ECO-SEOM-SEEO safety recommendations guideline for cancer patients receiving intravenous therapy.

PURPOSE: Cancer patients require implantation of venous access devices to meet their personalized therapeutic needs, which are often complex due to the nature of the medication and the disease status. Therefore, it is essential to have standardized protocols that guarantee the best results in health and patient safety. METHODS: To learn about the availability of protocols and aspects related to safety in clinical practice and to detect possible opportunities for improvement, a survey has been conducted in various Spanish hospitals, in addition to a review of the evidence regarding the various devices available and complications associated with the administration of chemotherapy. RESULTS: As a result of both analyses, the Foundation for Excellence and Quality in Oncology (ECO), the Spanish Society of Medical Oncology (SEOM), and the Spanish Society of Oncology Nursing (SEEO) have developed a catheter selection algorithm based on patient characteristics and treatment to facilitate the clinical decision-making process, as well as some recommendations aimed at ensuring patient safety and rational use of available resources. CONCLUSIONS: In conclusion, both the venous access catheter selection algorithm and the proposed recommendations aim to respond to the needs revealed in clinical practice and to become an integrable tool in electronic prescription systems to offer homogeneous criteria for action in cancer patients that require venous access, optimizing the use of available health resources with the highest safety and quality of life for the patient.

Current functioning of cardio-oncology units in Spain.

PURPOSE: The aim of the current survey was to describe the functioning of cardio-oncology (C-O) units in Spain. METHODS: All members of the Spanish Society of Cardiology pertaining to scientific communities related to C-O received questionnaires on the existence of specific programs at their institutions. A second, more extensive questionnaire was sent to the centers which reported C-O organization. RESULTS: We identified 56 centers with C-O programs of which 32 (62.5%) replied to the extended questionnaire. 28% of all centers reported having a multidisciplinary unit involving specialists in several areas. More than 80% of the centers developed surveillance protocols locally adapted which included advanced echocardiographic techniques (68%) or troponin (82%). CONCLUSIONS: The number of institutions with C-O programs is still limited but higher than reported in a survey in 2017. Development of multidisciplinary units of C-O should be promoted to improve the cardiovascular health of cancer patients.

Complexity and uncertainty in the critical care of cancer patients in the era of immunotherapy and targeted therapies / Complejidad e incertidumbre en cuidados críticos para pacientes con cáncer en la era de la inmunoterapia y terapias dirigidas

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Intensive care in cancer patients in the age of immunotherapy and molecular therapies: Commitment of the SEOM-SEMICYUC / Cuidados intensivos en pacientes con cáncer en la era de la inmunoterapia y las terapias moleculares: el compromiso de la SEOM-SEMICYUC

Cancer patients are a vulnerable group exposed to numerous and serious risks beyond cancer itself. In recent years, the prognosis of these individuals has improved substantially thanks to several advances such as immunotherapy, targeted molecular therapies, surgical techniques, or developments in support treatment. This coincides with the prolonged survival of oncological patients admitted to the ICU due to critical complications, and under the supervision of intensivists. The time has therefore come to revisit the intensive care support of these patients, which poses new professional as well as organizational challenges. An agreement was signed in 2017 between the SEOM and SEMICYUC with the aim of improving the quality of care of cancer patients with critical complications. The initiative seeks to aid in decision-making, standardize criteria, decrease subjectivity, generate channels of communication, and delve deeper into the ethical and scientific aspects of these situations. This document sets forth the most important reasons that have led us to undertake this initiative

Los pacientes con cáncer constituyen un colectivo vulnerable expuesto a numerosos riesgos graves, más allá del cáncer en sí. En los últimos años, el pronóstico de estos individuos ha mejorado sustancialmente gracias a varios avances, como la inmunoterapia, las terapias moleculares específicas, las técnicas quirúrgicas o el desarrollo de los tratamientos de soporte. Esto se traduce en un aumento de la supervivencia de los pacientes oncológicos hospitalizados en la UCI y que son llevados por intensivistas. Por lo tanto, ha llegado el momento de revisar el apoyo de cuidados intensivos para estos pacientes, lo que plantea nuevos desafíos profesionales y de organización. En este marco, en 2017 se firmó un acuerdo entre la SEOM y la SEMICYUC con el objetivo de mejorar la calidad de la atención de pacientes oncológicos con complicaciones críticas. Esta iniciativa busca ayudar en la toma de decisiones, estandarizar criterios, disminuir la subjetividad, generar canales de comunicación y profundizar en los aspectos éticos y científicos de estas situaciones. Este documento establece las razones más importantes que nos han llevado a emprender esta iniciativa

Intensive care in cancer patients in the age of immunotherapy and molecular therapies: Commitment of the SEOM-SEMICYUC.

Cancer patients are a vulnerable group exposed to numerous and serious risks beyond cancer itself. In recent years, the prognosis of these individuals has improved substantially thanks to several advances such as immunotherapy, targeted molecular therapies, surgical techniques, or developments in support treatment. This coincides with the prolonged survival of oncological patients admitted to the ICU due to critical complications, and under the supervision of intensivists. The time has therefore come to revisit the intensive care support of these patients, which poses new professional as well as organizational challenges. An agreement was signed in 2017 between the SEOM and SEMICYUC with the aim of improving the quality of care of cancer patients with critical complications. The initiative seeks to aid in decision-making, standardize criteria, decrease subjectivity, generate channels of communication, and delve deeper into the ethical and scientific aspects of these situations. This document sets forth the most important reasons that have led us to undertake this initiative.

The time has come for new models in febrile neutropenia: a practical demonstration of the inadequacy of the MASCC score

Since its publication more than 15 years ago, the MASCC score has been internationally validated any number of times and recommended by most clinical practice guidelines for the management of febrile neutropenia (FN) around the world. We have used an empirical data-supported simulated scenario to demonstrate that, despite everything, the MASCC score is impractical as a basis for decision-making. A detailed analysis of reasons supporting the clinical irrelevance of this model is performed. First, seven of its eight variables are "innocent bystanders" that contribute little to selecting low-risk candidates for ambulatory management. Secondly, the training series was hardly representative of outpatients with solid tumors and low-risk FN. Finally, the simultaneous inclusion of key variables both in the model and in the outcome explains its successful validation in various series of patients. Alternative methods of prognostic classification, such as the Clinical Index of Stable Febrile Neutropenia, have been specifically validated for patients with solid tumors and should replace the MASCC model in situations of clinical uncertainty (AU)

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The time has come for new models in febrile neutropenia: a practical demonstration of the inadequacy of the MASCC score.

Since its publication more than 15 years ago, the MASCC score has been internationally validated any number of times and recommended by most clinical practice guidelines for the management of febrile neutropenia (FN) around the world. We have used an empirical data-supported simulated scenario to demonstrate that, despite everything, the MASCC score is impractical as a basis for decision-making. A detailed analysis of reasons supporting the clinical irrelevance of this model is performed. First, seven of its eight variables are "innocent bystanders" that contribute little to selecting low-risk candidates for ambulatory management. Secondly, the training series was hardly representative of outpatients with solid tumors and low-risk FN. Finally, the simultaneous inclusion of key variables both in the model and in the outcome explains its successful validation in various series of patients. Alternative methods of prognostic classification, such as the Clinical Index of Stable Febrile Neutropenia, have been specifically validated for patients with solid tumors and should replace the MASCC model in situations of clinical uncertainty.

New clinical trials regulation in Spain: analysis of royal decree 1090/2015.

The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patient's safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as "low-intervention clinical trial". The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects' safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research.