Development and Validation of a Laryngeal Microsurgery Simulation Training System for Otolaryngology Residents.

OBJECTIVE: This study aims to create a synthetic laryngeal microsurgery simulation model and training program; to assess its face, content, and construct validity; and to review the available phonomicrosurgery simulation models in the literature. STUDY DESIGN: Nonrandomly assigned control study. SETTING: Simulation training course for the otolaryngology residency program at Pontificia Universidad Católica de Chile. METHODS: Resident (postgraduate year 1 [PGY1]/PGY2) and expert groups were recruited. A laryngeal microsurgery synthetic model was developed. Nine tasks were designed and assessed through a set of programmed exercises with increasing difficulty, to fulfill 5 surgical competencies. Imperial College Surgical Assessment Device sensors applied to the participants' hands measured time and movements. The activities were video-recorded and blindly assessed by 2 laryngologists using a specific and global rating scale (SRS and GRS). A 5-point Likert survey assessing validity was completed by experts. RESULTS: Eighteen participants were recruited (14 residents and 4 experts). Experts performed significantly better than residents in the SRS (p = .003), and GRS (p = .004). Internal consistency was demonstrated for the SRS (α = .972, p < .001). Experts had a shorter execution time (p = .007), and path length with the right hand (p = .04). The left hand did not show significant differences. The survey assessing validity resulted in a median 36 out of 40 points score for face validity; and 43 out of 45 points score, for global content validity. The literature review revealed 20 available phonomicrosurgery simulation models, only 6 with construct validity. CONCLUSION: The face, content, and construct validity of the laryngeal microsurgery simulation training program were established. It could be replicated and incorporated into residents' curricula.

Intratympanic gentamicin compared with placebo for Ménière's disease. / Gentamicina intratimpánica comparado con placebo para la enfermedad de Ménière.

INTRODUCTION: Ménière's disease is a multifactorial disorder affecting the inner ear, characterized by episodes of spontaneous and recurrent vertigo, fluctuating hearing loss and tinnitus. Intratympanic gentamicin therapy has been used to reduce the intensity and frequency of attacks in intractable Ménière's disease, but it is associated with hearing loss. There is controversy regarding its efficacy and safety. METHODS: We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified 13 systematic reviews that included 80 primary studies overall, of which three correspond to randomized trials. We concluded that intratympanic gentamicin may improve the control of vertigo, and result in little or no difference to tinnitus, but the certainty of the evidence is low. Furthermore, we are uncertain whether intratympanic gentamicin reduces hearing or the frequency of vertigo attacks as the certainty of the evidence has been assessed as very low.

INTRODUCCION: La enfermedad de Ménière es una anomalía del oído interno de etiología multifactorial, caracterizada por episodios de vértigo espontáneo y recurrente, hipoacusia fluctuante y tinnitus. La terapia con gentamicina intratimpánica para la enfermedad de Ménière ha sido utilizada buscando reducir la intensidad y frecuencia de las crisis, pero se ha asociado a pérdida auditiva, por lo que existe controversia respecto a su eficacia y seguridad. MÉTODOS: Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos 13 revisiones sistemáticas que en conjunto incluyeron 80 estudios primarios, de los cuales tres corresponden a ensayos aleatorizados. Concluimos que la gentamicina intratimpánica podría reducir el control del vértigo y resultar en poca o nula diferencia sobre el tinnitus, pero la certeza de evidencia es baja. Además, no es posible establecer con claridad si el uso de gentamicina intratimpánica disminuye la audición o la frecuencia de los ataques de vértigo porque la certeza de la evidencia existente ha sido evaluada como muy baja.

Gentamicina intratimpánica comparado con placebo para la enfermedad de Ménière / Intratympanic gentamicin compared with placebo for Ménière's disease

INTRODUCCION La enfermedad de Ménière es una anomalía del oído interno de etiología multifactorial, caracterizada por episodios de vértigo espontáneo y recurrente, hipoacusia fluctuante y tinnitus. La terapia con gentamicina intratimpánica para la enfermedad de Ménière ha sido utilizada buscando reducir la intensidad y frecuencia de las crisis, pero se ha asociado a pérdida auditiva, por lo que existe controversia respecto a su eficacia y seguridad. MÉTODOS Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES Identificamos 13 revisiones sistemáticas que en conjunto incluyeron 80 estudios primarios, de los cuales tres corresponden a ensayos aleatorizados. Concluimos que la gentamicina intratimpánica podría reducir el control del vértigo y resultar en poca o nula diferencia sobre el tinnitus, pero la certeza de evidencia es baja. Además, no es posible establecer con claridad si el uso de gentamicina intratimpánica disminuye la audición o la frecuencia de los ataques de vértigo porque la certeza de la evidencia existente ha sido evaluada como muy baja.

INTRODUCTION Ménière's disease is a multifactorial disorder affecting the inner ear, characterized by episodes of spontaneous and recurrent vertigo, fluctuating hearing loss and tinnitus. Intratympanic gentamicin therapy has been used to reduce the intensity and frequency of attacks in intractable Ménière's disease, but it is associated with hearing loss. There is controversy regarding its efficacy and safety. METHODS We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS We identified 13 systematic reviews that included 80 primary studies overall, of which three correspond to randomized trials. We concluded that intratympanic gentamicin may improve the control of vertigo, and result in little or no difference to tinnitus, but the certainty of the evidence is low. Furthermore, we are uncertain whether intratympanic gentamicin reduces hearing or the frequency of vertigo attacks as the certainty of the evidence has been assessed as very low.

Topical tranexamic acid for spontaneous epistaxis. / Ácido tranexámico tópico para la epistaxis espontánea.

INTRODUCTION: Spontaneous epistaxis is one of the most frequent problems in emergency services. New treatment alternatives have emerged, including topical tranexamic acid. However, there is controversy about the actual efficacy of this alternative. METHODS: We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified five systematic reviews that analyzed only one primary study, corresponding to a randomized trial. We concluded it is not clear whether topical tranexamic acid has any impact on hemostasis or risk of rebleeding because the certainty of the evidence is very low. On the other hand, its use could increase adverse effects.

INTRODUCCIÓN: La epistaxis espontánea es uno de los problemas más frecuentes en consultas de urgencia. Existen nuevas alternativas de tratamiento, entre las que se encuentra el ácido tranexámico tópico. Sin embargo, su rol en el manejo de la epistaxis espontánea sigue siendo poco claro, existiendo controversia en cuanto a su efectividad y seguridad. MÉTODOS: Realizamos una búsqueda en Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante el cribado de múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, analizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos cinco revisiones sistemáticas que en conjunto incluyeron un estudio primario, el cual corresponde a un ensayo aleatorizado. Concluimos que no está claro si el uso de ácido tranexámico tópico impacta en hemostasia o resangrado porque la certeza de la evidencia es muy baja, además su uso podría aumentar los efectos adversos.