Older people's perceptions and experiences of older people with the Sit-to-stand activity: An ethnographic pre-feasibility study / Percepções e experiências de idosos com a atividade Sit-to-stand: Um estudo etnográfico de pré-viabilidade / Percepciones y experiencias de los adultos mayores con respecto a la actividad Sit-to-stand: Un estudio etnográfico de viabilidad previa

Abstract Objective: the purpose of this pre-feasibility study was to examine perceptions and experiences of a Sit-to-stand activity with urban Brazilian community-dwelling older people in their homes. Method: the exploration method was focused ethnography. Purposive sampling was used to recruit 20 older people. Five means of data generation were used, namely: socio-demographic surveys, participant observations, informal interviews, formal semi-structured interviews, and field notes. Data analysis was qualitative content analysis. Results: the experience of mobility-challenged older people with the Sit-to-stand activity was dependent on their mobility expectations involving many factors that worked together to influence their beliefs and attitudes towards the activity, preferences, behaviors, and cultural perceptions. The participants of this study seemed to find the activity enjoyable; however, the most noticeable shortcomings for their engagement in the Sit-to-stand activity emerged as gaps in their personal and intrapersonal needs. Conclusion: the recommendations generated from the study findings call for the design of implementation strategies for the Sit-to-stand intervention that are tailored to this particular population's needs.

Resumo Objetivo: o objetivo deste estudo de pré-viabilidade foi examinar percepções e experiências da atividade de Sit-to-stand com idosos brasileiros residentes em suas casas, no meio urbano. Método: o método exploratório foi etnografia focada. Foi utilizada a amostragem intencional para recrutar 20 idosos. Foram utilizados cinco meios de geração de dados: inquéritos sociodemográficos, observações participantes, entrevistas informais, entrevistas formais semiestruturadas e notas de campo. Os dados foram analisados mediante análise de conteúdo qualitativo. Resultados: a experiência dos idosos com problemas de mobilidade na realização da atividade Sit-to-stand dependia de suas expectativas de mobilidade envolvendo muitos fatores coordenados que, de forma conjunta, influenciaram suas crenças e atitudes em relação à atividade, suas preferências, seus comportamentos e percepções culturais. Os participantes deste estudo pareciam considerar a atividade aprazível; no entanto, as deficiências mais perceptíveis para o engajamento dos participantes na atividade Sit-to-stand surgiram de falhas em suas necessidades pessoais e intrapessoais. Conclusão: as recomendações geradas a partir dos achados do estudo convocam a concepção de estratégias de implementação da intervenção Sit-to-stand adaptadas às necessidades dessa população em particular.

Resumen Objetivo: el propósito de este estudio de viabilidad previa fue examinar percepciones y experiencias con respecto a la actividad Sit-to-stand entre los adultos mayores de Brasil que viven en sus hogares en comunidades urbanas. Método: el método de exploración se enfocó en la etnografía. Se utilizó muestreo intencional para reclutar 20 adultos mayores. Se emplearon cinco medios para generar datos, a saber: encuestas sociodemográficas, observaciones participantes, entrevistas informales, entrevistas formales semiestructuradas y notas de campo. Para el análisis de los datos se recurrió a análisis de contenido cualitativo. Resultados: la experiencia de los adultos mayores con problemas de movilidad en relación con la actividad Sit-to-stand dependió de sus expectativas en torno a la movilidad, las cuales implicaron muchos factores que actuaron en conjunto para influenciar sus creencias y actitudes con respecto a la actividad, al igual que preferencias, conductas y percepciones culturales. Aparentemente, a los participantes de este estudio la actividad les resultó amena; sin embargo, los inconvenientes más notorios para adoptar la actividad Sit-to-stand surgió en la forma de déficits en sus necesidades personales e intrapersonales. Conclusión: las recomendaciones resultantes de los hallazgos del estudio indican la necesidad de diseñar estrategias de implementación para la intervención Sit-to-stand a la medida de las necesidades de este grupo poblacional específico.

Testes Ergométricos em Pacientes com Anemia Falciforme: Segurança, Viabilidade e Possíveis Implicações no Prognóstico / Exercise Testing In Patients with Sickle Cell Disease: Safety, Feasibility and Potential Prognostic Implication

Resumo Fundamento Pacientes com anemia falciforme (AF) têm risco aumentado de complicações cardiovasculares. O teste ergométrico é usado como marcador de prognóstico em uma série de doenças cardiovasculares. Entretanto, há uma escassez de evidências sobre exercícios em pacientes com AF, especialmente em relação à sua segurança, viabilidade e possível função prognóstica. Objetivos Usamos o teste em esteira máximo para determinar a segurança e a viabilidade do teste ergométrico em pacientes com AF. Além disso, os fatores associados à duração do exercício, bem como o impacto das alterações causadas pelo exercício em resultados clínicos, também foram avaliados. Métodos 113 pacientes com AF que passaram pelo teste ergométrico e por uma avaliação cardiovascular abrangente incluindo um ecocardiograma e os níveis do peptídeo natriurético do tipo B (BNP). O desfecho de longo prazo foi uma combinação de eventos incluindo morte, crises álgicas graves, síndrome torácica aguda ou internações hospitalares por outras complicações associadas â doença falciforme. A análise de regressão de Cox foi realizada para identificar as variáveis associadas ao resultado. Um p valor <0,05 foi considerado estatisticamente significativo. Resultados A média de idade foi de 36 ± 12 anos (intervalo, 18-65 anos), e 62 pacientes eram do sexo feminino (52%). A presença de alterações isquêmicas ao esforço e resposta pressórica anormal ao exercício foram detectadas em 17% e 9 % da´população estudada respectivamente. Dois pacientes apresentaram crise álgica com necessidade de internação hospitalar no período de 48 horas da realização do exame. Fatores associados à duração do exercício foram idade, sexo, velocidade máxima de regurgitação tricúspide (RT), e relação E/e', após a padronização quanto aos marcadores da gravidade da doença. Durante o período médio de acompanhamento de 10,1 meses (variando de 1,2 a 26), 27 pacientes (23%) apresentaram desfechos clínicos adversos. Preditores independentes de eventos adversos foram a concentração de hemoglobina, velocidade do fluxo transmitral tardio (onda A), e a resposta da PA ao exercício. Conclusões A realização de testes ergométricos em pacientes com AF, clinicamente estáveis, é viável. A duração do exercício estava associada à função diastólica e a pressão arterial pulmonar. A resposta anormal da PA foi um preditor independente de eventos adversos.

