Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 1.550
Filtrar
2.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 619-626, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31721598

RESUMEN

Introduction: In recent decades, medical devices (MDs) have increasingly become an integral part of patient care. However, when it comes to designing and appraising economic models, researchers typically follow pharmaceutical templates (e.g. CHEERS) to assess their economic viability. This study evaluates the generalizability of four device-specific criteria, as recommended by the recent MedtechHTA project, of learning curve, incremental innovation, dynamic pricing, and organizational impact with a broader group of MDs including diagnostics and implantables. The purpose was to determine the applicability of these criteria to a broader range of MDs.Areas Covered: We determined the extent to which these criteria could be applied to each device type and attempted to identify common themes. We performed a literature search using PubMed and Google of a range of devices to understand the clinical significance, operation, and economic viability.Expert Opinion: Our findings suggest that the four characteristics are not applicable to all device types. Prior evaluation of a device's intrinsic properties (such as longevity and device location) and its FDA risk classification could help to indicate the applicability of the criteria. Documenting this process when assessing the additional four criteria on the CHEERS checklist would improve the transparency of future economic evaluations.


Asunto(s)
Equipos y Suministros/economía , Modelos Económicos , Evaluación de la Tecnología Biomédica/métodos , Lista de Verificación , Análisis Costo-Beneficio/métodos , Humanos , Evaluación de la Tecnología Biomédica/economía
3.
BMC Health Serv Res ; 19(1): 762, 2019 Oct 28.
Artículo en Inglés | MEDLINE | ID: mdl-31660957

RESUMEN

BACKGROUND: Public engagement in health technology assessment (HTA) is increasing worldwide. There are several forms of public engagement and it is not always possible to determine which stakeholders participate in the HTA process and how they contribute. Our objective was to investigate which types of social representatives contributed to the public consultation on the incorporation of Trastuzumab for early-stage breast cancer treatment within the public health system in Brazil, held in 2012 by the National Committee for Health Technology Incorporation (CONITEC). METHODS: A mixed methods approach was used to analyze social representativeness and the composition of the corpus from the public consultation, which consisted of 127 contributions. Three types of analysis were performed using IRaMuTeQ software: classic lexical analysis, descending hierarchical classification and specificities analysis. The contributions were clustered according to the main categories of discourse observed, into four social representation categories: 1) patient representation/advocacy; 2) pharmaceutical industry/advocacy; 3) healthcare professionals; and 4) individual contributions. RESULTS: Category 1 contained words related to increased survival due to use of the drug and a low score for words pertaining to studies on Trastuzumab. The word "safety" obtained a positive score only in category 2, which was also the only category that exhibited a negative score for the word "risk". Category 3 displayed the lowest scores for "diagnosis" and "safety". The word "efficacy" had a negative score only in category 4. CONCLUSIONS: Each category exhibited different results for words related to health systems and to key concepts linked to HTA. Our analysis enabled the identification of the most prominent contributions for each category. Despite the promising results obtained, further research is needed to validate this software for use in analyzing public contributions.


Asunto(s)
Participación de la Comunidad , Evaluación de la Tecnología Biomédica/métodos , Trastuzumab/uso terapéutico , Brasil , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/patología , Femenino , Humanos , Estadificación de Neoplasias
4.
Int J Technol Assess Health Care ; 35(4): 257-262, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31296277

RESUMEN

OBJECTIVES AND BACKGROUND: Generic preference-based (GPB) measures of health-related quality of life (HRQL) are widely used as outcome measures in cost-effectiveness and cost-utility analyses (CEA, CUA). Health technology assessment agencies favor GPB measures because they facilitate comparisons among conditions and because the scoring functions for these measures are based on community preferences. However, there is no gold standard HRQL measure, scores generated by GPB measures may differ importantly, and changes in scores may fail to detect important changes in HRQL. Therefore, to enhance the accumulation of empirical evidence on how well GPB measures perform, we advocate that investigators routinely use two (or more) GPB measures in each study. METHODS: We discuss key measurement properties and present examples to illustrate differences in responsiveness for several major GPB measures across a wide variety of health contexts. We highlight the contributions of longitudinal head-to-head studies. RESULTS: There is substantial evidence that the performance of GPB measures varies importantly among diseases and health conditions. Scores are often not interchangeable. There are numerous examples of studies in which one GPB measure was responsive while another was not. CONCLUSIONS: Investigators should use two (or more) GPB measures. Study protocols should designate one measure as the primary outcome measure; the other measure(s) would be used in secondary analyses. As evidence accumulates it will better inform the relative strengths and weaknesses of alternative GPB measures in various clinical conditions. This will facilitate the selection and interpretation of GPB measures in future studies.


Asunto(s)
Prioridad del Paciente , Calidad de Vida , Encuestas y Cuestionarios/normas , Evaluación de la Tecnología Biomédica/métodos , Análisis Costo-Beneficio , Estado de Salud , Humanos , Estudios Longitudinales , Psicometría , Reproducibilidad de los Resultados
5.
Home Healthc Now ; 37(4): 222-226, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31274585

RESUMEN

The use of Patient-Reported Outcome Measures (PROMs) to improve patient outcomes, communication, and shared decision-making is of significance to home healthcare. Clinicians have begun to integrate health information technology (HIT) enabled PROM platforms (such as tablets) into routine care to facilitate collection of PROMs. To evaluate the feasibility and suitability of incorporating PROMs into the overall workflow in home healthcare, and integrating data collected with electronic health records (EHRs), we engaged two home healthcare agencies as pilot sites over the course of 4 months. We provided tablets enabled with an app version of the validated Patient-Reported Outcomes Measurement Information System to collect patient data. This was followed by surveys, interviews, and observations on aspects of feasibility, which we analyzed using summary statistics and qualitative analysis. Results show that the implementation of the HIT-enabled PROMs in the home healthcare setting is suitable for workflow, without negatively impacting goals of care. Additionally, the tablets were considered user-friendly by both clinicians and patients. Key to the utility of HIT-enabled PROMs in home healthcare is the integration of the data collected with existing data systems, in order to facilitate quality and improve outcomes, the success of which can depend on EHR platform ownership and the related ability or access to modify EHRs.


Asunto(s)
Servicios de Atención de Salud a Domicilio , Medición de Resultados Informados por el Paciente , Evaluación de la Tecnología Biomédica/métodos , Adulto , Anciano , Anciano de 80 o más Años , Registros Electrónicos de Salud , Estudios de Factibilidad , Femenino , Humanos , Masculino , Informática Médica/métodos , Informática Médica/normas , Persona de Mediana Edad
6.
Int J Technol Assess Health Care ; 35(4): 327-333, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31292015

RESUMEN

OBJECTIVES: The cost-effectiveness of molecular pathology testing is highly context dependent. The field is fast-moving, and national health technology assessment may not be relevant or timely for local decision makers. This study illustrates a method of context-specific economic evaluation that can be carried out in a limited timescale without extensive resources. METHODS: We established a multi-disciplinary group including an oncologist, pathologists and a health economist. We set out diagnostic and treatment pathways and costs using registry data, health technology assessments, guidelines, audit data, and estimates from the group. Sensitivity analysis varied input parameters across plausible ranges. The evaluation setting was the West of Scotland and UK NHS perspective was adopted. The evaluation was assessed against the AdHopHTA checklist for hospital-based health technology assessment. RESULTS: A context-specific economic evaluation could be carried out on a timely basis using limited resources. The evaluation met all relevant criteria in the AdHopHTA checklist. Health outcomes were expected to be at least equal to the current strategy. Annual cost savings of £637,000 were estimated resulting primarily from a reduction in the proportion of patients receiving intravenous infusional chemotherapy regimens. The result was not sensitive to any parameter. The data driving the main cost saving came from a small clinical audit. We recommended this finding was confirmed in a larger population. CONCLUSIONS: The method could be used to evaluate testing changes elsewhere. The results of the case study may be transferable to other jurisdictions where the organization of cancer services is fragmented.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico , Neoplasias Colorrectales/patología , Patología Molecular/economía , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Neoplasias Colorrectales/genética , Análisis Costo-Beneficio , Humanos , Modelos Econométricos , Metástasis de la Neoplasia , Patología Molecular/métodos , Años de Vida Ajustados por Calidad de Vida , Escocia , Sensibilidad y Especificidad , Medicina Estatal , Evaluación de la Tecnología Biomédica/métodos
7.
Int J Technol Assess Health Care ; 35(4): 280-290, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31337450

RESUMEN

OBJECTIVES: The aim of this study was to provide an overview of the methodological characteristics and compare the assessment methods applied in health technology assessments (HTAs) of public health interventions (PHIs). METHODS: We defined a PHI as a population-based intervention on health promotion or for primary prevention of chronic or nonchronic diseases. HTAs on PHIs were identified by systematically searching the Web pages of members of international HTA networks. We included only full HTA reports published between 2012 and 2016. Two reviewers extracted data on the methods used to assess effectiveness/safety, as well as on economic, social, cultural, ethical, and legal aspects using a-priori standardized tables. RESULTS: We included ten HTAs provided by four different organizations. Of these, all reports assessed the effectiveness of the interventions and conducted economic evaluations, seven investigated social/cultural aspects, and four each considered legal and ethical aspects, respectively. Some reports addressed applicability, context/setting, and intervention fidelity issues in different ways. We found that most HTAs adapted their methods to some extent, for example, by including nonrandomized studies, expanding the search strategy, involving stakeholders, or applying a framework to guide the HTA process. CONCLUSIONS: Our analysis provides a comprehensive overview of methods applied in HTAs on public health interventions. We found that a heterogeneous set of approaches is used to deal with the challenges of evaluating complex public health interventions.


Asunto(s)
Práctica de Salud Pública , Evaluación de la Tecnología Biomédica/métodos , Evaluación de la Tecnología Biomédica/organización & administración , Características Culturales , Promoción de la Salud/organización & administración , Humanos , Seguridad del Paciente/normas , Prevención Primaria/organización & administración , Medio Social , Evaluación de la Tecnología Biomédica/economía , Evaluación de la Tecnología Biomédica/ética
8.
Int J Technol Assess Health Care ; 35(4): 291-297, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31337452

RESUMEN

BACKGROUND: Traditional decision rules have limitations when a new technology is less effective and less costly than a comparator. We propose a new probabilistic decision framework to examine non-inferiority in effectiveness and net monetary benefit (NMB) simultaneously. We illustrate this framework using the example of repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT) for treatment-resistant depression. METHODS: We modeled the quality-adjusted life-years (QALYs) associated with the new intervention (rTMS), an active control (ECT), and a placebo control, and we estimated the fraction of effectiveness preserved by the new intervention through probabilistic sensitivity analysis (PSA). We then assessed the probability of cost-effectiveness using a traditional cost-effectiveness acceptability curve (CEAC) and our new decision-making framework. In our new framework, we considered the new intervention cost-effective in each simulation of the PSA if it preserved at least 75 percent of the effectiveness of the active control (thus demonstrating non-inferiority) and had a positive NMB at a given willingness-to-pay threshold (WTP). RESULTS: rTMS was less effective (i.e., associated with fewer QALYs) and less costly than ECT. The traditional CEAC approach showed that the probabilities of rTMS being cost-effective were 100 percent, 39 percent, and 14 percent at WTPs of $0, $50,000, and $100,000 per QALY gained, respectively. In the new decision framework, the probabilities of rTMS being cost-effective were reduced to 23 percent, 21 percent, and 13 percent at WTPs of $0, $50,000, and $100,000 per QALY, respectively. CONCLUSIONS: This new framework provides a different perspective for decision making with considerations of both non-inferiority and WTP thresholds.


Asunto(s)
Análisis Costo-Beneficio/métodos , Trastorno Depresivo Mayor/terapia , Terapia Electroconvulsiva/economía , Evaluación de la Tecnología Biomédica/métodos , Estimulación Magnética Transcraneal/economía , Terapia Electroconvulsiva/efectos adversos , Terapia Electroconvulsiva/métodos , Estudios de Equivalencia como Asunto , Humanos , Método de Montecarlo , Años de Vida Ajustados por Calidad de Vida , Proyectos de Investigación , Estimulación Magnética Transcraneal/efectos adversos , Estimulación Magnética Transcraneal/métodos
9.
Rev Bras Enferm ; 72(3): 617-623, 2019 Jun 27.
Artículo en Inglés, Portugués | MEDLINE | ID: mdl-31269124

RESUMEN

OBJECTIVE: To analyze cost-effectiveness and to calculate incremental cost-effectiveness ratio of the use of infusion pumps with drug library to reduce errors in intravenous drug administration in pediatric and neonatal patients in Intensive Care Units. METHODS: Mathematical modeling for economic analysis of the decision tree type. The base case was composed of reference and alternative settings. The target population was neonates and pediatric patients hospitalized in Pediatric and Neonatal Intensive Care Units, comprising a cohort of 15,034 patients. The cost estimate was based on the bottom-up and top-down approaches. RESULTS: The decision tree, after RollBack, showed that the infusion pump with drug library may be the best strategy to avoid errors in intravenous drugs administration. CONCLUSION: The analysis revealed that the conventional pump, although it has the lowest cost, also has lower effectiveness.


Asunto(s)
Bombas de Infusión/economía , Bombas de Infusión/normas , Errores de Medicación/prevención & control , Administración Intravenosa/métodos , Administración Intravenosa/normas , Brasil , Análisis Costo-Beneficio , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Neonatal/organización & administración , Unidades de Cuidado Intensivo Neonatal/estadística & datos numéricos , Unidades de Cuidado Intensivo Pediátrico/organización & administración , Unidades de Cuidado Intensivo Pediátrico/estadística & datos numéricos , Errores de Medicación/economía , Errores de Medicación/enfermería , Método de Montecarlo , Evaluación de la Tecnología Biomédica/métodos
10.
Emerg Med J ; 36(8): 456-458, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-31217181

RESUMEN

INTRODUCTION: Recent terror attacks and assassinations involving highly toxic chemical weapons have stressed the importance of sufficient respiratory protection of medical first responders and receivers. As full-face respirators cause perceptual-motor impairment, they not only impair vision but also significantly reduce speech intelligibility. The recent introduction of electronic voice projection units (VPUs), attached to a respirator, may improve communication while wearing personal respiratory protection. OBJECTIVE: To determine the influence of currently used respirators and VPUs on medical communication and speech intelligibility. METHODS: 37 trauma anaesthetists carried out an evaluation exercise of six different respirators and VPUs including one control. Participants had to listen to audio clips of a variety of sentences dealing with scenarios of emergency triage and medical history taking. RESULTS: In the questionnaire, operators stated that speech intelligibility of the Avon C50 respirator scored the highest (mean 3.9, ±SD 1.0) and that the Respirex Powered Respiratory Protective Suit (PRPS) NHS-suit scored lowest (1.6, 0.9). Regarding loudness the C50 plus the Avon VPU scored highest (4.1, 0.7), followed by the Draeger FPS-7000-com-plus (3.4, 1.0) and the Respirex PRPS NHS-suit scored lowest (2.3, 0.8). CONCLUSIONS: We found that the Avon C50 is the preferred model among the tested respirators. In our model, electronic voice projection modules improved loudness but not speech intelligibility. The Respirex PRPS NHS-suit was rated significantly less favourably in respect of medical communication and speech intelligibility.


Asunto(s)
Comunicación , Socorristas/estadística & datos numéricos , Diseño de Equipo/normas , Sustancias Peligrosas/efectos adversos , Ventiladores Mecánicos/efectos adversos , Diseño de Equipo/estadística & datos numéricos , Diseño de Equipo/tendencias , Humanos , Inteligibilidad del Habla , Encuestas y Cuestionarios , Evaluación de la Tecnología Biomédica/métodos , Evaluación de la Tecnología Biomédica/estadística & datos numéricos , Reino Unido , Ventiladores Mecánicos/estadística & datos numéricos , Ventiladores Mecánicos/tendencias , Calidad de la Voz
11.
JMIR Mhealth Uhealth ; 7(6): e14592, 2019 06 26.
Artículo en Inglés | MEDLINE | ID: mdl-31244482

RESUMEN

BACKGROUND: Pars plana vitrectomy (PPV) with intravitreous tamponade of gas or air has been widely used for a series of vitreoretinal diseases. It is estimated that 100,000 patients per year undergo PPV globally, and half of them were subsequently tamponaded with gas or air. According to Boyle's law (P1V1=P2V2), patients with an intravitreous remnant of gas or air will be under high risk of intraocular pressure (IOP) elevation and subsequent vision loss owing to the expanded intravitreous gas or air when traveling post operation to a place with a significantly higher altitude. We always explain to patients why postoperative travel is potentially risky. Emergency cases of elevated IOP caused by postoperative traveling would sometimes come to surgeons. However, there have been few disease education or reference tools for both the surgeons and patients to have better communication. OBJECTIVE: The aim of this study was to introduce and evaluate a mobile phone app developed by surgeons (the authors) for preliminary risk estimation of volume expansion and IOP elevation in patients with intravitreous gas or air when traveling to a place of higher altitude. METHODS: The app was developed on the iOS and Android operating systems. Boyle's law (P1V1=P2V2) was the theoretical basis of the app. Intravitreous gas or air volume and altitude values were independent factors to deduce the risk report. Consecutive patients underwent vitrectomy, and those with an intravitreous remnant of gas or air were recruited. The surgeons judged the vertical height of the fluid/gas interface through the dilated pupil; the patients were instructed to judge it according to their visual field when looking straight ahead and line it out on a chart included in the app. Finally, all the patients were required to fill a Likert scale-based questionnaire with 2 main items to evaluate the participants' user experience and attitudes toward the app. RESULTS: A total of 50 patients were included (30 males and 20 females). All patients could independently operate the app to complete the test. The median heights of the fluid/gas interface independently judged by the surgeon and patients were 40% (range: 10%-75%) and 41% (range: 9%-78%), respectively (P=.63). The median altitude of the participants' destinations was 150.0 m (range: 0-3490 m). The Bland-Altman analysis revealed a good agreement between the surgeons' and patients' judgments (bias of -0.3%), with 95% limits of agreement of -5.8% to 5.3%. Overall, the Likert scale revealed a positive attitude from the patients toward the app. CONCLUSIONS: The app is reliable for patients to have preliminary risk estimation of intravitreous gas or air volume expansion and IOP elevation if travel to a place of higher altitude is planned. The surgeons could also use it as a platform for better disease communication.


Asunto(s)
Altitud , Gases/análisis , Presión Intraocular/fisiología , Aplicaciones Móviles/normas , Medición de Riesgo/normas , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Aplicaciones Móviles/estadística & datos numéricos , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Medición de Riesgo/métodos , Evaluación de la Tecnología Biomédica/métodos , Vitrectomía/instrumentación , Vitrectomía/métodos
12.
Expert Rev Pharmacoecon Outcomes Res ; 19(4): 409-420, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-31210065

RESUMEN

Introduction: Orphan diseases are low-prevalence conditions with chronically debilitating or life-threatening consequences. Their treatments are generally called orphan drugs (OD). Health-technology assessment processes have traditionally considered cost-effectiveness analysis (CEA), when making reimbursement and pricing decisions for health-care plans. Valuing OD with standard CEA raises important issues due to uncertain evidence, inability to meet cost-effectiveness thresholds for reimbursement and high budget impact, among others. Multi-criteria decision analysis (MCDA) allows to overcome these issues and improve the technical and ethical quality of decisions regarding prioritization, coverage, and reimbursement of OD. Areas covered: A scoping review was conducted in order to characterize MCDA frameworks for assessing OD and implementation experiences. We reviewed electronic databases (Medline, Embase, Cochrane Library, EBSCO, CINAHL, EconLit, Web of Science, LILACS, Google Scholar) key journals (Orphanet Journal of Rare Diseases and Value in Health) and organization repositories. Expert opinion: The theoretical framework for MCDA considers areas related to characteristics of orphan diseases and their technologies' clinical and economic impact. Participation processes are critical in incorporating societal values in weighting different dimensions and constructing decision rules. Local implementation pilots considering different stakeholders are necessary in order to pinpoint specific barriers and opportunities.


Asunto(s)
Técnicas de Apoyo para la Decisión , Producción de Medicamentos sin Interés Comercial/métodos , Enfermedades Raras/tratamiento farmacológico , Presupuestos , Análisis Costo-Beneficio , Toma de Decisiones , Humanos , Producción de Medicamentos sin Interés Comercial/economía , Enfermedades Raras/economía , Mecanismo de Reembolso , Evaluación de la Tecnología Biomédica/métodos
13.
Cien Saude Colet ; 24(5): 1709-1722, 2019 May 30.
Artículo en Portugués, Inglés | MEDLINE | ID: mdl-31166506

RESUMEN

Given the financial impact of the adoption of new health technologies in health systems, choosing what technology should be introduced and when poses a major challenge for health managers. The health technology assessment (HTA) process should therefore be underpinned by transparent and objective criteria. The objective of this study was to analyze HTA processes in Brazil, overseen by the National Commission for the Incorporation of Health Technology (CONITEC), and to compare these processes with those in countries considered to be at the forefront of this field: Australia, Canada, and the United Kingdom. The following categories were used for the comparative analysis: program structure, definition and selection of topics, evidence review, use of HTA in decision making, program products and dissemination, and transparency. The findings show that there are more similarities than differences between these countries' processes and the CONITEC processes. The main differences identified were: composition of committees, entitlement to appeal, program evaluation, and timeframes for the implementation of recommendations/decisions. Despite making major strides in recent years, Brazil should continue to promote continuous improvement of its HTA process.


Asunto(s)
Tecnología Biomédica , Toma de Decisiones , Evaluación de la Tecnología Biomédica/métodos , Tecnología Biomédica/economía , Brasil , Prestación de Atención de Salud/economía , Prestación de Atención de Salud/métodos , Humanos , Internacionalidad , Programas Nacionales de Salud/economía
14.
Nurse Educ Today ; 80: 1-8, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31175963

RESUMEN

BACKGROUND: A mobile cooperation intervention was developed to facilitate the cooperation of nursing students with nurse teacher and to improve the students' clinical learning outcomes. The intervention consisted of training in a mobile application's functionality and its use during clinical practicum cooperation procedures. OBJECTIVES: To describe the development of a mobile application for student-teacher cooperation and to examine the acceptability of the mobile cooperation intervention for advancing intervention development. DESIGN: A user-centred design and a mobile application development lifecycle model were applied to develop a mobile application. A process evaluation that used mixed methods design was conducted within the intervention group after a randomized controlled trial of a complex mobile cooperation intervention. SETTING: The clinical practicum wards of seven hospitals in a hospital district in Finland. PARTICIPANTS: Second-year pre-registration nursing students (N = 52) from one nursing school. METHODS: Process evaluation questionnaires were completed upon completion of the five week intervention and essays were written by the students eleven weeks after the intervention ended. RESULTS: A system usability scale (SUS) assessed the overall usability of the mobile application as rather good (a mean SUS score of 69.86 out of 100). Positive feedback about the mobile application's usability and utility was reported and recommendations for further development were highlighted. The intervention demonstrated high acceptability. In general, the students actively used the mobile application for intervention procedures at home and in the clinical practicum ward. CONCLUSIONS: The findings support the high acceptability of mobile cooperation intervention and its potential while also providing evidence for the development team's future development of the mobile application. Additionally, this study provides an example of mobile application development and process evaluation in nursing education research.


Asunto(s)
Conducta Cooperativa , Aplicaciones Móviles/normas , Estudiantes de Enfermería/psicología , Adulto , Bachillerato en Enfermería/métodos , Bachillerato en Enfermería/estadística & datos numéricos , Femenino , Finlandia , Humanos , Relaciones Interpersonales , Masculino , Aplicaciones Móviles/tendencias , Estadísticas no Paramétricas , Estudiantes de Enfermería/estadística & datos numéricos , Encuestas y Cuestionarios , Evaluación de la Tecnología Biomédica/métodos
15.
Work ; 63(2): 165-180, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31156198

RESUMEN

BACKGROUND: A standard, reliable, objective measure is needed for identifying individuals with mild to moderate traumatic brain injury (TBI). OBJECTIVE: The purpose of this study was to examine balance using an AMTI OR6-7 force platform (FP), neurocognition and mood using the Automated Neuropsychological Assessment Metric4 (ANAM4), blood flow comparisons using a Brain Acoustic Monitor (BAM), and voice using Voice Analysis software (VA) for screening service members for a mild to moderate TBI. METHODS: Active duty and retired service member volunteers (n = 88, 35 with a diagnosis of mild to moderate TBI and 53 who never had a TBI) completed an informed consent document, and evaluations using the four technologies. RESULTS: Development of a clinical prediction rule yielded two FP variables and one ANAM4 Mood Scale variable (vigor) as helpful in predicting the presence of a TBI. Assuming a 15% pre-test probability, these predictors yield a post-test probability of 75.7% for a positive result with any two or more measures being positive, and a post-test probability of 2.3% for a negative result with zero measures being positive. CONCLUSIONS: This study demonstrated the usefulness of a force platform and a self-reported mood scale for predicting presence of mild to moderate TBI.


Asunto(s)
Lesiones Traumáticas del Encéfalo/diagnóstico , Tamizaje Masivo/instrumentación , Personal Militar/estadística & datos numéricos , Evaluación de la Tecnología Biomédica/métodos , Adulto , Instituciones de Atención Ambulatoria/organización & administración , Instituciones de Atención Ambulatoria/estadística & datos numéricos , Análisis de Varianza , Lesiones Traumáticas del Encéfalo/complicaciones , Lesiones Traumáticas del Encéfalo/psicología , Circulación Cerebrovascular/fisiología , Femenino , Humanos , Modelos Logísticos , Masculino , Tamizaje Masivo/métodos , Personal Militar/psicología , Pruebas Neuropsicológicas , Autoinforme , Estados Unidos , Voz/fisiología
16.
Int J Technol Assess Health Care ; 35(3): 221-228, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31190671

RESUMEN

OBJECTIVES: Indirect comparisons via a common comparator (anchored comparisons) are commonly used in health technology assessment. However, common comparators may not be available, or the comparison may be biased due to differences in effect modifiers between the included studies. Recently proposed population adjustment methods aim to adjust for differences between study populations in the situation where individual patient data are available from at least one study, but not all studies. They can also be used when there is no common comparator or for single-arm studies (unanchored comparisons). We aim to characterise the use of population adjustment methods in technology appraisals (TAs) submitted to the United Kingdom National Institute for Health and Care Excellence (NICE). METHODS: We reviewed NICE TAs published between 01/01/2010 and 20/04/2018. RESULTS: Population adjustment methods were used in 7 percent (18/268) of TAs. Most applications used unanchored comparisons (89 percent, 16/18), and were in oncology (83 percent, 15/18). Methods used included matching-adjusted indirect comparisons (89 percent, 16/18) and simulated treatment comparisons (17 percent, 3/18). Covariates were included based on: availability, expert opinion, effective sample size, statistical significance, or cross-validation. Larger treatment networks were commonplace (56 percent, 10/18), but current methods cannot account for this. Appraisal committees received results of population-adjusted analyses with caution and typically looked for greater cost effectiveness to minimise decision risk. CONCLUSIONS: Population adjustment methods are becoming increasingly common in NICE TAs, although their impact on decisions has been limited to date. Further research is needed to improve upon current methods, and to investigate their properties in simulation studies.


Asunto(s)
Evaluación de la Tecnología Biomédica/métodos , Análisis Costo-Beneficio , Interpretación Estadística de Datos , Humanos , Años de Vida Ajustados por Calidad de Vida , Medicina Estatal , Reino Unido
17.
Value Health ; 22(5): 570-574, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-31104736

RESUMEN

BACKGROUND: In this commentary, celebrating the 20th anniversary of the journal Value in Health, I present a brief overview and illustration of the evolution over the past 20 years of the methodological literature providing guidelines for multivariable and structural uncertainty analysis for cost-effectiveness estimates. METHODS: To illustrate the impact of the guidelines for uncertainty analyses, I show how the inclusion of multivariable and structural uncertainty analyses in cost-effectiveness analyses published in Value in Health changed over the past 20 years using publications from 1999/2000, 2007 and 2017. RESULTS: The commentary is organized in three sections: past, focusing on the development and use of methods for multivariable uncertainty analysis; present, focusing on the growing awareness of the need for structural uncertainty analysis, suggested frameworks for structural uncertainty analysis and how it is currently implemented; and future, considering different methods for combining multivariable and structural uncertainty analyses over the next decades. CONCLUSIONS: I conclude by suggesting how the continued evolution of uncertainty analyses in published studies and health technology assessment submissions can best take into account an important goal of cost-effectiveness analyses: to provide useful information to decision makers.


Asunto(s)
Análisis Costo-Beneficio/métodos , Interpretación Estadística de Datos , Incertidumbre , Toma de Decisiones , Humanos , Años de Vida Ajustados por Calidad de Vida , Evaluación de la Tecnología Biomédica/métodos
18.
Value Health ; 22(5): 593-600, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-31104740

RESUMEN

BACKGROUND: Oncology treatments have changed from chemotherapies to targeted therapies and more recently immuno-oncology. This has posed special challenges in the field of health technology assessment (HTA): capturing quality of life (QOL) associated with toxicity due to chemotherapy, crossover upon progression in targeted therapy trials, and survival extrapolation for immuno-oncology drugs. OBJECTIVES: To showcase 20 years of Value in Health (ViH) publications in oncology. METHODS: A review was undertaken of oncology articles published in ViH from May 1998 to August 2018. Full-length articles published in ViH with the keywords "oncology," "cancer," "h(a)ematology," and "malignancy" were included for review. Conference abstracts were excluded. RESULTS: Four major themes were identified: (1) QOL and the development of multiple functional assessment of cancer therapy tools and mapping instruments; (2) analysis of clinical evidence using indirect comparisons, network analyses, and adjustment for crossovers; (3) modeling, Markov models, partitioned survival models, and extrapolation methods; and (4) financial implications and how to deal with uncertainty, introduction of conditional reimbursement, managed entry, and risk share agreements. DISCUSSION: This review article highlights the important role ViH has played in disseminating HTA research in oncology. A few key issues loom on the horizon: precision medicine, further development and practical application of new QOL measures, methods for translating clinical evidence, and exploration of modeling techniques. For a better understanding of the complex interplay between access and financial risk management, ViH will no doubt continue to promote pioneering research in HTA and oncology.


Asunto(s)
Análisis Costo-Beneficio , Oncología Médica/métodos , Calidad de Vida , Evaluación de la Tecnología Biomédica , Humanos , Inmunoterapia , Neoplasias , Evaluación de la Tecnología Biomédica/economía , Evaluación de la Tecnología Biomédica/métodos
19.
Value Health ; 22(5): 611-618, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-31104743

RESUMEN

BACKGROUND: Cost-effectiveness acceptability curves (CEACs) and the cost-effectiveness acceptability frontier (CEAF) are the recommended graphical representations of uncertainty in a cost-effectiveness analysis (CEA). Nevertheless, many limitations of CEACs and the CEAF have been recognized by others. Expected loss curves (ELCs) overcome these limitations by displaying the expected foregone benefits of choosing one strategy over others, the optimal strategy in expectation, and the value of potential future research all in a single figure. OBJECTIVES: To revisit ELCs, illustrate their benefits using a case study, and promote their adoption by providing open-source code. METHODS: We used a probabilistic sensitivity analysis of a CEA comparing 6 cerebrospinal fluid biomarker test-and-treat strategies in patients with mild cognitive impairment. We showed how to calculate ELCs for a set of decision alternatives. We used the probabilistic sensitivity analysis of the case study to illustrate the limitations of currently recommended methods for communicating uncertainty and then demonstrated how ELCs can address these issues. RESULTS: ELCs combine the probability that each strategy is not cost-effective on the basis of current information and the expected foregone benefits resulting from choosing that strategy (ie, how much is lost if we recommended a strategy with a higher expected loss). ELCs display how the optimal strategy switches across willingness-to-pay thresholds and enables comparison between different strategies in terms of the expected loss. CONCLUSIONS: ELCs provide a more comprehensive representation of uncertainty and overcome current limitations of CEACs and the CEAF. Communication of uncertainty in CEA would benefit from greater adoption of ELCs as a complementary method to CEACs, the CEAF, and the expected value of perfect information.


Asunto(s)
Análisis Costo-Beneficio , Técnicas de Apoyo para la Decisión , Evaluación de la Tecnología Biomédica/métodos , Incertidumbre , Humanos , Modelos Estadísticos
20.
Value Health Reg Issues ; 18: 145-150, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-31082794

RESUMEN

OBJECTIVE: To describe the process and role of health technology assessment (HTA) in the context of drug policy in Malaysia. METHODS: We summarized the HTA process through review of documents and reports available in the public domain combined with the authors' experience. RESULTS: Health technology assessment plays an integral part in prioritizing treatment in public health facilities in Malaysia, particularly for the Ministry of Health Medicines Formulary (MOHMF). The MOHMF is the reference list of drugs allowed to be prescribed in the Ministry of Health (MOH) facilities. There are 2 organizations within the MOH that conduct HTA as their core activities, namely the Malaysian Health Technology Assessment Section and the Formulary Management Branch of Pharmacy Practice & Development Division. The assessment of pharmaceuticals for the purpose of listing medicines into the MOHMF is under the purview of the Formulary Management Branch. The evidence-based assessment focuses on safety, efficacy, effectiveness, and budget impact of the drug. Cost-effectiveness evidence is currently not mandatory but is of interest to the decision makers. The assessment outcomes are considered by the MOH Medicines List Review Panel for formulary decisions. CONCLUSIONS: Health technology assessment has supported formulary decisions in MOH. Evidence generation needs to progress beyond efficacy or effectiveness, safety, and budget impact to incorporate cost-effectiveness. Nevertheless, there are challenges to be met to achieve this. The impact of the HTA process is currently unknown and is yet to be evaluated formally.


Asunto(s)
Control de Medicamentos y Narcóticos/tendencias , Evaluación de la Tecnología Biomédica/métodos , Toma de Decisiones , Control de Medicamentos y Narcóticos/métodos , Humanos , Singapur
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA