Use of off-label medications in a neonatal intensive care unit / Uso de medicamentos off-label em unidade de terapia intensiva neonatal

ABSTRACT Objective: This paper aims to analyze the use of off label (OL) medicines, according to the National Regulatory Agency, in a neonatal intensive care unit of a high-risk maternity hospital in Northeast Brazil. Methods: A cross-sectional study was carried out, using a convenience sample of newborns that used mechanical ventilation at the Intensive Care Unit. As a reference, OL medications were considered for those without an approval for newborn usage by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) and by the Food and Drugs Administration (FDA). Results: The sample consisted of 158 newborns, 58.3% male, 87.7% premature, and 70.2% of low or very low birth weight. According to ANVISA, 440 out of the 1,167 prescriptions analyzed were OL, with 98.1% of newborns exposed to at least one of these drugs. According to the FDA, 484 prescriptions were OL, with 75.8% of newborns exposed to at least one of them. Anti-infectives were the most prescribed OL medications. Neonates who presented respiratory failure and pneumonia used these drugs more often; and there was no relation between their use and the number of deaths. Conclusions: Nearly all newborns at the Intensive Care Units, mainly preterm infants, are exposed to at least one off-label (OL) medication during hospital stay, according to the national and international regulatory agencies. No association was found between off-label prescriptions and the frequency of complications or neonatal deaths.

RESUMO Objetivo: Analisar o uso de medicamentos off-label (OL), segundo a agência reguladora nacional, em unidade de terapia intensiva neonatal de uma maternidade de alto risco em Aracaju. Métodos: Foi realizado um estudo transversal, utilizando amostra de conveniência de recém-nascidos (RN) da Unidade Intensiva, que fizeram uso de ventilação mecânica. Consideramos OL o medicamento que não era liberado para uso em RN nos bulários eletrônicos da Agência Nacional de Vigilância Sanitária (ANVISA) e da U.S. Food and Drug Administration (FDA). Resultados: A amostra consistiu de 158 neonatos, sendo 58,3% do sexo masculino, 87,7% prematuros e 70,2% com baixo ou muito baixo peso. De acordo com a ANVISA, das 1.167 prescrições analisadas, 440 foram OL, com 98,1% dos RN expostos a pelo menos um desses medicamentos. Já para a FDA, 484 prescrições foram OL, com 75,8% dos neonatos expostos a pelo menos um deles. As medicações OL mais prescritas foram os anti-infecciosos. Neonatos que apresentaram insuficiência respiratória e pneumonia fizeram mais uso deles e não houve relação entre o seu uso e o número de óbitos. Conclusões: Quase todos os RN internados, principalmente os prematuros, foram expostos a pelo menos um medicamento OL, de acordo com a agência reguladora nacional e internacional, durante a internação. Entretanto, isso não teve relação com a frequência de complicações nem de óbitos neonatais.

Impact of COVID-19 on clinical practice, income, health and lifestyle behavior of Brazilian urologists

ABSTRACT Objectives To evaluate the impact of COVID-19 on clinical practice, income, health and lifestyle behavior of Brazilian urologists during the month of April 2020. Materials and Methods A 39-question, web-based survey was sent to all urologist members of the Brazilian Society of Urology. We assessed socio-demographic, professional, health and behavior parameters. The primary goal was to evaluate changes in urologists' clinical practice and income after two months of COVID-19. We also looked at geographical differences based on the incidence rates of COVID-19 in different states. Results Among 766 urologists who completed the survey, a reduction ≥ 50% of patient visits, elective and emergency surgeries was reported by 83.2%, 89.6% and 54.8%, respectively. An income reduction of ≥ 50% was reported by 54.3%. Measures to reduce costs were implemented by most. Video consultations were performed by 38.7%. Modifications in health and lifestyle included weight gain (32.9%), reduced physical activity (60.0%), increased alcoholic intake (39.9%) and reduced sexual activity (34.9%). Finally, 13.5% of Brazilian urologists were infected with SARS-CoV-2 and about one third required hospitalization. Urologists from the highest COVID-19 incidence states were at a higher risk to have a reduction of patient visits and non-essential surgeries (OR=2.95, 95% CI 1.86 - 4.75; p< 0.0001) and of being infected with SARS-CoV-2 (OR=4.36 95%CI 1.74-10.54, p=0.012). Conclusions COVID-19 produced massive disturbances in Brazilian urologists' practice, with major reductions in patient visits and surgical procedures. Distressing consequences were also observed on physicians' income, health and personal lives. These findings are probably applicable to other medical specialties.

Importancia de la detección temprana de hemoglobinopatias en la población pediátrica en países en desarrollo / Importance of early detection of hemoglobinopathies in the pediatric population in developing countries

OBJETIVO: Alertar al personal de la salud sobre la importancia de la detección temprana de las he- moglobinopatías, dado que es el trastorno monogénico recesivo más frecuente. Pacientes y MÉTODO: Estudio retrospectivo del resultado de eletroforesis capilar (CE) de 152 pacientes entre 0 y 18 años que durante el año 2017 fueron evaluados por sospecha de hemoglobinopatías en un Hospital Universitario de Colombia. La información se tomó de los registros médicos y del Laboratorio de Hematología y Hemostasia, asegurando la privacidad de los datos y aprobado por el Comité de Ética local. RESULTADOS: De 152 pacientes, 48,6% tenía entre 7 y 18 años. La frecuencia de hemoglobinopatías fue de 42,7%. La variante más frecuente fue el rasgo de células falciformes (Hb S) con 14,5%. El hematólogo fue el profesional que más frecuentemente solicitó EC. DISCUSIÓN: Se detectó que las hemoglobinopatías se diagnostican usualmente en niños mayores de siete años. Esto puede favorecer las complicaciones y progresión de la enfermedad, y aumento en los costos de la salud. Se requiere más información y educación a los médicos generales y pediatras para un diagnóstico más temprano.

