Alimentos para usos médicos especiales en la Unión Europea: una actualización legislativa incompleta / Foods for special medical purposes in the European Union: an incomplete legislative update

Este artículo analiza el desarrollo, desde 1989 hasta 2019, de la legislación de la Unión Europea sobre los alimentos para usos médicos especiales dirigidos a pacientes y examina cómo desde 1997 los organismos científicos competentes de la Unión Europea y de los Estados Unidos de América han establecido valores de referencia de la dieta, así como niveles de ingesta superior tolerable para vitaminas y minerales basados en su seguridad. La actualización, mediante el Reglamento (UE) 2016/128, de la legislación de la Unión Europea de esta categoría de alimentos parece adecuada en el caso de los lactantes. Sin embargo, para los pacientes mayores de un año, los mínimos y máximos de vitaminas y minerales por 100 kcal de la Directiva 1999/21/CE no fueron modificados en este Reglamento, ignorando así los valores de referencia de la dieta y los niveles de ingesta superior tolerable del periodo 1997-2015, establecidos ambos por los citados organismos científicos

This article analyses, from 1989 until 2019, the development of the European Union legislation on food for special medical purposes, aimed at patients, and examines how from 1997 the competent scientific bodies of the European Union and the United States of America have established dietary reference values, as well as tolerable upper intake levels for vitamins and minerals based on their safety. The update, through the Regulation (EU) 2016/128, of the European Union legislation on this food category seems appropriate in the case of infants. However, for patients older than one year, the minimums and maximums of vitamins and minerals per 100 kcal from the Directive 1999/21/EC were not modified in this Regulation, thus ignoring the dietary reference values and the tolerable upper intake levels from the period 1997-2015, both established by the aforementioned scientific bodies

Propuesta de un diseño de carrera profesional para la enfermería militar / A proposal for military nursing career design

Introducción: En ausencia, en la actualidad, de un modelo de carrera profesional para enfermería militar se propone un diseño que, buscando la excelencia profesional, dé respuesta a las necesidades de la organización. Objetivo: Diseñar una propuesta de carrera profesional para la enfermería militar. Material y Métodos: Se diseñó un modelo de carrera profesional basado en tres variables, contempladas por la Ley de Carrera Militar: capacitación para asumir puestos de mayor responsabilidad, ascenso a sucesivos empleos militares y ocupación de destinos. Población y muestra: Personal en activo en la Escala de Oficiales Enfermeros (E.O.E.). Recogida de datos: Se obtuvieron datos, a través de la Dirección General de Personal, de la situación actual de la E.O.E. (años de servicio, empleos, efectivos/empleo, años/empleo). Se realizó una búsqueda de información en relación con todos los modelos propuestos en España por las Comunidades Autónomas (CC.AA.), así como, la legislación militar y civil de aplicación en este ámbito. Resultados: Se propone un modelo de carrera profesional en base a cinco grados correspondiendo con otros tantos empleos militares. Se describen las funciones y tipo de destino a ocupar de acuerdo al nivel de desempeño profesional. Conclusiones: Es preciso desarrollar un modelo de carrera profesional para la enfermería militar que oriente la trayectoria individual de sus componentes, la catalogación de puestos, los sistemas de evaluación y la formación precisa para alcanzar diversos niveles competenciales en base a las necesidades de las Fuerzas Armadas

Introduction: Due to the current inexistence of a specific professional career for the military nurses, this paper aims to propose a design that both stresses professional excelence and meets the needs of the organisation. Objectives: To design a proposal for the military nursing career. Materials and Methods: This new model for professional career was based on the three dimensions considered by the "Ley de Carrera Militar" (Military Career Law): abiltation to assume positions of higher responsibility, promotion to successive military positions and destination occupation. Population and Sample: Serving staff in the Official Military Nurse Scale (OMNS). Data gathering: Data were obtained through the "Dirección General de Personal" concerning current situations (service years, positions, effectives/ position, years/position). An information search was conducted through all the models proposed in Spain by the Autonomous Communities, and the relevant legislation, both military and civil. Results: The proposed model of nursing professional career is based on five degrees corresponding to the same number of military positions. The functions and type of destination are described according to the level of professional performance. Conclusions: It seems necessary to introduce a new model of professional career useful to guide the individual trajectory of the military nurses, the position lists, the evaluation systems and the required training to reach the different performance levels according to the needs of the Armed Forces

Papel del urólogo en el tratamiento del cáncer renal / Role of the urologist in the treatment of renal cancer

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Representación Femenina En Las Juntas Directivas De Asociaciones Y Sociedades Pediátricas / Female representation on boards of directors of paediatrics associations and societies

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Comentarios a la guía ESC 2017 sobre el tratamiento del infarto agudo de miocardio en pacientes con elevación del segmento ST / Comments on the 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment Elevation

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Validation of the prognostic value of new sub-stages within the AJCC 8th edition of non-small cell lung cancer

Background. The 8th edition of the American Joint Committee on Cancer (AJCC) staging system for non-small cell lung cancer (NSCLC) has been released. The current study tried to validate the prognostic significance of the new system among patients registered within the surveillance, epidemiology and end results (SEER) database. Methods. SEER database (2010-2013) has been accessed through SEER*Stat program and AJCC 8th edition stages were reconstructed utilizing the collaborative stage descriptions. Overall and lung cancer-specific survival analyses according to both 7th and 8 th editions were conducted through Kaplan-Meier analysis and multivariate analysis was conducted through a Cox proportional hazard model. Results. A total of 127,096 patients with NSCLC were identified in the period from 2010 to 2013. For overall survival assessment according to the 8th edition, P values for all pair-wise comparisons among different stages were significant (<0.0001) except for the comparisons between stage IB and IIA (P = 0.146); stage IIA and IIB (P = 0.165). For lung cancer-specific survival according to the 8th edition, P values for all pair-wise comparisons among different stages were significant (<0.001). Among patients with stage I disease, multivariate analysis for factors affecting overall and lung cancer-specific survival among patients with stage I disease was conducted. The following factors were associated with worse overall and lung cancer-specific survival: age ≥70 years, more advanced stage, male gender, squamous histology, no surgery and no radiotherapy (P < 0.0001 for all factors). Conclusion. This SEER analysis supports the prognostic significance of the added sub-stages described within AJCC 8th edition stages I and III. Further work is needed to incorporate molecular markers and personalize the future editions of the AJCC staging system (AU)

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A Model for Incident Review Committees in Behavioral Health Settings.

Despite the fact that incident review committees have been a key component of quality improvement in behavioral health settings for decades, specific models of how these committees are structured and operate are not well described. We present a model for an incident review committee that has been implemented in 2 large, academic acute care psychiatric hospitals. We believe the model not only permitted us to efficiently and effectively review untoward incidents, but that it also provided an approach to calibrating standards of care for the institution, engaging physicians in an interdisciplinary effort, promulgating a culture of quality review and improvement throughout the organization, promoting continuity and sustainability of the incident review process, and, most importantly, driving beneficial change in clinical practice. Demonstration of the effectiveness of this model requires formal investigation.

Influence of type 2 diabetes mellitus on Khorana venous thromboembolism risk in colorectal cancer patients

