Rapid health technology assessment of zanubrutinib in the treatment of B cell lymphomas / 中国药房

OBJECTIVE To rapidly assess the efficacy， safety and cost-effectiveness of novel highly selective Bruton’s tyrosine kinase （BTK） inhibitor zanubrutinib in the treatment of chronic lymphocytic leukemia （CLL）， small lymphocytic lymphoma （SLL） and mantle cell lymphoma （MCL）. METHODS Retrieved from PubMed， Cochrane Library， CNKI， Wanfang database， VIP， and health technology assessment （HTA） websites， systematic reviews/meta-analyses， randomized controlled trials （RCTs）， pharmacoeconomic studies and HTA reports related to zanubrutinib were collected from the database/website establishment to July 2023. The literature was screened according to inclusion and exclusion criteria， and its quality was assessed by using relevant evaluation tools. Data extraction was presented by qualitative description. RESULTS A total of 5 literature were included， comprising of 3 RCTs and 2 cost-effectiveness analyses. In terms of efficacy， compared with the control group， zanubrutinib treatment resulted in significantly longer progression-free survival （P＜0.05） and a higher overall response rate （P＜0.05）. However， there was no statistical significance in overall survival between 2 groups （P＞0.05）. In terms of safety， zanubrutinib had lower incidence of cardiac adverse events， incidence of major bleeding events， and drug discontinuation rate due to adverse drug events， compared to first-generation BTK inhibitors ibrutinib； but the risk of bleeding events caused by zanubrutinib was still higher， compared to traditional chemoimmunotherapy （bendamotine+rituximab）. In terms of cost-effectiveness， zanubrutinib was found to be cost-effective in the treatment of recurrent or refractory MCL， compared to ibrutinib. CONCLUSIONS Zanubrutinib demonstrates sound efficacy and safety in patients with CLL/SLL and MCL patients. Furthermore， it exhibits economic advantages for patients with relapsed or refractory MCL.

Drug Selection and Evaluation in Medical Institutions： A Scoping Review / 中国实验方剂学杂志

ObjectiveBy analyzing the current situation of drug selection and evaluation in medical institutions in the world，we aim to understand the development of relevant selection methods and tools，provide reference basis for drug selection in traditional Chinese medicine （TCM） medical institutions，and promote the optimization of drug catalogs in TCM medical institutions. MethodBased on the method of scoping review，the eight databases were systematically searched，the included documents were screened，extracted and analyzed，and the research results were graphically displayed. ResultA total of 23 articles were included in this study，including 13 in Chinese and 10 in English，involving 23 methods or tools related to drug selection. Of the 14 methods or tools from Chinese medical institutions，the earliest one was published in 2012，and five were published in 2022. The published methods or tools involved different levels of hospitals，different drug varieties，different evaluation angles，etc.，such as the drug selection methods of one county hospital and one township hospital， methods and tools for different types of drugs such as antibacterial drugs，ibuprofen preparations，proton pump inhibitors and hypoglycemic drugs used in pediatric intensive care units， Chinese patent medicine selection tools， tools for evaluation from the perspective of pharmacoeconomics， and universal tools for selecting domestic medical institutions. The nine drug selection tools of foreign medical institutions were from the European，American，Asian and African countries. It was first published in 1955. The contents included the formulation standards that medical institutions should follow for drug prescription sets，the management formulation and update of hospital prescription sets，and drug evaluation tools. ConclusionOn the whole，the drug selection methods and institutional methods of foreign medical institutions developed earlier than those in China. In recent years，Chinese medical institutions have paid high attention to drug selection and released various types of drug selection tools. However，the standardization should be further improved in the future.

Construction and Interpretation of Clinical Comprehensive Evaluation Index System for Chinese Patent Medicine Based on EVIDEM Framework / 中国实验方剂学杂志

ObjectiveTo establish the clinical comprehensive evaluation index system for Chinese patent medicine（CPM） based on Evidence and Value：Impact on DEcisionMaking（EVIDEM） framework， so as to promote the scientific， systematic and standardized implementation of clinical comprehensive evaluation of CPM. MethodThe clinical comprehensive evaluation index system was determined through literature review， semi-structured interview and Delphi method， and the weights of each index were clarified by analytic hierarchy process（AHP）. ResultThe recovery rates of both rounds of expert consultation were 100%， and the authority coefficient of experts was 0.90 and 0.905， respectively. Kendall's coordination coefficients（W） of the second- and third-level indicators in the first-round consultation were 0.320 and 0.283（P<0.001）， and in the second round were 0.411 and 0.351， respectively（P<0.001）. The finally constructed clinical comprehensive evaluation index system for CPM included 6 first-level indicators， 13 second-level indicators and 28 third-level indicators. Among the first-level indicators， the weights of effectiveness， safety， economy， innovation， suitability and accessibility were 37.34%， 32.68%， 11.85%， 5.87%， 5.79% and 6.47%， respectively. ConclusionThis study has constructed a universal clinical comprehensive evaluation index system for CPM， and the domain and criteria are introduced and interpreted in detail， which can provide reference and information for carrying out the clinical comprehensive evaluation of CPM， but it needs to be refined and improved in combination with the clinical practice of CPM for specialized diseases.

Current Situation of Health Technology Assessment in Traditional Chinese Medicine Hospitals / 中国实验方剂学杂志

ObjectiveThis study aims to understand the recognition of practitioners in traditional Chinese medicine （TCM） hospitals on hospital-based health technology assessment （HB-HTA）， assessment needs， challenges， and suggestions， so as to provide references for the future work. MethodThe convenient sampling method was adopted to survey the relevant practitioners in TCM hospitals. The questionnaire included 39 questions in 4 dimensions and was distributed through the online platform Weijuanxing. ResultA total of 244 questionnaires were recovered， and the obtained data were analyzed in SPSS. The results showed that 137 practitioners were very familiar with HB-HTA and there was no significant difference in the recognition of practitioners in different occupations （F=0.251； P=0.778）. The practitioners in Hong Kong， Macao， and Taiwan had lower recognition than those in other regions. In terms of the assessment needs， 127 practitioners believed that it was very necessary to carry out HB-HTA in TCM hospitals in the future. Chinese patent medicines/Chinese herbal medicine decoction pieces （5.91） and TCM appropriate technology （5.57） had higher assessment priority scores. The assessment needs were high for the effectiveness （235 practitioners） and safety （224 practitioners） of health technology. The lack of specialized organization and standardized evaluation process system and the shortage of talents were considered to be the major challenges for the future development in this field. ConclusionThe stakeholders carrying out the health technology assessment in TCM hospitals had certain awareness of HB-HTA. Most practitioners believed that it was necessary to carry out HB-HTA in TCM hospitals in the future， while the work might face challenges such as the lack of organizations and system and the shortage of talents， which requires policy support.

Calidad de los registros electrónicos de enfermería de un hospital de alta complejidad de la ciudad de Corrientes. Año 2021 / Quality of the electronic nursing records of a highly complex hospitalin the city of Corrientes. Year 2021

Introducción: hacer el registro de los cuidados que la Enfermería proporciona diariamente a los pacientes, es una tarea esencial, tanto para dar una adecuada calidad sanitaria como para el desarrollo de la profesión. Objetivo: identificar la calidad de los registros electrónicos de Enfermería de un hospital de alta complejidad de la ciudad de Corrientes. Metodología: se realizó un estudio cuantitativo de tipo descriptivo transversal donde se revisaron 133 historias clínicas digitales mediante una herramienta adaptada y previamente validada. Resultados: de forma específica, la variable identificación del paciente obtuvo calidad buena, en cuanto al registro de la valoración se identificó que el 92% de las historias clínicas registraron menos de 6 indicadores, una calidad deficiente, y el 8% restante registró calidad regular, y la variable intervenciones obtuvo una calidad deficiente con un 87% de registro de los indicadores. Conclusión: en los resultados de la investigación se llegó a la conclusión de que, la calidad de los registros electrónicos de enfermería del servicio de terapia intensiva del hospital es de calidad deficiente respecto al registro electrónico del proceso enfermero[AU]

Introduction: recording the care that nursing provides daily to patients is an essential task, both for providing adequate health quality and for the development of the profession. Objective:to identify the quality of the electronic nursing records of a highly complex hospital in the city of Corrientes. Methodology: a cross-sectional descriptive quantitative study was carried out where 133 digital medical records were reviewed using an adapted and previously validated tool. Results: specifically, the patient identification variable obtained good quality, regarding the assessment record, it was identified that 92% of the medical records re-gistered less than 6 indicators, a poor quality, and the remaining 8% re-gistered regular quality, and the variable interventions obtained a poorquality with 87% registering the indicators. Conclusion: in the results of the investigation, it was concluded that the quality of the electronic nursing records of the hospital's intensive care service is of poor quality compared to the electronic record of the nursing process[AU]

Introdução: registrar os cuidados que a enfermagem presta diaria-mente aos pacientes é tarefa essencial, tanto para a prestação de uma saúde de qualidade adequada, quanto para o desenvolvimento da profissão. Objetivo: identificar a qualidade dos registros eletrônicos de enfermagem de um hospital de alta complexidade da cidade de Corrientes. Metodologia: realizouse um estudo quantitativo descritivo transversal onde foram revistos 133 prontuários digitais por meio de um instrumento adaptado e previamente validado. Resultados: especificamente, a variável identificação do paciente obteve qualidade boa, quanto ao registro de avaliação, identificouse que 92% dos prontuários registraram menos de 6 indicadores, a qualidade ruim, e os 8% restantes registraram qualidade regular, e a variável as intervenções obtiveram uma qualidade ruim com 87% registrando os indicadores. Conclusão: nos resultados da investigação concluiuse que a qualidade do prontuário eletrônico de enfermagem do serviço de terapia intensiva do hospital é de baixa qualidade em relação ao prontuário eletrônico do processo de enfermagem[AU]

Estratégias de inovação em medicamentos e vacinas no âmbito do Ceis - modelos, mecanismos e expectativas / Innovation strategies in medicines and vaccines within the scope of CEIS - models, mechanisms, and expectations

RESUMO O artigo objetivou apresentar informações relevantes e originais sobre as estratégias de inovação utilizadas por Laboratórios Farmacêuticos Oficiais (LFO) para redução das vulnerabilidades do Sistema Único de Saúde (SUS) e capacitação produtiva e tecnológica do Complexo Econômico-Industrial da Saúde. Como métodos, foram utilizadas a revisão da literatura e a análise de dados primários oriundos de entrevistas realizadas em dois dos maiores LFO do País. Foram identificados e analisados os seus esforços e resultados em Pesquisa e Desenvolvimento (P&D) assim como a incorporação de tecnologias de medicamentos e vacinas, com destaque para as Parcerias para Desenvolvimento Produtivo (PDP). Conclui-se que, apesar de as atividades de P&D ainda precisarem avançar, benefícios foram trazidos pelos acordos de transferência de tecnologia, especialmente pelas PDP. No entanto, a capacidade industrial e tecnológica dos Institutos ainda é limitada e carente de investimentos, dificultando a acumulação e a difusão tecnológica. Dessa forma, melhorias são necessárias para que as estratégias de inovação para o SUS apresentem resultados mais efetivos e possam ser revertidos para o bem-estar da sociedade.

ABSTRACT The article aimed to present relevant and original information about the innovation strategies used by Official Pharmaceutical Laboratories (LFO) to reduce the vulnerabilities of the Brazilian Unified Health System (SUS) and the productive and technological capacity of the Health Economic-Industrial Complex. The methods used included a literature review and the analysis of primary data from interviews conducted in two of the largest LFOs in the country. Their efforts and results in Research and Development (R&D) and incorporation of medicines and vaccine technologies were identified and analyzed, with emphasis on Productive Development Partnerships (PDP). Although R&D activities still need to advance, benefits were brought about by technology transfer agreements, especially by PDPs. However, the industrial and technological capacity of the Institutes is still limited and lacks investments, which hinders technological accumulation and diffusion. Thus, improvements are necessary so that the innovation strategies for the SUS present more effective results and can be reversed to the welfare of society.

Direito à saúde, tratamentos experimentais e indústria farmacêutica: breves anotações / Right to health, experimental treatments and pharmaceutical industry: brief notes / Derecho a la salud, tratamientos experimentales y industria farmacéutica: brevesnotas

Objetivo: compreender o excesso de judicialização no Brasil e buscar algumas justificativas que levaram ao estado da arte. Metodologia: utilizou-se o método de pesquisa indutivo, realizando um levantamento bibliográfico e análise documental, com base em dados divulgados pelo Conselho Nacional de Justiça e, de forma complementar, em dados extraídos do sítio institucional da Agência Nacional de Saúde Suplementar. Resultados: a judicialização da saúde tem apresentado um caráter predominantemente individual, o que agrava o alcance da macrojustiça e do atendimento da coletividade. Além disso, as dificuldades estruturais do Sistema Único de Saúde tornam-se cada vez mais evidentes. Observa-se que a judicialização da saúde pode ser perversa do ponto de vista do excesso de concessão de tutelas de urgência, da prioridade da justiça individualizada e do destaque da microjustiça; elementos que prejudicam o funcionamento do sistema de saúde como um todo. Conclusão: a indústria farmacêutica apresenta intensa participação no processo de incorporação de medicamentos. No entanto, a complexidade e demora das etapas procedimentais da incorporação dessas novas tecnologias, não raro, resultam em demandas judiciais que derivam decisões polêmicas e nem sempre acertadas. Todo esse desenho acaba por desencadear pressão no órgão competente de incorporação, incompreensões sobre o funcionamento do SUS e fortalecimento da microjustiça.

Objective: to understand the excess of judicialization in Brazil and seek some justifications that led to the state of the art. Methods: an inductive research method was used, which involved conducting a bibliographic survey and documentary analysis of data released by the National Council of Justice and, in addition, data extracted from the institutional website of the National Supplementary Health Agency. Results: the judicialization of health has presented a predominantly individual aspect, which aggravates the reach of macrojustice and community care. In addition, the structural difficulties of the Unified Health System become increasingly evident. The judicialization of health can be perverse from the point of view of the excess of granting emergency guardianships, the priority of individualized justice, the prominence of microjustice; elements that undermine the functioning of the health system as a whole. Conclusion: the pharmaceutical industry plays an intense role in the drug incorporation process. However, the complexity and delay in the procedural stages of incorporating these new technologies often result in legal demands that result in controversial decisions that are not always correct. This entire design ends up triggering pressure on the competent incorporation body, misunderstandings about the functioning of the SUS and strengthening microjustice.

Objetivo: comprender el exceso de judicialización en Brasil y buscar algunas justificaciones que han llevado al estado del arte. Metodología: se utilizó el método de investigación inductivo, realizando un levantamiento bibliográfico y análisis documental, con base en datos divulgados por el Consejo Nacional de Justicia y, de forma complementaria, en datos extraídos del sitio web institucional de la Agencia Nacional de Salud Complementaria. Resultados: la judicialización de la salud ha presentado un carácter predominantemente individual, lo que agrava el alcance de la macrojusticia y de la atención de la colectividad. Además, las dificultades estructurales del Sistema Único de Salud son cada vez más evidentes. Se observa que la judicialización de la salud puede ser perversa desde el punto de vista de la concesión excesiva de tutelas de urgencia, de la prioridad de la justicia individualizada y del énfasis en la microjusticia; elementos que perjudican el funcionamiento del sistema de salud em su conjunto. Conclusión: la industria farmacéutica juega un papel intenso en el proceso de incorporación de medicamentos. Sin embargo, la complejidad y demora en las etapas procesales de incorporación de estas nuevas tecnologías derivan muchas veces en exigencias legales que derivan en decisiones controvertidas y no siempre correctas. Todo este diseño termina provocando presiones sobre el órgano constitutivo competente, malentendidos sobre el funcionamiento del SUS y fortalecimiento de la microjusticia.

Aportes de la Educación 4.0 y la caja de herramientas tecnológicas a exigencias educativas actuales / Contributions of Education 4.0 and the Technological Toolbox according to Current Educational Demands

Los cambios tecnológicos de la cuarta revolución industrial reflejan transformaciones en todos los ámbitos: laboral, educativo, político, etcétera, lo que cambia de manera radical la forma de estudiar, trabajar, comprar y socializar. El objetivo de este trabajo fue identificar elementos de la educación 4.0 y la caja de herramientas tecnológicas que aporten a las exigencias educativas actuales. El nuevo paradigma supone, por parte de las instituciones, una serie de acciones encaminadas a incrementar la flexibilidad de tiempo y espacio para toda la comunidad participante, tomar en cuenta las necesidades de aprendizaje de los alumnos, aplicar el aprendizaje semipresencial y el autoaprendizaje con base en las TIC, y mejorar las estrategias de aprendizaje colaborativo. Para el diseño de nuevos proyectos de innovación educativa se deben considerar los cuatro componentes centrales de la Educación 4.0: las competencias, los métodos de aprendizaje, las tecnologías de la información y la comunicación, y la infraestructura. La caja de herramientas del docente continúa siendo un elemento necesario para la estructuración metodológica de los contenidos y el apoyo tecnológico al proceso educativo en general, pues resulta un fenómeno complejo que forma parte del ecosistema de aprendizaje. Los requerimientos actuales, orientados a la adopción de la tecnología como una necesidad para hacer frente a la dinámica moderna de las economías y el conocimiento, demandan la modernización de la educación en sus diferentes niveles, en especial la educación superior con una visión regenerativa de la educación, los cuales incluyen elementos de la caja de herramientas y la Educación 4.0(AU)

The technological changes of the fourth industrial revolution show transformations in all areas (labor, education, politics, among others), which produces a radical change in the way to study, work, shop and socialize. The objective of this work was to identify elements of Education 4.0 and the technological toolbox that contribute to satisfy the current educational demands. The new paradigm implies that institutions take a series of actions aimed at increasing the flexibility of time and space for the whole participating community, considering the learning needs of students, applying blended learning and ICT-based self-learning, as well as improving collaborative learning strategies. In view of designing new educational innovation projects, consideration must be given to the four central components of Education 4.0: competences, learning methods, information and communication technologies, as well as infrastructure. Any professor's toolbox continues to be a necessary element for structuring contents methodologically and supporting the general educational process technologically, since this is a complex phenomenon belonging to the learning ecosystem. Current requirements, oriented to implementing technology as a necessity to face the modern dynamics of economies and knowledge, demand that education be modernized at different levels, especially higher education, with a regenerative vision of education, including elements from the toolbox and Education 4.0(AU)

Estratégias de Avaliação de Tecnologias em Saúde (ATS) para medicamentos para doenças raras: uma revisão rápida de escopo / Health Technology Assessment (HTA) strategies for drugs in rare diseases: a rapid scope review

A Avaliação de Tecnologias em Saúde (ATS) considera os domínios de benefícios clínicos, perfil epidemiológico, inovação, custo-efetividade, ética e de equidade no processo de decisão dos gestores em saúde. No contexto dos medicamentos para doenças raras, é desafiador o trabalho da ATS, dada a baixa disponibilidade de evidências robustas e o alto custo unitário das tecnologias. O objetivo da revisão foi analisar as estratégias disponíveis de avaliação das demandas de incorporação de medicamentos para o tratamento de doenças raras em sistemas de saúde. Foi realizada uma revisão rápida com busca estruturada na base de dados MEDLINE (via PubMed), Cochrane Library e Health Systems Evidence. Incluíram-se estudos sobre estratégias de avaliação de medicamentos utilizados para tratamento de doenças raras. Adicionalmente, foram realizadas buscas nas Agências de ATS do Brasil, Austrália, Nova Zelândia, Canadá, Reino Unido, França, Estados Unidos e Alemanha. A síntese dos resultados foi qualitativa com o agrupamento dos achados nos seguintes eixos temáticos: Segurança e efetividade, Custo-efetividade, Impacto orçamentário e Perspectiva da sociedade. Foram identificadas 267 publicações, sendo selecionadas 16 das bases de dados indexadas e 7 da literatura cinzenta. Com a análise dos documentos, pode-se concluir que a adoção de critérios específicos harmonizada com o atual modelo de ATS é um possível caminho a ser seguido no contexto dos medicamentos para doenças raras. Concomitante a isso, abordagens no sentido de incentivo a pesquisa e produção de dados de mundo real e a criação de comitês específicos para tratativa do tema nas agências de ATS apresentam-se como alternativa para lidar com as fragilidades no contexto de doenças raras.

The Health Technology Assessment (HTA) considers evidence regarding clinical benefits, epidemiological profile, innovation, cost-effectiveness, ethics and equity in its assessment process to support managers' decisions. In the context of drugs in rare diseases, the work of the ATS is challenging given the low availability of evidence and the high cost of technologies. The objective of the review was to analyze the available strategies for evaluating the demands for incorporating drugs for the treatment of rare diseases in health systems. A rapid review was performed with a structured search in the MEDLINE database (via PubMed), the Cochrane Library and Health Systems Evidence. Studies on strategies for evaluating drugs used to treat rare diseases were included and, additionally, searches were carried out in ATS Agencies in Brazil, Australia, New Zealand, Canada, United Kingdom, France, United States and Germany. The synthesis of the results was qualitative, grouping the major ones into thematic axes: Safety and effectiveness, Cost-effectiveness, Budgetary impact and Society's perspective. 267 publications were identified, 16 selected from indexed databases and 7 from gray literature. With the analysis of the documents, it can be concluded that the adoption of specific criteria harmonized with the current ATS model is a possible path to be followed in the context of drugs for rare diseases. At the same time, approaches to encourage research and the creation of specific committees to deal with the issue in HTA agencies would complement actions towards the consolidation of this work.

Desenvolvimento de aplicativo móvel para predição do risco de lesão por pressão: escala de glamorgan / Development of a mobile application for predicting the risk of pressure injury: Glamorgan Scale

Objetivo: Desenvolver um aplicativo móvel que utilize a Escala de Glamorgan para prever o risco de lesões por pressão em pacientes pediátricos, no cuidado à beira do leito. Método: Trata-se de um estudo metodológico para o desenvolvimento de um aplicativo móvel visando a predição do risco de lesão por pressão pela Escala de Glamorgan, com base no referencial metodológico de Cook & Dupras. Resultados: Seguindo as etapas estabelecidas pelo referencial metodológico, concluímos o desenvolvimento do aplicativo móvel em saúde intitulado "LPP - Escala de Glamorgan". O aplicativo é composto por cinco abas que fornecem informações relevantes sobre a avaliação e prevenção de lesões por pressão. Conclusão: O aplicativo foi desenvolvido conforme as etapas estabelecidas no referencial metodológico. Além disso, foi incluída uma aba específica para facilitar a aplicação rápida e intuitiva da Escala de Glamorgan por enfermeiros durante o atendimento à beira do leito.(AU)

Objective: To develop a mobile application that uses the Glamorgan Scale to predict the risk of pressure injuries in pediatric patients, in bedside care. Method: This is a methodological study for the development of a mobile application aimed at predicting the risk of pressure injury by the Glamorgan Scale, based on the methodological framework of Cook & Dupras. Results: Following the steps established by the methodological framework, we completed the development of the mobile health application entitled "LPP - Glamorgan Scale". The application consists of five tabs that provide relevant information on the assessment and prevention of pressure injuries. Conclusion: The application was developed according to the steps established in the methodological framework. In addition, a specific tab was included to facilitate the quick and intuitive application of the Glamorgan Scale by nurses during bedside care.(AU)

Objetivo: Desarrollar una aplicación móvil que utilice la Escala de Glamorgan para predecir el riesgo de lesiones por presión en pacientes pediátricos en cuidados de cabecera. Método: Se trata de un estudio metodológico para el desarrollo de una aplicación móvil dirigida a predecir el riesgo de lesión por presión mediante la Escala de Glamorgan, basado en el marco metodológico de Cook & Dupras. Resultados: Siguiendo los pasos establecidos por el marco metodológico, completamos el desarrollo de la aplicación móvil de salud titulada "LPP - Escala de Glamorgan". La aplicación consta de cinco pestañas que proporcionan información relevante sobre la evaluación y prevención de las lesiones por presión. Conclusión: La aplicación se desarrolló siguiendo los pasos establecidos en el marco metodológico. Además, se incluyó una pestaña específica para facilitar la aplicación rápida e intuitiva de la Escala de Glamorgan por parte del personal de enfermería durante los cuidados a pie de cama.(AU)

Evaluación de la profesionalización de los docentes de Enfermería y Tecnología de la Salud / Evaluation of Nursing and Health Technology teachers' professionalization i: en

Introducción: La profesionalización docente es una entidad de la esfera educativa que ha ganado un fuerte protagonismo entre los investigadores de esta área del conocimiento desde finales del siglo XX. Objetivo: Valorar el estado actual de la evaluación de la profesionalización de los docentes de las carreras de Enfermería y Tecnología de la Salud. Métodos: Se efectuó una investigación observacional y descriptiva, durante el año 2021, de los 144 docentes de la Facultad de Enfermería-Tecnología de la Salud de Santiago de Cuba, para lo cual se analizaron 6 variables: actividad docente, actividad científico-investigativa, actividad asistencial, actividad gerencial, actividad bioética y actuación profesional; y un total de 21 indicadores, en correspondencia con las exigencias actuales de la educación médica. Resultados: La triangulación metodológica de los instrumentos aplicados fue de 6,7, estimado como un nivel bajo de desarrollo, lo que permitió corroborar que la evaluación de la profesionalización de los docentes en el período evaluado se encontraba afectada. Conclusiones: Los problemas y las potencialidades identificados refrendan la necesidad de desarrollar la evaluación de la profesionalización de los docentes de esta Facultad.

Introduction: Teaching professionalization is an entity of educational sphere which has gained a strong role among researchers in this area of knowledge from the end of the 20th century. Objective: To assess the current state of evaluation of Nursing and Health Technology careers teachers' professionalization. Methods: An observational and descriptive investigation was carried out, during the year 2021, of the 144 teachers of Faculty of Nursing and Health Technology from Santiago de Cuba province, for which 6 variables were analyzed: teaching activity, scientific-investigative activity, care activity, management activity, bioethical activity and professional performance; as well as a total of 21 indicators, in correspondence with the current demands in medical education. Results: The methodological triangulation of the applied instruments was 6.7, estimated as a low level of development, which allowed corroborating that the evaluation of the teachers' professionalization was affected in that period. Conclusions: The problems and potentialities identified endorse the need to develop the evaluation of the teachers' professionalization in this Faculty.

