Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 290
Filtrar
1.
Rev Saude Publica ; 53: 111, 2019.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-31800908

RESUMEN

OBJECTIVE: To describe the four types of horizon scanning (HS) outputs developed by the National Committee for Health Technology Incorporation (CONITEC) and show their main repercussions on the decision-making processes of the Brazilian Ministry of Health (MH). METHODS: Descriptive study based on participant observation and document analysis of HS outputs (internal reports, alert reports, briefs and sections for CONITEC recommendation reports) developed between January 2014 and July 2018. RESULTS: Fifteen internal reports, six alert reports, two briefs and 57 HS sections were produced. Each output has a specific structure according to its purpose. The methodological approach adopted for developing HS outputs in Brazil is described by EuroScan International Network. The outputs had institutional and international repercussions. The activities resulted in the inclusion of HS as a tool for reducing health lawsuits in the legal framework of the MH. One of the internal reports on a high-cost drug not approved in Brazil for a rare disease was requested by the Health Technology Assessments Network for the Americas (RedETSA), showing the international relevance of the outputs. The HS sections in recommendation reports influenced discussions about incorporating technologies into the Unified Health System. CONCLUSIONS: The developed outputs have purposes ranging from helping build arguments for defense of the MH in cases of health judicialization to inform decision-making processes. In addition, HS sections in recommendation reports have grown in importance recently. CONITEC's HS system has been structured, and its role as a tool to inform health managers has shown to be been relevant.


Asunto(s)
Tecnología Biomédica/tendencias , Toma de Decisiones , Evaluación de la Tecnología Biomédica/tendencias , Brasil , Sistemas de Información en Salud/tendencias , Humanos , Informe de Investigación , Factores de Tiempo
2.
Int J Technol Assess Health Care ; 35(4): 263-265, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31355736

RESUMEN

OBJECTIVES: To report from the Scientific Development and Capacity Building Committee of Health Technology Assessment International (HTAi) on activities that are being undertaken within HTAi regarding the promotion of scientific rigor in the field of health technology assessment (HTA). METHODS: Retrieval of definitions of HTA that the SDCB committee considered reflective of the current practice of HTA, followed by a narrative synthesis of the core components of HTA. RESULTS: Several definitions of HTA have been provided, all sharing the notion that HTA is the formal, systematic, and transparent inquiry into the meaning and value, broadly defined, of health technologies, when used in specific patient populations.Many frameworks and tools have been developed for assessing the quality of specific tasks that may be conducted in the context of HTA. Collating such frameworks and tools is likely to be helpful in developing standards and in providing guidance as to how the scientific quality of HTA may be secured. Two current trends in HTA were noted: a stronger health systems focus, and the need to involve stakeholders throughout the HTA process. A wider systems' perspective requires that plausible alternative scenarios are being developed, and wide consultation of various stakeholders is a prerequisite to the development of such scenarios with data from various sources. CONCLUSIONS: Current trends in HTA will lead to different demands on the HTA expert. The task of this emerging policy professional would be not just to provide technical information for problem-solving, but also to combine it with a new function of facilitating public deliberation and learning.


Asunto(s)
Evaluación de la Tecnología Biomédica/organización & administración , Evaluación de la Tecnología Biomédica/tendencias , Humanos , Mejoramiento de la Calidad/normas , Participación de los Interesados , Evaluación de la Tecnología Biomédica/normas
3.
JMIR Mhealth Uhealth ; 7(4): e10967, 2019 04 26.
Artículo en Inglés | MEDLINE | ID: mdl-31025950

