Supporting evidence-based judicial decisions on health care in Brazil: an experience report / Apoio técnico-científico à tomada de decisão judicial em saúde no Brasil: um relato de experiência / Apoyo técnico-científico a la toma de decisiones judiciales en salud en Brasil: un relato de experiencia

Objective: The main objective of this study is to report on the implementation and results of the "Supporting Health-Related Judicial Decisions in Brazil" project conducted at the Health Technology Assessment Center, Hospital Sírio-Libanês through the "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde", in Brazil. Methods: This study is an experience report of a project conducted at the Health Technology Assessment Center, Hospital Sírio-Libanês. Results: The activities of the project occurred in 2023 and included two online training courses on primary studies and systematic reviews, 11 one-day workshops with technical-scientific content for members of the Technical Support Centers for the Judiciary (NATJus), 40 online technical-scientific consultations for magistrates on a digital platform, 11 technical-scientific reports addressing the most legally claimed technologies in Brazil; two methodological tools, a national forum (hybrid event), 10 chat-based mentorships for NATJus members; and the maintenance of an open-access blog, by publishing news on relevant topics on law and health. Discussion and conclusion: This project has contributed to the improvement of the judicial decision-making process by providing a range of activities aimed at aiding the prioritization of health technologies that are clearly effective and safe over those that are ineffective, harmful, or have uncertain effects.

Objetivo: O objetivo principal deste estudo é relatar a implementação e os resultados do projeto "Apoio técnico-científico à tomada de decisão judicial em Saúde no Brasil" realizado no Hospital Sírio-Libanês por meio do "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde". Métodos: Este estudo é um relato de experiência de um projeto realizado no Núcleo de Avaliação de Tecnologias em Saúde do Hospital Sírio-Libanês. Resultados: As atividades do projeto ocorreram em 2023 e incluíram dois cursos de formação online sobre estudos primários e revisões sistemáticas, 11 oficinas de um dia com conteúdo técnico-científico para membros dos Núcleos de Apoio Técnico ao Judiciário (NATJus), 40 consultas on-line técnico-científicas para magistrados em plataforma digital, 11 relatórios técnico-científicos abordando as tecnologias mais reivindicadas judicialmente no Brasil; duas ferramentas metodológicas, um fórum nacional (evento híbrido), 10 mentorias via chat para membros do NATJus; e a manutenção de um blog de acesso aberto, com publicação de notícias sobre temas relevantes de direito e saúde. Discussão e conclusão: Este projeto contribuiu para a melhoria do processo de tomada de decisão judicial, fornecendo uma série de atividades destinadas a ajudar na priorização de tecnologias de saúde que sejam claramente eficazes e seguras em detrimento daquelas que são ineficazes, prejudiciais ou têm efeitos incertos.

Objetivo: El objetivo principal de este estudio es informar sobre la implementación y los resultados del proyecto "Apoyo a las Decisiones Judiciales Relacionadas con la Salud en Brasil" realizado en el Centro de Tecnología en Salud del Hospital Sírio-Libanês a través del "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde", en Brasil. Métodos: Este estudio es un informe de experiencia de un proyecto realizado en el Centro de Tecnología en Salud del Hospital Sírio-Libanês. Resultados: Las actividades del proyecto ocurrieron en 2023 e incluyeron dos cursos de capacitación en línea sobre estudios primarios y revisiones sistemáticas, 11 talleres de un día de contenido técnico-científico para miembros de los Centros de Apoyo Técnico al Poder Judicial (NATJus), 40 consultas técnico-científicas en línea para magistrados en plataforma digital, 11 informes técnico-científicos que abordan las tecnologías más reclamadas legalmente en Brasil; dos herramientas metodológicas, un foro nacional (evento híbrido), 10 mentorías basadas en chat para miembros de NATJus; y el mantenimiento de un blog de acceso abierto, mediante la publicación de noticias sobre temas relevantes en derecho y salud. Discusión y conclusión: Este proyecto ha contribuido a mejorar el proceso de toma de decisiones judiciales proporcionando actividades para priorizar las tecnologías sanitarias claramente eficaces y seguras frente a aquellas que son ineficaces, nocivas o de efectos inciertos.

Domains and Methods of Medical Device Technology Evaluation: A Systematic Review.

Objectives: Identify, through a systematic review, the main domains and methods to support health technology assessment of Medical Devices (MD) from the perspective of technological incorporation into healthcare systems. Methods: Performed structured searches in MEDLINE, Embase, BVS, Cochrane Library, and Web of Science for full studies published between 2017 and May 2023. Selection, extraction, and quality assessment were performed by two blinded reviewers, and discrepancies were resolved by a third reviewer. Results: A total of 5,790 studies were retrieved, of which 41 were included. We grouped the identified criteria into eight domains for the evaluations. Conclusion: Overall, studies discuss the need to establish specific methods for conducting HTA in MD. Due to the wide diversity of MD types, a single methodological guideline may not encompass all the specificities and intrinsic characteristics of the plurality of MD. Studies suggest using clustering criteria through technological characterization as a strategy to make the process as standardized as possible.

Bridging Real-World Data Gaps: Connecting Dots Across 10 Asian Countries.