Background: Many studies have documented the association between venous thromboembolism (VTE) and colorectal cancer (CRC). The Khorana model is a VTE risk assessment model for predicting cancer-associated thrombosis. Type 2 diabetes (T2DM) has also been reported to increase the risk of VTE. Purpose: The aim of this study was to investigate the influence of T2DM on Khorana VTE risk in CRC patients and to explore the relationship between Khorana VTE category and CRC clinicopathological factors. Methods: This analysis included 615 CRC patients (205 with T2DM). Fibrinogen and D-dimer levels were compared within each group. A comparison was made of the proportion of patients in different Khorana VTE risk categories in CRC patients with and without T2DM. The association between Khorana VTE risk category and clinicopathological factors among all the CRC patients was evaluated. Results: Fibrinogen levels of CRC patients with T2DM were significantly higher than those of non-diabetes patients (4.13 ± 1.06 vs 3.94 ± 0.98, p < 0.001). A higher proportion of CRC patients with T2DM were in the Khorana intermediate-to-high risk category (H = 4.749, p = 0.029). Female sex, diabetes, colon location (compared with rectum), larger tumor size, advanced pT stage and pN stage were correlated with the intermediate-to-high Khorana VTE risk category, with odd ratios (95% confidence intervals [CI]) of 1.537 (1.064-2.220), 1.499 (1.027-2.186), 2.313 (1.588-3.370), 2.284 (1.542-3.383), 4.429 (2.088-9.396) and 1.822 (1.230-2.698), respectively. Conclusion: T2DM increases Khorana VTE risk in CRC patients. Female sex, diabetes, colon location, large tumor size and poor stage are associated with the intermediate-to-high Khorana VTE risk category (AU)

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An international survey on the role of the hospital transfusion committee.

BACKGROUND: Hospital transfusion committees (HTCs) can oversee all aspects of transfusion practice at a hospital. This survey sought to identify which quality variables were being reported at HTCs around the world. STUDY DESIGN AND METHODS: A working party composed of members of the Biomedical Excellence for Safer Transfusion (BEST) collaborative developed a survey of quality variables that could be potentially presented at HTC meetings. The survey was electronically sent to all BEST members who were encouraged to complete it if they were active on an HTC and to send it to other colleagues with similar experience. An expert panel was convened to determine which quality variables are the most important for review at HTC meetings. RESULTS: There were 121 respondents; the majority were from Europe (52%), Asia (19%), or North America (19%). Most respondents (68%) were at university hospitals. Of the 117 (97%) respondents with an HTC, the committee most often met quarterly (42%) and reviewed transfusion reactions (79%) and risk management-reported events (52%). The HTCs most commonly included transfusion medicine physicians, anesthesiologists, and other physicians who regularly transfuse blood products. Some of the most commonly reported quality variables included number of blood products transfused, wasted, and expired and the number of improperly labeled specimens. The expert panel analysis revealed that some variables that were deemed important were not being frequently reported at HTCs. CONCLUSION: There is variability in the variables being reported at HTCs around the world with some important variables not frequently reported.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Bleeding and Coagulation Management in Neurostimulation Devices.

INTRODUCTION: The Neurostimulation Appropriateness Consensus Committee (NACC) was formed by the International Neuromodulation Society (INS) in 2012 to evaluate the evidence to reduce the risk of complications and improve the efficacy of neurostimulation. The first series of papers, published in 2014, focused on the general principles of appropriate practice in the surgical implantation of neurostimulation devices. The NACC was reconvened in 2014 to address specific patient care issues, including bleeding and coagulation. METHODS: The INS strives to improve patient care in an evidence-based fashion. The NACC members were appointed or recruited by the INS leadership for diverse expertise, including international clinical expertise in many areas of neurostimulation, evidence evaluation, and publication. The group developed best practices based on peer-reviewed evidence and, in the absence of specific evidence, on expert opinion. Recommendations were based on international evidence in accordance with guideline creation. CONCLUSIONS: The NACC has recommended specific measures to reduce the risk of bleeding and neurological injury secondary to impairment of coagulation in the setting of implantable neurostimulation devices in the spine, brain, and periphery.

The Neurostimulation Appropriateness Consensus Committee (NACC) Recommendations for Infection Prevention and Management.

INTRODUCTION: The use of neurostimulation for pain has been an established therapy for many decades and is a major tool in the arsenal to treat neuropathic pain syndromes. Level I evidence has recently been presented to substantiate the therapy, but this is balanced against the risk of complications of an interventional technique. METHODS: The Neurostimulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society convened an international panel of well published and diverse physicians to examine the best practices for infection mitigation and management in patients undergoing neurostimulation. The NACC recommendations are based on evidence scoring and peer-reviewed literature. Where evidence is lacking the panel added expert opinion to establish recommendations. RESULTS: The NACC has made recommendations to improve care by reducing infection and managing this complication when it occurs. These evidence-based recommendations should be considered best practices in the clinical implantation of neurostimulation devices. CONCLUSION: Adhering to established standards can improve patient care and reduce the morbidity and mortality of infectious complications in patients receiving neurostimulation.

The Neurostimulation Appropriateness Consensus Committee (NACC) Safety Guidelines for the Reduction of Severe Neurological Injury.

INTRODUCTION: Neurostimulation involves the implantation of devices to stimulate the brain, spinal cord, or peripheral or cranial nerves for the purpose of modulating the neural activity of the targeted structures to achieve specific therapeutic effects. Surgical placement of neurostimulation devices is associated with risks of neurologic injury, as well as possible sequelae from the local or systemic effects of the intervention. The goal of the Neurostimulation Appropriateness Consensus Committee (NACC) is to improve the safety of neurostimulation. METHODS: The International Neuromodulation Society (INS) is dedicated to improving neurostimulation efficacy and patient safety. Over the past two decades the INS has established a process to use best evidence to improve care. This article updates work published by the NACC in 2014. NACC authors were chosen based on nomination to the INS executive board and were selected based on publications, academic acumen, international impact, and diversity. In areas in which evidence was lacking, the NACC used expert opinion to reach consensus. RESULTS: The INS has developed recommendations that when properly utilized should improve patient safety and reduce the risk of injury and associated complications with implantable devices. CONCLUSIONS: On behalf of INS, the NACC has published recommendations intended to reduce the risk of neurological injuries and complications while implanting stimulators.

Reflexión en torno al informe sobre consentimiento informado en pediatría del Comité de Bioética de la Academia Americana de Pediatría (2016) / Reflection on the report on the informed consent in paediatrics by the Bioethics Committee of the American Academy of Pediatrics (2016)

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Key issues in hymenoptera venom allergy: an update

In this review, the Hymenoptera Allergy Committee of the SEAIC analyzes the most recent scientific literature addressing problems related to the diagnosis of hymenoptera allergy and to management of venom immunotherapy. Molecular diagnosis and molecular risk profiles are the key areas addressed. The appearance of new species of hymenoptera that are potentially allergenic in Spain and the associated diagnostic and therapeutic problems are also described. Finally, we analyze the issue of mast cell activation syndrome closely related to hymenoptera allergy, which has become a new diagnostic challenge for allergists given its high prevalence in patients with venom anaphylaxis (AU)

En esta revisión el Comité de Alergia a Himenópteros de la SEAIC ha analizado la literatura científica más reciente sobre los principales problemas diagnósticos de la alergia a himenópteros, así como sobre las dificultades que pueden surgir durante la inmunoterapia con venenos. Se revisan especialmente las novedades relacionadas con el diagnóstico molecular y los perfiles moleculares de riesgo. También se describe la alergia a himenópteros poco habituales y los problemas diagnósticos y terapéuticos que esta conlleva. Por último, se tratan los síndromes de activación mastocitaria clonal, íntimamente relacionados con la alergia a himenópteros, que se han convertido en un nuevo reto diagnóstico para el alergólogo (AU)

Transició de les recomanacions en RCP pediàtrica i neonatal entre 2005 i 2015: guies 2010 / No disponible

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Barriers to Effective Deliberation in Clinical Research Oversight.

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call "deliberative pathologies," or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research.

Misconduct in third-party assisted reproduction: a committee opinion.

Physicians who are told or discover information that would be material to another party's participation in an assisted reproductive technology (ART) arrangement (such as lawyer's, donor's, gestational carrier's, or intended parent's) should encourage disclosure to that party. In some instances, it is ethically and legally permissive for the physician to either disclose material information to an affected party or to transfer care of a patient to another willing provider. In all cases involving the legal status or rights of the parties, referral to legal professionals is advised.