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BACKGROUND: Typically, researchers and clinicians determine the agenda in sarcoma research. However, patient involvement can have a meaningful impact on research. Therefore, the Patient-Powered Research Network (PPRN) of the Sarcoma Patient Advocacy Global Network (SPAGN) set up a Priority Setting Partnership (PSP). The primary objective of this partnership is to identify priorities for research and patient advocacy topics. METHODS: In the first phase of this PSP, including 264 sarcoma patients and carers from all over the world, 23 research topics regarding sarcomas and 15 patient advocacy topics were identified using an online survey. In the second phase, participants were asked to fill in a top five and a top three of research and patient advocacy topics, respectively. Additionally, sociodemographic characteristics and sarcoma characteristics were collected. Social media channels, local national patient advocacy groups and the SPAGN website were used to distribute the survey. RESULTS: In total, 671 patients (75%) and carers (25%) participated in this survey. The five highest ranked research topics were related to causes of sarcoma (43%), prognosis and risk of recurrence (40%), specific subtypes of sarcoma (33%), the role of immunotherapy, targeted therapy and combined therapy (30%), and hereditary aspects (30%). The three highest ranked patient advocacy topics were improving the diagnostic process of sarcoma (39%), access to tumor DNA analysis (37%) and establishing an international sarcoma registry (37%). CONCLUSIONS: This sarcoma PSP has identified priorities for research and patient advocacy, offering guidance for researchers, assisting funding agencies with assessing project relevance and empowering patient advocates to represent the needs of patients and carers.
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Cuidadores , Defensa del Paciente , Sarcoma , Humanos , Sarcoma/terapia , Femenino , Masculino , Cuidadores/psicología , Persona de Mediana Edad , Adulto , Encuestas y Cuestionarios , Investigación Biomédica , Anciano , Participación del Paciente , Adulto JovenRESUMEN
INTRODUCTION: There is no generalized consensus regarding perioperative prophylaxis of venous thromboembolism (VTE), either on using or timing it in patients undergoing spine surgery. VTE is a current concern because, even though being an uncommon event, it can cause serious complications. The aim of the present study is to propose guidelines for the prevention of thrombotic events in posterior spinal surgery, either as deep vein thrombosis or pulmonary thromboembolism. If the number of patients getting prophylaxis drugs is reduced a subsequent reduction of the incidence of epidural hematoma can be expected. MATERIALS AND METHODS: A number of 235 patients who had undergone posterior spinal arthrodesis in the previous five years were studied. Mechanical thromboprophylaxis measures consisting of compression stockings were applied in all of them. Anticoagulant drugs were also applied whenever risk factors for thrombosis were observed. Early weight-bearing was resumed immediately after surgery. Demographic, clinical, and surgical variables were collected, as well as complications appearing during the follow-up period, that was scheduled at one, two, four, six and twelve months after the surgery. Thrombotic events, if present, were diagnosed by clinical and imaging tests such as ultrasound and CT angiography. RESULTS: From the total 235 patients of this series, one hundred and fifty-three cases met the study inclusion criteria. A total of four thrombotic events appeared, one in the form of deep vein thrombosis and other three in the form of pulmonary thromboembolism. These last patients suffering an embolism died because of it. None of the variables studied had statistical significance for the occurrence of a thrombotic event. All four patients who suffered thrombotic events were receiving anticoagulant drugs, in addition to mechanical compression stockings, because of the presence of risk factors for thrombosis. CONCLUSIONS: By applying the fore mentioned protocol, adequate prevention of thromboembolic events was achieved in this study population of patients undergoing posterior spinal surgery.
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BACKGROUND: Therapeutic education programs are effective in several chronic conditions. However, evidence is lacking in multiple system atrophy (MSA). We aimed to assess efficacy and safety of a comprehensive therapeutic education program in people with MSA (PwMSA) and their caregivers. METHODS: In this prospective longitudinal study we included 16 PwMSA and their main caregivers in 4 groups of 4 dyads each. The program consisted of eight 60-min interdisciplinary sessions: introduction, orthostatic hypotension, speech therapy, gait and respiratory physiotherapy, psychological support, urinary dysfunction, occupational therapy/social work. UMSARS, NMSS, PDQ39, EQ5 and Zarit scales were administered at baseline and 6 months later. After each session participants filled-out a modified EduPark satisfaction questionnaire and a Likert scale. Educational material was generated for each session after suggestions by participants. RESULTS: At baseline PwMSA and caregivers were comparable in age and sex, with significant correlation between UMSARS-IV (disability) and PDQ39 (quality of life). Adherence to sessions was of 94,92 %. Total modified EduPark scores and Likert scales did not differ in PwMSA vs. caregivers, mild-moderate vs. severe-advanced cases or between genders. The significant difference in satisfaction across sessions (p = 0.03) was driven by higher scores in speech, respiratory and occupational therapy sessions. Longitudinally there was no significant worsening in any scale, nor a significant increase post-vs. pre-program in the number of consultations. CONCLUSIONS: The healthcare education program in MSA was feasible, satisfactory, and safe for patients and caregivers. The educational material of the program is being forwarded to incident MSA cases attending our clinic.
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Cuidadores , Atrofia de Múltiples Sistemas , Calidad de Vida , Sistema de Registros , Humanos , Masculino , Femenino , Atrofia de Múltiples Sistemas/terapia , Atrofia de Múltiples Sistemas/rehabilitación , Persona de Mediana Edad , Estudios Longitudinales , Anciano , Cuidadores/psicología , Cuidadores/educación , Proyectos Piloto , Educación del Paciente como Asunto , Satisfacción del Paciente , Estudios ProspectivosAsunto(s)
Servicio de Urgencia en Hospital , Insuficiencia Cardíaca , Humanos , Servicio de Urgencia en Hospital/estadística & datos numéricos , Insuficiencia Cardíaca/mortalidad , Masculino , Anciano , Femenino , Anciano de 80 o más Años , Enfermedad Aguda , Hospitalización/estadística & datos numéricos , Admisión del Paciente/estadística & datos numéricos , Mortalidad Hospitalaria , Estudios RetrospectivosRESUMEN
Se encontraron 4 revisiones sistemáticas que incluían este tipo de iatrogenia ocular, así como numerosos reportes de casos aislados. Los efectos adversos reportados comprenden: paresias oculomotoras, neuropatía óptica, atrofia óptica, síndromes miasteniformes, pseudo-orbitopatía tiroidea, síndrome del ápex orbitario e hipofisitis. La mayoría se manejaron sin interrupción o con interrupción parcial del tratamiento oncológico. Se requirieron tratamientos sistémicos agresivos para el manejo adecuado de la iatrogenia ocular.Es imprescindible que el oftalmólogo se familiarice con los nuevos tratamientos oncológicos ICI, capaces de provocar iatrogenia sobre la motilidad ocular grave e incapacitante para el paciente. La comunicación de efectos adversos con los tratamientos empleados puede ayudar al manejo más adecuado de estos pacientes. La investigación debe ir orientada al diagnóstico diferencial complejo y a optimizar las decisiones sobre los tratamientos oncológicos. (AU)
Cancer therapy relies on new antitumoral drugs called immune checkpoint inhibitors (ICI), which produce long-lasting anti-tumor responses and lengthen survival, but cause autoimmune-type toxicity. The clinical characteristics induced by ICI are not well characterized to date and careful collection of clinical data is required to accurately define its safety profile.We conducted a literature search in the main clinical search engines to identify pharmacological ocular iatrogenic events of ICIs related to ocular motility. Four systematic reviews were found that included this type of ocular iatrogenesis as well as numerous isolated case reports. Reported adverse effects include: oculomotor paresis, optic neuropathy, optic atrophy, myastheniform syndromes, thyroid pseudo-orbitopathy, orbital apex syndrome, and hypophysitis. Most were managed without interruption or with partial interruption of cancer treatment. Aggressive systemic treatments were required for adequate management of ocular iatrogenic events.It is essential that the ophthalmologist become familiar with the new ICI oncological treatments, capable of causing severe and disabling motilidad ocular iatrogenesis for the patient. The communication of adverse effects and the report of the treatments used can help the most appropriate management of these patients. Research should be oriented towards complex differential diagnosis and to optimize decisions on cancer treatments. (AU)
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Humanos , Diplopía , Oftalmología , Preparaciones Farmacéuticas , Enfermedades del Nervio Óptico , Atrofia ÓpticaRESUMEN
Presbyopia affects between 1.7 and 2 billion people worldwide. Presbyopia significantly impacts productivity and quality of life in both developed and developing countries. During accommodation, the human eye changes its dioptric power by altering the shape of the lens, but the exact nature of this change has not been fully explained. Recently, topical treatments have been marketed for the treatment of presbyopia and others are under investigation. In order to prepare a review of these novel therapies, we searched the major biomedical search engines. We found 15 randomized clinical trials and 12 reviews that met our review criteria. There are two different strategies for this purpose, the pinhole effect that increases depth of focus and "crystalline lens relaxation" for which parasympathetic mimetics and lens oxidation intermediates have been used. The results are generally favorable in terms of improvement of near visual acuity, although the follow-up period of the studies is short. These are novel strategies in the early stages of research that could be useful in the treatment of presbyopia.
