Observational Study to Compare Biological Drug Concentration Quantification Techniques and Immunogenicity in Patients with Immune-Mediated Diseases.

Measuring biological drugs' trough concentrations and the concentrations of anti-drug antibodies is a valuable practice for treatment optimization. ELISA techniques are the gold standard for biological drug concentration quantification, but new techniques such as chemiluminescence immunoassays present some advantages. The aim of this unicentric prospective observational study is to compare the infliximab, adalimumab, vedolizumab and ustekinumab trough levels and anti-adalimumab and anti-infliximab antibodies concentrations obtained when using a chemiluminescent instrument (i-TRACK®, Theradiag, Croissy-Beaubourg, France) and an ELISA instrument (TRITURUS®, Griffols, Barcelona, Spain). Linear regression, Pearson or Spearman tests, Bland-Altman plots and the Cohen kappa test were applied for every sample. The correlation was excellent for both assays in the measurement of all drug concentrations. In general, values were lower when measured using i-TRACK than when using TRITURUS, especially when the values were high. Both techniques proved valuable in clinical practice for monitoring adalimumab and infliximab drug concentration. However, the results were modest for ustekinumab and vedolizumab, so caution is recommended and further research is needed. The limited number of anti-drug antibody-positive samples precluded a comparison between the techniques.

The cardiovascular polypill as baseline treatment improves lipid profile and blood pressure regardless of body mass index in patients with cardiovascular disease. The Bacus study.

BACKGROUND: Pharmacological treatment with lipid-lowering and antihypertensive drugs has been proposed as a strategy to improve excess cardiovascular (CV) risk among obese individuals. The present study aimed to assess whether the CV polypill (Sincronium®) could be an effective strategy to help improve CV risk factor control in obese/overweight individuals requiring secondary prevention. METHODS: This was an observational, retrospective study reviewing the hospital medical records of 479 patients with established CV disease who initiated treatment with the CV polypill between 2013 and 2019 at a general hospital in Mexico. Patients were grouped as normal weight, overweight or obese according to their initial body mass index (BMI). We collected blood pressure (BP), lipid profile, and vascular age at the last visit recorded during the period following treatment. RESULTS: At the end of the study, all assessed lipid parameters improved compared to baseline regardless of the initial BMI category (all p<0.001). There was an increase from baseline regarding the proportion of patients with at target low-density lipoprotein cholesterol after treatment (2.3% vs. 30.1%; p<0.001), more than 80% of patients achieved triglyceride levels <200 mg/dL (p<0.001), and more than 80% achieved target BP levels in all BMI subgroups (p<0.001). The subanalyses in the elderly population yielded similar results, with a significant overall improvement in lipid and BP control after initiating the CV polypill strategy. CONCLUSIONS: The use of the CV polypill as baseline therapy for secondary prevention seems to be a reasonable strategy that enhances CV risk factor control regardless of the patient's BMI.

European Union Cohesion Policy: Socio-Economic Vulnerability of the Regions and the COVID-19 Shock.

The European Union Cohesion Policy for the period 2021-2027 focuses on five goals to make the European Union smarter, greener, more connected, more social and closer to citizens. However, a macroeconomic index is proposed as the predominant criterion for allocating the Structural Funds among regions. In this paper, we hypothesise that it is possible to take into account new, complementary criteria that better reflect citizens' quality of life. To that end, we build a composite index of socio-economic vulnerability for the 233 regions. The results show that following our multidimensional approach for allocating the Structural Funds, there are remarkable differences in the maps of priority regions. In addition, the COVID-19 pandemic represents a threat to well-being. Are all regions equally exposed to COVID-19 in terms of their socio-economic vulnerability? To address this issue, we estimate multilevel models which indicate that country characteristics interact with regions' characteristics to alter patterns of vulnerability. More specifically, increases in government expenditures in education and an improvement in political stability would reduce the regional vulnerability or foster the capacity for resilience, whereas increases in poverty would be associated with greater vulnerability. Likewise, more vulnerable regions would be the most exposed to the negative socio-economic effects of COVID-19. However, it is remarkable that several regions of Sweden and Finland would be among the group of regions whose socio-economic vulnerability would be the most negatively affected.

Evaluation of a Telemedicine pharmaceutical care program for coordination patient's transfer between hospital and primary care, using Telepharmacy.

OBJECTIVE: To report our experience with Telemedicine projects: a Telepharmacy Hospital Pharmacy/Primary Care Pharmacy Coordination Program and a Hospital Pharmacy/Primary Care Pharmacy  Electronic Cross-consultation Program. Results are reported in terms of  medication adherence, perceived quality and satisfaction, and economic  impact. METHOD: A) Telepharmacy Hospital Pharmacy/Primary Care Pharmacy Coordination Program: Phases of development: 1) Creation of a  work group; 2) definition of patient inclusion criteria; 3) selection of medicines; 4) integration of hospital and primary care pharmaceutical care; 5)  setting up of facilities in primary care; 6) logistics design; 7) creation of the Telemedicine system; 8) provision of training to primary care pharmacists; 9) establishment of a pharmaceutical care protocol; 10) obtaining patient informed consent. Medication adherence was evaluated using  dispensing records. Results were assessed based on a quality questionnaire.  Pharmacist evaluation was performed using a satisfaction questionnaire. The economic impact of the programs was assessed from patient's perspective from the estimated 1-year avoided direct costs of traveling from home to the  hospital. B) Webbased cross-consultation system: mining was performed of  web data from August 2018-June 2019. Analyzed items: hospital pharmacoterapeutic area, reasons, and results of consultation in primary and  hospital care. RESULTS: A) Telepharmacy Hospital Pharmacy / Primary Care Pharmacy Coordination Program: sample: 51 patients, 58% male. Mean  age  62.8 ± 18.0 years. 83.0% were pensioners; 69% were involved in an enteral  nutrition program. Baseline and post-intervention medication adherence, 95.82  ± 8.03 vs 85.23 ± 23.02 (p = 0.007). Patients  took 3.3 ± 1.4 hours to travel to the hospital; all patients assumed traveling costs. Average avoided cost per patient per year, €76.08 ± 38.77.  Average score on the satisfaction questionnaire, 9.4 ± 1.3 over 10. The most valued items were work/family reconciliation and cost savings. No items were identified as negative in the program. Pharmacist satisfaction was 9.0 ± 1.2 over 10. B) Electronic cross-consultation program: 458  consultations, 190 from secondary to primary care, and 268 from primary to secondary care. CONCLUSIONS: The Telemedicine programs enabled coordination of drug therapy monitoring between the hospital and the primary care pharmacy. Patients and professionals reported a high level of satisfaction with  the Telepharmacy Hospital Pharmacy/Primary Care Pharmacy Coordination Program, which had a very positive economic impact. Finally, the  two Telepharmacy programs integrate humanization strategies.

OBJETIVO: Analizar estrategias de Telemedicina y colaboración entre atención  primaria y atención hospitalaria: programa de Telefarmacia de Coordinación  entre los Equipos Asistenciales de Farmacia Hospitalaria y Atención Primaria y  la plataforma e-interconsulta. Describir la implantación del programa  Telefarmacia de Coordinación entre los Equipos Asistenciales de Farmacia  Hospitalaria y Atención Primaria y evaluar los resultados sobre adherencia  terapéutica, calidad percibida y satisfacción y económicos, así como las e- interconsultas realizadas entre atención hospitalaria y atención primaria.Método: A) Telefarmacia de Coordinación entre los Equipos Asistenciales de  Farmacia Hospitalaria y Atención Primaria: fases de implantación: 1) creación  del grupo de trabajo; 2) establecimiento de criterios de inclusión de pacientes;  3) selección de medicamentos; 4) integración de la documentación de la  atención farmacéutica; 5) acondicionamiento hospide la consulta de atención  primaria; 6) diseño logístico; 7) creación del sistema de Telemedicina; 8)  formación a farmacéuticos de atención primaria; 9) protocolización de la  atención farmacéutica; 10) información al paciente y consentimiento  informado. La adherencia se evaluó por registro de dispensaciones. Evaluación  de los resultados mediante cuestionario de calidad percibida. Evaluación por  farmacéuticos mediante encuesta de satisfacción. Análisis del impacto  económico según costes directos estimados de los desplazamientos evitados  desde el domicilio hasta el hospital durante un año. B) Plataforma e- interconsulta: explotación de los datos de la plataforma web de agosto de  2018 a junio de 2019. Se analizó: área farmacoterapéutica en atención  hospitalaria, motivos y resultados de las mismas en atención primaria y  atención hospitalaria. RESULTADOS: A) Telefarmacia de Coordinación entre los Equipos Asistenciales de Farmacia Hospitalaria y Atención Primaria: 51 pacientes incluidos, 58% varones. 62,8 ± 18,0 años de media de edad. 83,0% pensionistas; 69% adscritos al programa de nutrición enteral  domiciliaria. Adherencia previa y tras la implantación del programa: 95,82 ±  8,03 versus 85,23 ± 23,02 (p = 0,007). Los pacientes emplearon una media de 3,3 ± 1,4 horas en el desplazamiento al servicio de farmacia del hospital; el 100% asumió el gasto de los desplazamientos. Coste medio evitado por paciente/año: 76,08 ± 38,77 €. Media de valoración de la encuesta de satisfacción: 9,4 ± 1,3 sobre 10. Resultado de la encuesta de  satisfacción a farmacéuticos: 9,0 ± 1,2. B) Plataforma e-interconsulta: 458  consultas realizadas: 190 desde atención hospitalaria a atención primaria, y  268 desde atención primaria a atención hospitalaria. CONCLUSIONES: Estos programas de Telemedicina permiten un seguimiento farmacoterapéutico coordinado del paciente externo entre  farmacia hospitalaria y atención primaria. El programa Telefarmacia de Coordinación entre los Equipos Asistenciales de Farmacia Hospitalaria y  Atención Primaria cuenta con una alta valoración de calidad percibida por  pacientes y farmacéuticos y un elevado impacto económico para el paciente.  Ambos proyectos integran estrategias de humanización que facilitan  proporcionar una atención farmacéutica más cercana al paciente, evitándole  desplazamientos innecesarios al hospital.

