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The term 'perspective' in the context of economic evaluations and costing studies in healthcare refers to the viewpoint that an analyst has adopted to define the types of costs and outcomes to consider in their studies. However, there are currently notable variations in terms of methodological recommendations, definitions, and applications of different perspectives, depending on the objective or intended user of the study. This can make it a complex area for stakeholders when interpreting these studies. Consequently, there is a need for a comprehensive overview regarding the different types of perspectives employed in such analyses, along with the corresponding implications of their use. This is particularly important, in the context of low-and-middle-income countries (LMICs), where practical guidelines may be less well-established and infrastructure for conducting economic evaluations may be more limited. This article addresses this gap by summarising the main types of perspectives commonly found in the literature to a broad audience (namely the patient, payer, health care providers, healthcare sector, health system, and societal perspectives), providing their most established definitions and outlining the corresponding implications of their uses in health economic studies, with examples particularly from LMIC settings. We then discuss important considerations when selecting the perspective and present key arguments to consider when deciding whether the societal perspective should be used. We conclude that there is no one-size-fits-all answer to what perspective should be used and the perspective chosen will be influenced by the context, policymakers'/stakeholders' viewpoints, resource/data availability, and intended use of the analysis. Moving forward, considering the ongoing issues regarding the variation in terminology and practice in this area, we urge that more standardised definitions of the different perspectives and the boundaries between them are further developed to support future studies and guidelines, as well as to improve the interpretation and comparison of health economic evidence.
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BACKGROUND: The phenomenon of high-cost users (HCUs) in health care occurs when a small proportion of patients account for a large proportion of health care expenditures. By understanding this phenomenon during the COVID-19 pandemic, tailored interventions can be provided to ensure that patients receive the care they need and reduce the burden on the health system. OBJECTIVES: This study aimed to determine (1) whether the HCUs phenomenon occurred during the pandemic in Thailand by exploring the pattern of inpatient health expenditures over time from 2016 to 2021; (2) the patient characteristics of HCUs; (3) the top 5 primary diagnoses of HCUs; and (4) the potential predictors associated with being an HCU. METHODS: The secondary data analysis was conducted via inpatient department (IPD) e-Claim data from the National Health Security Office for the Universal Coverage Scheme, which provides health care to ~ 80% of the Thai population. Health care expenditure over time was calculated, and the characteristics of the population were examined via descriptive analysis. Multinomial logistic regression was applied to explore the potential predictors associated with being an HCU. RESULTS: The characteristics of HCUs remained relatively the same from 2016 to 2021. In terms of the proportion of male (55%) to female patients (45%), the age ranged from 55 to 57 years, with an estimated 8-day length of hospital stay and 7 admissions per year, and the average health care cost per patient was ≥ USD 2,860 (100,000 THB). The low-cost users (LCUs) group (the bottom 50% of the population), had more female patients (55%), a younger age ranging from 27 to 33 years, a 3-day length of stay, 1â2 admissions per year, and a lower average health care cost per patient, which was less than USD 315 (≤ 11,000 THB). CONCLUSION: The HCUs phenomenon still existed even with limited health care accessibility or lockdown measures implemented during the COVID-19 pandemic. This finding could indicate the uniqueness of the need for health services by HCUs, which differ from those of other population groups. By understanding the trends of health care utilization and expenditure, along with potential predictors associated with being an HCU, policies can be introduced to ensure the appropriate allocation of health resources to the right people in need of the right care during future pandemics.
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COVID-19 , Gastos en Salud , Humanos , Tailandia/epidemiología , COVID-19/epidemiología , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Gastos en Salud/estadística & datos numéricos , Adulto Joven , Adolescente , Hospitalización/estadística & datos numéricos , Hospitalización/economía , Pandemias/economía , Niño , Preescolar , Lactante , Análisis de Datos SecundariosRESUMEN
OBJECTIVES: This study aimed to perform a comprehensive review of modeling approaches and methodological and policy challenges in the economic evaluation (EE) of precision medicine (PM) across clinical stages. METHODS: First, a systematic review was performed to assess the approaches of EEs in the past 10 years. Next, a targeted review of methodological articles was conducted for methodological and policy challenges in performing EEs of PM. All findings were synthesized into a structured framework that focused on patient population, Intervention, Comparator, Outcome, Time, Equity and ethics, Adaptability and Modeling aspects, named the "PICOTEAM" framework. Finally, a stakeholder consultation was conducted to understand the major determinants of decision making in PM investment. RESULTS: In 39 methodological articles, we identified major challenges to the EE of PM. These challenges include that PM applications involve complex and evolving clinical decision space, that clinical evidence is sparse because of small subgroups and complex pathways in PM settings, a one-time PM application may have lifetime or intergenerational impacts but long-term evidence is often unavailable, and that equity and ethics concerns are exceptional. In 275 EEs of PM, current approaches did not sufficiently capture the value of PM compared with targeted therapies, nor did they differentiate Early EEs from Conventional EEs. Finally, policy makers perceived the budget impact, cost savings, and cost-effectiveness of PM as the most important determinants in decision making. CONCLUSIONS: There is an urgent need to modify existing guidelines or develop a new reference case that fits into the new healthcare paradigm of PM to guide decision making in research and development and market access.
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Atención a la Salud , Medicina de Precisión , Humanos , Análisis Costo-Beneficio , Políticas , PresupuestosRESUMEN
Economic analyses of healthcare interventions are an important consideration in evidence-based policymaking. A key component of such analyses is the costs of interventions, for which most are familiar with using budgets and expenditures. However, economic theory states that the true value of a good/service is the value of the next best alternative forgone as a result of using the resource and therefore observed prices or charges do not necessarily reflect the true economic value of resources. To address this, economic costs are a fundamental concept within (health) economics. Crucially, they are intended to reflect the resources' opportunity costs (the forgone opportunity to use those resources for another purpose) and they are based on the value of the resource's next-best alternative use that has been forgone. This is a broader conceptualization of a resource's value than its financial cost and recognizes that resources can have a value that may not be fully captured by their market price and that by using a resource it makes it unavailable for productive use elsewhere. Importantly, economic costs are preferred over financial costs for any health economic analyses aimed at informing decisions regarding the optimum allocation of the limited/competing resources available for healthcare (such as health economic evaluations), and they are also important when considering the replicability and sustainability of healthcare interventions. However, despite this, economic costs and the reasons why they are used is an area that can be misunderstood by professionals without an economic background. In this paper, we outline to a broader audience the principles behind economic costs and when and why they should be used within health economic analyses. We highlight that the difference between financial and economic costs and what adjustments are needed within cost calculations will be influenced by the context of the study, the perspective, and the objective.
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BACKGROUND: Typhoid vaccination has been shown to be an effective intervention to prevent enteric fever and is under consideration for inclusion in the national immunization program in Lao PDR. METHODS: A cost-utility analysis was performed using an age-structured static decision tree model to estimate the costs and health outcomes of introducing TCV. Vaccination strategies combined with five delivery approaches in different age groups compared to no vaccination were considered from the societal perspective, using the Gavi price of 1.5 USD per dose. The vaccination program was considered to be cost-effective if the incremental cost-effectiveness ratio was less than a threshold of 1 GDP per capita for Lao PDR, equivalent to USD 2,535 in 2020. RESULTS: In the model, we estimated 172.2 cases of enteric fever, with 1.3 deaths and a total treatment cost of USD 7,244, based on a birth cohort of 164,662 births without TCV vaccination that was followed over their lifetime. To implement a TCV vaccination program over the lifetime horizon, the estimated cost of the vaccine and administration costs would be between USD 470,934 and USD 919,186. Implementation of the TCV vaccination program would prevent between 14 and 106 cases and 0.1 to 0.8 deaths. None of the vaccination programs appeared to be cost-effective. CONCLUSIONS: Inclusion of TCV in the national vaccination program in Lao PDR would only be cost-effective if the true typhoid incidence is 25-times higher than our current estimate.
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Análisis de Costo-Efectividad , Fiebre Tifoidea , Humanos , Fiebre Tifoidea/epidemiología , Fiebre Tifoidea/prevención & control , Laos/epidemiología , Análisis Costo-Beneficio , Vacunación , Programas de InmunizaciónRESUMEN
BACKGROUND: Out-patient department (OPD) is a crucial component of the healthcare systems in low- and middle-income countries including Thailand. A considerable impact of coronavirus disease 2019 (COVID-19) pandemic and its control measures, especially the lockdown, on utilisation of OPD services was expected. This study thus aims to estimate the pattern of OPD utilisation during the COVID-19 pandemic in Thailand including overall utilisation and within each sub-groups including diagnostic group, age group, and health region. METHODS: This study was a secondary data analysis of aggregated outpatient data from patients covered under the Universal Coverage Scheme (UCS) in Thailand over a 4-year period (2017-2020). Interrupted time series analyses and segmented Quasi-Poisson regression were used to examine the impact of COVID-19 on the overall OPD utilisation including the impact on each diagnostic group, age groups, health regions, and provinces. RESULTS: Analysis of 845,344,946 OPD visits in this study showed a seasonal pattern and increasing trend in monthly OPD visits before the COVID-19 pandemic. A 28% (rate ratio (RR) 0.718, 95% confidence interval (CI): 0.631-0.819) and 11% (RR 0.890, 95% CI: 0.811-0.977) reduction in OPD visits was observed during the lockdown and post-lockdown periods, respectively, when compared to the pre-lockdown period. Diseases of respiratory system were most affected with a RR of 0.411 (95% CI: 0.320-0.527), while the number of visits for non-communicable diseases (ICD-10: E00-E90, I00-I99) and elderly (> 60 years) dropped slightly. The post-lockdown trend in monthly OPD visits gradually increased to the pre-pandemic levels in most groups. CONCLUSIONS: Thailand's OPD utilisation rate during the COVID-19 lockdown decreased in some diseases, but the service for certain group of patients appeared to remain available. After the COVID-19 lockdown, the rate returned to the pre-pandemic level in a timely manner. Equipped with a knowledge of OPD utilisation pattern during COVID-19 based on a national real-world database could aid with a better preparation of healthcare system for future pandemics.
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Instituciones de Atención Ambulatoria , COVID-19 , Anciano , Humanos , Control de Enfermedades Transmisibles , COVID-19/epidemiología , Pacientes Ambulatorios , Pandemias , Tailandia/epidemiología , Cobertura Universal del Seguro de Salud , Análisis de Series de Tiempo InterrumpidoRESUMEN
OBJECTIVES: Based on a real-world collaboration with innovators in applying early health economic modeling, we aimed to offer practical steps that health technology assessment (HTA) researchers and innovators can follow and promote the usage of early HTA among research and development (R&D) communities. METHODS: The HTA researcher was approached by the innovator to carry out an early HTA ahead of the first clinical trial of the technology, a soft robotic sock for poststroke patients. Early health economic modeling was selected to understand the potential value of the technology and to help uncover the information gap. Threshold analysis was used to identify the target product profiles. Value-of-information analysis was conducted to understand the uncertainties and the need for further research. RESULTS: Based on the expected price and clinical effectiveness by the innovator, the new technology was found to be cost-saving compared to the current practice. Risk reduction in deep vein thrombosis and ankle contracture, the incidence rate of ankle contracture, the compliance rate of the new technology, and utility scores were found to have high impacts on the value-for-money of the new technology. The value of information was low if the new technology can achieve the expected clinical effectiveness. A list of parameters was recommended for data collection in the impending clinical trial. CONCLUSIONS: This work, based on a real-world collaboration, has illustrated that early health economic modeling can inform medical innovation development. We provided practical steps in order to achieve more efficient R&D investment in medical innovation moving forward.
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Robótica , Humanos , Singapur , Análisis Costo-Beneficio , Economía Médica , Evaluación de la Tecnología BiomédicaRESUMEN
OBJECTIVES: The purpose of this study is to evaluate the validity of the standard approach in expert judgment for evaluating precision medicines, in which experts are required to estimate outcomes as if they did not have access to diagnostic information, whereas in fact, they do. METHODS: Fourteen clinicians participated in an expert judgment task to estimate the cost and medical outcomes of the use of exome sequencing in pediatric patients with intractable epilepsy in Thailand. Experts were randomly assigned to either an "unblind" or "blind" group; the former was provided with the exome sequencing results for each patient case prior to the judgment task, whereas the latter was not provided with the exome sequencing results. Both groups were asked to estimate the outcomes for the counterfactual scenario, in which patients had not been tested by exome sequencing. RESULTS: Our study did not show significant results, possibly due to the small sample size of both participants and case studies. CONCLUSIONS: A comparison of the unblind and blind approach did not show conclusive evidence that there is a difference in outcomes. However, until further evidence suggests otherwise, we recommend the blind approach as preferable when using expert judgment to evaluate precision medicines because this approach is more representative of the counterfactual scenario than the unblind approach.
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Juicio , Medicina de Precisión , Humanos , Niño , TailandiaRESUMEN
The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities. In this Health Policy paper, we review potential challenges to success in each of these dimensions and discuss policy implications. To guide our review, we developed a dashboard to highlight key characteristics of 26 leading vaccine candidates, including efficacy levels, dosing regimens, storage requirements, prices, production capacities in 2021, and stocks reserved for low-income and middle-income countries. We use a traffic-light system to signal the potential contributions of each candidate to achieving global vaccine immunity, highlighting important trade-offs that policy makers need to consider when developing and implementing vaccination programmes. Although specific datapoints are subject to change as the pandemic response progresses, the dashboard will continue to provide a useful lens through which to analyse the key issues affecting the use of COVID-19 vaccines. We also present original data from a 32-country survey (n=26â758) on potential acceptance of COVID-19 vaccines, conducted from October to December, 2020. Vaccine acceptance was highest in Vietnam (98%), India (91%), China (91%), Denmark (87%), and South Korea (87%), and lowest in Serbia (38%), Croatia (41%), France (44%), Lebanon (44%), and Paraguay (51%).
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Vacunas contra la COVID-19/clasificación , Vacunas contra la COVID-19/economía , Vacunas contra la COVID-19/provisión & distribución , COVID-19/prevención & control , Desarrollo de Medicamentos , Programas de Inmunización , Salud Global , Accesibilidad a los Servicios de Salud , Humanos , Cooperación Internacional , Aceptación de la Atención de Salud , Asignación de RecursosRESUMEN
OBJECTIVES: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR-The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. METHODS: The joint Task Force consisted of 15 members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to 2 rounds of peer review. RESULTS: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. CONCLUSIONS: The guidance and the checklist contain a series of questions, grouped by 6 phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.
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Tecnología Biomédica , Evaluación de la Tecnología Biomédica , Comités Consultivos , Lista de Verificación , Economía Médica , Humanos , Evaluación de la Tecnología Biomédica/métodosRESUMEN
Many countries seek to secure efficiency in health spending through establishing explicit priority setting institutions (PSIs). Since such institutions divert resources from frontline services which benefit patients directly, it is legitimate and reasonable to ask whether they are worth the money. We address this question by comparing, through simulation, the health benefits and costs from implementing two alternative funding approaches - one scenario in which an active PSI enables cost-effectiveness-threshold based funding decisions, and a counterfactual scenario where there is no PSI. We present indicative results for one dataset from the United Kingdom (published in 2015) and one from Malawi (published in 2018), which show that the threshold rule reliably resulted in decreased health system costs, improved health benefits, or both. Our model is implemented in Microsoft Excel and designed to be user-friendly, and both the model and a user guide are made publicly available, in order to enable others to parameterise the model based on the local setting. Although inevitably stylised, we believe that our modelling and results offer a valid perspective on the added value of explicit PSIs.
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Análisis Costo-Beneficio , Simulación por Computador , Humanos , Reino UnidoRESUMEN
OBJECTIVES: Health technology assessment (HTA) plays a central role in the coverage and reimbursement decision-making process for public health expenditure in many countries, including Thailand. However, there have been few attempts to quantitatively understand the benefits of using HTA to inform resource allocation decisions. The objective of this research was to simulate the expected net monetary benefit (NMB) from using HTA-based decision criteria compared to a first-come, first-served (FCFS) approach using data from Thailand. METHODS: A previously published simulation model was adapted to the Thai context which aimed to simulate the impact of using different decision-making criteria to adopt or reject health technologies for public reimbursement. Specifically, the simulation model provides a quantitative comparison between an HTA-based funding rule and a counterfactual (FCFS) funding rule to make decisions on which health technologies should be funded. The primary output of the model was the NMB of using HTA-based decision criteria compared to the counterfactual approach. The HTA-based decision rule in the model involved measuring incremental cost-effectiveness ratios against a cost-effectiveness threshold. The counterfactual decision rule was a FCFS (random) selection of health technologies. RESULTS: The HTA-based decision rule was associated with a greater NMB compared to the counterfactual. In the investigated analyses, the NMB ranged from THB24,238 million (USD725 million) to THB759,328 million (USD22,719 million). HTA-based decisions led to fewer costs, superior health outcomes (more quality-adjusted life-years). CONCLUSIONS: The results support the hypothesis that HTA can provide health and economic benefits by improving the efficiency of resource allocation decision making.
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Asignación de Recursos , Evaluación de la Tecnología Biomédica , Análisis Costo-Beneficio , Años de Vida Ajustados por Calidad de Vida , TailandiaRESUMEN
OBJECTIVES: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR-The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. METHODS: The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review. RESULTS: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. CONCLUSIONS: The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.
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Tecnología Biomédica , Evaluación de la Tecnología Biomédica , Comités ConsultivosRESUMEN
Public health emergencies (PHEs), such as the COVID-19 crisis, are threats to global health and public order. We recommend that countries bolster their PHE responses by investing in health technology assessment (HTA), defined as a systematic process of gathering pertinent information on and evaluating health technologies from a medical, economic, social and ethical standpoint. We present examples of how HTA organizations in low- and middle-income countries have adapted to supporting PHE-related decisions during COVID-19 and describe the ways HTA can help the response to a PHE. In turn, we advocate for HTA capacity to be further developed globally and for increased institutional acceptance of these methods as a building block for preparedness and response to future PHEs. Finally, the long-term potential of HTA in strengthening health systems and embedding confidence and transparency into scientific policy should be recognized.
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COVID-19 , Evaluación de la Tecnología Biomédica , Humanos , Salud Pública , Política de Salud , Urgencias MédicasRESUMEN
BACKGROUND: Health technology assessment (HTA) agencies have an important role to play in managing the rising demands on health systems. However, creating and running such agencies potentially diverts resources from frontline services. A large number of studies address the question of 'what is the impact of HTA?'. Several points of heterogeneity in this literature include: purpose of the study, definition of HTA, definition of impact, and scope and rigour of evaluations. Our study seeks to address several limitations in this literature. This study aims to explore the mechanisms of impact of an HTA agency. In doing so, we consider HTA as an institution rather than a knowledge product to build an impact evaluation framework from an international, multi-stakeholder and multi-dimensional perspective. METHODS: We conducted 9 key informant interviews with experts from the international HTA community. We addressed several questions, informed by existing frameworks of impact within the literature, to understand their perspectives on the mechanisms of impact of an HTA agency. We analyse data using logic modelling and impact mapping, as tools to understand and visualise mechanisms of change. FINDINGS: Our impact mapping highlights several distinct, but not necessarily mutually exclusive, mechanisms through which the overall impact of an HTA agency is achieved. These are: the effective conduct of HTA studies; effective use of HTA in agenda-setting and policy formulation processes; effective engagement and external communications; good institutional reputation and fit within the healthcare and policy-making system; effective use of HTA as a tool for the negotiation of health technology prices; and the effective implementation of policy change regarding health technologies. We also identify indicators of these effects. CONCLUSIONS: Our findings and resulting evaluation framework complement and add to existing literature by offering a new perspective on the mechanisms by which HTA agencies generate impact. This new perspective considers HTA as an institution rather than a knowledge product, is international, multi-dimensional, and includes multi-stakeholder views. We hope the analysis will be useful to countries interested in managing HTA performance.
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INTRODUCTION: Despite the documented benefits of using health technology assessments (HTA) to inform resource allocation in health care systems, HTA remains underused, especially in low- and middle-income countries. A survey of global health practitioners was conducted to reveal the top reasons ("excuses") that they had heard from colleagues, policymakers or other stakeholders for not using HTA in their settings. METHODS: There were 193 respondents to the survey. Most responses were from individuals in research organisations (37%), ministries of health (27%) and other government agencies (14%). Participants came from Southeast Asia (40%), the Western Pacific (30%), Africa (15%), Europe (7%), the Americas (7%) and the Eastern Mediterranean region (2%). RESULTS: The top five reasons encountered by respondents related to lack of data, lack of technical skills for HTA, the technocratic nature of the work, the lack of explicit decision rules and the perception that HTA puts a "price on life". CONCLUSIONS: This study aimed to understand and address the top reasons for not using HTA. They fall into three categories: (1) misconceptions about HTA; (2) feasibility issues; and (3) values, attitudes and politics. Previous literature has shown that these reasons can be addressed when identified, and even imperfect HTA analyses can provide useful information to a decision-maker.
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Infecciones por Coronavirus/prevención & control , Pandemias/prevención & control , Neumonía Viral/prevención & control , Vacunación/métodos , Vacunas Virales/provisión & distribución , Adulto , Betacoronavirus/inmunología , COVID-19 , Vacunas contra la COVID-19 , Niño , Infecciones por Coronavirus/economía , Infecciones por Coronavirus/inmunología , Países Desarrollados , Países en Desarrollo , Humanos , Cooperación Internacional , Pandemias/economía , Equipo de Protección Personal/economía , Equipo de Protección Personal/provisión & distribución , Proyectos Piloto , Neumonía Viral/economía , Neumonía Viral/inmunología , SARS-CoV-2 , Factores de Tiempo , Incertidumbre , Vacunación/economía , Vacunación/legislación & jurisprudencia , Vacunas Virales/efectos adversos , Vacunas Virales/economía , Vacunas Virales/normas , Organización Mundial de la Salud/organización & administraciónRESUMEN
Traditional and complementary medicines are increasingly considered possible options for prevention and symptomatic treatment of the novel coronavirus, COVID-19. With renewed attention on these therapies from researchers and policy makers alike, the well-documented challenges of evaluating their safety and efficacy are once again of global concern. Between 2005 and 2018, the World Health Organization conducted a series of surveys, in which 88 percent of responding member states confirmed that their biggest challenge in traditional medicine was the need for technical guidance on research and evaluation. As a first step in pursuing this need, our commentary summarizes thirteen international and regional guidance documents by three broad categories on evaluating safety, efficacy, and product quality for market-based approval and distribution of these treatments. We highlight the paucity of updated international recommendations on these subjects and identify gaps that could inform the current evidence base. All available guidance note the need for evidence surrounding the efficacy of these treatments and practices but are also quick to caution against methodological difficulties in the conduct of such evaluations. Evidence suggests that improved evaluation methods on efficacy and effectiveness are crucial toward expanding future research into establishing the cost-effectiveness of these therapies, in the context of shifting acceptance, interest, and integration of traditional medicines into health systems, and as another step toward Universal Health Coverage.
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COVID-19/terapia , Terapias Complementarias/economía , Terapias Complementarias/métodos , Salud Global , Terapias Complementarias/efectos adversos , Terapias Complementarias/normas , Análisis Costo-Beneficio , Humanos , Fitoterapia/métodos , Fitoterapia/normas , Guías de Práctica Clínica como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , SARS-CoV-2RESUMEN
BACKGROUND: At the height of the COVID-19 pandemic, Thailand had almost depleted its critical care resources, particularly intensive care unit (ICU) beds and ventilators. This prompted the necessity to develop a national guideline for resource allocation. This paper describes the development process of a national guideline for critical resource allocation in Thailand during the COVID-19 pandemic. METHODS: The guideline development process consisted of three steps: (1) rapid review of existing rationing guidelines and literature; (2) interviews of Thai clinicians experienced in caring for COVID-19 cases; and (3) multi-stakeholder consultations. At steps 1 and 2, data was synthesized and categorized using a thematic and content analysis approach, and this guided the formulation of the draft guideline. Within step 3, the draft Thai critical care allocation guideline was debated and finalized before entering the policy-decision stage. RESULTS: Three-order prioritization criteria consisting of (1) clinical prognosis using four tools (Charlson Comorbidity Index, Sequential Organ Failure Assessment, frailty assessment and cognitive impairment assessment), (2) number of life-years saved and (3) social usefulness were proposed by the research team based on literature reviews and interviews. At consultations, stakeholders rejected using life-years as a criterion due to potential age and gender discrimination, as well as social utility due to a concern it would foster public distrust, as this judgement can be arbitrary. It was agreed that the attending physician is required to be the decision-maker in the Thai medico-legal context, while a patient review committee would play an advisory role. Allocation decisions are to be documented for transparency, and no appealing mechanism is to be applied. This guideline will be triggered only when demand exceeds supply after the utmost efforts to mobilize surge capacity. Once implemented, it is applicable to all patients, COVID-19 and non-COVID-19, requiring critical care resources prior to ICU admission and during ICU stay. CONCLUSIONS: The guideline development process for the allocation of critical care resources in the context of the COVID-19 outbreak in Thailand was informed by scientific evidence, medico-legal context, existing norms and societal values to reduce risk of public distrust given the sensitive nature of the issue and ethical dilemmas of the guiding principle, though it was conducted at record speed. Our lessons can provide an insight for the development of similar prioritization guidelines, especially in other low- and middle-income countries.
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COVID-19 , Cuidados Críticos , Enfermedad Crítica , Asignación de Recursos para la Atención de Salud , Accesibilidad a los Servicios de Salud , Pandemias , Guías de Práctica Clínica como Asunto , Toma de Decisiones , Revelación , Ética Médica , Recursos en Salud , Hospitalización , Humanos , Unidades de Cuidados Intensivos , Pronóstico , SARS-CoV-2 , Discriminación Social , Valores Sociales , Participación de los Interesados , Tailandia , ConfianzaRESUMEN
BACKGROUND: Progress towards achieving Universal Health Coverage and institutionalizing healthcare priority setting through health technology assessment (HTA) in the Association of South-East Asian Nations (ASEAN) region varies considerably across countries because of differences in healthcare expenditure, political support, access to health information and technology infrastructure. To explore the status and capacity of HTA in the region, the ASEAN Secretariat requested for member countries to be surveyed to identify existing gaps and to propose solutions to help countries develop and streamline their priority-setting processes for improved healthcare decision-making. METHODS: A mixed survey questionnaire with open- and closed-ended questions relating to HTA governance, HTA infrastructure, supply and demand of HTA and global HTA networking opportunities in each country was administered electronically to representatives of HTA nodal agencies of all ASEAN members. In-person meetings or email correspondence were used to clarify or validate any unclear responses. Results were collated and presented quantitatively. RESULTS: Responses from eight out of ten member countries were analysed. The results illustrate that countries in the ASEAN region are at different stages of HTA institutionalization. While Malaysia, Singapore and Thailand have well-established processes and methods for priority setting through HTA, other countries, such as Cambodia, Indonesia, Lao PDR, Myanmar, the Philippines and Vietnam, have begun to develop HTA systems in their countries by establishing nodal agencies or conducting ad-hoc activities. DISCUSSION AND CONCLUSION: The study provides a general overview of the HTA landscape in ASEAN countries. Systematic efforts to mitigate the gaps between the demand and supply of HTA in each country are required while ensuring adequate participation from stakeholders so that decisions for resource allocation are made in a fair, legitimate and transparent manner and are relevant to each local context.