Health technology assessment (HTA)

卫生技术评估 (HTA)
  • 文章类型: Journal Article
    新的健康技术正在不断发展。然而,它们对健康的影响和对卫生系统的影响并不总是很清楚。面对这种情况,在过去的45年里,卫生技术评估(HTA)在与医疗保健系统中技术实施有关的决策过程中发挥了重要作用。根据CoreModel®EUnetHTA,“完整的HTA”应涵盖九个领域:健康问题和当前技术使用,描述和技术特征,安全,临床有效性,成本和经济评价,伦理分析,组织方面,患者和社会方面,法律方面。在HTA的所有领域中,该方法是基于证据的,并使用流行病学数据,系统评价,以收集有关干预措施和比较者的临床疗效和安全性以及组织和经济模型的最佳证据。一个例外是伦理分析,使用基于价值的方法。虽然在新生儿重症监护病房(NICU)有高度先进的技术环境,HTA尚未在该领域广泛用于确定诊断和治疗程序的“价值”。NICU中使用的诊断工具的一个例子是近红外光谱(NIRS),一种能够实时监测危重新生儿外周组织状况的非侵入性装置。这种诊断工具的可用性可以改善对新生儿临床情况的最合适治疗的选择。NIRS的预期好处激发了对完整HTA的需求。结论:HTA在新生儿重症监护中的应用还很少,但它可能是确定该领域使用的技术的“值”的适当工具。临床试验和HTA的实施可能有助于对新生儿重症监护新技术进行循证评估。这可以促进将最佳健康技术快速引入临床实践。已知内容:•健康技术评估(HTA)在与医疗保健系统中技术的实施有关的决策过程中发挥了重要作用•HTA中道德的中心地位已经众所周知。事实上,道德在HTA中无处不在,和价值判断渗透到所有级别的HTA新功能:•HTA在新生儿重症监护中仍然很少使用,但它可能是确定该领域使用的技术的“价值”的适当工具•临床试验和HTA的实施可能有助于对新生儿重症监护新技术进行基于证据的评估,并将最佳和道德上可接受的健康技术引入临床实践。
    New health technologies are constantly developing. However, their impacts on health and implications for health systems are not always clear. Faced with this situation, in the last 45 years, Health Technology Assessment (HTA) has taken an important role in the decision-making process related to the implementation of technologies in healthcare systems. According to the Core Model® EUnetHTA, a \"full HTA\" should cover nine domains: health problems and current use of technology, description and technical characteristics, safety, clinical effectiveness, costs and economic evaluation, ethical analysis, organizational aspects, patients and social aspects, legal aspects. In all domains of a HTA, the approach is evidence-based and uses epidemiological data, systematic reviews to gather the best level of proofs regarding clinical efficacy and safety of interventions and comparators and organizational and economic models. One exception is the ethical analysis, that uses value-based approach. Although in Neonatal Intensive Care Units (NICUs) there are highly advanced technological environments, HTA has not yet been widely used in this field for determining the \"value\" of the diagnostic and therapeutic procedures. An example of diagnostic tool used in NICUs is the near-infrared spectroscopy (NIRS), a noninvasive device that enables real-time monitoring of the condition of peripheral tissues in critically ill newborns. The availability of this diagnostic tool could improve the choice of the most appropriate treatment to the clinical situation of the newborn. The expected benefit of NIRS motivates the need of a full HTA.    Conclusion: HTA is still little used in Neonatal Critical Care, but it may be the appropriate tool to determine the \"value\" of technologies used in this field. The implementation of clinical trials and HTA may help in an evidence-based evaluation of new technologies for the neonatal critical care. This could facilitate the rapid introduction of the best health technologies into clinical practice. What is Known: • Health Technology Assessment (HTA) has taken an important role in the decision-making process related to the implementation of technologies in healthcare systems • The centrality of ethics in HTA has been known. In fact, ethics is everywhere in HTA, and value judgments permeate all levels of HTA What is New: • HTA is still little used in Neonatal Critical Care, but it may be the appropriate tool to determine the \"value\" of technologies used in this field • The implementation of clinical trials and HTA may help in an evidence-based evaluation of new technologies for the neonatal critical care and in introduction of the best and ethically acceptable health technologies into clinical practice.
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  • 文章类型: Journal Article
    Dalbavancin是一种半合成脂糖肽长效抗生素,被批准用于治疗急性细菌性皮肤和皮肤结构感染(ABSSSI)。在当前以可用病床短缺为特征的医疗保健场景中,其功能可能很有用。
    为了优化dalbavancin的使用,我们实施了若干措施,从而在两个医院环境中从医疗保健系统和患者的角度提出了改进策略。在急诊科,我们只住院符合临床标准而不是逻辑标准的患者(即,需要抗生素治疗输液)。在2017-2023年期间,这一战略应用于40个案例,从而避免了40次住院,总共节省了280天的住院时间。在内科病房和外科,当不再需要住院治疗时,我们尽可能早地让病人出院。在2017-2023年期间,这一战略应用于189个案例,节省至少1,134天的住院时间。在229例患者中,有228例(99.5%)患者的治疗结果良好。
    我们在ABSSSI中使用dalbavancin的经验总体上非常令人满意。功效接近100%。轻微严重的轻微不良事件很少发生。同时,这一策略允许更有效地分配医院病床。Dalbavancin为ABSSSI的管理提供了理想的药效学/药代动力学特征,尤其是在医院病床短缺至关重要的环境中。
    UNASSIGNED: Dalbavancin is a semisynthetic lipoglycopeptide long-acting antibiotic approved for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). Its features can be useful in the current healthcare scenario characterized by the shortage of available hospital beds.
    UNASSIGNED: We implemented several actions in order to optimize the use of dalbavancin allowing an improvement strategy both from the healthcare system and the patient\'s perspective in two hospital settings. In the Emergency Department we hospitalized only patients who met the clinical criteria and not the logistic criteria (i.e., the need for antibiotic therapy infusion). During the years 2017-2023, this strategy was applied in 40 cases, thus avoiding 40 hospitalizations for a total saving of 280 days of hospitalization.In the Internal Medicine ward and surgery department when there was no longer any need for hospitalization, we discharged the patient as early as possible. During the years 2017-2023, this strategy was applied in 189 cases, saving at least 1,134 days of hospitalization. The outcome of the treated patients was favorable in 228 out of 229 patients (99.5%).
    UNASSIGNED: Our experience using dalbavancin in ABSSSI has been very satisfactory overall. The efficacy was close to 100%. Minor adverse events of slight severity occurred rarely. At the same time, this strategy allowed a more efficient allocation of hospital beds. Dalbavancin presents an ideal pharmacodynamic/pharmacokinetic profile for the management of ABSSSI especially in settings where shortage of hospital beds is critical.
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  • 文章类型: Journal Article
    从根本上说,精确肿瘤学说明了肿瘤的分子谱分析可以阐明其生物学行为的途径,多样性,以及通过识别不同的基因突变可能的结果,蛋白质水平,和其他支持癌症进展的生物标志物。下一代测序成为当前临床实践中诊断和治疗指导不可或缺的诊断工具。如今,组织分析受益于通过综合基因组分析和液体活检等方法的进一步支持。然而,肿瘤领域的精准医学存在特定的障碍,例如成本效益平衡和广泛的可及性,特别是在低收入和中等收入国家。一个关键问题是如何有效地将下一代测序扩展到所有癌症患者,从而赋予治疗决策权力。关注还延伸到组织样本的质量和保存,以及卫生技术的评估。此外,随着技术的进步,正在开发新的下一代测序评估,包括碎片组学的研究。因此,我们的目标是描述下一代测序的主要用途,讨论它的\'应用程序,局限性,和未来的路径在肿瘤学。
    Fundamentally precision oncology illustrates the path in which molecular profiling of tumors can illuminate their biological behavior, diversity, and likely outcomes by identifying distinct genetic mutations, protein levels, and other biomarkers that underpin cancer progression. Next-generation sequencing became an indispensable diagnostic tool for diagnosis and treatment guidance in current clinical practice. Nowadays, tissue analysis benefits from further support through methods like comprehensive genomic profiling and liquid biopsies. However, precision medicine in the field of oncology presents specific hurdles, such as the cost-benefit balance and widespread accessibility, particularly in countries with low- and middle-income. A key issue is how to effectively extend next-generation sequencing to all cancer patients, thus empowering treatment decision-making. Concerns also extend to the quality and preservation of tissue samples, as well as the evaluation of health technologies. Moreover, as technology advances, novel next-generation sequencing assessments are being developed, including the study of Fragmentomics. Therefore, our objective was to delineate the primary uses of next-generation sequencing, discussing its\' applications, limitations, and prospective paths forward in Oncology.
