"It was unusual but amazing": demand creation for PrEP among adolescents' men who have sex with men (MSM) and transgender women (TGW) in Brazil / "Foi inusitado, mas surpreendente": criação de demanda por PrEP entre homens adolescentes que fazem sexo com homens (HSH) e mulheres trans (MT) no Brasil / "Fue inusual, pero sorprendente": la creación de demanda por PrEP entre hombres adolescentes que tienen sexo con hombres (HSH) y mujeres trans (MT) en Brasil

Abstract: This study aimed to analyze the challenges in demand creation for participation in an HIV pre-exposure prophylaxis (PrEP) project in two Brazilian capitals. This qualitative study was conducted with men who have sex with men and transgender women aged 15 to 19 years who lived in two Brazilian state capitals. For this analysis, 27 semi-structured interviews carried out from 2019 to 2020 were evaluated by reflexive thematic content analysis. For participants, PrEP demand creation was essential for their interaction, mediation, bonding, and attachment and proved effective for PrEP acceptability and adherence. Adolescents' narratives showed that the strategies promoted HIV combination prevention, opened up opportunities for recruitment meetings, helped to negotiate with and convince individuals to use PrEP, strengthened peer education, and evoked a feeling of "being with" and "walking together" despite the challenges. Face-to-face or online interactions using social technologies played a crucial role in recruiting adolescents for the project, expanding knowledge on PrEP and other combination prevention strategies and access to health services and self-care.

Resumo: Este estudo analisou desafios na criação de demanda para participação em um projeto de profilaxia pré-exposição (PrEP) ao HIV em duas capitais brasileiras. Trata-se de um estudo qualitativo realizado com homens que fazem sexo com homens e mulheres transgênero de 15 a 19 anos residentes de duas capitais brasileiras. Para esta análise, foram avaliadas 27 entrevistas semiestruturadas realizadas entre 2019 e 2020 com análise temática de conteúdo reflexiva. Para os participantes, a criação de demanda por PrEP foi essencial para o processo de interação, mediação, vínculo e apego e mostrou-se eficaz para a aceitabilidade e adesão à PrEP. As narrativas dos adolescentes mostraram que as estratégias promoveram a prevenção combinada do HIV, abriram oportunidades para reuniões de recrutamento, ajudaram a negociar e convencer os indivíduos a usar a PrEP, fortaleceram a educação entre pares e evocaram um sentimento de "estar com" e "caminhar juntos", apesar dos desafios. As interações, sejam presenciais ou online, com o uso de tecnologias sociais, desempenharam um papel crucial no recrutamento de adolescentes para o projeto, na ampliação do conhecimento sobre PrEP e demais estratégias combinadas de prevenção, e no acesso a serviços de saúde e autocuidado.

Resumen: Este estudio analizó los desafíos para crear demanda para la participación en un proyecto de profilaxis pre-exposición (PrEP) al VIH en dos capitales brasileñas. Se trata de un estudio cualitativo realizado con hombres que tienen sexo con hombres y mujeres transgénero de 15 a 19 años residentes de dos capitales brasileñas. Para este análisis, se evaluaron 27 entrevistas semiestructuradas realizadas entre 2019 y 2020 con un análisis temático de contenido reflexivo. Para los participantes, crear la demanda por PrEP fue fundamental para el proceso de interacción, mediación, vínculo y apego y demostró ser eficaz para la aceptabilidad y adhesión de la PrEP. Los relatos de los adolescentes mostraron que las estrategias promovieron la prevención combinada del VIH, posibilitaron reuniones de reclutamiento, ayudaron a negociar y convencer a las personas a usar la PrEP, fortalecieron la educación entre pares y evocaron un sentimiento de "estar con" y "caminar juntos", a pesar de los desafíos. Las interacciones, ya sean de manera presencial o online, con el uso de las tecnologías sociales, tuvieron un papel fundamental en el reclutamiento de adolescentes para el proyecto, en la ampliación del conocimiento sobre la PrEP y las demás estrategias de prevención combinadas, y en el acceso a servicios de salud y autocuidado.

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.

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.

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.

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)

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.

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.

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.

Programa de inserção profissional para equipes de enfermagem de um hospital do interior paulista / Professional insertion program for the nursing team of a hospital in the interior of São Paulo

Os programas de inserção profissional são essenciais para a melhor adaptação dos trabalhadores recém contratados em hospitais e facilitam seu desenvolvimento e integração. Este estudo objetivou analisar um Programa de Inserção Profissional para Enfermeiros, Técnicos e Auxiliares de Enfermagem de um hospital no interior do estado de São Paulo e elaborar estrutura de um website educativo com conteúdos que norteiam a prática laboral da equipe de enfermagem recém contratada. Trata-se de um estudo descritivo, metodológico e de abordagem quantitativa, sendo a coleta de dados realizada no último trimestre de 2020. Os critérios de inclusão estabelecidos foram o trabalhador ter participado do Programa, estar regularmente contratado no hospital e fora do período de experiência e estar apto para a realização de suas funções. Utilizou-se dois instrumentos; o primeiro foi o de caracterização sociodemográfica e laboral e o segundo foi o Impacto do Treinamento no Trabalho. As análises estatísticas foram apresentadas por meio de frequências absolutas e relativas para as variáveis qualitativas e média, desvio padrão, mediana, mínimo e máximo para as quantitativas. A associação entre a resposta média para cada questão do instrumento Impacto do Treinamento no Trabalho e as características dos trabalhadores foi verificada por meio dos testes Man-Whitney e Kruskal-Wallis. As análises foram realizadas no software IBM-SPSS v.21.0 e o nível de significância adotado foi de 5%. Participaram deste estudo 104 trabalhadores, sendo 78 técnicos de enfermagem (75%), 22 enfermeiros (21,2%) e quatro auxiliares de enfermagem (3,8%); 62 (59,8%) eram formados de um a nove anos, 80 (76,5%) não trabalharam anteriormente no hospital em estudo e 56 (53,8%) não possuíam outros vínculos empregatícios. A idade média dos trabalhadores foi 32 anos, 84 (80,8%) eram do sexo feminino, 46 (44,2%) solteiros, 102 (98,1%) tinham filhos e dentre os que possuíam filhos, 89 (85,6%) tinham de um a dois filhos. Em relação a renda mensal, 62 (59,6%) recebiam de um a dois salários mínimos (R$ 1.045,00 a R$ 2.090,00), 56 (54,2%) se declararam católicos, 52 (50%) eram brancos e 70 (67,3%) residiam na mesma cidade em que o hospital se localiza. Quanto ao tempo de participação no Programa de Inserção, 48 (46,2%) dos pesquisados haviam participado dele há menos de um mês da data de coleta de dados. Em relação ao impacto do treinamento no trabalho, verificou-se que as médias se mantiveram entre 4,1 e 4,7 retratando bons índices de concordância, quando comparadas a outros estudos descritos na literatura e não verificou-se associações entre os dados sociodemográficos e laborais e o impacto do treinamento no trabalho. No que se refere ao desempenho dos trabalhadores no ambiente de trabalho, o programa em questão foi considerado satisfatório. Contudo, nas questões referentes às atitudes dos trabalhadores no ambiente de trabalho, observou-se a necessidade de otimizar a autoconfiança destes profissionais. A análise do impacto dos treinamentos realizados no ambiente laboral pode estabelecer subsídios para intervenções que promovam melhorias contínuas na qualidade e segurança dos serviços prestados pela equipe de enfermagem nos ambientes hospitalares, visando os trabalhadores, os usuários do Serviço e a instituição

Professional insertion programs are essential for the better adaptation of newly hired workers in hospitals and facilitate their development and integration. This study aimed to analyze a Professional Insertion Program for Nurses, Technicians and Nursing Assistants of a hospital in the state of São Paulo and to develop a structure of an educational website with contents that guide the work practice of the newly hired nursing team. It is a descriptive, methodological and quantitative study, and data collection was performed in the last quarter of 2020. The inclusion criteria established were the worker having participated in the Program, being regularly hired in the company outside the period of experience and being able to perform his/her duties. Two instruments were used; the first was the socio-demographic and labor characterization and the second was the Impact of Training at Work. Statistical analyses were presented by means of absolute and relative frequencies for the qualitative and mean variables, standard deviation, median, minimum and maximum for quantitative variables. The association between the mean answer for each question of the Work Training Impact instrument and the characteristics of the workers was verified using the Man-Whitney and Kruskal-Wallis tests. The analyses were performed in the IBM-SPSS v.21.0 software and the level of significance adopted was 5%. This study included 104 workers, 78 (75%) nursing technicians, 22 (21.2%) nurses and four (3.8%) nursing assistants; 62 (59.8%) had been in the form for one to nine years, 80 (76.5%) did not previously work at the hospital under study and 56 (53.8%) had no other employment ties. The average age of the workers was 32 years, 84 (80.8%) were female, 46 (44.2%) were single, 102 (98.1%) had children and among those who had children, 89 (85.6%) had one to two children. Regarding monthly income, 62 (59.6%) received one to two minimum wages (R$ 1,045.00 to R$ 2,090.00), 56 (54.2%) declared themselves Catholic, 52 (50%) were white and 70 (67.3%) lived in the same city where the hospital is located. Regarding the time of participation in the Insertion Program, 48 (46.2%) of the surveyed had participated in it less than one month from the date of data collection. Regarding the impact of training at work, it was found that the means remained between 4.1 and 4.7 portraying good concordance indices, when compared to other studies described in the literature and in the associations of sociodemographic and work data and the impact of training at work. As regards the performance of workers in the work environment, the programme in question was considered satisfactory. However, in the questions related to the attitudes of workers in the work environment, it was observed the need to optimize the self-confidence of these professionals. The analysis of the impact of training performed on the work environment can establish subsidies for interventions that promote continuous improvements in the quality and safety of the services provided by the nursing team in hospital environments, aiming at workers, users of the Service and the institution

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.

Desinvestimento de tecnologias em saúde no Sistema Único de Saúde: um perfil no período 2012-2022 / Disinvestment of health technologies in the Brazilian Unified Health System: a profile between 2012-2022

O termo "desinvestimento" se refere ao processo de retirada de recursos de intervenções que oferecem pouco ou nenhum ganho em saúde frente a seu custo. O intuito deste processo é reforçar práticas comprovadamente seguras, efetivas ou mais custo-efetivas, otimizando os resultados em saúde e a sustentabilidade econômica dos sistemas de saúde. O objetivo do trabalho foi caracterizar o processo de desinvestimento de medicamentos conduzido pela Comissão Nacional de Incorporação de Tecnologias (CONITEC) no Sistema Único de Saúde (SUS) entre 2012 e 2022, de forma exploratória através de análise documental dos seus relatórios técnicos de recomendações. Foram coletados nome do medicamento; sua classificação pelo sistema ATC; indicação clínica; demandante; realização de Consulta Pública; modalidade de desinvestimento recomendada e justificativa para o desinvestimento. Também foi avaliado o alinhamento das diretrizes de tratamento com as decisões de desinvestimento e o status de registro sanitário das tecnologias desinvestidas em diferentes ocasiões. Foram avaliados 30 relatórios de recomendação, correspondentes a 90 medicamentos. Três relatórios tiveram como recomendação a manutenção de sete tecnologias de perfil diversificado no SUS. Outros três relatórios eram referentes a tecnologias que foram incorporadas sob a modalidade ad experimentum e que, portanto, foram reavaliadas após três anos no SUS. Quanto às tecnologias efetivamente desinvestidas (80), elas se dividiram principalmente pelos grupos L (agentes antineoplásicos e imunomoduladores; 29,3%), J (anti-infecciosos de uso sistêmico; 21,3%) e A (aparelho digestivo e metabolismo; 20%). As principais indicações clínicas dos medicamentos desinvestidos foram: artrite reumatoide; HIV; hepatite C; e doença de Crohn. Justificativas mais mencionadas foram a indisponibilidade de registro ativo do medicamento no país (24,1%), seguida por problemas relacionados à segurança (20,6%) e efetividade (19,9%). Todas as demandas tiveram origem interna do Ministério da Saúde. Em 31,3%, houve exclusão do medicamento para indicação específica e, em 30%, exclusão total do sistema de saúde; em 27,5%, optou-se por excluir apenas determinada apresentação farmacêutica; em 10% as exclusões foram de apresentação para indicação específica; e em 1,2% ocorreu restrição de uso. Consulta Pública foi realizada em 36% dos casos. Após a publicação da Diretriz de Avaliação de Desempenho de Tecnologias em Saúde no final de 2016, o perfil de medicamentos desinvestidos por categoria ATC e por indicações clínicas adquiriram maior diversidade; as justificativas para o desinvestimento, que antes focavam em questões relacionadas a efetividade e segurança, passaram a se concentrar na indisponibilidade do medicamento no mercado; as modalidades de desinvestimento se acumularam mais em exclusões do SUS e exclusões de apresentação, e a Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos se tornou a principal demandante; submissão a consultas públicas subiu de 11,9% para 86,8%. O máximo de adequação estrutural identificado nos relatórios em relação aos tópicos preconizados pela Diretriz foi de 46,2%. Embora as iniciativas de desinvestimento tenham avançado nos últimos anos, o tema ainda enfrenta dificuldades para estabelecer uma agenda sólida no país.

Disinvestment refers to withdrawing resources from interventions that offer little or no health gain compared to their cost, seeking to reinforce practices proven to be safe, effective or more cost-effective and to optimize health outcomes and the economic sustainability of health systems. This study aimed to characterize the drug divestment process conducted by the National Commission for Incorporation of Technologies (CONITEC) in the Brazilian Unified Health System (SUS) between 2012 and 2022, in an exploratory way through their the technical recommendations reports. Drug name and ATC classification, clinical indication, proponents, occurrence of Public Consultation, recommended divestment modality and justifications for disinvestment were evaluated. We also evaluated the agreement of treatment guidelines with disinvestment decisions and the sanitary registration status of technologies disinvested at different times. We evaluated 30 recommendations reports corresponding to 90 drugs. Three reports recommended the maintenance of seven technologies in SUS. Another three reports referred to technologies that were incorporated under the ad experimentum modality and then were reassessed after three years in SUS. As for the technologies effectively disinvested (80), the drugs mainly belonged to the ATC classes L (29.3%), J (21.3%) and A (20%). The main clinical indications of the disinvested drugs were: rheumatoid arthritis, HIV, hepatitis C, and Crohn's disease. The main justifications were absence of market approval for the drug in Brazil (24.1%) and problems related to safety (20.6%) and effectiveness (19.9%). All requests were from the Brazilian Ministry of Health. Public Consultation was carried out in 36% of the situations. There were recommendations to exclude the drug for a specific indication in 31.3% of the cases and total exclusion from the SUS in 30%; exclusion of a particular pharmaceutical presentation and exclusion of presentation for a specific indication occurred in 27.5% and 10%, respectively. After the publication of the Methodological Guideline for Performance Avaliation of Health Technologies ate the end of 2016, the profile of drugs disinvested by ATC category and by clinical indications acquired bigger diversity; the justifications for disinvestment, which previously focused on issues related to effectiveness and safety, passed to focus on the unavailability of the drug on the market; disinvestment modalities concentrated more on SUS exclusions and presentation exclusions; the Secretaria of Science, Technology, Innovation and Strategic Insums became the main proponent of disinvestment demands; submission to public consultations grow up from 11.9% to 86.8%. The maximum structural adequacy identified of the reports in relation to the topics recommended by the Guideline was 46,2%. The lack of standardization and overly simplified reporting formats stood out. Although divestment initiatives have advanced in recent years, this theme still needs to improve in establishing a solid agenda in Brazil.

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.