Systematic review of gender bias in vortioxetine clinical trials.

This paper evaluates gender bias in the published clinical trials of Vortioxetine. We conducted a systematic review of controlled clinical trials of Vortioxetine for the treatment of depression. The literature search was performed using MEDLINE and following the corresponding international recommendations. We identified 42 articles, of which 23 were included. The proportion of women ranged from 47%-75% and the percentage of women included in the 10,404 total patients sample was 65%. The separate analysis of the main variable between the subpopulations of men and women was only carried out in 3/23 publications included. In contrast, 6/23 trials analyzed secondary variables separated by sex. No trials discussed the results separately by sex. The proportion of women included was slightly higher than that in clinical trials of other antidepressants. However, the analysis of the main result or secondary variables by sex, as well as discussing the results separately by sex, are scarce. This gives rise to gender bias in these works.

Systematic Review of Gender Bias in the Clinical Trials of New Long-Acting Antipsychotic Drugs.

PURPOSE/BACKGROUND: This article evaluates gender bias in the published clinical trials of new long-acting antipsychotics. METHODS/PROCEDURES: We conducted a review of controlled clinical trials of the new prolonged-release antipsychotics (aripiprazole, risperidone, or paliperidone) for the treatment of schizophrenia published in MEDLINE over the last 10 years and available in full text in English. The study followed the corresponding international recommendations. RESULTS: We identified 132 trials, and of these, 40 met the inclusion and exclusion criteria. We found that only 36.41% of the total patients were women. The separate analysis of the main variable between the subpopulations of men and women was carried out in only 6 of the 40 works included. In contrast, in 15 trials, this analysis was performed on secondary variables, generally related to safety. Only 3 of the 40 trials discussed the results separately according to sex. CONCLUSIONS: The clinical trials of long-acting atypical antipsychotic drugs show a far-from-negligible gender bias. Women are underrepresented, and the main and secondary variables are not analyzed separately according to gender. This is despite international recommendations establishing these criteria as part of a package of minimum requirements for meeting scientific validity and making results apt to extrapolate to the general population of patients.

Motivaciones y experiencias emocionales del primer equipo multidisciplinario hospitalario entrenado para atender casos de Ébola en Andalucía (2014-2016) / Motivations and emotional experiences of the first hospital multidisciplinary team trained to care for people with Ebola in Andalusia, Spain (2014-2016)

Objetivo: El Hospital Universitario Virgen del Rocío (HUVR) de Sevilla fue elegido centro referente andaluz para atender posibles casos de contagio de Ébola. Tras la alerta sanitaria (OMS, 2014) se conformó un equipo de profesionales voluntarios sanitarios/as y no sanitarios/as, que recibió entrenamiento y atendió un posible caso. Se plantea como objetivo comprender sus motivaciones y experiencias emocionales, e identificar los elementos que facilitan y dificultan su funcionamiento. Método: Estudio cualitativo, interpretativo y fenomenológico. Unidad de observación: equipo de profesionales del HUVR entrenado para atender casos de Ébola. Unidades de análisis: trabajo en equipo, motivaciones, emociones. Se realizan tres entrevistas a informantes clave y tres grupos de discusión; participan 23 profesionales de 60 que integran el equipo (2014-2016). Se analizan con QSRNUDISTVivo10 (análisis de contenido) las categorías: motivaciones, emociones, elementos influyentes en el funcionamiento. Validez: se triangularon fuentes de datos, técnicas, perspectivas disciplinarias y se expusieron los resultados al equipo de profesionales, que mostró su acuerdo. Resultados: Perciben interés formativo, responsabilidad profesional, autoestima profesional, atracción por el riesgo o lealtad al líder como motivaciones para ofrecerse voluntariamente. Expresan su evolución emocional, del miedo y estrés original al autocontrol de la presión, tranquilidad y confianza, a través de la formación y cohesión del equipo, elementos esenciales para su funcionamiento. La familia, el servicio de origen, los recursos, los medios de comunicación y la gestión de las emociones influyen, facilitando o entorpeciendo el éxito del equipo. Conclusión: Conocer los factores que les motivan e influyen puede servir para orientar la gestión de equipos multidisciplinarios eficaces y satisfechos en casos de alertas sanitarias (AU)

Objective: The Hospital Universitario Virgen del Rocío (HUVR) of Seville was chosen as the reference Andalusian site to treat possible cases of Ebola. After the health alert (WHO, 2014), a voluntary group of healthcare and non-healthcare professionals was set up, which, after being trained, treated a possible case. In this light, the aim is to understand the motivations and emotional experiences of this group and to identify the facilitators of and obstacles to its operation. Method: Qualitative, interpretative and phenomenological study. Observation unit: professional team of the HUVR trained to treat Ebola cases. Analysis units: teamwork, motivations and emotions. Three interviews with key informants were conducted, as well as three discussion groups involving 23 of the 60 team members (2014-2016). A content analysis of the motivations, emotions and elements affecting the team's operation was conducted with QSRNUDISTVivo10. Validity: data sources, techniques and disciplinary perspectives were triangulated. The results were presented to the team, which duly agreed with the findings. Results: Training, professional responsibility, professional self-esteem, risk appetite or loyalty to the leader stood out as motivations to voluntarily join the team. Emotional experiences evolved from fear and stress to self-pressure control, while essential elements for the team's operation were found to be calmness and confidence based on training and teamwork. Family, source department, resources, communication media and emotional management were facilitators of or obstacles to the team's success. Conclusion: An understanding of the key motivational and influential factors may be important in the management of effective and successful multidisciplinary teams during health alerts (AU)

[Motivations and emotional experiences of the first hospital multidisciplinary team trained to care for people with Ebola in Andalusia, Spain (2014-2016)]. / Motivaciones y experiencias emocionales del primer equipo multidisciplinario hospitalario entrenado para atender casos de Ébola en Andalucía (2014-2016).

OBJECTIVE: The Hospital Universitario Virgen del Rocío (HUVR) of Seville was chosen as the reference Andalusian site to treat possible cases of Ebola. After the health alert (WHO, 2014), a voluntary group of healthcare and non-healthcare professionals was set up, which, after being trained, treated a possible case. In this light, the aim is to understand the motivations and emotional experiences of this group and to identify the facilitators of and obstacles to its operation. METHOD: Qualitative, interpretative and phenomenological study. Observation unit: professional team of the HUVR trained to treat Ebola cases. Analysis units: teamwork, motivations and emotions. Three interviews with key informants were conducted, as well as three discussion groups involving 23 of the 60 team members (2014-2016). A content analysis of the motivations, emotions and elements affecting the team's operation was conducted with QSRNUDISTVivo10. VALIDITY: data sources, techniques and disciplinary perspectives were triangulated. The results were presented to the team, which duly agreed with the findings. RESULTS: Training, professional responsibility, professional self-esteem, risk appetite or loyalty to the leader stood out as motivations to voluntarily join the team. Emotional experiences evolved from fear and stress to self-pressure control, while essential elements for the team's operation were found to be calmness and confidence based on training and teamwork. Family, source department, resources, communication media and emotional management were facilitators of or obstacles to the team's success. CONCLUSION: An understanding of the key motivational and influential factors may be important in the management of effective and successful multidisciplinary teams during health alerts.