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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.
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Objective To evaluate the efficacy,safety and economy of teriparatide in the treatment of osteoporosis.Methods PubMed,Embase,Cochrane Library,Web of Science,CNKI,WanFang Data,VIP databases and websites related to health technology evaluation were systematically searched to collect high-quality clinical evidence and economic evaluation literature of teriparatide in the treatment of osteoporosis from the inception to January 20,2023.Two researchers independently identified studies,extracted data,assessed the quality of included studies,and descriptive analyzed and summarised the results.Results A total of 25 literatures were included,involving 3 HTA reports,15 systematic review/Meta-analyses and 7 economic studies were included.In terms of effectiveness,the evaluation results showed that teriparatide could improve bone mineral density in patients with osteoporosis,reduce the incidence of vertebral/non-vertebral fractures in primary and secondary osteoporosis and prevent the fractures in postmenopausal osteoporosis compared to bisphosphonates and placebos.In terms of safety,teriparatide was proven to be safe with no elevated risk of adverse drug reactions.In terms of economic cost,teriparatide has a higher cost and economic disadvantage compared with bisphosphonates,however,for people with severe postmenopausal osteoporosis and high risk of fracture,teriparatide can be considered as a potential cost-effect treatment option.Conclusion Teriparatide is effective and safe in the treatment of osteoporosis,but it is not cost-effective advantages compared with the existing other anti-osteoporosis medications.
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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.
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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.
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AIM:To rapidly evaluate the effective-ness,safety and economy of dienogest in the treat-ment of endometriosis so as to provide evidence-based reference for clinical drug selection and deci-sion.METHODS:Retrieved from PubMed,Embase,Cochrane Library,CNKI,SinoMed,Wanfang and health technology assessment(HTA)organization websites,HTA report,systematic review/Meta-anal-ysis and pharmacoeconomic study were included during the inception to Sep 2023.Data extraction and quality evaluation were carried out for the lit-erature that met the inclusion and exclusion crite-ria,and the research results were summarized and analyzed qualitatively.RESULTS:Nine systematic re-view/Meta-analyses,and 2 pharmacoeconomic studies were included.The quality of Meta-analysis literatures was low,and the quality of economic re-search was good.In terms of effectiveness,com-pared with no treatment,dienogest can significant-ly reduce postoperative recurrence rate,VAS score,and improve pregnancy rate and effective rate;Di-enogest has similar therapeutic effects in terms of recurrence rate as GnRHa and COC;With regard to recurrence rate and pregnancy rate,dienogest is superior to danazol,gestrinone,and mifepristone.In terms of safety,compared with placebo,the inci-dence of vaginal bleeding and headache was signifi-cantly increased with dienogest,and there was no difference in bone loss;The incidence of vaginal bleeding caused by dienogest was significantly high-er than that of GnRHa,but the incidence of hot flashes and bone loss was lower.In terms of econo-my,dienogest has a more cost-effective advantage comparing with GnRHa,but does not have econom-ic benefits comparing with COC.CONCLUSION:Di-enogest has good effectiveness and safety in the treatment of endometriosis,and economically su-perior to GnRHa,but inferior to COC.
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Reducing low-value care is a key measure to optimize service model for cancer patients and improve the quality of and value of care.We summarizes the conceptual connotation of low-value medical services for cancer patients,compares the relevant measurement indicators at home and abroad,explains the logic of low-value medical services use for cancer patients at the three levels of"individual-institution-system",and proposes strategies for reducing low-value medical services for cancer patients in five aspects:construction of service value framework,dissemination of evaluation results,connection of drug access mechanisms,moni-toring of cancer care services,and empowering shared decision-making.
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Health technology assessment(HTA)is an important tool to inform health decision-making.Although highly related to ethical issues in the context of HTA,equity has attracted much attention from the academia,a consensus has not yet been reached on how to define and evaluate equity in China and abroad.It introduces the concept of equity,pointes out the necessity to realize health equity and the reflection of equity in healthcare sector,and further elaborates four ways to consider equity,and described the official practice of equity in HTA at home and abroad.It proposes several suggestions for China's HTA:considering equity in HTA and the discussion of equity should depend on specific decision-making scenarios;clarifying what health measurement perspective should be adopted before measuring health equity;paying attention to the value judgment of equity adopted by various stakeholders;conducting basic researches on the general population's preference for health measurement perspectives and value judgments of equity in China in a gesture to improve the evaluation system of equity in HTA.
