The Role of Regulatory Sciences from the Perspective of the Cuban Medicines Regulatory Agency: The Impact of COVID-19 in Promoting Innovation, Cooperation and Scientific Thinking.

The authors aim to familiarize the reader with the Center for the State Control of Medicines, Medical Equipment and Devices (CECMED) and the agency's perspective regarding the development and implementation of regulatory sciences as an interactive tool to promote cooperation and scientific thinking. The authors share their viewpoint on the preparedness of Latin American regulatory agencies by assessing innovation (i.e. novel biopharmaceuticals, vaccines, etc.), analyzing the challenges which are impacting healthcare and patients, and posing suggestions for a collaborative regional and international approach. To conclude, the authors' share recommendations for the implementation of regional initiatives aimed at supporting regulatory science, with the goal to promote the exchange of scientific cooperation as a vital element to maximize regulatory skills and competencies.

El clima organizacional de la clínica estomatológica Fe Dora Beris, del municipio de Santiago de Cuba / Organizational environment at Fe Dora Beris Dental Clinic, of Santiago de Cuba municipality

Introducción: el clima organizacional, conocido como clima laboral, es el ambiente humano y físico donde se desarrolla el trabajo. Para medir el clima interno de la institución médica Fe Dora Beris, se aplicó una encuesta a los trabajadores. Objetivo: caracterizar el clima laboral en una clínica estomatológica y sus módulos, en el municipio de Santiago de Cuba, desde febrero hasta abril del 2013. Método: se realizó un estudio transversal, con un universo de 33 trabajadores, presentes físicamente en el momento de la ejecución del trabajo en la Clínica Estomatológica Fe Dora Beris, de Santiago de Cuba. Se tomaron como bases las propuestas de la OMS y de la Organización Panamericana de la Salud (OPS), con 80 ítems relacionados con el instrumento Inventario de Clima Organizacional, y un test de motivación confeccionado y validado por el Centro de Técnicas de Dirección de La Habana (CETED), y se incluyeron los trabajadores de los módulos estomatológicos. El informe primario fue introducido en una base de datos Excel. Resultados: en las dimensiones de Reciprocidad y Participación el liderazgo se comportó de forma satisfactoria en la clínica, no así en los módulos estomatológicos, donde en el ciento por ciento los trabajadores quedaron insatisfechos. El personal no está motivado debido a la falta de recursos en la unidad. No reciben capacitación para mejorar su trabajo y, en el caso de los módulos, existe una pobre atención por parte de los directivos. Conclusiones: en la dimensión Motivación, y por consecuencia en todas las dimensiones de los módulos estomatológicos correspondientes a dicha clínica, el clima laboral resultó inadecuado.

Introduction: organizational or work environment is the human and physical environment in which the daily work unfolds. In order to measure the internal climate of the institution a survey to staff was applied. Objective: to characterize the organizational climate in a dental clinic and its modules, at the Santiago de Cuba municipality, in Cuba, from February to April, 2013. Method: a cross-sectional descriptive study with a universe of 33 workers, physically working at the dental clinic "Fe Dora Beris" of Santiago of Cuba, at the time of research, was conducted. Proposals with 80 items, of the World Health Organization (WHO) and the Panamerican Health Organization (PAHO) related to organizational climate, and a test of motivation, produced and validated by the Centre for Management Techniques of Havana (CMT), were applied to the clinic and its modules´ workers. Primary data was stored in an Excel database. Results: at the clinic leadership behaved satisfactorily. On the other hand, in the dimensions of Reciprocity and Participation, workers at all modules were dissatisfied. They are not motivated due to the lack of resources at the unit, no training to improve their work and, in the case of the modules, poor attention from managers. Conclusions: organizational climate was unsatisfactory. Motivation dimension in modules corresponding to the clinic was proved unsatisfactory.

El clima organizacional de la clínica estomatológica Fe Dora Beris, del municipio de Santiago de Cuba / Organizational environment at Fe Dora Beris Dental Clinic, of Santiago de Cuba municipality

Introducción: el clima organizacional, conocido como clima laboral, es el ambiente humano y físico donde se desarrolla el trabajo. Para medir el clima interno de la institución médica Fe Dora Beris, se aplicó una encuesta a los trabajadores. Objetivo: caracterizar el clima laboral en una clínica estomatológica y sus módulos, en el municipio de Santiago de Cuba, desde febrero hasta abril del 2013. Método: se realizó un estudio transversal, con un universo de 33 trabajadores, presentes físicamente en el momento de la ejecución del trabajo en la Clínica Estomatológica Fe Dora Beris, de Santiago de Cuba. Se tomaron como bases las propuestas de la OMS y de la Organización Panamericana de la Salud (OPS), con 80 ítems relacionados con el instrumento Inventario de Clima Organizacional, y un test de motivación confeccionado y validado por el Centro de Técnicas de Dirección de La Habana (CETED), y se incluyeron los trabajadores de los módulos estomatológicos. El informe primario fue introducido en una base de datos Excel.Resultados: en las dimensiones de Reciprocidad y Participación el liderazgo se comportó de forma satisfactoria en la clínica, no así en los módulos estomatológicos, donde en el ciento por ciento los trabajadores quedaron insatisfechos. El personal no está motivado debido a la falta de recursos en la unidad. No reciben capacitación para mejorar su trabajo y, en el caso de los módulos, existe una pobre atención por parte de los directivos. Conclusiones: en la dimensión Motivación, y por consecuencia en todas las dimensiones de los módulos estomatológicos correspondientes a dicha clínica, el clima laboral resultó inadecuado.(AU)