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Presbiopía , Presbiopía/tratamiento farmacológico , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Soluciones Oftálmicas/uso terapéutico , Agudeza Visual , CristalinoRESUMEN
El vértigo es un síntoma común que puede tener diversas causas y requerir un enfoque integral para su diagnóstico y tratamiento desde atención primaria. Se propone un algoritmo de diagnóstico basado en la clasificación propuesta por la Comisión de Otoneurología de la SEORL-PCF, que facilita la clasificación de los diferentes tipos de vértigo y proporciona criterios de derivación de pacientes desde atención primaria hacia otras especialidades. Se realiza una revisión de los tratamientos disponibles basada en la causa subyacente para un manejo terapéutico adecuado. Se espera que este documento se convierta en una herramienta valiosa para los profesionales que atienden a pacientes con vértigo. El documento se basa en evidencia científica y en la experiencia de expertos en el campo de las diferentes especialidades médicas implicadas; y busca mejorar la comprensión y el abordaje clínico del vértigo agudo desde atención primaria.(AU)
Vertigo is a common symptom that can have various causes and may require a comprehensive approach for its diagnosis and treatment from primary care. A diagnostic algorithm based on the classification proposed by the Otoneurology Commission of the SEORL-PCF is suggested, which facilitates the classification of the different types of vertigo and provides referral criteria for patients from primary care to other specialties. A review of the available treatments based on the underlying cause is conducted for appropriate therapeutic management. This document is expected to become a valuable tool for professionals treating patients with vertigo. The document is based on scientific evidence and on the experience of experts in the field from various medical specialties; and seeks to improve the understanding and clinical approach to acute vertigo from primary care.(AU)
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Humanos , Masculino , Femenino , Atención Primaria de Salud , Algoritmos , Vértigo/diagnóstico , Vértigo/tratamiento farmacológico , OtolaringologíaRESUMEN
Vertigo is a common symptom that can have various causes and may require a comprehensive approach for its diagnosis and treatment from primary care. A diagnostic algorithm based on the classification proposed by the Otoneurology Commission of the SEORL-PCF is suggested, which facilitates the classification of the different types of vertigo and provides referral criteria for patients from primary care to other specialties. A review of the available treatments based on the underlying cause is conducted for appropriate therapeutic management. This document is expected to become a valuable tool for professionals treating patients with vertigo. The document is based on scientific evidence and on the experience of experts in the field from various medical specialties; and seeks to improve the understanding and clinical approach to acute vertigo from primary care.
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Derivación y Consulta , Vértigo , Humanos , Consenso , Vértigo/diagnóstico , Vértigo/etiología , Vértigo/terapia , Atención Primaria de Salud , AlgoritmosRESUMEN
Cancer therapy relies on new antitumoral drugs called immune checkpoint inhibitors (ICI), which produce long-lasting anti-tumor responses and lengthen survival, but cause autoimmune-type toxicity. The clinical characteristics induced by ICI are not well characterized to date and careful collection of clinical data is required to accurately define its safety profile. We conducted a literature search in the main clinical search engines to identify pharmacological ocular iatrogenic events of ICIs related to ocular motility. Four systematic reviews were found that included this type of ocular iatrogenesis as well as numerous isolated case reports. Reported adverse effects include: oculomotor paresis, optic neuropathy, optic atrophy, myastheniform syndromes, thyroid pseudo-orbitopathy, orbital apex syndrome, and hypophysitis. Most were managed without interruption or with partial interruption of cancer treatment. Aggressive systemic treatments were required for adequate management of ocular iatrogenic events. It is essential that the ophthalmologist become familiar with the new ICI oncological treatments, capable of causing severe and disabling motilidad ocular iatrogenesis for the patient. The communication of adverse effects and the report of the treatments used can help the most appropriate management of these patients. Research should be oriented towards complex differential diagnosis and to optimize decisions on cancer treatments.
