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.

Revisión sistemática de la literatura de las intervenciones diseñadas para el comportamiento de automedicación no responsable

La automedicación no responsable se ha convertido en un problema de salud pública global en las últimas décadas, por sus consecuencias individuales (por ejemplo, la intoxicación) y colectivas (por ejemplo, la resistencia microbiana a los antibióticos). Las intervenciones orientadas a este comportamiento han sido aisladas y muy diferentes. Aunque se tiene evidencia de que su aplicación puede traer beneficios en diferentes poblaciones, no se halló en la literatura una compilación sistemática de dichas intervenciones. El objetivo de la presente revisión es sistematizar la literatura científica sobre las diferentes alternativas de intervención del comportamiento individual de automedicación no responsable. En cuanto al método, la revisión de literatura involucró la búsqueda sistemática de “automedicación” e “intervención” en las bases de datos académicas internacionales con contenidos de psicología, suscritas por la Biblioteca de la Universidad del Rosario. Como resultado se encontró que las intervenciones orientadas al comportamiento de automedicación no responsable se pueden clasificar en dos grandes grupos: (a) intervenciones regulatorias, con dirección “arriba hacia abajo”, que suponen una acción de los Estados nacionales por medio de sus legislaciones o de entidades internacionales (por ejemplo, Organización Mundial de la Salud); y (b) intervenciones educativas, con dirección “abajo hacia arriba”, que suponen acciones con individuos y comunidades con el fin de enseñar acerca del uso adecuado de los medicamentos. Se concluye acerca de la necesidad de complementar ambos tipos de intervención, los cuales, si bien demuestran resultados positivos, aisladamente son insuficientes para contrarrestar integralmente este fenómeno creciente y complejo.

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.

Assessing and Reporting the Adverse Effects of Antipsychotic Medication: A Systematic Review of Clinical Studies, and Prospective, Retrospective, and Cross-Sectional Research

Objective: Adverse effects (AEs) of antipsychotic medication have important implications for patients and prescribers in terms of wellbeing, treatment adherence and quality of life. This review summarises strategies for collecting and reporting AE data across a representative literature sample to ascertain their rigour and comprehensiveness. Methods: A PsycINFO search, following PRISMA Statement guidelines, was conducted in English-language journals (1980–July 2014) using the following search string: (antipsychotic* OR neuroleptic*) AND (subjective effect OR subjective experience OR subjective response OR subjective mental alterations OR subjective tolerability OR subjective wellbeing OR patient perspective OR self-rated effects OR adverse effects OR side-effects). Of 7,825 articles, 384 were retained that reported quantified results for AEs of typical or atypical antipsychotics amongst transdiagnostic adult, adolescent, and child populations. Information extracted included: types of AEs reported; how AEs were assessed; assessment duration; assessment of the global impact of antipsychotic consumption on wellbeing; and conflict of interest due to industry sponsorship. Results: Neurological, metabolic, and sedation-related cognitive effects were reported most systematically relative to affective, anticholinergic, autonomic, cutaneous, hormonal, miscellaneous, and non-sedative cognitive effects. The impact of AEs on patient wellbeing was poorly assessed. Cross-sectional and prospective research designs yielded more comprehensive data about AE severity and prevalence than clinical or observational retrospective studies. 3 Conclusions: AE detection and classification can be improved through the use of standardised assessment instruments and consideration of subjective patient impact. Observational research can supplement information from clinical trials to improve the ecological validity of AE data.

Medication incidents in primary care medicine: protocol of a study by the Swiss Federal Sentinel Reporting System.

BACKGROUND/RATIONALE: Patient safety is a major concern in healthcare systems worldwide. Although most safety research has been conducted in the inpatient setting, evidence indicates that medical errors and adverse events are a threat to patients in the primary care setting as well. Since information about the frequency and outcomes of safety incidents in primary care is required, the goals of this study are to describe the type, frequency, seasonal and regional distribution of medication incidents in primary care in Switzerland and to elucidate possible risk factors for medication incidents. Label="METHODS AND ANALYSIS" ="METHODS"/> <AbstractText STUDY DESIGN AND SETTING: We will conduct a prospective surveillance study to identify cases of medication incidents among primary care patients in Switzerland over the course of the year 2015. PARTICIPANTS: Patients undergoing drug treatment by 167 general practitioners or paediatricians reporting to the Swiss Federal Sentinel Reporting System. INCLUSION CRITERIA: Any erroneous event, as defined by the physician, related to the medication process and interfering with normal treatment course. EXCLUSION CRITERIA: Lack of treatment effect, adverse drug reactions or drug-drug or drug-disease interactions without detectable treatment error. PRIMARY OUTCOME: Medication incidents. RISK FACTORS: Age, gender, polymedication, morbidity, care dependency, hospitalisation. STATISTICAL ANALYSIS: Descriptive statistics to assess type, frequency, seasonal and regional distribution of medication incidents and logistic regression to assess their association with potential risk factors. Estimated sample size: 500 medication incidents. LIMITATIONS: We will take into account under-reporting and selective reporting among others as potential sources of bias or imprecision when interpreting the results. ETHICS AND DISSEMINATION: No formal request was necessary because of fully anonymised data. The results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT0229537.

Surveillance for adverse events after DTwP/Hib vaccination in Brazil: Sensitivity and factors associated with reporting

We estimated the sensitivity, i.e., the proportion of all cases of adverse events following immunization (AEFIs) reported to the Brazilian passive surveillance for adverse events following immunization (PSAEFI) with the diphtheria-tetanus-whole-cell pertussis-Haemophilus influenzae type b (DTwP/Hib) vaccine, as well as investigating factors associated with AEFIs reporting. During 2003-2004, 8303 AEFIs associated with DTwP-Hib were reported; hypotonic-hyporesponsive episodes (HHEs), fever and convulsions being the most common. Cure without sequel was achieved in 98.4% of the cases. The mean sensitivity of the PSAEFI was 22.3% and 31.6%, respectively, for HHE and convulsions, varying widely among states. Reporting rates correlated positively with the Human Development Index and coverage of adequate prenatal care, correlating negatively with infant mortality rates. Quality of life indicators and the degree of organization of health services are associated with greater PSAEFI sensitivity. In addition to consistently describing the principal AEFIs, PSAEFI showed the DTwP/Hib vaccine to be safe and allayed public fears related to its use. (C) 2010 Elsevier Ltd. All rights reserved.

Impact of educational interventions on adverse drug events reporting

Spontaneous adverse drug events (ADE) reporting is the main source of data for assessing the risk/benefit of drugs available in the pharmaceutical market. However, its major limitation is underreporting, which hinders and delays the signal detection by Pharmacovigilance (PhV). To identify the techniques of educational intervention (EI) for promotion of PhV by health professionals and to assess their impact. A systematic review was performed in the PUBMED, PAHO, LILACS and EMBASE databases, from November/2011 to January/2012, updated in March/2013. The strategy search included the use of health descriptors and a manual search in the references cited by selected papers. 101 articles were identified, of which 16 met the inclusion criteria. Most of these studies (10) were conducted in European hospitals and physicians were the health professionals subjected to most EI (12), these studies lasted from one month to two years. EI with multifaceted techniques raised the absolute number, the rate of reporting related to adverse drug reactions (ADR), technical defects of health technologies, and also promoted an improvement in the quality of reports, since there was increased reporting of ADR classified as serious, unexpected, related to new drugs and with high degree of causality. Multifaceted educational interventions for multidisciplinary health teams working at all healthcare levels, with sufficient duration to reach all professionals who act in the institution, including issues related to medication errors and therapeutic ineffectiveness, must be validated, with the aim of standardizing the Good Practice of PhV and improve drug safety indicators.

Ascertainment, meta-analysis and reporting of adverse reactions in clinical trials of antibiotics

The ascertainment and analysis of adverse reactions to investigational agents presents a significant challenge because of the infrequency of these events, their subjective nature and the low priority of safety evaluations in many clinical trials. A one year review of antibiotic trials published in medical journals demonstrates the lack of standards in identifying and reporting these potentially fatal conditions. This review also illustrates the low probability of observing and detecting rare events in typical clinical trials which include fewer than 300 subjects. Uniform standards for ascertainment and reporting are suggested which include operational definitions of study subjects. Meta-analysis of selected antibiotic trials using multivariate regression analysis indicates that meaningful conclusions may be drawn from data from multiple studies which are pooled in a scientifically rigorous manner. ^