Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines

[EN] 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 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff 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 ‘‘nonresponders”. 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)

Violencia externa en el trabajo en el sector servicios: Consideraciones generales, notificación y protocolos de actuación External violence at work in the service sector general considerations: Notification and action protocol

La violencia en el lugar de trabajo es un fenómeno emergente que afecta a todos los sectores y categorías laborales. Su prevención y manejo exige una actuación coordinada de todas las instituciones implicadas. Partiendo de la normativa legal existente, se crea la necesidad de poner en marcha las medidas preventivas dirigidas a eliminar o minimizar el riesgo, para conseguir este objetivo se deben elaborar procedimientos de trabajo que establezcan las actuaciones a seguir ante situaciones de violencia externa, estos procedimientos son de aplicación a todos los trabajadores y tienen que ser difundidos a todos los estamentos de la empresa. La información y formación de los trabajadores en relación con este tema es otra de las medidas preventivas que hay que poner en marcha, para que estos adquieran las habilidades necesarias con el fin de evitar la violencia externa. Para conocer la dimensión exacta del problema es preciso disponer de los datos referidos a las situaciones de violencia externa que suceden en nuestra organización, por lo que es imprescindible elaborar un plan de notificación y registro.<br>Violence in the workplace is a new problem that affects all types of sectors and professional categories. Its prevention and management requires coordinated action by all institutions involved. According to current legislation, we need to implement preventive measures to remove or minimize this risk. To achieve this goal, we must develop working procedures establishing actions to be taken in situations of external violence. These procedures should be applied to all workers and distributed to all levels in the company. The information and training of workers in relation to this subject is another of the preventive measures which have to be carried out, so that they acquire the necessary skills to avoid external violence. To know the real dimension of the problem it is necessary to record accurately all external violence situations which occur in our organization, for which it is essential to develop a notification and registration plan

Patologías relacionadas con las condiciones ambientales de un hospital terciario de la Comunidad de Madrid

Introducción: El Síndrome del edificio enfermo (SEE) cursa con una mayor incidencia de síntomas como cefaleas, irritación de mucosas y sensación de fatiga, que mejoran o incluso desaparecen al abandonar el edificio. La Organización Mundial de la Salud (OMS) estima que este problema afecta al 30% de los edificios modernos y causa molestias al 10-30% de sus ocupantes. Objetivo: Determinar si los síntomas manifestados por los trabajadores de un hospital terciario de la Comunidad de Madrid se corresponden con los síntomas que definen el SEE. Material y Método: Estudio descriptivo transversal. Se pasó un cuestionario a un grupo de trabajadores, seleccionados de forma aleatoria y voluntaria. Resultados: Se recogieron 207 cuestionarios, 164 (79,2%) de mujeres y 43 (20,8%) de hombres. La edad media fue 41,4 años, 42,6 en mujeres y 36,6 en hombres (p< 0,01). Se encontró reagrupamiento de casos en algunas áreas del hospital (laboratorios y quirófanos) y se midieron condiciones ambientales: humedad 23-26% (valores recomendados superiores al 30%) y temperatura normal. Se encontraron 92 casos (44,4%) con síntomas que definen el SEE. Conclusiones: El edificio en el que se desarrolla nuestro estudio cumple los criterios que se establecen en la definición de SEE