Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 1.619
Filtrar
1.
Orv Hetil ; 162(14): 542-554, 2021 03 30.
Artículo en Húngaro | MEDLINE | ID: mdl-33784247

RESUMEN

Összefoglaló. Bevezetés: Az idoalku (time trade-off) egy nemzetközileg széles körben alkalmazott életminoség- és egészséghasznosság-mérési módszer. Az idoalkuval mért hasznosságértékek az egészségügyi technológiák költséghatékonysági vizsgálatakor az életminoséggel korrigált életév (quality-adjusted life year, QALY) mutatószám számítására használhatók. Kevés ismerettel rendelkezünk arról, hogy Magyarországon milyen betegségekben állnak rendelkezésre idoalkuval mért hasznosságértékek. Célkituzés: Célunk szisztematikus irodalmi áttekintés keretében összefoglalni és katalogizálni az idoalku módszerrel mért hasznosságértékeket közlo publikációkat Magyarországon. Módszer: 2020 januárjában szisztematikus folyóirat-keresést végeztünk a PubMed, Web of Science és Matarka elektronikus adatbázisokban. Beválogatási kritériumaink a következok voltak: (1) eredeti közlemények, melyek (2) idoalku módszerrel mértek hasznosságértéket, és (3) magyarországi mintán mért adatokat közöltek. Eredmények: 9 eredeti közleményt válogattunk be, amelyek összesen 7 krónikus betegségben (Crohn-betegség, idoskori maculadegeneratio, krónikus migrén, pemphigus, psoriasis, primer dysmenorrhoea és rheumatoid arthritis) 23 egészségi állapot hasznosságát határozták meg. A kutatások mintanagysága 108 és 1996 fo között alakult. Két kutatás betegcsoportokat vizsgált, ketto az általános populációt, és három vizsgálatban szerepelt mindketto. Hat kutatás használta a hagyományos idoalku valamelyik formáját, egy pedig az összetett idoalku módszert. Egy kutatásban szerepelt 'rosszabb a halálnál' válaszlehetoség. A leggyakrabban alkalmazott idotáv a standard 10 év volt (71%). Az egyes állapotok hasznosságának átlaga 0,34 (kezeletlen pemphigus vulgaris) és 0,94 (enyhe primer dysmenorrhoea) között változott. A 'non-traderek' aránya az egyes kutatásokban 0 és 29% között változott. Következtetések: Egyre több krónikus betegségben elérhetok a magyar társadalom vagy betegek preferenciáin alapuló egészséghasznosság-értékek. A hazai idoalku-vizsgálatok többsége megfelel a nemzetközi minoségi követelményeknek. Az idoalku módszer alkalmazása javasolt más krónikus állapotokban is, a felmért hasznosságértékek segíthetik az egészségügyi technológiákkal kapcsolatos finanszírozói döntéshozatalt. Orv Hetil. 2021; 162(14): 542-554. INTRODUCTION: Time trade-off (TTO) is a widely used method to assess health-related quality of life and health utilities for economic evaluations of health technologies. Little is known about the use of TTO in the Hungarian context. OBJECTIVE: To systematically summarize the existing literature on the method in Hungary. METHOD: In January 2020, we conducted a systematic literature search in three electronic databases (MEDLINE, Web of Science and the Hungarian Periodicals Table of Contents Database). Our inclusion criteria were: (1) original publications, which (2) measured utilities by using TTO, (3) from a Hungarian sample. RESULTS: Nine publications containing seven original studies were included that reported utilities for 23 different health states in seven chronic diseases (age-related macular degeneration, chronic migraine, Crohn's disease, pemphigus, primary dysmenorrhoea, psoriasis and rheumatoid arthritis). Sample sizes ranged from 108 to 1996 respondents. Two studies used general population samples, another two used patient groups and three studies used both. Six studies used a form of conventional TTO and one used composite TTO method. The most frequent timeframe was 10 years (71%). The lowest mean utility was 0.34 (uncontrolled pemphigus vulgaris), while the highest was 0.94 (mild primary dysmenorrhoea). The overall proportion of non-traders ranged between 0 and 29% across studies. CONCLUSIONS: A growing number of studies are using TTO to assess utilities for chronic conditions from the general population or patients in Hungary. The majority of Hungarian TTO studies have met international quality standards. The assessment of TTO utilities is recommended also in other chronic conditions to assist health technology assessment. Orv Hetil. 2021; 162(14): 542-554.