Introduction: organizational or work environment is the human and physical environment in which the daily work unfolds. In order to measure the internal climate of the institution a survey to staff was applied.Objective: to characterize the organizational climate in a dental clinic and its modules, at the Santiago de Cuba municipality, in Cuba, from February to April, 2013.Method: a cross-sectional descriptive study with a universe of 33 workers, physically working at the dental clinic “Fe Dora Beris” of Santiago of Cuba, at the time of research, was conducted. Proposals with 80 items, of the World Health Organization (WHO) and the Panamerican Health Organization (PAHO) related to organizational climate, and a test of motivation, produced and validated by the Centre for Management Techniques of Havana (CMT), were applied to the clinic and its modules´ workers. Primary data was stored in an Excel database.Results: at the clinic leadership behaved satisfactorily. On the other hand, in the dimensions of Reciprocity and Participation, workers at all modules were dissatisfied. They are not motivated due to the lack of resources at the unit, no training to improve their work and, in the case of the modules, poor attention from managers.Conclusions: organizational climate was unsatisfactory. Motivation dimension in modules corresponding to the clinic was proved unsatisfactory.(AU)

Cardiac outcomes 3 years after screening for asymptomatic coronary artery disease in patients with type 2 diabetes: value of myocardial perfusion imaging and coronary calcium score.

OBJECTIVE: The aim of the study was to identify the possible association among myocardial perfusion imaging (MPI) variables, coronary calcium score (CCS), and adverse events at medium term in type 2 asymptomatic diabetes mellitus patients. MATERIALS AND METHODS: Patients who participated in a first study that included a stress-rest MPI and a CCS assessment were asked to take part in this study. The present study protocol required a control single-photon emission computerized tomography after 3 years. Forty-one patients gave their informed consent. RESULTS: Of the 41 patients, 13 (32%) showed perfusion defects at the initial MPI. Of them, at 3 years, five continued showing perfusion defects, whereas another two had new defects (incidence of ischemia of 17%). Thus, 61% of the initial positive MPIs were normal at 3 years (P=0.04). In these cases the therapy was modified between the two studies. Left ventricular ejection fraction at stress showed a slight increase at 3 years (P=NS). Ventricular volumes significantly decreased at 3 years (P<0.01). Three patients (7.3%) developed an event during the follow-up (FU): two noncardiac deaths and one non-ST elevation myocardial infarction. The only variables that showed a possible association with the occurrence of events at FU were a CCS higher than 100 and less than 5 metabolic equivalents (METS) reached during the stress test (P=0.01). CONCLUSION: A CCS higher than 100 and a low functional capacity (<5 METS), but not an abnormal MPI, can be associated with cardiac events at 3-year FU in asymptomatic type 2 diabetic patients.

Interrelationship between myocardial perfusion imaging, coronary calcium score, and endothelial function in asymptomatic diabetics and controls.

BACKGROUND: Coronary artery disease is a leading cause of death among diabetics, and silent ischemia is a major concern in patients with diabetes mellitus (DM). METHODS: To detect the prevalence of ischemia in diabetics by myocardial perfusion imaging (MPI), and compare it to a control group without DM but with coronary risk factors, as well as to explore the relationship between silent ischemia, endothelial dysfunction, and coronary calcium, 59 patients (Group I) and 42 controls (Group II) were included. All underwent clinical and laboratory evaluations, gated MPI, brachial artery vasodilation measured by ultrasonography, and coronary calcium score (CCS). RESULTS: Twenty diabetics showed perfusion defects, vs seven controls (P = .04). There was no significant difference between both groups regarding the brachial artery vasodilator responsiveness: 4.49% ± 4.26% (diabetics) vs 4.70% ± 4.98% (controls). Mean CCS was 74 in diabetics vs five in controls (P = .01). The only risk factor significantly associated with an abnormal MPI was the presence of diabetes (P = .03). In the whole population of patients and in diabetics, the abnormal endothelium-dependent vasodilation, the CCS >100, and the cholesterol/HDL ratio >4, showed an OR >1. CCS exhibited the higher OR among the whole population: OR 2.15 [95% CI 0.42-10.99]; while for diabetics it was the cholesterol/HDL ratio: OR 3.95 [95% CI 0.71-21.84]. CONCLUSIONS: Reversible perfusion defects and coronary calcium are more frequent in diabetics. CCS, abnormal endothelium-dependent vasodilation, and cholesterol/HDL ratio higher than 4, showed an association with perfusion abnormalities in asymptomatic diabetics.

Tuberculosis en atención primaria de salud: presentación de 2 casos / Tuberculosis in primary health care. Report of 2 cases

Se presentan 2 casos de tuberculosis diagnosticados en el área de salud Mártires de Calabazar. El primero de ellos es una mujer de 46 años, desnutrida y alcohólica, con antecedentes de ser un contacto de tuberculosis y síntomas respiratorios de más un mes de evolución. El segundo, una niña de 15 meses, contacto intradomiciliario del primero, con una prueba de tuberculina hiperérgica. En ambos casos se indicaron estudios microbiológicos y radiográficos, estos últimos con signos reveladores del diagnóstico. Se realizó tratamiento completo, directamente observado, específico para cada caso, con alta clínica de ambos(AU)

Tuberculosis en atención primaria de salud: presentación de 2 casos / Tuberculosis in primary health care. Report of 2 cases

Se presentan 2 casos de tuberculosis diagnosticados en el área de salud Mártires de Calabazar. El primero de ellos es una mujer de 46 años, desnutrida y alcohólica, con antecedentes de ser un contacto de tuberculosis y síntomas respiratorios de más un mes de evolución. El segundo, una niña de 15 meses, contacto intradomiciliario del primero, con una prueba de tuberculina hiperérgica. En ambos casos se indicaron estudios microbiológicos y radiográficos, estos últimos con signos reveladores del diagnóstico. Se realizó tratamiento completo, directamente observado, específico para cada caso, con alta clínica de ambos.