RESUMO
TRIAL DESIGN: An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B. METHODS: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. INCLUSION CRITERIA: NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community)- classified as non-responders. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 µg doses (two complete guidelines). The objective of this study was to provide Health workers-staff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine. The primary outcome was the measurement of antibody antiHBs before the first Fendrix® dose and a month after the administration of each dose. Other outcome was collection of adverse effects during administration and all those that could be related to the vaccine and that occur within 30 days after each dose. In this study, only one group was assigned. There was no randomization or masking. RESULTS: The participants were recruited between April 13, 2018 and October 31, 2019. 67 participants were enrolled in the Clinical Trial and included the analyses. The primary immunisation consists of 4 separate 0.5 ml doses of Fendrix®, administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once the positivity was reached in any of the doses, the participant finished the study and was not given the following doses. 68.66% (46 out 67) had a positive response to first dose of Fendrix®. 57.14% (12 out 21) had a positive response to second dose of Fendrix®. 22.22% (2 out 9) had a positive response to third dose of Fendrix and 42.96% (3 out 7) had a positive response to last dose of Fendrix®. Overall, 94.02% (64 out 67) of participants had a positive response to Fendrix®. No serious adverse event occurred. CONCLUSIONS: The use of Fendrix®, is a viable vaccine alternative for NHS workers classified as "non-responders". Revaccination of healthy non-responders with Fendrix®, resulted in very high proportions of responders without adverse events. TRIAL REGISTRATION: The trial was registered in the Spanish National Trial Register (REEC), ClinicalTrials.gov and inclusion has been stopped (identifier NCT03410953; EudraCT-number 2016-004991-23). FUNDING: GRS 1360/A/16: Call for aid for the financing of research projects in biomedicine, health management and socio-health care to be developed in the centres of the Regional Health Management of Autonomous Community of Castile-Leon. In addition, this work has been supported by the Spanish Platform for Clinical Research and Clinical Trials, SCReN (Spanish Clinical Research Network), funded by the Subdirectorate General for Research Evaluation and Promotion of the Carlos III Health Institute (ISCIII), through the project PT13/0002/0039 and project PT17/0017/0023 integrated in the State Plan for R&D&I 2013-2016 and co-financed by and the European Regional Development Fund (ERDF).
Assuntos
COVID-19 , Hepatite B , Atenção à Saúde , Hepatite B/prevenção & controle , Vacinas contra Hepatite B , Humanos , SARS-CoV-2 , VacinaçãoRESUMO
En una sala de Electrofisiología del Servicio de Cardiología en donde se efectúan procedimientos guiados con rayos X de ablación con radiofrecuencia y de implantes de desfibrilador biventricular, se registraron dosis mensuales anormalmente elevadas en el dosímetro personal de solapa de una auxiliar de enfermería que trabaja en la misma, con valores de dosis equivalente personal, Hp(10), de 125 mSv y de dosis equivalente personal superficial, Hp(0.07) de 128.1 mSv. Ante la ansiedad producida en la trabajadora al conocer las lecturas de su dosímetro, y dado que no se dispone de precedentes investigados en la instalación, se ha realizado un estudio para dilucidar si la dosis registrada ha podido ser recibida por la trabajadora o si solo ha sido recibida por el dosímetro. Se hacen medidas con un monitor ambiental en condiciones simuladas de los procedimientos, para estimar las dosis reales que pueda recibir el personal de la sala. Se comparan estos valores con los del rendimiento del equipo de RX en haz directo medidos durante la revisión anual de control de calidad del mismo, concluyéndose que ha sido el dosímetro, y no la trabajadora, el que se ha expuesto a radiación directa, siendo la situación más probable la de que dicho dosímetro cayó sobre el tubo de RX, normalmente orientado hacia el techo, un tiempo del orden de 1 minuto. Paralelamente a estas estimaciones dosimétricas, el Servicio de Prevención de Riesgos Laborales realizó la vigilancia de la salud, concluyendo que la trabajadora no tenía ningún indicio de haber recibido dosis de la magnitud registrada por su dosímetro (AU)
In a room of electrophysiology from the cardiology service where procedures are made guided with X-Rays of ablation with radiofrequency and from implants ventricular defibrillation; there were registered monthly doses usually high in the same personal dosimeter flap of a nursing assistant who works there with values of equivalent personal doses, Hp (10), of superficial equivalent doses, Hp (0.07) of 128.1mSv. In view of the anxiety produced in the worker upon knowing the readings of its dosimeter, and since there is no disposition of precedents investigated in the facility, and it has been carried out a study for explaining if the doses registered could has been received by the worker if it is only received by the dosimeter (AU)
Assuntos
Humanos , Feminino , Radiometria/métodos , Medida de Exposição à Radiação , Medição de Radiação , Protetores contra Radiação , Precauções Universais/tendênciasRESUMO
El estado de bienestar en que vivimos en los países desarrollados hace que surja la necesidad de buscar herramientas que sean una imagen fiel del estado de salud de la población como es la medición de la calidad de vida relacionada con la salud. El objetivo de nuestro estudio es conocer la calidad de vida relacionada con la salud (CVRS) de los trabajadores sanitarios como medida de su estado de salud. Para ello hemos realizado un estudio transversal, prospectivo y descriptivo de una muestra de 542 trabajadores seleccionada por muestreo sistemático. Como variable dependiente se evaluó la CVRS a través del cuestionario SF-36. Este cuestionario evalúa el estado de salud a través de 7 escalas (Función física, rol físico, salud general, vitalidad, función social, rol emocional y salud mental) valoradas de 0 a 100 (siendo 100 el mejor valor) y de dos dominios globales estandarizados para población general siendo su valor 50, (índice general de salud física e índice general de salud mental). Se tiene en cuenta la edad y el sexo para el análisis de los resultados. Los resultados más relevantes obtenidos son: Edad media 46 años (DE 10,4), 82% mujeres. Función física: 88.7 (Población general-PG-: 84.7); Rol físico: 86.5 (PG: 83.2); Dolor: 71.9 (PG: 79); Salud general: 70 (PG: 68.3); Vitalidad: 66.1 (PG: 66.9); Función social: 86.4 (PG: 90.1); Rol emocional: 87.8 (PG: 88.6); Salud mental: 72.6 (PG: 73). Índice global de salud física: 51.9; Índice global de salud mental: 49.8. Los valores encontrados tanto para las escalas de salud física como mental son ligeramente mejores que los establecidos para la población general para el mismo rango de edad y sexo, salvo en la escala de dolor (AU)
The welfare state in whom we live in the developed countries does that there arises the need to look for tools that are a faithful image of the health of the population such as it is the measurement of the quality of life related to the health. The aim of our study is to know the health related quality of life (HRQOL) of the sanitary workers as measure of their health status. For it we have realized a cross-sectional, prospective and descriptive study of a sample of 542 workers selected by systematic sampling. The dependent variable was assessed HRQOL by the SF-36. This questionnaire assesses the health status across 7 scales (physical function, role physical, general health, vitality, social function, emotional role and mental health) from 0 to 100 (100 being the best value) and two global domains standardized for general population value being 50, (general index of physical health, and general index of mental health). It takes into account the age and the sex for the analysis of the results. The most important results obtained are: Middle Age 46 years (SD 10,4), 82 % women. Physical function: 88.7 (PG-general population: 84.7), role physical, 86.5 (PG: 83.2); Pain 71.9 (PG 79), general health: 70 (PG: 68.3); Vitality: 66.1 (PG: 66.9 ), social function: 86.4 (PG: 90.1), Role emotional 87.8 (PG: 88.6); Mental Health: 72.6 (PG 73). Global index of physical health: 51.9; global Index of mental health: 49.8. The values found so much for the scales of physical as mental health are lightly better than the established ones for the general population for the same range of age and sex, except in the scale of pain (AU)
Assuntos
Humanos , Qualidade de Vida , Recursos Humanos em Hospital/estatística & dados numéricos , Nível de Saúde , Estudos Transversais , Estudos Prospectivos , 24419RESUMO
Hemos analizado a través de un estudio epidemiológico descriptivo con una muestra de 806 trabajadores, la prevalencia de sobrepeso/obesidad en un medio sanitario. Para ello utilizamos datos obtenidos de la historia clínico laboral de nuestros trabajadores y la obtención de datos antropométricos. Definimos como sobrepeso un IMC>25 y obesidad >30. Los resultados obtenidos en porcentajes generales de sobrepeso y obesidad son similares a los descritos en la literatura; por sexos, los hombres de la muestra presentan más obesidad que las mujeres a pesar de estandarizar por edad (en contra de lo publicado). Conclusiones: Existe una elevada prevalencia de obesidad/sobrepeso en nuestra muestra, al igual que en la población general, lo cual hace necesaria la participación del médico del trabajo desde los Servicios de Prevención para la identificación y seguimiento de los perfiles ponderales de los trabajadores y establecer estrategias adecuadas para reducir la prevalencia
We have analyzed through an epidemiological descriptive study with a sample of 806 workers, the prevalence of overweight / obesity in a sanitary way. For it we use information obtained of the history clinical labour of our workers and the obtaining of information anthropometrics. We define as overweight an IMC> 25 and obesity> 30. Them proved obtained in general percentages of overweight and obesity they are similar to described in the literature; for sexes, the men of the sample present more obesity than the women in spite of standardizing for age (against it published). Conclusions: A high prevalence of obesity / overweight exists in our sample, as in the general population, which makes necessary the participation of the doctor of the work from the Services of Prevention for the identification and follow-up of the perfilies consider them of the workers and to establish strategies adapted to reduce the prevalence
Assuntos
Humanos , Obesidade/epidemiologia , Sobrepeso/epidemiologia , Estudos Epidemiológicos , Serviços de Saúde do Trabalhador/estatística & dados numéricos , Índice de Massa Corporal , Pessoal de Saúde , Distribuição por Idade e SexoRESUMO
La información sobre la presencia de morbilidad en un colectivo de trabajadores podría ser una de las señas de identidad de las condiciones en las que se desempeña el trabajo. El objetivo es conocer el estado de salud en un colectivo de trabajadores sanitarios y los posibles factores laborales con los que pudiera estar relacionado. Para ello, se ha realizado un estudio transversal, prospectivo, descriptivo y analítico en una muestra de 554 trabajadores seleccionados por muestreo sistemático. Se incluyeron variables generales, hábitos saludables y tóxicos, variables laborales y presencia de morbilidad. Se ha realizado un análisis estadístico descriptivo y multivariante. Entre los resultados más relevantes conviene destacar que se trata de un colectivo de trabajadores de edad media de 46 años (DE: 10,4), 82% mujeres, sin actividad física (45%), fumadores (23%) y bebedores habituales (24%). La categoría más representada es la de enfermería (24%). Un 56% es personal fijo, con una antigüedad media de 14 años. Un 24% había sufrido accidentes de trabajo. Un 25% realiza turnos con diferencias significativas por categorías. Un 55% presenta alguna patología, siendo la osteomuscular la más prevalente (30%). En el análisis multivariante, la variable que mayor influencia ejerció sobre la morbilidad es la edad (OR: 1,04; IC 95%: 1.004-1.044). Respecto a las variables laborales, la única que ha mostrado relación independiente con la presencia de patología es la categoría y, concretamente, el colectivo de los celadores con la patología osteomuscular (OR: 2.685. IC 95%: 1,08-6,6) No se ha encontrado relación independiente del resto de variables estudiadas con la presencia de morbilidad (AU)
Information on the presence of disease in a group of workers could be one of the hallmarks of the conditions under which work is performed. We intended to know the health status in a group of health workers and possible job factors with which it may be related. We therefore performed a cross-sectional, prospective, descriptive, analytical study of a sample of 554 workers selected by systematic sampling. Variables included general, healthy habits and toxic industrial variables and presence of disease. Descriptive and multivariate statistical analysis. Among the most relevant results, it was a group of workers of average age 46 years (SD 10.4), 82% women, 45% no physical activity, smoking 23% and 24% regular drinkers. The most represented category was the nurses (24%). 56% permanent staff. Average age of 14. Accidents at work 24%. 25% were shifts with significant differences by category. 55% had some disease, being the most prevalent musculoskeletal (30%). In the multivariate analysisthe variable exerted the greatest influence on morbidity was age (OR: 1.04; 95% CI: 1,004-1,044). With regard to labor the only variable that showed an independent correlation with the presence of disease was more and more specifically the group of guards with musculoskeletal diseases (OR: 2,685; 95% CI: 1.08-6.6) No relationship was found independent of other variables the presence of disease (AU)