The economic trend and the health care landscape are rapidly evolving across Asia. Effective real-world data (RWD) for regulatory and clinical decision-making is a crucial milestone associated with this evolution. This necessitates a critical evaluation of RWD generation within distinct nations for the use of various RWD warehouses in the generation of real-world evidence (RWE). In this article, we outline the RWD generation trends for 2 contrasting nation archetypes: "Solo Scholars"-nations with relatively self-sufficient RWD research systems-and "Global Collaborators"-countries largely reliant on international infrastructures for RWD generation. The key trends and patterns in RWD generation, country-specific insights into the predominant databases used in each country to produce RWE, and insights into the broader landscape of RWD database use across these countries are discussed. Conclusively, the data point out the heterogeneous nature of RWD generation practices across 10 different Asian nations and advocate for strategic enhancements in data harmonization. The evidence highlights the imperative for improved database integration and the establishment of standardized protocols and infrastructure for leveraging electronic medical records (EMR) in streamlining RWD acquisition. The clinical data analysis and reporting system of Hong Kong is an excellent example of a successful EMR system that showcases the capacity of integrated robust EMR platforms to consolidate and produce diverse RWE. This, in turn, can potentially reduce the necessity for reliance on numerous condition-specific local and global registries or limited and largely unavailable medical insurance or claims databases in most Asian nations. Linking health technology assessment processes with open data initiatives such as the Observational Medical Outcomes Partnership Common Data Model and the Observational Health Data Sciences and Informatics could enable the leveraging of global data resources to inform local decision-making. Advancing such initiatives is crucial for reinforcing health care frameworks in resource-limited settings and advancing toward cohesive, evidence-driven health care policy and improved patient outcomes in the region.

Next-generation sequencing impact on cancer care: applications, challenges, and future directions.

Fundamentally precision oncology illustrates the path in which molecular profiling of tumors can illuminate their biological behavior, diversity, and likely outcomes by identifying distinct genetic mutations, protein levels, and other biomarkers that underpin cancer progression. Next-generation sequencing became an indispensable diagnostic tool for diagnosis and treatment guidance in current clinical practice. Nowadays, tissue analysis benefits from further support through methods like comprehensive genomic profiling and liquid biopsies. However, precision medicine in the field of oncology presents specific hurdles, such as the cost-benefit balance and widespread accessibility, particularly in countries with low- and middle-income. A key issue is how to effectively extend next-generation sequencing to all cancer patients, thus empowering treatment decision-making. Concerns also extend to the quality and preservation of tissue samples, as well as the evaluation of health technologies. Moreover, as technology advances, novel next-generation sequencing assessments are being developed, including the study of Fragmentomics. Therefore, our objective was to delineate the primary uses of next-generation sequencing, discussing its' applications, limitations, and prospective paths forward in Oncology.

Pharmaceutical innovativeness index: methodological approach for assessing the value of medicines - a case study of oncology drugs.

BACKGROUND: We propose a framework to assess the value of pharmaceutical innovations, with explicit clinical and methodological parameters, based on the therapeutic value and health needs. RESEARCH DESIGN AND METHODS: The study was based on the adaptation of health technology assessment methods documented in the literature, which was applied to a sample of oncological drugs. Difficulties and issues during the application of those tools were identified and addressed to develop a new framework with new and revised domains and clear classification criterion for each domain. Scores were assigned to each level and domain according to their relevance to generate the final score of innovativeness. RESULTS: The Pharmaceutical Innovation Index (PII) includes four domains, two related to clinical and social dimensions - Therapeutic Need and Added Therapeutic Value - and other two about methodological features - Study Design and Quality (risk of bias). The scores combined after assigned to each domain results Index of the Innovativeness of the medicines represents the degree of pharmaceutical innovation. CONCLUSION: This work proposes a transparent methodology with well-defined criteria and script; the algorithm developed with authors' weightings and criteria may be switched to best adjust to other applications, perspective or clinical indications, while keeping the transparency and objectiveness.

[Judicialization of high priced medications in Argentina: quali-quantitative study]. / Judicialización de medicamentos de alto precio en Argentina: estudio cuali-cuantitativo.

INTRODUCTION: The economic consequences of mandatory coverage, through judicial means, of high-priced medications constitutes a growing problem, which merits knowing its local characteristics to provide possible solutions. OBJECTIVE: To identify medications, diseases involved, economic impact and contextual factors of the judicialization of high-priced medications in the Argentine Health System(MEP). METHODS: Quali-quantitative descriptive study that retrospectively analyzed legal protection resources by MEP from three national and provincial databases from January 2017 to December 2020, evaluating the existing relationship between lawsuits with regulatory approval, inclusion in benefit packages and relationship with journalistic articles for the three most frequently prosecuted drugs. RESULTS: 405 lawsuits were included, mainly from the Ministry of National Health. The three most prosecuted medications were nusinersen (21.7%), palbociclib (5.9%) and agalsidase-alfa (4.7%). Only 69.4% of medications were approved for marketing in Argentina at the time of the protection; 45.7% were incorporated into the Single Reimbursement System, and 16.8% had a report from the National Commission for the Evaluation of Health Technologies and Clinical Excellence (CONETEC), which was negative in 87.1% of cases. The average time from request to provision of the medication was 150 days. A temporal correlation was observed between the appearance of the MEP in the national graphic press and the appeals occurrence. CONCLUSIONS: Judicialization focused on very highpriced medications for rare or oncological diseases. The rulings were mostly in favor of the plaintiff, and access times to the medication took a long time. The mass media anticipated the judicial processes.

Introducción: Las consecuencias económicas de la cobertura obligatoria, vía judicial, de medicamentos de alto precio constituye un problema creciente, que amerita conocer sus características locales para aportar posibles soluciones. OBJETIVO: Identificar medicamentos, enfermedades, impacto económico y factores contextuales de la judicialización de medicamentos de alto precio (MEP) Argentina. Métodos: Estudio descriptivo cuali-cuantitativo que analizó retrospectivamente recursos de amparos legales por MEP de tres bases de datos nacionales y provinciales durante 4 años, evaluando relación existente entre amparos con aprobación regulatoria, inclusión de los MEP al paquete de beneficios y relación con notas periodísticas. RESULTADOS: Se incluyeron 405 amparos provenientes principalmente del Ministerio de Salud Nacional. Los tres medicamentos más judicializados fueron nusinersen (21.7%), palbociclib (5.9%) y agalsidasa-alfa (4.7%). Solo el 69.4% de los medicamentos se encontraban aprobados para la comercialización en Argentina al momento del amparo; el 45.7% se encontraban incorporados al Sistema Único de Reintegros y el 16.8% contaban con informe de la Comisión Nacional de Evaluación de Tecnologías Sanitarias y Excelencia Clínica (CONETEC), negativa en el 87.1% de casos. El tiempo promedio desde la solicitud hasta la provisión del medicamento fue de 150 días. Se observó una correlación temporal entre la aparición del MEP en la prensa nacional gráfica y la presentación de amparos de dicho MEP. CONCLUSIONES: La judicialización se concentró en medicamentos de altísimo precio para enfermedades poco frecuentes u oncológicas. Los fallos fueron mayoritariamente a favor del demandante, siendo los tiempos de acceso al medicamento prolongados. Los medios de comunicación anticiparon los procesos judiciales.

