We propose three potential applications in leading regulatory remits, highlighting opportunities to support regulatory oversight and informed consent decisions.

Comportamiento de la pesquisa activa estudiantil en el Policlínico Dr. Mario Muñoz Monroy

Introducción: En la prevención de la COVID-19, es clave la pesquisa activa a la población, esta actividad no solo deberá estar encaminada a la detección precoz de casos sospechosos, sino también debe constituir una herramienta de comunicación. Objetivo: Describir el comportamiento de la pesquisa activa estudiantil para el enfrentamiento a la COVID-19 en el Policlínico Dr. Mario Muñoz Monroy de la provincia Santiago de Cuba. Métodos: Se realizó un estudio descriptivo y transversal, en el consultorio fueron ubicados ocho estudiantes, se tuvo en cuenta el requisito de vivir dentro o cercano a él, se excluyeron los estudiantes que participaron en los centros de aislamiento o zona roja, además de las embarazadas o aquellos que presentaron alguna enfermedad que le impidiera participar en la pesquisa; la muestra estuvo constituida por 437 viviendas y una población de 1 071 habitantes. Resultados: Predominaron los estudiantes de la carrera de Medicina. Se observó superioridad del sexo femenino en la población pesquisada. El 45,7 % de la población teníariesgos a la enfermedad, con significación del sexo femenino, la hipertensión arterial estaba presente en el 52,5 % de los pesquisados, seguida de la diabetes. Entre los síntomas predominaron la tos, secreción nasal y fiebre. Se reportaron 13 positivos, del grupo de edades entre 20 a 39 años, el más representativo con siete pacientes y en cuanto al sexonueve féminas; la mayor cantidad de positivos correspondieron al mes de febrero con 10 para un 76,9 %. Conclusiones: La pesquisa realizada por los estudiantes permitió identificar los síntomas y signos relacionados con la COVID-19, en cada de uno de los pacientes sospechosos y específicamente los vulnerables, garantizando un diagnóstico precoz para la debida atención de la enfermedad.

Introduction: In the prevention of COVID-19, active search of the population is key, this activity should not only be aimed at the early detection of suspected cases, but should also be a communication tool. Objective: To describe the experiences of the student active search developed in the Dr. Mario Muñoz Monroy Teaching Polyclinic, in Santiago de Cuba. Methods: Descriptive, cross-sectional study was carried out in the Office, 8 students were located, taking into account the requirement to live in or near it, students who participated in isolation centers or red zones were excluded, in addition to pregnant women or those who had a disease that prevented them from participating in the research; the sample consisted of 437 dwellings and a population of 1,071 inhabitants. Results: Predominance of the students of the Medicine career was observed. A superiority of the female sex was observed in the surveyed population. The 45.7% of the population has risks to the disease, with significance of the female sex, arterial hypertension is presented in 52.5% of those surveyed, followed by diabetes. Among the symptoms, cough, runny nose and fever predominated. 13 positives were reported, being the age group between 20 to 39 years, the most representative with 7 patients, and in terms of sex 9 females; the largest number of positives belongs to the month of February with 10 (76.9%). Conclusions: The research carried out by the students made it possible to identify the symptoms and signs related to COVID-19, in each of the suspected patients and specifically the vulnerable ones, guaranteeing an early diagnosis for proper care of the disease.

Use of online recruitment strategies in a randomized trial of cancer survivors.

BACKGROUND/AIMS: Despite widespread Internet adoption, online advertising remains an underutilized tool to recruit participants into clinical trials. Whether online advertising is a cost-effective method to enroll participants compared to other traditional forms of recruitment is not known. METHODS: Recruitment for the Survivorship Promotion In Reducing IGF-1 Trial, a community-based study of cancer survivors, was conducted from June 2015 through December 2016 via in-person community fairs, advertisements in periodicals, and direct postal mailings. In addition, "Right Column" banner ads were purchased from Facebook to direct participants to the Survivorship Promotion In Reducing IGF-1 Trial website. Response rates, costs of traditional and online advertisements, and demographic data were determined and compared across different online and traditional recruitment strategies. Micro-trials optimizing features of online advertisements were also explored. RESULTS: Of the 406 respondents to our overall outreach efforts, 6% (24 of 406) were referred from online advertising. Facebook advertisements were shown over 3 million times (impressions) to 124,476 people, which resulted in 4401 clicks on our advertisement. Of these, 24 people ultimately contacted study staff, 6 underwent prescreening, and 4 enrolled in the study. The cost of online advertising per enrollee was $794 when targeting a general population versus $1426 when accounting for strategies that specifically targeted African Americans or men. By contrast, community fairs, direct mail, or periodicals cost $917, $799, or $436 per enrollee, respectively. Utilization of micro-trials to assess online ads identified subtleties (e.g. use of an advertisement title) that substantially impacted viewer interest in our trial. CONCLUSION: Online advertisements effectively directed a relevant population to our website, which resulted in new enrollees in the Survivorship Promotion In Reducing IGF-1 Trial at a cost comparable to traditional methods. Costs were substantially greater with online recruitment when targeting under-represented populations, however. Additional research using online micro-trial tools is needed to evaluate means of more precise recruitment to improve yields in under-represented groups. Potential gains from faster recruitment speed remain to be determined.