Asunto(s)
Enfermedad Crónica , Utilización de Instalaciones y Servicios , Calidad de Vida , Evaluación de la Tecnología Biomédica , Enfermedad Crónica/terapia , Utilización de Instalaciones y Servicios/estadística & datos numéricos , Humanos , Hungría , Evaluación de la Tecnología Biomédica/métodos , Factores de Tiempo
2.
Value Health ; 24(3): 346-352, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33641768

RESUMEN

OBJECTIVES: Determining the price and reimbursement of a new medicine is a national competence within the Member States of the European Union that is carried out by health technology authorities and is based mainly on the added therapeutic value (ATV). The primary objective of this study was to compare the ATVs granted by the French (Haute Autorité de Santé, HAS) and the German (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWIG) authorities. The secondary objective was to analyze the reasons for the discrepancies observed. METHODS: Retrospective cohort of all ATVs assigned by HAS and IQWIG for the period 2011 to 2017. ATV assessments were classified as major, considerable, minor, no benefit, or not quantifiable. The concordance between the authorities was evaluated, and a qualitative analysis of highly discordant assessments was performed. RESULTS: One hundred and ninety-one drugs were evaluated by both agencies. The overall percentage of agreement was 50.3%. It was 73.1% for no benefit of ATVs, 37.5% for minor ATVs, 31.2% for considerable ATVs, and 5% for major ATVs. Highly conflicting assessments (n = 35) mainly concerned antineoplastic drugs (n = 14) and anti-infectives (n = 14). The main reasons for inconsistency concerned the following: a different appreciation of the subgroup analysis of efficacy data (n = 15), the appropriateness of comparators (n = 15), the surrogate endpoints (n = 10), methodological differences (n = 8), and the benefit/risk criteria that were used (n = 6). CONCLUSION: In the context of the common assessment of ATVs promoted by the European Commission, the harmonization between member states regarding the way evaluation criteria are assessed deserves to be addressed.


Asunto(s)
Análisis Costo-Beneficio/métodos , Medicamentos bajo Prescripción/economía , Evaluación de la Tecnología Biomédica/métodos , Determinación de Punto Final , Francia , Alemania , Humanos
3.
Value Health ; 24(2): 244-249, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33518031

RESUMEN

OBJECTIVES: Cost-effectiveness analysis (CEA) embeds an assumption at odds with most economic analysis-that of constant returns to health in the creation of happiness (utility). We aim to reconcile it with the bulk of economic theory. METHODS: We generalize the traditional CEA approach, allow diminishing returns to health, and align CEA with the rest of the health economics literature. RESULTS: This simple change has far-reaching implications for the practice of CEA. First, optimal cost-effectiveness thresholds should systematically rise for more severe diseases and fall for milder ones. We provide formulae for estimating how these thresholds vary with health-related quality of life (QoL) in the sick state. Practitioners can also use our approach to account for treatment outcome uncertainty. Holding average benefits fixed, risk-averse consumers value interventions more when they reduce outcome uncertainty ('insurance value') and/or when they provide a chance at positively skewed outcomes ('value of hope'). Finally, we provide a coherent way to combine improvements in QoL and life expectancy (LE) when people have diminishing returns to QoL. CONCLUSION: This new approach obviates the need for increasingly prevalent and ad hoc exceptions to CEA for end-of-life care, rare disease, and very severe disease (eg, cancer). Our methods also show that the value of improving QoL for disabled people is greater than for comparable non-disabled people, thus resolving an ongoing and mathematically legitimate objection to CEA raised by advocates for disabled people. Our Generalized Risk-Adjusted Cost-Effectiveness (GRACE) approach helps align HTA practice with realistic preferences for health and risk.


