Valor de la hemodiálisis concertada y la hospitalaria mediante un análisis de decisión multicriterio / Value of concerted and hospital hemodialysis through a multi-criteria decision analysis

Objetivo Evaluar el valor de la prestación de servicios de diálisis concertada frente a la hospitalaria para el tratamiento de la enfermedad renal crónica en España mediante la metodología de análisis de decisión multicriterio. Método Se utilizó el marco de evaluación EVIDEM (Evidence and Value: Impact on Decision Making) para el cálculo del valor estimado de ambos modelos de prestación de la diálisis (concertada vs. hospitalaria) mediante un taller virtual en el que participaron diferentes perfiles: directivos y gestores, profesionales y responsables de unidades y representantes de pacientes y familiares. Las puntuaciones se combinaron mediante un modelo lineal aditivo, que combinó la ponderación del modelo con la puntuación individual de los criterios, y cada valor se transformó a una escala entre el 0 y 1. Resultados La estimación del valor para la diálisis concertada fue de 0,29 (DE: ±0,2) y de 0,39 (DE: ±0,2) para la diálisis hospitalaria. Todos los perfiles otorgaron un mayor valor a la hemodiálisis hospitalaria. El mayor valor para la diálisis hospitalaria fue de los pacientes (0,44); el menor valor medio fue de los directivos (0,36) y el rango para la diálisis concertada estuvo entre los pacientes (0,31) y los cargos intermedios (0,27). Conclusiones La hemodiálisis hospitalaria obtuvo un mayor valor que la diálisis concertada. En general, los panelistas afirmaron que resulta un ejercicio útil e interesante y que, en cierta medida, aporta seguridad en la toma de decisiones, ya que permite ordenar, racionalizar y considerar, de manera explícita y transparente, los diferentes criterios involucrados (AU)

Objective To evaluate the value of the provision of contracted versus hospital dialysis services for the treatment of chronic kidney disease in Spain using the multicriteria decision analysis methodology. Method The EVIDEM (Evidence and Value: Impact on Decision Making) evaluation framework was used to calculate the estimated value of both dialysis delivery models (arranged vs. hospital) through a virtual workshop in which different profiles participated: directors and managers, professionals and heads of units and representatives of patients and relatives. The scores were combined using an additive lineal model, which combined the weight of the model with the individual score of the criteria, and each value was transformed to a scale between 0 and 1. Results The estimated value for arranged dialysis was 0.29 (DS: ±0.2) and 0.39 (DS: ±0.2) for hospital dialysis. All profiles gave a higher value to hospital hemodialysis compared to contracted hemodialysis. The highest value for hospital dialysis was for patients (0.44), with the lowest mean value for directors (0.36) and the range for arranged dialysis being between patients (0.31) and intermediate positions (0.27). Conclusions Hospital hemodialysis obtained a higher value than concerted dialysis. In general, the panelists affirmed that it is a useful and interesting exercise and that, to a certain extent, it provides security in decision-making, since it allows ordering, rationalizing and considering, in an explicit and transparent manner, the different criteria involved (AU)

Value of concerted and hospital hemodialysis through a multi-criteria decision analysis.

OBJECTIVE: To evaluate the value of the provision of contracted versus hospital dialysis services for the treatment of chronic kidney disease in Spain using the multicriteria decision analysis methodology. METHOD: The EVIDEM (Evidence and Value: Impact on Decision Making) evaluation framework was used to calculate the estimated value of both dialysis delivery models (arranged vs. hospital) through a virtual workshop in which different profiles participated: directors and managers, professionals and heads of units and representatives of patients and relatives. The scores were combined using an additive lineal model, which combined the weight of the model with the individual score of the criteria, and each value was transformed to a scale between 0 and 1. RESULTS: The estimated value for arranged dialysis was 0.29 (DS: ±0.2) and 0.39 (DS: ±0.2) for hospital dialysis. All profiles gave a higher value to hospital hemodialysis compared to contracted hemodialysis. The highest value for hospital dialysis was for patients (0.44), with the lowest mean value for directors (0.36) and the range for arranged dialysis being between patients (0.31) and intermediate positions (0.27). CONCLUSIONS: Hospital hemodialysis obtained a higher value than concerted dialysis. In general, the panelists affirmed that it is a useful and interesting exercise and that, to a certain extent, it provides security in decision-making, since it allows ordering, rationalizing and considering, in an explicit and transparent manner, the different criteria involved.

Avaliação de tecnologia assistiva sobre câncer de próstata e mama para deficientes visuais em países lusófonos / Evaluation of assistive technology about prostate and breast cancer for visually impaired persons in portuguese-speaking countries / Evaluación de tecnología de asistencia en cáncer de próstata y mama para personas con discapacidad visual en países de habla portuguesa

Objetivo: Avaliar a acessibilidade de tecnologia assistiva sobre câncer de próstata e de mama por deficientes visuais de dois países lusófonos. Métodos: Estudo metodológico de avaliação de tecnologia assistiva em saúde. Dados coletados com instrumento validado, constituído por 17 itens distribuídos nos atributos objetivos, acesso, clareza, estruturação e apresentação, relevância e eficácia e interatividade. Na análise, aplicaram-se Teste Qui-quadrado de Pearson, Teste Exato de Fisher ou Razão de Verossimilhança de acordo com os pressupostos dos testes. Os aspectos éticos foram respeitados. Resultados: A amostra foi de 62 participantes. As variáveis que tiveram diferenças estatísticas significantes foram escolaridade (p=0,006), tipos de deficiência (p=0,010) e desenvolvimento da deficiência (p= 0,005). Todas os atributos e itens obtiveram boas avaliações com alguns tópicos que não houve diferença estatística em ambos os países. Conclusão: As tecnologias assistivas sobre câncer de mama e próstata foram bem avaliadas, independente do país, brasileiros e portugueses as consideraram adequadas. (AU)

Objective: To evaluate the accessibility of assistive technology about prostate and breast cancer by visually impaired persons in two Portuguese-speaking countries. Methods: Methodological study of an assess assistive health technology. Data were collected from a validated instrument, comprising of 17 items distributed in the attributes, objective, access, clarity, structure and presentation, relevance and effectiveness and interactivity. In the analysis, the Pearson's Chi-squared test and the Fisher's exact test or likelihood ratios were applied according to the assumptions of the tests. The ethical aspects involved in the research were respected. Results: The sample was of 62 participants. The variables that exhibited any statistical diferences ware: schooling (p = 0.006); types of disabilities (p = 0.010) and; disabilities development (p = 0.005). All attributes and items had good evaluations, with some topics that there was no statistical difference among the countries. Conclusion: Assistive technology about prostate and breast cancer were well evaluated, regardless of the country, were considered adequate by brazilians and portuguese. (AU)

Objetivo: Evaluar la accesibilidad de la tecnología de asistencia en el cáncer de próstata y mama por personas con daño visual de dos países de habla portuguesa. Métodos: Estudio metodológico para evaluar la tecnología asistencial sanitaria. Datos recolectados con un instrumento validado, compuesto por 17 ítems distribuidos en los atributos objetivos, acceso, claridad, estructuración y presentación, relevancia y efectividad e interactividad. En el análisis se aplicó la prueba de chi-cuadrado de Pearson, la prueba exacta de Fisher o razón de verosimilitud según los supuestos de las pruebas. Se respetaron los aspectos éticos. Resultados: La muestra estuvo formada por 62 participantes. Las variables que presentaron diferencias estadísticamente significativas fueron educación (p = 0,006), tipos de discapacidad (p = 0,010) y desarrollo de la discapacidad (p = 0,005). Todos los atributos e ítems obtuvieron buenas evaluaciones con algunos temas que no hubo diferencia estadística en ambos países. Conclusion: Las tecnologías de asistencia en cáncer de mama y próstata fueron bien evaluadas, independientemente del país, brasileños y portugueses las consideraron apropiadas. (AU)

Potencialidades de um website para um centro de atenção psicossocial infantojuvenil / Potentials of a website for a child and youth psychosocial care center / Potencialidades de un sitio web para un centro de atención psicosocial para niños y adolescentes

Objetivo: evidenciar, a partir do feedback dos usuários, familiares, coordenadores e profissionais do Centro de Atenção Psicossocial Infanto Juvenil (CAPSi), a potencialidade do e-Mental Health na promoção do acesso através de um website.Método: pesquisa com abordagem metodológica qualitativa através de um estudo exploratório, do tipo pesquisa-ação utilizando o Knowledge Translation e a Metodologia da Dinâmica do Espelhamento Digital. A coleta de dados ocorreu entre os meses de agosto e setembro de 2018 no CAPSi da cidade de Pelotas, RS, Brasil. Resultados: o website iCanguru demonstrou ser capaz de melhorar o acesso, atuar na prevenção e promoção em saúde mental infanto-juvenil, aproximar a população rural e dar suporte cidades desassistidas. Conclusão: o website iCanguru pode ser uma excelente estratégia para superar algumas das barreiras de acesso e ser uma porta de entrada para o CAPSi. Descritores: e-Saúde; Serviços comunitários de saúde mental; Intervenção baseada em internet; Acesso a tecnologias em saúde; Avaliação das tecnologias de Saúde. (AU)

Objective: To demonstrate, based on the feedback from users, family members, coordinators, and professionals of the Center for Psychosocial Care for Children and Youths, the potential of e-Mental Health in promoting access through a website. Methods: Qualitative research approach through an exploratory study - action research, using Knowledge Translation and the Methodology of Digital Mirroring Dynamic. Data collection occurred between August and September 2018 at Center for Psychosocial Care for Children and Youths in the city of Pelotas, RS, Brazil. Results: The iCanguru website demonstrated to be able to improve access, prevention, and mental health promotion for children and youths, approaching the rural population and unsupported cities. Conclusion: The iCanguru website can be an excellent strategy to overcome some of the barriers to access and be a gateway to Center for Psychosocial Care for Children and Youths. (AU)

Objetivo: Destacar, a partir de la retroalimentación de los usuarios, familias, coordinadores y profesionales del Centro de Atención Psicosocial a la Infancia y la Adolescencia, el potencial de la e-Salud Mental para promover el acceso a través de un sitio web. Métodos: Investigación con enfoque metodológico cualitativo a través de un estudio exploratorio, del tipo de investigación acción utilizando la Traducción del Conocimiento y la Metodología de la Dinámica del Mirroring Digital. La recolección de datos se llevó a cabo entre agosto y septiembre de 2018 en Centro de Atención Psicosocial a la Infancia y la Adolescencia en la ciudad de Pelotas, RS, Brasil. Resultados: El sitio web iCanguru demostró ser capaz de mejorar el acceso, actuar en la prevención y promoción de la salud mental de niños y adolescentes, acercar a la población rural y apoyar a las ciudades no asistidas. Conclusión: El sitio web de iCanguru puede ser una excelente estrategia para superar algunas de las barreras de acceso y ser una puerta de entrada a Centro de Atención Psicosocial a la Infancia y la Adolescencia. (AU)

Metodología de la comparación indirecta ajustada con emparejamiento en la evaluación de fármacos hematooncológicos / Matching-Adjusted Indirect Comparisons in the assessment of hemato-oncological drugs