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Oftalmopatía de Graves , Atrofia Óptica , Enfermedades del Nervio Óptico , Humanos , Inhibidores de Puntos de Control Inmunológico/efectos adversos , Movimientos Oculares , OjoRESUMEN
Microwave hydrothermal treatment was selected to extract valuable fractions with bioactive and gelling properties from Evernia prunastri lichen with potential for topical applications. The impact of the extraction processing conditions on the soluble extracts, mucilage fraction and residual solid phase was analyzed within a lichen global valorization approach. A particular stress was made on the thermo-rheological and structural characteristics of the extracted glucan and galactomannan polymers, the corresponding gelled matrices, and their cosmetic feasibility. Results revealed that the proposed microwave-assisted treatment showed a relevant influence on the phytochemical features of the aqueous soluble extracts, accounting the major protein content at 120 °C and the enhanced antioxidant and anti-tyrosinase properties at 140 °C. Extracts at 200 °C showed the highest anti-inflammatory (COX-1 and COX-2 inhibition) efficacies. The biopolymer analyses indicated that those recovered after lichen hydrothermal treatment at 160 °C featured a good extraction performance, the highest molecular weight, apparent viscosity, and antiproliferative potential. The thermo-rheological properties of the corresponding matrices formulated at 10 % and 60 or 80 °C exhibited the strongest and most thermo-reversible characteristics, as well as antifreezing feasibility. Another advantage of the selected fractions was the absence of skin irritation according to the in vitro skin irritation assay.
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Líquenes , Parmeliaceae , Líquenes/química , Glucanos , Polímeros/química , GelesRESUMEN
BACKGROUND AND OBJECTIVE: Allergic conjunctivitis is the most common type of ocular allergy. The objective of this study was to evaluate the efficacy of a new once-daily, preservative-free, bilastine 0.6% eye drop formulation for the treatment of allergic conjunctivitis. METHODS: Two double-masked, vehicle controlled, clinical studies (a Phase 2 Dose Ranging Study and a Phase 3 Efficacy Study) were conducted to assess the efficacy of bilastine ophthalmic solution for the treatment of signs and symptoms of allergic conjunctivitis. Both studies used the Ora-CAC® Conjunctival Allergen Challenge (CAC) Model to allow observations of allergic responses under controlled conditions. Each study was analyzed separately and then combined to create an integrated dataset. RESULTS: Efficacy was achieved for the primary efficacy endpoint of ocular itching for three bilastine concentrations (0.2%, 0.4%, and 0.6%) at 15 minutes and 8 hours post-instillation and bilastine 0.6% ophthalmic solution was also efficacious at 16 hours post-instillation. Bilastine 0.6% ophthalmic solution demonstrated non-inferiority to ketotifen 0.025% at the onset of action. From the integrated data set, differences between vehicle and bilastine 0.6% were significant at all time points both at onset (15 minutes) and at a prolonged duration (16 hours) after instillation. CONCLUSION: This multi-trial assessment suggests that bilastine 0.6% ophthalmic solution is efficacious for the treatment of the signs and symptoms of allergic conjunctivitis, with a rapid and prolonged duration of action, and has a favorable safety profile. The added convenience of a once-a-day dosing regimen may contribute to patient adherence and improve their quality of life.
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El Servicio de Indicación Farmacéutica (SIF) es el servicio profesional a través del cual el farmacéutico atiende la consulta de los pacientes sobre un síntoma menor con el fin de obtener un remedio adecuado. Requiere de una actuación protocolizada y conlleva una elevada responsabilidad por parte del farmacéutico. INDICA+PRO es un proyecto realizado desde 2017 para evaluar el impacto y la implantación del SIF en la farmacia comunitaria española. Este artículo evalúa la implantación del SIF en una única farmacia.En la etapa de implantación del SIF a través de INDICA+PRO se detectaron factores de implantación (barreras y facilitadores) para los que se utilizaron una serie de estrategias. Como parte de la implementación se propusieron estrategias como destacar las ventajas del SIF para la farmacia, realizar incentivos por la prestación del servicio o la distribución de tareas dentro del equipo. Entre los facilitadores se encontró la disponibilidad de la zona de atención personalizada, la buena relación con los centros de salud cercanos y la realización de otros servicios profesionales en la farmacia.Las ventajas obtenidas por la realización del SIF obtenidas siguiendo el procedimiento protocolizado, dentro del programa SEFAC eXPERT®, establecido fueron, entre otras, la mejora en el seguimiento del paciente, el incremento en la comunicación del equipo y con el paciente facilitado por el historial farmacoterapéutico de la farmacia y la elaboración de informes estandarizados. (AU)
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Humanos , Servicios Comunitarios de Farmacia/organización & administración , Medicamentos con Supervisión Farmacéutica , Administración FarmacéuticaRESUMEN
Understanding particle deposition in the human lung is crucial for the assessment of environmental pollutants and the design of new drug delivery systems. Traditionally, research has been carried out by experimental analysis, but this generally requires expensive equipment and exposure of volunteers to radiation, resulting in limited data. To overcome these drawbacks, there is an emphasis on the development of numerical models capable of accurate predictive analysis. The most advanced of these computer simulations are based on three-dimensional computational fluid dynamics. Solving the flow equations in a complete, fully resolved lung airway model is currently not feasible due to the computational resources required. In the present work, a simplified lung model is presented and validated for accurate prediction of particle deposition. Simulations are performed for an 8-path approximation to a full lung airway model. A novel boundary condition method is used to ensure accurate results in truncated flow branches. Simulations are performed at a steady inhalation flow rate of 18 l min-1, corresponding to a low activity breathing rate, while the effects of particle size and density are investigated. Comparison of the simulation results with available experimental data shows that reasonably accurate results can be obtained at a small fraction of the cost of a full airway model. The simulations clearly evaluate the effect of both particle size and particle density. Most importantly, the results show an improvement over a previously documented single-path model, both in terms of accuracy and the ability to obtain regional deposition rates. The present model represents an improvement over previously used simplified models, including single-path models. The multi-path reduced airway approach described can be used by researchers for general and patient-specific analyses of particle deposition and for the design of effective drug delivery systems.
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Pruebas Respiratorias , Modelos Biológicos , Humanos , Pulmón , Administración por Inhalación , Simulación por Computador , Tamaño de la Partícula , AerosolesRESUMEN
In the Mediterranean basin, the tick species Hyalomma lusitanicum Koch stands out among other species of the Hyalomma genus due to its wide distribution, and there is great concern about its potential role as a vector and/or reservoir and its continuous expansion to new areas because of climate warming and human and other animal movements. This review aims to consolidate all the information on H. lusitanicum, including taxonomy and evolution, morphological and molecular identification, life cycle, sampling methods, rearing under laboratory conditions, ecology, hosts, geographical distribution, seasonality, vector role and control methods. The availability of adequate data is extremely relevant to the development of appropriate control strategies in areas where this tick is currently distributed as well as in new areas where it could become established in the near future.
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Ixodidae , Garrapatas , Animales , Humanos , ClimaRESUMEN
BACKGROUND: The End TB Strategy calls for the global scale-up of treatment for latent TB infection (LTBI). We aimed to evaluate a nurse-led care programme for LTBI by identifying gaps in the care cascade in a low-incidence TB setting.METHODS: We included people at risk of TB over a 15-year period. We define three main outcomes in the LTBI care cascade: 1) attendance at the first appointment, 2) completion of the evaluation process, and 3) completion of treatment.RESULTS: We identified 6,126 individuals (2,369 TB contacts, 1,749 biological therapy candidates, and 2,008 transplant candidates). Overall, 5,938 (96.9%) attended, 5,872/5,938 (98.9%) completed the evaluation and 1,624/1,847 (87.9%) completed treatment. Pre-biological (aOR 2.32, 95% CI 1.54-3.49) and pre-transplant (aOR 1.82, 95% CI 1.20-2.76) candidates were more likely to attend the first appointment, while age was associated with completing the evaluation process (aOR 1.02, 95% CI 1.003-1.04). Female sex (aOR 1.47, 95% CI 1.08-1.99) was associated with completing the treatment.CONCLUSION: Successful assessment and treatment of LTBI is achievable when delivered as a part of a comprehensive, nurse-led, patient-centred programme in specialist TB clinics.