RESUMEN

BACKGROUND: Augmented reality (AR) is a technology that integrates digital information into the user's real-world environment. It offers a new approach for treatments and education in medicine. AR aids in surgery planning and patient treatment and helps explain complex medical situations to patients and their relatives. OBJECTIVE: This systematic and bibliographic review offers an overview of the development of apps in AR with a medical use case from March 2012 to June 2017. This work can aid as a guide to the literature and categorizes the publications in the field of AR research. METHODS: From March 2012 to June 2017, a total of 1309 publications from PubMed and Scopus databases were manually analyzed and categorized based on a predefined taxonomy. Of the total, 340 duplicates were removed and 631 publications were excluded due to incorrect classification or unavailable technical data. The remaining 338 publications were original research studies on AR. An assessment of the maturity of the projects was conducted on these publications by using the technology readiness level. To provide a comprehensive process of inclusion and exclusion, the authors adopted the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. RESULTS: The results showed an increasing trend in the number of publications on AR in medicine. There were no relevant clinical trials on the effect of AR in medicine. Domains that used display technologies seemed to be researched more than other medical fields. The technology readiness level showed that AR technology is following a rough bell curve from levels 4 to 7. Current AR technology is more often applied to treatment scenarios than training scenarios. CONCLUSIONS: This work discusses the applicability and future development of augmented- and mixed-reality technologies such as wearable computers and AR devices. It offers an overview of current technology and a base for researchers interested in developing AR apps in medicine. The field of AR is well researched, and there is a positive trend in its application, but its use is still in the early stages in the field of medicine and it is not widely adopted in clinical practice. Clinical studies proving the effectiveness of applied AR technologies are still lacking.


Asunto(s)
Realidad Aumentada , Bibliometría , Humanos , Evaluación de la Tecnología Biomédica/métodos , Evaluación de la Tecnología Biomédica/tendencias
4.
JMIR Mhealth Uhealth ; 7(4): e11656, 2019 04 26.
Artículo en Inglés | MEDLINE | ID: mdl-31025951

RESUMEN

Although patients express an interest in using mobile health (mHealth) interventions to manage their health and chronic conditions, many current mHealth interventions are difficult to use. Usability testing is critical for the success of novel mHealth interventions. Researchers recognize the utility of using qualitative and quantitative approaches for usability testing, but many mHealth researchers lack the awareness of integration approaches from advances in mixed methods research that can add value to mHealth technology. As efficient usability testing proceeds iteratively, we introduce a novel mixed methods design developed specifically for mHealth researchers. The iterative convergent mixed methods design involves simultaneous qualitative and quantitative data collection and analysis that continues cyclically through multiple rounds of mixed methods data collection and analysis until the mHealth technology under evaluation is found to work to the satisfaction of the researcher. In cyclical iterations, early development is more qualitatively driven but progressively becomes more quantitatively driven. Using this design, mHealth researchers can leverage mixed methods integration procedures in the research question, data collection, data analysis, interpretation, and dissemination dimensions. This study demonstrates how the iterative convergent mixed methods design provides a novel framework for generating unique insights into multifaceted phenomena impacting mHealth usability. Understanding these practices can help developers and researchers leverage the strengths of an integrated mixed methods design.


Asunto(s)
Evaluación de la Tecnología Biomédica/métodos , Telemedicina/normas , Humanos , Evaluación de la Tecnología Biomédica/tendencias , Telemedicina/métodos , Interfaz Usuario-Computador
5.
Int J Technol Assess Health Care ; 35(2): 77-81, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30813983

RESUMEN

OBJECTIVES: This article retrospectively examines the evolution of rapid assessments (RAs) produced by the Health Technology Assessment (HTA) Program at the Institute of Health Economics over its 25-year relationship with a single requester, the Alberta Health Ministry (AHM). METHODS: The number, types, and methodological attributes of RAs produced over the past 25 years were reviewed. The reasons for developmental changes in RA processes and products over time were charted to document the push-pull tension between AHM needs and the HTA Program's drive to meet those needs while responding to changing methodological benchmarks. RESULTS: The review demonstrated the dynamic relationship required for HTA researchers to meet requester needs while adhering to good HTA practice. The longstanding symbiotic relationship between the HTA Program and the AHM initially led to increased diversity in RA types, followed by controlled extinction of the less fit (useful) "transition species." Adaptations in RA methodology were mainly driven by changes in best practice standards, requester needs, the healthcare environment, and staff expertise and technology. CONCLUSIONS: RAs are a useful component of HTA programs. To remain relevant and useful, RAs need to evolve according to need within the constraints of HTA best practice.


Asunto(s)
Administración en Salud Pública , Evaluación de la Tecnología Biomédica/organización & administración , Alberta , Humanos , Estudios Retrospectivos , Evaluación de la Tecnología Biomédica/tendencias
6.
Value Health ; 22(3): 267-275, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30832964

RESUMEN

Cost-effectiveness models that present results in terms of cost per quality-adjusted life-year for health technologies are used to inform policy decisions in many parts of the world. Health state utilities (HSUs) are required to calculate the quality-adjusted life-years. Even when clinical studies assessing the effectiveness of health technologies collect data on HSUs to populate a cost-effectiveness model, which rarely happens, analysts typically need to identify at least some additional HSUs from alternative sources. When possible, HSUs are identified by a systematic review of the literature, but, again, this rarely happens. In 2014, ISPOR established a Good Practices for Outcome Research Task Force to address the use of HSUs in cost-effectiveness models. This task force report provides recommendations for researchers who identify, review, and synthesize HSUs for use in cost-effectiveness models; analysts who use the results in models; and reviewers who critically appraise the suitability and validity of the HSUs selected for use in models. The associated Minimum Reporting Standards of Systematic Review of Utilities for Cost-Effectiveness checklist created by the task force provides criteria to judge the appropriateness of the HSUs selected for use in cost-effectiveness models and is suitable for use in different international settings.


Asunto(s)
Comités Consultivos , Análisis Costo-Beneficio/métodos , Años de Vida Ajustados por Calidad de Vida , Informe de Investigación , Evaluación de la Tecnología Biomédica/métodos , Comités Consultivos/tendencias , Análisis Costo-Beneficio/tendencias , Indicadores de Salud , Humanos , Aceptación de la Atención de Salud , Informe de Investigación/tendencias , Evaluación de la Tecnología Biomédica/tendencias
7.
JMIR Mhealth Uhealth ; 7(2): e12425, 2019 02 08.
Artículo en Inglés | MEDLINE | ID: mdl-30735145

RESUMEN

BACKGROUND: Smart homes are considered effective solutions for home health care for the elderly, as smart home technologies can reduce care costs and improve elderly residents' independence. To develop a greater understanding of smart homes for health care services (SHHSs), this study accentuated the necessity of ecological approaches with an emphasis on environmental constraints. This study was based on 2 rationales: (1) users are inclined to perceive the service quality and service experience from environments (ie, servicescape) owing to the intangibility of health care and the pervasiveness of smart home technologies, and (2) both service domains are complex adaptive systems in which diversified and undefined service experiences-not only a few intended service flows-can be generated by complex combinations of servicescape elements. OBJECTIVE: This study proposed the conceptual framework of a Smart Servicescape Wheel (SSW) as an ecological approach delineating the extensive spectrum of environmental constraints in SHHSs. METHODS: The SSW framework was established based on a literature review. RESULTS: Generally divided by perceptible and imperceptible servicescapes, the SSW consists of the perceptible Physical scape (ie, hardware components, environmental cues, and human states) and Social scape (ie, service relationships and social relationships) as well as the imperceptible Datascape (ie, computing intelligence, databases, and communication networks). Following the ecological approach, each category of the SSW is subdivided and defined at the level of components or functions. CONCLUSIONS: The SSW's strengths lie in the various application opportunities for SHHSs. In terms of service planning and development, the SSW can be utilized to (1) establish the requirements for SHHS development, (2) associate with work domain analysis by defining component layers, and (3) understand the real contexts of SHHSs for the enhanced prediction of diverse service experiences. Regarding service management, it can be applied to develop measurement items for the operation and evaluation of SHHSs.


Asunto(s)
Sector de Atención de Salud/tendencias , Servicios de Atención de Salud a Domicilio/tendencias , Evaluación de la Tecnología Biomédica/métodos , Humanos , Evaluación de la Tecnología Biomédica/tendencias
8.
Rofo ; 191(7): 635-642, 2019 Jul.
Artículo en Inglés, Alemán | MEDLINE | ID: mdl-30763963

