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3.
Farm. hosp ; 43(4): 121-127, jul.-ago. 2019. graf, tab
Artigo em Inglês | IBECS | ID: ibc-183898

RESUMO

Objective: There are differences between countries regarding data requirements for orphan drug evaluation and it is also unknown which criteria might determine the price and reimbursement decision. This study aimed to identify the key criteria for price and reimbursement of orphan drugs in Spain, approved by the European Commission, between January 2012 and June 2018. Method: A descriptive analysis of the orphan drugs and its characteristics was performed. Outcomes criteria assessed were: therapeutic area, existence of alternative treatment, rarity of the disease, clinical trial outcomes and therapeutic positioning report assessment. Hypotheses for each variable regarding Spanish pricing and reimbursement were made and tested with two regression analyses. Results: Out of 78 orphan drugs approved by the European Commission, 82.1% asked pricing and reimbursement in Spain. From this, 43.8% had pricing and reimbursement approved and 20.3% rejected. Mean time from Spanish marketing authorisation approval to pricing and reimbursement approval was 12.1 ± 5.1 months. Having a positive therapeutic positioning report and no therapeutic alternatives would be associated with a positive pricing and reimbursement in Spain. Conclusions: It remains challenging to establish which are the driving criteria for pricing and reimbursement approval of orphan drugs in Spain. Further research should be done including other variables that might influence the pricing and reimbursement final decision in Spain


Objetivo: Los requisitos para la evaluación de los medicamentos huérfanos difieren entre los países miembros de la Unión Europea y tampoco se sabe qué criterios influyen en la decisión final sobre precio y financiación. Este estudio ha tenido como objetivo identificar los criterios clave para establecer el precio y la financiación de los medicamentos huérfanos en España, una vez aprobados por la Comisión Europea, entre enero de 2012 hasta junio de 2018. Método: Se realizó un análisis descriptivo de los medicamentos huérfanos y sus características. Los criterios evaluados fueron: área terapéutica, existencia de tratamientos alternativos, rareza de la enfermedad, tipo de resultados de los ensayos clínicos e informe de posicionamiento terapéutico. Para cada variable se estableció una hipótesis con respecto a la aprobación de precio y financiación y se analizaron con dos análisis de regresión. Resultados: De las 78 aprobaciones de medicamentos huérfanos realizadas por la Comisión Europea, el 82,1% solicitaron precio y financiación en España. De estas, el 43,8% fueron aprobadas y el 20,3% fueron rechazadas. El tiempo medio desde la aprobación de la autorización de comercialización en España hasta la aprobación del precio y la financiación fue de 12,1 ± 5,1 meses. Un informe de posicionamiento positivo y la falta de alternativas terapéuticas se asociaría con una aprobación de precio y financiación. Conclusiones: Sigue siendo un reto establecer cuáles son los criterios clave para la aprobación de los medicamentos huérfanos en España. Los próximos estudios deberían incluir un mayor número de variables que puedan influir en el precio y la decisión de financiación


Assuntos
Produção de Droga sem Interesse Comercial/economia , Produção de Droga sem Interesse Comercial/normas , Tecnologia Biomédica/normas , Alocação de Custos/normas , Custos e Análise de Custo , Modelos Logísticos , Comercialização de Medicamentos
4.
Khirurgiia (Mosk) ; (5): 120-127, 2019.
Artigo em Russo | MEDLINE | ID: mdl-31169829

RESUMO

During 2012-2018 in the Russian Federation, pursuant to Presidential Decree No. 599 of 05.07.2012, a set of state support measures was implemented aimed at increasing the specific gravity of Russian publications indexed in international databases. The national project 'Science' (NPS) designed to realize the goals set by Presidential Decree No.204 of 05.07.2018 'On the National Goals and Strategic Tasks for Development of the Russian Federation until 2024' continues and develops the theme of increasing the publication activity of the Russian Federation in the internationalized space. One of the six NPS targets is 'The place of the Russian Federation in terms of specific gravity in the total number of articles in areas defined by the priorities of scientific and technological development in publications indexed in international databases'. The purpose of this study was to evaluate the basic value of this indicator for biomedical disciplines related to the priority direction (paragraph 20c) of the Strategy for Scientific and Technological Development of the Russian Federation. We compared volumes of publication flows of the Russian Federation in 20 biomedical disciplines with a similar indicator of countries ranked fifth in the number of publications on the subject area under consideration, indexed in the Web of Science Core Collection (WoS CC). A 5-10 fold lag of the Russian Federation was recorded for the most part of the priority areas in the field of biomedicine identified by the NTS passport. The impact of public policy measures aimed at increasing the national biomedical publication stream for the period of 2012-2018 was estimated as insufficient to meet the considered NTS target.


Assuntos
Pesquisa Biomédica/estatística & dados numéricos , Tecnologia Biomédica/estatística & dados numéricos , Bases de Dados Factuais/estatística & dados numéricos , Política Pública , Editoração/estatística & dados numéricos , Pesquisa Biomédica/normas , Tecnologia Biomédica/normas , Internacionalidade , Política Pública/legislação & jurisprudência , Política Pública/tendências , Editoração/normas , Federação Russa
6.
IEEE Pulse ; 10(3): 15-18, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31135346

RESUMO

Access to health care has long been considered to be a human right. It was formally declared in 1946 when the heads of states wrote the constitution of the World Health Organization (WHO). But more than 70 years after the fact, the global community still has yet to achieve it.


Assuntos
Atenção Primária à Saúde , Tecnologia Biomédica/história , Tecnologia Biomédica/organização & administração , Tecnologia Biomédica/normas , História do Século XX , História do Século XXI , Humanos , Atenção Primária à Saúde/história , Atenção Primária à Saúde/organização & administração , Atenção Primária à Saúde/tendências , Organização Mundial da Saúde
7.
Res Synth Methods ; 10(2): 267-286, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31013000

RESUMO

BACKGROUND: Model-based meta-analysis (MBMA) is increasingly used to inform drug-development decisions by synthesising results from multiple studies to estimate treatment, dose-response, and time-course characteristics. Network meta-analysis (NMA) is used in Health Technology Appraisals for simultaneously comparing effects of multiple treatments, to inform reimbursement decisions. Recently, a framework for dose-response model-based network meta-analysis (MBNMA) has been proposed that combines, often nonlinear, MBMA modelling with the statistically robust properties of NMA. Here, we aim to extend this framework to time-course models. METHODS: We propose a Bayesian time-course MBNMA modelling framework for continuous summary outcomes that allows for nonlinear modelling of multiparameter time-course functions, accounts for residual correlation between observations, preserves randomisation by modelling relative effects, and allows for testing of inconsistency between direct and indirect evidence on the time-course parameters. We demonstrate our modelling framework using an illustrative dataset of 23 trials investigating treatments for pain in osteoarthritis. RESULTS: Of the time-course functions that we explored, the Emax model gave the best fit to the data and has biological plausibility. Some simplifying assumptions were needed to identify the ET50 , due to few observations at early follow-up times. Treatment estimates were robust to the inclusion of correlations in the likelihood. CONCLUSIONS: Time-course MBNMA provides a statistically robust framework for synthesising evidence on multiple treatments at multiple time points. The use of placebo-controlled studies in drug-development means there is limited potential for inconsistency. The methods can inform drug-development decisions and provide the rigour needed in the reimbursement decision-making process.


Assuntos
Tecnologia Biomédica/normas , Meta-Análise em Rede , Osteoartrite/terapia , Resultado do Tratamento , Teorema de Bayes , Ensaios Clínicos como Assunto , Humanos , Modelos Lineares , Manejo da Dor/métodos , Reprodutibilidade dos Testes
9.
AACN Adv Crit Care ; 30(1): 48-59, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30842073

RESUMO

The prevalence of complex technology in the health care arena has increased dramatically in the 21st century. Nurses working in acute and critical care have the greatest interaction with technology, using it to manage patients and optimize clinical outcomes as well as to prevent errors and adverse events. The successful implementation of complex medical technology is, in itself, a complex process. The purpose of this article is to provide nurse leaders and clinical nurses with an overview of key steps in product selection, associated risk assessment, and establishing a business case for technology. We review an educational and competency assessment framework based on adult learning principles and discuss strategies for successful technology adoption. An example of evaluation of a program using the New World Kirkpatrick Model is included, along with a tool for clinicians to use that summarizes the selection and implementation process.


Assuntos
Atitude do Pessoal de Saúde , Atitude Frente aos Computadores , Tecnologia Biomédica/normas , Competência Clínica , Desenho de Equipamento/normas , Pessoal de Saúde/educação , Pessoal de Saúde/normas , Adulto , Feminino , Pessoal de Saúde/psicologia , Humanos , Masculino , Pessoa de Meia-Idade
10.
Int J Med Inform ; 123: 11-22, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30654899

RESUMO

BACKGROUND: Many forms of home-based technology targeting stroke rehabilitation have been devised, and a number of human factors are important to their application, suggesting the need to examine this information in a comprehensive review. OBJECTIVE: The systematic review aims to synthesize the current knowledge of technologies and human factors in home-based technologies for stroke rehabilitation. METHODS: We conducted a systematic literature search in three electronic databases (IEEE, ACM, PubMed), including secondary citations from the literature search. We included articles that used technological means to help stroke patients conduct rehabilitation at home, reported empirical studies that evaluated the technologies with patients in the home environment, and were published in English. Three authors independently conducted the content analysis of searched articles using a list of interactively defined factors. RESULTS: The search yielded 832 potentially relevant articles, leading to 31 articles that were included for in-depth analysis. The types of technology of reviewed articles included games, telerehabilitation, robotic devices, virtual reality devices, sensors, and tablets. We present the merits and limitations of each type of technology. We then derive two main human factors in designing home-based technologies for stroke rehabilitation: designing for engagement (including external and internal motivation) and designing for the home environment (including understanding the social context, practical challenges, and technical proficiency). CONCLUSION: This systematic review presents an overview of key technologies and human factors for designing home-based technologies for stroke rehabilitation.


Assuntos
Tecnologia Biomédica/normas , Serviços de Assistência Domiciliar/normas , Reabilitação do Acidente Vascular Cerebral/normas , Acidente Vascular Cerebral/terapia , Humanos
11.
Biosci Trends ; 12(6): 560-568, 2019 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-30606978

RESUMO

Since serious problematic cases regarding the technical safety of technically demanding operations were reported in Japan, the Ministry of Health, Labor and Welfare issued new regulations on June 10, 2016 requiring each hospital to check the status of informed consent, skill of surgery team and governance system of the surgical unit, when the highly difficult new medical technologies were introduced to a hospital. In order to firmly establish this new system for highly difficult new medical technologies, it is very important and informative to survey the current situation for guidelines and consensus regarding introduction of medical technology with special skills in Japan and overseas. Based on the survey of questionnaires, document retrieval, and expert interviews, we found that documentation related to the introduction process of highly difficult medical technologies is very rare, and the regulations were mainly issued by academic societies. Moreover, even if such documentation existed, the quality of the regulations is poor and not sufficient enough to perform surgical practice safely. Therefore, for medical practitioners, comprehensive and concrete regulations should be issued by the government or ministry to legally follow in regard to technically demanding operations. A new practice guideline was proposed by our special research group to regulate the introduction process of highly difficult new medical technologies in hospitals in Japan. This guideline, gained understanding from relevant academic societies, provided a comprehensive view on the interpretation of "high difficulty new medical technology" prescribed by the law and show the basic idea at a preliminary examination from the viewpoints of "Surgeon's requirement", "Guidance system", "Medical safety" , and "Informed consent". These efforts will contribute to the improvement of the quality of guidelines regarding "highly difficult new medical technology".


Assuntos
Tecnologia Biomédica/normas , Assistência à Saúde/normas , Difusão de Inovações , Hospitais/normas , Tecnologia Biomédica/legislação & jurisprudência , Competência Clínica , Assistência à Saúde/organização & administração , Administração Hospitalar/legislação & jurisprudência , Administração Hospitalar/normas , Hospitais/estatística & dados numéricos , Humanos , Consentimento Livre e Esclarecido/normas , Japão , Legislação Hospitalar/normas , Legislação Hospitalar/estatística & dados numéricos , Segurança do Paciente , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Guias de Prática Clínica como Assunto , Cirurgiões/legislação & jurisprudência , Cirurgiões/normas , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Procedimentos Cirúrgicos Operatórios/legislação & jurisprudência , Procedimentos Cirúrgicos Operatórios/métodos , Procedimentos Cirúrgicos Operatórios/normas , Inquéritos e Questionários/estatística & dados numéricos
14.
Nat Commun ; 9(1): 5217, 2018 12 06.
Artigo em Inglês | MEDLINE | ID: mdl-30523263

RESUMO

International challenges have become the standard for validation of biomedical image analysis methods. Given their scientific impact, it is surprising that a critical analysis of common practices related to the organization of challenges has not yet been performed. In this paper, we present a comprehensive analysis of biomedical image analysis challenges conducted up to now. We demonstrate the importance of challenges and show that the lack of quality control has critical consequences. First, reproducibility and interpretation of the results is often hampered as only a fraction of relevant information is typically provided. Second, the rank of an algorithm is generally not robust to a number of variables such as the test data used for validation, the ranking scheme applied and the observers that make the reference annotations. To overcome these problems, we recommend best practice guidelines and define open research questions to be addressed in the future.


Assuntos
Tecnologia Biomédica/métodos , Diagnóstico por Imagem/métodos , Processamento de Imagem Assistida por Computador/métodos , Avaliação da Tecnologia Biomédica/métodos , Pesquisa Biomédica/métodos , Pesquisa Biomédica/normas , Tecnologia Biomédica/classificação , Tecnologia Biomédica/normas , Diagnóstico por Imagem/classificação , Diagnóstico por Imagem/normas , Humanos , Processamento de Imagem Assistida por Computador/normas , Reprodutibilidade dos Testes , Inquéritos e Questionários , Avaliação da Tecnologia Biomédica/normas
15.
Conf Proc IEEE Eng Med Biol Soc ; 2018: 1755-1758, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-30440735

RESUMO

Historically, Classic Extended Physiological Proprioception (EPP) as an upper-limb prosthesis control topology has been outperforming functionally all other topologies of the past. A novel Biomechatronic EPP controller has been designed to overcome shortcomings of the classic EPP control topology, and has been hypothesized to be functionally equivalent to the classic EPP topology. Using the dSpace realtime hardware platform and other mechanical and electronic components, the following were developed in the lab: (a) A Biomechatronic EPP controller, (b) a classic EPP controller, (c) an "unconnected" controller and (d) an EMG controller. All four topologies were tested in the lab using the target experiments methodology. Initial results of one subject show that performance of (a) is superior or comparable to (b) and superior to (c) and (d).


Assuntos
Membros Artificiais , Robótica , Membros Artificiais/normas , Tecnologia Biomédica/instrumentação , Tecnologia Biomédica/normas , Humanos , Propriocepção , Robótica/instrumentação , Robótica/normas
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