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Tuberculosis Latente , Tuberculosis , Humanos , Femenino , Tuberculosis Latente/diagnóstico , Tuberculosis Latente/tratamiento farmacológico , Tuberculosis Latente/epidemiología , IncidenciaRESUMEN
Antecedentes y objetivo La simulación en el aprendizaje quirúrgico responde a necesidades éticas y pragmáticas. Nuestro propósito es describir los efectos sobre las habilidades quirúrgicas de la realización de un taller de entrenamiento quirúrgico en cirugía de estrabismo con fantomas. La preocupación por la seguridad del paciente obliga a plantearse el empleo de simuladores (virtuales y físicos tridimensionales) y modelos animales permite al aspirante practicar sin riesgos los procedimientos antes de enfrentarse a un caso real. Material y métodos Realización de un taller con contenido teórico previo y práctica real con fantomas diseñados para simular cirugía de estrabismo (globo ocular, 6 músculos, conjuntiva, párpado y cápsula de Tenon insertados en cráneo) de dimensiones anatómicas reales. Encuesta de satisfacción y evaluación subjetiva de aprendizaje por parte del alumno y del tutor experto según el modelo de evaluación de Kirkpatrick. Resultados Completaron la encuesta 100% de los 26 alumnos asistentes a dos cursos (15 alumnos en un curso y 11 alumnos en otro curso) y 100% de los tres tutores que participaron en ambos cursos; 20 eran médicos residentes y 20 especialistas en oftalmología. La satisfacción global de los alumnos fue de 8,2 (± 0,68). Conclusiones Según los resultados de la encuesta de evaluación de acciones formativas de Kirkpatrick, la percepción de alumnos y tutores es que el entrenamiento con fantomas en cirugía de estrabismo puede ayudar a mejorar las habilidades necesarias para una práctica segura e independiente. Siendo el objetivo último mejorar la seguridad del paciente (AU)
Background and purpose Simulation in surgical learning responds to ethical and pragmatic needs. Our purpose is to describe the effects on surgical skills of conducting a surgical training workshop on strabismus surgery with phantoms. Concern for patient safety makes it necessary to consider the use of simulators (virtual and three-dimensional physical) and animal models that allow the applicant to safely practice the procedures before facing a real case. Material and methods Realization of a workshop with previous theoretical content and real practice with phantoms designed to simulate strabismus surgery (eyeball, six muscles, conjunctiva, eyelid and Tenon capsule inserted in the skull) of real anatomical dimensions. Satisfaction survey and subjective evaluation of learning by the student and the expert tutor according to the Kirkpatrick evaluation model. Results 100% of the 26 students attending two courses (15 students in one course and 11 students in another course) and 100% of the three tutors who participated in both courses completed the survey. Twenty were resident doctors and 20 specialists in ophthalmology. The overall satisfaction of the students was 8.2 (± 0.68). Conclusions According to the results of the Kirkpatrick training actions evaluation survey, the perception of students and tutors is that training with phantoms in strabismus surgery can help improve the skills necessary for safe and independent practice. The ultimate goal being to improve patient safety (AU)
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Humanos , Competencia Clínica , Oftalmología/educación , Estrabismo/cirugía , Estudiantes de Medicina , Entrenamiento Simulado , Simulación de Paciente , Estudios TransversalesRESUMEN
BACKGROUND AND PURPOSE: Simulation in surgical learning responds to ethical and pragmatic needs. Our purpose is to describe the effects on surgical skills of conducting a surgical training workshop on strabismus surgery with phantoms. Concern for patient safety makes it necessary to consider the use of simulators (virtual and three-dimensional physical) and animal models that allow the applicant to safely practice the procedures before facing a real case. MATERIAL AND METHODS: Realization of a workshop with previous theoretical content and real practice with phantoms designed to simulate strabismus surgery (eyeball, 6 muscles, conjunctiva, eyelid and tenon capsule inserted in the skull) of real anatomical dimensions. Satisfaction survey and subjective evaluation of learning by the student and the expert tutor according to the Kirkpatrick evaluation model. RESULTS: Total, 100% of the 26 students attending two courses (15 students in one course and 11 students in another course) and 100% of the 3 tutors who participated in both courses completed the survey. 20 were resident doctors and 20 specialists in ophthalmology. The overall satisfaction of the students was 8.2 (±0.68). CONCLUSIONS: According to the results of the Kirkpatrick training actions evaluation survey, the perception of students and tutors is that training with phantoms in strabismus surgery can help improve the skills necessary for safe and independent practice. The ultimate goal being to improve patient safety.
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Oftalmología , Estrabismo , Estudiantes de Medicina , Humanos , Oftalmología/educación , Competencia Clínica , Estrabismo/cirugíaRESUMEN
BACKGROUND: Bilastine is a second-generation antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. This trial evaluated the efficacy and safety of a new bilastine 0.6% preservative-free eye-drops formulation for the symptomatic treatment of allergic conjunctivitis. METHODS: This phase 3, multicenter, double-masked, randomized study evaluated the efficacy, safety and tolerability of bilastine 0.6% ophthalmic solution compared to ketotifen 0.025% and vehicle. The primary efficacy endpoint was ocular itching reduction. The Ora-CAC® Allergen Challenge Model was used to assess ocular and nasal symptoms at 15 minutes (onset of action) and 16 hours post-treatment. RESULTS: Subjects (N=228) were 59.6% male, and the mean (SD) age was 44.1 (13.4) years. Bilastine demonstrated efficacy in reducing ocular itching compared to vehicle at both onset of action and 16 hours post-treatment (P <0.001). Ketotifen showed improvement compared to vehicle 15 minutes post-treatment (P <0.001). Bilastine demonstrated statistical non-inferiority to ketotifen for all 3 post-CAC timepoints at 15 minutes post-instillation, based on an inferiority margin of 0.4. Bilastine demonstrated improvement over vehicle (P <0.05) for conjunctival redness, ciliary redness, episcleral redness, chemosis, eyelid swelling, tearing, rhinorrhea, ear and palate pruritus and nasal congestion at 15 minutes post-treatment. Ophthalmic bilastine was safe and well tolerated. Mean drop comfort scores were significantly better (P <0.05) for bilastine compared with ketotifen immediately upon instillation, and similar compared with vehicle. CONCLUSIONS: Ophthalmic bilastine effectively reduced ocular itching for 16 hours post-treatment, suggesting that it could be used as a once-daily treatment for the signs and symptoms of allergic conjunctivitis. ClinicalTrials.gov identifier: NCT03479307.
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Background and objectives: Bilastine is a nonsedating second-generation antihistamine for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. Our study aimed to evaluate the optimal dose, efficacy, and safety of a newly developed once-daily preservative-free ophthalmic formulation of bilastine for allergic conjunctivitis. Methods: Our phase 2, single-center, double-masked, randomized trial compared the efficacy of 3 doses of a bilastine ophthalmic formulation (0.2%, 0.4%, and 0.6%) with that of vehicle for the treatment of allergic conjunctivitis. The primary efficacy endpoint was the reduction in ocular itching. The Ora-CAC Conjunctival Allergen Challenge model was used to assess ocular and nasal symptoms at the onset of action (15 minutes) and at 8- and 16-hours after treatment. Tolerance and safety were also evaluated. Results: A total of 121 adults with seasonal and/or perennial ocular allergy were randomized. Bilastine ophthalmic formulations 0.2%, 0.4%, and 0.6% were significantly superior (P>.001) to vehicle for the treatment of ocular itching at 3, 5, and 7 minutes after challenge at onset of action (15 minutes) and at 8 hours after treatment. Bilastine 0.6% was also effective at 16 hours after treatment. Treatment differences for bilastine 0.6% were statistically significant (P<.001) compared to vehicle at all timepoints for tearing, eyelid swelling, and nasal symptoms. No relevant adverse events were observed. Conclusions: All the tested ophthalmic bilastine doses were efficacious for rapid reduction of ocular itching. The 0.6% formulation was effective up to 16 hours after treatment, making it suitable for once-daily administration. The new formulation was safe and well tolerated (AU)