医疗设备准入评估模型设计与实践

按照世界卫生组织医疗器械技术序列《采购流程与资源指南》中医疗器械标准购置流程,以微型卫生技术评估(Mini-HTA)、VAC价值分析评估以及项目评估模型为依据,建立了标准且完整的医疗设备医院层级准入评估模型。该模型主要包括技术评估、效益评估、安全评估以及附件因素评估等四项指标,以实际证据为依据,采用定性、定量相结合的方式对医疗设备进行评估。应用该模型,对医院2019年50万元以上医疗设备进行准入评估,认为可有效优化医院资源配置,为医疗设备购置决策提供依据。     

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。     

医院医疗器械临床试验的特点及管理对策

该文通过分析中山大学附属第三医院近10年完成的医疗器械临床试验的一般资料,结合临床试验过程中的管理经验,对我院医疗器械临床试验的特点及存在问题进行阐述,并提出相应的管理对策以保证医疗器械试验的质量,提高医院对医疗器械临床试验管理的规范性。     

浅议医疗器械技术评估

本文描述了卫生技术评估的基本概念、重要作用及开展现状,借鉴国外经验,提出了大力推动我国医疗器械技术评估工作的建议。     

西班牙卫生技术评估的发展应用及启示

西班牙卫生技术评估的发展在全球是成功经验之一,经过多年发展,西班牙已经建立了较为成熟的卫生技术评估体系。通过文献复习,总结了西班牙卫生技术评估工作的基本特征、地位、决策过程、医院卫生技术评估发展的相关经验。提出了将HTA作为政府卫生政策的重要工具,加强卫生技术评估协作网建设,大力发展医院卫生技术评估,建立立体全面的卫生技术评估协作体系等政策建议。     

浅议卫生技术人员的绩效评估

卫生技术人员绩效评估是医院人力资源管理的一项重要的基础性工作，也是深化人事分配制度改革的重要举措。建立充分量化、便于操作、富有实效的绩效评估体系，已成为医院人事部门探索思考的问题。本文就卫生技术人员绩效评估的现状及存在的问题进行分析，探讨适合专业特点的卫生技术人员绩效评估方法。     

从贝尔蒙报告审视医疗器械临床试验的伦理问题

医疗器械临床试验是最直接最有效地检测医疗器械性能的方式，贝尔蒙报告是对基本的道德原则及方针的陈述，用来帮助在解决涉及人体实验对象的科研中所产生的道德问题。本文从贝尔蒙报告角度来审视医疗器械临床试验的伦理问题，介绍了贝尔蒙报告产生的背景概念和医疗器械临床试验的概念及基本流程；贝尔蒙报告中的三项原则尊重个人、善行和平等公正原则在医疗器械临床试验中的体现以及针对贝尔蒙报告来解决医疗器械临床试验中产生的伦理问题的重大意义。通过知情同意的具体体现、对风险和好处的评估及受试者的选择和研究成果的分配三方面来解决临床试验中产生的伦理问题。     

我国开展医院卫生技术评估的路径与策略

随着我国卫生医疗领域改革的不断深入和新版《医疗技术临床应用管理办法》的实施,医院在卫生技术准入和管理中的作用逐渐加强,对以医院卫生技术评估为代表的循证支持决策的需求也在增加。本文基于对我国开展医院卫生技术评估试点医院评估项目问题和经验的总结,并结合国际上典型国家的理论基础和实践经验,探索提出我国医院卫生技术评估的发展路径:一是技术路径,包括评估的技术类型、评估流程和评估结果等,并从五个维度提出了我国开展医院卫生技术评估需要重点关注的十个因素;二是治理路径,即如何引入和引导利益相关方以独立的方式参与评估。我国开展医院卫生技术评估试点项目和理论研究的发展目标是尽快探索出符合我国国情的医院卫生技术评估方法、流程及相关制度,发展策略是加强国家指导和与全国医院绩效考核工作相结合以强化认知共识;与医疗联合体建设相结合推进决策转化应用;注重在医院内部通过成果实施、传播和升华培养评估文化;加强卫生技术评估决策转化监管与评估。     

我国医疗器械临床试验监管现状分析及对策探讨

医疗器械的临床试验是医疗器械管理中的重要组成部分。一方面,通过临床试验,医疗器械的安全性和有效性得到合理评估,为医疗器械上市提供科学依据。另一方面,临床试验耗时长,花费多,如果管理不当,有可能增加社会成本,给生产企业甚至消费者带来沉重的经济负担,进而影响医疗器械行业的发展。本文分析了我国医疗器械临床试验管理现状及存在的问题,并且提出了一些改革医疗器械临床试验监管的对策建议。     

我院医疗器械临床试验PDCA专项整改

我院以PDCA循环理论为指导,展开医疗器械临床试验专项整改活动。具体根据机构办对科室医疗器械临床试验运行质量检查记录,对照科室临床试验运行质量评分标准,对整改前、整改期间和整改后的科室医疗器械临床试验运行质量得分以及各要素的得分情况进行统计分析。经过PDCA整改后,科室医疗器械临床试验质量得分、各要素的得分及得分率均显著提高,初步建立了医疗器械临床试验运行管理稳态的长效机制。     

Joint project of the International Network of Agencies for Health Technology Assessment--Part 2: Managing the diffusion of positron emission tomography with health technology assessment

OBJECTIVES: Since 1997, members of the International Network of Agencies for Health Technology Assessment (INAHTA) have collaborated on a Joint Project to track the diffusion, evaluation, and clinical policy of positron emission tomography (PET). Part 2 of this updated Joint Project report summarizes HTA-based strategies for directing the clinical use of PET and a discussion on the value of HTA in managing the diffusion of high cost diagnostic technologies, which were presented at an INAHTA-sponsored workshop at the Health Technology Assessment International Annual Meeting in 2004 on strategies for managing high cost diagnostic technologies. METHODS: A summary of the workshop proceedings is presented. CONCLUSIONS: Sharing assessment work, universal agreement in assessment conclusions, stakeholder input, and modeling techniques help manage the uncertainty in the evidence base while targeting clinical use of PET toward the most promising indications. Emphasis on HTA findings, linkage between financing of clinical PET and outcome evaluation, and targeted dissemination of scientific findings empower providers to reduce unnecessary utilization and contain costs within a quality improvement framework. Above all, a trustworthy source of HTA information and a process that is conducive to using scientific evidence as the basis for decision making are essential for managing the diffusion of complex and costly diagnostic technologies in patient care.     

我国卫生技术现存问题分析

利用卫生统计年鉴数据,通过比较分析我国卫生技术的现状,找出我国卫生技术评估存在的问题。建立权威性的卫生技术评估机构,发挥药物经济性评估在卫生技术中的意义,从而合理配置卫生技术资源,解决当前问题,有利于更好的开展卫生技术的改革与发展。     

The health basket in primary care: an emperor without clothes. SESPAS Report 2012

Despite the apparent stagnation, the development of primary care in response to social changes in recent decades is undeniable, both in figures and in the perception of those providing or using primary care. The traditional difficulties of defining roles and allocating resources among levels of care should be reassessed. A model is required that adjusts the health basket in primary care to today's society, to citizen's new needs and demands, and to the legitimate progress of health professionals, while maintaining the comprehensiveness of this level of care. A model with new resource allocation would increase decision-making in primary health care, thereby improving efficiency in this setting. With a view to equity, because of economies of scale, these changes should be agreed on by the Interregional Council, as the representative of the autonomous communities. The support of the Network of Agencies for Health Technology Assessment, the Institute for Health Information, the GuíaSalud Project and the participation of civil society in its many forms, can offer knowledge and experience for the design, implementation and evaluation of actions designed both to improve clinical practice and enhance the organizational and economic infrastructure necessary to support it.     

Development and Pilot Test of the Registry Evaluation and Quality Standards Tool: An Information Technology–Based Tool to Support and Review Registries

ObjectivesHealth technology assessment (HTA) bodies are increasingly making use of real-world evidence and data. High-quality registries could be an asset for this; nevertheless, there is a lack of specified standards to assess the quality of data in the registry, or the registry itself. The European Network for Health Technology Assessment Joint Action 3 led the work to develop a tool for the evaluation of clinical registries: the “Registry Evaluation and Quality Standards Tool” (REQueST).MethodsREQueST was developed in 4 steps: (1) A partnership between HTA bodies across Europe drafted the assessment criteria. (2) Multiple rounds of consultation across HTA bodies and the public domain developed an Excel version of REQueST. (3) This version was transformed into a web-based application. (4) An external pilot tested this REQueST tool with SMArtCARE and NeuroTransData registries.ResultsHaute Autorité de Santé, the National Institute for Health and Care Excellence, and the Croatian Institute of Public Health led the development of REQueST. Another 4 HTA bodies contributed regularly to development meetings, and all European Network for Health Technology Assessment partners were invited to contribute. Eight methodological, 12 essential, and 3 supplementary criteria were identified. Both pilot registries scored well, fulfilling the requirements for >70% of criteria, with none failed. Feedback by registry holders led to streamlining of the process and clarification of the criteria.ConclusionsThe REQueST tool uses an iterative and collaborative methodology with registry holders. It has the potential to maximize the utility of registry data for decision making by regulatory and HTA bodies and provides a foundation for future research.     

Comparing methods for full versus single technology appraisal: a case study of docetaxel and paclitaxel for early breast cancer

OBJECTIVE: The aim of this study is to compare and contrast the reports of the rapid National Institute for Health and Clinical Excellence (NICE) single technology (STA) process with the full Health Technology Assessment Report (TAR) for the same technologies (docetaxel and paclitaxel for the adjuvant treatment of early breast cancer). METHODS: Documentary analysis was used to compare three reports. A data extraction form was developed to record information on the decision problem addressed in each report, literature searching methods, the clinical effectiveness review, cost-effectiveness analysis, conclusions and issues of concern. RESULTS: The decision problems and search strategies for the STAs differed from those reported in the TAR. Not all trials of clinical effectiveness included in the TAR were reported by manufacturers. The methods and assumptions used to assess the cost-effectiveness of the technologies were generally similar between reports, although only one common health economic comparison was presented across the three reports. The TAR supports the STA results for docetaxel but suggested that the manufacturer's cost-effectiveness estimates for paclitaxel were highly optimistic. CONCLUSIONS: Although the STA process provides the opportunity for rapid appraisal of new technologies, there remains uncertainty concerning the extent to which STAs adequately address the specific decision problem under consideration.     

Decision-Oriented Health Technology Assessment: One Step Forward in Supporting the Decision-Making Process in Hospitals

ObjectivesThis article outlines the Decision-Oriented Health Technology Assessment: a new implementation of the European network for Health Technology Assessment Core Model, integrating the multicriteria decision-making analysis by using the analytic hierarchy process to introduce a standardized methodological approach as a valued and shared tool to support health care decision making within a hospital.MethodsFollowing the Core Model as guidance (European network for Health Technology Assessment. HTA core model for medical and surgical interventions. Available from: http://www.eunethta.eu/outputs/hta-core-model-medical-and-surgical-interventions-10r. [Accessed May 27, 2014]), it is possible to apply the analytic hierarchy process to break down a problem into its constituent parts and identify priorities (i.e., assigning a weight to each part) in a hierarchical structure. Thus, it quantitatively compares the importance of multiple criteria in assessing health technologies and how the alternative technologies perform in satisfying these criteria. The verbal ratings are translated into a quantitative form by using the Saaty scale (Saaty TL. Decision making with the analytic hierarchy process. Int J Serv Sci 2008;1:83–98). An eigenvectors analysis is used for deriving the weights’ systems (i.e., local and global weights’ system) that reflect the importance assigned to the criteria and the priorities related to the performance of the alternative technologies.ResultsCompared with the Core Model, this methodological approach supplies a more timely as well as contextualized evidence for a specific technology, making it possible to obtain data that are more relevant and easier to interpret, and therefore more useful for decision makers to make investment choices with greater awareness.ConclusionsWe reached the conclusion that although there may be scope for improvement, this implementation is a step forward toward the goal of building a “solid bridge” between the scientific evidence and the final decision maker’s choice.     

Elements for assessment of telemedicine applications.

OBJECTIVES: As an initiative of the International Network of Agencies for Health Technology Assessment, an approach to assessment of telemedicine applications was prepared to assist decision makers who are considering introduction and use of this technology. METHODS: Review and commentary drawing on published assessment frameworks and reports of primary evaluations of telemedicine, with particular reference to experience in Finland and Canada. RESULTS: Elements of the approach included development of a business case (considering population and services, personnel and consumers, delivery arrangements, specifications and costs); subsequent evaluation of the telemedicine application; and follow-up (covering the domains of technical assessment, effectiveness, user assessment of the technology, costs of telemedicine, trials, economic evaluation methods, and sensitivity analysis). CONCLUSIONS: Decision makers should link introduction of new and often costly technology to appraisal of its feasibility, followed by evaluation of the application, including longer term consideration of its sustainability and impact on the healthcare system. As the effectiveness and efficiency of telemedicine applications will often be strongly influenced by local issues, results of assessments may not be generalizable.