Asunto(s)
Análisis Costo-Beneficio/métodos , Personas con Discapacidad , Calidad de Vida , Evaluación de la Tecnología Biomédica/métodos , Felicidad , Humanos , Índice de Severidad de la Enfermedad , Incertidumbre
5.
Endocrinol. diabetes nutr. (Ed. impr.) ; 67(9): 602-610, nov. 2020. ilus, tab
Artículo en Español | IBECS | ID: ibc-197342

RESUMEN

La medición de la densidad mineral ósea mediante la absorciometría radiológica de doble energía es la técnica de elección para la valoración ósea y un predictor importante del riesgo de fractura. Sin embargo, la mayoría de las fracturas por fragilidad ocurren en personas sin osteoporosis densitométrica, especialmente en enfermedades endocrinológicas. Las herramientas para la estimación del riesgo de fracturas como FRAX han mejorado la sensibilidad diagnóstica aunque no consideran otras características óseas adicionales. La investigación de la microarquitectura ósea supone una mejoría en el abordaje de estos pacientes. En este documento elaborado por miembros del grupo de trabajo de Metabolismo Mineral y Óseo de la Sociedad Española de Endocrinología y Nutrición se revisan los nuevos avances en absorciometría radiológica de doble energía y otras técnicas más complejas para el estudio de la microarquitectura ósea así como los datos disponibles en diabetes tipo 2 y patología paratiroidea


Bone mineral density using dual-energy X-ray absorptiometry is the gold standard for the assessment of bone and an important predictor of fracture risk. However, most fragility fractures occur in people without densitometric osteoporosis, especially in endocrinological diseases. Fracture risk estimation tools such as FRAX have improved diagnostic sensitivity but do not include additional skeletal features. Bone microarchitecture research represents an improvement in the treatment of these patients. In this document members of the Mineral and Bone Metabolism Working Group of the Spanish Society of Endocrinology and Nutrition review new advances in dual-energy X-ray absorptiometry and other complex techniques for the study of bone microarchitecture as well as the available data on type 2 diabetes and parathyroid pathology


Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Osteogénesis Imperfecta/diagnóstico , Evaluación de la Tecnología Biomédica/métodos , Indicadores de Salud , Densidad Ósea , Absorciometría de Fotón , Diabetes Mellitus Tipo 2/diagnóstico , Hiperparatiroidismo Primario/diagnóstico , Sociedades Médicas/normas , Fracturas de la Columna Vertebral/diagnóstico , Fracturas de la Columna Vertebral/prevención & control , Factores de Riesgo
6.
Value Health ; 23(7): 831-841, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32762984

RESUMEN

OBJECTIVE: This study examines European decision makers' consideration and use of quantitative preference data. METHODS: The study reviewed quantitative preference data usage in 31 European countries to support marketing authorization, reimbursement, or pricing decisions. Use was defined as: agency guidance on preference data use, sponsor submission of preference data, or decision-maker collection of preference data. The data could be collected from any stakeholder using any method that generated quantitative estimates of preferences. Data were collected through: (1) documentary evidence identified through a literature and regulatory websites review, and via key opinion leader outreach; and (2) a survey of staff working for agencies that support or make healthcare technology decisions. RESULTS: Preference data utilization was identified in 22 countries and at a European level. The most prevalent use (19 countries) was citizen preferences, collected using time-trade off or standard gamble methods to inform health state utility estimation. Preference data was also used to: (1) value other impact on patients, (2) incorporate non-health factors into reimbursement decisions, and (3) estimate opportunity cost. Pilot projects were identified (6 countries and at a European level), with a focus on multi-criteria decision analysis methods and choice-based methods to elicit patient preferences. CONCLUSION: While quantitative preference data support reimbursement and pricing decisions in most European countries, there was no utilization evidence in European-level marketing authorization decisions. While there are commonalities, a diversity of usage was identified between jurisdictions. Pilots suggest the potential for greater use of preference data, and for alignment between decision makers.


Asunto(s)
Investigación sobre Servicios de Salud/organización & administración , Prioridad del Paciente , Mecanismo de Reembolso , Proyectos de Investigación , Evaluación de la Tecnología Biomédica/métodos , Tecnología Biomédica/economía , Conducta de Elección , Costos y Análisis de Costo , Toma de Decisiones , Técnicas de Apoyo para la Decisión , Europa (Continente) , Humanos , Proyectos Piloto , Encuestas y Cuestionarios
7.
Value Health ; 23(7): 907-917, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32762993

RESUMEN

OBJECTIVE: This review summarizes and critically examines methods used to generate utilities for child and adolescent health states in previous National Institute for Health and Care Excellence (NICE) technology assessments (TA) and highly specialized technology (HST) evaluations. METHODS: We identified all NICE TA and HST evaluations in which the licensed indication for the technology included people younger than 18 and included in the review all evaluations using a cost-utility analysis. RESULTS: The review includes 40 TA and HST evaluations. Most assessments generated utility values with the EQ-5D scored using the adult version of the EQ-5D either exclusively (n = 16) or alongside other utility measures and direct elicitation methods of patient own utility (n = 17), although 7 did not use the EQ-5D. Eight assessments used both the EQ-5D child- and adolescent-specific preference-based measures: Health Utilities Index Mark 2 (n = 6), child- and adolescent-specific preference-based measure for atopic dermatitis (n = 1), and youth version of the EQ-5D (EQ-5D-Y) valued using the adult EQ-5D value set (n = 1) or generated using mapping and valued using the adult EQ-5D value set (n = 2). Some cost-utility analyses used age adjustment (utility subtractions, weights, and published mapping formulae) from the adult EQ-5D UK population norms to reflect the general population or disease-free health for children and adolescents (n = 9), and 1 assessment assumed full health (utility value of 1). CONCLUSION: The review found limited use of child and adolescent population-specific measures to generate health state utility values for children and adolescents in NICE technology assessments. Often assessments involve the use of an adult-specific measure to reflect the health of children.


Asunto(s)
Estado de Salud , Calidad de Vida , Evaluación de la Tecnología Biomédica/métodos , Adolescente , Niño , Análisis Costo-Beneficio , Humanos , Encuestas y Cuestionarios
8.
Value Health ; 23(6): 689-696, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-32540225

RESUMEN

OBJECTIVES: Value and health technology assessment (V/HTA) is often used in clinical, access, and reimbursement decisions. V/HTA data-source selection may not be transparent, which is a necessary element for stakeholder understanding and trust and for fostering accountability among decision makers. Peer review is considered one mechanism for judging data trustworthiness. Our objective was (1) to use publicly available documentation of V/HTA methods to identify requirements for inclusion of peer-reviewed evidence sources, (2) to compare and contrast US and non-US approaches, and (3) to assess evidence sources used in published V/HTA reports. METHODS: Publicly available methods documentation from 11 V/HTA organizations in North America and Europe were manually searched and abstracted for descriptions of requirements and recommendations regarding search strategy and evidence-source selection. The bibliographies of a subset of V/HTA reports published in 2018 were manually abstracted for evidence-source types used in each. RESULTS: Heterogeneity in evidence-source retrieval and selection was observed across all V/HTA organizations, with more pronounced differences between US and non-US organizations. Not all documentation of organizations' methods address the evidence-source selection processes (7 of 11), and few explicitly reference peer-reviewed sources (3 of 11). Documentation of the evidence-source selection strategy was inconsistent across reports (6 of 13), and the level of detail provided varied across organizations. Some information on evidence-source selection was often included in confidential documentation and was not publicly available. CONCLUSIONS: Disparities exist among V/HTA organizations in requirements and guidance regarding evidence-source selection. Standardization of evidence-source selection strategies and documentation could help improve V/HTA transparency and has implications for decision making based on report findings.


Asunto(s)
Documentación/normas , Revisión por Pares , Evaluación de la Tecnología Biomédica/métodos , Europa (Continente) , Humanos , América del Norte
11.
s.l; s.n; maio 2020.
No convencional en Portugués | LILACS, Coleciona SUS, BRISA/RedTESA | ID: biblio-1096806