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  • 文章类型: Journal Article
    国际临床化学和实验室医学联合会(IFCC)新兴技术部的健康技术评估(HTA)工作组旨在开发一种方法方法,用于为实验室医学技术生成结构化的HTA信息。这种方法旨在支持该国的决策过程,区域,和/或医院级别关于引入特定技术。该模型的重点主要是在“组织方面”和“成本和经济评估”领域内定义评估元素,潜在的区别在于诊断技术的类型(例如,基因测试,分子测试)。为了实现这个项目的目标,对国际HTA机构的网站进行了文献综述和审查。该研究旨在确定用于评估实验室诊断技术的多学科方法学方法,并查明所使用的领域和评估要素。我们发现了7篇方法学文章,描述了用于评估实验室诊断技术的方法学方法。在所考虑的HTA组织中,发现了23份报告,其中7个由欧洲HTA网络(EUnetHTA)生产,4由国家健康与护理卓越诊断评估计划(NICEDAP)制定,和其他HTA机构的12。EUnetHTA报告是涵盖各个领域的快速合作评估,虽然NICEDAP报告侧重于诊断指南,包括技术的描述,临床需要和实践,诊断测试,准确度,有效性,和成本效益。最后,将针对实验室专业人员进行调查,以引入评估要素,根据诊断技术的类型来区分,主要用于组织和经济领域。
    The Health Technology Assessment (HTA) Working Group of the Emerging Technology Division of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) aims to develop a methodological approach for producing structured HTA information for laboratory medicine technologies. This approach seeks to support decision-making processes at the country, regional, and/or hospital levels regarding the introduction of specific technologies. The focus of this model will primarily be on defining assessment elements within the domains of \'organizational aspects\' and \'costs and economic evaluations\', potentially differentiated by the type of diagnostic technology (e.g., genetic tests, molecular tests). To achieve this project\'s goal, a literature review and examination of websites of international HTA agencies have been conducted. The research aims to identify multidisciplinary methodological approaches used to assess laboratory diagnostic technologies and to pinpoint the domains and assessment elements utilized. We found 7 methodological articles describing methodological approaches adopted to assess laboratory diagnostic technologies. Among the HTA organizations considered, 23 reports were found, of which 7 were produced by the European Network of HTA (EUnetHTA), 4 by the National Institute for Health and Care Excellence Diagnostic Assessment Program (NICE DAP), and 12 by other HTA agencies. The EUnetHTA reports were rapid collaborative assessments covering various domains, while the NICE DAP reports focused on diagnostic guidances, including descriptions of technologies, clinical need and practice, diagnostic tests, accuracy, effectiveness, and cost-effectiveness. Finally, a survey targeting laboratory professionals will be conducted to introduce assessment elements, differentiated by the type of diagnostic technology, primarily for organizational and economic domains.
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  • 文章类型: Journal Article
    本文对台湾卫生技术评估(HTA)的发展和管理进行了思考,借鉴我作为前卫生和福利部长的经验。这篇文章探讨了我对HTA的最初愿景,取得进展,面临的挑战,以及在我任职期间吸取的教训。讨论的关键领域包括基于证据的决策,需要一个平衡的决策系统,一个独立的HTA组织的价值证明方面的挑战,并为希望建立自己的HTA机构的国家提供建议。
    This article offers reflections on the development and management of health technology assessment (HTA) in Taiwan, drawing from my experience as a former Minister of Health and Welfare. The article explores my original vision for HTA, progress made, challenges faced, and the lessons learned during my tenure. Key areas discussed include evidence-based decision-making, the need for a balanced decision-making system, challenges in value justification of an independent HTA organization, and recommendations for countries looking to establish their own HTA agencies.
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  • 文章类型: Journal Article
    健康干预和技术评估计划(HITAP)成立于2007年。本文重点介绍了15年以上经验的15个教训,注意到关于HITAP做得很好的五项成就,它目前正在研究的五个领域,和未来工作的五个目标。HITAP建设了HTA的能力,并将研究与泰国的政策和实践联系起来。来自学术和政策领域的合作者,HITAP动员了区域和全球支持,并开发了全球公共产品,以增强HTA领域。HITAP的半自治结构促进了这些变化,尽管他们并非没有挑战。HITAP的目标是继续其关于公共卫生干预和撤资的HTA工作,有效地与利益相关者接触,并战略性地管理其人力资源。往前走,HITAP将在HTA上开发和更新全球公共产品,致力于新兴主题,如早期HTA,解决数字健康问题,现实世界的证据和公平,支持HTA在全球的发展,特别是在低收入环境中,并寻求更有效地与公众接触。HITAP寻求从其经验中学习并在确定的领域进行投资,以使其能够可持续发展。它的旅程可能与其他有兴趣开发HTA计划的国家和机构有关。
    The Health Intervention and Technology Assessment Program (HITAP) was established in 2007. This article highlights 15 lessons from over 15 years of experience, noting five achievements about what HITAP has done well, five areas that it is currently working on, and five aims for work in the future. HITAP built capacity for HTA and linked research to policy and practice in Thailand. With collaborators from academic and policy spheres, HITAP has mobilized regional and global support, and developed global public goods to enhance the field of HTA. HITAP\'s semi-autonomous structure has facilitated these changes, though they have not been without their challenges. HITAP aims to continue its work on HTA for public health interventions and disinvestments, effectively engaging with stakeholders and strategically managing its human resources. Moving forward, HITAP will develop and update global public goods on HTA, work on emerging topics such as early HTA, address issues in digital health, real-world evidence and equity, support HTA development globally, particularly in low-income settings, and seek to engage more effectively with the public. HITAP seeks to learn from its experience and invest in the areas identified so that it can grow sustainably. Its journey may be relevant to other countries and institutions that are interested in developing HTA programs.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    药物再利用面临各种挑战,可能会阻碍其成功。我们开发了一个框架,概述了药物再利用的关键挑战,以探索卫生技术评估(HTA)方法何时以及如何解决这些问题。我们在数据访问类别中确定了20个药物再利用挑战,研究和开发,合作,商业案例,监管和法律挑战。早期纳入HTA方法,包括文献综述,实证研究,利益相关者咨询,卫生经济评价和不确定性评估,可以帮助解决这些挑战。HTA方法可以评估再利用药物的价值主张,为进一步的研究提供信息,并最终帮助为患者带来具有成本效益的再利用药物。
    Drug repurposing faces various challenges that can impede its success. We developed a framework outlining key challenges in drug repurposing to explore when and how health technology assessment (HTA) methods can address them. We identified 20 drug-repurposing challenges across the categories of data access, research and development, collaboration, business case, regulatory and legal challenges. Early incorporation of HTA methods, including literature review, empirical research, stakeholder consultation, health economic evaluation and uncertainty assessment, can help to address these challenges. HTA methods canassess the value proposition of repurposed drugs, inform further research and ultimately help to bring cost-effective repurposed drugs to patients.
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  • 文章类型: Journal Article
    骨关节炎(OA)是一种退行性关节疾病,具有巨大的全球负担,导致慢性疼痛和生活质量下降。有效管理OA,同时最大限度地利用医疗保健资源至关重要。卫生经济学和卫生技术评估(HTA)是提供评估临床,经济,以及医疗技术和干预措施的伦理方面。本文介绍了卫生经济学和HTA过程在OA管理中的作用。它还说明了在特定的医疗保健环境中进行成本效益分析的一个例子,根据最近一项涉及透明质酸治疗膝关节OA的临床试验。虽然HTA提供了有价值的见解,它面临着数据可用性和资源限制等挑战。将卫生经济学纳入决策可以增强患者护理,并在OA和其他医疗保健领域有效分配资源。
    Osteoarthritis (OA) is a degenerative joint disease with a substantial global burden, causing chronic pain and reduced quality of life. Managing OA efficiently while maximizing healthcare resources is crucial. Health economics and health technology assessment (HTA) are central tools providing a framework to evaluate the clinical, economic, and ethical aspects of healthcare technologies and interventions. This article presents some insights into the role of health economics and the HTA process in OA management. It also illustrates an example of cost-effectiveness analysis in a specific healthcare context, on the basis of a recent clinical trial involving hyaluronic acid treatment for knee OA. While HTA offers valuable insights, it faces challenges like data availability and resource constraints. Integrating health economics into decision-making can enhance patient care and allocate resources effectively in OA and other healthcare domains.
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  • 文章类型: Journal Article
    目的:确定巴生谷公立大学临床年医学生对健康技术评估(HTA)的认知水平及其预测因素,马来西亚。
    方法:对巴生谷四所公立大学的临床年医学生进行了分层随机抽样的横断面研究,马来西亚。使用自我管理的在线问卷收集了有关HTA意识水平及其相关因素的数据。描述性的,双变量,使用IBMSPSS版本27进行多变量分析,以确定HTA及其预测因子的认知水平。
    结果:大多数(69%)的参与者对HTA的认识水平较低。对HTA的高水平认识的预测因素是对HTA的态度(调整后的优势比(AOR)=7.417,95%置信区间(CI):3.491,15.758),HTA上的同伴交互(AOR=0.320,95%CI:0.115,0.888),和以前的HTA培训(AOR=4.849,95%CI:1.096,21.444)。
    结论:公立大学的大多数未来医生对HTA的认识都很低。这项研究强调了对HTA的态度之间的相互作用,同伴互动,和以前的培训作为HTA意识的有影响力的预测因子。建议采取综合全面的教育方法,以培养积极的态度并利用同伴互动的积极方面,同时减轻误解的潜在负面影响。通过结构化计划强调早期接触HTA概念对于增强下一代医疗保健专业人员的能力至关重要。使他们能够驾驭HTA的复杂性,并为马来西亚及其他地区的循证医疗保健实践做出贡献。
    OBJECTIVE: To determine the level of awareness of health technology assessment (HTA) and its predictors among clinical year medical students in public universities in Klang Valley, Malaysia.
    METHODS: A cross-sectional study using the stratified random sampling method was conducted among clinical year medical students in four public universities in Klang Valley, Malaysia. Data on the level of awareness of HTA and its associated factors were collected using a self-administered online questionnaire. Descriptive, bivariate, and multivariate analyses were performed using IBM SPSS version 27 to determine the level of awareness of HTA and its predictors.
    RESULTS: Majority (69 percent) of participants had a low level of awareness of HTA. The predictors of high-level awareness of HTA were attitude toward HTA (adjusted odds ratio (AOR) = 7.417, 95 percent confidence interval (CI): 3.491, 15.758), peer interaction on HTA (AOR = 0.320, 95 percent CI: 0.115, 0.888), and previous training on HTA (AOR = 4.849, 95 percent CI: 1.096, 21.444).
    CONCLUSIONS: Most future doctors in public universities exhibit a low awareness of HTA. This study highlights the interplay between attitudes toward HTA, peer interaction, and previous training as influential predictors of HTA awareness. An integrated and comprehensive educational approach is recommended to cultivate a positive attitude and harness the positive aspects of peer interaction while mitigating the potential negative impact of misconceptions. Emphasizing early exposure to HTA concepts through structured programs is crucial for empowering the upcoming generation of healthcare professionals, enabling them to navigate HTA complexities and contribute to evidence-based healthcare practices in Malaysia and beyond.
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