Desenvolvimento de um protótipo de software baseado na caderneta de saúde da pessoa idosa / Development of a software prototype based on the health booklet of the elderly person / Desarrollo de un prototipo de software basado en la cartilla de salud de la persona mayor

RESUMO: Objetivo: descrever o desenvolvimento de um protótipo de software baseado na Caderneta de Saúde da Pessoa Idosa, utilizando a Avaliação Heurística para análise de sua usabilidade. Método: pesquisa aplicada de desenvolvimento tecnológico, utilizando a Avaliação Heurística de Nielsen como forma de realizar a análise de usabilidade, iniciada em novembro de 2021 em Juiz de Fora e São João Del Rei. Resultados: o protótipo inicial conta com 5 telas, que contêm alguns dados relevantes para o cuidado em saúde da pessoa idosa, como idade, comorbidades e histórico de alergias. Os idosos conseguirão fazer a edição dos dados pessoais, mas somente os profissionais conseguirão incluir os dados de saúde dos pacientes, com o objetivo de torná-los mais fidedignos. Conclusão: a utilização deste aplicativo contribuirá para atualizar e avançar com o uso de tecnologias voltadas para o cuidado em saúde, e que trará benefícios para os sistemas de saúde e para os usuários.

ABSTRACT Objective: to describe the development of a software prototype based on the Health Booklet for the Elderly, using Heuristic Evaluation to analyze its usability. Method: applied technological development research, using Nielsen's Heuristic Evaluation as a way of carrying out usability analysis, which began in November 2021 in Juiz de Fora and São João Del Rei. Results: the initial prototype has 5 screens, which contain some relevant data for the health care of the elderly, such as age, comorbidities, and history of allergies. The elderly will be able to edit their personal data, but only professionals will be able to include the patient's health data, with the aim of making it more reliable. Conclusion: The use of this application will help to update and advance the use of technologies aimed at health care and will bring benefits to health systems and users.

RESUMEN Objetivo: describir el desarrollo de un prototipo de software basado en la Cartilla de Salud de la Persona Mayor, utilizando la Evaluación Heurística para analizar su usabilidad. Método: investigación aplicada de desarrollo tecnológico, utilizando la Evaluación Heurística de Nielsen como medio para realizar el análisis de usabilidad, iniciada en noviembre de 2021 en Juiz de Fora y São João Del Rei. Resultados: el prototipo inicial cuenta con 5 pantallas, que contienen algunos datos relevantes para el cuidado de la salud de las personas mayores, como la edad, las comorbilidades y el historial de alergias. Los ancianos podrán editar sus datos personales, pero sólo los profesionales podrán incluir los datos de salud del paciente, con el objetivo de hacerlo más fiable. Conclusión: El uso de esta aplicación contribuirá a actualizar y avanzar en el uso de las tecnologías destinadas a la atención sanitaria, y aportará beneficios a los sistemas de salud y a los usuarios.

Reversão das recomendações emitidas pela Comissão Nacional de Incorporação de Tecnologias no SUS após Consultas Públicas / Reversal of the recommendations issued by the National Commission for the Incorporation of Technologies in SUS after Public Consultations

Resumo O trabalho analisou o efeito das Consultas Públicas (CP) e suas contribuições nas recomendações da Comissão Nacional de Incorporação de Tecnologias (CONITEC). Trata-se de estudo descritivo e retrospectivo, com abordagem qualiquantitativa, com fonte de dados secundárias de acesso público, entre 2012 e 2017. Elaborou-se banco de dados para caracterizar as CP de medicamentos e suas contribuições, o que permitiu identificar casos de reversões entre a recomendação preliminar e final da CONITEC. Analisou-se as contribuições nos casos de reversão para caracterização de eixos argumentativos e tipo de embasamento. Das 307 demandas de incorporação, 205 destes passaram por CP, com 23.894 contribuições. A reversão das recomendações ocorreu em 9% das CP abertas (15 medicamentos), todas no sentido da não incorporação para incorporação. Principais eixos argumentativos trataram de benefícios clínicos e menores eventos adversos, prevalecendo o envio de experiências clínicas e opiniões. Evidencia-se avanços nos processos de incorporação de tecnologias no SUS pela realização da CP e ficou claro o desafio que os tomadores de decisão enfrentam nos espaços institucionais para o aprimoramento da participação social no sentido de fortalecer o benefício público.

Abstract The work analyzed the effect of Public Consultations (PC) and their contributions to the recommendations of the National Commission for the Incorporation of Technologies (CONITEC). This is a descriptive and retrospective study with a qualitative-quantitative approach using a secondary data source of public access, between 2012 and 2017. A database was developed to characterize the PC of medications and their contributions, which allowed the identification of cases of reversals between the preliminary and final recommendation of CONITEC. We analyzed the contributions in cases of reversal for characterization of argumentative axes and type of basis. Of the 307 demands for incorporation of medications, 205 went through PC, with 23,894 contributions. The reversal of the recommendations occurred in 9% of the open PC (15 medications), all in the sense of non-incorporation for incorporation. Main argumentative axes dealt with clinical benefits and minor adverse events, with prevalence of the submission of clinical experiences and opinions. Advances in the processes of incorporation of technologies in the SUS by performing PC were found and the challenge that decision makers face in institutional spaces for the improvement of social participation to strengthen the public benefit was clear.

Application of photoplethysmography for atrial fibrillation in early warning, diagnosis and integrated management / 生物医学工程学杂志

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Early diagnosis and effective management are important to reduce atrial fibrillation-related adverse events. Photoplethysmography (PPG) is often used to assist wearables for continuous electrocardiograph monitoring, which shows its unique value. The development of PPG has provided an innovative solution to AF management. Serial studies of mobile health technology for improving screening and optimized integrated care in atrial fibrillation have explored the application of PPG in screening, diagnosing, early warning, and integrated management in patients with AF. This review summarizes the latest progress of PPG analysis based on artificial intelligence technology and mobile health in AF field in recent years, as well as the limitations of current research and the focus of future research.

Rapid health technology assessment of linaclotide in the treatment of constipated irritable bowel syndrome / 中国药房

OBJECTIVE To comprehensively evaluate the effectiveness， safety and economics of linaclotide in the treatment of constipated irritable bowel syndrome （IBS-C）， and to provide the evidence-based basis for clinical application. METHODS Rapid health technology assessment method was adopted； PubMed， Embase， the Cochrane Library， Web of Science， CNKI， Wanfang data， VIP database， SinoMed， and related HTA websites were searched. Systematic review/meta-analysis， HTA reports and pharmacoeconomic research about linaclotide were collected. After literature screening， data extraction and quality evaluation， descriptive analysis was used to classify and summarize the research results. RESULTS A total of 11 literature were included， involving 7 systematic reviews/meta-analyses and 4 pharmacoeconomic research. In terms of effectiveness， compared with placebo， linaclotide could achieve FDA specified endpoint and European Medicines Agency-recommended endpoint faster， significantly improved patients’ complete spontaneous bowel movements （CSBM）， abdominal pain， constipation and quality of life， and relieved patients’ global symptoms； compared with the indirect evidence of lubiprostone， plecanatide and tenapanor， the efficacy of linaclotide at the FDA specified endpoint， CSBM， abdominal pain relief， and global relief response were the best. In terms of safety， the incidence of overall adverse drug reactions， diarrhea and flatulence caused by linaclotide were significantly higher than placebo，but patients can tolerate them. In terms of economics， compared with traditional therapeutic drugs， linaclotide showed an economic advantage. CONCLUSIONS Linaclotide has advantages in efficacy， safety and economics in the treatment of IBS-C. It is an effective strategy for the treatment of IBS-C.

Rapid health technology assessment of baloxavir marboxil in the treatment of influenza / 中国药房

OBJECTIVE To evaluate the effectiveness， safety and economy of baloxavir marboxil in the treatment of influenza， and to provide evidence-based reference for the introduction of new drugs in hospitals and clinical medication decisions. METHODS Retrieved from PubMed， Embase， Web of Science， Cochrane Library， Epistemonikos， CBM， CNKI， VIP， Wanfang database， official websites and relevant databases of health technology assessment （HTA） institutions， the results of the included studies were descriptively analyzed after literature screening， data extraction and quality evaluation. RESULTS A total of 11 studies were included， involving 6 systematic reviews/meta-analyses and 5 pharmacoeconomic studies. Compared with placebo， baloxavir marboxil significantly shortened the time to alleviation of symptoms （TTAS） and time to resolution of fever （TTRF）， reduced the virus titer change from baseline at 24 h and 48 h after treatment and the incidence of bronchitis， with statistical significance （P＜ 0.05）. Compared with neuraminidase inhibitors （NAIs）， there were no significant differences in shortening TTRF and reducing the incidence of complications， pneumonia and bronchitis （P＞0.05）. The majority of studies suggested that there were no significant differences in shortening TTAS （P＞0.05）. Only very low-quality literature suggested that baloxavir marboxil could significantly reduce the virus titer change from baseline at 24 h and 48 h after treatment. In terms of safety， the incidences of adverse events （AEs） and drug-related adverse events （DRAEs） induced by baloxavir marboxil showed no significant differences， compared with peramivir and zanamivir （P＞0.05）. Some studies considered that the incidences of AEs and DRAEs with baloxavir marboxil were lower than placebo， oseltamivir and laninamivir. Compared with oseltamivir in China and laninamivir in Japan， baloxavir marboxil showed cost-effectiveness advantages. CONCLUSIONS Compared with placebo， baloxavir marboxil has good efficacy， safety and economy. Compared with NAIs （oseltamivir）， baloxavir marboxil has good economic advantages in China， but further high-quality studies are still needed regarding its safety and efficacy.

Progress of mobile medical technology in the prevention and treatment of diabetic foot / 中国实用护理杂志

The article summarized and analyzed the application status, specific application methods, shortcomings and prospects of mobile medical technology in the prevention and treatment of diabetic foot, and to provide reference for the application and future research of mobile medical technology in the prevention and treatment of diabetic foot in our country.

Clinical comprehensive evaluation of Xiangju Capsules in treatment of rhinosinusitis / 中国中药杂志

The articles involving Xiangju Capsules were retrieved, and qualitative research and quantitative research methods were combined to evaluate the evidence of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) of this drug. Multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Xiangju Capsules in the treatment of rhinosinusitis and clarify the precise clinical positioning. The dimensions are graded A, B, C, or D. Multi-source safety evidence showed that the main adverse reactions were gastrointestinal reactions, rash, itching, dizziness, and headache. Based on the available studies, the risk is controllable and the safety is grade A. Meta-analysis showed that Xiangju Capsules + conventional western medicine could recover the Lund-Kennedy score, Lund-Mackay score, and CT score, relieve headache, nasal congestion, olfactory disturbance, and facial pain, with the effectiveness is grade B. The incremental cost-effectiveness ratio of Xiangju Capsules + conventional western medicine compared with conventional western medicine alone in the treatment of chronic rhinosinusitis was 263.71 yuan, about 0.82% of the per capita disposable income. The results of sensitivity analysis showed that the research results were relatively robust. Based on the assumption that the per capita disposable income in 2020 will be the threshold of patients' willingness to pay, it is more economical to use Xiangju Capsules + conventional western medicine. The drug belongs to grade A of the national medical insurance, with an average daily cost of 3.06 yuan, and the economy is grade B. This formula is modified from classic formulas and characteristic empirical formulas, be capable of improving immunity and preventing repeated attacks. It can be used for acute and chronic rhinitis-rhinosinusitis. It had a wide range of applicability, especially for the patients with head and face tenderness. Service innovation was reflected in the measures to guarantee supply, capacity, scalability, and coverage of grass-roots sales channels. The industrial innovation was improved through the management of medicinal resources, pharmaceutical industry, production technology, quality control, scientific research and development, and this formula won three national invention patents. Comprehensively, the innovation of Xiangju Capsules is grade B. According to the survey of 188 medical practitioners and 196 patients in 20 provinces, municipalities, and autonomous regions of China, the drug was characterized by easy preparation and administration, individualized medication, simple technology and management, convenient use, storage, and transport, and controllable adverse reactions, with the suitability is grade B. Xiangju Capsules showed the cost of 45.9 and 275.4 yuan for treatment of acute and chronic rhinitis-rhinosinusitis, respectively, being well affordable. It was sold in 35 000 medical institutions in China. The dosage form was suitable for transportation, storage, and grass-root application. With rich, sustainable, and available medicinal resources, the accessibility of Xiangju Capsules is grade A. This drug can be used for both acute and chronic rhinitis-rhinosinusitis, clearing heat and expelling pus, and strengthening the exterior to prevent relapse. After this drug was available on the market, over 4 000 cases were studied, with rich experience in human use accumulated, and characteristics of traditional Chinese medicine is grade B. Overall, the clinical value of Xiangju Capsules is class B. It is suggested that Xiangju Capsules should be used in accordance with the relevant policies of basic clinical drug administration to play its role.

Clinical Comprehensive Evaluation of Jinsang Kaiyin Preparation in Treatment of Acute Pharyngitis/Laryngitis / 中国实验方剂学杂志

ObjectiveTo comprehensively evaluate the clinical application value of four types of Jinsang Kaiyin preparation（JSKYs） and the other two Chinese patent medicines（CPMs） in the treatment of acute pharyngitis/laryngitis，so as to provide evidence for their rational clinical use and regulatory decision-making. MethodAccording to the guideline for clinical comprehensive evaluation of CPM，the effectiveness，safety，economy，innovation，suitability and accessibility of four JSKYs and the other two CPM in the treatment of acute pharyngitis/laryngitis were comprehensively evaluated，which were ranked based on the quantitative scoring tool. Result① Effectiveness：Compared with the control group，JSKYs can improve the total effectiveness rate of acute pharyngitis/laryngitis and improve the symptoms. Network meta-analysis showed that the probability of JSKY ranked the first in terms of total effectiveness rate.② Safety：JSKYs did not show acute toxicity and long-term toxicity. The main adverse reactions were skin rash，abdominal pain，diarrhea，nausea and vomiting，etc，which were similar with the other two CPM.③ Economy：For patients with acute laryngitis（wind heat syndrome），compared with drug A，JinsangKaiyin capsule has the comparable cost-effectiveness. For patients with acute pharyngitis（wind heat syndrome），compared with drug B，JinsangKaiyin capsul has low cost and better effectiveness.④ Innovation：Compared with the other two CPM，the indications of JSKYs have their own unique population. JSKYs have six patent approval certifications and has been approved for sale in the Philippines.⑤ Suitability：Compared with the other two CPM，the investigated doctors，pharmacists and patients all believed that the instruction of JSKY was clearer and easier to understand，the use and storage conditions were more convenient，etc.⑥ Accessibility：JSKYs are included in the category B of the National Basic Medical Insurance（2022 edition），which has good cost-effectiveness and affordability for medical insurance and self paid patients. JSKYs do not contain endangered animals and plants. The supply of raw materials can meet the demand of production at present. ConclusionAs for the drug value calculation，JSKY obtained the highest score. Based on all dimensions of evidence，expert consensus on JSKY is class A，which can be directly converted into decision making.

Mechanism and enlightenment of public participation in the NICE health technology assessment in England / 中国药房

OBJECTIVE To analyze the public participation mechanism of National Institute for Health and Care Excellence （NICE） health technology assessment in England and to provide experience for the dynamic adjustment of Chinese medical insurance catalog. METHODS By retrieving related literature and official websites， types and mechanisms of public participation （management organization， selection method， participation mode， evaluation feedback） in NICE health technology assessment were analyzed comprehensively； and based on this， suggestions were put forward to adjust the public participation in Chinese medical insurance catalog. RESULTS & CONCLUSIONS The current public participation types of NICE health technology assessment were patient and carer organizations， HTA committee lay members， patient expert and public observers. At the management level， NICE has set up a public participation team and made guidelines on public participation matters. For different public participation types， NICE has established different selection procedures， such as expression of interest， NICE invitation， open recruitment， nomination， NICE decision， etc. The public participation types are various and in the whole assessing process from the initial determination of the scope of the health technology assessment to the final appeal. Also， NICE has established a flexible and dynamic evaluation feedback system to optimize the way of public participation and the health technology assessment process； NICE has undertaken extensive international cooperation and exchanges to promote public participation at the national and international levels. It is suggested that our country should combine the national conditions， clarify the channel of public participation in health technology evaluation， set up a working group of public participation affairs， strengthen patients’ participation in evaluation and feedback， improve decision-making transparency， and improve the public participation mechanism of health technology evaluation from the aspects of channel opening， management mechanism， evaluation feedback， information disclosure and so on.