RESUMEN

INTRODUÇÃO: O Coronavírus da Síndrome Respiratória Aguda Grave 2 (abreviado para SARSCoV-2, do inglês Severe Acute Respiratory Syndrome Coronavirus 2), anteriormente conhecido como novo coronavírus (2019-nCoV), é um agente zoonótico recémemergente que surgiu em dezembro de 2019, em Wuhan, China. O referido vírus causa manifestações respiratórias, digestivas e sistêmicas, que se articulam na doença denominada COVID-19 (do inglês Coronavirus Disease 2019) (1). Ainda não há informações robustas sobre a história natural da doença, tampouco sobre as medidas de efetividade para manejo clínico dos casos de infecção pelo COVID19, restando ainda muitos detalhes a serem esclarecidos. No entanto, sabe-se que o vírus tem alta transmissibilidade e provoca uma síndrome respiratória aguda que varia de casos leves ­ cerca de 80% ­ a casos muito graves com insuficiência respiratória ­ entre 5% e 10% dos casos ­, requerendo tratamento especializado em unidades de terapia intensiva (UTI) (2). Sua letalidade varia, principalmente, conforme a faixa etária. TECNOLOGIA: O remdesivir (RDV) é um medicamento de atividade antiviral de amplo espectro contra vírus de ácido ribonucleico (ribonucleic acid, RNA), desenvolvido em 2017 como uma opção de tratamento compassivo para a infecção pelo vírus Ebola, e posteriormente testado para síndrome respiratória do Oriente Médio (cujo agente causador é denominado MERS-CoV, do inglês Middle East Respiratory Syndrome Coronavirus) e SARS-CoV (4). Seu mecanismo de ação parece interferir na síntese da RNA polimerase viral, causando atraso na terminação da cadeia e diminuição da produção de RNA viral. Cumpre ressaltar que, atualmente, o medicamento RDV ainda está em ensaios clínicos randomizados e foi aprovado para uso compassivo na Agência Europeia de Medicamentos (EMA, do inglês European Medicines Agency) e não possui registro na Agência Nacional de Vigilância Sanitária (ANVISA). Entretanto, tem sido descrito como a terapia mais promissora por ter uma potente atividade in vitro contra o SARSCoV-2. Nesse sentido, a Agência Norte-americana de Medicamentos e Alimentos (FDA, do inglês Food and Drug Administration) recomendou, por meio de uma carta, o uso emergencial do RDV, devido à publicação do Ensaio Clínico Randomizado (ECR) de Wang e col. (2020). OBJETIVO: O objetivo desta nota técnica é analisar as evidências científicas sobre a eficácia, efetividade e segurança do medicamento RDV para o tratamento de pacientes com COVID-19. METODOLOGIA: Foram realizadas buscas nas bases de dados Medline (via PubMed) e Embase, no banco de dados de publicações sobre COVID-19 da Organização Mundial de Saúde (OMS) e no MedRxiv (base pre-print de artigos na área de saúde) (11), com acesso em 20 de abril de 2020 e renovação das buscas em 05 de maio de 2020. A seleção dos estudos foi realizada em duas etapas. Na primeira etapa, foram avaliados os títulos e resumos das publicações identificadas por meio da estratégia de busca e pré-selecionadas as publicações potencialmente elegíveis (fases 1 e 2). Na segunda etapa (fase 3), foi realizada a avaliação do texto na íntegra das publicações préselecionadas para a confirmação da elegibilidade. O processo de seleção foi realizado por meio da plataforma Rayyan. A busca nas plataformas MEDLINE (via PubMed), Embase, MedRxiv e no banco de dados sobre a Covid-19 da OMS resultou em 369 publicações (83 no PubMed, 101 no Embase, 92 no banco da OMS e 93 no MedRxiv), sendo que 71 eram duplicadas. Foram lidos os títulos e resumos das 137 publicações (fase 1 e 2), três estudos foram submetidos à leitura completa (fase 3): uma série de casos com 12 pacientes, um estudo de coorte com de uso compassivo do medicamento em pacientes com Covid-19 e uma revisão sistemática (RS) que comparou o RDV em comparação a placebo, outro medicamento ativo, RDV em outras doses ou esquemas, ou melhor tratamento de suporte. CONCLUSÕES: O primeiro ECR do RDV em comparação ao placebo foi publicado recentemente, porém, o estudo com pacientes adultos internados no hospital por COVID-19 grave não demostrou resultados estatisticamente significantes para nenhum desfecho avaliado. No entanto, a FDA autorizou o uso do RDV de forma emergencial nos EUA. Os resultados dos estudos devem ser interpretados com cautela, pois nenhum deles foi conclusivo para demonstrar a eficácia, efetividade e segurança do RDV, principalmente em razão da pequena quantidade de pacientes incluídos e da ausência de grupo comparador nos estudos observacionais. No dia 23 de março de 2020, o diretor geral da OMS, Dr. Tedros Adhanom Ghebreyesus, anunciou a realização de um grande estudo clínico para testar medicamentos com atividade antiviral contra o SARS-CoV-2 (21). Esse estudo já possui registro de protocolo (NCT04321616) e se propõe a avaliar os medicamentos remdesivir, lopinavir/ritonavir, cloroquina/hidroxicloroquina e interferon beta. Portanto, é necessário e prudente aguardar os resultados de estudos que serão divulgados em um horizonte temporal próximo para estimar o real benefício dessa tecnologia no tratamento de pacientes com a COVID-19.


Asunto(s)
Humanos , Antivirales/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Infecciones por Coronavirus/tratamiento farmacológico , Medicina Basada en la Evidencia , Betacoronavirus/efectos de los fármacos , Evaluación de la Tecnología Biomédica/métodos , Análisis Costo-Eficiencia
12.
J Med Internet Res ; 22(4): e15521, 2020 04 23.
Artículo en Inglés | MEDLINE | ID: mdl-32324143

RESUMEN

BACKGROUND: Health care is becoming more complex. For an increasing number of individuals, interacting with health care means addressing more than just one illness or disorder, engaging in more than one treatment, and interacting with more than one care provider. Individuals with severe mental illnesses such as schizophrenia are disproportionately affected by this complexity. Characteristic symptoms can make it harder to establish and maintain relationships. Treatment failure is common even where there is access to effective treatments, increasing suicide risk. Knowledge of complex adaptive systems has been increasingly recognized as useful in understanding and developing health care. A complex adaptive system is a collection of interconnected agents with the freedom to act based on their own internalized rules, affecting each other. In a complex health care system, relevant feedback is crucial in enabling continuous learning and improvement on all levels. New technology has potential, but the failure rate of technology projects in health care is high, arguably due to complexity. The Nonadoption, Abandonment, and challenges to Scale-up, Spread, and Sustainability (NASSS) framework and complexity assessment tool (NASSS-CAT) have been developed specifically to help identify and manage complexity in technology-related development projects in health care. OBJECTIVE: This study aimed to use a pilot version of the NASSS-CAT instrument to inform the development and deployment of a point-of-care dashboard supporting schizophrenia care in west Sweden. Specifically, we report on the complexity profile of the project, stakeholders' experiences with using NASSS-CAT, and practical implications. METHODS: We used complexity assessment to structure data collection and feedback sessions with stakeholders, thereby informing an emergent approach to the development and deployment of the point-of-care dashboard. We also performed a thematic analysis, drawing on observations and documents related to stakeholders' use of the NASSS-CAT to describe their views on its usefulness. RESULTS: Application of the NASSS framework revealed different types of complexity across multiple domains, including the condition, technology, value proposition, organizational tasks and pathways, and wider system. Stakeholders perceived the NASSS-CAT tool as useful in gaining perspective and new insights, covering areas that might otherwise have been neglected. Practical implications derived from feedback sessions with managers and developers are described. CONCLUSIONS: This case study shows how stakeholders can identify and plan to address complexities during the introduction of a technological solution. Our findings suggest that NASSS-CAT can bring participants a greater understanding of complexities in digitalization projects in general.


Asunto(s)
Esquizofrenia/terapia , Evaluación de la Tecnología Biomédica/métodos , Humanos , Suecia
13.
Value Health ; 23(4): 471-480, 2020 04.
Artículo en Inglés | MEDLINE | ID: mdl-32327164

RESUMEN

OBJECTIVES: Our goal was to estimate the relative importance assigned to health technology assessment (HTA) criteria by stakeholders involved in the HTA process. HTA is an increasingly common framework used in the appraisal of drugs for public reimbursement. It identifies clinical, economic, social, and organizational criteria to be considered. The criteria can vary across jurisdictions and are typically appraised by multidisciplinary expert committees. Guidance on the relative weighing of criteria is often absent. METHODS: We elicited stakeholders' preferences using a single-scenario discrete choice experiment and a best-worst scaling model with conviction scores to assess the weights assigned to selected criteria by HTA stakeholders. We recruited 111 HTA stakeholders across multiple jurisdictions, including members of expert committees, clinical and economic experts, patients, and public payer representatives. Each judged twelve hypothetical cancer drug profiles for suitability for public funding and identified which characteristics were best and worst. In addition to standard discrete choice experiment and best-worst scaling models, we estimated a hybrid model to obtain a ranking of criteria by importance they played in the appraisal. RESULTS: A strong clinical benefit proved the most important criterion, followed by cost considerations, presence of adverse events, and availability of other treatments. The importance of clinical benefit was moderated by unmet need, adverse events, and number of patients. CONCLUSION: Policymakers might want to consider providing an explicit weighing scheme, or moving to a 2-stage selection process with an assessment of the quality of clinical evidence as a gatekeeping step for a full HTA review.


Asunto(s)
Antineoplásicos/administración & dosificación , Neoplasias/tratamiento farmacológico , Mecanismo de Reembolso , Evaluación de la Tecnología Biomédica/métodos , Antineoplásicos/efectos adversos , Antineoplásicos/economía , Conducta de Elección , Humanos , Neoplasias/economía , Proyectos Piloto
14.
Ann Intern Med ; 172(1): 30-34, 2020 01 07.
Artículo en Inglés | MEDLINE | ID: mdl-31739344

RESUMEN

Infection control is a complex task that spans people, products, and practices in diverse settings. For years, the Healthcare Infection Control Practices Advisory Committee (HICPAC) has provided advice and guidance to the Centers for Disease Control and Prevention (CDC) on how best to prevent infections. These recommendations have focused largely on health care delivery practices and occasionally on general categories of products. With an influx of novel infection control products and growing use of these products by frontline clinicians, an efficient process for developing transparent, rigorous product recommendations that includes myriad data sources was necessary. To address this gap, the CDC asked HICPAC to develop a process that would help inform committees considering product-related recommendations. This article describes the process to develop this approach and provides an outline of how the tool may be used when products with infection control claims are recommended in guidelines or recommendations for infection prevention.


Asunto(s)
Infección Hospitalaria/prevención & control , Desinfección/métodos , Control de Infecciones/métodos , Comités Consultivos , Centers for Disease Control and Prevention, U.S. , Desinfección/estadística & datos numéricos , Humanos , Control de Infecciones/normas , Evaluación de la Tecnología Biomédica/métodos , Evaluación de la Tecnología Biomédica/normas , Estados Unidos
16.
J Clin Epidemiol ; 117: 138-148, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31112801

RESUMEN

OBJECTIVE: The objective of the study was to clarify how the Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept of certainty of evidence applies to certainty ratings of test accuracy. STUDY DESIGN AND SETTING: After initial brainstorming with GRADE Working Group members, we iteratively refined and clarified the approaches for defining ranges when assessing the certainty of evidence for test accuracy within a systematic review, health technology assessment, or guideline. RESULTS: Ranges can be defined both for single test accuracy and for comparative accuracy of multiple tests. For systematic reviews and health technology assessments, approaches for defining ranges include some that do not require value judgments regarding downstream health outcomes. Key challenges arise in the context of a guideline that requires ranges for sensitivity and specificity that are set considering possible effects on all critical outcomes. We illustrate possible approaches and provide an example from a systematic review of a direct comparison between two test strategies. CONCLUSIONS: This GRADE concept paper provides a framework for assessing, presenting, and making decisions based on the certainty of evidence for test accuracy. More empirical research is needed to support future GRADE guidance on how to best operationalize the candidate approaches.


Asunto(s)
Técnicas y Procedimientos Diagnósticos/normas , Evaluación de la Tecnología Biomédica/métodos , Toma de Decisiones , Humanos , Sensibilidad y Especificidad , Revisiones Sistemáticas como Asunto
17.
Int J Health Plann Manage ; 35(1): 397-408, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31290187

RESUMEN

Given resource constraints and the potential for increasingly high-cost, cost-effective medicines to become available, policymakers require strategies that go beyond cost-effectiveness when making resource allocation decisions. This manuscript presents a five-step framework that complements traditional health technology assessment (HTA) guidance documents that policymakers in Asia-Pacific and elsewhere may consider when setting up HTA guidelines and/or evaluating whether or not to subsidize a medicine or other health innovations. The framework recommends that subsidy decisions be based on five criteria: the relative burden of the condition as compared with other conditions (step 1), comparative and cost-effectiveness of the medicine (steps 2 and 3), the short-term impact on the budget (step 4), and other considerations including patient and societal preferences (step 5). Our approach, which is a complement to traditional HTA guidance documents, is not prescriptive but provides an evidence-based framework that HTA agencies in Asia-Pacific can follow as they aim to deliver value-based medicines to their constituents.


Asunto(s)
Análisis Costo-Beneficio , Evaluación de la Tecnología Biomédica/métodos , Asia Sudoriental , Presupuestos , Costo de Enfermedad , Lejano Oriente , Humanos , Evaluación de la Tecnología Biomédica/organización & administración , Resultado del Tratamiento
18.
Clin Pharmacol Ther ; 107(1): 136-139, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31376148

RESUMEN

"Regulatory science" (RS) has been defined in various ways, but, nevertheless, the definitions of RS in different parts of the world include many common elements. It seems to be a common view that RS is not basic or applied science but, rather, focuses on the estimation and prediction of safety and efficacy. Thus, we think RS overall should incorporate not only RS specifically for medical product assessment but also RS engineering to provide prediction and estimation tools for those purposes, including guideline/guidance development. It is important as well to consider the potential contribution of RS to rational medicine (i.e., to evidence-based medicine in a broader context), and especially to real-world evidence generation. We will look at how definitions of RS have evolved, and how we believe RS might develop in the future. Taking a patient-centric view, we re-emphasize RS is an ethical science contributing to society and human welfare.


Asunto(s)
Medicina Basada en la Evidencia/organización & administración , Salud Global/legislación & jurisprudencia , Evaluación de la Tecnología Biomédica/métodos , Medicina Basada en la Evidencia/legislación & jurisprudencia , Regulación Gubernamental , Humanos , Atención Dirigida al Paciente/legislación & jurisprudencia , Atención Dirigida al Paciente/organización & administración
20.
Value Health ; 22(11): 1318-1328, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31708070

RESUMEN

BACKGROUND: Integrating patient preferences in Health Technology Assessment (HTA) is argued to improve uptake, adherence, and patient satisfaction. However, how to elicit and incorporate these preferences in HTA in a systematic and scientifically valid manner is subject to debate. OBJECTIVE: This article provides a systematic review of the challenges to integrating patient preferences in HTA that have been raised in the literature about patient preferences in HTA. METHODS: A systematic review of articles published between 2013 and 2017 addressing challenges to the integration of patient preferences in HTA was conducted in 7 databases. All issues with respect to the integration of patient preferences in HTA were extracted and divided into 5 categories: conceptual, normative, procedural, methodological, and practical issues. The issues were ranked according to how often they were mentioned. RESULTS: Of 2147 retrieved articles, 67 were included in the analysis. Thirty-seven unique research issues were identified. In the majority of the articles, methodological issues were posed (82%), followed by procedural (73%), normative (51%), practical (24%), and conceptual (9%) issues. Frequently posed methodological issues concerned preference heterogeneity and choice of method. Common procedural issues concerned how to evaluate the impact of preference studies and their degree of being evidence based. CONCLUSIONS: This article provides an overview of issues with respect to the integration of patient preferences in HTA procedures. Most issues were of a methodological or procedural nature; yet, the large number of different issues points to the overall importance of further researching the different aspects concerned with patient preferences in HTA. Through its ranking of how many articles mention particular issues, this article proposes an implicit research agenda.


Asunto(s)
Prioridad del Paciente , Proyectos de Investigación , Evaluación de la Tecnología Biomédica/métodos , Humanos , Reproducibilidad de los Resultados
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA
...