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The pricing and reimbursement of orphan drugs are related to the accessibility of patients,and are of great significance to the prevention and guarantee of rare diseases.European countries have formed special standards and paths for health technology evaluation,and established special payment funds and diversified risk-sharing agreements,which have effectively improved the accessibility of orphan drugs.Based on this,it selected typical European countries to compare the orphan drug pricing and reimbursement methods.Then,it put forward some suggestions"building orphan drug health technology evaluation accelerated program,exploring the health of orphan drug classification security mechanism,and attaining supply incentives and development incentives through orphan drug pricing and adjustment",to optimize the basis for the orphan drug market access mechanism to provide reference.
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The access evaluation of new medical technology is an important part of the preclinical application of medical technology and plays a vital role in ensuring the quality and safety of medical services.However,in the con-crete practice of access evaluation,there are still some problems such as imperfect access theoretical framework,imperfect evaluation index system.With the strategic support of health policies,laws,and regulations,the theory and method of HB-HTA are used for reference,core elements such as assessment subject,assessment object,and assessment content are comprehensively considered,the index system is designed from the dimensions of tech-nical characteristics,safety,effectiveness,economy and applicability,and the access evaluation framework of im-ported medical new technologies is constructed.To offer a theoretical framework and evidence-based basis for medi-cal facility medical technology access management.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Subject(s)
Humans , Varicose Ulcer/therapy , Wound Healing , Brazil , Compression Bandages , Cost-Effectiveness AnalysisABSTRACT
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.
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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.
Subject(s)
Orphan Drug Production , Technology Assessment, Biomedical , Rare DiseasesABSTRACT
La educación de posgrado en Cuba tiene una función determinante en el desarrollo de los profesionales. Al respecto, en la Universidad de Ciencias Médicas de Santiago de Cuba se ha implementado un modelo formativo para la gestión de la evaluación de las tecnologías sanitarias, en el cual se establece la interrelación e interconexión del enfoque en ciencia, tecnología y sociedad, así como el empleo del contexto y la contextualización en los referentes que permiten la transformación del proceso de formación de posgrado. En el actual artículo se expone cómo la aplicación de dicho modelo ha contribuido a moldear la preparación e incrementar la cultura de los gestores de ciencia, tecnología e innovación en salud, a la vez que ha favorecido la calidad de la educación de posgrado desde una perspectiva integral, materializada en la mejora de su gestión.
Postgraduate education in Cuba has a determining role in the development of professionals. In this regard, the University of Medical Sciences from Santiago de Cuba has implemented a training model for the management of health technologies assessment, which establishes the interrelation and interconnection of the approach in science, technology and society, as well as the use of context and contextualization in the referents that allow the transformation of postgraduate training process. In the current article, it is exposed how the application of said model has contributed to shaping the training and improving the culture of health science, technology and innovation managers, at the same time that it has favored the quality of postgraduate education from an integral perspective, materialized in the improvement of its management.
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En un contexto de atención médica en constante evolución, la evaluación de tecnologías sanitarias se ha vuelto esencial. Este proceso evalúa la efectividad, seguridad y costo-efectividad de las tecnologías médicas, desde medicamentos hasta dispositivos. La evaluación respalda decisiones clínicas informadas, reduciendo la variabilidad en la práctica y mejorando la atención al paciente. Además, desempeña un papel crucial en las políticas de salud al guiar la asignación eficiente de recursos y promover el acceso equitativo a las tecnologías sanitarias. Como conclusión se puede decir que la evaluación de tecnologías sanitarias es esencial para garantizar sistemas de salud sostenibles y una atención de calidad.
In an ever-evolving healthcare environment, health technology assessment has become essential. This process evaluates the effectiveness, safety and cost-effectiveness of medical technologies, from drugs to devices. The assessment supports informed clinical decisions, reducing practice variability and improving patient care. It also plays a crucial role in health policy by guiding the efficient allocation of resources and promoting equitable access to health technologies. In conclusion, health technology assessment is essential to ensure sustainable health systems and quality care.
Em um contexto de saúde em constante evolução, a avaliação da tecnologia da saúde tornou-se essencial. Esse processo avalia a eficácia, a segurança e a relação custo-benefício das tecnologias médicas, de medicamentos a dispositivos. A avaliação apóia decisões clínicas fundamentadas, reduzindo a variabilidade na prática e melhorando o atendimento ao paciente. Ela também desempenha um papel fundamental na política de saúde, orientando a alocação eficiente de recursos e promovendo o acesso equitativo às tecnologias de saúde. Em conclusão, a avaliação da tecnologia em saúde é essencial para garantir sistemas de saúde sustentáveis e atendimento de qualidade.