Real Decreto 601/2019 sobre justificación y optimización: aspectos prácticos / Royal Decree 601/2019 on justification and optimization: Practical aspects

El Real Decreto 601/2019 de 18 de octubre es fruto de la transposición parcial al ordenamiento jurídico español de la Directiva EURATOM 59/2013. Este Real Decreto recoge los mandatos de la Directiva relacionados con la necesidad de justificar y optimizar la exposición médica, incluida la de personas asintomáticas, la propuesta de requisitos más estrictos en cuanto a la información que debe proporcionarse al paciente, el registro y la notificación de las dosis de los procedimientos médico-radiológicos, el uso de niveles de referencia para diagnóstico y la disponibilidad de dispositivos indicadores de dosis. El artículo revisa los aspectos más relevantes y novedades relacionadas con los principios de justificación, optimización, control de dosis y las obligaciones derivadas del derecho a la información y el consentimiento. El Real Decreto considera fundamental que exista un alto nivel de competencia, y una nueva enumeración de responsabilidades y funciones de los radiólogos, las cuales se detallan y analizan.(AU)

The Royal Decree 601/2019 of 18th october is the result of the partial transposition into the Spanish legal system of the EURATOM Directive 59/2013. This Royal Decree includes the mandates of the Directive related to the need to justify and optimize medical exposure, including that of asymptomatic people, proposal of stricter requirements regarding the information that must be provided to the patient, registration and notification of the doses of medical-radiological procedures, use of reference levels for diagnosis and the availability of dose-indicating devices. The article reviews the most relevant aspects and novelties related to the principles of justification, optimization, dose control and the obligations derived from the right to information and consent. This Royal Decree considers essential for radiologists to develop a high level of competence and a new list of responsibilities and functions, which are detailed and analysed in this article.(AU)

Royal Decree 601/2019 on justification and optimization: Practical aspects.

The Royal Decree 601/2019 of 18th October is the result of the partial transposition into the Spanish legal system of the Euratom Directive 59/2013. This Royal Decree includes the mandates of the Directive related to the need to justify and optimize medical exposure, including that of asymptomatic people, proposal of stricter requirements regarding the information that must be provided to the patient, registration and notification of the doses of medical-radiological procedures, use of reference levels for diagnosis and the availability of dose-indicating devices. The article reviews the most relevant aspects and novelties related to the principles of justification, optimization, dose control and the obligations derived from the right to information and consent. This Royal Decree considers essential for radiologists to develop a high level of competence and a new list of responsibilities and functions, which are detailed and analysed in this article.

Micafungin as antifungal prophylaxis in non-transplanted haemotological patients / Micafungina como profilaxis antifúngica en pacientes hematológicos no trasplantados

INTRODUCTION: Fungal infections are a major cause of morbidity and mortality in the haematological patients. These infections are mainly due to Candida spp. and Aspergillus spp. Mortality by these infections is high, but rates have descended in the latest series due to better antifungal agents. Echinocandins are, in vitro, very active against Candida and Aspergillus spp. The objective of the study is to analyse the efficacy and safety of micafungin in the antifungal prophylaxis of haematological patients on chemotherapy. MATERIAL AND METHODS: A multicentre, observational retrospective study was performed in 7 Haematology Departments in Spain. Patients admitted to these departments with chemotherapy or immunosuppressive treatment, and who had received antifungal prophylaxis with micafungin between 1 January 2009 and 31 December 2014 were included. RESULTS: There were 5 cases of probable or proven fungal infection (4.8%) according to the 2008 EORTC criteria: 2 proven, 3 probable. The types of fungal infection were 3 aspergillosis and 2 candidiasis. There were no drop-outs from the prophylaxis with micafungin due to toxicity. CONCLUSION: Micafungin is an antifungal agent which, used in prophylaxis, has demonstrated good efficacy and an excellent toxicity profile, making it an apparently interesting option in patients requiring antifungal prophylaxis during their hospitalisation episode

INTRODUCCIÓN: Las infecciones fúngicas son una importante causa de morbilidad y mortalidad en los pacientes hematológicos. Estas infecciones son principalmente debidas a Candida spp.y Aspergillus spp. La mortalidad debida a estas infecciones es alta, pero ha descendido a lo largo de las últimas series gracias a los mejores agentes antifúngicos. Las equinocandinas son, in vitro, muy activas contra Candida y Aspergillus spp. El objetivo de este estudio es analizar la eficacia y seguridad de micafungina en la profilaxis antifúngica de pacientes hematológicos en tratamiento quimioterápico. MATERIAL Y MÉTODOS: Un estudio multicéntrico, observacional, retrospectivo se llevó a cabo en 7 servicios de Hematología en España. Se incluyeron los pacientes ingresados con quimioterapia o tratamiento inmunosupresor que hubieran recibido micafungina como profilaxis entre el 1 de enero de 2009 y el 31 de diciembre de 2014. RESULTADOS: Hubo 5 casos de infección fúngica probable o probada (4,8%) según los criterios de la EORTC de 2008: 2 probadas, 3 probables. Las infecciones fúngicas fueron 3 aspergilosis y 2 candidiasis. No hubo ningún abandono de la profilaxis con micafungina debido a toxicidad. CONCLUSIÓN: Micafungina es un agente antifúngico que, usado en profilaxis, ha demostrado buena eficacia y excelente perfil de toxicidad, siendo una opción interesante en pacientes que requieren profilaxis antifúngica durante su hospitalización

Micafungin as antifungal prophylaxis in non-transplanted haemotological patients.

OBJECTIVE: Fungal infections are a major cause of morbidity and mortality in the haematological patients. These infections are mainly due to Candida spp. and Aspergillus spp. Mortality by these infections is high, but rates have descended in the latest series due to better antifungal agents. Echinocan-dins are, in vitro, very active against Candida and Aspergillus spp. The objective of the study is to analyse the efficacy and safety of micafungin in the antifungal prophylaxis of haema-tological patients on chemotherapy. METHODS: A multicentre, observational retrospective study was performed in 7 Haematology Depart-ments in Spain. Patients admitted to these departments with chemotherapy or immunosuppressive treatment, and who had received antifungal prophylaxis with micafungin between 1 January 2009 and 31 December 2014 were included. RESULTS: There were 5 cases of probable or proven fun-gal infection (4.8%) according to the 2008 EORTC criteria: 2 proven, 3 probable. The types of fungal infection were 3 as-pergillosis and 2 candidiasis. There were no drop-outs from the prophylaxis with micafungin due to toxicity. CONCLUSIONS: Micafungin is an antifungal agent which, used in prophylaxis, has demonstrated good efficacy and an excellent toxicity profile, making it an apparently interesting option in patients requiring antifungal prophylaxis during their hospitalisation episode.

Establishing a baseline for a national paediatric antimicrobial stewardship programme.

BACKGROUND: The majority of antimicrobial stewardship programmes focus on prescribing in adult populations; however, there is a recognized need for targeted paediatric antimicrobial stewardship to improve the quality and safety of prescribing amongst this patient group. OBJECTIVES: To describe the current epidemiology of antimicrobial prescribing in paediatric inpatient populations in Scotland to establish a baseline of evidence and identify priority areas for quality improvement to support a national paediatric antimicrobial stewardship programme. METHODS: A total of 559 paediatric inpatients were surveyed during the Scottish national point prevalence survey of healthcare-associated infections and antimicrobial prescribing, 2016. The prevalence of antimicrobial prescribing was calculated and characteristics of antimicrobial prescribing were described as proportions and compared between specialist hospitals and paediatric wards in acute hospitals. RESULTS: Prevalence of antimicrobial use in paediatric inpatients was 35.4% (95% CI = 31.6%-39.4%). Treatment of community- and hospital-acquired infections accounted for 47.1% and 20.7% of antimicrobial use, respectively, with clinical sepsis being the most common diagnosis and gentamicin the most frequently prescribed antimicrobial for the treatment of infection. The reason for prescribing was documented in the notes for 86.5% of all prescriptions and, of those assessed for compliance against local policy, 92.9% were considered compliant. CONCLUSIONS: Data from national prevalence surveys are advantageous when developing antimicrobial stewardship programmes. Results have highlighted differences in the prescribing landscape between paediatric inpatient populations in specialist hospitals and acute hospitals, and have informed priorities for the national antimicrobial stewardship programme, which reinforces the need for a targeted paediatric antimicrobial stewardship programme.

Cribado de riesgos derivados del consumo de drogas utilizando la herramienta ASSIST (Alcohol, smoking and substances involvement screening test) en pacientes de atención primaria: estudio transversal / Drug using risks screening in primary care patients using the ASSIST test: Cross sectional study

Objetivo: El objetivo es estimar la prevalencia de consumos de riesgo de drogas y patrones de consumo en atención primaria. Diseño: Estudio multicéntrico descriptivo transversal. Emplazamiento: Cinco centros de salud del área Sur de Madrid. Participantes: Población consultante en atención primaria entre 16-100 años. Mediciones: Se utilizó el test ASSIST validado al castellano de la Organización Mundial de la Salud para el cribado de consumo de drogas. Se calculó la puntuación total para cada droga. Resultados: Se realizaron un total de 441 cribados. La edad media fue de 51,3 años y un 56,1% presentó algún consumo de riesgo moderado o grave para alguna de las 9 sustancias cribadas. Las drogas con cribado de riesgo más consumidas fueron el tabaco (41,7%), el alcohol (15,4%), los sedantes o los hipnóticos (13,7%) y el cannabis (5,7%), encontrándose algunas diferencias: los hombres consumían más alcohol y cannabis; las mujeres tenían mayor consumo de sedantes/hipnóticos que los hombres. Se observó policonsumo en un 16% de los sujetos. Conclusiones: Existen riesgos derivados del consumo tabaco, alcohol, sedantes y cannabis en atención primaria. Existe una mayor prevalencia de sedantes e hipnóticos

Objective: The aim of this study is to estimate risky-drug use patterns of consumption of primary care patients. Design: Multicentric descriptive cross-sectional study. Setting: five primary health care centers of the South of Madrid. Participants: all patients between 16-100 year-old consulting with their family physician. Measurements: Spanish-validated World Health Organization ASSIST test was use to screen risky drug use in primary care. Total points scored at the test were obtained. Results: A sum of 441 screening test were collected. Mean age was 51,3 years and 51.6% of patients presented a moderate-severe risky drug use out of the nine drugs tested. The more frequent drug use screened were tobacco (41.7%) followed by alcohol (15.4%), hypnotics (13.7%) and cannabis (5.7%). Differences were found between genders in the patterns: men had higher risky drug uses compared to women regarding alcohol and cannabis. Women had higher sedatives/hypnotics consumption prevalence. A 16% of patients presented with polyconsumption drug use patterns. Conclusions: There is risk derived from drug misuse in primary care for tobacco, alcohol, hypnotics and cannabis as detected by the ASSIST test. There is a higher rate of hypnotics than expected

[Drug using risks screening in primary care patients using the ASSIST test: Cross sectional study]. / Cribado de riesgos derivados del consumo de drogas utilizando la herramienta ASSIST (Alcohol, smoking and substances involvement screening test) en pacientes de atención primaria: estudio transversal.

OBJECTIVE: The aim of this study is to estimate risky-drug use patterns of consumption of primary care patients. DESIGN: Multicentric descriptive cross-sectional study. SETTING: five primary health care centers of the South of Madrid. PARTICIPANTS: all patients between 16-100 year-old consulting with their family physician. MEASUREMENTS: Spanish-validated World Health Organization ASSIST test was use to screen risky drug use in primary care. Total points scored at the test were obtained. RESULTS: A sum of 441 screening test were collected. Mean age was 51,3 years and 51.6% of patients presented a moderate-severe risky drug use out of the nine drugs tested. The more frequent drug use screened were tobacco (41.7%) followed by alcohol (15.4%), hypnotics (13.7%) and cannabis (5.7%). Differences were found between genders in the patterns: men had higher risky drug uses compared to women regarding alcohol and cannabis. Women had higher sedatives/hypnotics consumption prevalence. A 16% of patients presented with polyconsumption drug use patterns. CONCLUSIONS: There is risk derived from drug misuse in primary care for tobacco, alcohol, hypnotics and cannabis as detected by the ASSIST test. There is a higher rate of hypnotics than expected.

Results from the third Scottish National Prevalence Survey: is a population health approach now needed to prevent healthcare-associated infections?

BACKGROUND: Healthcare-associated infections (HCAIs) are a major public health concern and a significant cause of morbidity and mortality. A robust and current evidence base that is specific to local, national and Europe-wide settings is necessary to inform the development of strategies to reduce HCAI and contain antimicrobial resistance. AIM: To measure the prevalence of HCAI and antimicrobial prescribing and identify key priority areas for interventions to reduce the burden of infection. METHODS: A national rolling point-prevalence survey (PPS) in National Health Service (NHS) acute, NHS non-acute, NHS paediatric, and independent hospitals was carried out between September and November 2016 using the European Centre for Disease Prevention and Control protocol designed for the European PPS. FINDINGS: The prevalence of HCAI was 4.6%, 2.7%, and 3.2% in acute adults, paediatric and non-acute patient groups, respectively. The most frequent HCAI types reported in adult patients were urinary tract infection and pneumonia. The prevalence of antimicrobial prescribing was 35.7%, 29.3%, and 13.8% in acute adults, paediatric, and non-acute patient groups, respectively. Respiratory, skin and soft tissue, gastrointestinal, and urinary tract infections were the most common infections being treated at the time of survey. CONCLUSION: HCAI continues to be a public health concern in Scotland. Urinary tract infection and pneumonia continue to place a significant burden on patients and on healthcare delivery, including those that develop in the community and require hospital admission. A broader population health approach which focuses on reducing the risk of infection upstream would reduce these infections in both community and hospital settings.

Neuroprotective Effects of Selected Microbial-Derived Phenolic Metabolites and Aroma Compounds from Wine in Human SH-SY5Y Neuroblastoma Cells and Their Putative Mechanisms of Action.

Moderate wine consumption has shown the potential to delay the onset of neurodegenerative diseases. This study investigates the molecular mechanisms underlying the protective effects of wine-derived phenolic and aroma compounds in a neuroinflammation model based on SIN-1 stress-induced injury in SH-SY5Y neuroblastoma cells. Cell pretreatment with microbial metabolites found in blood after wine consumption, 3,4-dihydroxyphenylacetic (3,4-DHPA), 3-hydroxyphenylacetic acids and salicylic ß-d-O-glucuronide, at physiologically concentrations (0.1-10 µM) resulted in increased cell viability versus SIN-1 control group (p < 0.05). Results also showed significant decreases in mitogen-activated protein kinase (MAPK) p38 and ERK1/2 activation as well as in downstream pro-apoptotic caspase-3 activity by some of the studied compounds. Moreover, pretreatment with p38, MEK, and ERK1/2-specific inhibitors, which have a phenolic-like structure, also resulted in an increase on cell survival and a reduction on caspase-3 activity levels. Overall, these results contribute with new evidences related to the neuroprotective actions of wine, pointing out that wine-derived human metabolites and aroma compounds may be effective at protecting neuroblastoma cells from nitrosative stress injury by inhibiting neuronal MAPK p38 and ERK1/2, as well as downstream caspase 3 activity.

Leiomiosarcoma de arteria pulmonar: una enfermedad infrecuente y de difícil diagnóstico / Pulmonary artery leiomyosarcoma: uncommon and difficult to diagnose

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The expression level of BAALC-associated microRNA miR-3151 is an independent prognostic factor in younger patients with cytogenetic intermediate-risk acute myeloid leukemia.

Acute myeloid leukemia (AML) is a heterogeneous disease whose prognosis is mainly related to the biological risk conferred by cytogenetics and molecular profiling. In elderly patients (⩾60 years) with normal karyotype AML miR-3151 have been identified as a prognostic factor. However, miR-3151 prognostic value has not been examined in younger AML patients. In the present work, we have studied miR-3151 alone and in combination with BAALC, its host gene, in a cohort of 181 younger intermediate-risk AML (IR-AML) patients. Patients with higher expression of miR-3151 had shorter overall survival (P=0.0025), shorter leukemia-free survival (P=0.026) and higher cumulative incidence of relapse (P=0.082). Moreover, in the multivariate analysis miR-3151 emerged as independent prognostic marker in both the overall series and within the unfavorable molecular prognostic category. Interestingly, the combined determination of both miR-3151 and BAALC improved this prognostic stratification, with patients with low levels of both parameters showing a better outcome compared with those patients harboring increased levels of one or both markers (P=0.003). In addition, we studied the microRNA expression profile associated with miR-3151 identifying a six-microRNA signature. In conclusion, the analysis of miR-3151 and BAALC expression may well contribute to an improved prognostic stratification of younger patients with IR-AML.

Lesión medular traumática en la infancia y adolescencia en Asturias / Traumatic spinal cord injury in children and adolescents in Asturias

Introducción. La lesión medular traumática es rara en la infancia, pero con graves complicaciones. Objetivo. Conocer la incidencia, etiología y características sociodemográficas de los pacientes pediátricos y adolescentes con lesión medular traumática en Asturias. Pacientes y métodos. Censo de pacientes entre 0-17 años codificados como ‘lesión medular traumática con o sin fractura vertebral’ en Asturias entre 1934 y 2013. Se recogen variables sociodemográficas, hospitalarias y clínicas. Resultados. Se registran 72 pacientes, la mayoría varones (79,2%), con una edad media de 16 años (rango: 5-17 años). La incidencia en 2011 fue de 7,3 por millón. Predominaron las lesiones completas (68,1%) y la localización dorsal (44,4%). Hubo lesión ósea en el 95,8%, y en la mitad de ellos, afectación de dos o más vértebras. La etiología predominante fueron los accidentes de tráfico (52,1%), sobre todo de vehículos de cuatro ruedas (63,4%), con una mayoría de varones con una edad media de 17 años y una localización dorsal (46,3%). En segundo y tercer lugar se situaron la etiología laboral y la deportiva, con el mismo número de casos. En la laboral predominaron los varones y el nivel torácico (77,8%), y el mecanismo fundamental fue el golpe directo. En la deportiva, la mayoría fueron varones, y la zambullida fue la causa más importante, de predominio cervical. Conclusiones. Son necesarios estudios centrados en este grupo poblacional que permitan determinar sus características diferenciadoras para establecer programas de cuidados adaptados a sus necesidades, así como las medidas preventivas más oportunas para reducir las posibilidades de una lesión con tan graves repercusiones (AU)

Introduction. Traumatic spinal cord injury (TSCI) is rare in childhood, but it has serious complications. Aim. To assess incidence, causes and socio-demographic aspects of TSCI among children and adolescents in Asturias. Patients and methods. It was made a census of children among aged 0-17 years codified as ‘TSCI with or without vertebral fracture’ in Asturias between 1934 and 2013. Socio-demographic, hospital and clinical variables were picked up. Results. In total 72 patients were registered, most of them males (79.2%), with an average age of 16 (range: 5-17). The estimated incidence in 2011 was found to be 7.3/million children/year for children aged 0-17 years. Complete TSCIs (68.1%) and dorsal localization (44.4%) were found to be more common. There was bone injury in 95.8% with two or more vertebras affected in a half of the cases. The main cause was traffic accidents (52.1%) mainly the four wheels vehicles (63.4%), most of them males with an average age of 17 and dorsal localization (46.3%). On second and third place were work-related injuries and sports-related injuries, with the same number of cases. In work related injuries, males were the majority, with dorsal level (77.8%) and the direct blow was the fundamental mechanism. In sports there were males also the dominant, being diving the most important cause, with cervical level. Conclusions. It is necessary to carry out studies focused on this population group in order to indentify the own characteristics, to establish care and preventive programs, adapted to their necessities (AU)

Utilización del factor VII activado en lavado bronco alveolar en un caso de hemorragia pulmonar / Use of recombinant activated factor VII in bronchoalveolar lavage in a case of pulmonary

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[Traumatic spinal cord injury in children and adolescents in Asturias]. / Lesion medular traumatica en la infancia y adolescencia en Asturias.

INTRODUCTION: Traumatic spinal cord injury (TSCI) is rare in childhood, but it has serious complications. AIM: To assess incidence, causes and socio-demographic aspects of TSCI among children and adolescents in Asturias. PATIENTS AND METHODS: It was made a census of children among aged 0-17 years codified as 'TSCI with or without vertebral fracture' in Asturias between 1934 and 2013. Socio-demographic, hospital and clinical variables were picked up. RESULTS: In total 72 patients were registered, most of them males (79.2%), with an average age of 16 (range: 5-17). The estimated incidence in 2011 was found to be 7.3/million children/year for children aged 0-17 years. Complete TSCIs (68.1%) and dorsal localization (44.4%) were found to be more common. There was bone injury in 95.8% with two or more vertebras affected in a half of the cases. The main cause was traffic accidents (52.1%) mainly the four wheels vehicles (63.4%), most of them males with an average age of 17 and dorsal localization (46.3%). On second and third place were work-related injuries and sports-related injuries, with the same number of cases. In work related injuries, males were the majority, with dorsal level (77.8%) and the direct blow was the fundamental mechanism. In sports there were males also the dominant, being diving the most important cause, with cervical level. CONCLUSIONS: It is necessary to carry out studies focused on this population group in order to indentify the own characteristics, to establish care and preventive programs, adapted to their necessities.

TITLE: Lesion medular traumatica en la infancia y adolescencia en Asturias.Introduccion. La lesion medular traumatica es rara en la infancia, pero con graves complicaciones. Objetivo. Conocer la incidencia, etiologia y caracteristicas sociodemograficas de los pacientes pediatricos y adolescentes con lesion medular traumatica en Asturias. Pacientes y metodos. Censo de pacientes entre 0-17 años codificados como 'lesion medular traumatica con o sin fractura vertebral' en Asturias entre 1934 y 2013. Se recogen variables sociodemograficas, hospitalarias y clinicas. Resultados. Se registran 72 pacientes, la mayoria varones (79,2%), con una edad media de 16 años (rango: 5-17 años). La incidencia en 2011 fue de 7,3 por millon. Predominaron las lesiones completas (68,1%) y la localizacion dorsal (44,4%). Hubo lesion osea en el 95,8%, y en la mitad de ellos, afectacion de dos o mas vertebras. La etiologia predominante fueron los accidentes de trafico (52,1%), sobre todo de vehiculos de cuatro ruedas (63,4%), con una mayoria de varones con una edad media de 17 años y una localizacion dorsal (46,3%). En segundo y tercer lugar se situaron la etiologia laboral y la deportiva, con el mismo numero de casos. En la laboral predominaron los varones y el nivel toracico (77,8%), y el mecanismo fundamental fue el golpe directo. En la deportiva, la mayoria fueron varones, y la zambullida fue la causa mas importante, de predominio cervical. Conclusiones. Son necesarios estudios centrados en este grupo poblacional que permitan determinar sus caracteristicas diferenciadoras para establecer programas de cuidados adaptados a sus necesidades, asi como las medidas preventivas mas oportunas para reducir las posibilidades de una lesion con tan graves repercusiones.

Fiebre y síndrome de Brugada / Fever and Brugada syndrome

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MicroRNA expression at diagnosis adds relevant prognostic information to molecular categorization in patients with intermediate-risk cytogenetic acute myeloid leukemia.

Acute myeloid leukemia (AML) is a heterogeneous disease, and optimal treatment varies according to cytogenetic risk factors and molecular markers. Several studies have demonstrated the prognostic importance of microRNAs (miRNAs) in AML. Here we report a potential association between miRNA expression and clinical outcome in 238 intermediate-risk cytogenetic AML (IR-AML) patients from 16 institutions in the CETLAM cooperative group. We first profiled 670 miRNAs in a subset of 85 IR-AML patients from a single institution and identified 10 outcome-related miRNAs. We then validated these 10 miRNAs by individual assays in the total cohort and confirmed the prognostic impact of 4 miRNAs. High levels of miR-196b and miR-644 were independently associated with shorter overall survival, and low levels of miR-135a and miR-409-3p with a higher risk of relapse. Interestingly, miR-135a and miR-409-3p maintained their independent prognostic value within the unfavorable molecular subcategory (wild-type NPM1 and CEBPA and/or FLT3-ITD), and miR-644 retained its value within the favorable molecular subcategory. miR-409-3p, miR-135a, miR-196b and mir-644 arose as prognostic markers for IR-AML, both overall and within specific molecular subgroups.