人工晶体卫生技术评估方法学分析及启示

目的通过分析国际典型的人工晶体卫生技术评估(HTA)案例，为我国开展相关评估提供方法学参考。方法通过范围综述方法检索国际卫生技术评估网络成员HTA机构网站，对纳入的人工晶体HTA报告进行结构化信息提取和分析。结果共纳入3个国家5家HTA机构的15篇HTA报告，其中，rHTA 12篇，fHTA 3篇。HTA评估的核心维度为安全性和有效性,支持医保部门的研究需要纳入经济性维度。对现有研究证据开展系统分析是当前主流方法，但针对重大决策的HTA一般会进行本土化数据收集和分析。结论可为我国开展人工晶体HTA的总体设计、评估问题、评估维度、工具方法、具体指标等选择提供方法学参考，从而助力我国高值耗材治理决策制定。     

泰国卫生技术评估机制建设现状及启示

文章介绍了泰国卫生技术评估的发展历程、具体应用、机构建设,以及运行机制和规范化评估工具。启示我国在国家级HTA机构发展良好的基础上,应鼓励各地区设立和发展HTA机构;建立完整规范的决策转化机制;逐步建设形成适合我国的卫生技术评估规范化工具;建设HTA数据共享平台,以不断提升我国卫生技术评估能力。     

国内外卫生技术评估研究现状及应用

卫生技术评估(HTA)主要评估某项卫生技术的有效性、安全性、经济性和社会影响。它被广泛应用于卫生保健领域和医疗服务系统,其研究成果是卫生决策的重要依据。但HTA在我国的发展时间较短,仍属新领域。本文将对HTA的有关内容做一简要介绍,旨在推广这一新型评估技术的应用。     

欧洲卫生技术评估术语表的开发及启示

系统介绍了欧洲卫生技术评估术语表的产生背景、开发过程和应用意义,并提出了开发我国HTA术语表,建立HTA交流平台,引进国外卫生技术评估报告等建议。     

CT卫生技术评估报告分析及启示

目的为我国开展影像学诊断设备卫生技术评估（HTA）提供方法学参考。方法检索国际卫生技术评估机构网站,对纳入的CT HTA报告进行结构化信息提取和分析。结果共纳入4个国家6家机构的24篇HTA报告。其中,快速卫生技术评估12篇,全面卫生技术评估12篇。评估核心维度为有效性、经济性和安全性。纳入报告均采用了文献综述分析,部分针对重大决策的HTA进行了Meta分析、成本-效果分析和预算影响分析。 结论可为我国CT等影像学诊断设备技术评估提供参考,提高我国大型医疗设备治理决策的科学化水平。     

卫生技术评估认知与需求现况调查

目的 了解浙江省卫生技术及管理人员对卫生技术评估(HTA)的认知和需求,为进一步开展HTA工作提供建议.方法 采用问卷调查与访谈相结合的方法对3家医院,1家公共卫生机构,8家卫生行政机构的102位运用HTA结果的潜在使用者和22位决策者进行了调查.结果 被调查者认为卫生技术相关政策法规在卫生技术信息来源最为重要,卫生技术临床疗效在用于决策的卫生技术相关信息中最为重要,相关研究质量太差是影响卫生技术评估的最大障碍.结论 浙江省卫生技术及管理人员对于HTA有一定的认知与需求,但关注度不够,针对遇到的障碍提出了HTA进一步发展的建议.     

金砖五国卫生技术评估应用比较研究

卫生技术评估(HTA)能够为医疗卫生服务提供可靠决策依据。结合文献及国内外卫生技术评估网站的相关资料,从HTA的机构设置、职责范围、资金来源、流程等方面,对金砖五国HTA情况进行梳理和比较分析发现,金砖五国HTA发展水平不一,各国处于HTA发展的不同阶段。其中,巴西和中国的HTA体系发展较为完善,南非发展较为缓慢。金砖五国的HTA发展面临着缺乏专业知识、医疗卫生体系不健全等挑战,需加快发展步伐;巴西、中国仍需进一步加大政府投入,完善HTA体系建设评估指南,提升HTA研究能力;印度应扩大HTA评估网络,提高评估流程的透明度和客观性;南非需加快建立HTA机构。     

决策过程中医院管理者的信息需求分析——基于欧洲九个国家的访谈研究

在欧洲,新卫生技术评估一般依据医院的标准。然而,卫生技术评估(HTA)的指导大纲,如EUnet HTA核心网模型,是由国家卫生技术评估组织制定的,并且按照国家的标准进行决策。该文阐述了一项访谈研究结果,关于欧洲医院管理者决定投资新疗法时所需的信息。这项研究属于Ad Hop HTA的项目。来自欧洲9个国家的53个医院管理者接受了面对面的系统的访谈。医院管理者指出新疗法的临床价值、经济效益、安全性和组织协调方面的信息与决策最为相关。考虑经济因素时,医院管理者一般只着眼于预算效果和报销补偿。除了传统的卫生技术评估的所有信息外,医院管理者有时需要关于新疗法的政治和战略意义方面的信息,尤其是新疗法和医院战略目标之间的关系。如果未来的研究能够证实该研究结果,当医院管理者对新疗法做投资决策时,医院的卫生技术评估指南应该反映医院管理者的信息需求。     

卫生技术评估的发展

卫生技术评估(HTA)仍属新领域。它起源于美国，再传播到欧洲，目前已遍及全世界，在过去的10年中发展尤其迅速。本文概述了HTA的起源、演变、未来发展及相关领域，并重点介绍了英国、瑞典、美国、荷兰及中国HTA的开展情况。     

我国卫生技术评估研究质量影响因素的定性研究

目的挖掘卫生技术评估(HTA)研究质量的影响因素,为提高HTA研究质量、促进研究结果的实践运用提供参考。方法运用关键知情人访谈法,共访谈22名HTA研究者和17名卫生技术管理决策者。结果访谈对象认为的HTA研究质量的影响因素基本一致,包括研究课题的经费投入、研究者本身的学术水平能力、研究课题实施环节中的研究数据质量、研究方法学的严谨性、与课题委托方的沟通交流情况、提出的建议是否符合实际并可操作等。结论加强研究人员与决策人员的沟通交流,提高研究人员的理论素养和实践水平,构建卫生技术管理科学决策机制,加大HTA研究投入,多措并举提高HTA研究质量。     

Health care policy: qualitative evidence and health technology assessment

Since the late 1990s health technology assessment (HTA) has gained influence as a research and evaluation approach supporting health care policy. The focus on this methodology is congruent with the growing importance of evidence-based health care. Although HTA is a multidisciplinary discipline from a theoretical point of view, practice shows that social, ethical and psychological aspects are seldom truly integrated into the assessment of health technology. HTA is still very much biased by the medical and pharmaceutical research traditions. This contribution focuses on the question of how qualitative research findings could be useful as an additional source of information or as 'evidence' in HTA. Medical and health care scientists are seldom acquainted with qualitative research or judge it as a less (or un-)reliable form of research. 'Qualitative dimensions' of health care are not considered 'real' evidence. This contribution argues that qualitative findings could be put higher in the hierarchy of evidence generating research in health care. First it can be realized by improving the knowledge of the nature of qualitative research. Second qualitative findings can become more trustworthy information, if researchers themselves respect methodological prerequisites and clarify their theoretical perspective, research aims and use of research methods. Some methodological characteristics of qualitative research and 'evidence' are discussed for their contribution to HTA and evidence-based health care.     

The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries

ObjectiveMiddle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage.MethodsWe selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA.ResultsAll countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation.ConclusionsThe study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies.     

新加坡、韩国和日本卫生技术评估发展概况及启示

主要对新加坡、韩国和日本3国卫生技术评估的发展概况进行综述,从而为我国卫生技术评估的发展提供经验参考。     

Health technology assessment in The Netherlands

The Dutch healthcare system is not a single overall plan, but has evolved from a constantly changing mix of institutions, regulations, and responsibilities. The resulting system provides high-quality care with reasonable efficiency and equal distribution over the population. Every Dutch citizen is entitled to health care. Health insurance is provided by a mix of compulsory national insurance and public and private insurance schemes. Hospitals generally have a private legal basis but are heavily regulated. Supraregional planning of high-tech medical services is also regulated. Hospitals function under fixed, prospective budgets with regulation of capital investments. Independent general practitioners serve a gatekeeper role for specialist and hospital services and are paid by capitation or fee for service. Specialists are paid by fee for service. All physicians' fees are controlled by the Ministry of Economic Affairs. Coverage of benefits is an important method of controlling the cost of services. There is increasing concern about health care quality. Health technology assessment (HTA) has become increasingly visible during the last 15 years. A special national fund for HTA, set up in 1988, has led to many formal and informal changes. HTA has evolved from a research activity into policy research for improving health care on the national level. In 1993 the government stated formally that enhancing effectiveness in health care was one of its prime targets and that HTA would be a prime tool for this purpose. The most important current issue is coordination of HTA activities, which is now undertaken by a new platform representing the important actors in health care and HTA.     

英国和瑞典卫生技术评估的发展

英国和瑞典开展卫生技术评估较为成熟。对两国卫生技术评估的发展历程和主要机构进行回顾．希望从中汲取经验,进而对我国卫生技术评估的的发展起借鉴作用。     

Evaluating health interventions: exploiting the potential

The importance of the evaluation of health care interventions (EHI) including formal health technology assessment (HTA) cannot be over-emphasised, as its results can inform and improve resource allocation decisions in all parts of the health care system, public and private. At present, fragmented and inefficient resource allocation processes are a universal problem and, as a consequence, patients are deprived of care from which they could benefit. Such outcomes are not only inefficient but also unethical. In this paper we focus on HTA, which emphasises the need to link evidence to policy and practice, but our conclusions can be applied to all types of EHI. There is a need for greater use of economic evidence within HTA. Four principle characteristics of HTA are discussed in this paper: types of knowledge and evaluation, and commissioning and knowledge utilisation. Policy-makers must invest in improving research and receptor capacities for producing and using knowledge, improve quality control, and invest in research into dissemination and implementation mechanisms. The potential of HTA is great, and its use has increased, but it remains largely unexploited in most countries.     

Health technology assessment and the regulation of medical devices and procedures in Quebec. Synergy, collusion, or collision?

In this paper, we discuss the complex relationship between health technology assessment (HTA) and the regulation of medical devices and procedures. The relationship is first examined through a conceptual framework describing the itinerary from research to three levels of policy making: micro (standards of medical practice), meso (institutional rules), and macro (health policies). Four reports from the Quebec Health Technology Assessment Council (CETS) are used to illustrate how HTA activities can influence the regulatory mechanisms operating at each decision-making level. We then discuss the skillful balancing act required from HTA agencies to constantly negotiate the right distance from the regulatory process at which to operate. We propose that HTA agencies should not be incorporated into any regulatory, auditing, or monitoring process. Finally, the relationship between health technology assessment and health care reform is discussed. It is suggested that HTA activities will contribute most during the data-driven preparation and consolidation phases of a reform process. The fast pace of events and the political turmoil characteristic of the implementation phase provide a less receptive environment for HTA contributions.     

Health technology assessment in its local contexts: studies of telehealthcare

Health technology assessment (HTA) is one of the major research enterprises of late modernity, reaching into fields of previously autonomous professional practice, and critically interrogating the organisation and delivery of health care. The 'evaluation' of new health technologies within the field of HTA is increasingly a normative political expectation, as discourses of 'evidence-based' practice run through health policy in the UK and elsewhere. Despite its importance in governing the direction of innovation in health care delivery, there are hardly any empirical studies of HTA in practice. In this paper, we draw on two ethnographic studies of telehealthcare implementation and evaluation in the UK to explore the practical conduct of HTA, and we focus specifically on the social organisation and conduct of randomised controlled trials of these new technologies. The paper examines how evaluation forms a mediating set of practices that make the embedding or normalisation of a new technology possible; and present a simple model of the social and technical contingencies within the evaluation process.     

Health technology assessment in Denmark

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, coordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.     

Health technology assessment: the contribution of qualitative research

The pragmatism in health care has made health technology assessment (HTA) restrict its scope to a particular set of problems, c.q. methods. The "multidisciplinary and comprehensive nature" of HTA, as the concept is presented in certain definitions, is lacking. Health care is also dominated by a positivistic-rationalistic approach of evaluation. In contrast, social studies of evaluations learn that a major difference has to be made between scientific research on (potential) impact of a technology and valuing these effects. In this contribution, we will discuss how the positivistic scientific bias of current HTA practice can be made up with other research traditions. More specifically, we focus on the question of how social scientists and particularly how qualitative research can contribute to HTA, complementary to positivistic studies of evidence and efficacy.