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INTRODUCTION: The development of post-stroke epilepsy (PSE) is related to a worse clinical outcome in stroke patients. Adding a biomarker to the clinical diagnostic process for the prediction of PSE may help to establish targeted and personalized treatment for high-risk patients, which could lead to improved patient outcomes. We assessed the added value of a risk assessment and subsequent targeted treatment by conducting an early Health Technology Assessment. METHODS: Interviews were conducted with four relevant stakeholders in the field of PSE to obtain a realistic view of the current healthcare and their opinions on the potential value of a PSE risk assessment and subsequent targeted treatment. The consequences on quality of life and costs of current care of a hypothetical care pathway with perfect risk assessment were modeled based on information from a literature review and the input from the stakeholders. Subsequently, the maximum added value (the headroom) was calculated. Sensitivity analyses were performed to test the robustness of this result to variation in assumed input parameters, i.e. the accuracy of the risk assessment, the efficacy of anti-seizure medication (ASM), and the probability of patients expected to develop PSE. RESULTS: All stakeholders considered the addition of a predictive biomarker for the risk assessment of PSE to be of value. The headroom amounted to 12,983. The sensitivity analyses demonstrated that the headroom remained beneficial when varying the accuracy of the risk assessment, the ASM efficacy, and the number of patients expected to develop PSE. DISCUSSION: We showed that a risk assessment for PSE development is potentially valuable. This work demonstrates that it is worthwhile to undertake clinical studies to evaluate biomarkers for the prediction of patients at high risk for PSE and to assess the value of targeted prophylactic treatment.
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Epilepsia , Accidente Cerebrovascular , Humanos , Calidad de Vida , Evaluación de la Tecnología Biomédica , Accidente Cerebrovascular/complicaciones , Epilepsia/tratamiento farmacológico , Epilepsia/etiología , Biomarcadores , Convulsiones/etiología , Convulsiones/terapia , Medición de RiesgoRESUMEN
The diagnostic work-up of patients referred to the haematologist for bleeding evaluation is performed in a stepwise way: bleeding history and results of screening laboratory tests guide further diagnostic evaluation. This can be ineffective, time-consuming and burdensome for patients. To improve this strategy, the initial laboratory investigation can be extended. In a model-based approach, effectiveness and costs of a conventional stepwise versus a newly proposed all-in-one diagnostic approach for bleeding evaluation were evaluated and compared, using data from an observational patient cohort study, including adult patients referred for bleeding evaluation. In the all-in-one approach, specialized platelet function tests, coagulation factors, and fibrinolysis tests were included in the initial investigation. Final diagnosis, hospital resource use and costs and patient burden were compared. A total of 150 patients were included. Compared to the stepwise approach, in the all-in-one approach, 19 additional patients reached a diagnosis and patient burden was lower, but total costs per patient were higher [359, 95% bootstrapped confidence interval (BCI) 283-518, p = 0.001]. For bleeding evaluation of patients referred to the haematologist, an all-in-one diagnostic approach has a higher diagnostic yield and reduces patient burden, at a higher cost. This raises the question what costs justify the diagnosis of a bleeding disorder and a less burdensome diagnostic strategy.
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Trastornos de la Coagulación Sanguínea , Trastornos Hemorrágicos , Adulto , Humanos , Trastornos de la Coagulación Sanguínea/diagnóstico , Trastornos Hemorrágicos/diagnóstico , Hemorragia , Fibrinólisis , Análisis Costo-BeneficioRESUMEN
OBJECTIVES: This study aimed to investigate the cost-effectiveness, budget impact (BI), and impact of uncertainty of future developments concerning whole-genome sequencing (WGS) as a clinical diagnostic test compared with standard of care (SoC) in patients with locally advanced and metastatic non-small cell lung cancer. METHODS: A total of 3 likely scenarios to take place within 5 years (according to experts) were simulated using a previously developed, peer reviewed, and published decision model. The scenarios concerned "WGS results used for treatment selection" (scenario 1), "WGS-based biomarker for immunotherapy" (scenario 2), and "off-label drug approval for WGS results" (scenario 3). Two diagnostic strategies of the original model, "SoC" and "WGS as a diagnostic test" (base model), were used to compare our scenarios with. Outcomes were reported for the base model, all scenarios separately, combined (combined unweighted), and weighted by likelihood (combined weighted). Cost-effectiveness, BI, and value of information analyses were performed for WGS compared with SoC. RESULTS: Total costs and quality-adjusted life-years for SoC in metastatic non-small cell lung cancer were 149 698 and 1.235. Incremental outcomes of WGS were 1529/0.002(base model), -222/0.020(scenario 1), -2576/0.023(scenario 2), 388/0.024(scenario 3), -5041/0.060(combined unweighted), and -1715/0.029(combined weighted). The annual BI for adopting WGS for this population in The Netherlands ranged between 682 million (combined unweighted) and 714 million (base model). The consequences of uncertainty amounted to 3.4 million for all scenarios (combined weighted) and to 699 000 for the diagnostic yield of WGS alone (combined weighted). CONCLUSIONS: Our findings suggest that it is likely for WGS to become cost-effective within the near future if it identifies more patients with actionable targets and show the impact of uncertainty regarding its diagnostic yield. Modeling future scenarios can be useful to consider early adoption of WGS while timely anticipating on unforeseen developments before final conclusions are reached.
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Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Humanos , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/genética , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/genética , Análisis Costo-Beneficio , Uso Fuera de lo Indicado , Países Bajos , Años de Vida Ajustados por Calidad de VidaRESUMEN
Low levels of knowledge and awareness on cervical cancer play a role in limiting cervical cancer prevention uptake. This systematic review aimed to identify effective educational interventions to increase cervical cancer awareness, knowledge, and subsequently screening or vaccination uptake in African women. A literature search was conducted in Medline and EMBASE databases. We examined original, peer-reviewed English literature published between 2005 and 2020. Nineteen studies examining health education interventions' impact on awareness, knowledge, and screening or vaccination uptake in African women were included. Ten studies were controlled trials, nine performed pre- and post-measurements in one group. Most studies were published between 2015 and 2020 (86%), many were from Nigeria (47%). Studies were mostly set up in communities and schools. The most frequently used intervention was lectures, alone or combined with videos and practical demonstrations. Sixteen studies evaluated knowledge or awareness, and all showed a statistically significant improvement following the intervention. Of the ten studies that evaluated screening uptake, either as the single outcome or combined with knowledge or awareness, six found a significant rise in screening uptake after intervention. Educational interventions increased knowledge and awareness in African women, some boosted uptake of cervical cancer screening, especially when using peer health educators and culturally tailored methods. Innovative approaches such as self-collected HPV testing and mHealth also demonstrated a potential to increase uptake of screening. More research is needed to identify and analyse barriers to screening uptake, which can still be present even after a successful educational intervention.
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Telemedicina , Neoplasias del Cuello Uterino , Femenino , Humanos , Neoplasias del Cuello Uterino/prevención & control , Detección Precoz del Cáncer , Educación en Salud , NigeriaRESUMEN
BACKGROUND: In oncology, Whole Genome Sequencing (WGS) is not yet widely implemented due to uncertainties such as the required infrastructure and expertise, costs and reimbursements, and unknown pan-cancer clinical utility. Therefore, this study aimed to investigate possible future developments facilitating or impeding the use of WGS as a molecular diagnostic in oncology through scenario drafting. METHODS: A four-step process was adopted for scenario drafting. First, the literature was searched for barriers and facilitators related to the implementation of WGS. Second, they were prioritized by international experts, and third, combined into coherent scenarios. Fourth, the scenarios were implemented in an online survey and their likelihood of taking place within 5 years was elicited from another group of experts. Based on the minimum, maximum, and most likely (mode) parameters, individual Program Evaluation and Review Technique (PERT) probability density functions were determined. Subsequently, individual opinions were aggregated by performing unweighted linear pooling, from which summary statistics were extracted and reported. RESULTS: Sixty-two unique barriers and facilitators were extracted from 70 articles. Price, clinical utility, and turnaround time of WGS were ranked as the most important aspects. Nine scenarios were developed and scored on likelihood by 18 experts. The scenario about introducing WGS as a clinical diagnostic with a lower price, shorter turnaround time, and improved degree of actionability, scored the highest likelihood (median: 68.3%). Scenarios with low likelihoods and strong consensus were about better treatment responses to more actionable targets (26.1%), and the effect of centralizing WGS (24.1%). CONCLUSIONS: Based on current expert opinions, the implementation of WGS as a clinical diagnostic in oncology is heavily dependent on the price, clinical utility (both in terms of identifying actionable targets as in adding sufficient value in subsequent treatment), and turnaround time. These aspects and the optimal way of service provision are the main drivers for the implementation of WGS and should be focused on in further research. More knowledge regarding these factors is needed to inform strategic decision making regarding the implementation of WGS, which warrants support from all relevant stakeholders.
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Consenso , Oncología Médica , Neoplasias/diagnóstico , Secuenciación Completa del Genoma/métodos , Análisis de Datos , Eficiencia , Predicción , Implementación de Plan de Salud , Secuenciación de Nucleótidos de Alto Rendimiento , Humanos , Neoplasias/genética , Neoplasias/terapia , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Factores de Tiempo , Incertidumbre , Secuenciación Completa del Genoma/economía , Secuenciación Completa del Genoma/tendenciasRESUMEN
OBJECTIVES: Value of information (VOI) analysis can support health technology assessment decision making, but it is a long way from being standard use. The objective of this study was to understand barriers to the implementation of VOI analysis and propose actions to overcome these. METHODS: We performed a process evaluation of VOI analysis use within decision making on tomosynthesis versus digital mammography for use in the Dutch breast cancer population screening. Based on steering committee meeting attendance and regular meetings with analysts, we developed a list of barriers to VOI use, which were analyzed using an established diffusion model. We proposed actions to address these barriers. Barriers and actions were discussed and validated in a workshop with stakeholders representing patients, clinicians, regulators, policy advisors, researchers, and the industry. RESULTS: Consensus was reached on groups of barriers, which included characteristics of VOI analysis itself, stakeholder's attitudes, analysts' and policy makers' skills and knowledge, system readiness, and implementation in the organization. Observed barriers did not only pertain to VOI analysis itself but also to formulating the objective of the assessment, economic modeling, and broader aspects of uncertainty assessment. Actions to overcome these barriers related to organizational changes, knowledge transfer, cultural change, and tools. CONCLUSIONS: This in-depth analysis of barriers to implementation of VOI analysis and resulting actions and tools may be useful to health technology assessment organizations that wish to implement VOI analysis in technology assessment and research prioritization. Further research should focus on application and evaluation of the proposed actions in real-world assessment processes.
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Análisis Costo-Beneficio , Toma de Decisiones , Modelos Económicos , Participación de los Interesados , Evaluación de la Tecnología Biomédica/economía , Detección Precoz del Cáncer , Humanos , Mamografía , Países Bajos , Innovación Organizacional , IncertidumbreRESUMEN
OBJECTIVES: Decision makers adopt health technologies based on health economic models that are subject to uncertainty. In an ideal world, these models parameterize all uncertainties and reflect them in the cost-effectiveness probability and risk associated with the adoption. In practice, uncertainty assessment is often incomplete, potentially leading to suboptimal reimbursement recommendations and risk management. This study examines the feasibility of comprehensive uncertainty assessment in health economic models. METHODS: A state transition model on peripheral arterial disease treatment was used as a case study. Uncertainties were identified and added to the probabilistic sensitivity analysis if possible. Parameter distributions were obtained by expert elicitation, and structural uncertainties were either parameterized or explored in scenario analyses, which were model averaged. RESULTS: A truly comprehensive uncertainty assessment, parameterizing all uncertainty, could not be achieved. Expert elicitation informed 8 effectiveness, utility, and cost parameters. Uncertainties were parameterized or explored in scenario analyses and with model averaging. Barriers included time and resource constraints, also of clinical experts, and lacking guidance regarding some aspects of expert elicitation, evidence aggregation, and handling of structural uncertainty. The team's multidisciplinary expertise and existing literature and tools were facilitators. CONCLUSIONS: While comprehensive uncertainty assessment may not be attainable, improvements in uncertainty assessment in general are no doubt desirable. This requires the development of detailed guidance and hands-on tutorials for methods of uncertainty assessment, in particular aspects of expert elicitation, evidence aggregation, and handling of structural uncertainty. The issue of benefits of uncertainty assessment versus time and resources needed remains unclear.
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Economía Médica , Incertidumbre , Análisis Costo-Beneficio , Estudios de Factibilidad , Estudios de Casos Organizacionales , Evaluación de la Tecnología BiomédicaRESUMEN
BackgroundDigital breast tomosynthesis (DBT) is a promising screening test, but its outcomes and cost-effectiveness remain uncertain.PurposeTo determine if biennial DBT is cost-effective in a screening setting, when compared with digital mammography (DM) in the Netherlands, and to quantify the uncertainty.Materials and MethodsIn this study, performed from March 2018 to February 2019, the MIcrosimulation SCreening ANalysis model was used to conduct a probabilistic sensitivity analysis (PSA), consisting of 10 000 model runs with 1 000 000 women simulated per run. The Bayesian Cost-Effectiveness Analysis package and the Sheffield Accelerated Value of Information tool were used to process PSA outcomes. Two simulated cohorts born in 1970 were invited to undergo biennial screening between ages 50 and 74 years-one cohort was assigned to DM screening, and one was assigned to DBT screening. DM input parameters were based on data from the Dutch breast cancer screening program. DBT parameters were based on literature and expert opinion. Willingness-to-pay thresholds of 20 000 ($22 000) and 35 000 ($38 500) per life-year gained (LYG) were considered. Effects and costs were discounted at 3.5% per year.ResultsDBT resulted in a gain of 13 additional life-years per 1000 women invited to screening (7% increase, 13 of 193), followed over lifetime, compared with DM and led to 2% (four of 159) fewer false-positive results. DBT screening led to incremental discounted lifetime effects of 5.09 LYGs (95% confidence interval: -0.80, 9.70) and an increase in lifetime costs of 137 555 ($151 311) per 1000 women (95% confidence interval: 31 093 [$34 202], 263 537 [$289 891]) compared with DM, resulting in a mean incremental cost-effectiveness ratio of 27 023 ($29 725) per LYG. The probability of DBT being more cost-effective was 0.36 at 20 000 and 0.66 at 35 000 per LYG.ConclusionSwitching from digital mammography to biennial digital breast tomosynthesis is not cost-effective at a willingness-to-pay threshold of 20 000 per life-year gained, but digital breast tomosynthesis has a higher probability of being more cost-effective than digital mammography at a threshold of 35 000 per life-year gained.© RSNA, 2020Online supplemental material is available for this article.See also the editorial by Slanetz in this issue.
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Neoplasias de la Mama/diagnóstico por imagen , Mamografía/economía , Anciano , Teorema de Bayes , Análisis Costo-Beneficio , Detección Precoz del Cáncer , Femenino , Humanos , Esperanza de Vida , Tamizaje Masivo , Persona de Mediana Edad , Sensibilidad y EspecificidadRESUMEN
Thus far, the association between residual vein occlusion and immediate compression therapy and postthrombotic syndrome is undetermined. Therefore, we investigated whether compression therapy immediately after diagnosis of deep vein thrombosis affects the occurrence of residual vein obstruction (RVO), and whether the presence of RVO is associated with postthrombotic syndrome and recurrent venous thromboembolism. In a prespecified substudy within the IDEAL (individualized duration of elastic compression therapy against long-term duration of therapy for prevention of postthrombotic syndrome) deep vein thrombosis (DVT) study, 592 adult patients from 10 academic and nonacademic centers across The Netherlands, with objectively confirmed proximal DVT of the leg, received no compression or acute compression within 24 hours of diagnosis of DVT with either multilayer bandaging or compression hosiery (pressure, 35 mm Hg). Presence of RVO and recurrent venous thromboembolism was confirmed with compression ultrasonography and incidence of postthrombotic syndrome as a Villalta score of at least 5 at 6 and 24 months. The average time from diagnosis until assessment of RVO was 5.3 (standard deviation, 1.9) months. A significantly lower percentage of patients who did receive compression therapy immediately after DVT had RVO (46.3% vs 66.7%; odds ratio, 0.46; 95% confidence interval, 0.27-0.80; P = .005). Postthrombotic syndrome was less prevalent in patients without RVO (46.0% vs 54.0%; odds ratio, 0.65; 95% confidence interval, 0.46-0.92; P = .013). Recurrent venous thrombosis showed no significant association with RVO. Immediate compression should therefore be offered to all patients with acute DVT of the leg, irrespective of severity of complaints. This study was registered at ClinicalTrials.gov (NCT01429714) and the Dutch Trial registry in November 2010 (NTR2597).
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Síndrome Postrombótico/prevención & control , Medias de Compresión , Tromboembolia Venosa/prevención & control , Trombosis de la Vena/terapia , Adulto , Anciano , Humanos , Incidencia , Persona de Mediana Edad , Síndrome Postrombótico/etiología , Recurrencia , Prevención Secundaria , Resultado del Tratamiento , Tromboembolia Venosa/etiologíaRESUMEN
Background: In 2013, eribulin was reimbursed under a coverage with evidence development (CED) as third or later chemotherapy line for advanced breast cancer (ABC) patients in the Netherlands because of uncertain cost effectiveness. In 2016, the final decision of reimbursing eribulin was taken without considering the evidence collected during CED research. We analysed the cost effectiveness of eribulin versus non-eribulin chemotherapy, using real-world data.Methods: A three health states (progression-free, progressed disease, dead) partitioned survival model was developed. The SOuth East Netherlands Advanced BREast Cancer (SONABRE) registry informed the effectiveness and costs inputs. Health state utility values were obtained from the literature. Incremental cost-effectiveness ratio (ICER) between the eribulin and matched non-eribulin chemotherapy was estimated. Deterministic and probabilistic sensitivity analyses and scenario analyses were performed. The financial risk (i.e., the expected value of perfect information (EVPI) plus the expected monetary loss (eML) associated with reimbursing eribulin) and budget impact associated with reimbursing eribulin were calculated.Results: Eribulin led to higher health benefits (0.07 quality-adjusted life year (QALY)) and costs (15,321) compared with non-eribulin chemotherapy. This resulted in an ICER of 220,608. At a 80,000 per QALY threshold, the risk of reimbursing eribulin was 9,791 per patient (EVPI 13, eML 9,778). Scaled up to the Dutch population, the estimated annual budget impact was 1.9 million and the annual risk of reimbursing eribulin was 2.7 million.Conclusion: From a Dutch societal perspective, eribulin is not cost effective when considering its list price as third and later chemotherapy line for ABC patients.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Costos de los Medicamentos/estadística & datos numéricos , Furanos/uso terapéutico , Cetonas/uso terapéutico , Modelos Económicos , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Neoplasias de la Mama/diagnóstico , Neoplasias de la Mama/economía , Neoplasias de la Mama/mortalidad , Simulación por Computador , Análisis Costo-Beneficio , Progresión de la Enfermedad , Femenino , Furanos/economía , Humanos , Reembolso de Seguro de Salud/economía , Reembolso de Seguro de Salud/estadística & datos numéricos , Cetonas/economía , Persona de Mediana Edad , Países Bajos/epidemiología , Supervivencia sin Progresión , Años de Vida Ajustados por Calidad de Vida , Sistema de Registros/estadística & datos numéricosRESUMEN
BACKGROUND: Examine whether the use of different ages has an impact on the valuation of EQ-5D-Y health states for a hypothetical child or adolescent. METHODS: A survey was administered during regular classes among a convenience sample of university students in the Netherlands. Respondents first valued 6 EQ-5D-Y health states (2 mild, 2 moderate, 2 severe) describing a hypothetical child/adolescent of a certain age on a visual analogue scale (VAS). After 1 h respondents valued the same six health states again but this time the age of the child was different. Age differed between 4, 10 and 16 year old. RESULTS: Number of respondents was 311. No significant differences in valuation of the six health states were found between the age of 10 and 16. One moderate health state was valued significantly better for a 4-year old compared to a 10 and a 16 year old. The same applied for one severe health state that was valued higher for a 4-year old compared to a 16-year old. CONCLUSION: Our study shows that, except for one moderate and one severe health state, other EQ-5D-Y health states were not valued significantly different when description of age differed. It is possible that problems in specific health domains are considered more severe for older children/adolescents compared to younger children who might still be dependent on their caregivers. Future research should examine whether our findings are also present in a broader set of EQ-5D-Y health states, with a choice-based method like TTO or DCE, and a more heterogeneous sample.
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Estado de Salud , Calidad de Vida , Escala Visual Analógica , Adolescente , Adulto , Factores de Edad , Niño , Preescolar , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Dimensión del Dolor/métodos , Encuestas y Cuestionarios , Adulto JovenRESUMEN
PURPOSE: We aimed to evaluate quality of life (QoL) using the European Quality of Life Five-Dimensions questionnaire (EQ-5D-3L) in a real-world cohort of Dutch advanced breast cancer (ABC) patients. Secondary, we reported differences in QoL between subgroups of patients based on age, comorbidity, tumor-, and treatment characteristics, and assessed the association of duration of metastatic disease and time to death with QoL. METHODS: ABC patients who attended the outpatient clinic between October 2010 and May 2011 were asked to fill out the EQ-5D-3L questionnaire. Patient-, disease-, and treatment characteristics were obtained from the medical files. Health-utility scores were calculated. Subgroups were described and compared for utility scores by parametric and non-parametric methods. RESULTS: A total of 92 patients were included with a median utility score of 0.691 (Interquartile range [IQR] 0.244). Patients ≥ 65 years had significantly worse median utility scores than younger patients; 0.638 versus 0.743, respectively (p = 0.017). Moreover, scores were significantly worse for patients with versus those without comorbidity (medians 0.620 versus 0.725, p = 0.005). Utility scores did not significantly differ between subgroups of tumor type, type of systemic treatment, number of previous palliative treatment(s), or number or location of metastatic site(s). The remaining survival was correlated with utility scores (correlation coefficient (r) = 0.260, p = 0.0252), especially in the subgroup < 65 years (r = 0.340, p = 0.0169), whereas there was no significant correlation with time since metastatic diagnosis (r = - 0.106, p = 0.3136). CONCLUSION: Within this real-world cross-sectional study, QoL was significantly associated with age, comorbidity, and remaining survival duration. The observation of a lower QoL in ABC patients, possibly indicating the last period of life, may assist clinical decision-making on timing of cessation of systemic antitumor therapy.
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Neoplasias de la Mama/psicología , Calidad de Vida/psicología , Anciano , Estudios de Cohortes , Estudios Transversales , Femenino , Humanos , Masculino , Sistema de Registros , Encuestas y CuestionariosRESUMEN
BACKGROUND: This study estimated the lifetime cost-effectiveness and equity impacts associated with two lifestyle interventions in the Dutch primary school setting (targeting 4-12 year olds). METHODS: The Healthy Primary School of the Future (HPSF; a healthy school lunch and structured physical activity) and the Physical Activity School (PAS; structured physical activity) were compared to the regular Dutch curriculum (N = 1676). An adolescence model, calculating weight development, and the RIVM Chronic Disease Model, calculating overweight-related chronic diseases, were linked to estimate the lifetime impact on chronic diseases, quality adjusted life years (QALYs), healthcare, and productivity costs. Cost-effectiveness was expressed as the additional costs/QALY gained and we used 20,000 as threshold. Scenario analyses accounted for alternative effect maintenance scenarios and equity analyses examined cost-effectiveness in different socioeconomic status (SES) groups. RESULTS: HPSF resulted in a lifetime costs of 773 (societal perspective) and a lifetime QALY gain of 0.039 per child versus control schools. HPSF led to lower costs and more QALYs as compared to PAS. From a societal perspective, HPSF had a cost/QALY gained of 19,734 versus control schools, 50% probability of being cost-effective, and beneficial equity impact (0.02 QALYs gained/child for low versus high SES). The cost-effectiveness threshold was surpassed when intervention effects decayed over time. CONCLUSIONS: HPSF may be a cost-effective and equitable strategy for combatting the lifetime burden of unhealthy lifestyles. The win-win situation will, however, only be realised if the intervention effect is sustained into adulthood for all SES groups. TRIAL REGISTRATION: Clinicaltrials.gov ( NCT02800616 ). Registered 15 June 2016 - Retrospectively registered.
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Estilo de Vida , Calidad de Vida , Instituciones Académicas , Adolescente , Adulto , Niño , Preescolar , Análisis Costo-Beneficio , Ejercicio Físico , Femenino , Estado de Salud , Humanos , Masculino , Años de Vida Ajustados por Calidad de Vida , Adulto JovenRESUMEN
OBJECTIVES: In theory, a successful coverage with evidence development (CED) scheme is one that addresses the most important uncertainties in a given assessment. We investigated the following: (1) which uncertainties were present during the initial assessment of 3 Dutch CED cases, (2) how these uncertainties were integrated in the initial assessments, (3) whether CED research plans included the identified uncertainties, and (4) issues with managing uncertainty in CED research and ways forward from these issues. METHODS: Three CED initial assessment dossiers were analyzed and 16 stakeholders were interviewed. Uncertainties were identified in interviews and dossiers and were categorized in different causes: unavailability, indirectness, and imprecision of evidence. Identified uncertainties could be mentioned, described, and explored. Issues and ways forward to address uncertainty in CED schemes were discussed during the interviews. RESULTS: Forty-two uncertainties were identified. Thirteen (31%) were caused by unavailability, 17 (40%) by indirectness, and 12 (29%) by imprecision. Thirty-four uncertainties (81%) were only mentioned, 19 (45%) were described, and the impact of 3 (7%) uncertainties on the results was explored in the assessment dossiers. Seventeen uncertainties (40%) were included in the CED research plans. According to stakeholders, research did not address the identified uncertainty, but CED research should be designed to focus on these. CONCLUSIONS: In practice, uncertainties were neither systematically nor completely identified in the analyzed CED schemes. A framework would help to systematically identify uncertainty, and this process should involve all stakeholders. Value of information analysis, and the uncertainties that are not included in this analysis should inform CED research design.
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Costos de los Medicamentos , Medicina Basada en la Evidencia/economía , Cobertura del Seguro/economía , Seguro de Salud/economía , Mecanismo de Reembolso/economía , Incertidumbre , Toma de Decisiones Clínicas , Análisis Costo-Beneficio , Humanos , Modelos Económicos , Modelos Estadísticos , Países Bajos , Selección de Paciente , Rituximab/economía , Rituximab/uso terapéutico , Participación de los Interesados , Trastuzumab/economía , Trastuzumab/uso terapéutico , alfa-Glucosidasas/economía , alfa-Glucosidasas/uso terapéuticoRESUMEN
PURPOSE: To determine the effect of revascularisation for peripheral arterial disease (PAD) on QoL in the first and second year following diagnosis, to compare the effect depicted by Short Form Six Dimensions (SF-6D) and EuroQoL five Dimensions (EQ-5D) utilities, and Visual Analogue Scale (VAS) scores and to analyse heterogeneity in treatment response. METHODS: Longitudinal data from 229 PAD patients were obtained in an observational study in southern Netherlands. Utility scores were calculated with the international (SF-6D) and Dutch (EQ-5D) tariffs. We analysed treatment effect at years 1 and 2 through propensity score-matched ANCOVAs. Thereby, we estimated the marginal means (EMMs) of revascularisation and conservative treatment, and identified covariates of revascularisation effect. RESULTS: A year after diagnosis, 70 patients had been revascularised; the EMMs of revascularisation were 0.038, 0.077 and 0.019 for SF-6D, EQ-5D and VAS, respectively (always in this order). For conservative treatment these were - 0.017, 0.038 and 0.021. At 2-year follow-up, the EMMs of revascularisation were 0.015, 0.077 and 0.027, for conservative treatment these were - 0.020, 0.013 and - 0.004. Baseline QoL (and rest pain in year 2) were covariates of treatment effect. CONCLUSIONS: We measured positive effects of revascularisation and conservative treatment on QoL a year after diagnosis, the effect of revascularisation was sustained over 2 years. The magnitude of effect varied between the metrics and was largest for the EQ-5D, which may be most suitable for QoL measurement in PAD patients. Baseline QoL influenced revascularisation effect, in clinical practice this may inform expected QoL gain in individual patients.
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Procedimientos Endovasculares/psicología , Enfermedad Arterial Periférica/psicología , Enfermedad Arterial Periférica/terapia , Calidad de Vida/psicología , Adulto , Anciano , Tratamiento Conservador/métodos , Procedimientos Endovasculares/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Dolor/psicología , Encuestas y CuestionariosRESUMEN
In the article, 'A Cost Analysis of School-Based Lifestyle Interventions', we calculated the societal costs of two school-based lifestyle interventions: 'the Healthy Primary School of the Future' and 'the Physical Activity School'.
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Current guidelines for economic evaluations do not provide specific recommendations for the evaluation of school-based lifestyle interventions. This study examined and discussed the key aspects in the design of economic evaluations on school-based interventions targeting weight-related behaviours among 4-12â¯year olds. The PubMed and CRD databases (NHS EED) were searched. Grey literature was identified from reference lists and websites of relevant organizations. Full economic evaluations on school-based interventions targeting physical activity, sedentariness, or diet were selected. Key aspects included the objective, audience, intervention, comparator, population, type of analysis, perspective, costs, outcomes, and time horizon. Information was also extracted on measuring and valuing costs and outcomes, linking and extrapolating outcomes, and the maintenance of intervention effects. The 23 included studies reported on cost-effectiveness (CEAs) (Nâ¯=â¯12), cost-utility (CUAs) (Nâ¯=â¯9), social cost benefit (SCBA) (Nâ¯=â¯2), and social return on investment (SROI) (Nâ¯=â¯1) analysis. The usual practice comparator was generally not clearly defined. The SROI analysis was the single study that included outcomes in other persons than the child. Healthcare costs (Nâ¯=â¯14), productivity costs (Nâ¯=â¯4), and costs to the household (Nâ¯=â¯3), or education (Nâ¯=â¯2) sector were examined. The outcome in trial-based CEAs consisted of a variety of weight-related measures. Seven distinctive models were used to extrapolate health and/or productivity costs. To enhance the usefulness of economic evaluations on school-based lifestyle interventions in allocating public health budgets, transparent reporting on key aspects, broadening the scope of economic evaluations, and standardizing the measurement, valuation, and extrapolation of costs and outcomes should be improved. This study was conducted in Maastricht, the Netherlands.
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Peso Corporal/fisiología , Análisis Costo-Beneficio , Estilo de Vida , Servicios de Salud Escolar , Niño , Dieta , Ejercicio Físico/fisiología , Femenino , Humanos , Masculino , Países BajosRESUMEN
A uniform approach for costing school-based lifestyle interventions is currently lacking. The objective of this study was to develop a template for costing primary school-based lifestyle interventions and apply this to the costing of the "Healthy Primary School of the Future" (HPSF) and the "Physical Activity School" (PAS), which aim to improve physical activity and dietary behaviors. Cost-effectiveness studies were reviewed to identify the cost items. Societal costs were reflected by summing up the education, household and leisure, labor and social security, and health perspectives. Cost inputs for HPSF and PAS were obtained for the first year after implementation. In a scenario analysis, the costs were explored for a hypothetical steady state. From a societal perspective, the per child costs were 2.7/$3.3 (HPSF) and - 0.3/$- 0.4 (PAS) per day during the first year after implementation, and 1.0/$1.2 and - 1.3/$- 1.6 in a steady state, respectively (2016 prices). The highest costs were incurred by the education perspective (first year: 8.7/$10.6 (HPSF) and 4.0/$4.9 (PAS); steady state: 6.1/$7.4 (HPSF) and 2.1/$2.6 (PAS)), whereas most of the cost offsets were received by the household and leisure perspective (first year: - 6.0/$- 7.3 (HPSF) and - 4.4/$- 5.4 (PAS); steady state: - 5.0/$- 6.1 (HPSF) and - 3.4/$- 4.1 (PAS)). The template proved helpful for costing HPSF and PAS from various stakeholder perspectives. The costs for the education sector were fully (PAS) and almost fully (HPSF) compensated by the savings within the household sector. Whether the additional costs of HPSF over PAS represent value for money will depend on their relative effectiveness.
Asunto(s)
Costos y Análisis de Costo , Promoción de la Salud/economía , Conducta de Reducción del Riesgo , Instituciones Académicas , Costos y Análisis de Costo/métodosRESUMEN
PURPOSE: To provide an overview of model characteristics and outcomes of model-based economic evaluations concerning chemotherapy and targeted therapy (TT) for metastatic breast cancer (MBC); to assess the quality of the studies; to analyse the association between model characteristics and study quality and outcomes. METHODS: PubMED and NHS EED were systematically searched. Inclusion criteria were as follows: English or Dutch language, model-based economic evaluation, chemotherapy or TT as intervention, population diagnosed with MBC, published between 2000 and 2014, reporting life years (LY) or quality-adjusted life-year (QALY) and an incremental cost-effectiveness ratio. General characteristics, model characteristics and outcomes of the studies were extracted. Quality of the studies was assessed through a checklist. RESULTS: 24 studies were included, considering 50 comparisons (20 concerning chemotherapy and 30 TT). Seven comparisons were represented in multiple studies. A health state-transition model including the following health states: stable/progression-free disease, progression and death was used in 18 studies. Studies fulfilled on average 14 out of the 26 items of the quality checklist, mostly due to a lack of transparency in reporting. Thirty-one per cent of the incremental net monetary benefit was positive. TT led to higher iQALY gained, and industry-sponsored studies reported more favourable cost-effectiveness outcomes. CONCLUSIONS: The development of a disease-specific reference model would improve the transparency and quality of model-based cost-effectiveness assessments for MBC treatments. Incremental health benefits increased over time, but were outweighed by the increased treatment costs. Consequently, increased health benefits led to lower value for money.