Trends in Reproductive Indicators of Green and Hawksbill Sea Turtles over a 30-Year Monitoring Period in the Southern Gulf of Mexico and Their Conservation Implications.

Long-term monitoring programs of species at risk are efficacious tools to assess population changes, evaluate conservation strategies, and improve management practices to ensure populations reach levels at which they can fulfill their ecological roles. For sea turtles, annual nesting beach surveys are the most accessible method to estimating the population abundance and reproductive output, especially when these are done in primary nesting sites. However, little data exist on the long-term assessment of these parameters. Here, we present the trends of the nest abundance, female size, hatching, and emergence success of hawksbill (Eretmochelys imbricata) and green (Chelonia mydas) turtles at key nesting beaches in the southern Gulf of Mexico over 31 years (from 1990 to 2021). The nest abundance showed an increasing trend in both species as a result of the sustained protection and conservation effort, but there was no significant temporal trend in the annual female size, clutch size, hatching, and emergence success. However, these indicators showed decreasing mean values over the last decade and should be closely monitored. We suggest these decreases link to the combined effects of ocean warming and anthropogenic pressures affecting the sea turtle foraging grounds. Aside from protecting key nesting sites, protecting and restoring crucial foraging habitats should be an immediate priority requiring international cooperation.

Pharmacokinetic and clinical monitoring through posologic changes in adalimumab intensification regimen from 40 mg every week to 80 mg every other week.

BACKGROUND: Adalimumab dose escalation is often recommended for inflammatory bowel disease patients in cases of loss of response. The usual adalimumab intensification regimen was 40 mg every week. Recently the pharmaceutical companies commercialized the 80mg injection pen. In the biosimilars era, this pen was sold at the same price as the 40mg pen. Due to this and for patient comfort, we proposed that our stable intensified adalimumab patients on a 40mg every-week regimen, change to a dose of 80mg every-other-week. AIM AND METHODS: an observational study was performed to monitor outcome through this posologic change. Clinical, analytic parameters and adalimumab trough levels were prospectively obtained at baseline, 4 and 12 months after posologic change. The evolution of this cohort and calculates savings were described. RESULTS: 13 patients were included in the study and the median time of adalimumab intensification prior to posologic change to 80mg eow was 32 months (IQR 29-63). At 4 months, all patients maintained adalimumab 80mg every-other-week. After month 4, two patients returned to the previous regimen after mild worsening, without significant changes in CRP, calprotectin or adalimumab-trough-levels. At 1 year, adalimumab was stopped in one patient in remission with undetectable levels and positive adalimumab-antibodies. No significant differences in adalimumab-trough-levels were noted before and after the posologic change. Costs fell from 16276 €/patient/year of treatment to 8812.15 €/patient/year of treatment. CONCLUSION: In IBD patients with stable response to adalimumab intensification regimen of 40 mg every-week, changing to 80mg every-other-week seems to maintain response and similar adalimumab-trough-levels. Furthermore, it is cost-saving, although some patients may perceive mild symptoms.

Standard Non-Personalized Electric Field Modeling of Twenty Typical tDCS Electrode Configurations via the Computational Finite Element Method: Contributions and Limitations of Two Different Approaches.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation procedure to modulate cortical excitability and related brain functions. tDCS can effectively alter multiple brain functions in healthy humans and is suggested as a therapeutic tool in several neurological and psychiatric diseases. However, variability of results is an important limitation of this method. This variability may be due to multiple factors, including age, head and brain anatomy (including skull, skin, CSF and meninges), cognitive reserve and baseline performance level, specific task demands, as well as comorbidities in clinical settings. Different electrode montages are a further source of variability between tDCS studies. A procedure to estimate the electric field generated by specific tDCS electrode configurations, which can be helpful to adapt stimulation protocols, is the computational finite element method. This approach is useful to provide a priori modeling of the current spread and electric field intensity that will be generated according to the implemented electrode montage. Here, we present standard, non-personalized model-based electric field simulations for motor, dorsolateral prefrontal, and posterior parietal cortex stimulation according to twenty typical tDCS electrode configurations using two different current flow modeling software packages. The resulting simulated maximum intensity of the electric field, focality, and current spread were similar, but not identical, between models. The advantages and limitations of both mathematical simulations of the electric field are presented and discussed systematically, including aspects that, at present, prevent more widespread application of respective simulation approaches in the field of non-invasive brain stimulation.

Development of the @Antidotos_bot chatbot tool for poisoning management.

OBJECTIVE: To describe the development of the Antidotos_bot chatbot tool, which is used to facilitate the search for information in the Antidote Administration Guide and to perform useful calculations in the use of antidotes. METHOD: In January 2019, we proposed developing a freely accessible chatbot on Telegram® using Xenioo®. Software development  defined the way it interacts with users and incorporated calculation  functionalities. Internal validation was conducted and it was presented as  Antidotos_bot in June 2019. RESULTS: Antidotos_bot included information in Spanish on 49 antidotes and 57 poisonings. Three types of calculations were provided  and two treatment algorithms could be consulted. Consultation was  possible through 332 questions. Internal validation needed five sets of  training over 2 months. By July 2020, it had 415 users. The most  frequently consulted antidotes were glucagon, penicillin G, protamine, n- acetylcysteine and flumazenyl. Regarding monthly activity, there was an  average of 29 calculations and an average of three new users and three  queries per user. CONCLUSIONS: Antidotos_bot is a poisoning management decisionmaking tool that provides up-to-date information in a user-friendly manner. It could contribute to improving the quality and safety of care in  emergency situations.

Objetivo: Describir el desarrollo del simulador conversacional Antidotos_bot, para facilitar la búsqueda de información en la Guía de  administración de Antídotos y realizar cálculos útiles en el uso de  antídotos.Método: En enero de 2019 planteamos el desarrollo de un simulador conversacional de libre acceso en Telegram®, empleando la  plataforma Xenioo®. En el desarrollo del software se definió la forma de  interacción con el usuario y se incorporaron funcionalidades de cálculo. Se  realizó una validación interna y en junio de 2019 se presentó  Antidotos_bot.Resultados: Antidotos_bot incorporó información en castellano sobre 49  antídotos en 57 intoxicaciones, permitiendo realizar tres tipos de cálculos y consultar dos algoritmos de tratamiento. La consulta fue posible mediante  332 preguntas. La validación interna precisó cinco entrenamientos diferentes durante 2 meses. En julio 2020, Antidotos_bot  tenía 415 usuarios y los antídotos más consultados fueron glucagón,  penicilina G, protamina, n-acetilcisteína y flumazenilo. Mensualmente  fueron realizados 29 cálculos, el número medio de nuevos usuarios fue de  3 y el número medio de consultas por usuario fue de 3.Conclusiones: Antidotos_bot es una herramienta de apoyo en la toma de  decisiones en intoxicaciones, que proporciona información actualizada de  forma ágil, y podría contribuir a mejorar la calidad y seguridad asistencial  en situaciones de emergencia.

Bilateral Motor Cortex tDCS Effects on Post-Stroke Pain and Spasticity: A Three Cases Study.

Stroke patients frequently suffer from chronic limb pain, but well-suited treatment approaches have been not established so far. Transcranial direct current stimulation (tDCS) is a safe and non-invasive brain stimulation technique that alters cortical excitability, and it has been shown that motor cortex tDCS can reduce pain. Some data also suggest that spasticity may be improved by tDCS in post-stroke patients. Moreover, multiple sessions of tDCS have shown to induce neuroplastic changes with lasting beneficial effects in different neurological conditions. The aim of this pilot study was to explore the effect of multiple anodal tDCS (atDCS) sessions on upper limb pain and spasticity of stroke patients, using a within-subject, crossover, sham-controlled design. Brain damage was of similar extent in the three patients evaluated, although located in different hemispheres. The results showed a significant effect of 5 consecutive sessions of atDCS, compared to sham stimulation, on pain evaluated by the Adaptive Visual Analog Scales -AVAS-, and spasticity evaluated by the Fugl-Meyer scale. In two of the patients, pain was completely relieved and markedly reduced, respectively, only after verum tDCS. The pain improvement effect of atDCS in the third patient was considerably lower compared to the other two patients. Spasticity was significantly improved in one of the patients. The treatment was well-tolerated, and no serious adverse effects were reported. These findings suggest that multiple sessions of atDCS are a safe intervention for improving upper limb pain and spasticity in stroke patients, although the inter-individual variability is a limitation of the results. Further studies including longer follow-up periods, more representative patient samples and individualized stimulation protocols are required to demonstrate the efficacy and safety of tDCS for improving limb symptoms in these patients.

Early psychological impact of the 2019 coronavirus disease (COVID-19) pandemic and lockdown in a large Spanish sample.

BACKGROUND: Epidemic outbreaks have significant impact on psychological well-being, increasing psychiatric morbidity among the population. We aimed to describe the early psychological impact of COVID-19 and its contributing factors in a large Spanish sample, globally and according to mental status (never mental disorder NMD, past mental disorder PMD, current mental disorder CMD). METHODS: An online questionnaire was conducted between 19 and 26 March, five days after the official declaration of alarm and the lockdown order. Data included sociodemographic and clinical information and the DASS-21 and IES questionnaires. We analysed 21 207 responses using the appropriate descriptive and univariate tests as well as binary logistic regression to identify psychological risk and protective factors. RESULTS: We found a statistically significant gradient in the psychological impact experienced in five domains according to mental status, with the NMD group being the least affected and the CMD group being the most affected. In the three groups, the depressive response was the most prevalent (NMD = 40.9%, PMD = 51.9%, CMD = 74.4%, F = 1011.459, P < 0.001). Risk factors were female sex and classification as a case in any psychological domain. Protective factors were younger age and ability to enjoy free time. Variables related to COVID-19 had almost no impact except for having COVID-19 symptoms, which was a risk factor for anxiety in all three groups. CONCLUSIONS: Our results can help develop coping strategies addressing modifiable risk and protective factors for each mental status for early implementation in future outbreaks.

Improving People's Self-Reported Experience with the Health Services: The Role of Non-Clinical Factors.

The main aim of this study was to analyse the association between non-clinical factors and the self-reported experience of people with the main health services of the Spanish public healthcare system. Specifically, we analysed whether factors such as the treatment received from health staff, the confidence transmitted to the patient by the doctor, or waiting time for a diagnostic test had an influence on people reporting a more satisfactory experience with primary, specialised, and hospital care services. We used cross-sectional microdata from the Spanish Healthcare Barometer survey of 2015 comprising a sample of 7800 individuals. We applied a probit-adapted ordinary least squares estimation, which is one of the most widely used methods in recent studies on subjective well-being. Our findings suggest that individuals' interaction with non-clinical factors was positively correlated with the overall health services experience. Treatment received from health staff was one of the most relevant factors to ensure that individuals report a more satisfactory experience with primary care. Time devoted by physicians to each patient and waiting time for a non-emergency admission were the most correlated factors in specialised and hospital care services, respectively. This study could have implications for public policies. First, it shows policy-makers the influence of non-clinical factors when individuals rate their overall experience with the main health services in Spain. Second, it identifies the key factors where the health system could reallocate more public resources to improve people's experience and thus the health system responsiveness.

Assessing the performance of the least developed countries in terms of the Millennium Development Goals.

This article presents a proposal for assessing the progress of least developed countries towards the achievement of the Millennium Development Goals over the period 2000-2015. Composite indices are built to perform spatial and temporal benchmarking relying on the P2 Distance method. The results are contrasted with other indices developed under a multi-criterion approach with a double reference point. The main findings are that all the countries have improved their situation and country disparities have been reduced. Cambodia and Ethiopia have registered the best trends and South Sudan and Timor-Leste show the worse performance. Considering the position in the 2015 ranking, Rwanda and Bhutan performed the best, while Somalia and Chad rank in the last position. Having now reached the end of the Millennium Development Goals period, the gap with respect to the world average indicates that much work remains to be done in the 2030 Agenda for Sustainable Development.

Eventos adversos en pacientes hospitalizados reportados por enfermería: un estudio multicéntrico en México / Nursing reported hospitalized patients adverse events: A multi-centric study in Mexico / Eventos adversos em pacientes hospitalizados relatados por enfermagem: um estudo multicéntrico no México

Introducción: Los eventos adversos (EA) son un daño no intencionado derivado de la atención sanitaria que se relacionan con los recursos humanos, los factores del sistema o las condiciones clínicas del paciente. Objetivo: Analizar factores relacionados con la calidad y la seguridad del paciente a través de los reportes de EA. Metodología: Diseño transversal, multicéntrico, realizado en 5 institutos nacionales de salud y en un hospital de alta especialidad, se estudiaron los EA ocurridos durante 18 meses, para lo cual se utilizó el instrumento SYREC 2007; análisis descriptivo y evaluación de asociación entre grado de evitabilidad y factores intrínsecos, extrínsecos y del sistema; se observaron los aspectos éticos vigentes. Resultados: Se analizaron un total de 540 EA, ocurrieron 55.5% en hombres, 58.7% estaban en estado de alerta, el 92.6% de los EA ocurrió en el servicio asignado, el 55.9% no se reportó a la familia, se consideró sin duda como evitable en el 70.5%, los factores del sistema estuvieron presentes en 80.6%, hubo asociación significativa entre estos y la evitabilidad del suceso. Discusión: Los principales resultados encontrados son coincidentes con otras investigaciones internacionales tales como: To err is human 1999, el estudio ENEAS de España 2006 y con el de prevalencia IBEAS 2010; en todos ellos se hizo evidente la necesidad de reforzar la cultura de la notificación de los EA y el clima para la seguridad del paciente, además de promover una reflexión interpersonal acerca de la calidad de los servicios asistenciales. Conclusiones: Los factores relacionados con el sistema tienen un mayor peso en la aparición de EA. Es de vital importancia su identificación a fin de poder evitarlos.

Introduction: Adverse events (AE) are unintended harms derived from human health attention, system factors, or clinical conditions in the patients. Objective: To analyze factors influencing the quality of patient healthcare and safety through the review of diverse records on AEs. Methodology: This transversal and multi-centric design study was carried out in five National Institutes of Health and a high specialty hospital. AEs in an 18 month period were studied using the SYREC 2007 instrument. Descriptive analysis, as well as assessments on the association between the preventability degree and the intrinsic, extrinsic, and system factors were all performed. Current ethical issues were observed. Results: A total of 540 AEs were analyzed; 55.5% occurred in men; 58.7% occurred during state of alertness; 92.6% occurred at the assigned service; 55.9% were not reported to the families; 70.5% were considered preventable; and system factors were present in 80.6% of them. A significant association between the AEs and the possibility to prevent them was found. Discussion: The main findings were consistent with those of other international studies including: ''To err is human'', 1999, the ENEAS study in Spain, 2006, and the IBEAS prevalence study, 2010. All of these studies emphasize the need to strengthen the culture of AE-notifying and to improve the patient safety climate, as well as to promote inter-personal reflections on to the quality of care services. Conclusions: System-related factors have the strongest influence on the occurrence of AEs, and thus, their identification becomes critical in order to enhance the quality of healthcare services.

Introdução: Os Eventos Adversos (EA) são um dano não intencionado derivado da atenção sanitária que se relaciona com os recursos humanos, os fatores do sistema ou as condições clínicas do paciente. Objetivo: Analisar fatores relacionados com a qualidade e a segurança do paciente a través dos relatórios de EA. Metodologia: Desenho transversal, multicéntrico, realizado em cinco Institutos Nacionais de Saúde e um hospital de alta especialidade, estudaram-se os EA ocorridos durante 18 meses, para o qual se utilizou o instrumento SYREC 2007; análise descritiva e avaliação de associação entre grau de evitabilidade e fatores intrínsecos, extrínsecos e do sistema; observaram-se os aspectos éticos vigentes. Resultados: Analisaram-se um total de 540 EA, ocorreram 55.5% em homens, 58.7% estavam em estado de alerta, o 92.6% o EA aconteceu no serviço assignado, o 55.9% não se informou à família, considerou-se sem dúvida como evitável no 70.5%, os fatores do sistema estiveram presentes em 80.6%, houve associação significativa entre estes e a evitabilidade do evento. Discussão: Os principais resultados encontrados são coincidentes com outras pesquisas internacionais tais como: ''To err is human'' 1999, o estudo ENEAS da Espanha 2006 e com o de prevalência IBEAS 2010; em todos eles se fez evidente a necessidade de reforçar a cultura da notificação dos EA e o clima para a segurança do paciente, além de promover una reflexão interpessoal acerca da qualidade dos serviços assistenciais. Conclusões: Os fatores relacionados com o sistema têm um maior peso na aparição de EA. É de vital importância sua identificação a fim de poder evitá-los.

Photon spectrum and absorbed dose in brain tumor.

Using Monte Carlo methods a BOMAB phantom inside a treatment hall with a brain tumor nearby the pituitary gland was treated with photons produced by a Varian 6MV linac. The photon spectrum and the absorbed dose were calculated in the tumor, pituitary gland and the head. The treatment beam was collimated to illuminate only the tumor volume; however photons were noticed in the gland. Photon fluence reaching the tumor is and 15.7 times larger than the fluence in the pituitary gland, on the other hand the absorbed dose in the tumor is 37.1 times larger than the dose in the gland because photons that reach the pituitary gland are scattered, by the head and the tumor, through Compton effect.

Factores relacionados con eventos adversos reportados por enfermería en unidades de cuidados intensivos. Proyecto multicéntrico / Factors related to nursing-reported adverse events in intensive care units: Multicenter project / Fatores relacionados com a presença de eventos adversos informados pela enfermagem na unidade de cuidados intensivos. Projeto multicêntrico

La atención a la salud a veces puede representar un riesgo para los pacientes, que puede derivar en daño físico, psicológico, social, económico, e incluso la muerte. Estos incidentes se denominan eventos adversos (EA) y se presentan durante el proceso de atención. Objetivo: Determinar la ocurrencia de los EA en las áreas de cuidados intensivos y conocer los factores intrínsecos, extrínsecos y del sistema que están presentes en la aparición de un EA, así como su evitabilidad y gravedad. Métodos: Estudio multicéntrico, analítico, transversal y observacional, en siete instituciones de salud de carácter público y de alta especialidad en México. La muestra estuvo compuesta por 137 personas durante el periodo comprendido del 1-04-2012 al 31-01-2013. Los datos se recolectaron con la ficha de notificación de EA tomada y adaptada del proyecto SYREC 2007. Se utilizó el programa estadístico SPSS versión 17. Se realizaron pruebas de correlación de Spearman y phi, U de Mann-Witney, Kruskal-Wallis y Chi2. Resultados: El 58% de los EA se presentaron en pacientes masculinos, el 60% en edad pediátrica. Los EA relacionados con el cuidado fueron los más frecuentes con un 29.9%. En el 51% estuvieron relacionados con invalidez temporal. En un 75% de los casos se pudieron evitar. Sobresalen los factores del sistema con un 98%.Conclusiones: La población más vulnerable son los niños y los adultos mayores, los EA están relacionados directamente con el cuidado de enfermería y su mayoría son evitables. Es necesario implementar estrategias para la gestión de la seguridad del paciente para detectar, registrar, prevenir y minimizar su frecuencia.

Health treatment can sometimes involve risk for patients, which can result in physical, psychological, social, or financial damage, and even death. These incidents are called adverse events (AE) and occur during the treatment process.ObjectiveTo determine the occurrence of AE in intensive care areas, and identify the intrinsic, extrinsic, and systemic factors involved in an AE, and to assess their severity and how to avoid them. Methods Multi-centric, analytic, transversal, and observational study conducted on 7 public and high specialty health institutions in Mexico with a sample of 137 individuals. The study was carried out from 04/01/2012 to 01/31/2013. Data were collected through SYREC 2007 project adapted AE notification charts. SPSS version 17 was used. Spearman, Phi, Mann-Whitney U, Kruskal-Wallis and Chi2 tests were performed. Results:58% of AE occurred among male patients, 60% among the pediatric population. The most frequent AE were those related to care (29.9%). 51% were related to temporal disability. 75% of the cases could not be avoided. Systemic factors were the prevalent ones with 98%. Conclusions: The most vulnerable populations are children and the elderly. AE are directly related to nursing care and most are avoidable. It is necessary to implement strategies to manage patient safety in order to detect, register, prevent, and minimize the frequency of AE.

A atenção à saúde representa em vários momentos um risco para os pacientes, que pode derivar em dano físico, psicológico, social, económico, inclusivé a morte. Estes incidentes denominam-se eventos adversos (EA), apresentam-se durante o processo de atenção. Objetivo Determinar a ocorrência dos EA nas áreas de cuidados intensivos e conhecer fatores intrínsecos, extrínsecos e do sistema que estão presentes no aparecimento de um EA, bem como a possibilidade de evita-los e a sua gravidade. Métodos: Estudo multicêntrico, analítico, transversal e observacional, em 7 instituições de saúde pública e de alta especialidade no México. A amostra foi de (n = 137) durante o periodo compreendido entre 01-04-2012 e 31-01-2013. Os dados foram recolhidos com a ficha de notificação de EA tomada e adaptada do projeto SYREC 2007. Utilizou-se o programa estatístico SPSS versão 17. Realizaram-se testes de correlação de Spearman e Phi, U de Mann-Witney, Kruskal-Wallis e Chi2. Resultados: Os 58% dos EA apresentaram-se nos pacientes masculinos, os 60% na idade pediátrica. Os EA mais frequentes foram relacionados com o cuidado, com 29.9%. 51% estiveram relacionados com incapacidade temporária. Em 75% dos casos pôde-se evitar. Sobressaem os fatores do sistema com 98%. Conclusões: A população mais vulnerável são as crianças e os idosos, os EA relacionam-se diretamente com o cuidado da enfermagem e a sua maioria são evitáveis. É necessário implementar estratégias para a gestão da segurança do paciente para detectar, registrar, prevenir e minimizar a sua frequência.

Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial.

BACKGROUND: Corticosteroids have been used to treat head injuries for more than 30 years. In 1997, findings of a systematic review suggested that these drugs reduce risk of death by 1-2%. The CRASH trial--a multicentre international collaboration--aimed to confirm or refute such an effect by recruiting 20000 patients. In May, 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment. METHODS: 10008 adults with head injury and a Glasgow coma score (GCS) of 14 or less within 8 h of injury were randomly allocated 48 h infusion of corticosteroids (methylprednisolone) or placebo. Primary outcomes were death within 2 weeks of injury and death or disability at 6 months. Prespecified subgroup analyses were based on injury severity (GCS) at randomisation and on time from injury to randomisation. Analysis was by intention to treat. Effects on outcomes within 2 weeks of randomisation are presented in this report. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN74459797. FINDINGS: Compared with placebo, the risk of death from all causes within 2 weeks was higher in the group allocated corticosteroids (1052 [21.1%] vs 893 [17.9%] deaths; relative risk 1.18 [95% CI 1.09-1.27]; p=0.0001). The relative increase in deaths due to corticosteroids did not differ by injury severity (p=0.22) or time since injury (p=0.05). INTERPRETATION: Our results show there is no reduction in mortality with methylprednisolone in the 2 weeks after head injury. The cause of the rise in risk of death within 2 weeks is unclear.

Rapid prenatal diagnosis of aneuploidies and zygosity in multiple pregnancies by amniocentesis with single insertion of the needle and quantitative fluorescent PCR.

OBJECTIVE: To investigate amniotic fluid (AF) samples retrieved in multiple pregnancies by single insertion of the needle, for rapid assessment of chromosome copy number, zygosity, and cross-contamination between fetuses, using Quantitative Fluorescent Polymerase Chain Reaction (QF-PCR) amplification of highly polymorphic microsatellite markers. METHODS: Fifty-two multiple pregnancies were selected (47 twins, 5 triplets) and 108 samples of amniotic fluid were sampled between 12 to 20 weeks of gestation (mean 15.5) using the single-needle technique. Aneuploidy screening by QF-PCR amplification of short tandem repeats (STRs) on chromosomes X, Y, 21, 13, and 18 was carried out within 24 h of collection. Owing to the sampling procedure, the eventual presence of contamination between fetuses was also evaluated in every case. RESULTS: Normal and aneuploid fetuses were readily identified by QF-PCR. Fetal reduction was made available, for trisomic fetuses, without further waiting for completion of fetal karyotyping. In twin gestations, the ultrasound examination of chorionicity was always in agreement with the molecular assessment of zygosity. Contamination between fetuses due to the sampling procedure with a single puncture was never observed. CONCLUSION: Rapid prenatal diagnosis of aneuploidies by QF-PCR is a sensitive, efficient, and reliable assay. When applied in multiple pregnancies, it has the added value of allowing the assessment of zygosity in all cases, independently of chorionicity and fetal sex.