Abstract Background Patients with sickle cell disease (SCD) are at increased risk for cardiovascular complications. Exercise testing is used as a prognostic marker in a variety of cardiovascular diseases. However, there is a lack of evidence on exercise in SCD patients, particularly regarding its safety, feasibility, and possible prognostic role. Objectives We used the maximal treadmill test to determine safety and feasibility of the exercise testing in SCD patients. Additionally, the factors associated with exercise duration, as well as the impact of exercise-induced changes on clinical outcome, were also assessed. Methods One-hundred thirteen patients with SCD, who underwent exercise testing, were prospectively enrolled. A comprehensive cardiovascular evaluation, including echocardiography and B-type natriuretic peptide (BNP) levels, were obtained. The long-term outcome was a composite endpoint of death, severe acute painful episodes, acute chest syndrome, or hospitalization for other SCD-related complications. Cox regression analysis was performed to identify the variables associated with the outcome. A p-value<0.05 was considered to be statistically significant. Results The mean age was 36 ± 12 years (range, 18-65 years), and 62 patients were women (52%). Ischemic electrocardiogram and abnormal blood pressure (BP) response to exercise were detected in 17% and 9%, respectively. Two patients experienced pain crises within 48 hours that required hospitalization. Factors associated with exercise duration were age, sex, tricuspid regurgitation (TR) maximal velocity, and E/e' ratio, after adjustment for markers of disease severity. During the mean follow-up of 10.1 months (ranging from 1.2 to 26), the endpoint was reached in 27 patients (23%). Independent predictors of adverse events were hemoglobin concentration, late transmitral flow velocity (A wave), and BP response to exercise. Conclusions Exercise testing in SCD patients who were clinically stable is feasible. Exercise duration was associated with diastolic function and pulmonary artery pressure. Abnormal BP response was an independent predictor of adverse events.

Factibilidad, eficacia y satisfacción lograda por la intervención transdisciplinaria de un comité de ética clínico-hospitalario. Un estudio cualicuantitativo / Feasibility, effectiveness, and satisfaction achieved by the transdisciplinary intervention of a clinical-hospital ethics committee. A qualitative and quantitative study

Introducción. Las funciones del Comité de Ética Clínica (CEC) son educativas, normativas, consultivas, mediadoras y reflexivas. Como cualquier servicio de salud, las consultas de casos a un CEC deben ser sujetas a revisión y mejora de la calidad. Los objetivos fueron evaluar la factibilidad, la efectividad y la satisfacción de las recomendaciones ético-asistenciales dadas por el CEC, y evaluar su impacto en el equipo tratante y en la familia. Población y métodos. Estudio descriptivo, retrospectivo, cualicuantitativo, de casos clínicos presentados en el Comité de Ética Clínica del hospital desde el 1 de enero de 2013 hasta el 31 de diciembre de 2017, según datos del libro de actas, historias clínicas, registros de la Oficina de Comunicación a Distancia y entrevistas semiestructuradas al equipo de salud. Resultados. Se analizaron 108 casos (106 pacientes), 73 casos con encuesta y registros, y 35 solamente con registros. Los motivos principales más frecuentes de consulta fueron los siguientes: adecuación del esfuerzo terapéutico (46/42,6 %), compromiso neurológico grave (15/13,9 %), calidad de vida del paciente (11/10,2 %), conflictos entre el paciente, la familia y el sistema de salud (7/6,5 %), y rechazo del tratamiento por la familia (6/5,6 %). Se hallaron niveles altos de satisfacción (> 95 %) y niveles moderados de factibilidad (> 74 %) y efectividad (> 85 %). Solo en 50/108 casos (46,3 %) quedó registro en la historia clínica de la consulta al CEC y el 44 % de los profesionales opinó que la consulta tuvo un impacto positivo en la familia y en el paciente. Conclusiones. Los resultados contribuyeron a descubrir oportunidades de mejora, especialmente en la documentación y en la comunicación en el proceso de consulta.

Introduction. A clinical ethics committee (CEC) has educational, regulatory, advisory, mediation, and reflexive functions. As any health care service, the consults with the CEC should be subjected to review and quality improvement. The study objectives were to assess the feasibility, effectiveness, and satisfaction with the bioethical recommendations made by the CEC and assess their impact on the treating team and the patient's family. Population and methods. Descriptive, retrospective, qualitative, and quantitative study of clinical cases submitted to the hospital's CEC between January 1 st, 2013 and December 31, 2017 using data from the CEC minute book, medical records, registries from the Office for Remote Communication, and semi-structured interviews with health care team members. Results. A total of 108 cases (106 patients) were analyzed: 73 cases with survey and registries and 35 with registries only. The main most frequent reasons for consultation were adequacy of therapeutic effort (46/42.6%), severe neurological involvement (15/13.9%), patient's quality of life (11/10.2%), patient-family-health system conflict (7/6.5%), and family's refusal of treatment (6/5.6%). High levels of satisfaction (> 95%) and moderate levels of feasibility (> 74%) and effectiveness (> 85%) were observed. In only 50/108 cases (46.3%), the consultation with the CEC was registered in the medical record, 44% of health care providers stated that the consultation had a positive impact on the patient and their family. Conclusions. Results helped to establish improvement opportunities, especially in terms of documentation and communication in the consultation process.

Two-Step Purification of L-Asparaginase from Acrylaway® L

Abstract L-Asparaginase (L-ASNase) is a biopharmaceutical used for acute lymphoblastic leukaemia (ALL) treatment, dramatically increasing the patients' chance of cure. However, its production and distribution in developing countries were disrupted because of its low profitability, which caused great concern among patients. This study evaluates the feasibility of combining fractional precipitation and aqueous two-phase systems (ATPS) to purify L-ASNase from a low-grade product, commercially known as Acrylaway® L. The ATPS purification results were not particularly expressive compared to the two-step purification process composed of ethanol precipitation and gel filtration, which was able to recover the target molecule with a purification factor over 5 fold. Thus, we studied a purification process capable of manufacturing pharmaceutical grade L-ASNase from a commercially available low-grade raw material; however, improvements regarding its throughput must be achieved, and high purity is the first step to apply it as a new biopharmaceutical product. The proposed process could pose as a short-time solution to mitigate its shortage while a cost-effective production plant is being developed.

ELMO, a new helmet interface for CPAP to treat COVID-19-related acute hypoxemic respiratory failure outside the ICU: a feasibility study / ELMO, uma nova interface do tipo capacete para CPAP no tratamento da insuficiência respiratória aguda hipoxêmica por COVID-19 fora da UTI: estudo de viabilidade

ABSTRACT Objective: To assess the feasibility of using a new helmet interface for CPAP, designated ELMO, to treat COVID-19-related acute hypoxemic respiratory failure (AHRF) outside the ICU. Methods: This was a proof-of-concept study involving patients with moderate to severe AHRF secondary to COVID-19 admitted to the general ward of a public hospital. The intervention consisted of applying CPAP via the ELMO interface integrated with oxygen and compressed air flow meters (30 L/min each) and a PEEP valve (CPAP levels = 8-10 cmH2O), forming the ELMOcpap system. The patients were monitored for cardiorespiratory parameters, adverse events, and comfort. Results: Ten patients completed the study protocol. The ELMOcpap system was well tolerated, with no relevant adverse effects. Its use was feasible outside the ICU for a prolonged amount of time and was shown to be successful in 60% of the patients. A CPAP of 10 cmH2O with a total gas flow of 56-60 L/min improved oxygenation after 30-to 60-min ELMOcpap sessions, allowing a significant decrease in estimated FIO2 (p = 0.014) and an increase in estimated PaO2/FIO2 ratio (p = 0.008) within the first hour without CO2 rebreathing. Conclusions: The use of ELMOcpap has proven to be feasible and effective in delivering high-flow CPAP to patients with COVID-19-related AHRF outside the ICU. There were no major adverse effects, and ELMO was considered comfortable. ELMOcpap sessions significantly improved oxygenation, reducing FIO2 without CO2 rebreathing. The overall success rate was 60% in this pilot study, and further clinical trials should be carried out in the future. (ClinicalTrials.gov identifier: NCT04470258 [http://www.clinicaltrials.gov/])