HTA criteria adopted in different models of public healthcare systems for orphan drugs: A scoping review.

Access to drugs for rare diseases constitutes a challenge to healthcare systems, especially those with public funding. This study aimed to map and summarize the criteria used by HTA agencies in different healthcare systems to evaluate reimbursement recommendations for orphan drugs. A comprehensive literature search was performed on the databases PubMed, LILACS, Scopus, and Embase and the gray literature (Google Scholar and websites of HTA agencies). Publications addressing the criteria used by HTA agencies in countries with public healthcare systems when evaluating reimbursement recommendations for orphan drugs were included. This scoping review included 23 studies published between 2014 and 2023, mostly consisting of reviews of HTA reports, guidance documents, and original articles. The criteria were mapped from 19 countries and ranked within three models of healthcare systems (National Health System, National Health Insurance, and Social Health Insurance). All models shared concerns about unmet needs and disease nature. In addition, NHS countries (e.g., United Kingdom, Sweden, and Italy) prioritized innovation and system-level impact, while SHI countries (e.g., Germany, France, the Netherlands) usually valued budget impact and employed expedited evaluation processes. This review provides a comprehensive understanding of the general tendencies of each healthcare system model in establishing differentiated criteria to address the challenges posed by the limited evidence and investment in the field of rare diseases.

Electronic Decision-Making Tool for Smoking Cessation (Pare de Fumar Conosco) Versus Standard of Care: A Cost-Effectiveness Analysis.

OBJECTIVES: The study aimed to evaluate the cost-effectiveness of the Pare de Fumar Conosco software compared with the standard of care adopted in Brazil for the treatment of smoking cessation. METHODS: In the cohort of smokers with multiple chronic conditions, we developed an decision tree model for the benefit measures of smoking cessation. We adopted the perspectives of the Brazilian Unified Health System and the service provider. Resources and costs were measured by primary and secondary sources and effectiveness by a randomized clinical trial. The incremental cost-effectiveness ratio (ICER) was calculated, followed by deterministic and probabilistic sensitivity analyses and deterministic and probabilistic sensitivity analyses. No willingness to pay threshold was adopted. RESULTS: The software had a lower cost and greater effectiveness than its comparator. The ICER was dominant in all of the benefits examined (-R$2 585 178.29 to -R$325 001.20). The cost of the standard of care followed by that of the electronic tool affected the ICER of the benefit measures. In all probabilistic analyses, the software was superior to the standard of care (53.6%-82.5%). CONCLUSION: The Pare de Fumar Conosco software is a technology that results in cost savings in treating smoking cessation.

Critical appraisal of the Colombian clinical practice guide for the prevention, diagnosis and treatment of suicidal ideation and/or behaviour (adoption).

INTRODUCTION: Suicide is a complex, global public health problem. The Colombian clinical practice guideline provides relevant input for its prevention, diagnosis and treatment. The objective was to evaluate the methodological quality, credibility and applicability of the Colombian clinical practice guideline for suicidal behaviour. METHODS: An academic group of 12 evaluators was established to assess the guide and its recommendations in a standardised way, using the AGREE-II and AGREE-REX instruments. The evaluations were given in the range of 0.0-1.0 with 0.7 as a cut-off point for appropriate quality. RESULTS: The global assessment of the AGREE-II was greater than 0.7 in the dimensions: "scope and objective" (0.86), "clarity of presentation" (0.89), "applicability" (0.73) and "editorial independence" (0.89). The lowest scores were for "participation of those involved" (0.67) and "rigour in preparation" (0.69). With the AGREE-REX, the results in all dimensions were below 0.70, which indicates lower quality and suitability for use. CONCLUSIONS: The adoption process of the Colombian guideline for suicidal behaviour was a rigorous methodological process, while the practice recommendations were valued as of low applicability due to low support in local evidence. It is necessary to strengthen the generation and synthesis of evidence at the national level to give greater support and applicability to the practice recommendations.

Application of natural language processing to predict final recommendation of Brazilian health technology assessment reports.

INTRODUCTION: Health technology assessment (HTA) plays a vital role in healthcare decision-making globally, necessitating the identification of key factors impacting evaluation outcomes due to the significant workload faced by HTA agencies. OBJECTIVES: The aim of this study was to predict the approval status of evaluations conducted by the Brazilian Committee for Health Technology Incorporation (CONITEC) using natural language processing (NLP). METHODS: Data encompassing CONITEC's official report summaries from 2012 to 2022. Textual data was tokenized for NLP analysis. Least Absolute Shrinkage and Selection Operator, logistic regression, support vector machine, random forest, neural network, and extreme gradient boosting (XGBoost), were evaluated for accuracy, area under the receiver operating characteristic curve (ROC AUC) score, precision, and recall. Cluster analysis using the k-modes algorithm categorized entries into two clusters (approved, rejected). RESULTS: The neural network model exhibited the highest accuracy metrics (precision at 0.815, accuracy at 0.769, ROC AUC at 0.871, and recall at 0.746), followed by XGBoost model. The lexical analysis uncovered linguistic markers, like references to international HTA agencies' experiences and government as demandant, potentially influencing CONITEC's decisions. Cluster and XGBoost analyses emphasized that approved evaluations mainly concerned drug assessments, often government-initiated, while non-approved ones frequently evaluated drugs, with the industry as the requester. CONCLUSIONS: NLP model can predict health technology incorporation outcomes, opening avenues for future research using HTA reports from other agencies. This model has the potential to enhance HTA system efficiency by offering initial insights and decision-making criteria, thereby benefiting healthcare experts.

Asimetrías entre la coordinación nacional y la autonomía de los gobiernos estatales en la adopción de tecnologías sanitarias frente a la COVID-19 en Argentina / Asymmetries between national articulation and the autonomy of state governments in implementing health technologies to fight COVID-19 in Argentina / Assimetrias entre a articulação nacional e a autonomia de governos estaduais na implementação de tecnologias de saúde em combate à COVID-19 na Argentina

Resumen: En pandemia, en Argentina y en otros países se observó variabilidad en las políticas públicas implementadas sobre tecnologías sanitarias para prevención y tratamiento de la COVID-19. El objetivo fue analizar cómo se procesaron en Argentina los movimientos de coordinación vs. cooperación, y de autonomía vs. reparto de autoridad entre entidades, explorando asimetrías entre diferentes entidades en la implementación de políticas públicas sobre tecnologías sanitarias en pandemia y las influencias de otros actores. Se realizó una revisión documental del período 2020-2021 (informes técnicos publicados por la Organización Mundial de la Salud, organismos nacionales y sociedades científicas, leyes, fallos judiciales, prensa, encuestas y entrevistas en profundidad a miembros de los Ministerios de Salud de Argentina). Se indagó sobre procesos y resultados de la toma de decisiones en los Ministerios de Salud, mapeando la cobertura y recomendación de cada tecnología y el partido político provincial gobernante. Hubo heterogeneidad en resultados y procesos entre los Ministerios, y disputas en el interior de los mismos. La adherencia a recomendaciones oficiales fue baja, influyendo distintos criterios técnico-políticos (relaciones de poder, presión social, de los medios, académicos, poder Judicial y Legislativo). En algunos casos se observó una fuerte tensión entre oficialismo y oposición al partido gobernante a partir de la discusión sobre tecnologías. Cada provincia argentina definió sus políticas sobre tecnologías sanitarias para COVID-19 con autonomía, y la toma de decisiones en la administración pública en pandemia fue desordenada, compleja y no lineal.

Abstract: Argentina, as other countries, showed several public policies related to the health technologies implemented to fight and treat the COVID-19 pandemic. This study sought to analyze how articulation vs. cooperation and autonomy vs. division of powers between entities occurred in Argentina, exploring asymmetries between several entities in implementing public policies related to health technologies during the pandemic and the influences of other actors. For this, a documentary research was carried out related to 2020-2021 (technical reports published by the World Health Organization, national agencies and scientific societies, laws, court decisions, press, and research and in-depth interviews with members of the Argentine Ministries of Health). The processes and results of decision-making in the Ministries of Health were analyzed, outlining the coverage and orientations of each technology and the political party in power in the province. This study found heterogeneous results and processes between Ministries and disputes within them. It also observed the poor adherence to official guidelines due to technical-political criteria (power relations, social, media, academic, judiciary, and legislative pressure). Some cases showed a strong tension between the government and its opposition over the discussion of technologies. Each province in Argentina has autonomously defined its policies on health technologies for COVID-19, and decision-making in public administration was disorderly, complex, and non-linear during the pandemic.

Resumo: Na Argentina, assim como em outros países, houve uma variabilidade de políticas públicas relacionadas às tecnologias de saúde implementadas no combate e tratamento da COVID-19 durante a pandemia. Este estudo buscou analisar como ocorreram a articulação vs. cooperação, e a autonomia vs. divisão de poderes entre as entidades na Argentina, explorando assimetrias entre diferentes entidades na implementação de políticas públicas relacionadas a tecnologias de saúde na pandemia, bem como as influências de outros atores. Para tanto, realizou-se uma pesquisa documental para o período de 2020-2021 (relatórios técnicos publicados pela Organização Mundial da Saúde, agências nacionais e sociedades científicas, leis, decisões judiciais, imprensa, pesquisas e entrevistas em profundidade com membros dos Ministérios da Saúde da Argentina). Os processos e os resultados da tomada de decisão nos Ministérios da Saúde foram analisados, traçando a cobertura e orientações de cada tecnologia e o partido político no poder na província. Observou-se uma heterogeneidade nos resultados e processos entre os Ministérios, e disputas em seu interior. Houve uma baixa adesão às orientações oficiais, influenciada por diferentes critérios técnico-políticos (relações de poder, pressão social, midiática, acadêmica, do poder Judiciário e do Legislativo). Em alguns casos, observou-se uma forte tensão entre governo e oposição a partir da discussão das tecnologias. Cada província da Argentina definiu suas políticas sobre tecnologias de saúde para a COVID-19 de forma autônoma, e a tomada de decisões na administração pública foi desordenada, complexa e não linear durante a pandemia.

Assessment of educational technology in lactation physiology by health students / Evaluación de tecnología educativa en fisiología de la lactancia por estudiantes de salud / Avaliação de tecnologia educacional de fisiologia da lactação por estudantes da saúde

ABSTRACT Objectives: to assess the suitability, facilitators, and barriers of using a video clip for teaching lactation physiology to health students. Methods: a cross-sectional study was conducted with online data collection at a higher education institution, using the Assistive Technology Assessment Instrument and open-ended questions. The sample consisted of 88 students. Results: the video clip was deemed suitable in all attributes. Facilitators identified included attractiveness, musicality, and ease of access. Barriers noted were the music's speed and the necessity for prior knowledge. The video clip achieved adequate scores for interactivity (1.71), purpose (1.77), relevance (1.64), and clarity (1.77). The overall average of the attributes was 1.72. Conclusions: the video clip can serve as an effective learning strategy to enhance hybrid education, potentially contributing to the promotion and support of breastfeeding. However, some barriers underscore the importance of prior knowledge for a complete understanding of the content.

RESUMEN Objetivos: evaluar la idoneidad, los facilitadores y las barreras del uso de un videoclip para enseñar fisiologia de la lactancia a estudiantes de salud. Métodos: se realizo un estudio transversal con recopilación de datos en línea en una institución de educación superior, utilizando el Instrumento de Evaluación de Tecnologia Asistiva y preguntas abiertas. La muestra consistió en 88 estudiantes. Resultados: el videoclip fue considerado adecuado en todos los atributos. Los facilitadores identificados incluyeron atractivo, musicalidad y facilidad de acceso. Las barreras señaladas fueron la velocidad de la música y la necesidad de conocimientos previos. El videoclip obtuvo puntuaciones adecuadas en interactividad (1.71), propósito (1.77), relevancia (1.64) y claridad (1.77). El promedio general de los atributos fue de 1.72. Conclusiones: el videoclip puede servir como una estrategia de aprendizaje efectiva para mejorar la educación híbrida, potencialmente contribuyendo a la promoción y el apoyo de la lactancia materna. Sin embargo, algunas barreras subrayan la importancia del conocimiento previo para una comprensión completa del contenido.

RESUMO Objetivos: avaliar a adequação, facilitadores e barreiras para o uso de um videoclipe para aprendizagem da fisiologia da lactação por estudantes da saúde. Métodos: estudo transversal com coleta de dados online em uma instituição de ensino superior, utilizando o Instrumento de Avaliação de Tecnologia Assistiva e questões abertas. A amostra incluiu 88 estudantes. Resultados: o videoclipe foi avaliado como adequado em todos os atributos. Facilitadores identificados incluíram atratividade, musicalidade e praticidade de acesso. Barreiras apontadas foram a velocidade da música e a necessidade de conhecimento prévio. O videoclipe obteve média adequada para interatividade (1,71), objetivo (1,77), relevância (1,64) e clareza (1,77). A média global dos atributos foi 1,72. Conclusões: o videoclipe pode ser utilizado como estratégia de aprendizagem que potencializa o ensino híbrido na formação, com potencial para contribuir com a promoção e apoio ao aleitamento materno. No entanto, algumas barreiras destacam a necessidade de conhecimento prévio para a compreensão total do conteúdo.

Implementação de tecnologias em saúde no Brasil: análise de orientações federais para o sistema público de saúde / Implementation of health technologies in Brazil: analysis of federal guidelines for the public health system

Resumo O objetivo foi identificar o arcabouço regulatório e as orientações federais que sustentam o processo de implementação de tecnologias em saúde no Sistema Único de Saúde (SUS), por meio da análise de documentos e legislações relacionados à Política Nacional de Gestão de Tecnologias de Saúde, publicados entre 2009 e 2021. Foi realizada busca e seleção dos documentos e posterior extração de dados, agrupados por três categorias: normativas estruturantes, recomendações na avaliação de tecnologias e recomendações nas diretrizes clínicas. Em 38,8% das normativas, foram identificadas citações à implementação relacionadas principalmente às diretrizes clínicas do SUS, mas nenhum documento dedicado a orientar as ações de implementação. As recomendações relacionadas às implementações foram identificadas em 27,1% dos relatórios e em 66,1% das diretrizes, mas sem padronização e, de modo geral, pouco detalhadas, com foco em recursos e ações necessárias para a disponibilização da tecnologia, ao invés de métodos e intervenções para implementação. Os resultados confirmam a existência de uma lacuna de diretrizes formais para guiar o processo de implementação no Brasil, o que se constitui em oportunidade para o desenvolvimento de modelos alinhados à realidade do SUS.

Abstract This study aimed to identify the regulatory framework and federal guidelines that support the process of implementing health technologies in the Unified Health System (SUS) through analysis of documents and legislation related to the National Health Technology Management Policy, published between 2009 and 2021. The search and selection of documents and subsequent data extraction were carried out. The documents were grouped into three categories: structural regulatory documents, recommendations on evaluation of technologies, and recommendations on clinical guidelines. In 38.8% of the regulatory documents, citations to implementation related mainly to SUS clinical guidelines were identified; however, no document dedicated to guiding implementation actions was identified. Recommendations related to implementations were identified in 27.1% of the reports and 66.1% of the guidelines, although without standardization and, in general, in little detail, focusing on resources and actions needed for making technology available rather than on methods and interventions for its implementation. The results evidence a gap in formal guidelines to guide the implementation process in Brazil, representing an opportunity for the development of models aligned with the reality of the SUS.

Polyphenol analysis in human milk by a rapid, cost-effective, and accurate micromethod: translational development / Análise de polifenóis no leite humano por meio de um micrométodo rápido, econômico e preciso: desenvolvimento translacional

ABSTRACT Objective: To develop a rapid method for analysing polyphenols, which are potentially active antioxidants against neonatal oxidative stress, from small human milk (HM) volumes. Methods: Acid and alkaline extractions were compared using two dyes: Folin-Ciocalteu and Fast Blue BB. Linearity, sensitivity, recovery percentage, polyphenol content, precision, and stability were assessed in 14 HM samples and compared using the Kruskal-Wallis H test (p<0.05). The best technique was applied to 284 HM samples to determine their polyphenolic content and its association with maternal diet by multifactorial linear regression. Results: Acidic extraction successfully recovered the gallic acid reference standard, whereas alkaline extraction overestimated it. Calibration curves for all methods were linear (R2>0.96) up to 500 mg/L. All bicarbonate-based Folin-Ciocalteu methods assayed were stable and repeatable, whereas Fast Blue BB-based variants were not. HM polyphenols (mean=94.68 mg/L) positively correlated to the dietary intake of hydroxycinnamic acids, the most consumed polyphenolic family in this population. Conclusions: A bicarbonate-based Folin-Ciocalteu micromethod allowed the accurate determination of polyphenols in HM, which might be useful for translational research settings and HM banks.

RESUMO Objetivo: Desenvolver um método rápido para analisar polifenóis, que são antioxidantes potencialmente ativos contra o estresse oxidativo neonatal, em pequenos volumes de leite humano (LH). Métodos: Foram comparadas extrações ácidas e alcalinas usando dois corantes: Folin-Ciocalteu e Fast Blue BB. Foram avaliadas variáveis como linearidade, sensibilidade, percentagem de recuperação, teor de polifenóis, precisão e estabilidade em 14 amostras de LH, comparadas usando o teste de Kruskal-Wallis H (p<0,05). A melhor técnica foi aplicada a 284 amostras de LH para determinar seu teor polifenólico e sua associação com a dieta materna por regressão linear multifatorial. Resultados: A extração ácida recuperou com sucesso o padrão de referência do ácido gálico, enquanto a extração alcalina o superestimou. As curvas de calibração para todos os métodos foram lineares (R2>0,96) até os 500 mg/L. Todos os métodos testados baseados em Folin-Ciocalteu com bicarbonato foram estáveis e repetíveis, enquanto as variantes baseadas em Fast Blue BB não. Os polifenóis do HM (média=94,68 mg/L) correlacionaram-se positivamente com a ingestão dietética de ácidos hidroxicinâmicos, a família de polifenóis mais consumida nesta população. Conclusões: Um micrométodo baseado em bicarbonato de Folin-Ciocalteu permitiu a determinação precisa de polifenóis no HM, o que pode ser útil para configurações de pesquisa translacional e bancos de HM.

Evaluation of software technical quality for collecting data from patients under palliative care / Evaluación de la calidad técnica del software para la recogida de datos de pacientes en cuidados paliativos / Avaliação da qualidade técnica de software para coleta de dados de pacientes em cuidados paliativos

ABSTRACT Objectives: to evaluate software technical quality for collecting data from patients under palliative care. Methods: this is methodological technology evaluation research, according to the technical standard International Organization for Standardization/International Electrotechnical Commission 25040-2011, developed from August 2021 to August 2023. Eight nurses and eight information technology professionals participated as judges, who evaluated six quality characteristics and 23 subcharacteristics. Items that reached a percentage of agreement greater than 70% were considered suitable. Results: the characteristics evaluated by nurses/information technology professionals received the following percentages of agreement, respectively: functional suitability (94%-84%); reliability (100-70%); usability (89.9-66.8%); performance efficiency (95.8%-86.1%); compatibility (95.8-79.6%); and safety (96%-83.4%). Conclusions: the software was considered suitable in quality evaluation to offer support to nurses in collecting patient data under palliative care, with the potential to operationalize the first Nursing Process stage.

RESUMEN Objetivos: evaluar la calidad técnica del software para la recolección de datos de pacientes en cuidados paliativos. Métodos: se trata de una investigación metodológica de evaluación de tecnología, según la norma técnica International Organization for Standardization/International Electrotechnical Comission 25040-2011, desarrollada de agosto de 2021 a agosto de 2023. Participaron como jueces ocho enfermeros y ocho profesionales de tecnologías de la información, quienes evaluaron seis características de calidad y 23 subcaracterísticas. Se consideraron adecuados los ítems que alcanzaron un porcentaje de acuerdo superior al 70%. Resultados: las características evaluadas por enfermeros/profesionales de tecnologías de la información recibieron los siguientes porcentajes de acuerdo, respectivamente: adecuación funcional (94%-84%); confiabilidad (100-70%); usabilidad (89,9-66,8%); eficiencia del desempeño (95,8%-86,1%); compatibilidad (95,8-79,6%); y seguridad (96%-83,4%). Conclusiones: el software fue considerado adecuado en la evaluación de calidad para ofrecer apoyo a los enfermeros en la recolección de datos de los pacientes en cuidados paliativos, con potencial para operacionalizar la primera etapa del Proceso de Enfermería.

RESUMO Objetivos: avaliar a qualidade técnica de software para coleta de dados de pacientes sob cuidados paliativos. Métodos: trata-se de pesquisa metodológica de avaliação de tecnologia, conforme norma técnica International Organization for Standardization/International Electrotechnical Comission 25040-2011, desenvolvida de agosto de 2021 a agosto de 2023. Participaram oito enfermeiros e oito profissionais de tecnologia da informação como juízes, os quais avaliaram seis características e 23 subcaracterísticas de qualidade. Consideraram-se adequados os itens que atingiram porcentual de concordância superior a 70%. Resultados: as características avaliadas pelos enfermeiros/profissionais de tecnologia da informação receberam os seguintes porcentuais de concordância, respectivamente: adequação funcional (94%-84%); confiabilidade (100-70%); usabilidade (89,9-66,8%); eficiência de desempenho (95,8%-86,1%); compatibilidade (95,8-79,6%); e segurança (96%-83,4%). Conclusões: o software foi considerado adequado na avaliação de qualidade para oferecer suporte ao enfermeiro na coleta de dados do paciente em cuidados paliativos, com potencial para operacionalizar a primeira etapa do Processo de Enfermagem.

Lactation physiology video clip: health professionals` assessment in hospital care / Videoclip de la fisiología de la lactancia: evaluación por profesionales de la salud en la atención hospitalaria / Videoclipe da fisiologia da lactação: avaliação por profissionais da saúde na atenção hospitalar

ABSTRACT Objective: To evaluate the usability of a lactation physiology video clips by healthcare professionals and to identify barriers and facilitators for this usage in hospitals. Method: Cross-sectional study juxtaposed with the Knowledge Translation Model. The video clip was evaluated with the System Usability Scale self-applied to 63 health professionals from a university hospital in southern Brazil, from April to September 2022. Spearman's correlation test was used. Results: The usability of the video clip obtained the best imaginable classification with a positive association with longer training time (p=0.038) and motivation for using it (p=0.035). The facilitators went to have institutional capacity building; physical space and moments of guidance for breastfeeding; brevity of the video clip with easy and playful information. Barriers were overcrowding and turnover, limited audiovisual equipment and internet equipment. Conclusion: The excellence of the usability of the video clip in the hospital highlights the potential for its application in continuing education with professionals and in health education with users. It is concluded that the longer the training time and the motivation for using technologies in daily care, the better professionals evaluate usability.

RESUMEN Objetivo: Evaluar la usabilidad de un videoclip sobre fisiología de la lactancia por parte de profesionales de la salud e identificar barreras y facilitadores para su uso en el hospital. Método: Estudio transversal yuxtapuesto al Modelo de Traducción del Conocimiento. El videoclip fue evaluado mediante la Escala de Usabilidad del Sistema autoadministrada en 63 profesionales de la salud de un hospital universitario, en el sur de Brasil, de abril a septiembre de 2022. Se utilizó la prueba de correlación de Spearman. Resultados: La usabilidad del videoclip obtuvo la mejor calificación imaginable con una asociación positiva con mayor tiempo de entrenamiento (p=0,038) y motivación para su uso (p=0,035). Los facilitadores debían tener formación institucional; espacio físico y momentos de orientación para la lactancia materna; brevedad del videoclip con informaciones fáciles y divertidas. Las barreras fueron la superpoblación y la rotación, y el limitado equipamiento audiovisual y de internet. Conclusión: La excelencia de la usabilidad de videoclips en el hospital resalta el potencial de su aplicación en la educación continua con los profesionales y en la educación sanitaria con los usuarios. Se concluye que cuanto mayor es el tiempo de formación y la motivación por el uso de las tecnologías en el cuidado diario, mejor evalúan los profesionales la usabilidad.

RESUMO Objetivo: Avaliar a usabilidade de um videoclipe da fisiologia da lactação por profissionais da saúde, identificando barreiras e facilitadores para o seu uso no hospital. Método: Estudo transversal justaposto ao Modelo de Tradução do Conhecimento. O videoclipe foi avaliado com a System Usability Scale autoaplicada em 63 profissionais de saúde de um hospital universitário, no sul do Brasil, de abril a setembro de 2022. Foi utilizado o teste de correlação de Spearman. Resultados: A usabilidade do videoclipe obteve classificação melhor imaginável com associação positiva ao maior tempo de formação (p=0,038) e motivação para o uso (p=0,035). Os facilitadores foram ter capacitação institucional; espaço físico e momentos de orientação para amamentação; brevidade do videoclipe com informações fáceis e lúdicas. As barreiras foram superlotação e rotatividade, limitação de equipamentos audiovisuais e de internet. Conclusão: Quanto maior o tempo de formação e a motivação para o uso de tecnologias no cotidiano assistencial melhor os profissionais avaliam a usabilidade. A usabilidade do videoclipe no hospital aponta o potencial de sua aplicação na educação permanente com profissionais e na educação em saúde com usuários.

Real-world evidence: experiences and challenges for decision making in Latin America.

OBJECTIVE: The Health Technology Assessment (HTA) process aims to optimize health system funding of technologies. In recent years there has been an increase in what is known as Real-World Evidence (RWE) as a complement to clinical trials. The objective of Health Technology Assessment International's Latin American Policy Forum 2022 was to explore the utility of incorporating RWE into HTA and decision-making processes in the region. METHODS: This article is based on a background document, survey, and the deliberative work of the country representatives who participated in the Forum. RESULTS: There is a growing interest in the use of Real-World Data / Real-World Evidence in HTA processes in Latin America, although currently there are no specific local guidelines for RWE use by HTA agencies. At present, its use is limited to certain areas such as adding context to HTA reports, the evaluation of adverse events, or cost estimation.Potential future uses of RWE were identified, including the creation of risk-sharing agreements, the assessment of technology performance in routine practice, providing information on outcomes that are not so easily evaluated in clinical trials (e.g., the identification of specific subpopulations or quality of life), and the estimation of input parameters for economic evaluations. CONCLUSIONS: The participants agreed that there are several areas presenting significant potential to expand the application of RWD/RWE and that the development of normative frameworks for its use could be helpful.

Análisis costo-efectividad del tratamiento con terapia compresiva en la cicatrización de úlceras venosas / Cost-effectiveness analysis of the treatment with compressive therapy in the healing of venous ulcers / Análise de custo-efetividade do tratamento com terapia compressiva na cicatrização de úlceras venosas

Objetivo: analizar el costo-efectividad y calcular la relación costoefectividad incremental del tratamiento multicapa compresivo con respecto al inelástico (bota de Unna y estiramiento corto) según la literatura actual. Método: estudio cuantitativo de costo-efectividad a través de un modelo con ayuda del software TreeAge® para la elaboración del árbol de decisión. Los supuestos anunciados se obtuvieron mediante el uso de datos secundarios de la literatura para estimar el costo y la efectividad de los parámetros asumidos. Para ello, se realizó una revisión sistemática de la literatura con metaanálisis. Resultados: el árbol de decisión, después del Roll Back, mostró que la terapia multicapa prevaleció sobre las alternativas en el caso base, presentó un costo intermedio por aplicación, pero obtuvo la mayor efectividad. El gráfico del análisis de costo-efectividad también demostró que había un dominio extendido de la bota de Unna sobre el vendaje de estiramiento corto. El análisis de sensibilidad reveló que el vendaje multicapa sigue siendo la alternativa con mayor costoefectividad, dentro del umbral de disposición a pagar. Conclusión: la alternativa con mayor costo-efectividad fue el vendaje multicapa, considerado estándar de oro en la literatura. La segunda alternativa con mayor costo-efectividad fue la bota de Unna, la terapia más utilizada en Brasil.

Objective: to analyze the cost-effectiveness and calculate the incremental cost-effectiveness ratio of multilayer compressive treatment in relation to inelastic (Unna boot and short stretch) therapy according to the current literature. Method: quantitative study about cost-effectiveness through modeling with the aid of TreeAge® software for construction of the decision tree. The anticipated assumptions were obtained by using secondary literature data to estimate the cost and effectiveness of the assumed parameters. A systematic literature review with meta-analysis was performed for this end. Results: the decision tree after Roll Back showed that the multilayer therapy dominated the alternatives in the base case, representing an intermediate cost per application, although with the highest effectiveness. The cost-effectiveness analysis graph also showed extended dominance of the Unna boot in relation to the short stretch bandage. The sensitivity analysis showed that multilayer bandage remains a more cost-effective alternative, within the threshold of willingness to pay. Conclusion: the most cost-effective alternative was multilayer bandage, considered the gold standard in the literature. The second most cost-effective alternative was the Unna boot, the most used therapy in Brazil.

Objetivo: analisar a custo-efetividade e calcular a razão de custoefetividade incremental do tratamento compressivo multicamadas em relação ao inelástico (bota de Unna e curto estiramento) de acordo com a literatura atual. Método: estudo quantitativo sobre custo-efetividade por meio de modelagem com auxílio do software TreeAge® para a construção da árvore de decisão. Os pressupostos anunciados foram obtidos pelo uso de dados secundários de literatura para estimativa do custo e efetividade dos parâmetros assumidos. Para tal, foi realizada uma revisão sistemática de literatura com metanálise. Resultados: a árvore de decisão, após Roll Back mostrou que a terapia multicamadas dominou as alternativas no caso-base, representando custo intermediário por aplicação, porém, com a maior efetividade. O gráfico da análise de custo-efetividade também mostrou uma dominância estendida da bota de Unna em relação à bandagem de curto estiramento. A análise de sensibilidade mostrou que a bandagem multicamadas permanece como alternativa mais custo-efetiva, dentro do limiar de disposição para pagar. Conclusão: a alternativa com maior custo-efetividade foi a bandagem multicamadas, considerada padrão ouro na literatura. A segunda alternativa mais custo-efetiva foi a bota de Unna, terapia mais utilizada no Brasil.

Estudo comparativo entre empresa farmacêutica global e instituição pública de produção e inovação em saúde / Comparative study between global pharmaceutical company and public institution of production and innovation in health

RESUMO O cenário tecnológico no campo da saúde é um fato alarmante, mormente no contexto provocado pela Covid-19. Nessa conjuntura, a Fundação Oswaldo Cruz, por meio da Unidade de Bio-Manguinhos, e o Butantan foram protagonistas para o acesso universal, dialogando com estratégicas internacionais. No adensamento da discussão estratégica para Instituições Públicas de Produção e Inovação em Saúde (Ippis), o uso de diretrizes da Avaliação de Tecnologias em Saúde destaca-se como via de mudança paradigmática para a introdução de tecnologias no Sistema Único de Saúde (SUS) alinhada à visão de inovação de futuro em saúde consonante às demandas nacionais. Este artigo, desenvolvido metodologicamente mediante pesquisas descritiva qualitativa, bibliográfica, documental e trabalho de campo, buscou traçar simetrias e assimetrias baseado nas experiências coletadas em empresa farmacêutica global e instituição de referência nacional pública do campo de incorporação tecnológica em saúde. Como resultados, são explicitados pontos-chave para o fortalecimento técnico e político do Complexo Econômico-Industrial da Saúde, por meio da revisão organizacional das Ippis quanto a aspectos de inovação e de gestão, culminado na promoção de melhorias na Política de ciência, tecnologia e inovação em resposta ao desafio da sustentabilidade, efetividade e acesso no SUS.

ABSTRACT The technological scenario in the field of health is an alarming fact, especially in the context caused by COVID-19. In this context, the Oswaldo Cruz Foundation, through the Bio-Manguinhos Unit, and the Butantan Institute were protagonists for universal access, dialoguing with international strategies. In the strategic discussion for Public Institutions of Production and Innovation in Health (IPPIS), the use of guidelines of the Technological Assessment in Health stands out as a way of paradigmatic change for the introduction of technologies in the Unified Health System (SUS) in line with the vision of future innovation in health in accordance with national demands. This article, methodologically developed through qualitative descriptive research, bibliographical, documentary and field work, sought to trace symmetries and asymmetries based on the experiences collected in a global pharmaceutical company and a public national reference institution in the field of technological incorporation in health. As a result, key points are explained for the technical and political strengthening of the Health Economic-Industrial Complex, through the organizational review of the IPPIS regarding innovation and management aspects, culminating in the promotion of improvements in the science, technology and innovation policy in response to the challenge of sustainability, effectiveness and access in the SUS.

Challenges and opportunities in building a health economic framework for personalized medicine in oncology.

Personalized medicine has allowed for knowledge at an individual level for several diseases and this has led to improvements in prevention and treatment of various types of neoplasms. Despite the greater availability of tests, the costs of genomic testing and targeted therapies are still high for most patients, especially in low- and middle-income countries. Although value frameworks and health technology assessment are fundamental to allow decision-making by policymakers, there are several concerns in terms of personalized medicine pharmacoeconomics. A global effort may improve these tools in order to allow access to personalized medicine for an increasing number of patients with cancer.