Objetivo: La comparación indirecta ajustada con emparejamiento es unametodología desarrollada para la evaluación de nuevos tratamientos frente asus alternativas cuando no se dispone de comparación directa mediante unensayo clínico aleatorizado y controlado. Estas comparaciones son de especial interés en el área de la hematooncología, en la que la incertidumbre en latoma de decisiones sobre la inclusión de nuevos fármacos se ve frecuentementeacentuada tanto por la gravedad de la enfermedad como por el elevadocoste del tratamiento. El objetivo de este artículo es describir cómo la metodología de comparación indirecta ajustada con emparejamiento ha sido empleadahasta la fecha en la evaluación de fármacos hematooncológicos por parte deagencias internacionales.Método: Para la obtención de los datos del análisis se ha realizado una búsqueda exhaustiva en las páginas web de las agencias nacionales europeasentre enero de 2015 y octubre de 2019 que mostraran información públicadel proceso evaluativo. Se revisaron las evaluaciones de estas agencias paraobtener un listado de fármacos oncohematológicos para los que constara lapresentación de documentación de una comparación indirecta ajustada con emparejamiento. Para este listado de fármacos se analizó para cada agenciaseleccionada el papel que dicha comparación tuvo en la evaluación.Resultados: Se han encontrado 13 tratamientos para patologías hematooncológicas en las que el laboratorio había presentado comparaciones conmetodología de comparación indirecta ajustada con emparejamiento en sudocumentación, principalmente a partir del primer semestre de 2018. (AU)

Objective: Matching-Adjusted Indirect Comparison is a methodologythat has been developed to assess new treatments vs alternatives whena direct comparison is not available through a randomized controlledtrial. These comparisons are of particular interest in the areas of oncology and hematology where uncertainty in decision-making on the inclusion of new drugs is frequently accentuated by both the severity of thedisease and the high cost of treatment. The objective of this study wasto describe how Matching-Adjusted Indirect Comparison methodologyhas been used to date in the assessment of hematological cancer drugsby international agencies.Method: Between January 2015 and October 2019, an exhaustivesearch was conducted of the websites of European National Agencies that provided public information on the assessment process. Theassessments provided by these agencies were reviewed to obtain a listof hematological cancer drugs for which the presentation of a MatchedAdjusted Indirect Comparison was recorded. For this list of drugs, the role of the comparison in the assessment process was analyzed for eachselected agency.Results: Thirteen hematological and oncological treatments were foundin which the pharmaceutical marketing authorization holder had presentedMatching-Adjusted Indirect Comparisons: most of this information referredto the first half of 2018. Acceptance of this methodology diverges amongagencies, ranging from 50% in the case of the British National Institutefor Health and Clinical Excellence, to 40% in the case of French NationalAuthority for Health, to not having been taken into account in any of the3 cases assessed by the German Institute for Quality and Efficiency inHealth Care. The main cause of non-acceptance was matching-relatedproblems.Conclusions: Matching- Adjusted Indirect Comparison methodology isa tool that is being utilized in the decision-making process for assessingnew hematological cancer treatments. (AU)

Fortalezas y debilidades del proceso de evaluación de tecnología sanitaria en distintos países de Europa y Latinoamérica / Strengths and weaknesses of the Health Technology Assessment process in different European and Latin American countries

La Evaluación de Tecnologías Sanitarias (ETESA) es una herramienta técnica que intenta reducir la incertidumbre a la hora de tomar decisiones de cobertura en salud. Métodos: el presente trabajo es una revisión narrativa sobre el proceso de ETESA en un grupo de países de Europa y Latinoamérica a fin de realizar un análisis comparativo de una serie de variables que resultan relevantes para brindar solidez al proceso. Resultados: se encontraron similitudes y diferencias entre los países, tanto en el número de entidades participantes como en el foco de la decisión y hasta la dependencia del poder político. Discusión: los hallazgos han permitido identificar una serie de lecciones aprendidas que merecerían ser consideradas a la hora de avanzar en la creación de una Agencia Nacional de ETESA en Argentina

[Therapeutic positioning reports: Experience in Spain during the period 2013-2019]. / Informes de posicionamiento terapéutico: experiencia en España en el periodo 2013-2019.

OBJECTIVE: Describe the characteristics of the therapeutic positioning reports (TPRs) published in Spain in the period 2013-2019. DESIGN AND DATA SOURCE: Systematic review of all TPRs published in the website of the Spanish Agency of Medicines and Health Products (AEMPS). SELECTION OF STUDIES: All TPRs published since May 2013, until March 2019 DATA EXTRACTION: The main variables collected were the therapeutic groups assessed, the number of TPRs, the time of elaboration, the existence of restrictions versus the authorized indications and the information on the efficiency of medicines. RESULTS: During the period under review, 214 TPRs were carried out, with an average production time of 8.8 months, almost three times the objective of 3-month initially set. 57% of the TPRs established restrictions of use with respect to the approved indications. 26% of TPRs referred to the existence of economic data, although none included details on the efficiency. 10% of TPRs were updated. CONCLUSIONS: For TPRs to meet their objective of improving the efficiency of the assessment process and the consistency in the decisions on price, reimbursement and financing of medicines by the SNS, the deadlines established for publication must be met, incorporating systematically information on the efficiency of the drugs and including periodic updates with the new information generated.

[Eleven years of economic evaluations of medical devices by the Spanish Network of Assessment Agencies. Methodological quality and cost-utility impact]. / Once años de evaluaciones económicas de productos sanitarios en la Red de Agencias de Evaluación. Calidad metodológica e impacto del coste-utilidad.

OBJECTIVE: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS). METHOD: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years. RESULTS: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required. CONCLUSIONS: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio.

Judicialización de medicamentos de alto costo en Argentina / Judicialization of high-cost drugs in Argentina

INTRODUCCIÓN Los medicamentos de alto costo son causa frecuente de recursos de amparo. El objetivo del estudio fue identificar los medicamentos de alto costo judicializados, las patologías involucradas, el impacto económico y los factores contextuales. METODOS Se realizó un estudio descriptivo cuali-cuantitativo. Se incluyó un análisis retrospectivo de amparos por medicamentos de alto costo. Se analizaron notas periodísticas y la relación entre amparos con aprobación regulatoria e inclusión a paquetes de beneficios. RESULTADOS Se analizaron 405 amparos sobre medicamentos de alto costo entre el 01/01/2017 y 31/12/2020. El 53% de los demandantes eran mujeres, el 35% menores y más del 80% con cobertura de salud. El 42% se inició en Buenos Aires. Los medicamentos más judicializados fueron nusinersen (21,73%), palbociclib (5,93%) y agalsidasa alfa (4,69%). El 21,91% fueron en pacientes con atrofia muscular espinal y el 12,09% en cáncer de mama. El 69,35% estaban aprobados por ANMAT y el 45,74% incluido en SUR al momento del amparo El 16,80% de los casos judicializados habían sido evaluados por CONETEC. El objeto del amparo fue el rechazo a la provisión en el 80% y el fallo a favor del demandante en el 90%, con tiempo hasta el acceso de 150 días. El costo por paciente del tratamiento con nusinersen fue de ARS 28.200.000; con palbociclib de ARS 6.028.089 y con agalsidasa alfa hasta ARS 35.582.112. Se observó una relación temporal entre la aparición del nusinersen en prensa nacional y la cantidad de amparos; más de la mitad fueron previos a la aprobación de la comercialización en el país. DISCUSIÓN La judicialización se concentró en medicamentos de altísimo costo para enfermedades poco frecuentes y en medicamentos oncológicos. Casi la totalidad de los fallos son a favor del demandante, siendo los tiempos de acceso al medicamento prolongados. Los medios de comunicación y los informes de evaluación de tecnologías sanitarias podrían afectar estos procesos.

La formación de posgrado para la gestión del proceso de evaluación de tecnologías sanitarias desde una perspectiva teórica / Postgraduate training for the management of the health technologies evaluation from a theoretical perspective

Los profesionales de la salud desempeñan un papel clave en la utilización racional y la regulación de los recursos sanitarios disponibles. En este artículo se presentan los fundamentos teóricos y las tendencias históricas que caracterizan la formación de posgrado de los gestores de ciencia, tecnología e innovación en salud para la gestión de la evaluación de tecnologías sanitarias. Asimismo, se define el concepto de formación de posgrado para la gestión de la evaluación de tecnologías sanitarias y se determinan las tres etapas que han caracterizado la evolución de este proceso, asociadas con las demandas que provienen del contexto histórico del desarrollo de esta actividad en las instituciones de salud. Se constató que no existe una propuesta teórico-metodológica que permita la apropiación, actualización y profundización en los conocimientos y las habilidades para la gestión de la evaluación de tecnologías sanitarias.

Health professionals play a key role in the rational use and regulation of the available health resources. The theoretical bases and the historical tendencies that characterize the postgraduate training of the science, technology and innovation in health agents for the management of the health technologies evaluation are presented in this work. The training postgraduate concept for the management of the health technologies evaluation is defined. The three stages which have characterized the course of this process, associated with the demands coming from the historical context of the development of this activity in the health institutions are determined. It was verified that a methodological theoretical proposal that allows the appropriation, updating and deepening in the knowledge and skills for the management of the health technologies evaluation doesn't exist.

[Ethics in health technology assessment. Review]. / Ética y evaluación de tecnologías sanitarias. Revisión.

INTRODUCTION: Bioethics and the health technologies assessment emerged to help make decisions. The objective of the work was to know, with respect to the health technologies assessment, the scientific production on its ethical issues, the degree of incorporation of these in practice, the inclusion of the values in the deliberative processes and the most relevant approaches to ethical analysis. METHODOLOGY: A narrative review was made, based on a systematic search of literature in both natural and hierarchical language, using the terms technology assessment biomedical, ethics and deliberation (and its related terms). All types of papers published between May 2007 and April 2017 in Spanish, French, English or Italian that included both ethical aspects and health technology assessment were included. The PUBMED, OVID-Medline, Scopus databases and secondary searches were explored from the identified works. The information was extracted by a single researcher and managed with Mendeley and EPIINFO 7.2. RESULTS: A total of 141 papers were identified, including 85 after revision by title and summary, with the following characteristics: 29 reviews (5 systematic), 16 frameworks, 18 methodological works and 29 with description of experiences. Multiple frameworks, approaches and methods in ethical analysis were identified. CONCLUSION: The health technologies assessment has an approach excessively mechanistic, and can be improved by incorporating the values of the stakeholder, through deliberative processes. The methods of ethical analysis that seem most suitable are the axiological ones and those developed specifically for the health technologies assessment.

Evaluación de Tecnologías Sanitarias (ETESA) una visión global del concepto y de sus alcances / Health Technology Assessment (HTA). An overview of the concept and its scope

La progresivas preocupación de los países para optimizar el acceso, la eficiencia y la calidad de la salud, han impulsado la utilización más apropiada de las intervenciones en salud. Por ende, el interés tanto de profesionales sanitarios como de tomadores de decisiones en salud, ha sido orientado hacia la medicina basada en la evidencia, la eficacia comparativa y la Evaluación de Tecnologías Sanitarias (ETESA). Aunque los conceptos anteriormente señalados son convergentes en sus características, no son sinónimos. Sin embargo, todos estos, se basan en la orientación sistemática de pruebas y el enfoque en resultados relevantes para el paciente entre otras. Como consecuencia de todo esto, el interés no sólo implica los conceptos de eficacia, efectividad y eficiencia; sino que también en práctica clínica, costes y transparencia. En este artículo se resumen los conceptos de economía de la salud, evaluación económica, tecnología sanitaria (TS) y ETESA. Luego, se comenta el ciclo de vida de una TS, razones para implementar un programa de ETESA; para finalizar con algunos ejemplos de TS emergentes, comentarios respecto de la evidencia científica en la ETESA; y algunos ejemplos de estudios de ETESA en la práctica clínica cotidiana.

The progressive concern of countries to optimize access, efficiency and quality of health have led to the most appropriate use of health interventions. Therefore, the interest of both health professionals and health decision makers has been oriented towards evidence-based policy, comparative efficacy and Health Technologies Assessment (HTA). Although the aforementioned concepts are converging in their characteristics, they are not synonymous. However, all these are based on systematic testing orientation and focus on relevant patient outcomes among others. As a consequence of all this, interest does not only imply the concepts of effectiveness, effectiveness and efficiency, but also in clinical practice, costs and transparency.This manuscript summarizes concepts of health economics, economic evaluation, health technology and HTA. Then, the life cycle of a health technology and the reasons for implementing an HTA program are discussed. Concluding with some examples of emerging health technologies, comments on the scientific evidence in HTA, and some examples of HTA studies in daily clinical practice.

[Priority setting of health interventions. Review of criteria, approaches and role of assessment agencies]. / Priorización de intervenciones sanitarias. Revisión de criterios, enfoques y rol de las agencias de evaluación.

OBJECTIVE: This study was carried out to develop an explicit health priority setting methodology to support decision-making regarding the technologies to be assessed for inclusion in the National Health Service service portfolio. The primary objective is to identify and analyse the criteria, approaches and conceptual frameworks used for national/international priority setting. METHOD: An exhaustive review of the literature was carried out. For this purpose, a search of the main biomedical databases was performed and assessment agency websites were reviewed, among other sources. RESULTS: In general terms, it was found that there are no standardised criteria for priority setting, although some consensus and common trends have been identified regarding key elements (criteria, models and strategies, key actors, etc.). Globally, 8 key domains were identified: 1) need for intervention; 2) health outcomes; 3) type of benefit of the intervention; 4) economic consequences; 5) existing knowledge on the intervention/quality of and uncertainties regarding the evidence; 6) implementation and complexity of the intervention/feasibility; 7) priority, justice and ethics; and 8) overall context. CONCLUSIONS: The review provides a thorough analysis of the relevant issues and offers key recommendations regarding considerations for developing a national prioritisation framework. Findings are envisioned to be useful for different public organisations that are aiming to establish healthcare priorities.

[Perceived satisfaction and usefulness of suicide prevention information for patients and relatives]. / Satisfacción y utilidad percibidas por pacientes y familiares acerca de la información sobre prevención de suicidio.

OBJECTIVE: To assess the satisfaction of persons with suicidal behaviour and their relatives using patient information material included in the Clinical Practice Guidelines on Prevention and Treatment of Suicidal Behaviour. METHOD: The sample was made up of 57 patients with suicidal ideation or behaviour, and 52 relatives. The participants were recruited through a suicide prevention programme (Programa de intervención intensiva en conducta suicida [PII] - Suicidal Behaviour Intensive Intervention Programme) and a family association (Federación de Asociaciones de Familiares y Personas con enfermedad mental de Galicia [FEAFES] - Galician Federation of Associations of Relatives and Persons with mental diseases). An ad-hoc questionnaire was designed to ascertain the degree of perceived satisfaction and usefulness of using the information included in the guidelines. RESULTS: The descriptive data of the sample is presented, along with an exploratory factorial analysis of the questionnaire that yielded two dimensions, i.e., format and usefulness. Patients scored significantly lower than the relatives in two dimensions; nevertheless, no significant differences were found between the two groups in the level of general satisfaction. The socio-demographic variables did not influence the results. Similarly, no differences were observed between patients with and without history of suicidal behaviour. Participants stressed that Primary Care was the setting best suited for dissemination of this type of information. CONCLUSIONS: In general, both patients and relatives displayed a high level of satisfaction with the patient information material assessed. Furnishing information of this type to patients with suicidal ideation and/or behaviour could act as a preventive-educational tool.

Análisis del Proceso de Actualización de Medicamentos en el Cuadro Básico y Catálogo de Insumos del Sector Salud.

OBJECTIVES: The high costs generated by the current epidemiological profile and the introduction of new technologies, impact on public health systems, this situation is complicated when the health budget is low and causes the drug to be paid by the patient's pocket. In this situation it is necessary to design strategies that strengthen the approval of drugs that will be used in public health institutions in Mexico. To describe the results of the drug approval process for use in public health institutions to ensure the efficacy, safety, and efficiency of health technologies used in public health institutions in Mexico. METHODS: We conducted a cross-sectional drug approval process, from September 2011 to December 2012, with a descriptive analysis for each stage in the process considered. RESULTS: Of the 394 applications received for approval of health technology, 244 (62%) were for drugs; of these, 151 (62%) met the requirements for evaluation (32% and 68% were modifications inclusions), finally was approved of 42% (61% of the changes and 33% of inclusions). The 73% of the applications were for consensus approval, 12% were conditioned at low price and 6% were approved by majority vote. The main reasons for refusal were lack of clinical evidence (31%) and methodological problems in the economic evaluation (27%). CONCLUSIONS: The strengthening of the process was conducted with methodological rigor based on critical analysis of scientific evidence, with transparency and legitimacy under a legal framework to promote resource optimization. The highest percentage of requests was for drugs which are the most commonly used therapeutic technology; for this reason it requires a proper selection process to ensure greater health benefit that ensures efficient use of economic resources. The economic evaluation was a support tool to consider in addition to price, the value of health determined by the quality of evidence, establishing a GDP per capita as a threshold to define a drug as an efficient alternative.

Evaluación de tecnologías sanitarias: la experiencia en el Ministerio de Salud de Brasil / Health technology assessment: experience in the Ministry of Health of Brazil

El presente artículo tiene como objetivo describir las principales actividades llevadas a cabo por el Ministerio de Salud de Brasil (MINSAB) para el desarrollo del área de Evaluación de Tecnologías Sanitarias (ETS). Se trata de una descripción basada en los esfuerzos y estrategias del MINSAB para fortalecer esta área en los últimos años. Son cinco los ejes de acción acogidos para dicho propósito: (i) la adopción de una Política Nacional para la Gestión de Tecnologías en Salud; (ii) el apoyo al proceso de toma de decisiones en el Sistema Único de Salud; (iii) la promoción de la realización de estudios en ETS; (iv) la formación de recursos humanos estratégicos y (v) la articulación institucional nacional e internacional. No obstante, persisten los desafíos para lograr una estructuración más efectiva de la ETS en Brasil, como la creación de una institución gubernamental con mayor agilidad administrativa, entre otras.

This article aims to describe the main activities carried out by the Ministry of Health of Brazil (MHB) for the development of Health Technology Assessments (HTA). It is a description based on the MHB efforts and strategies to strengthen this area in the last years. Five are the lines of action put in place for that purpose: (i) adoption of a National Policy for the Management of Health Technology, (ii) supporting the decision making process in the Unified Health System, (iii ) promotion of the performance of studies on HTA, (iv) training of strategic human resources, and (v) institutional coordination at national and international levels. However, challenges remain to achieve a more effective structure for HTA in Brazil, like the creation of a government institution with greater administrative flexibility, among others.

Evaluación de Tecnologías Sanitarias (ETES): significados para el mejoramiento de la gestión de los directivos / Health Technology Assessment (ETES): meanings for the improvement of management of managers

INTRODUCCIÓN: El presente estudio está dirigido a brindar información sobre la importancia de incorporar a la práctica diaria las Evaluaciones de Tecnologías Sanitarias. Contribuir a enriquecer el pensamiento epidemiológico de los directivos del sistema de salud, disminuir subestimaciones para su uso postergado, crear una cultura de la evaluación. El contexto socioeconómico cubano actual, exige de la aplicación de las ETES en los servicios a las diferentes instancias del sistema. Medir el impacto de intervenciones en salud, su eficacia, efectividad, eficiencia, produce resultados que pueden contribuir a rediseñar propósitos y objetivos de programas, servicios y diferentes sistemas organizativos sanitarios, racionalizar inversiones futuras de equipos y tecnologías específicas para optimizar recursos humanos y materiales; especialmente si tenemos en cuenta las dificultades de recursos que enfrenta el país. Todo ello incrementaría la satisfacción de usuarios y prestadores con los servicios y favorecería positivamente el fortalecimiento de un proceso de toma de decisiones en salud sobre bases científicas. DEFINICIONES NECESARIAS: La Epidemiología, una de las ciencias básicas de la Salud