RESUMO Objetivo: Avaliar a viabilidade do uso de uma nova interface do tipo capacete para CPAP, denominada ELMO, para o tratamento da insuficiência respiratória aguda (IRpA) hipoxêmica por COVID-19 fora da UTI. Métodos: Estudo de prova de conceito envolvendo pacientes com IRpA hipoxêmica moderada a grave secundária à COVID-19, internados na enfermaria geral de um hospital público. A intervenção consistiu na aplicação de CPAP por meio da interface ELMO integrada a fluxômetros de oxigênio e ar comprimido (30 L/min cada) e a uma válvula de PEEP (níveis de CPAP = 8-10 cmH2O), formando o sistema ELMOcpap. Os pacientes foram monitorados quanto a parâmetros cardiorrespiratórios, eventos adversos e conforto. Resultados: Dez pacientes completaram o protocolo do estudo. O sistema ELMOcpap foi bem tolerado, sem efeitos adversos relevantes. Seu uso foi viável fora da UTI por tempo prolongado e mostrou-se bem-sucedido em 60% dos pacientes. Uma CPAP de 10 cmH2O com fluxo total de gás de 56-60 L/min melhorou a oxigenação após sessões de ELMOcpap de 30-60 min, permitindo redução significativa da FIO2 estimada (p = 0,014) e aumento da PaO2/FIO2 estimada (p = 0,008) na primeira hora, sem reinalação de CO2. Conclusões: O uso do ELMOcpap mostrou-se viável e eficaz no fornecimento de CPAP de alto fluxo a pacientes com IRpA hipoxêmica por COVID-19 fora da UTI. Não houve nenhum efeito adverso importante, e o ELMO foi considerado confortável. As sessões de ELMOcpap melhoraram significativamente a oxigenação, reduzindo a FIO2 sem reinalação de CO2. A taxa global de sucesso foi de 60% neste estudo piloto, e novos ensaios clínicos devem ser realizados. (ClinicalTrials.gov identifier: NCT04470258 [http://www.clinicaltrials.gov/])

Autocoleta de swab nasofaríngeo e teste molecular em pool testing como estratégias para detecção de coronavírus da síndrome respiratória aguda grave 2 (SARS-CoV-2): viabilidade em estudantes de medicina da Universidade Federal de Minas Gerais, 2021 / Autocolección de hiopados nasofaríngeos y pruebas moleculares en pool testing como estrategias para la detección del Coronavirus Síndrome Respiratorio Agudo Severo 2 (SARS-CoV-2): viabilidad en estudiantes de medicina de la Universidad Federal de Minas Gerais, Brasil, 2021 / Self-collected nasopharyngeal swab and molecular test using pool testing as strategies to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): feasibility in medical students at the Universidade Federal de Minas Gerais, Brazil, 2021

Objetivo: Demonstrar a viabilidade da utilização combinada da autocoleta de swab nasofaríngeo e pool testing para detecção do SARS-CoV-2 em inquéritos epidemiológicos. Métodos: A experiência envolveu amostra de 154 estudantes da Universidade Federal de Minas Gerais, que realizaram a autocoleta do swab nasofaríngeo em cabines individuais e sem supervisão. O teste molecular foi realizado utilizando-se a técnica de pool testing. Resultados: A obtenção de amostras durou cerca de 5 minutos por pessoa. Realizou-se análise para detecção de RNA endógeno em 40 amostras e os resultados indicaram que não houve falhas decorrentes da autocoleta. Nenhum dos pools detectou presença de RNA viral. O custo da realização do teste molecular (RT-PCR) por pool testing com amostras obtidas por autocoleta foi cerca de dez vezes menor do que nos métodos habituais. Conclusão: As estratégias investigadas mostraram-se economicamente viáveis e válidas para a pesquisa de SARS-CoV-2 em inquéritos epidemiológicos.

Objetivo: Demostrar la viabilidad del uso combinado de la auto recolección de swabs nasofaríngeos y tests por agrupamiento (pool testing) para la detección del SARS-CoV-2 en encuestas epidemiológicas. Métodos: La prueba involucró a una muestra de 154 estudiantes de la Universidade Federal de Minas Gerais, quienes realizaron e autorecolectado del hisopo nasofaríngeo en cabinas individuales sin supervisión. La prueba molecular se realizó utilizando la técnica de prueba de grupo. Resultados: La obtención de muestras duró unos 5 minutos por persona. Se realizó un análisis para detectar ARN endógeno en 40 muestras y los resultados indicaron que no hubo fallas derivadas de la autorecolección. Ninguno de los grupos detectó la presencia de ARN viral. El costo de realizar una prueba molecular (RT-PCR) por pool con muestras obtenidas por auto-recolección fue aproximadamente 10 veces menor que con los métodos habituales. Conclusión: Las estrategias investigadas demostraron ser económicamente viables y válidas para la investigación del SARS-CoV-2 en encuestas epidemiológicas.

Objective: To show the feasibility of the combined use of self-collected nasopharyngeal swab and pool testing to detect SARS-CoV-2 in epidemiological surveys. Methods: This experience included a sample of 154 students at the Universidade Federal de Minas Gerais, who performed self-collected nasopharyngeal swab in individual cabins and without supervision. The molecular test was performed using the pool testing technique. Results: It took each person 5 minutes to collect the sample. An analysis was performed to detect endogenous RNA in 40 samples. The results showed that there were no failures resulting from self-collection. None of the pools detected the presence of viral RNA. The cost of molecular testing (RT-PCR), by pool testing, with samples obtained by self-collection was about ten times lower than the usual methods. Conclusion: The strategies that were investigated proved to be economically feasible and valid for the research on SARS-CoV-2 in epidemiological surveys.

A feasibility analysis of digital interface to transfer information during doctors' handovers / Uma análise de viabilidade de interface digital para transferência de informações durante a passagem dos médicos / Análisis de viabilidad de la interfaz digital para apoyar los traspasos de turnos medicos

Objective: To report the pre-deployment analysis of a digital system to transfer patient information during physicians' obstetric shift sessions. Methods: A literature review explored evidence concerning electronic handover applications in hospitals. A survey met local approaches used to shift changing and the expectations of managers' stakeholders. To explore local practices, we analyzed a sample 251 obstetric handovers. Finally, requirements for the system were listed, and end-users evaluated mockups of the proposed design. Results: From the literature review, easy-to-use and integration with existing systems were the most critical requests to achieve user adherence. The main system requirement was using the hospital infrastructure to ensure full access to the current medical record. Mockup validation by end-users pinpointed items to improve a complete implementation and the positive acceptance of prefilled structured entries. Conclusions: There are blockages to overcome deficits in the quality of the information in clinical handovers to safely transfer patient care between doctors' shifts.

Objetivo: Relatar a análise pré-implantação de um sistema para transferência de dados clínicos durante as sessões de plantão obstétrico. Métodos: Uma revisão de literatura explorou evidências sobre sistemas hospitalares em uso. Um questionário levantou abordagens empregadas e as expectativas das partes interessadas. Para explorar as práticas, analisamos uma amostra de 251 transferências de plantão. Os requisitos para o sistema foram listados e os usuários finais avaliaram protótipos de interface. Resultados: A partir da revisão da literatura, a facilidade de uso e a integração com sistemas eletrônicos existentes foram os quesitos mais críticos para alcançar a adesão dos usuários. O principal requisito de sistema foi utilizar a infraestrutura do hospital para garantir o acesso ao prontuário eletrônio. Na validação das interfaces, identificaram-se itens de melhoria antes da implementação plena e uma aceitação de entradas estruturadas, pré-preenchidas. Conclusões: Há desafios para superar déficits na qualidade da informação clínica trocada em sessões de transferência de plantões médicos, para garantir a segurança do atendimento ao paciente.

Objetivo: Reportar el análisis previo al despliegue de un sistema digital para transferir información de pacientes durante las sesiones de turno de médicos obstétricos. Métodos: Uma revisión de literatura explorou evidencias sobre sistemas hospitalares em uso. Um questionário levantou abordagens empregadas e as expectativas das partes interessadas. Para explorar las prácticas, analizamos una muestra de 251 transferencias de planta. Los requisitos para el sistema de listados y los usuarios finales para evaluar los prototipos de la interfaz. Resultados: partir de la revisión de la literatura, la facilidad de uso y la integración de los sistemas electrónicos existentes para las preguntas más críticas para alcanzar el objetivo de los usuarios. O principal requisito de sistema para utilizar una infraestructura del hospital para garantizar o acesso ao prontuário eletrônio. Na validação das interfaces, identificaram-se itens de melhoria antes da implementação plena e uma aceitação de entradas estruturadas, pré-preenchidas. Conclusiones: Há desafios para superar los déficits en la calidad de la información clínica trocada en sesiones de transferencia de plantas médicas, para garantizar una atención segura al paciente.

Safety and feasibility of overlapped delta-shaped anastomosis technique for digestive tract reconstruction during complete laparoscopic right hemicolectomy / 中华肿瘤杂志

Objective: To explore the clinical safety and feasibility of overlapped delta-shaped anastomosis (ODA) in totally laparoscopic right hemicolectomy (TLRHC). Methods: From May 2017 to October 2019, of the 219 patients who underwent TLRHC at the Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College, 104 cases underwent ODA (ODA group) and 115 cases underwent conventional extracorporeal anastomosis (control group) were compared the surgical outcomes, postoperative recovery, pathological outcomes and perioperative complications. Results: The length of the skin incision in the ODA group was significantly shorter than that in the control group [(5.6±0.9) cm vs. (7.1±1.7) cm, P<0.05], and the time to first flatus and first defecation after surgery in the ODA group was significantly earlier than that in the control group [(1.7±0.7) days vs. (2.0±0.7) days; (3.2±0.6) days vs. (3.3±0.7) days, P<0.05]. While the anastomosis time, operation time, intraoperative blood loss, the time of first ground activities, the number of bowel movements within 12 days after surgery, postoperative hospital stay, tumor size, the distal and proximal margins, the number of lymph node harvested and postoperative TNM stage in the ODA group did not differ from that of the control group (P>0.05). The postoperative complication rates of patients in the ODA group and the control group were 3.8% (4/104) and 4.3% (5/115), respectively, and the difference was not significant (P>0.05). Conclusion: The application of ODA technology in TLRHC can significantly shorten thelength of skin incisionand the recovery time of bowel function, and can obtain satisfactory short-term efficacy.

Research on the Necessity and Feasibility of Current Medical Device Supervision Legislation / 中国医疗器械杂志

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.

Feasibility and perioperative safety of transoral robotic surgery with da Vinci Xi platform / 中华耳鼻咽喉头颈外科杂志

Objective: To explore the feasibility and perioperative safety of transoral robotic surgery with da Vinci Xi platform for pharyngolaryngeal tumors. Methods: A retrospective analysis was performed on 55 consecutive cases with resection of pharyngolaryngeal tumors by transoral robotic surgery with da Vinci Xi platform from July 27, 2020 to October 31, 2021 in the Department of Head and Neck Surgery, Fudan University Eye, Ear, Nose and Throat Hospital, including 44 males and 11 females, aged 25-79 years. There were 41 cases of oropharyngeal tumors, 9 cases of parapharyngeal space tumors, 2 cases of laryngeal tumors, 2 cases of hypopharyngeal tumors and 1 case of retropharyngeal space tumor. Operative time, intraoperative blood loss, postoperative hospital stay, perioperative tracheotomy, nasal feeding, hemorrhage and other complications were analyzed. Results: Of the 55 patients, 54 received resection of pharyngolaryngeal tumors by da Vinci robot through oral approach, and only 1 case of pyriform sinus carcinoma underwent a conversion to open surgery due to poor exposure of lower margin. The average surgical time for the patients with transoral robotic surgeries was 64.4 min, the average blood loss was 24.8 ml, the average postoperative hospital stay was 6.9 d, and the average oral feeding time was 11.1 d. Seventeen patients (30.9%) underwent preventive tracheotomy during surgery. Among 38 cases of laryngeal cancer, 28 underwent simultaneously neck dissection. No serious complications occurred in all patients during and after operation. The follow-up time was 1-15 months. Aside from 1 patient had a relapse 10 months after surgery, other patients had no recurrence or metastasis. Conclusion: Transoral robotic surgery with da Vinci Xi is safe, effective and minimally invasive for resection of pharyngolaryngeal tumors under reasonable indications.

Overlap esophagojejunostomy with multi-mode modifications in totally laparoscopic total gastrectomy: safety and feasibility of 152 cases from a single center / 中华胃肠外科杂志

Objective: Currently, the Overlap anastomosis is one of the most favored reconstruction methods of intracorporeal esophagojejunostomy (EJS). Despite many advantages of the method, it remains some shortcomings to be improved when it comes to the retraction of the esophagus stump, the insertion of the anvil fork of the linear stapler into a "pseudo" lumen, and the closure of the common entry hole. This study aims to investigate the safety and feasibility of a multi-mode modified Overlap anastomosis. Methods: A descriptive case series study was conducted. Medical records of 152 consecutive patients who underwent totally laparoscopic total gastrectomy (TLTG) with our multi-mode modified Overlap EJS method by the same surgical team at our department from February 2017 to June 2020 were retrospectively analyzed. The multi-mode modified Overlap method mainly included (1) After ensuring the safety of tumor resection margin (proximal margin was at least 3 cm from the tumor), the esophagus was partially transected from left to right (with 5-8 mm width esophagus continuation). The specimen was then placed in a plastic bag which was tied up at the mouth using strings with a part of the esophageal wall poking through. Then the plastic bag containing the specimen was transferred to the right lumbar region, while the patient's body position was adjusted so that the abdominal esophagus could be pulled by the gravity of the specimen. (2) Using the "three-direction traction" method. The esophageal lumen was properly exposed, then guided by the gastric tube, the anvil fork was accurately placed into the esophageal lumen for completing the side-to-side EJS. (3) The 3-0 barbed suture was used in the closure of the common entry hole of the stapler from dorsally to ventrally with simple one-layer continuous suture (the stitch going from inside to inside) followed by continuous Lembert's suture (the stitch going from outside to outside). Combined with clinicopathological characteristics, the perioperative outcomes and postoperative complications of the whole group were analyzed and evaluated. Results: The study cohort included 129 men and 23 women, with a mean age of (60.2±9.1) years and a mean body mass index (BMI) of (23.2±3.1) kg/m(2). Of the 152 patients, 23 patients (15.1%) had a history of previous abdominal surgery; dentate line was invaded by tumor in 21 patients (13.8%). The mean length of the proximal resection margin was (3.3±0.3) cm and the postoperative pathological examination indicated negative resection margin tumor. The mean operative time and anastomotic time were (302.1±39.9) minutes and (29.8±5.4) minutes, respectively. The mean estimated blood loss was (87.9±46.4) ml. The mean length of postoperative hospital stay was (12.3±7.3) days. The overall severe postoperative complications (Clavien-Dindo ≥ II) occurred in 22 patients (14.5%). Six cases of pancreatic leakage were successfully recovered by adequate drainage, inhibition of pancreatic exocrine secretion and nutritional support. Ten cases of pneumonia and three cases of abdominal infection were cured with anti-infection and physical therapy. Two patients developed anastomotic leakage postoperatively. One case was caused by excessive tension of the Roux loop of the jejunum and excessive opening on the side of the jejunum after side-to-side anastomosis, and the other case was caused by an accidental intraoperative occurrence of "nasogastric tube stapled to the side-to-side anastomosis". Both of them recovered after conservative treatment including adequate drainage, anti-infection, and adequate nutritional support. One patient underwent immediate open surgery because of Peterson's hernia 7 days after TLTG, and the patient died due to extensive small bowel necrosis. Conclusions: Multi-mode modified overlap method simplifies the operation and reduces the difficulty of EJS. It is a safe and feasible method for EJS.

Safety and feasibility of intrathoracic modified overlap esophagojejunostomy in laparoscopic radical resection of Siewert type Ⅱ adenocarcinoma of esophagogastric junction / 中华胃肠外科杂志

Objective: The study aimed to investigate the safety and feasibility of intrathoracic modified overlap method in laparoscopic radical resection of Siewert type II adenocarcinoma of the esophagogastric junction (AEG). Methods: A descriptive case series study was conducted. The clinical data of 27 patients with Siewert type II AEG who underwent transthoracic single-port assisted laparoscopic total gastrectomy and intrathoracic modified overlap esophagojejunostomy in Guangdong Provincial Hospital of Chinese Medicine from May 2017 to December 2020 were retrospectively analyzed. The intrathoracic modified overlap esophagojejunostomy was performed as follows: (1) The Roux-en-Y loop was made; (2) The jejunum side was prepared extraperitoneal for overlap anastomosis; (3) The esophagus side was prepared intraperitoneal for overlap anastomosis; (4) The overlap esophagojejunostomy was performed; (5) The common outlet was closed after confirmation of anastomosis integrity without bleeding; (6) A thoracic drainage tube was inserted into the thoracic hole with the diaphragm incision closed. The intraoperative and postoperative results were reviewed. Results: All 27 patients were successfully operated, without mortality or conversion to laparotomy. The operative time, digestive tract reconstruction time and esophageal-jejunal anastomosis time were (327.5±102.0) minute, 50 (28-62) minute and (29.0±7.4) minute, respectively. The blood loss was 100 (20-150) ml. The postoperative time to flatus and postoperative hospital stay were (4.7±3.7) days and 9(6-73) days, respectively. Three patients (11.1%) developed postoperative grade III complications according to the Clavien-Dindo classification, including 1 case of anastomotic fistula with empyema, 1 case of pleural effusion and 1 case of pancreatic fistula, all of whom were cured by puncture drainage and anti-infective therapy. Conclusions: The intrathoracic modified overlap esophagojejunostomy is safe and feasible in laparoscopic radical resection of Siewert type II AEG.

Feasibility analysis of immediate implant placement in the maxillary molar region / 中华口腔医学杂志

Objective: To study the clinical outcomes and feasibility of immediate implantation after flap surgery and minimally invasive extraction in the maxillary molar area and to provide a reference for it. Methods: Forty-one patients (41 molars in total) with maxillary molars that could not be preserved, treated from June 2018 to June 2020 at the Department of Oral and Maxillofacial Surgery at the Affiliated Hospital of Qingdao University, were selected. There are 24 males and 17 females with the age of (49.7±1.8) years (range 18-66 years). Pre-operative cone-beam CT (CBCT) was taken for measurement and analysis. After flap surgery and minimally invasive tooth extraction, the inflammatory granulation tissues attached to the soft and hard tissues were completely scraped and clipped, followed by the preparation of the implants in the correct three-dimensional position. Torque value and implant stability quotient (ISQ) were recorded after implant placement and with non-submerged healing. CBCT examination was taken 6 months after surgery and ISQ value was checked before crown restoration. CBCT examination was also taken 1 year after the permanent restoration. The survival rate of 6 months after surgery, the success rate of 1 year after permanent restoration, and the size of jump gaps immediately after surgery, 6 months after surgery, 1 year after permanent restoration respectively, were performed. The ISQ values were compared immediately and 6 months after surgery. Results: A total of 41 implants were placed in 41 patients. Six months after surgery, the survival rate was 100% (41/41). Twelve months after permanent restoration, the success rate of the implant restoration was 100% (41/41). The torque value after implant implantation was (42.77±0.79) N·cm. The buccal and palatal jump gaps were (3.15±0.16) mm and (2.86±0.18) mm immediately after surgery, respectively. The mesial and distal jump gaps were (2.94±0.19) mm and (3.77±0.21) mm, respectively. CBCT showed that no jump gap around the implants at 6 months after surgery and 1 year after permanent restoration. The ISQ values at immediately and 6 months after surgery were (74.78±0.59) and (80.20±0.49) respectively, and the difference was statistically significant (t=-9.03, P<0.001). Conclusions: Immediate dental implantation in the correct three-dimensional position could achieve good osseointegration by means of flap surgery, minimally invasive extraction and thorough removal of inflammatory tissue on the surface of soft and hard tissues. The clinical outcomes were satisfactory.

Feasibility study on the preparation of novel negative pressure materials for constructing new matrix of full-thickness skin defect wounds in rats / 中华烧伤杂志

Objective: To explore the feasibility on the preparation of novel negative pressure materials for constructing new matrix of full-thickness skin defect wounds in rats. Methods: The experimental research method was applied. The microstructure of polyurethane foam dressing which was commonly used in negative pressure treatment was observed under scanning electron microscope, and its pore diameter was detected (n=5). Polycaprolactone (PCL) and polybutylene succinate (PBS) were used respectively as raw materials for the preparation of PCL and PBS negative pressure materials by melt spinning technology, with the measured pore diameter of polyurethane foam dressing as the spinning spacing at the spinning rates of 15, 25, and 35 mm/s, respectively. The microstructures of the prepared negative pressure materials were observed under scanning electron microscope, and their fiber diameters were measured. The tensile strength and tensile modulus of the prepared negative pressure materials and polyurethane foam dressing were measured by tensile testing machine and composite testing machine, respectively (n=5), to screen the spinning rate for subsequent preparation of negative pressure materials. Human skin fibroblasts (Fbs) in logarithmic growth phase were co-cultured with PCL negative pressure material and PBS negative pressure material prepared at the selected spinning rate, respectively. After 1, 4, and 7 day (s) of co-culture, the cell activity and adhesion in the materials was detected by living/dead cells detection kit, and the cell proliferation level in the materials was detected by cell counting kit 8 method (n=5). A full-thickness skin defect wound was prepared on the back of 18 5-6 weeks old Sprague-Dawley rats (gender unlimited). Immediately after injury, the injured rats were divided into PCL+polyurethane group, PBS+polyurethane group, and polyurethane alone group according to the random number table (with 6 rats in each group). The wounds were covered with materials containing corresponding component and performed with continuous negative pressure suction at the negative pressure of -16.7 kPa. The wound tissue along with materials directly contacted to the wound (hereinafter referred to as wound specimens) were collected from 3 rats in each group after 7 and 14 days of negative pressure treatment (NPT), respectively. The growth of granulation tissue and the attachment of material to wound surface were observed after hematoxylin-eosin staining, the collagen fiber deposition was observed after Masson staining, and CD34 and interleukin-6 (IL-6) positive cells were detected and counted by immunohistochemical staining. Data were statistically analyzed with one-way analysis of variance, analysis of variance for factorial design, least significant difference-t test, Kruskal-Wallis H test, Mann-Whitney U test, and Bonferroni correction. Results: The microstructure of polyurethane foam dressing was loose and porous, with the pore diameter of (815±182) μm. The spinning spacing for the subsequent negative pressure material was set as 800 μm. The microstructures of PBS negative pressure material and PCL negative pressure material were regular, with vertically interconnected layers and continuous fibers in even thickness, but the fibers of PBS negative pressure material were straighter than those of PCL negative pressure material. There was no obvious difference in the microstructure of negative pressure materials prepared from the same raw material at different spinning rates. The fiber diameters of PCL negative pressure materials prepared at three spinning rates were similar (P>0.05). The fiber diameters of PBS negative pressure materials prepared at spinning rates of 25 mm/s and 35 mm/s were significantly smaller than the fiber diameter of PBS negative pressure material prepared at the spinning rate of 15 mm/s (with t values of 4.99 and 6.40, respectively, P<0.01). Both the tensile strength and tensile modulus of PCL negative pressure materials prepared at three spinning rates were similar (P>0.05). The tensile strength of PBS negative pressure materials prepared at spinning rates of 15 mm/s and 25 mm/s was significantly lower than that of PBS negative pressure materials prepared at the spinning rate of 35 mm/s (with t values of 9.20 and 8.92, respectively, P<0.01), and the tensile modulus was significantly lower than that of PBS negative pressure materials prepared at the spinning rate of 35 mm/s (with t values of 2.58 and 2.47, respectively, P<0.05). Subsequently, PCL negative pressure material was prepared at the spinning rate of 35 mm/s, and PBS negative pressure material was prepared at the spinning rate of 15 mm/s. After 1, 4, and 7 day (s) of co-culture, the number of human skin Fbs that adhered to PCL negative pressure material and PBS negative pressure material increased with time, and there was no significant difference between the two materials. After 1 and 7 day (s) of co-culture, the proliferation levels of human skin Fbs between the two negative pressure materials were similar (P>0.05). After being co-cultured for 4 days, the proliferation level of human skin Fbs in PBS negative pressure material was significantly higher than that in PCL negative pressure material (t=6.37, P<0.01). After 7 days of NPT, the materials were clearly identifiable and a small amount of collagen fibers were also observed in the wound specimens of rats in the three groups; a small amount of granulation tissue was observed in the wound specimens of rats in polyurethane alone group. After 14 days of NPT, a large number of granulation tissue and collagen fibers were observed in the wound specimens of rats in the three groups; the materials and wound tissue in the wound specimens of rats in PCL+polyurethane group could not be clearly distinguished. After 7 and 14 days of NPT, the collagen fibers in the wound specimens of rats in polyurethane alone group were denser than those in the other two groups. After 7 days of NPT, the number of CD34 positive cells in the wound specimens of rats in PBS+polyurethane group was 14.8±3.6 per 400 times visual field, which was significantly less than 27.8±9.1 in polyurethane alone group (t=3.06, P<0.05); the number of IL-6 positive cells was 60 (49, 72), which was significantly more than 44 (38, 50) in polyurethane alone group (Z=2.41, P<0.05). After 14 days of NPT, the number of IL-6 positive cells in the wound specimens of rats in PBS+polyurethane group was 19 (12, 28) per 400 times visual field, which was significantly more than 3 (1, 10) in PCL+polyurethane group and 9 (2, 13) in polyurethane alone group (with Z values of 2.61 and 2.40, respectively, P<0.05). Conclusions: The prepared PCL negative pressure material and PBS negative pressure material have good biocompatibility, and can successfully construct the new matrix of full-thickness skin defect wounds in rats. PCL negative pressure material is better than PBS negative pressure material in general.

Cost-analysis and cost-effectiveness of physical activity interventions in Brazilian primary health care: a randomised feasibility study / Análise de custo e custo-efetividade de intervenções de atividade física na atenção primária à saúde no Brasil: um estudo de viabilidade randomizado

Abstract Physical exercise programs have been carried out in primary health care in Brazil and have provided good results in terms of effectiveness, their economic contribution has not been investigated yet. The aim of the study is to verify the feasibility of brief counseling physical activity intervention and to compare its economic cost and cost-effectiveness with supervised physical exercise intervention in primary care. A multi-arm parallel feasibility trial, with equal randomization [1:1:1] was conducted in Basic Health Units in Brazil. 61 participants were randomized in Brief Counseling Intervention (BCI), Supervised Physical Exercise Intervention (SPEI) and Control Group (CG). Interventions lasted one year. The BCI is more economical than the SPEI, costing around 50% less in the economic comparisons (session cost, annual cost and cost per participant annually). At leisure time, the cost to move one person to the physically active category at 12 months is estimated in R$369.00 for BCI and R$426.21 for the SPEI. The Incremental Cost-effectiveness Ratio (ICER) is R$310.32. The BCI is feasible and more economic, however, the cost effective is not that different. Thus, it is strongly recommended that the two interventions be offered at primary care in Brazil.

Resumo Programas de exercício físico são ofertados na atenção primária à saúde no Brasil, apresentando bons resultados na eficácia, sua contribuição econômica ainda não foi investigada. O objetivo do estudo é verificar a viabilidade de uma intervenção breve de aconselhamento para atividade física, e comparar seu custo econômico e custo-efetividade com a intervenção supervisionada de exercício físico na atenção primária. Um estudo de viabilidade de múltiplos braços paralelos, com igual randomização [1:1:1] foi realizado em Unidades Básicas de Saúde no Brasil. 61 participantes foram randomizados em Intervenção Breve de Aconselhamento (BCI), Intervenção Supervisionada de Exercício Físico (SPEI) e Grupo Controle (CG). As intervenções tiveram duração de 1 ano. BCI é mais econômica que SPEI, custando cerca de 50% menos nas comparações econômicas (custo da sessão, custo anual e custo por participante anualmente). No lazer, o custo de mudança de uma pessoa para a categoria fisicamente ativa aos 12 meses é estimado em R$ 369,00 na BCI e R$ 426,21 na SPEI. O Índice de Custo-Efetividade Incremental (ICER) é de R$ 310,32. BCI é viável e mais econômica; no entanto, o custo-benefício não é tão diferente. Assim, é altamente recomendável que as duas intervenções sejam oferecidas.

Teleoncology Orientation of Low-Income Breast Cancer Patients during the COVID-19 Pandemic: Feasibility and Patient Satisfaction / Orientação teleoncológica de pacientes de baixa renda com câncer de mama durante a pandemia de COVID-19: Viabilidade e satisfação do paciente

Abstract Objective The present study aims to assess the feasibility and patient satisfaction of teleoncology orientation in a vulnerable population of breast cancer patients assessed in a government health system during the coronavirus pandemic in 2020. Methods Eligible patients received an invitation to receive remote care to minimize exposure to an environment in which the risk of respiratory infection was present. The means of communication was telephone through an application that allows free conversation with no charge. An anonymous-response questionnaire based on a Likert-type scale was sent through a cell phone application or e-mail directly to each patient or close relative of the patient immediately after teleconsultation. Responses to the questions, which addressed utility, facility, interface quality, interaction quality, reliability, satisfaction, and interest in future evaluation, were compiled and analyzed. Results A total of 176 eligible patients scheduled for consultation were evaluated and 98 were included. Seventy (71.4%) successfully undertook the teleorientation. The questionnaire was submitted by 43 (61.4%) patients. The overall teleoncology orientation was classified as very positive by 41 (95.3%) patients. Specifically, regarding the questionnaire items, 43 (100%) patients scored 4 or 5 (agreed that the teleconsultation was beneficial) concerning the facility, followed by 42 (97.2%) for the interface quality, 41 (95.3%) for both utility and interaction quality, 40 (93%) for satisfaction and interest in future evaluation, and, finally, 39 (90.6%) for reliability. Conclusion Teleoncology orientation of low-income breast cancer patients is most feasible and leads to high patient satisfaction.

Resumo Objetivo O presente estudo teve como objetivo avaliar a viabilidade e satisfação em relação à orientação teleoncológica realizada em população vulnerável de pacientes com câncer de mama e provenientes do sistema público de saúde durante a pandemia do coronavírus em 2020. Métodos Pacientes elegíveis foram agendados para atendimento remoto visando minimizar exposição a ambientes com risco de infecção respiratória. O meio de comunicação foi o telefone, pois permite conversa sem custos. Um questionário anônimo com base na escala Likert foi enviado através de aplicativo de telefone celular ou e-mail para paciente ou familiares, logo após a teleconsulta. As respostas, que abordavam utilidade, facilidade, qualidade da interface, qualidade da interação, confiabilidade, satisfação e interesse em avaliações futuras, foram compiladas e analisadas. Resultados Um total de 176 pacientes elegíveis para teleconsulta foram avaliados e 98 foram incluídos. Setenta (71,4%) realizaram a teleorientação com sucesso. O questionário foi respondido por 43 (61,4%) pacientes. De maneira geral, a teleorientação foi classificada como muito positiva por 41 (95,3%) pacientes. Em relação aos itens avaliados, 43 (100%) pacientes pontuaram 4 ou 5 (concordaram que a teleconsulta era benéfica) em relação à facilidade do serviço, seguido por 42 (97,2%) para a qualidade da interface, 41 (95,3%) tanto para a utilidade quanto para a qualidade da interação, 40 (93%) para satisfação e interesse em avaliação futura e 39 (90,6%) para confiabilidade em relação ao método. Conclusão A orientação teleoncológica empacientes de baixa renda e com câncer de mama mostrou ser viável e com altas taxas de satisfação.

Reducing alcohol-related risks among adolescents: a feasibility study of the SHAHRP program in Brazilian schools / Redução de riscos relacionados ao uso de álcool entre adolescentes: um estudo de viabilidade do programa SHAHRP em escolas brasileiras

Abstract The SHAHRP program was effective reducing drinking and alcohol - harms in Australia, but cross-cultural adaptation is required before replication. This study aimed at assessing the feasibility of SHAHRP in Brazil focused on implementation and acceptability. A mixed-methodsdesign was used: quantitative for implementing the program and evaluation and qualitative for acceptability. The quantitative design was a pilot of a randomized controlled trial. Private schools were randomly divided into four intervention (n=160) and four control (n=188) schools. Student's mean age was 12.7 years. The fidelity of implementation and likely outcome measures were assessed. Qualitative data on acceptability were provided by students and teachers. The percentage of implementation varied from 62.5% to 87.5%. Behaviours such as alcohol-harms requires a larger cohort and longer follow-up to be adequately evaluated. The risk reduction approach and activities had good acceptability from students and teachers. Quantitative and qualitative outcomes on knowledge and decision-making indicated possible improvement in SHAHRP schools. The program is feasible and well accepted in a Brazilian setting, opening the way for a more comprehensive evaluation and dissemination.

Resumo O programa SHAHRP foi eficaz na Austrália, mas precisa de adaptação transcultural para replicação em outro país. Este estudo teve como objetivo avaliar a viabilidade do SHAHRP no Brasil com base na sua implementação e aceitação. Utilizou-se métodos mistos: quantitativo para a implementação do programa e da avaliação e qualitativo para aceitação. O desenho quantitativo foi o piloto de um estudo clínico randomizado. Participaram escolas particulares: quatro intervenções (n = 160) e quatro controles (n = 188). Os alunos tinham 12,7 anos em média. A fidelidade da implementação e possíveis medidas de resultados foram avaliadas. Os dados qualitativos sobre aceitação foram relatados por alunos e professores. A fidelidade de implementação variou de 62,5% a 87,5%. Comportamentos como danos causados ​​pelo uso de álcool precisam de uma amostra maior e de mais tempo para avaliação. A abordagem de redução de riscos e as atividades do programa foram bem aceitas por alunos e professores. Os resultados quantitativos e qualitativos sobre conhecimento e tomada de decisão indicaram possível melhora nas escolas-intervenção. O programa é viável e bem aceito no cenário brasileiro, abrindo caminho para avaliação e disseminação mais abrangentes.

Evaluation of blood pressure through home monitoring in brazilian primary care: a feasibility study / Avaliação da pressão arterial através da monitorização residencial na atenção básica brasileira: um estudo de viabilidade

Abstract Blood pressure measurements taken in a clinical setting are subject to errors, therefore there are advantages to monitoring blood pressure at home, especially in in patients diagnosed with hypertension. The study describes the feasibility of home monitoring to assess blood pressure in primary care and compares blood pressure measured at home and during a medical consultation. This cross-sectional study was carried out with patients whose used home blood pressure in the morning and evening, thrice for seven consecutive day sat home. Participants included patients older than 18 years with suspected whitecoat hypertension, taking antihypertensives, or those intolerant of ambulatory blood pressure monitoring, and excluded patients who did not follow the protocol, suffered from an irregular heart rate, and pregnant women. Of the 134 patients who participated in the study, 63.3% had altered blood pressure when measured at health facilities and 48% had higher blood pressure at home. The mean difference between the methods was 10.1 mmHg for systolic and 4.3 mmHg for diastolic. The prevalence of whitecoat hypertension was 19.4%. Blood pressure monitoring at home is a practicable strategy in the Brazilian healthcare system.

Resumo A medição da pressão arterial no consultório está sujeita a erros; assim, a monitorização residencial da pressão arterial é utilizada para o monitoramento e diagnóstico da hipertensão. Descrever a viabilidade da monitorização residencial para avaliar a pressão arterial na atenção primária e comparar os valores da pressão arterial através da monitorização residencial e medida de consultório. Estudo transversal realizado com pacientes que utilizaram a monitorização residencial pela manhã e pela noite, em triplicata por sete dias consecutivos em domicílio. Foram incluídos pacientes maiores de 18 anos, com suspeita de hipertensão do avental branco, utilizando anti-hipertensivos ou intolerantes a monitorização ambulatorial. Foram excluídos pacientes que não seguiram o protocolo, aqueles que apresentavam ritmo cardíaco irregular ou mulheres grávidas. 134 pacientes participaram do estudo, 63,3% apresentaram pressão arterial alteradas em consultório e 48% pela monitorização residencial. A diferença média dos métodos foi de 10,1 mmHg para sistólica e 4,3 mmHg para diastólica. A prevalência de hipertensão do avental branco foi 19,4%. A monitorização residencial da pressão arterial no sistema de saúde brasileiro provou ser uma estratégia viável.

Can Supervised Pelvic Floor Muscle Training Through Gametherapy Relieve Urinary Incontinence Symptoms in Climacteric Women? A Feasibility Study / O treinamento por meio de gameterapia pode aliviar os sintomas de incontinência urinária em mulheres climatéricas? Um estudo de viabilidade

Abstract Objective To investigate the feasibility of pelvic floor muscle training (PFMT) through gametherapy for relieving urinary symptoms of climacteric women with stress ormixed urinary incontinence (UI). Methods Randomized clinical trial, divided into two groups: Gametherapy (G_Game) and Control (G_Control). Both groups received recommendations about unsupervised PFMT, and G_Game also received supervised PFMT through gametherapy. After 5 consecutive weeks, the feasibility was investigated considering participant adherence, urinary symptoms (evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF] questionnaire), and pelvic floor function (PERFECT Scheme: power, endurance, repetition and fast). The Fisher exact, Kruskal-Wallis, Wilcoxon sign paired, and Mann-Whitney U tests were used by intention-to-treat analysis, using STATA 15.1 (StataCorp, College Station, TX, USA) software. Results The present study included 20 women per group and observed a higher adherence in G_Game. In the intragroup analysis, a decrease in the ICIQ-UI-SF score was observed in both groups (14.0 to 10.0; 13.5 to 0), associated with increased endurance (2.5 to 3.5; 2.5 to 4.0) in G_Control and G_Game, respectively. Moreover, there was a concomitant increase in pelvic floor muscles (PFMs) power (2.0 to 3.0), repetition (3.0 to 5.0), and fast (10.0 to 10.0) in G_Game. In the intergroup analysis, a reduction of UI was observed (p<0.001; r=0.8), as well an increase in PFM power (p=0.027, r=0.2) and endurance (p=0.033; r=0.3) in G_Game. Conclusion The feasibility of supervised PFMT through gametherapy was identified by observing participant adherence, relief of urinary symptoms, and improvement in PFM function.

Resumo Objetivo Investigar a viabilidade do treinamento dos músculos do assoalho pélvico (TMAP) por meio de gameterapia no alívio de sintomas urinários em mulheres climatéricas com incontinência urinária (IU) de esforço ou mista. Métodos Ensaio clínico randomizado, dividido em dois grupos: Gameterapia (G_Game) e Controle (G_Controle). Ambos os grupos receberam recomendações sobre TMAP não supervisionado, e G_Gametambém recebeu TMAP supervisionado por meio de gameterapia. Após 5 semanas consecutivas, a viabilidade foi investigada considerando a aderência das participantes, sintomas urinários (avaliados pelo questionário International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-UI-SF]) e função do assoalho pélvico (esquema PERFECT: power, endurance, repetition, fast). Os testes exatos de Fisher, Kruskal-Wallis, sinal de Wilcoxon pareado e Mann-Whitney U foram usados pela análise de intenção de tratar, usando o software STATA 15.1 (StataCorp, College Station, TX, EUA). Resultados O presente estudo incluiu 20 mulheres por grupo e observou uma maior adesão no G_Game. Na análise intragrupo, foi observada diminuição no escore do ICIQUI- SF emambos os grupos (de 14,0 para 10,0; de 13,5 para 0), associada ao aumento da resistência (de 2,5 para 3,5; de 2,5 para 4,0) em G_Control e G_Game, respectivamente. Além disso, houve um aumento concomitante no power (de 2,0 para 3,0), repetition (de 3,0 para 5,0) e fast (de 10,0 para 10,0) dosmúsculos do assoalho pélvico (MAPs) no G_Game. Na análise intergrupos, foi observada redução da IU (p<0,001; r=0,8), assim como do power (p=0,027; r=0,2) e da endurance (p=0,033; r=0,3) dos MAPs no G_Game. Conclusão A viabilidade do TMAP supervisionado por meio de gameterapia foi identificada pela observação da aderência das participantes, pelo alívio dos sintomas urinários e pela melhora da função dos MAPs.