RESUMEN

BACKGROUND: Health technology assessments (HTAs) are an interdisciplinary method to support sustainable, evidence-based healthcare decisions. They systematically assess medical products, procedures, and technologies with respect to medical, economic, legal, social, and ethical aspects. METHOD: This review analyzes the current use of HTAs in radiology in Germany and discusses challenges associated with HTAs. In particular, incentive structures of various players in the healthcare field involved in HTA implementation are considered for both the inpatient and outpatient sectors. Taking into account that the Joint Federal Committee (G-BA) has different authority between sectors ("ban reservation" for inpatients and "authorization right" for outpatients), we focus on the repercussions on reimbursement for new diagnosis or treatment methods by statutory health insurance companies. RESULTS: The G-BA's authority implicitly creates a paradox in terms of incentives to implement and finance HTAs: in the outpatient sector HTAs are considered necessary to evaluate new medical services while players may not have sufficient incentive to implement and finance HTAs in the inpatient sector. CONCLUSION: Characteristics of HTAs differ widely with respect to the items to be assessed. Therefore, an HTA for drug effectiveness is not easily transferable to radiological procedures. Within radiology, each method must be assessed individually (e. g. according to tumor stage). Despite these challenges, systematic compilation and critical assessment (regarding both cost and medical effectiveness) of available evidence should be a basic component of evidence-based radiology. As companies in healthcare fail to invest in studies that advance evidence-based radiology and considering the lack of incentive for such investments, public funding institutions need to accept the challenge to support studies that assess the benefit of radiological procedures. KEY POINTS: · HTAs should be a basic component of evidence-based radiology.. · G-BA's authority implicitly creates a paradox in terms of inventives to implement and finance HTAs.. · University hospitals and public funding institutions need to support studies that assess the benefit of radiological procedures.. CITATION FORMAT: · Winkelmann C, Neumann T, Zeidler J et al. Health Technology Assessments in Radiology in Germany: Lack of Demand, Lack of Supply. Fortschr Röntgenstr 2019; 191: 635 - 642.


Asunto(s)
Tecnología Biomédica/estadística & datos numéricos , Tecnología Biomédica/tendencias , Radiología/estadística & datos numéricos , Radiología/tendencias , Evaluación de la Tecnología Biomédica/estadística & datos numéricos , Evaluación de la Tecnología Biomédica/tendencias , Tecnología Biomédica/economía , Predicción , Alemania , Necesidades y Demandas de Servicios de Salud/economía , Necesidades y Demandas de Servicios de Salud/tendencias , Humanos , Radiología/economía , Evaluación de la Tecnología Biomédica/economía
9.
Value Health Reg Issues ; 18: 78-82, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30641410

RESUMEN

OBJECTIVES: To describe the process, challenges, and future direction of health technology assessment (HTA), focusing on the drug selection of the National List of Essential Medicines (NLEM) in Thailand. METHODS: Literature and government documents were reviewed and analyzed by authors with experiences in HTA and drug policy in the country. RESULTS: The structure of HTA and its process in the drug selection of the NLEM were described, followed by the outcomes of the use of HTA. Examples of lowering drug prices, as a result of price negotiation using HTA, were presented. A few examples were also provided to demonstrate how decisions were made from considering factors beyond cost-effectiveness findings. Finally, challenges on various issues including improvement of HTA structure and process were discussed for the future direction of HTA in Thailand. CONCLUSIONS: HTA has been adopted as a tool for the drug selection of the NLEM to help Thailand achieve universal health coverage. Nevertheless, various challenges exist and need to be addressed.


Asunto(s)
Control de Medicamentos y Narcóticos/métodos , Evaluación de la Tecnología Biomédica/métodos , Cobertura Universal del Seguro de Salud/tendencias , Predicción , Humanos , Evaluación de la Tecnología Biomédica/tendencias , Tailandia , Cobertura Universal del Seguro de Salud/legislación & jurisprudencia
10.
IEEE Rev Biomed Eng ; 12: 319-332, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-29994684

RESUMEN

The maturation of pervasive computing technologies has dramatically altered the face of healthcare. With the introduction of mobile devices, body area networks, and embedded computing systems, care providers can use continuous, ecologically valid information to overcome geographic and temporal barriers and thus provide more effective and timely health assessments. In this paper, we review recent technological developments that can be harnessed to replicate, enhance, or create methods for assessment of functional performance. Enabling technologies in wearable sensors, ambient sensors, mobile technologies, and virtual reality make it possible to quantify real-time functional performance and changes in cognitive health. These technologies, their uses for functional health assessment, and their challenges for adoption are presented in this paper.


Asunto(s)
Cognición/fisiología , Prestación de Atención de Salud/tendencias , Rendimiento Físico Funcional , Evaluación de la Tecnología Biomédica/tendencias , Teléfono Celular/tendencias , Sistemas de Computación , Humanos , Realidad Virtual , Dispositivos Electrónicos Vestibles/tendencias
11.
Value Health Reg Issues ; 18: 176-183, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-29954696

RESUMEN

INTRODUCTION: Singapore has a robust health care system that is well known for delivering good health outcomes. In the public health care sector, subsidies and financial assistance are provided for drugs listed on the Standard Drug List and Medication Assistance Fund. Additional financing mechanisms are also available to provide further support for patients in need. With new technologies entering the market at high costs, health technology assessment (HTA) is playing an increasingly important role to inform their relative value and determine how best to allocate finite health care resources to ensure long-term sustainability of the health care system. ROLE OF HTA: National HTA efforts are currently focused on informing subsidy decision making and improving patient access to cost-effective drugs. The Agency for Care Effectiveness (ACE) was established in 2015 to support the Ministry of Health Drug Advisory Committee make evidence-based recommendations for the public funding of drugs. Standardized HTA methods and processes have been developed in line with international best practice to ensure that ACE's evaluations are conducted in a consistent and robust manner. Since ACE's establishment, subsidies are now provided earlier within a drug's life cycle, and value-based pricing has led to more cost-effective prices being negotiated with companies to improve affordability for patients and the public health care system. CONCLUSION: To achieve greater impact, Singapore needs to expand its HTA capacity beyond subsidy decision making and drive appropriate care in a sustainable manner for future generations.


Asunto(s)
Control de Medicamentos y Narcóticos/métodos , Evaluación de la Tecnología Biomédica/normas , Análisis Costo-Beneficio , Toma de Decisiones , Humanos , Singapur , Evaluación de la Tecnología Biomédica/métodos , Evaluación de la Tecnología Biomédica/tendencias
12.
Value Health Reg Issues ; 18: 24-29, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30419447

RESUMEN

South Korea is the first Asian country to mandate the submission of pharmacoeconomic data for reimbursement decision making. For a new drug to be listed, it must demonstrate its value in terms of comparative effectiveness and cost effectiveness. The Health Insurance Review and Assessment Service (HIRA) judges the submitted drug's value and decides whether its coverage is appropriate on the basis of the recommendation of the Pharmaceutical Benefit Coverage Assessment Committee. Once the drug has been accepted by HIRA, the National Health Insurance Service and the sponsoring company negotiate the price and expected sales volume. Even if HIRA acknowledges the value of the drug, it cannot be listed if the negotiation fails. In the off-patent market, generic and original branded drugs are treated equally in terms of pricing. Once generics enter the market, both drug prices should be lowered to 53.55% or less of the on-patent price. Since the current system was implemented, concerns have been raised about a decline in the accessibility of new drugs, especially for high-priced drugs used to treat serious diseases. In 2013, several measures had been introduced aimed at improving the accessibility of these drugs. A risk-sharing scheme and an increase in the maximum acceptable cost-effectiveness ratio were subsequently initiated. Although these schemes have been successful in improving access to high-priced drugs, they are often criticized for reducing transparency in pricing. Finding a balance between accessibility and efficiency is still a challenge in Korea.


Asunto(s)
Control de Medicamentos y Narcóticos/métodos , Evaluación de la Tecnología Biomédica/métodos , Toma de Decisiones , Costos de los Medicamentos/legislación & jurisprudencia , Costos de los Medicamentos/tendencias , Control de Medicamentos y Narcóticos/tendencias , Humanos , Programas Nacionales de Salud/economía , Programas Nacionales de Salud/tendencias , Mecanismo de Reembolso , República de Corea , Evaluación de la Tecnología Biomédica/tendencias
13.
Value Health Reg Issues ; 17: 219-223, 2018 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-30528780

RESUMEN

In February and September of 2017, the International Society for Pharmacoeconomics and Outcomes Research Health Technology Assessment Council held roundtables focused on Latin America to discuss health technology assessment best practices, collaboration opportunities, and regional experiences regarding health policies to improve the affordability of and access to healthcare technologies. The access to high-cost technologies, increased social pressure to achieve universal coverage, population aging, and the limits of traditional mechanisms to control costs create political pressure to begin considering other pricing alternatives, including value-based pricing, in Latin America. This article attempts to conceptualize key stakeholders' perceptions of their experiences, opportunities, and barriers to implementing value-based pricing in Latin America.


Asunto(s)
Costos y Análisis de Costo , Economía Farmacéutica/tendencias , Evaluación de la Tecnología Biomédica/tendencias , Cobertura Universal del Seguro de Salud/tendencias , Envejecimiento , Tecnología Biomédica/economía , Política de Salud , Humanos , América Latina
14.
Respir Care ; 63(9): 1162-1173, 2018 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-30166411

RESUMEN

Although the fundamentals of extracorporeal membrane oxygenation (ECMO) have not changed in 3 decades, the technical elements continue to improve and have evolved from an assemblage of individual components to more integrated systems with added features, enhanced safety, and improved maneuverability. The introduction of polymethylpentene (PMP) fiber technology has expanded the development of artificial membranes that have low resistance, are more biocompatible, and can be used for extended durations. Extracorporeal carbon dioxide removal techniques continue to be enhanced as stand alone technology and modified renal dialysis systems are introduced. Research continues in the development of compact and wearable artificial lungs that are intended to support patients for prolonged periods (eg, patients awaiting lung transplantation). The use of high-fidelity simulation training has become a standard and important method for reinforcing technical skills, refining troubleshooting sequences, and enhancing team interactions. Modifications to mannequins and ECMO systems coupled with clinical and physiologic scenarios will help achieve greater realism and enhance learning. ECMO technology continues to improve, with adaptability and versatility being essential attributes.


Asunto(s)
Oxigenación por Membrana Extracorpórea/tendencias , Oxigenación por Membrana Extracorpórea/educación , Humanos , Maniquíes , Entrenamiento Simulado , Evaluación de la Tecnología Biomédica/tendencias
15.
Pharmacoeconomics ; 36(12): 1439-1451, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-30003435

RESUMEN

OBJECTIVE: Precision medicine allows healthcare interventions to be tailored to groups of patients based on their disease susceptibility, diagnostic or prognostic information, or treatment response. We analysed what developments are expected in precision medicine over the next decade and considered the implications for health technology assessment (HTA) agencies. METHODS: We performed a pragmatic literature search to account for the large size and wide scope of the precision medicine literature. We refined and enriched these results with a series of expert interviews up to 1 h in length, including representatives from HTA agencies, research councils and researchers designed to cover a wide spectrum of precision medicine applications and research. RESULTS: We identified 31 relevant papers and interviewed 13 experts. We found that three types of precision medicine are expected to emerge in clinical practice: complex algorithms, digital health applications and 'omics'-based tests. These are expected to impact upon each stage of the HTA process, from scoping and modelling through to decision-making and review. The complex and uncertain treatment pathways associated with patient stratification and fast-paced technological innovation are central to these effects. DISCUSSION: Innovation in precision medicine promises substantial benefits but will change the way in which some health services are delivered and evaluated. The shelf life of guidance may decrease, structural uncertainty may increase and new equity considerations will emerge. As biomarker discovery accelerates and artificial intelligence-based technologies emerge, refinements to the methods and processes of evidence assessments will help to adapt and maintain the objective of investing in healthcare that is value for money.


Asunto(s)
Tecnología Biomédica/métodos , Medicina de Precisión/métodos , Evaluación de la Tecnología Biomédica/tendencias , Inteligencia Artificial/tendencias , Biomarcadores/metabolismo , Tecnología Biomédica/tendencias , Toma de Decisiones , Humanos , Medicina de Precisión/tendencias , Incertidumbre
16.
Value Health ; 21(6): 707-714, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29909876

RESUMEN

OBJECTIVES: To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality of evidentiary requirements that could occur; and to identify strategic issues and trends of regulatory and HTA synergy. METHODS: Two separate questionnaires were developed to assess stakeholders' perceptions on regulatory and HTA alignment, one for pharmaceutical companies and the other for regulatory and HTA agencies. The responses were analyzed using descriptive statistics. RESULTS: Seven regulatory and 8 HTA agencies from Australia, Canada, and Europe and 19 international companies developing innovative medicine responded to the survey. This study provided a snapshot of the current regulatory and HTA landscape. Changes made over the past 5 years were reflected in three main areas: there is an increasing interaction between regulatory and HTA agencies; current conditional regulatory approvals are not always linked with flexible HTA approaches; and companies are more supportive of joint scientific advice. Four types of evidentiary requirements were identified as building blocks for better alignment: acceptable primary end points, inclusion of an active comparator, use of patient-reported outcomes, and choice and use of surrogate end point. CONCLUSIONS: The study showed that the gap between regulatory and HTA requirements has narrowed over the past 5 years. All respondents supported synergy between regulatory and HTA stakeholders, and the study provided several recommendations on how to further improve evidentiary alignment including the provision of joint scientific advice, which was rated as a key strategy by both agencies and companies.


Asunto(s)
Medicina Basada en la Evidencia/organización & administración , Agencias Gubernamentales/organización & administración , Sector de Atención de Salud/organización & administración , Evaluación de la Tecnología Biomédica/organización & administración , Australia , Biomarcadores , Canadá , Industria Farmacéutica/legislación & jurisprudencia , Industria Farmacéutica/organización & administración , Determinación de Punto Final , Europa (Continente) , Medicina Basada en la Evidencia/tendencias , Agencias Gubernamentales/tendencias , Sector de Atención de Salud/tendencias , Humanos , Medición de Resultados Informados por el Paciente , Pacientes , Mecanismo de Reembolso , Encuestas y Cuestionarios , Evaluación de la Tecnología Biomédica/tendencias , Resultado del Tratamiento
17.
Heart ; 104(22): 1817-1822, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-29773657

RESUMEN

The National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) promotes the adoption of innovative diagnostic and therapeutic technologies into National Health Service (NHS) clinical practice through the publication of guidance and briefing documents. Since the inception of the programme in 2009, there have been 7 medical technologiesguidance, 3 diagnostics guidance and 23 medtechinnovation briefing documents published that are relevant to the heart and circulation. Medical technologies guidance is published by NICE for selected single technologies if they offer plausible additional benefits to patients and the healthcare system. Diagnostic guidance is published for diagnostic technologies if they have the potential to improve health outcomes, but if their introduction may be associated with an increase in overall cost to the NHS. Medtechinnovation briefings provide evidence-based advice to those considering the implementation of new medical devices or diagnostic technologies. This review provides reference to all of the guidance and briefing medical technology documents that NICE has published that are relevant to the heart and circulation and reflect on their diverse recommendations. The interaction of MTEP with other NICE programmes is integral to its effectiveness and the means by which consistency is ensured across the different NICE programmes is described. The importance of the input of clinical experts from the cardiovascular professional community and the engagement by NICE with cardiovascular professional societies is highlighted as being fundamental to ensuring the quality of guidance outputs as well as to promoting their implementation and adoption.


Asunto(s)
Academias e Institutos/tendencias , Cardiología/tendencias , Calidad de la Atención de Salud/tendencias , Medicina Estatal/tendencias , Evaluación de la Tecnología Biomédica/tendencias , Academias e Institutos/normas , Cardiología/normas , Difusión de Innovaciones , Medicina Basada en la Evidencia/tendencias , Humanos , Guías de Práctica Clínica como Asunto , Evaluación de Programas y Proyectos de Salud , Calidad de la Atención de Salud/normas , Medicina Estatal/normas , Evaluación de la Tecnología Biomédica/normas , Reino Unido
18.
Biosci Trends ; 12(2): 102-108, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29760354

RESUMEN

Health technology assessment (HTA) is a field of scientific policy research that adopts multidisciplinary approaches to conduct systematic evaluation of health technologies and inform decision making. Although achievements have been made by HTA activities among academics, providers, and policy makers, development of the field of HTA in China is fragmented and not yet formally integrated in health policy making processes. All stakeholders need to make more efforts to strengthen HTA knowledge translation and facilitate a decision making process that is based on evidence including HTA findings. This article reviews how the field of HTA has developed in China, analyzes what factors have been influencing China's HTA development, and proposes policy recommendations.


Asunto(s)
Medicina Basada en la Evidencia/organización & administración , Política de Salud/historia , Evaluación de la Tecnología Biomédica/historia , China , Toma de Decisiones , Política de Salud/tendencias , Historia del Siglo XX , Historia del Siglo XXI , Evaluación de la Tecnología Biomédica/métodos , Evaluación de la Tecnología Biomédica/tendencias
19.
Trials ; 19(1): 87, 2018 Feb 02.
Artículo en Inglés | MEDLINE | ID: mdl-29394905

RESUMEN

BACKGROUND: HTA Programme funding is governed by the need for evidence and scientific quality, reflecting funding of the National Institute for Health Research (NIHR) by the NHS. The need criterion incorporates covering the spectrum of diseases, but also taking account of research supported by other funders. This study compared the NIHR HTA Programme portfolio of research with the UK burden of disease as measured by Disability-adjusted Life Years (DALYs). METHODS: A retrospective cross-sectional study using a cohort of all funded primary research and evidence syntheses projects received by the HTA Programme from April 2011 to March 2016 (n = 363); to determine the proportion of spend by disease compared with burden of disease in the UK calculated using 2015 UK DALY data. RESULTS: The programme costing just under £44 million broadly reflected UK DALY burden by disease. Spend was lower than disease burden for cancer, cardiovascular and musculoskeletal diseases, which may reflect the importance of other funders, notably medical charities, which concentrate on these diseases. CONCLUSION: The HTA Programme spend, adjusted for other relevant funders, broadly matches disease burden in the UK; no diseases are being neglected.


Asunto(s)
Academias e Institutos/economía , Investigación Biomédica/economía , Evaluación de la Discapacidad , Necesidades y Demandas de Servicios de Salud/economía , Evaluación de Necesidades/economía , Años de Vida Ajustados por Calidad de Vida , Apoyo a la Investigación como Asunto/economía , Evaluación de la Tecnología Biomédica/economía , Academias e Institutos/tendencias , Investigación Biomédica/tendencias , Costo de Enfermedad , Estudios Transversales , Necesidades y Demandas de Servicios de Salud/tendencias , Humanos , Evaluación de Necesidades/tendencias , Evaluación de Programas y Proyectos de Salud , Apoyo a la Investigación como Asunto/tendencias , Estudios Retrospectivos , Evaluación de la Tecnología Biomédica/tendencias , Factores de Tiempo , Reino Unido/epidemiología
20.
Chemosphere ; 199: 546-568, 2018 May.
Artículo en Inglés | MEDLINE | ID: mdl-29455125

RESUMEN

Epidemiological studies have shown the association of airborne particulate matter (PM) size and chemical composition with health problems affecting the cardiorespiratory and central nervous systems. PM also act as cloud condensation nuclei (CNN) or ice nuclei (IN), taking part in the clouds formation process, and therefore can impact the climate. There are several works using different analytical techniques in PM chemical and physical characterization to supply information to source apportionment models that help environmental agencies to assess damages accountability. Despite the numerous analytical techniques described in the literature available for PM characterization, laboratories are normally limited to the in-house available techniques, which raises the question if a given technique is suitable for the purpose of a specific experimental work. The aim of this work consists of summarizing the main available technologies for PM characterization, serving as a guide for readers to find the most appropriate technique(s) for their investigation. Elemental analysis techniques like atomic spectrometry based and X-ray based techniques, organic and carbonaceous techniques and surface analysis techniques are discussed, illustrating their main features as well as their advantages and drawbacks. We also discuss the trends in analytical techniques used over the last two decades. The choice among all techniques is a function of a number of parameters such as: the relevant particles physical properties, sampling and measuring time, access to available facilities and the costs associated to equipment acquisition, among other considerations. An analytical guide map is presented as a guideline for choosing the most appropriated technique for a given analytical information required.


Asunto(s)
Material Particulado/análisis , Evaluación de la Tecnología Biomédica/métodos , Contaminantes Atmosféricos/análisis , Monitoreo del Ambiente/métodos , Estudios Epidemiológicos , Humanos , Evaluación de la Tecnología Biomédica/tendencias
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA