Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation.

OBJECTIVES: Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for "prescribable" health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. METHODS: We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. RESULTS: When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. CONCLUSIONS: Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

Closing the loop between horizon scanning and health technology assessment - an overview of topics submitted for appraisal in England.

OBJECTIVES: Horizon scanning for health technology appraisal (HTA) in England involves topic notification to the National Institute for Health and Care Excellence (NICE) via technology briefings. This activity is undertaken by the Innovation Observatory with submission timelines designed to ensure that HTA decisions align with regulatory approval time. In this paper, we aimed to track and assess the progression and current status of the topics notified for HTA and provide a descriptive analysis of these topics. METHODS: Technology briefings were mapped from submission to NICE technology appraisal/highly specialized technologies recommendations from April 2017 until October 2021. This was done using a combination of searches on Google and NICE website, searching a downloadable spreadsheet containing NICE topic selection decisions, and querying NICE Topic Selection team. Analysis was undertaken regarding type of indications and interventions of submitted topics and published guidance. RESULTS: Six-hundred and ninety-three topics entered the NICE scoping process, of which 94 percent were prioritized. As of November 2021, approximately 39 percent of prioritized topics were in scoping/in progress, 31 percent were proposed/completed, 20 percent were suspended/terminated, and 4 percent were referred back to Innovation Observatory (IO) for further monitoring. CONCLUSIONS: Our work demonstrates that horizon scanning for HTA is a complex and time-intensive process. Timelines and progress through HTA is challenging due to the growing number of innovative medicines, significant uncertainties, and limited transparency in clinical development and regulatory pathways. A better understanding of clinical trials and regulatory requirements may help eliminate some of this uncertainty and improve timely HTA.

Modelo para la evaluación de la eficacia diagnóstica de la tomografía computarizada de haz cónico en odontología / A model of diagnostic efficacy for the evaluation of CBCT in dentistry

Introducción: Debido al riesgo que conlleva la exposición a radiación ionizante, se han establecido los principios de protección radiológica, con el propósito de regular las actividades que involucran su uso. Uno de estos principios es la justificación de los exámenes, es decir, la indicación del examen cuando exista la posibilidad de que éste entregue información en beneficio del paciente. Esto implica que dicho examen se evalúe en cuanto a su rendimiento, de manera que exista evidencia que indique su capacidad de entregar la información necesaria para la indicación específica del paciente. Revisión: Para evaluar el rendimiento de los exámenes imagenológicos, con el fin de orientar su uso como herramienta diagnóstica en las distintas indicaciones odontológicas, se ha usado el modelo de Eficacia Diagnóstica descrito por Fryback y Thornbury en 1991.En odontología, el uso de la tomografía computarizada de haz cónico (TCHC) ha aumentado debido a sus ventajas como herramienta diagnóstica. Aún así, son pocas las investigaciones en altos niveles del modelo de Eficacia Diagnóstica -más relacionados con características aplicables al paciente--y muchas las investigaciones en bajos niveles -más relacionado con calidad técnica y de exactitud diagnóstica-. Conclusiones: La evidencia del rendimiento de la TCHC en bajos niveles puede generar una idea equivoca sobre sus indicaciones, dando la impresión de que cuenta con respaldo científico suficiente que justifica su uso. Es necesaria investigación enfocada en el beneficio de los pacientes con el uso de TCHC para las distintas indicaciones en odontología. (AU)

Introduction: Due to the risk of exposure to ionizing radiation, principles of radiation protection have been established, with the aimto regulate activities that involve the use of ionizing radiation. The principle of justification means that the indication of the exam must be associated to the possibility of providing information for the benefit of the patient. The indication of an exam that results in a benefit for the patient entails the evaluation of the exam in terms of its performance. This evaluation should demonstrate the exam has ability to deliver the necessary information for the specific need of the patient. Review: The Diagnostic Efficacy model, described by Fryback and Thornbury in 1991, is used to evaluate the performance of imaging tests, in order to guide its use as a diagnostic tool in different dental indications. In dentistry, the use of TCHC has increased due to the advantages as a diagnostic tool. Still, there are few investigations at high levels of the Diagnostic Efficacy model - related to characteristics that involve the patient - and many investigations at low levels - more related to technical quality and diagnostic accuracy. Conclusions: Evidence of the performance of CBCT at low levels generates a misunderstanding about its use, giving the impression that CBCT has sufficient scientific support to justify its use. Currently, the evaluation of the performance of the TCHC has focused on evaluating the lowest levels of this model, the image quality and the diagnostic precision, although evidence at this level remains limited. Research focusing on the benefit of patients with the use of CBCT for the different indications in dentistry is needed. (AU)

Ciencia, tecnología y sociedad en el modelo formativo para la gestión de la evaluación de tecnologías sanitarias / Science, technology and society in the training model for the management of health technology assessment i: en

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.

La importancia de la evaluación de tecnologías sanitarias: estado del arte / The importance of health technology assessment: state of the art / A importância da avaliação da tecnologia em saúde: o estado da arte

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.

End-User Assessment of an Innovative Clothing-Based Sensor Developed for Pressure Injury Prevention: A Mixed-Method Study.

This study aimed to evaluate a clothing prototype that incorporates sensors for the evaluation of pressure, temperature, and humidity for the prevention of pressure injuries, namely regarding physical and comfort requirements. A mixed-method approach was used with concurrent quantitative and qualitative data triangulation. A structured questionnaire was applied before a focus group of experts to evaluate the sensor prototypes. Data were analyzed using descriptive and inferential statistics and the discourse of the collective subject, followed by method integration and meta-inferences. Nine nurses, experts in this topic, aged 32.66 ± 6.28 years and with a time of profession of 10.88 ± 6.19 years, participated in the study. Prototype A presented low evaluation in stiffness (1.56 ± 1.01) and roughness (2.11 ± 1.17). Prototype B showed smaller values in dimension (2.77 ± 0.83) and stiffness (3.00 ± 1.22). Embroidery was assessed as inadequate in terms of stiffness (1.88 ± 1.05) and roughness (2.44 ± 1.01). The results from the questionnaires and focus groups' show low adequacy as to stiffness, roughness, and comfort. The participants highlighted the need for improvements regarding stiffness and comfort, suggesting new proposals for the development of sensors for clothing. The main conclusions are that Prototype A presented the lowest average scores relative to rigidity (1.56 ± 1.01), considered inadequate. This dimension of Prototype B was evaluated as slightly adequate (2.77 ± 0.83). The rigidity (1.88 ± 1.05) of Prototype A + B + embroidery was evaluated as inadequate. The prototype revealed clothing sensors with low adequacy regarding the physical requirements, such as stiffness or roughness. Improvements are needed regarding the stiffness and roughness for the safety and comfort characteristics of the device evaluated.

Health technology assessment for oral health in the past decade: a scoping review.

BACKGROUND: Health technology assessment (HTA) is the systematic evaluation of various properties and effects of a health technology. HTA can serve as a bridge between the world of knowledge and that of decision making, offering decision makers the best summary of scientific evidence. Scoping HTA reports in the context of dentistry can help researchers identify grey areas; help practitioners make evidence-based decisions and further initiate better policy making. AIM: To provide an overview on HTAs pertaining to oral health and dentistry in the past decade, map the extension and scope of the methodological practices, key findings, and limitations. METHODOLOGY: A scoping review was conducted using the Joanna Briggs Institute framework. A comprehensive search for HTA reports was done through the International Network of Agencies for Health Technology Assessment Database from January 2010 to December 2020. Consecutively, electronic databases (PubMed and Google Scholar) were searched. Finally, thirty-six reports were included in this review and analyzed. RESULTS: A total of 709 articles were initially identified, of which thirty-six met the inclusion criteria. Reviewed HTAs focused on various specialties of dentistry worldwide. Maximum number of reports (N = 5) were related to "prosthodontics and dental implants" and technologies related to preventive dentistry were most commonly assessed (N = 4). CONCLUSION: Functional, appropriate, and evidence-based information provided through HTA pertaining to oral health on a regular basis will enable decision makers to have enough data to make decisions on the future use of new technology, modify existing policies, accelerate its translation into practice, and ensure provision of robust dental healthcare services.

Preliminary evaluation of an automated robotic transfer assist device in the home setting.

PURPOSE: The purpose of this study was to examine the effects of six weeks of routine use of a novel robotic transfer device, the AgileLife Patient Transfer System, on mobility-related health outcomes, task demand, and satisfaction relative to previous transfer methods. MATERIALS AND METHODS: Six end users and five caregivers used the system in their homes for six weeks. Participants completed several surveys examining perceived demands related to preparing and performing a transfer and mobility-related health outcomes pre and post intervention. Participants were also asked about their satisfaction with using the technology compared to previous transfer methods. RESULTS: Both end users and caregivers reported reduction in perceived physical demand (p = 0.007) and work (p ≤ 0.038) when preparing for and performing a transfer. End users indicated that the device intervention had a positive impact, indicating some improvements to health-related quality of life as well as improved competence, adaptability, and self-esteem post-intervention. All participants were highly likely to recommend the technology to others. CONCLUSION: The AgileLife Patient Transfer System is a promising new form of transfer technology that may improve the mobility and mobility-related health of individuals with disabilities and their caregivers in home settings.Implications for rehabilitationRobotic transfer assistance reduced physical demand and work among end users and caregivers.The robotic device had a positive impact on some quality of life outcomes after 6 weeks of use.Users were highly likely to recommend the robotic transfer device to others.

Judicialização de produtos à base de canabidiol no Brasil: uma análise de 2019 a 2022 / Judicialization of cannabidiol-based products in Brazil: an analysis from 2019 to 2022 / Judicialización de productos a base de cannabidiol en Brasil: un análisis de 2019 a 2022

Este estudo analisou as ações judiciais de pacientes que solicitaram ao Sistema Único de Saúde produtos à base de canabidiol (CBD) durante o período de 2019 a 2022, descrevendo características sociodemográficas, clínicas e jurídicas. Trata-se de um estudo transversal composto pela avaliação das notas técnicas emitidas pelos Núcleos de Apoio Técnico do Judiciário (NatJus), que embasaram as decisões judiciais. Os dados foram obtidos do sistema e-NatJus, do Ministério da Justiça, utilizando técnicas de web scraping. Regressão logística foi empregada para estimar razões de chances com intervalos de 95% de confiança. Foram analisadas 1.115 notas técnicas das ações demandantes de CBD, das quais 54,7% dos pacientes eram do sexo masculino, com idade média de 18,4 anos, em sua maioria da Região Sul do país (38,8%), e 49,6% buscavam tratamento para epilepsia. Das ações com pareceres favoráveis, 28,8% não tinham evidências científicas, 26,5% pleitearam produtos sem registro na Agência Nacional de Vigilância Sanitária e 25,3% dos que tinham registro não estavam em conformidade com a indicação terapêutica. Os pacientes da Região Nordeste tiveram a chance de parecer favorável aumentada em 3 vezes; e os que tinham diagnóstico de epilepsia, em 2,3 vezes. Os pareceres técnicos que deram suporte aos magistrados para as decisões judiciais das demandas de pacientes por produtos à base de canabidiol no Brasil estavam, em sua maioria, em conformidade com evidências científicas, denotando a importância dos NatJus na qualificação do acesso a produtos medicinais no país.

The study analyzed the lawsuits of patients who requested cannabidiol (CBD)-based products from the Brazilian Unified National Health System during the period from 2019 to 2022, describing sociodemographic, clinical, and legal characteristics. This is a cross-sectional study composed of the evaluation of the technical notes issued by the Center for Technical Support of the Judiciary (NatJus), which supports judicial decisions. The data were obtained from the e-NatJus system, of the Brazilian Ministry of Justice, using web scraping techniques. Logistic regression was used to estimate odds ratios with 95% confidence intervals. We analyzed 1,115 technical notes of the CBD plaintiffs, of which 54.7% of the male patients, with a mean age of 18.4 years, mostly from the South Region of the country (38.8%), and 49.6% sought treatment for epilepsy. Regarding the actions with favorable opinions, 28.8% had no scientific evidence, 26.5% pleaded for products without registration with the Brazilian Health Regulatory Agency, and 25.3% of those that had registration were not in compliance with the therapeutic indication. Patients from the Northeast Region had a chance of a favorable opinion increased by 3.0 times and those diagnosed with epilepsy by 2.3. The expert opinions that supported the magistrates for the judicial decisions regarding the demands of patients for cannabidiol-based products in Brazil were mostly in accordance with scientific evidence, denoting the importance of NatJus in the qualification of access to medicinal products in the country.

El estudio analizó las acciones legales de pacientes que solicitaron al Sistema Único de Salud brasileño productos a base de cannabidiol (CBD) durante el período de 2019 a 2022, describiendo características sociodemográficas, clínicas y legales. Se trata de un estudio transversal compuesto por la evaluación de las notas técnicas emitidas por los Núcleos de Apoyo Técnico del Poder Judicial (NatJus) que basaron las decisiones judiciales. Los datos se obtuvieron del sistema e-NatJus, del Ministerio de Justicia brasileño, mediante técnicas de web scraping. La regresión logística se empleó para estimar los odds ratios con intervalos del 95% de confianza. Fueron analizadas 1.115 notas técnicas de las acciones demandantes de CBD que tenían 54,7 % de los pacientes del género masculino, con una edad media de 18,4 años, en su mayoría de la Región Sur del país (38,8%) y 49,6% buscaban tratamiento para la epilepsia. De las acciones con opiniones favorables, el 28,8% no tenían evidencias científicas, el 26,5% pleitearon productos sin registro en la Agencia Nacional de Vigilancia Sanitaria y el 25,3% de los que tenían registro, no estaban en conformidad con la indicación terapéutica. Los pacientes de la Región Nordeste tuvieron la posibilidad de opiniones favorables aumentada en 3,0 veces y los que tenían diagnóstico de epilepsia en 2,3. Los dictámenes técnicos que dieron apoyo a los magistrados para las decisiones judiciales de las demandas de los pacientes por productos a base de cannabidiol en Brasil estaban en su mayoría en conformidad con las evidencias científicas, denotando la importancia de NatJus en la calificación del acceso a productos medicinales en el país.

Video clip for learning the physiology of lactation: evaluation by the family support network for breastfeeding women / Videoclip para aprender la fisiología de la lactancia: evaluación realizada por la red de apoyo familiar para mujeres en lactancia / Videoclipe para aprendizagem da fisiologia da lactação: avaliação pela rede de apoio familiar às lactantes

ABSTRACT Objective: to evaluate the adequacy of using a care-educational technology with video clips for learning the physiology of lactation by the family support network for breastfeeding women. Method: a methodological study guided by the Knowledge Translation in Action Model. The collection procedure was carried out from July to September 2022 in the city of Santa Cruz do Sul, state of Rio Grande do Sul, Brazil. After the childcare consultation, each puerperal woman indicated one or more members of her support network to participate in the research. In face-to-face interviews, 52 participants answered the following instruments: Assistive Technology Assessment and Face Validation of Educational Technologies in Health. Normality of the variables was verified using the Kolmogorov-Smirnov test. The quantitative variables with normal distribution were described by mean and standard deviation. Face Validity Index and Cronbach's Alpha were calculated. Results: the video clip was evaluated as adequate (1.75) in all attributes: Interactivity (1.75), Objectivity (2.00), Relevance and efficacy (2.00) and Clarity (2.00). Face validity was excellent (0.969). Both instruments obtained Cronbach's Alpha values of 0.883 and 0.852, respectively, indicating reliability in this population. Conclusion: the video clip for learning the physiology of lactation is suitable for use by the family support network for breastfeeding mothers.

RESUMEN Objetivo: evaluar lo adecuado de utilizar una tecnología de atención-educativa del tipo videoclip para aprender la fisiología de la lactancia con la red de apoyo familiar para mujeres en lactancia. Método: estudio metodológico guiado por el Modelo de Traducción del Conocimiento en Acción. Los datos se recolectaron entre julio y septiembre de 2022 en la ciudad de Santa Cruz do Sul, estado do Río Grande do Sul, Brasil. Después de la consulta de puericultura, cada puérpera indicó al menos un integrante de su red de apoyo para que participara de la investigación. En sendas entrevistas presenciales, 52 participantes respondieron los siguientes instrumentos: Evaluación de Tecnología de Asistencia y Validación de la Apariencia de Tecnologías Educativas en Salud. La normalidad de las variables se verificó con la prueba de Kolmogorov-Smirnov. Las variables cuantitativas con distribución normal se describieron con valores medios y desviaciones estándar. Se calcularon el Índice de Validez de la Apariencia y el coeficiente Alpha de Cronbach. Resultados: el videoclip fue evaluado como adecuado (1,75) en todos los atributos: Interactividad (1,75), Objetividad (2,00), Relevancia y eficacia (2,00) y Claridad (2,00). La validez de la apariencia fue excelente (0,969). Ambos instrumentos obtuvieron coeficientes Alpha de Cronbach de 0,883 y 0,852 respectivamente, indicando confiabilidad en esta población. Conclusión: el videoclip para aprender la fisiología de la lactancia es adecuado para ser usado por la red de apoyo familiar para mujeres en lactancia.

RESUMO Objetivo: Avaliar a adequação do uso da tecnologia cuidativo-educacional, do tipo videoclipe, para aprendizagem da fisiologia da lactação pela rede de apoio familiar às lactantes. Método: Estudo metodológico, guiado pelo Modelo de Tradução do Conhecimento em Ação. A coleta foi desenvolvida na cidade de Santa Cruz do Sul, no Estado do Rio Grande do Sul, Brasil, no período de julho a setembro de 2022. Após a consulta de puericultura, a puérpera indicou um ou mais membros de sua rede de apoio para participar da pesquisa. Em entrevista presencial, 52 participantes responderam os instrumentos: Avaliação de Tecnologia Assistiva e Validação de Aparência de Tecnologias Educacionais em Saúde. A normalidade das variáveis foi verificada com o teste de Kolmogorov Smirnov. As variáveis quantitativas com distribuição normal foram descritas pela média e o desvio padrão. Foram calculados o Índice de Validade de Aparência e o Alpha de Cronbach. Resultados: O videoclipe foi avaliado como adequado (1,75) em todos os atributos interatividade (1,75), objetividade (2,00), relevância e eficácia (2,00) e clareza (2,00). A validade de aparência foi excelente (0,969). Ambos os instrumentos obtiveram Alpha de Cronbach, 0,883 e 0,852 respectivamente, apontando a confiabilidade nesta população. Conclusão: O videoclipe para aprendizagem da fisiologia da lactação está adequado ao uso pela rede de apoio familiar às lactantes.

Calibración y mantenimiento de aparatos de láser de baja potencia: estudio descriptivo

Resumen: Introducción: El láser de baja potencia es una técnica utilizada en varias áreas de la salud: fisioterapia, odontología, otorrinolaringología y dermatología, entre otras. Para lograr los efectos terapéuticos la dosificación es fundamental y depende de los niveles de energía emitidos por los equipos. Objetivo: Conocer el estado de calibración y mantenimiento de los equipos de laserterapia de baja potencia, en servicios de fisioterapia u homólogos de instituciones de Montevideo, Uruguay. Método: Se realizó un estudio descriptivo, transversal en servicios de fisioterapia de Montevideo. Se analizaron 20 equipos de láser de baja potencia. Resultados: 7 de los aparatos evaluados se mantuvieron dentro de los límites adecuados de emisión. De los 13 láser fuera de los límites para entregar una emisión adecuada, 6 tenían un desajuste leve, 1 presentaba un desajuste moderado y 6 presentaban un desajuste severo con dosis nulas o que no generaban emisión. Del total de equipos evaluados solo 6 habían realizado una calibración previa y solo 2 de estos se encontraban dentro de los tiempos recomendados. Conclusión: Se observó un gran número de equipos de láser de baja potencia con desajustes en su emisión. En la mayoría de los casos no se lleva un correcto mantenimiento de los aparatos de láser de baja potencia. Se entiende relevante que los equipos sean calibrados para poder ofrecer una terapéutica segura y efectiva a los usuarios.

Resumo: Introdução: O laser de baixa potência é uma técnica utilizada em diversas áreas da saúde: fisioterapia, odontologia, otorrinolaringologia, dermatologia, dentre outras. Para obter efeitos terapêuticos, a dosagem é essencial e depende dos níveis de energia emitidos pelo equipamento. Objetivo: conhecer o estado de calibração e manutenção de equipamentos de laserterapia de baixa potência, em serviços de fisioterapia ou congêneres de instituições em Montevideu - Uruguai. Método: estudo descritivo, transversal, realizado em serviços de fisioterapia em Montevideo, Uruguai. 20 equipamentos de laser de baixa potência foram analisados. Resultados: 7 dos aparelhos avaliados permaneceram dentro dos limites de emissão adequados. Dos 13 lasers fora dos limites para entregar a emissão adequada, 6 tiveram uma leve incompatibilidade, 1 teve uma incompatibilidade moderada e 6 apresentaram uma incompatibilidade grave. Do total de equipamentos avaliados, apenas 6 haviam realizado uma calibragem prévia e apenas 2 destes estavam dentro do prazo recomendado (1 ano). Conclusão: observou-se um grande número de equipamentos de laser de baixa potência com desequilíbrios em sua emissão. Na maioria dos casos, os dispositivos a laser de baixa potência não recebem manutenção adequada. Acredita-se importante que os equipamentos sejam calibrados para oferecer uma terapia segura e eficaz aos usuários.

Abstract: Introduction: The low-power laser is a technique used in several areas of health: physiotherapy, dentistry, otorhinolaryngology and dermatology, among others. To achieve therapeutic effects, the dosage is essential and depends on the energy levels emitted by the device. Objective: To know the status of calibration and maintenance of low power laser therapy devices, in physiotherapy services or counterparts of institutions in Montevideo - Uruguay. Method: A descriptive, cross-sectional study was conducted in physiotherapy services in Montevideo, Uruguay. 20 low-power laser devices were analyzed. Results: 7 of the devices evaluated remained within the appropriate emission limits. Of the 13 lasers outside the limits to deliver adequate emission, 6 had a slight mismatch, 1 had a moderate mismatch, and 6 presented a severe mismatch. Among the total devices evaluated, only 6 had performed a previous calibration and only 2 of these were within the recommended times frames. Conclusion: A large number of low-power laser devices with imbalances in their emission was observed. In most cases, low-power laser devices are not properly maintained. Equipment should be timely calibrated in order to offer safe and effective therapy to users.

Agreement between two methods for assessment of maximal inspiratory pressure in patients weaning from mechanical ventilation.

BACKGROUND: Respiratory muscle strength in patients with an artificial airway is commonly assessed as the maximal inspiratory pressure (MIP) and is measured using analogue or digital manometers. Recently, new electronic loading devices have been proposed to measure respiratory muscle strength. This study evaluates the agreement between the MIPs measured by a digital manometer and those according to an electronic loading device in patients being weaned from mechanical ventilation. METHODS: In this prospective study, the standard MIP was obtained using a protocol adapted from Marini, in which repetitive inspiratory efforts were performed against an occluded airway with a one-way valve and were recorded with a digital manometer for 40 seconds (MIPDM). The MIP measured using the electronic loading device (MIPELD) was obtained from repetitively tapered flow resistive inspirations sustained for at least 2 seconds during a 40-second test. The agreement between the results was verified by a Bland-Altman analysis. RESULTS: A total of 39 subjects (17 men, 55.4±17.7 years) was enrolled. Although a strong correlation between MIPDM and MIPELD (R=0.73, P<0.001) was observed, the Bland-Altman analysis showed a high bias of -47.4 (standard deviation, 22.3 cm H2O; 95% confidence interval, -54.7 to -40.2 cm H2O). CONCLUSIONS: The protocol of repetitively tapering flow resistive inspirations to measure the MIP with the electronic loading device is not in agreement with the standard protocol using one-way valve inspiratory occlusion when applied in poorly cooperative patients being weaned from mechanical ventilation.

Additional treatment with mistletoe extracts for patients with breast cancer compared to conventional cancer therapy alone - efficacy and safety, costs and cost-effectiveness, patients and social aspects, and ethical assessment.

Background: Chemotherapy is often used in the treatment of breast cancer in women. Side effects such as diarrhea, fatigue, hair loss, fever or disturbances in blood formation impair the women's quality of life. An essential treatment goal of the accompanying mistletoe therapy (MT) used in complementary medicine is to improve the health-related quality of life during cancer therapy. Aim and methods: The HTA report on which this article is based examines the medical efficacy and safety, costs and cost-effectiveness, patient and social aspects, and ethical aspects of MT in women with breast cancer. Systematic reviews were conducted for this purpose. The search period of the literature search ranged from 2004 to October 2020. Results: A total of 2 evidence-based medical guidelines, 3 randomized trials assessing efficacy and 1 additional non-randomized intervention trial, as well as 3 observational studies assessing safety, a cost analysis, 12 cross-sectional studies on patient aspects and 17 articles on ethical evaluation were included. Improvements in health-related quality of life compared to the control group were small to moderate. Due to the high risk of bias in the studies, it is possible that the difference is not caused by MT. One study with a small sample size showed no effect on progression-free survival after 5 years. Studies on the effect of MT on overall survival are lacking. In seven studies, local skin reactions of low and moderate severity were reported in a median of 25% (range 5 to 94%) of patients, and mild to moderate systemic reactions in a median of 2% (range 0 to 8%) of patients. A comparative cost analysis from Germany reported significantly lower medical costs within 5 years after surgery for patients with MT than for patients without MT, but the underlying observational study did not control for systematic bias. With regard to patient aspects, the frequency of use and the reasons for use from the patient's or practitioner's point of view were mainly investigated. A median of 25% (range 7 to 46%) of patients with breast cancer and 29% (range 29 to 79%) of treatment providers use MT. The main motivations of patients for use were to reduce side effects, strengthen the immune system and take an active role in the treatment process. Patients felt insufficiently advised. Studies on other aspects are lacking. The ethical evaluation was able to identify 6 overarching themes; the central challenge is the insufficient evidence on efficacy and safety.

Desafios globais na avaliação de tecnologias em saúde dos dispositivos médicos personalizados impressos em 3D Global / challenges in health technology assessment of personalized 3D printed medical devices

Objetivo: Consolidar as informações de aspectos regulatórios, de desenvolvimento e implicações para avaliação dos dispositivos médicos personalizados. Métodos: Foram realizadas buscas nas agências internacionais de avaliação de tecnologias e consulta aos documentos de harmonização sanitária e estudos públicos de análise de impacto regulatório realizados por agências regulatórias de diversos países. Resultados: Ainda não há evidências científicas robustas sobre a eficácia e a segurança de dispositivos impressos em 3D; isso significa que o paciente deve ser suficientemente informado para poder dar consentimento válido. A quantidade e a qualidade atuais das evidências e as características exclusivas dessas tecnologias podem apresentar desafios na realização de avaliações de tecnologias abrangentes. Conclusão: O uso dos dispositivos médicos personalizados impressos em 3D tem grande potencial no setor de saúde, especialmente nos tratamentos de condições específicas de pacientes em que não há tecnologias comercialmente disponíveis, porém o estado da evidência pode ser uma barreira para sua adoção nos serviços de saúde. De forma a viabilizar o intercâmbio de informações e contribuir para a pesquisa colaborativa, a adoção de termo comum nos estudos é imprescindível. A falta de consenso sobre a terminologia pode apresentar desafios para a elaboração de estudos de avaliação de tecnologias que realizam buscas dependentes de estratégias de pesquisa e revisão da literatura, como avaliações econômicas e revisões sistemáticas.

Objective: Consolidate information on regulatory aspects, development and implications for the evaluation of personalized medical devices. Methods: Searches were carried out in international technology assessment agencies, consultation of health harmonization documents, public studies of regulatory impact analysis carried out by regulatory agencies from different countries. Results: There is still no robust scientific evidence on the efficacy and safety of 3D printed devices, which means that the patient must be sufficiently informed to be able to give valid consent. The current quantity and quality of evidence and the unique characteristics of these technologies can present challenges in conducting comprehensive technology assessments. Conclusion: The use of personalized 3D printed medical devices has great potential in the healthcare sector, especially in the treatment of specific patient conditions where there are no commercially available technologies, but the state of evidence can be a barrier to their adoption in healthcare services. In order to facilitate the exchange of information and contribute to collaborative research, the adoption of a common term in the studies is imperative. The lack of consensus on terminology can present challenges for the development of technology assessment studies that perform searches dependent on research strategies and literature review, such as economic evaluations and systematic reviews.

Primary HPV-DNA screening in women under 30 years of age: health technology assessment / Tamización primaria con prueba ADN-VPH en mujeres menores de 30 años: evaluación de tecnología sanitaria

Background: Primary screening with Human Papilloma Virus (HPV) testing was introduced in Colombia in 2014 for individuals between 30 and 65 years of age. When the result is positive, cytology triage is performed for colposcopy referral. The convenience of initiating HPV-DNA testing for screening at 25 years of age is currently a subject of discussion. Therefore, the objective of this health technology assessment (HTA) is to analyze the available evidence regarding safety, efficacy, cost-effectiveness, values and preferences, ethical dilemmas and considerations pertaining to the implementation of the HPV-DNA test as a cervical screening strategy in women under 30 years of age in the Colombian context. Domains to be assessed: Clinical efficacy and safety 1. Cumulative rate of cervical intraepithelial neoplasia (CIN) grade 2 or high-er after 2 screening rounds. 2. Cumulative rates of invasive cancer of the uterine cervix after 2 screening rounds. 3. Safety: referral to colposcopy. Cost-effectiveness Cost-effectiveness for Colombia. Other domains considered Ethical considerations associated with cervical screening in women under 30 years of age. Organizational and individual considerations. Barriers and facilitators pertaining to the implementation of cervical screening in women under 30 years of age in the Colombian context. Methods: Clinical efficacy and safety assessment A systematic literature search of systematic reviews and clinical trials was conducted in MEDLINE, Embase and CENTRAL. The body of evidence was rated using the GRADE approach. An interdisciplinary team was then convened to create a working group to review the retrieved evidence. This led to the discussion and construction of the conclusions following the guidelines of a formal consensus in accordance with the RAND/UCLA methodology. Economic study Systematic literature research of studies that had assessed cost-effectiveness for Colombia. Results: Clinical outcomes An integrative analysis of 5 randomized clinical trials that met the inclusion critera was performed. Compared with cytology, primary HPV-DNA testing in women under 30 years of age could be associated with a lower frequency of CIN+2 lesions during the first screening round (RR: 1.57; CI: 1.20 to 2.04; low evidence certainty), and a lower incidence of CIN+2 (RR: 0.67; CI: 0.48 to 0.92; low evidence certainty). Moreover, it is associated with a lower frequency of invasive carcinoma at the end of follow-up (RR: 0.19; CI: 0.07 to 0.53; high evidence certainty). Economic results From the financial point of view, the use of HPVDNA testing plus cytology-based triage starting at 25 years of age is perhaps the most cost-effective option for Colombia (incremental cost-effectiveness ratio, COP 8,820,980 in 2013). Other implications Two studies suggest that barriers to implementation attributable to intermediation, public unrest and geographic considerations could be overcome with the use of new screening technologies or strategies. It is important to consider administration and service provision alternatives in order to overcome some acceptability and access barriers. Any cervical screening program must take into consideration ethical principles of nonmaleficence, beneficence, autonomy and equity. Future studies should focus on analyzing new screening techniques with emphasis on the population under 30 years of age. Conclusions: The use of HPV-DNA testing as a screening strategy in women under 30 years of age is a potentially efficacious and cost-effective intervention for Colombia. Future studies should focus on analyzing new screening technologies, with emphasis on the population under 30 years of age.

Antecedentes: A partir del 2014 en Colombia se incorporó la Tamización primaria con prueba de Virus del Papiloma Humano (VPH) desde los 30 hasta los 65 años, cuando la prueba es positiva se hace triage con citología para remisión a colposcopia. Actualmente se discute la conveniencia de iniciar la tamización con prueba de ADN de VPH a partir de los 25 años. De esta manera, el objetivo de esta evaluación de tecnologías sanitarias es analizar la evidencia disponible en torno a la seguridad, efectividad, costoefectividad, valores y preferencias, dilemas éticos y aspectos relacionados con la implementación para el contexto colombiano de la prueba ADN-VPH como estrategia de tamización cervical en mujeres menores de 30 años. Dominios a evaluar: Eficacia clínica y seguridad 1. Tasa acumulada de neoplasia intraepitelial cervical (NIC) grado 2 o más avanzado luego de 2 rondas de tamización. 2. Tasas acumuladas de cáncer invasor de cérvix luego de 2 rondas de tamización. 3. Seguridad: remisión a colposcopia. Costo-efectividad Costo efectividad para Colombia. Otros dominios considerados Aspectos éticos asociados a la tamización cervical en mujeres menores de 30 años. Aspectos organizacionales y del individuo. Barreras y facilitadores relacionados con la implementación en el contexto colombiano de la tamización cervical en mujeres menores de 30 años. Métodos: Evaluación de efectividad y seguridad clínicas Se realizó una búsqueda sistemática de la literatura en MEDLINE, Embase y CENTRAL de revisiones sistemáticas y ensayos clínicos. Se calificó el cuerpo de la evidencia con la aproximación GRADE. Posteriormente, se convocó a un grupo interdisciplinario a una mesa de trabajo en donde se presentó la evidencia recuperada, dando paso a la discusión y a la construcción de las conclusiones, siguiendo los lineamientos de un consenso formal acorde a la metodología RAND/UCLA. Estudio económico Se hizo una búsqueda sistemática de la literatura de estudios que hubieran evaluado el costo-efectividad para Colombia. Resultados: De 7.659 referencias recuperadas se incluyeron 8 estudios. Resultados clínicos Se realizó un análisis integrativo de 5 ensayos clínicos aleatorizados que cumplieron con los criterios de inclusión. Cuando se compara frente a la citología, la tamización primaria con ADN-VPH en mujeres menores de 30 años, podría asociarse con una mayor frecuencia de detección de lesiones NIC2+ durante la primera ronda de cribado (RR: 1.57; IC: 1,20 a 2,04; certeza en la evidencia baja), con una menor incidencia de NIC2+ (RR:0,67; IC: 0,48 a 0,92; certeza en la evidencia baja) y se asocia con una menor frecuencia de carcinoma invasor al término del seguimiento (RR: 0,19; IC: 0,07 a 0,53; certeza en la evidencia alta). Resultados económicos Desde el punto de vista económico, la alternativa de ADN-VPH y triage con citología desde los 25 años quizás representa la alternativa más costo-efectiva para Colombia (razón costo-efectividad incremental $8.820.980 COP año 2013). Otras implicaciones Dos estudios sugieren que las barreras de implementación, atribuibles a circunstancias de intermediación, de orden público y de carácter geográfico, podrían ser solventadas por nuevas tecnologías o estrategias de cribado. Es importante considerar alternativas de forma de administración y de prestación de servicios para solventar algunas barreras de aceptabilidad y acceso. Todo programa de tamización cervical debe contemplar los principios éticos de no maleficencia, beneficencia, autonomía y equidad. Futuros estudios deben enfocarse en analizar nuevas tecnologías de cribado con énfasis en población menor de 30 años. Conclusiones: El uso de la prueba ADN-VPH como estrategia de tamización en mujeres menores de 30 años es una intervención probablemente efectiva y costoefectiva para Colombia. Futuros estudios deben enfocarse en analizar nuevas tecnologías de cribado con énfasis en población menor de 30 años.

Tamización primaria con prueba ADN-VPH en mujeres menores de 30 años: evaluación de tecnología sanitaria / Primary HPV-DNA screening in women under 30 years of age: health technology assessment

Antecedentes A partir del 2014 en Colombia se incorporó la Tamización primaria con prueba de Virus del Papiloma Humano (VPH) desde los 30 hasta los 65 años, cuando la prueba es positiva se hace triage con citología para remisión a colposcopia. Actualmente se discute la conveniencia de iniciar la tamización con prueba de ADN de VPH a partir de los 25 años. De esta manera, el objetivo de esta evaluación de tecnologías sanitarias es analizar la evidencia disponible en torno a la seguridad, efectividad, costoefectividad, valores y preferencias, dilemas éticos y aspectos relacionados con la implementación para el contexto colombiano de la prueba ADN-VPH como estrategia de tamización cervical en mujeres menores de 30 años. Dominios a evaluar Eficacia clínica y seguridad 1. Tasa acumulada de neoplasia intraepitelial cervical (NIC) grado 2 o más avanzado luego de 2 rondas de tamización. 2. Tasas acumuladas de cáncer invasor de cérvix luego de 2 rondas de tamización. 3. Seguridad: remisión a colposcopia. Costo-efectividad Costo efectividad para Colombia. Otros dominios considerados Aspectos éticos asociados a la tamización cervical en mujeres menores de 30 años. Aspectos organizacionales y del individuo. Barreras y facilitadores relacionados con la implementación en el contexto colombiano de la tamización cervical en mujeres menores de 30 años. Métodos Evaluación de efectividad y seguridad clínicas Se realizó una búsqueda sistemática de la literatura en MEDLINE, Embase y CENTRAL de revisiones sistemáticas y ensayos clínicos. Se calificó el cuerpo de la evidencia con la aproximación GRADE. Posteriormente, se convocó a un grupo interdisciplinario a una mesa de trabajo en donde se presentó la evidencia recuperada, dando paso a la discusión y a la construcción de las conclusiones, siguiendo los lineamientos de un consenso formal acorde a la metodología RAND/UCLA. Estudio económico Se hizo una búsqueda sistemática de la literatura de estudios que hubieran evaluado el costo-efectividad para Colombia. Resultados De 7.659 referencias recuperadas se incluyeron 8 estudios. Resultados clínicos Se realizó un análisis integrativo de 5 ensayos clínicos aleatorizados que cumplieron con los citerios de inclusión. Cuando se compara frente a la citología, la tamización primaria con ADN-VPH en mujeres menores de 30 años, podría asociarse con una mayor frecuencia de detección de lesiones NIC2+ durante la primera ronda de cribado (RR: 1.57; IC: 1,20 a 2,04; certeza en la evidencia baja), con una menor incidencia de NIC2+ (RR:0,67; IC: 0,48 a 0,92; certeza en la evidencia baja) y se asocia con una menor frecuencia de carcinoma invasor al término del seguimiento (RR: 0,19; IC: 0,07 a 0,53; certeza en la evidencia alta). Resultados económicos Desde el punto de vista económico, la alternativa de ADN-VPH y triage con citología desde los 25 años quizás representa la alternativa más costo-efectiva para Colombia (razón costo-efectividad incremental $8.820.980 COP año 2013). Otras implicaciones Dos estudios sugieren que las barreras de implementación, atribuibles a circunstancias de intermediación, de orden público y de carácter geográfico, podrían ser solventadas por nuevas tecnologías o estrategias de cribado. Es importante considerar alternativas de forma de administración y de prestación de servicios para solventar algunas barreras de aceptabilidad y acceso. Todo programa de tamización cervical debe contemplar los principios éticos de no maleficencia, beneficencia, autonomía y equidad. Futuros estudios deben enfocarse en analizar nuevas tecnologías de cribado con énfasis en población menor de 30 años. Conclusiones El uso de la prueba ADN-VPH como estrategia de tamización en mujeres menores de 30 años es una intervención probablemente efectiva y costoefectiva para Colombia. Futuros estudios deben enfocarse en analizar nuevas tecnologías de cribado con énfasis en población menor de 30 años.

Background Primary screening with Human Papilloma Virus (HPV) testing was introduced in Colombia in 2014 for individuals between 30 and 65 years of age. When the result is positive, cytology triage is performed for colposcopy referral. The convenience of initiating HPV-DNA testing for screening at 25 years of age is currently a subject of discussion. Therefore, the objective of this health technology assessment (HTA) is to analyze the available evidence regarding safety, efficacy, cost-effectiveness, values and preferences, ethical dilemmas and considerations pertaining to the implementation of the HPV-DNA test as a cervical screening strategy in women under 30 years of age in the Colombian context. Domains to be assessed Clinical efficacy and safety 1. Cumulative rate of cervical intraepithelial neoplasia (CIN) grade 2 or high-er after 2 screening rounds. 2. Cumulative rates of invasive cancer of the uterine cervix after 2 screening rounds. 3. Safety: referral to colposcopy Cost-effectiveness Cost-effectiveness for Colombia. Other domains considered Ethical considerations associated with cervical screening in women under 30 years of age. Organizational and individual considerations. Barriers and facilitators pertaining to the implementation of cervical screening in women under 30 years of age in the Colombian context. Methods Clinical efficacy and safety assessment A systematic literature search of systematic reviews and clinical trials was conducted in MEDLINE, Embase and CENTRAL. The body of evidence was rated using the GRADE approach. An interdisciplinary team was then convened to create a working group to review the retrieved evidence. This led to the discussion and construction of the conclusions following the guidelines of a formal consensus in accordance with the RAND/UCLA methodology. Economic study Systematic literature research of studies that had assessed cost-effectiveness for Colombia. Results Out of the 7,659 references retrieved, 8 studies were included. Clinical outcomes An integrative analysis of 5 randomized clinical trials that met the inclusion critera was performed. Compared with cytology, primary HPV-DNA testing in women under 30 years of age could be associated with a lower frequency of CIN+2 lesions during the first screening round (RR: 1.57; CI: 1.20 to 2.04; low evidence certainty), and a lower incidence of CIN+2 (RR: 0.67; CI: 0.48 to 0.92; low evidence certainty). Moreover, it is associated with a lower frequency of invasive carcinoma at the end of follow-up (RR: 0.19; CI: 0.07 to 0.53; high evidence certainty). Economic results From the financial point of view, the use of HPVDNA testing plus cytology-based triage starting at 25 years of age is perhaps the most cost-effective option for Colombia (incremental cost-effectiveness ratio, COP 8,820,980 in 2013). Other implications Two studies suggest that barriers to implementation attributable to intermediation, public unrest and geographic considerations could be overcome with the use of new screening technologies or strategies. It is important to consider administration and service provision alternatives in order to overcome some acceptability and access barriers. Any cervical screening program must take into consideration ethical principles of nonmaleficence, beneficence, autonomy and equity. Future studies should focus on analyzing new screening techniques with emphasis on the population under 30 years of age. Conclusions The use of HPV-DNA testing as a screening strategy in women under 30 years of age is a potentially efficacious and cost-effective intervention for Colombia. Future studies should focus on analyzing new screening technologies, with emphasis on the population under 30 years of age.

Incorporação de medicamentos no SUS: comparação entre oncologia e componente especializado da assistência farmacêutica / Incorporation of medicines in the Unified Health System (SUS): comparison between oncology and the specialized component of pharmaceutical care

Resumo O cumprimento dos prazos legais para incorporação e disponibilização de tecnologias no Sistema Único de Saúde (SUS) é fundamental para o acesso da população aos medicamentos considerados essenciais. Objetivou-se analisar o cumprimento destes prazos comparando a Oncologia e o Componente Especializado de Assistência Farmacêutica (CEAF). Comparou-se os processos de incorporação de medicamentos no SUS da Oncologia e do CEAF que foram submetidos à Conitec no período de 01 de janeiro de 2017 a 30 de abril de 2020. No período, 83 processos de incorporação de medicamentos foram recomendados para incorporação pela Conitec, dos quais 13 (15,66%) eram da Oncologia e 70 (84,34%) eram do CEAF. Verifica-se que o tempo de análise e recomendação pela Conitec até a publicação da decisão pelo Ministério da Saúde foi, em média, 15 dias maior para processos que continham medicamentos oncológicos e o tempo para disponibilização das tecnologias incorporadas da área da oncologia foi, em média, 389 dias maior que do CEAF. Reconhece-se o importante avanço obtido com a criação da Conitec no Brasil, porém os resultados deste estudo apontam para a necessidade de aprimoramento do processo de disponibilização de tecnologias incorporadas no SUS, em especial da Oncologia.

Abstract Compliance with legal deadlines for the assessment and incorporation of technologies in Brazil's Unified Health System (SUS) is essential to ensure public access to essential medicines. The scope of this paper was to analyze the compliance with legal deadlines for incorporation and availability of medicines in the SUS, comparing Oncology and the Specialized Component of Pharmaceutical Assistance (SCPA). A comparison was made of the drugs incorporated that were submitted to Conitec in the period from January 1, 2017, to April 30, 2020. A total of 85 drugs were recommended for incorporation by Conitec, of which 15 (17.64%) were for Oncology and 70 (82.36%) were for SCPA. The time between analysis and recommendation by Conitec until the publication of the decision by the Ministry of Health was, on average, 86 days longer for oncological drugs and the availability timeframe of technologies incorporated in the oncology area was, on average, 389 days longer than for SCPA. The major progress achieved with the creation of Conitec in Brazil is acknowledged, but the results of this study point to a pressing need to improve the process of making available technologies incorporated into the SUS, especially in oncology.

TIC en actividad física y parámetros cardiovasculares en mayores: una revisión / Health technology tools used to increase physical activity and improve cardiovascular parameters in older adults: A review

Introducción: El envejecimiento es una etapa de cambios físicos y psicológicos. La inactividad es uno de los grandes problemas que la generación de adultos mayores presenta, aumentando el riesgo de sarcopenia y de enfermedades crónicas. En los últimos años se ha producido un incremento en el uso de la tecnología, apareciendo las herramientas TIC (acrónimo de tecnología de la información y la comunicación) como intervención para aumentar la actividad física y mejorar los problemas de salud asociados. Objetivo: En esta revisión se evalúa la efectividad de las herramientas TIC para aumentar la actividad física y mejorar los parámetros cardiovasculares en adultos mayores. Metodología: Se incluyeron estudios que usaran herramientas TIC para aumentar los niveles de actividad física en adultos mayores y que evaluaran el efecto de ese aumento en los parámetros cardiovasculares realizando la búsqueda en las principales bases de datos. Resultados: en esta revisión se incluyeron 11 estudios que reportan el uso de una gran variedad de herramientas TIC. A pesar de estas diferencias, se ha demostrado la efectividad de estas intervenciones en el aumento de la actividad física y la reducción de los parámetros cardiovasculares. Discusión: La falta de adhesión de la generación de adultos mayores a la tecnología sería una desventaja, pero se ha demostrado que los adultos mayores jóvenes están más familiarizados con estas y el número de los que las usan va creciendo con el tiempo. Conclusión: Las herramientas TIC muestran efectividad en el aumento de la actividad física en los adultos mayores y en la mejora de los parámetros cardiovasculares.(AU)

Introduction: Ageing is a period of physical and psychological changes. Inactivity is one of the biggest problems among the older adult population increasing the risk of sarcopenia and chronic diseases. Physical activity is an effective intervention to improve health outcomes. In recent years, there has been an increase in the use of technology, with health technology tools (ICT) appearing as an intervention to increase physical activity and improve associated health problems. Objective: In this review, we evaluated the effectiveness of health technology to increase physical activity and to improve cardiovascular parameters in older adults. Methodology: Studies with a great variety of health technology tools to increase physical activity levels, and that evaluated the effect of that increase on cardiovascular parameters were included by searching the main databases. Results: Eleven studies reporting the use of a variety of ICT tools were included in this review. Despite these differences, the effectiveness of health technology tool interventions has been demonstrated in increasing physical activity and reducing cardiovascular parameters. Discussion: The lack of adherence of older adults to health technology would be a disadvantage, but it has been shown that younger older adults are more familiar with health technology tools and the number using them is increasing. Conclusion: Health technology tools show effectiveness in increasing physical activity in older adults and improving cardiovascular parameters.(AU)

Acordo de Compartilhamento de Risco: projeto-piloto no Sistema Único de Saúde / Risk Sharing Agreement: a pilot project in the Brazilian Unified Health System

O Acordo de Compartilhamento de Risco é definido como um acordo no qual o Estado concorda em oferecer acesso temporário a um novo medicamento, enquanto a indústria farmacêutica aceita receber pelo produto conforme o desempenho do medicamento em reais condições de uso. A partilha de risco depende, necessariamente, da coleta de evidências adicionais, que podem se referir aos benefícios terapêuticos ou ao volume de pacientes, conforme avaliação de seu uso na prática. Os autores descreveram a experiência do projeto-piloto de Acordo de Compartilhamento de Risco no Sistema Único de Saúde.

Risk Sharing Agreement is defined as an agreement in which the State agrees to offer temporary access to a new drug, while the pharmaceutical industry accepts to receive the product according to the performance of the drug in real conditions of use. Risk sharing necessarily depends on the collection of additional evidence that may refer to the therapeutic benefits or the volume of patients, according to the assessment of its use in practice. The authors described the experience of the pilot project of a Risk Sharing Agreement in the Unified Health System.

Risk Sharing Agreement: a pilot project in the Brazilian Unified Health System

Risk Sharing Agreement is defined as an agreement in which the State agrees to offer temporary access to a new drug, while the pharmaceutical industry accepts to receive the product according to the performance of the drug in real conditions of use. Risk sharing necessarily depends on the collection of additional evidence that may refer to the therapeutic benefits or the volume of patients, according to the assessment of its use in practice. The authors described the experience of the pilot project of a Risk Sharing Agreement in the Unified Health System.