OBJECTIVE: The objective of this study is to spread awareness among health personnel about the importance of early detection of hemoglobinopathies since it is the most frequent monogenic recessive disorder worldwide. PATIENTS AND METHOD: Retrospective study of the results of capillary electropho resis (CE) of 152 patients aged between 0 and 18 years who were evaluated in 2017 due to suspected hemoglobinopathies in a University Hospital in Colombia. The information was collected from me dical records and the Hematology and Hemostasis Laboratory, ensuring data privacy and approved by the local Ethics Committee. RESULTS: Of 152 patients, 48.6% were aged between 7 and 18. The frequency of hemoglobinopathies was 42.7%. The most frequent hemoglobin variant was the sickle cell trait (Hb S) with 14.5%. The hematologist was the professional who most frequently requested CE. DISCUSSION: We found that hemoglobinopathies are usually diagnosed late in pediatric patients. This may favor complications and progression of the disease and increase healthcare costs. More information and education are required for general physicians and pediatricians in order to achieve early diagnosis.

Variabilidad terapéutica en lactantes con bronquiolitis hospitalizados en unidades de cuidados intensivos latinoamericanas / Therapeutic variability in infants admitted to Latin-American pediatric intensive units due to acute bronchiolitis

Resumen: Objetivo: describir las terapias utilizadas en lactantes con bronquiolitis aguda admitidos en 20 Uni dades de Cuidados Intensivos (UCI) pediátricos miembros de LARed en 5 países latinoamerica nos. Pacientes y Método: Estudio observacional retrospectivo, multicéntrico, de datos del Registro Latinoamericano de Falla Respiratoria Aguda Pediátrica. Se incluyeron niños menores de 2 años ingresados a UCI pediátrica por bronquiolitis aguda comunitaria entre mayo-septiembre 2017. Se recolectaron datos demográficos, clínicos, soporte respiratorio, terapias utilizadas y resultados clí nicos. Se realizó análisis de subgrupos según ubicación geográfica, tipo financiación y presencia de academia. Resultados: Ingresaron al registro 1155 pacientes con falla respiratoria aguda. Seis casos fueron excluidos por no tener formulario completo. De los 1147 pacientes, 908 eran menores de 2 años. De ellos, 467 tuvieron diagnóstico de bronquiolitis aguda, correspondiendo a la principal causa de ingreso a UCI pediátrica por falla respiratoria aguda (51,4%). Las características demográficas y de gravedad entre los centros fueron similares. El soporte máximo respiratorio más frecuente fue cánula nasal de alto flujo (47%), seguido por ventilación mecánica no invasiva (26%) y ventilación mecánica invasiva (17%), con un coeficiente de variación (CV) amplio entre los centros. Hubo una gran dispersión en uso de terapias, siendo frecuente el uso de broncodilatadores, antibióticos y corticoides, con CV hasta 400%. El análisis de subgrupos mostró diferencias significativas en soporte respiratorio y tratamientos utilizados. Un paciente falleció en esta cohorte. Conclusión: Detectamos gran variabilidad en el soporte respiratorio y tratamientos entre UCI pediátricas latinoamericanas. Esta variabilidad no es explicada por disparidades demográficas ni clínicas. Esta heterogeneidad de tratamientos debería promover iniciativas colaborativas para disminuir la brecha entre la evidencia científica y la práctica asistencial.

Abstract: The objective of this study was to describe the management of infants with acute bronchiolitis admit ted to 20 pediatric intensive care units (PICU) members of LARed in 5 Latin American countries. Pa tients and Method: Retrospective, multicenter, observational study of data from the Latin American Registry of Acute Pediatric Respiratory Failure. We included children under 2 years of age admitted to the PICU due to community-based acute bronchiolitis between May and September 2017. Demo graphic and clinical data, respiratory support, therapies used, and clinical results were collected. A subgroup analysis was carried out according to geographical location (Atlantic v/s Pacific), type of insurance (Public v/s Private), and Academic v/s non-Academic centers. Results: 1,155 patients were included in the registry which present acute respiratory failure and 6 were excluded due to the lack of information in their record form. Out of the 1,147 patients, 908 were under 2 years of age, and out of those, 467 (51.4%) were diagnosed with acute bronchiolitis, which was the main cause of admission to the PICU due to acute respiratory failure. The demographic and severity characteristics among the centers were similar. The most frequent maximum ventilatory support was the high-flow nasal can nula (47%), followed by non-invasive ventilation (26%) and invasive mechanical ventilation (17%), with a wide coefficient of variation (CV) between centers. There was a great dispersion in the use of treatments, where the use of bronchodilators, antibiotics, and corticosteroids, representing a CV up to 400%. There were significant differences in subgroup analysis regarding respiratory support and treatments used. One patient of this cohort passed away. Conclusion: we detected wide variability in respiratory support and treatments among Latin American PICUs. This variability was not explained by demographic or clinical differences. The heterogeneity of treatments should encourage collabora tive initiatives to reduce the gap between scientific evidence and practice.

Analysis of psychiatrists' prescription of opioid, benzodiazepine, and buprenorphine in Medicare Part D in the United States

Abstract Introduction The opioid epidemic is a severe problem in the world, especially in the United States, where prescription opioid overdose accounts for a quarter of drug overdose deaths. Objective To describe psychiatrists' prescription of opioid, benzodiazepine, and buprenorphine in the United States. Methods We conducted a retrospective cross-sectional study of the 2016 Medicare Part D claims data and analyzed psychiatrists' prescriptions of: 1) opioids; 2) benzodiazepines, whose concurrent prescription with opioids can cause overdose death; 3) buprenorphine, a partial opioid agonist for treating opioid addiction; 4) and naltrexone microsphere, a once-monthly injectable opioid antagonist to prevent relapse to opioid dependence. Prescribers with 11 or more claims were included in the analysis. Results In Medicare Part D in 2016, there were a total of 1,131,550 prescribers accounting for 1,480,972,766 total prescriptions and 78,145,305 opioid prescriptions, including 25,528 psychiatrists (2.6% of all prescribers) accounting for 44,684,504 total prescriptions (3.0% of all prescriptions) and 131,115 opioid prescriptions (0.2% of all opioid prescriptions). Psychiatrists accounted for 17.3% of benzodiazepine, 16.3% of buprenorphine, and 33.4% of naltrexone microsphere prescriptions. The opioid prescription rate of psychiatrists was much lower than that of all prescribers (0.3 vs 5.3%). The buprenorphine prescription rate of psychiatrists was much higher than that of all prescribers (2.3 vs. 0.1%). There was a substantial geographical variation across the United States. Conclusions The results show that, proportionally, psychiatrists have lower rates of opioid prescription and higher rates of benzodiazepine and buprenorphine prescription.

Migraña Abdominal: variaciones en el diagnóstico y tratamiento entre gastroenterólogos y neurólogos pediatras / Abdominal migraines: variations in diagnosis and care between pediatric gastroenterologists and neurologists

Resumen: Introducción: La migraña abdominal (MA) es infrecuente y poco estudiada. Nuestro objetivo fue investigar el diagnóstico y tratamiento de niños y adolescentes con MA y compararlos entre gastroen terólogos y neurólogos pediatras. Pacientes y Método: Todos los cuadros de MA (1-18 años) de un hospital de EE. UU, con diagnóstico de MA o sus variantes (ICD-9 346.2 o IC-10 G43.D, G43.D0, G43.D1) entre 2011-2017 fueron revisados. La información sobre diagnóstico, intervalo desde inicio de síntomas, criterios diagnósticos, pruebas diagnósticas, tratamiento y resultado se analizaron. Re sultados: Sesenta y nueve historias médicas fueron identificadas. La edad media al diagnóstico fue 9,7 años. El 48% de los pacientes fueron del sexo femenino. Cincuenta (72,4%) pacientes fueron tratados solo por gastroenterólogos pediatras, y 10/69 (14,5%) por neurológos pediatras exclusivamente. 6/69 (8,7%) fueron inicialmente evaluados por gastroenterología y posteriormente referidos a neurología, y 2/69 (2,9%) fueron inicialmente evaluados por neurología y luego referidos a gastroenterología. 3/10 (30%) de las MA diagnosticadas por neurólogos no mencionaban que el paciente tuviera dolor abdominal, sin embargo, todos los diagnósticos realizados por gastroenterólogos presentaron dicho síntoma (p=0,0035). 5/50 (10%) de las historias médicas de gastroenterología y ninguna de las histo rias de neurología mencionaban los criterios de Roma. Conclusiones: La mayoría de los niños fueron diagnosticados por pediatras gastroenterólogos. Los gastroenterólogos rara vez utilizaron los criterios de Roma. Pacientes evaluados por neurología son frecuentemente diagnosticados con MA, incluso sin presentar dolor abdominal (criterio necesario para el diagnóstico). Se recomienda educación para el correcto y oportuno diagnóstico de la migraña abdominal.

Abstract: Introduction: Abdominal migraine (AM) is uncommon and understudied. Our objective was to investigate the diagnosis and treatment of children and adolescents with AM and compare with that of pediatric gastroenterologists and neurologists. Patients and Method: All AM cases (1-18 years) from a USA hospital with diagnosis of abdominal migraine or its variants (ICD-9 346.2 or IC-10 G43.D, G43.D0, G43.D1) between 2011 and 2017 were reviewed. Information on diagnosis, interval from onset of symptoms, diagnostic criteria, diagnostic tests, treatment, and outcome were analyzed. Results: 69 medical records were identified. The mean age at diagnosis was 9.7 years, and 48% of patients were female. 50/69 (72.4%) patients were exclusively treated by a pediatric gastroenterologist and 10/69 (14.5%) exclusively by a pediatric neurologist. 6/69 (8.7%) were initially evaluated by gas troenterology and referred to neurology, and 2/69 (2.9%) were initially evaluated by neurology and then referred to gastroenterology. 3/10 (30%) of the AM diagnosed by neurologists did no report ab dominal pain (AP), however, all diagnoses made by gastroenterologists did (p = 0.0035). 5/50 (10%) of the gastroenterology medical records and no neurology medical records mentioned Rome criteria. Conclusions: Most of the children were diagnosed by pediatric gastroenterologists. Gastroenterolo gists rarely use the Rome criteria. Patients evaluated by neurologists are frequently diagnosed with AM even without AP (a criterion that is required for its diagnosis). Education is recommended for the correct and timely diagnosis of AM.

Profile and generalist physician knowledge about neurology in emergency department: headache management / Perfil e conhecimento em neurologia do médico generalista no setor de emergência: abordagem de cefaleias

Abstract Background: Neurological complaints are frequent in emergency department routine. Among them, headache is a common disorder, which requires a certain degree of knowledge on Neurology because of its extensive differential diagnosis. Objective: To assess general practice physicians' level of knowledge about headaches, in addition to outlining the profile of professionals who attend in emergency departments, as well as the profile of their respective workplaces in terms of neurological approach. Methods: We included in evaluation physicians who attend emergency care units for adult public as general practitioners. A questionnaire was applied with questions regarding participants' general knowledge on headache, neurological approach, demographic profile, and workplace profile. Results: 159 physicians answered the questionnaire. The professionals' profile corresponded to recently graduated individuals (mean of 6.31 years). Knowledge about headache management was regular. Those who do not have any specialization or are not majoring a specialization were statistically significantly more confident in neurological patients care (p=0.006). Only 18.24% reported access to Magnetic Resonance Imaging and 35.85% had no access to any type of neuroimaging. Conclusions: General practice physicians often do not feel confident when performing neurological exams, demonstrating low knowledge about the topic. The profile of professionals working in these departments is predominantly of newly graduates, which may affect in some way on care quality. There was also a lack of structure for adequate care.

Resumo Introdução: Queixas neurológicas são frequentes na rotina de setores de emergência. Entre elas, a cefaleia é um distúrbio comum, que por seu diagnóstico diferencial amplo, exige certo grau de conhecimento em Neurologia. Objetivo: Avaliar o nível de conhecimento em cefaleias de médicos generalistas, além de traçar o perfil dos profissionais que atendem em setores de emergência nesta função, assim como de seus respectivos locais de trabalho em termos de abordagem neurológica. Métodos: Foram incluídos na avaliação médicos que atendem em unidades de pronto-atendimento para público adulto, na função de generalista. Um questionário foi aplicado com perguntas referentes ao conhecimento geral dos participantes sobre cefaleia, abordagem neurológica, perfil demográfico e perfil do local de trabalho. Resultados: 159 médicos responderam ao questionário. O perfil dos profissionais presentes na amostra correspondeu a indivíduos graduados recentemente (média de 6,31 anos). O conhecimento a respeito da abordagem de cefaleias foi regular. Aqueles que não possuem nenhuma especialização, nem estão cursando uma residência, se mostraram, de forma estatisticamente significativa, mais seguros no atendimento de pacientes neurológicos (p=0,006). Apenas 18,24% referiram ter acesso à Ressonância Magnética e 35,85% não tiveram acesso a nenhum tipo de neuroimagem. Conclusão: Médicos generalistas frequentemente não sentem segurança ao realizar atendimento e exame neurológicos, demonstrando pouco conhecimento acerca do assunto. O perfil dos profissionais que atuam nesses setores é predominantemente de recém graduados, o que pode impactar de alguma forma na qualidade de atendimento. Verificou-se também falta de estrutura para um atendimento adequado.

Practices related to assessment of sedation, analgesia and delirium among critical care pediatricians in Brazil / Práticas relacionadas à avaliação de sedação, analgesia e delirium entre pediatras intensivistas no Brasil

ABSTRACT Objective To understand the use of tools, protocols and comfort measures related to sedation/analgesia, and to screen the occurrence of delirium in pediatric intensive care units. Methods A survey with 14 questions was distributed by e-mail to Brazilian critical care pediatricians. Eight questions addressed physician and hospital demographics, and six inquired practices to assess sedation, analgesia, and delirium in pediatric intensive care units. Results Of 373 questionnaires sent, 61 were answered (16.3%). The majority of physicians were practicing in the Southeast region (57.2%). Of these, 46.5% worked at public hospitals, 28.6% of which under direct state administration. Of respondents, 57.1% used formal protocols for sedation and analgesia, and the Ramsay scale was the most frequently employed (52.5%). Delirium screening scores were not used by 48.2% of physicians. The Cornell Assessment of Pediatric Delirium was the score most often used (23.2%). The majority (85.7%) of physicians did not practice daily sedation interruption, and only 23.2% used non-pharmacological measures for patient comfort frequently, with varied participation of parents in the process. Conclusion This study highlights the heterogeneity of practices for assessment of sedation/analgesia and lack of detection of delirium among critical care pediatricians in Brazil.

RESUMO Objetivo Compreender o uso de ferramentas, protocolos e medidas de conforto relacionadas à sedação/analgesia, além de rastrear a presença de delirium em unidades de terapia intensiva pediátricas. Métodos Um inquérito com 14 questões foi distribuído, por meio de correio eletrônico, para médicos pediatras intensivistas brasileiros. Oito questões eram sobre os dados demográficos dos médicos e dos hospitais, e seis questões eram sobre as práticas na avaliação da sedação, analgesia e delirium em unidades de terapia intensiva pediátrica. Resultados Responderam ao inquérito 61 médicos dos 373 e-mails enviados (taxa de resposta de 16,3%). A maioria dos médicos era da Região Sudeste (57,2%) e 46,5% trabalhavam em hospitais públicos, sendo 28,6% sob administração direta do Estado. Dos respondedores, 57,1% utilizavam protocolos formais de sedação e analgesia, sendo a escala de Ramsay a mais utilizada (52,5%). Não utilizavam escores de rastreamento de delirium 48,2% dos médicos, e o Cornell Asssessment of Pediatric Delirium (23,2%) foi o mais utilizado. A maioria (85,7%) dos médicos não utilizou a prática da interrupção diária da sedação, e apenas 23,2% utilizavam medidas não farmacológicas para o conforto do paciente com frequência, com a participação heterogênea dos pais nesse processo. Conclusão Este estudo destaca a heterogeneidade nas práticas de avaliação da sedação/analgesia e insuficiência de rastreamento de delirium entre os intensivistas pediátricos brasileiros.

Physicians' behavior regarding non-acceptance of oral restriction (nil per os) by dysphagic patient with risk of laryngotracheal aspiration / Comportamento do médico diante da não aceitação de restrição da via oral pelo paciente disfágico com risco de aspiração laringotraqueal

ABSTRACT Objective: To define physician´s behavior in the face of a mentally capable elderly dysphagic patients at risk of pulmonary aspiration, who do not accept oral restriction. Methods: Observational, cross-sectional study, presenting a clinical case of an independent elderly with clinical complaints of dysphagia and laryngotracheal aspiration by flexible endoscopic evaluation of swallowing who rejected the proposal to restrict oral diet. A questionnaire about the patient's decision-making process was used to assess whether the physician was sympathetic and justify their answer, and if they are aware of hierarchy of ethical principles (recognition of the person´s value, autonomy, beneficence, nonmaleficence and justice), in the decision-making process, and which was the main principle that guided their decision. Results: One hundred participants were classified by time since graduation as Group I (less than 10 years) and Group II (more than 10 years). Of them, 60% agreed with the patient's decision, with no difference between the groups. The main reason was autonomy of patients, in both groups. Among those who were not sympathetic, the main argument was beneficence and nonmaleficence, considering the risk between benefit and harm. As to awareness about the hierarchy of principles, we did not find differences between the groups. Autonomy was the principle that guided those who were sympathetic with the patient's decision, and justice among those who didnot agree. Conclusion: Physicians were sympathetic with the patient's decision regarding autonomy, despite the balance between risks of beneficence and nonmaleficence, including death. We propose to formalize a non-compliance term.

RESUMO Objetivo: Definir o comportamento médico diante de paciente idoso disfágico com risco de aspiração laringotraqueal e mentalmente capaz que não aceita a restrição da via oral. Métodos: Estudo observacional, transversal. Apresentamos um caso clínico de idoso, que vive independente, com queixas clínicas e videoendoscopia da deglutição comprovando disfagia e aspiração, que recusou a proposta de restrição da via oral. Um questionário foi aplicado sobre o processo de decisão do paciente, procurando avaliar se o médico torna-se solidário, e que justifique sua resposta, e se tem ciência da hierarquia dos princípios éticos (reconhecimento do valor da pessoa, autonomia, beneficência, não maleficência e justiça), no processo de decisão e qual o principal princípio que norteia sua decisão. Resultados: Cem participantes foram classificados por tempo de formados em Grupo I (até 10 anos) e Grupo II (mais de 10 anos). Deles 60% tornaram-se solidários à decisão do paciente, sem diferença entre os grupos. O principal argumento foi a autonomia do paciente nos dois grupos. Entre os não solidários, foi o binômio beneficência e não maleficência, e o balanço do risco/benefício e malefício. Considerando a ciência sobre a hierarquia dos princípios que regem a decisão, não encontramos diferença entre eles. A autonomia foi o principal princípio na decisão entre os solidários e a justiça entre os não solidários. Conclusão: O médico foi solidário à decisão do paciente em respeito à sua autonomia, apesar dos riscos ponderados da beneficência e da maleficência, inclusive de morte. Propomos o termo de recusa de conduta formalizada.

Safe surgery: analysis of physicians adherence to protocols, and its potential impact on patient safety / Cirurgia segura: análise da adesão do protocolo por médicos e possível impacto na segurança do paciente

ABSTRACT Objectives : to identify surgeons' knowledge and compliance rate to the Safe Surgery Protocol, as well as to assess the incidence of surgery-related adverse events, including patients' knowledge about the protocol. Methods: this is a cross-sectional and prospective study. An instrument was developed to collect the socio-graphic characteristics of sixty-eight surgeons and residents, their knowledge and adherence to the safe surgery protocol. Eighty-two patients were assessed regarding their awareness about the surgical procedure. The operating environment was also evaluated. Descriptive statistics and the odds ratio are presented. Results: the surgeons, despite their previous contact with the protocol throughout the graduation period, were poorly compliant with it. Adverse events such as the use of uncalibrated equipments or the presence of foreign bodies in several equipments such as drills and cautery pens were identified. In addition, some of the adverse events were identified and fixed, after patients had already been anesthesized, but before the beginning of the surgical procedure. Patients demonstrated knowledge about the operation they would undergo, but they did not know about its duration, and they were not introduced to the surgical team. Conclusion: there were failures in the dynamics and compliance regarding some phases of the protocol, which may impact the laterality errors and patient safety.

RESUMO Objetivo: identificar o conhecimento e a taxa de adesão ao Protocolo de Cirurgia Segura pelos cirurgiões, assim como a incidência de eventos adversos relacionados à operação, além do conhecimento dos pacientes sobre o protocolo. Métodos: estudo transversal, prospectivo com caráter quantitativo. Para a coleta de dados, foi elaborado, pelos autores, um instrumento que coletou o perfil sócio gráfico de sessenta e oito cirurgiões e residentes, o conhecimento e a adesão destes ao protocolo de cirurgia segura. Oitenta e dois pacientes foram entrevistados, e o ambiente de cirurgia avaliado. Os dados foram analisados de maneira descritiva e teste Razão das Chances com Índice de Confiança (IC) de 95%. Resultados: parte dos cirurgiões demonstraram que apesar do contato com o protocolo durante o período de formação, houve deficiência à adesão, ocasionando eventos adversos como o uso de equipamentos não calibrados ou presença de corpos estranhos nos equipamentos, como brocas e canetas. Além disso, foi constatado que em pacientes já anestesiados, as falhas foram percebidas e reparadas antes do começo do procedimento. No caso dos pacientes, estes demonstraram conhecimento quanto à cirurgia que iriam realizar, porém não sabiam a duração da mesma ou tinham sido introduzidos à equipe cirúrgica. Conclusão: houve falhas na dinâmica e na adesão de algumas etapas do protocolo, prejudicando a lateralidade no processo e a segurança do paciente.

Factors influencing achievement of low-density lipoprotein cholesterol goals in mexico: the international cholesterol management practice study

ABSTRACT Background The International Cholesterol Management Practice Study is a multinational collaborative effort to describe the effectiveness of the lipid-lowering therapy (LLT) as well as the main barriers to achieve the low-density lipoprotein cholesterol (LDL-C) goals Objective The objective of the study was to investigate factors associated with the achievement of LDL-C goals in Mexico using real-life data Methods This was a cross-sectional observational study from 18 physicians across different health facilities in Mexico, who provided information about their practices between August 2015 and August 2016. We included patients treated for ≥3 months with any LLT in whom LDL-C measurement on stable LLT was available for the previous 12 months Results We included 623 patients with a mean age of 59.3 ± 12.7 years; 55.6% were women. The mean LDL-C value on LLT was 141.8 ± 56.1 mg/dL. At enrollment, 97.4% of patients were receiving statin therapy (11.3% on high-intensity treatment). Only 24.8% of the very-high cardiovascular (CV) risk patients versus 26.4% of the high risk and 52.4% of the moderate risk patients achieved their LDL-C goals. Independent factors associated with non-achievement of LDL-C goal were statin intolerance, overweight and obesity, abdominal obesity, female sex, high CV risk, use of public health-care service, metabolic syndrome, type 2 diabetes, and hypertriglyceridemia. Higher-level of education was associated with a lower risk of not achieving LDL-C goals Conclusions Achievement of LDL-C goals is suboptimal in Mexico, especially in patients with the highest CV risk. The main barriers to achieve the goal are easily detectable. Implementation of LLT should be adapted to the patient’s needs and profile.

Diferencias en el tratamiento antitrombótico y pronóstico en función del sexo en pacientes con síndrome coronario agudo tratados con stent / Sex-specific differences in antithrombotic therapy and prognosis in patients with acute coronary syndrome treated with stent

Resumen Antecedentes y objetivo: El interés sobre la influencia del sexo en pacientes con síndrome coronario agudo (SCA) tratados con stent y nuevos antiagregantes inhibidores de P2Y12 en la práctica clínica es creciente. Se analizan las diferencias en función del sexo en el tratamiento con doble antiagregación plaquetaria (DAPT) y los eventos adversos isquémicos y hemorrágicos Materiales y métodos: Estudio prospectivo de pacientes consecutivos con diagnóstico de SCA tratados con stent coronario desde julio de 2015 hasta enero de 2016. Resultados: De un total de 283 pacientes incluidos, 75 (26.5%) correspondió a mujeres y 208 (73.5%) a hombres. La edad media fue de 71 ± 13 y 66.5 ± 13 años, respectivamente. Un 44% de mujeres se presentó como SCA con elevación del segmento ST contra un 52.4 de los hombres, p = 0.21. Las mujeres mostraron un mayor riesgo de sangrado (CRUSADE), sin diferencias en el riesgo isquémico (GRACE y TIMI). Se usaron stents farmacoactivos con más frecuencia en mujeres (88.9 vs. 75.5%, p = 0.04). Se observó una tendencia de menor prescripción del ticagrelor en mujeres (42.6 vs. 50.9%, p = 0.29) en favor de un mayor uso del clopidogrel. No se identificaron diferencias en cuanto a la prescripción del prasugrel. Las mujeres presentaron al año una menor mortalidad (1.4 vs. 6.7%, p = 0.19), aunque mayor sangrado (23.3 vs. 17.4%, p = 0.27). Conclusiones: En este estudio de pacientes consecutivos con SCA tratados con stent se registró una mayor prescripción de clopidogrel en las mujeres que en los hombres. Las mujeres presentaron una menor incidencia anual de mortalidad, pero mayor sangrado en comparación con los hombres, no significativo.

Abstract Aims and objective: Impact of sex-related differences in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention and treated with new P2Y12 inhibitors is not adequately characterised. We aimed to analyse gender-based differences in dual antiplatelet therapy, and adverse cardiovascular events and bleeding. Materials and methods: Prospective-observational study of the consecutive ACS patients treated with stent from July 2016 to January 2016, with a follow-up of 1 year. Results: We examined 283 patients, 75 (26.5%) women and 208 (73.5%) men. Women were older than men (71 ± 13 vs. 66,5 ± 13 years). There were 44% of women and 52% of men presenting with ST-elevation ACS (p = 0.21). Women had a higher bleeding risk (CRUSADE), without differences in the ischaemic risk (GRACE and TIMI). More women were treated with drug-eluting stent (88.9 vs. 75.5%, p = 0.04). There was a lower rate of ticagrelor prescription in women (42.6 vs. 50.9%, p = 0.29), in favour of clopidogrel. No differences were observed in prasugrel prescription. No significant differences were observed after a year of follow up, but women had a tendency towards lower mortality (1.4 vs. 6.7%, p = 0.19) and higher bleeding rates (23.3 vs. 17.4%, p = 0.27). Conclusions: In our study of patients presenting with ACS treated with stent, clopidogrel was preferred in women, whereas ticagrelor was the most frequent prescription in men. No significant differences were noted in clinical outcomes, but women experienced a tendency towards less mortality and more bleeding events.

A census of laparoscopic and robotic urological practice: a survey of minimally invasive surgery department of the Brazilian Society of Urology

ABSTRACT Minimally invasive urologic surgery has been developing in Brazil and now is a routine part of care in many regions and patients with different conditions benefit from it. Training in laparoscopic and robotic surgery has evolved and concerns exist both over the quality of surgical training and the practical effect on results of the urological training. This is an unprecedented study which undertook a census to determinate the current state of laparoscopic and robotic urological practice and to know the mains barriers to adequate practice in Brazil. In august 2017, surveys, consisting of an anonymous questionnaire with 15 questions, were sent via internet to the mailing list of the Brazilian Society of Urology (SBU). With these data, activities related to laparoscopy and robotic surgery of our urologists and the mains difficulties and barriers to practice laparoscopy and robotic surgery were evaluated. In our survey, 413 questionnaires were completed. Majority of the responders were currently working in the southeast region of Brazil (52.1%) and 75.5% of the surgeons performed laparoscopic surgery while, only 12.8%, robotic surgery. The lack of experience on the technique and the lack of equipment were the mains barriers and difficulties for not executing laparoscopic and robotic surgeries, respectively. Proper longitudinal training and access to good equipment in minimally invasive surgery are still barriers for urologists in our country.

Actitudes de los médicos familiares mexicanos sobre el uso de placebos en la práctica clínica / Attitudes of Mexican family physicians on the use of placebos in clinical practice

Resumen Introducción: El uso de placebo se ha extendido en la práctica a pesar de ser polémico. En México, la práctica de medicina familiar es predominante institucional y trabaja con un cuadro básico de medicamentos. Objetivo: Determinar la frecuencia y actitud del médico familiar en la utilización de placebos en la práctica clínica. Método: Estudio transversal, observacional, multicéntrico, en 307 médicos familiares con práctica activa, en 27 estados de la República Mexicana. Se usó cuestionario con datos sociodemográficos, preguntas sobre frecuencia de uso y actitudes elaboradas por consenso. Se analizó con chi cuadrada. Resultados: 75 % utilizó placebos (IC 95 % = 69.7-79.4 %); 122 (39.7 %) placebos puros, principalmente agua (p < 0.05), y 220 (71.6 %) placebos impuros, principalmente vitaminas y exámenes de laboratorio. Los usaron más en pacientes con síntomas físicos no explicados médicamente (178, 45.5 %), incluidos 122 (31.2 %) pacientes “sanos preocupados” o con padecimientos crónicos (40, 12.5 %). Motivos de prescripción: 249 (81 %) por el efecto psicológico, cuando demostraron beneficio (176, 57 %), aun cuando implicara engaño (78, 25 %) o evidencia de eficacia insuficiente (57, 19 %). El principal motivo fue por insistencia del paciente. Conclusiones: Se utilizaron más placebos impuros, principalmente en pacientes sanos preocupados y en aquellos con padecimientos crónicos.

Abstract Introduction: The use of placebo has spread in clinical practice despite being controversial. In Mexico, the practice of family medicine is predominantly institutional and works with an essential medications list. Objective: To determine the frequency and family doctor attitude regarding the use of placebos in clinical practice. Method: Cross-sectional, observational, multicenter study of 307 family doctors with active practice in 27 states of the Mexican Republic. A questionnaire was used with sociodemographic data and consensus-developed questions about frequency of use and attitudes. For analysis, the square-chi test was used. Results: 75% used placebos (95% CI=69.7-79.4%); 122 (39.7%) used pure placebos, mainly water (p < 0.05), and 220 (71.6%), impure placebos, mainly vitamins and laboratory tests. They were used more in patients with medically unexplained physical symptoms (178, 45.5%), including 122 (31.2%) “healthy worried” patients, or who had chronic conditions (40, 12.5%). Reasons for prescription: 249 (81%) for the psychological effect, when they showed benefit (176, 57%), even when it implied deceiving (78, 25%) or insufficient evidence of efficacy (57, 19%). The main reason was because of patient insistence. Conclusions: More impure placebos were used, mainly in healthy worried patients and in those with chronic conditions.

Percepciones y actitudes de médicos de atención primaria respecto de las Guías de Práctica Clínicas en el Régimen de Garantías en Salud / Perceptions and attitudes of Chilean primary care physicians toward clinical practice guidelines

Background: Clinical practice guidelines (CPGs) promote better quality and equity in health care and potentially they could improve patients' outcomes. However, their implementation is hindered by a number of factors including some related to health care professionals. Aim: To assess the perceptions and attitudes of primary care physicians regarding CPGs developed by the Chilean Ministry of Health in the context of the Health Sector Reform. Material and Methods: An adaptation of the survey "Knowledge, perceptions and attitudes towards Clinical Practice Guidelines" was sent to 1,264 primary care physicians in Chile and answered completely by 354. The analysis assessed the attitudes towards CPG, their use in primary care and their relationship with socio demographic features of respondents. Results: Eighty two percent of respondents reviewed the flowcharts of the guidelines, 85% consulted their online version. The classification of evidence levels and the strength of recommendations generated a high level of confidence with the guidelines in 70 and 64% of respondents. Eighty five percent considered that CPG could help to standardize clinical practice. The most relevant barrier hindering CPG use was the lack of a brief, simple and easy to access format in 63% of respondents. The three dimensions of the theory of planned behavior (attitude toward behavior, subjective norms, and perceived behavioral control) were associated with a greater frequency of guideline use. A higher age and not being Chilean were associated with a lower frequency of use. Conclusions: The identified factors associated with CPG use should be considered in future guideline design.

Inercia clínica en el tratamiento con insulina en el primer nivel de atención / Clinical inertia in insulin treatment at the primary care level

Resumen Introducción: Poco se ha evaluado el rechazo de los médicos a prescribir insulina a sus pacientes; el retraso en intensificar el tratamiento impide una atención adecuada y de calidad. Objetivo: Identificar la percepción de los médicos acerca de las barreras para iniciar la insulina en los pacientes con diabetes. Método: Por Índice Smith y análisis multivariado, en 81 médicos familiares se evaluó la relevancia y agrupación de los conceptos relacionados con las barreras para la prescripción de insulina. Resultados: 35.8 % de los médicos mostró confianza en prescribir insulina; casi la mitad calificó la intensificación del tratamiento entre moderadamente y poco importante (39.5 y 6.2 %). Las barreras se relacionaron con el médico (39.5 %), el paciente (37 %), el tratamiento con insulina (11.1 %) y la institución (6.2 %); 6.2 % de los médicos no percibió ninguna barrera. Las barreras se agruparon en cinco factores, que explicaron 62.48 % de la varianza: cultura de los pacientes, falta de habilidades, miedo a los eventos adversos, inseguridad y falta de capacitación. Conclusión: La inercia clínica no resultó de una condición clínica compleja o comorbilidades del paciente, sino de la percepción del médico y de su confianza en sus habilidades clínicas y comunicativas.

Abstract Introduction: Refusal of physicians to prescribe insulin to their patients has been scarcely evaluated; the delay in treatment intensification hinders adequate and quality care. Objective: To identify the perception of primary care physicians about barriers to initiate insulin treatment in patients with diabetes. Method: Using the Smith Index and multivariate analysis, the relevance and grouping of concepts related to barriers to insulin prescription were assessed in 81 family doctors. Results: Only 35.8% of physicians showed confidence for prescribing insulin; almost half of them rated treatment intensification between moderately and little important (39.5% and 6.2%). Barriers were related to the physician (39.5%), the patient (37%), insulin treatment (11.1%) and the institution (6.2%); 6.2 % of physicians did not perceive any barrier. The barriers were grouped in 5 factors that explained 62.48% of the variance: patient cultural level, lack of medical skills, fear of adverse events, insecurity and lack of training. Conclusion: Clinical inertia was not the result of a complex medical condition or patient comorbidities, but of doctor’s perception and confidence in his/her clinical and communication skills.

Gravity of the non-authorized use of substances not intended for clinical use in invasive aesthetic procedures: the portuguese case

SUMMARY INTRODUCTION: There is a worldwide increase in the number of invasive aesthetic procedures, and there is a general apprehension in medical societies towards the assurance of patient safety, that is dependent on the quality and certification of providers, of the materials and substances used, and where they take place. It is the main objective of this study to determine the perception of the gravity of non-authorized substances for clinical use in invasive aesthetic procedures among Portuguese plastic surgeons and its variation by the clinical sector of practice. METHODS: We proceeded to an inquiry by using a questionnaire, measured in a Linkert scale, and the collected data were statistically treated with a non-parametric Kruskal-Wallis test. RESULTS: We obtained a 41,4% answer rate and a global perception that this is a serious problem - a median of 8,00 and mean of 7,45 points on a 1 to 10 scale. 70% of the plastic surgeons that answered the questionnaire work both in the private and public sector, 19% exclusively in the public sector and 11% only in private practice. The perception of the problem was most serious among those that work exclusively in the private sector (statistically significant difference). CONCLUSION: The causes of the observed difference may reside in various reasons: the higher number of patients submitted to invasive aesthetic procedures exclusively in private practice; the higher perception of regulatory deficits in the private sector; scarce specific health politics for procedures outside the traditional boundaries of medicine; the difficulty for independent regulatory agencies to adopt effective measures.

RESUMO INTRODUÇÃO: Os procedimentos estéticos invasivos estão a aumentar globalmente, e são acompanhados por uma apreensão das sociedades médicas sobre a segurança desses procedimentos, dependentes da qualidade e certificação dos prestadores, dos dispositivos e substâncias utilizados e do local onde são efetuados. O presente estudo procura aferir a percepção dos cirurgiões plásticos portugueses sobre a gravidade da utilização de substâncias não autorizadas para uso clínico em procedimentos estéticos, e a sua variação consoante o setor em que exercem a atividade clínica. MÉTODOS: Foi utilizado um inquérito sob a forma de questionário, medido numa escala de Likert, e os dados foram tratados estatisticamente pelo teste não paramétrico de Kruskal-Wallis. RESULTADOS: Obteve-se uma taxa de resposta de 41,4% e a perceção global é a de que o problema é grave — mediana de 8,00 e média de 7,45 numa escala de 1 a 10. Setenta por cento dos cirurgiões plásticos que responderam ao inquérito trabalham num regime misto, 19% exclusivamente no setor público e 11% apenas no setor privado. A percepção do problema como mais grave (diferença estatisticamente significativa) foi observada na atividade exclusiva no setor privado. CONCLUSÕES: A diferença observada pode dever-se a vários fatores: à maior observação de pacientes submetidos a esses procedimentos exclusivamente no setor privado; à maior percepção de déficits de regulação no setor privado; ao déficit de políticas de saúde específicas a técnicas utilizadas fora do contexto tradicional da medicina; à dificuldade de as agências administrativas reguladoras independentes adotarem práticas efetivas no setor privado da saúde.

Controversias en el manejo de la fractura de cadera en el adulto mayor. Encuesta nacional a Traumatólogos especialistas en cirugía de cadera / Management of hip fractures in the elderly. A national survey among Chilean orthopaedic surgeons

Background: As the population ages, patients exposed to osteoporotic fractures increase, especially hip fracture, which is the most severe and costly. Aim: To characterize surgical practices in the management of hip fractures in older patients through a nationwide survey of specialized hip surgeons dedicated to the care of these patients. Material and Methods: A survey composed of 32 questions was formulated, including demographic factors, preoperative evaluation, definitive treatment, and postoperative management. It was sent to 140 specialists. 84 of them replied (61%), and 71 answers were included. Results: Eighty six percent of respondents agreed that orthogeriatric management is fundamental in the outcome of these patients, but only 73% had the collaboration of an internist or a geriatrician. Although 97% considered 72 hours or less the ideal time to perform surgery, only 52% of the respondents declared performing surgery within that timeframe, with differences between private and public system. Regarding surgical treatment, 94-98% of femoral neck fractures are treated with an arthroplasty and 98-99% of per-subtrochanteric fractures are treated with internal fixation and osteosynthesis. Osteoporosis treatment is only carried out by 51% of the respondents and with significant variation. Conclusions: This survey shows that there is agreement in surgical practice between specialists treating these patients, but clear differences in preoperative optimization, treatment timeframe, and post fracture medical treatment.

Perfil e adequação do uso de antibacterianos em crianças internadas em hospital geral no sul do brasil / Profile and appropriate use of antibiotics among children in a general hospital in southern brazil

RESUMO Objetivo: Verificar o perfil e a adequabilidade do uso de antibacterianos em crianças hospitalizadas. Métodos: Estudo transversal. Foi feita a análise de todas as crianças que utilizaram antibacterianos durante a internação de janeiro a dezembro de 2015, em um hospital filantrópico de direito privado de grande porte no sul do Brasil. As informações foram obtidas por revisão dos prontuários e incluíram dados demográficos (idade, sexo, raça e peso corporal) e clínicos (motivo da internação, uso deantibacterianos e desfecho clínico). Utilizou-se estatística descritiva. Resultados: Dos 318 pacientes incluídos, 61,3% eram do sexo masculino. A faixa etária variou de 2 a 11 anos (média: 5,8±2,9 anos de idade). A prevalência do uso de antibacterianos foi de 24,4% considerando o total de 1.346 crianças que foram hospitalizadas. O tempo de internação apresentou mediana de quatro dias. O principal motivo de internação foi clínico e o antibacteriano mais prescrito foi a cefazolina, sendo a via intravenosa predominante. Em relação ao uso de antibacterianos, 62,2% apresentaram prescrições de antibacterianos consideradas adequadas. A subdosagem e a superdosagem tiveram, respectivamente, os valores de 11,7 e 14,6% dos pacientes incluídos. Quanto aos intervalos de administração, 8% foram caracterizados com intervalos longos e 3,5%, curtos. Conclusões: Apesar de a prevalência encontrada do uso de antibacterianos nas crianças hospitalizadas não ser tão elevada, parte considerável da amostra apresentou inadequabilidade quanto ao uso desse tipo de medicamento, se considerados a dose e o intervalo de utilização. Esses dados são motivo de preocupação para o desenvolvimento de resistência bacteriana e ocorrência de reações adversas.

ABSTRACT Objective: To examine the profile and appropriate use of antibiotics among hospitalized children. Methods: A cross-sectional study was conducted with children who had taken antibiotics during hospitalization in a private philanthropic hospital in Southern Brazil, from January to December 2015. The data were obtained by reviewing medical records, encompassing demographic data (age, gender, ethnicity, and body weight) and clinical data (causes of hospitalization, use of antibiotics, and clinical outcome). Descriptive statistics was used to present the data. Results: Of the 318 participants included in the study, 61.3% were male patients. The age range varied between 2 and 11 years, with mean age of 5.8±2.9 years. The prevalence of antibiotics was 24.4% out of the 1,346 hospitalized children. Median hospital stay was four days. The main cause of hospitalization was clinical instability, and the most commonly prescribed antibiotics was Cefazolin, mostly administered intravenously. Regarding the administration of antibiotics, 62.2% were adequately prescribed, even though underdose was 11.7%, and overdose was 14.6% in the studied patients. Antibiotic administration intervals were characterized as long in 8% of cases, and short in 3.5% of cases. Conclusions: Although the prevalence of antibiotics among hospitalized children was not that high, a considerable part of the sample presented inadequacy regarding the dosage and range of use. These data raise concerns about bacterial resistance and adverse reactions.