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.

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)

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.

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.

Rapid health technology assessment of Xuesaitong injection in the treatment of stroke / 中国药房

OBJECTIVE To evaluate the efficacy， safety and economical efficiency of Xuesaitong injection in the treatment of stroke by rapid health technology assessment，so as to provide evidence for clinical rational drug use. METHODS Retrieved from Wanfang database， CBM， CNKI，PubMed，Cochrane Library，Embase， INAHTA and HTAI databases or organization websites， health technology assessment （HTA） reports， meta-analysis/systematic reviews and pharmacoeconomic studies related to Xuesaitong injection in the treatment of stroke were summarized and analyzed. RESULTS A total of 29 pieces of literature were included. Among them， 14 studies were conducted on meta-analysis/systematic reviews，15 studies were conducted on pharmacoeconomics， HTA was not obtained. The results of meta-analysis/systematic reviews showed that Xuesaitong injection had certain advantages for stroke in improving the total effective rate， clinical symptoms and related scale scores compared with blank control group and some drug control groups. Safety studies had shown that the adverse reactions of Xuesaitong injection were mainly allergic-like reactions. The results of pharmacoeconomic evaluation are quite different， which may also be related to the long time span among various studies and the adjustment of some drug prices. CONCLUSIONS Xuesaitong injection in the treatment of stroke is helpful to improve the clinical efficacy and evaluation indexes， but there are some serious adverse reactions， and it is not economically superior to some chemical drugs.

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.

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.

Introduction of measurement methods of health utility for cancer patients / 中国药房

Cancer is one of the major fatal diseases that seriously threaten human health， and its burden needs to be solved urgently. Health technology assessment （HTA） can provide scientific evidence-based basis for cancer diagnosis， treatment， prevention and related policy formulation. Cost-utility analysis is the gold standard for economic evaluation in HTA， and the accurate measurement of its health utility is one of the key elements to determine the accuracy of its results. This article focuses on systematic introduction of direct measures， multi-attribute health utility scales， and mapping methods in the field of cancer measurement and reviews their applications in cancer patients. Among them， direct measures are complex， costly， and require a high level of subject knowledge； multi-attribute health utility measures are currently the preferred method for measuring health utility in cancer patients； with the continuous development and refinement of disease-specific utility measures in multi-attribute health utility instruments， the mapping method may gradually decrease in future applications. This paper can provide a reference for the selection of health utility measurement tools for HTA in the field of cancer， and provide evidence-based basis for optimizing resource allocation and policy formulation in the field of cancer.

Three oral Chinese patent medicines for children with tic disorder: a rapid health technology assessment / 中国中药杂志

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as "some concerns" and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(<7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.

Rapid health technology assessment of four oral Chinese patent medicines in treatment of functional gastrointestinal disorders / 中国中药杂志

To provide proof of the evidence-based medicine and decision-making information for the clinical decision of functional gastrointestinal disorders(FGIDs), this study evaluated and compared the efficacy, safety, and economy of four oral Chinese patent medicines(CPMs) in the treatment of FGIDs using the method of rapid health technology assessment. The literature was systematically retrieved from CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, Cochrane Library and ClinicalTrials.gov from the establishment of the databases to May 1, 2022. Two evaluators screened out the literature, extracted data, evaluated the quality of the literature, and descriptively analyzed the results according to the prepared standard. Eventually, 16 studies were included, all of which was rando-mized controlled trial(RCT). The results showed that Renshen Jianpi Tablets, Renshen Jianpi Pills, Shenling Baizhu Granules, and Buzhong Yiqi Granules all had certain effects on the treatment of FGIDs. Renshen Jianpi Tablets treated FGIDs and persistent diarrhea. Shenling Baizhu Granules treated diarrhea with irritable bowel syndrome and FGIDs. Buzhong Yiqi Granules treated diarrhea with irritable bowel syndrome, FGIDs, and chronic diarrhea in children. Renshen Jianpi Pills treated chronic diarrhea. The four oral CPMs all have certain effects on the treatment of FGIDs and have specific advantages for specific patients. Compared with other CPMs, Renshen Jianpi Tablets have higher clinical universality. However, there are problems such as insufficient clinical research evidence, generally low quality of evidence, lack of comparative analysis among medicines, and lack of academic evaluation. More high-quality clinical research and the economic research should be carried out in the future, so as to provide more evidence for the evaluation of the four CPMs.

Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version) / 中国中药杂志

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.

Interações entre regulação sanitária e Avaliação de Tecnologias em Saúde para cobertura em sistemas de saúde e a integralidade do cuidado / Interactions between health regulation and Health Technology Assessment for coverage in health systems and comprehensive care

Resumo Este estudo analisa as interações entre os processos regulatórios e de avaliação de tecnologias de saúde (ATS) voltados para a cobertura dos sistemas de saúde. Foi realizada revisão em cinco bases de dados visando identificar experiências de articulação entre processos regulatórios e processos de ATS, sendo incluídas 19 publicações. Quanto ao tipo de processo, destacaram-se o early dialogue, scientific advice e parallel advice como forma de interação entre ATS e regulação. Os estudos abordaram a interação entre a ATS e a regulação sanitária para as políticas de cobertura de medicamentos em sistemas de saúde, sendo escassas as evidências em relação a outros produtos. Ademais, essa interação é descrita basicamente para o que se refere à entrada de novas tecnologias nos sistemas de saúde. A interação entre ATS e regulação sanitária resultou na redução de prazos para a comercialização e incorporação da tecnologia nos sistemas de saúde. Os tipos de processo de interação identificados podem apresentar benefícios para todo o sistema de saúde, aumentando a cobertura e a integralidade do cuidado, entretanto, apesar dos avanços, ainda persistem barreiras para a interação entre agências reguladoras e a gestão de sistemas de cobertura.

Abstract This study analyzes the interactions between regulatory and health technology assessment (HTA) processes aimed at health systems coverage. A review was carried out in five databases to identify experiences of articulation between regulatory processes and HTA processes, and 19 publications were selected. Regarding the type of process, early dialogue, scientific advice and parallel advice stood out as forms of interaction between HTA and regulation. The studies addressed the interaction between HTA and health regulation for medicines coverage policies in health systems, with scant evidence in relation to other products. Furthermore, this interaction is basically described according to the entry of new technologies into health systems. The interaction between HTA and health regulation resulted in reduced deadlines for the commercialization and incorporation of the technology into health systems. The types of interaction processes identified can benefit the entire health system, increasing coverage and comprehensiveness of care. However, despite advances, some barriers to interaction between regulatory agencies and the management of coverage systems still persist.

Smartphone and application use in self-management of chronic kidney disease: a cross-sectional feasibility study

ABSTRACT INTRODUCTION: Smartphone and application use can improve communication and monitoring of chronic diseases, including chronic kidney disease, through self-management and increased adherence to treatment. OBJECTIVE: To assess smartphone use in patients with chronic kidney disease on dialysis and their willingness to use mobile applications as a disease self-management strategy. DESIGN AND SETTING: This was a cross-sectional study of chronic kidney disease patients on hemodialysis in the São Francisco Valley in the Northeast Region, Brazil. METHODS: The questionnaire developed by the authors was administered between April and June 2021. Cronbach's alpha coefficient for the construct was 0.69. Associations between the dependent and independent variables were determined using univariate analysis. Multivariate analysis with logistic regression analysis was also performed. RESULTS: A total of 381 patients were included, of whom 64% had a smartphone, although only 3.1% knew of a kidney disease-related application. However, 59.3% believed that using an application could help them manage their disease. Having a smartphone was associated with treatment adherence, higher educational attainment, and higher per capita income. Educational attainment remained an independent factor in multivariate analysis. CONCLUSION: More than 64% of patients had a smartphone, although few knew of applications developed for kidney disease. More than half of the population believed that technology use could benefit chronic kidney disease treatment. Smartphone ownership was more common among the younger population, with higher educational attainment and income, and was associated with greater adherence to hemodialysis sessions.

Expected Benefits and Challenges of Using Economic Evaluations to Make Decisions About the Content of Newborn Screening Programs in Vietnam: A Scoping Review of the Literature

Abstract Screening newborns for genetic and other diseases is one of the most effective ways to improve health and reduce disease in a population. In developed countries, newborn screening has been a cornerstone of public health for decades. In many developing countries, however, newborn screening is still in its infancy. Many countries still lack screening programs. When a program is available, it generally lacks well-defined criteria on which decision-makers can justify the choice of diseases screened for and the methods used. One of the reasons put forward to understand this observation is the fact that little consideration is given by decision-makers to economic evaluations as a pillar of decision-making, as is the case in industrialized countries. This article provides a brief description of the challenges of using economic evaluation of newborn screening in developing countries. This will be illustrated by the example of the national newborn screening program in Vietnam.