Safety and Efficacy of Oral Fexofenadine in Children with Seasonal Allergic Rhinitis - a Pooled Analysis of Three Studies

Allergic rhinitis is one of the most common clinical conditions in children; however, data regarding the safety of antihistamines in children with seasonal allergic rhinitis are limiting. To evaluate the safety and efficacy of fexofenadine in children with seasonal allergic rhinitis, data were pooled from three, double-blind, randomized, placebo-controlled, parallel-group, 2-week trials in children (6-11 year) with seasonal allergic rhinitis. All studies assessed fexofenadine HCl 30 mg b.i.d.; two studies included fexofenadine HCl at 15 and 60 mg b.i.d. Patients (and investigators) reported any adverse events during the trial. Physical examinations, including measurements of vital signs and laboratory tests, were performed. Efficacy assessments (total symptom score and individual symptom scores) were evaluated. Exposure to fexofenadine HCl 30 mg b.i.d. and to any fexofenadine dose exceeded 10,000 and 17,000 patient days, respectively. Incidences of adverse events, and discontinuations because of adverse events, were low and similar across treatment groups. In the placebo group, 24.4% of subjects reported adverse events compared with 24.1% for fexofenadine HCl 30 mg b.i.d., and 28.4% for all fexofenadine-treated groups. The most common adverse event overall was headache (4.3% placebo; 5.8% fexofenadine HCl 30 mg b.i.d.; and 7.2% any fexofenadine doses). Treatment-related adverse events were similar across treatment groups with no sedative effects. Fexofenadine HCl 30 mg b.i.d. was significantly superior to placebo in reducing the total symptom score and all individual seasonal allergic rhinitis symptoms, including nasal congestion (p < 0.05). Fexofenadine, at doses of up to 60 mg b.i.d., is safe and non-sedating, and fexofenadine HCl 30 mg b.i.d. effectively reduces all seasonal allergic rhinitis symptoms in children aged 6-11 years.

Child anxiety, resiliency, and the FRIENDS for Life program

Anxiety disorders are the most commonly diagnosed group of mental disorders in children (Kessler et al., 2012). Resiliency, defined as a child’s ability to successfully overcome an adverse event (Newland, 2014) is believed to be comprised of protective factors such as self-esteem and positive coping strategies (Rutter, 1987). These protective factors are related to child anxiety in that their presence or absence may augment or hinder a child’s resiliency towards anxiety-provoking events and situations (Lo Casico, Guzzo, & Pace, 2013; Thorne, Andrews, & Nordstokke, 2013). The FRIENDS for Life (FFL) program is a school-based anxiety prevention program which aims to decrease anxiety and increase resiliency in 8- to 11-year-old children (Barrett & Sonderegger, 2003). Previous studies have shown FFL to be an effective tool in decreasing anxiety and increasing resiliency; however, not all previous studies have utilized control or comparison groups (Brownlee et al., 2013; Neil & Christensen 2007; Stopa, Barrett, & Golingi, 2011). Moreover, existing FRIENDS literature has not previously considered the potential role of parent anxiety in child outcomes. The present study aimed to evaluate child anxiety, resiliency, and parent anxiety in relation to the FFL program while including a no-treatment control group. It was hypothesized that child anxiety would decrease and child resiliency would increase following FFL. Results obtained from a non-identified school-based sample were not entirely consistent with predictions, such that decreases in anxiety and increases in resiliency were observed in both the experimental and control groups.

Sternoclavicular Septic Arthritis Caused by Acupuncture over the Posterior Neck

Acupuncture has been used therapeutically for thousands of years and is considered a relatively safe procedure. Sternoclavicular joint (SCJ) arthritis is a rare joint infection and has never been reported as an adverse event of acupuncture. We report the case of a 50-year-old woman who presented with progressive left neck, shoulder and upper chest pain after acupuncture. A computerized tomography (CT) scan revealed septic arthritis over the left sternoclavicular joint (SCJ) and methicillin-sensitive Staphylococcus aureus bacteraemia was noted. The patient was discharged uneventfully after intravenous antibiotic treatment. SCJ septic arthritis should be considered if unilateral neck and upper chest pain occurs after acupuncture.

Vandetanib for the Treatment of Advanced Medullary Thyroid Cancer Outside a Clinical Trial: Results from a French Cohort

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Efficacy and safety of patisiran for familial amyloidotic polyneuropathy: a phase II multi-dose study

BACKGROUND: Transthyretin-mediated amyloidosis is an inherited, progressively debilitating disease caused by mutations in the transthyretin gene. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of patisiran (ALN-TTR02), a small interfering RNA encapsulated within lipid nanoparticles, in patients with transthyretin-mediated familial amyloid polyneuropathy (FAP).

Endoscopic band ligation without resection in selected patients for small and superficial upper gastrointestinal tract lesions

Background and aim: The aim of this study was to evaluate the efficacy of endoscopic band ligation (EBL) in carefully selected patients who would benefit from this method of resection. Methods: Patients with early upper gastrointestinal and small (< 15 mm) lesions treated with EBL (Duette® Multi-Band Mucosectomy) were prospectively recruited and retrospectively analyzed between 2010 and 2015. All cases were discussed in a multidisciplinary cancer committee and it was concluded that, owing to patient conditions, surgery was not possible and that not conducting histology would not change the clinical management. A first endoscopic control with biopsies was planned at 4-8 weeks. If there was no persistence of the lesion, new controls were programmed at 6 and 12 months. Results: The group (n = 12) included 5 esophagus lesions (adenosquamous carcinoma, n = 1; carcinoma squamous, n = 2; adenocarcinoma, n = 2); 4 gastric lesions (high grade dysplasia, n = 1; adenocarcinoma, n = 2; neuroendocrine tumor [NET], n = 1), and 3 duodenal lesions (NETs) (n = 3). The mean tumor diameter was 9.6 ± 2.8 mm (range 4-15). Only one minor adverse event was described. At first follow-up (4-8 weeks), there was 91.6% and 75% of endoscopic and histological remission, respectively. At 6-month follow-up there was 70% of both endoscopic remission and negative biopsies. And at 12 months, there was 100% and 75% of endoscopic and histological remission, respectively. Persisting lesions were T1 cancers. The median follow-up was 30.6 months. Conclusion: EBL without resection is an easy and safe technique that should be considered in patients with multiple morbidities and small superficial UGI lesions.

Impact of a fall prevention program in the Internal Medicine wards of a tertiary care university hospital

Objective: To determine whether a falls prevention program reduces the incidence of falls within a hospital. Materials and methods: Each patient admitted to the Internal Medicine ward was classiied into a risk category (high, medium, low) according to the scale of J.H. Downton, and then various general and speciic measures were applied by risk group. Interventions included appointments, teaching materials, and training of medical staff and family. Furthermore, a registration system was developed that allowed adverse event fe edback to the program and identiicat ion of the causes of the fall. The SPSS version 20.0 was used for the data analysis. Descriptive analysis was used for quantitative variables, and qualitative variables were expressed as proportions. To compare the rate of pre- and post-program implementation falls, x 2 was used, with a  = 0.05 determining a signiicant statistical value. Results: Since the implementation of the program, the rate of falls per 1000 days/patient decreased from 1.9 in 2007 to 0.67 in the period 2008-2013, representing a decrease of the rate of falls of up to 70%, with a statistically signiicant difference (P=.02). Conclusions: The implementation of a falls prevention program is an effective tool and reduces the rate and complications associated with them.

Medición de la cultura de seguridad del paciente en un hospital público de primer nivel en el municipio de Villeta

Esta investigación midió la percepción del personal asistencial sobre la cultura de seguridad de los pacientes en un hospital de primer nivel de complejidad por medio de un estudio descriptivo de corte transversal. Se utilizó como herramienta de medición la encuesta ‘Hospital Survey on Patient Safety Cultura’ (HSOPSC) de la Agency of Healthcare Research and Quality (AHRQ) versión en español, la cual evalúa doce dimensiones. Los resultados mostraron fortalezas como el aprendizaje organizacional, las mejoras continuas y el apoyo de los administradores para la seguridad del paciente. Las dimensiones clasificadas como oportunidades de mejora fueron la cultura no punitiva, el personal, las transferencias y transiciones y el grado en que la comunicación es abierta. Se concluyó que aunque el personal percibía como positivo el proceso de mejoramiento y apoyo de la administración también sentía que era juzgado si reportaba algún evento adverso.

Evaluación de las causas de los eventos adversos o incidentes que afectan la seguridad del paciente, en el hospital central de la policía de enero 2012 a diciembre 2013

TITULO DEL TRABAJO: Evaluación de las causas de los eventos adversos o incidentes que afectan la seguridad del paciente, en el hospital central de la policía de enero 2012 a diciembre 2013. OBJETIVO: Determinar y analizar la causa raíz de los principales factores de riesgo que afectan la seguridad del paciente que puedan ocasionar eventos adversos en la atención de los pacientes, con el uso de la teoría de restricciones TOC en el Hospital Central de la Policía HOCEN. MATERIALES Y METODO: Se realizó una investigación descriptiva de naturaleza mixta – cuantitativa de tipo correlacional, la población es la totalidad de pacientes atendidos en el hospital de la policía entre enero de 2012 a diciembre de 2013, en el cual se presentaron un total de 189 eventos adversos los cuales sirvieron de objeto a esta investigación, la recolección de datos se realizó por medio de tablas de Excel 2010, posterior a esto se exporto la información al software de IBM SPSS Statistics 19 donde se analiza la información arrojando datos descriptivos y tablas de frecuencia. Finalmente haciendo uso de la Teoría de restricciones TOC se identificó la causa raíz para la ocurrencia de eventos adversos y plantear una intervención estratégica que promueva un sistema efectivo de seguridad del paciente en pro de la búsqueda de la mejora continua. RESULTADOS: Se analizaron 189 eventos adversos, de los cuales 89 fueron reportados en el turno de la noche, seguido por el turno de la mañana con 57, el turno tarde con 27, 28 eventos que no registraron horario, el servicio con mayor ocurrencia es el de medicina interna con 25 eventos, y finalmente la caída de pacientes, lo relacionado con medicamentos, nutriciones y accesos vasculares son los eventos con mayor incidencia. CONCLUSIONES: Se pudo concluir que es necesario que los procesos de seguridad del paciente deben tener un lineamiento directo desde la dirección de la organización permitiendo que las mejoras sean de inmediata aplicación, también es importante generar en el personal una actitud de compromiso frente al proceso de mejora, hay que redefinir las políticas institucionales ya que se concluyó por medio de la teoría de restricciones TOC que el principal factor para la ocurrencia de eventos adversos son las multitareas que el personal tiene que realizar en el proceso de atención.

La seguridad del paciente en atención primaria en salud ¿una actividad que podría quedar en el olvido?

Los eventos adversos (EA) están presentes en todos los niveles de atención en salud y deben ser evaluados de manera integral, tanto en los servicios hospitalarios como en el entorno de la Atención Primaria en Salud (APS). Los EA que se presentan en los servicios hospitalarios, son diferentes a los que se presentan en los servicios de Atención Primaria en Salud (APS) y por ello se debe dar un abordaje diferenciado. La seguridad del paciente debe ser una prioridad para todos los sistemas de salud. Desde esta perspectiva se deben identificar cuáles son las herramientas más adecuadas para el reporte, análisis, intervenciones y acciones de mejora, con las que deben contar los programas de seguridad del paciente y la apropiación de conceptos de gestión de riesgo, facilita la identificación y el manejo institucional de situaciones que ponen en peligro la integridad y la vida de los pacientes.

Well-trained, healthy triathletes experience no adverse health risks regarding oxidative stress and DNA damage by participating in an ultra-endurance event

Also physical exercise in general is accepted to be protective, acute and strenuous exercise has been shown to induce oxidative stress. Enhanced formation of free radicals leads to oxidation of macromolecules and to DNA damage. On the other hand ultra-endurance events which require strenuous exercise are very popular and the number of participants is continuously increasing worldwide. Since only few data exists on Ironman triathletes, who are prototypes of ultra-endurance athletes, this study was aimed at assessing the risk of oxidative stress and DNA damage after finishing a triathlon and to predict a possible health risk. Blood samples of 42 male athletes were taken 2 days before, within 20 min after the race, 1, 5 and 19 days post-race. Oxidative stress marker increased only moderately after the race and returned to baseline after 5 days. Marker of DNA damage measured by the SCGE assay with and without restriction enzymes as well as by the sister chromatid exchange assay did either show no change or deceased within the first day after the race. Due to intake during the race and the release by the cells plasma concentrations of vitamin C and α-tocopherol increased after the event and returned to baseline 1 day after. This study indicates that despite a temporary increase in some oxidative stress markers, there is no persistent oxidative stress and no DNA damage in response to an Ironman triathlon in trained athletes, mainly due to an appropriate antioxidant intake and general protective alterations in the antioxidant defence system.

Psychosocial and communication variables involved in mediating the individual experience of older adults following a severe weather event

The recent floods in south-east Queensland have focused policy, academic and community attention on the challenges associated with severe weather events (SWE), specifically pre-disaster preparation, disaster-response and post-disaster community resilience. Financially, the cost of SWE was $9 billion in the 2011 Australian Federal Budget (Swan 2011); psychologically and emotionally, the impact on individual mental health and community wellbeing is also significant but more difficult to quantify. However, recent estimates suggest that as many as one in five will subsequently experience major emotional distress (Bonanno et al. 2010). With climate change predicted to increase the frequency and intensity of a wide range of SWE in Australia (Garnaut 2011; The Climate Institute 2011), there is an urgent and critical need to ensure that the unique psychological and social needs of more vulnerable community members - such as older residents - are better understood and integrated into disaster preparedness and response policy, planning and protocols. Navigating the complex dynamics of SWE can be particularly challenging for older adults and their disaster experience is frequently magnified by a wide array of cumulative and interactive stressors, which intertwine to make them uniquely vulnerable to significant short and long-term adverse effects. This current article provides a brief introduction to the current literature in this area and highlights a gap in the research relating to communication tools during and after severe weather events.

A process mining-based investigation of adverse events in care processes

This paper proposes the Clinical Pathway Analysis Method (CPAM) approach that enables the extraction of valuable organisational and medical information on past clinical pathway executions from the event logs of healthcare information systems. The method deals with the complexity of real-world clinical pathways by introducing a perspective-based segmentation of the date-stamped event log. CPAM enables the clinical pathway analyst to effectively and efficiently acquire a profound insight into the clinical pathways. By comparing the specific medical conditions of patients with the factors used for characterising the different clinical pathway variants, the medical expert can identify the best therapeutic option. Process mining-based analytics enables the acquisition of valuable insights into clinical pathways, based on the complete audit traces of previous clinical pathway instances. Additionally, the methodology is suited to assess guideline compliance and analyse adverse events. Finally, the methodology provides support for eliciting tacit knowledge and providing treatment selection assistance.

Detecting Adverse Events in Clinical Trial Free Text

Thesis (Master's)--University of Washington, 2013