A. Identify Candidate Topics 确定候选主题

To a large extent, assessment topics are determined, or bounded, by the mission or purpose of an organization. 在很大程度上,评估主题由组织的使命或目的决定或限制。For example, national and regional health plans and other third-party payers generally assess technologies on a reactive basis; a new medical or surgical procedure that is not recognized by payers as being standard or established may become a candidate for assessment. 例如,国家和区域卫生计划以及其他第三方支付机构通常以反应基准来评估技术;因为标准或者已存的治疗,付款方不认可的新的治疗或者手术,可能成为评估的候选。For the US Centers for Medicare and Medicaid Services (CMS), some assessment topics arise in the form of requests for national coverage policy determinations that cannot be resolved at the local level or that are recognized to be of national interest. 对于美国医疗保险和医疗补助服务中心(CMS),一些评估主题出现在国家政策决策上,因为这些主题无法在地方一级解决或被认定为具有国家利益。These requests typically originate with Medicare contractors that administer the program in their respective regions, Medicare beneficiaries (people who are eligible for Medicare), physicians, health product companies, health professional associations, or government entities. 这些要求通常来源于在各自区域管理该计划的医疗保险承包商,医疗保险受益人(符合Medicare资格的人员),医生,医疗产品公司,医疗专业协会或政府机构。CMS may request assistance in the form of “evidence reports” or HTAs from a sister agency, AHRQ, which typically commissions these from one of its Evidence-based Practice Centers (part of the AHRQ Effective Healthcare Program). CMS可能会向姊妹机构AHRQ寻求“证据报告”或HTA的协助;AHRQ通常将其委任给某一循证医学实践中心(循证医学中心也是AHRQ有效医疗保健计划的一部分)。

Apart from requests from CMS, the AHRQ Effective Healthcare Program solicits topic nominations from the public. 除了CMS的要求外,AHRQ有效医疗保健计划也向公众征求主题的提名。Its online topic nomination form requests information about: the health care intervention of interest; any specific comparator(s); patient groups and subgroups affected; health benefits or outcomes; risks/harms/side effects; which (if any) of 14 priority health conditions/diseases are involved; which (if any) of six priority populations is involved; which (if any) federal health program (e.g., Medicare, Medicaid) is involved; why the topic is important; whether the question represents uncertainty for clinicians or policymakers; stakeholders in this topic; how the findings will be used; technical experts relevant to the topic; and any supporting documentation. 其线上提名请求的信息是关于:医疗干预的益处;任何特定的对照;患者组和受影响的亚组;健康益处或结果;风险/危害/副作用;(如果有的话)14个优先健康状况/疾病中,涉及哪些疾病;(如果有的话)在六个优先人群中,涉及哪个人群;(如果有的话)涉及哪些联邦卫生计划(如Medicare,Medicaid);为什么这个话题很重要?对临床医生或政策制定者而言,这个问题是否代表不确定性?这个话题的利益相关者;如何使用研究结果?与专题相关的技术专家;和任何支持文件。

For the UK National Institute for Health and Care Excellence (NICE), topics are not determined internally, but are referred from the UK Department of Health. 对于英国国家卫生与保健优化研究所 (NICE)而言,主题并不是内部决定的,而是由英国卫生部提交。Topics are selected based on such factors as burden of disease, impact on resources, and whether there is inappropriate variation in practice across the UK (NICE 2013).

For the Cochrane Collaboration, potential topics generally arise from members of the more than 50 review groups, who are encouraged to investigate topics of interest to them, subject to the agreement of their review groups. 对于科克伦协作组织,潜在的议题通常由50多个审查小组的成员提出,科克伦协作组织鼓励他们调查他们感兴趣的话题,但须经其审查小组的同意。However, there is as yet no standard or common priority-setting process used across the Cochrane Collaboration (Nasser 2013).

Horizon Scanning

The demand for early information about new, emerging, and existing health care interventions and related trends has prompted the development and evolution of “horizon scanning” functions (Carlsson 1998; Douw 2003; Harper 1998; Packer 2012). Horizon scanning is intended to serve multiple purposes, including, e.g., the following: 水平扫描旨在提供多种用途,如以下列举:

  • Identify potential topics for HTA and information for setting priorities among them 确定HTA的潜在主题和优先级
  • Identify areas of technological change 确定技术变革的领域
  • Anticipate and identify new indications or uses of technologies 预测和识别新适应症和技术的使用
  • Identify variations in use of technologies 确定技术使用的变化
  • Identify inappropriate use of technologies, including over-use, under-use, and improper use 确定技术使用不合理,包括过度使用,使用不足和使用不当
  • Forecast the health and economic impacts of technologies 预测技术对健康和经济的影响
  • Identify levels in improvement in effectiveness in relation to additional costs that would demonstrate the cost-effectiveness of a new technology 确定因为新技术成本效果的额外成本而提升效果的程度
  • Anticipate potential social, ethical, or legal implications of technologies 预测技术潜在的对社会,道德或法律影响
  • Plan data collection to monitor adoption, diffusion, use, and impacts of technologies 规划收集数据,以用于监测技术的采用,传播,使用和影响
  • Enable health care providers, payers, and patients to plan for, adapt to, and manage technological change, including “rising”/emerging technologies and “setting” (becoming obsolescent) technologies (for potential disinvestment) 使卫生保健提供者,付款人和患者能够规划,适应和管理技术变革,包括“上升”/新兴技术和“已存的”(过时的)技术(可能会减少投入)

Most horizon scanning programs generate rapidly completed, brief descriptions of new or emerging technologies and their potential impacts. 大多数水平扫描程序可以快速完成,简要描述新技术和新兴技术及其潜在的影响。Certainly, there are tradeoffs inherent in using early information that may be incomplete or unreliable as opposed to waiting long enough for more definitive information that opportunities to benefit from it may have passed. 当然,使用早期的,可能不完整的或不可靠的信息是固有的权衡,如果为了更明确的信息而等待足够长,从中受益的机会可能已经过去了。HTA programs have made use of horizon scanning in important ways. HTA项目在很多重要方面充分使用了水平扫描。While the major thrust of horizon scanning has been to identify “rising” (new and emerging) technologies that eventually may merit assessment, horizon scanning can identify “setting” technologies that may be outmoded, superseded by newer ones, and candidates for disinvestment (Henshall 2012.) In either case, horizon scanning provides an important input into setting assessment priorities.

Examples of national and international horizon scanning programs are: 国家和国际水平扫描项目,如:

  • AHRQ Healthcare Horizon Scanning System (US) AHRQ医疗水平扫描系统(美国)
  • Canadian Network for Environmental Scanning in Health (CNESH, secretariat at Canadian Agency for Drugs and Technologies in Health [CADTH]) 加拿大卫生环境扫描网络(CNESH,加拿大卫生部药物和技术署秘书处)
  • Centers for Medicare and Medicaid Services Council for Technology and Innovation (US) 医疗保险和医疗补助服务中心技术与创新委员会(美国)
  • ECRI Institute Health Technology Forecast ECRI 健康技术预测研究所
  • EuroScan International Network (International Information Network on New and Emerging Technologies) (secretariat at NHSC, UK) 欧洲扫描国际网络(新兴技术国际信息网络)(英国NHSC秘书处)
  • Health Policy Advisory Committee on Technology (HealthPACT, Australia and New Zealand) 卫生政策技术咨询委员会(HealthPACT,澳大利亚和新西兰)
  • National Evidence-based Healthcare Collaborating Agency Horizon Scanning Center for Innovative Global Health Technology (NECA H-SIGHT, South Korea) 针对全球创新卫生技术的国家循证医学合作机构水平扫描中心(NECA H-SIGHT,韩国)
  • National Horizon Scanning Centre (NHSC, UK) 国家水平扫描中心(NHSC,英国)

For example, the purposes of EuroScan, a collaborative network involving about 20 HTA agencies, are to collect and share information on innovative health care technologies to support decision making and adoption and use of effective, useful, and safe technologies, as well as to provide a forum for sharing and developing methods for early identification and assessment of new and emerging technologies and predicting their potential impacts. 例如,涉及约20家HTA机构的合作网络EuroScan,该组织旨在收集和分享关于创新型医疗技术的信息,以支持决策和效、有用及安全的技术的应用,并提供一个分享和开发早期识别、评估新兴技术和预测其潜在影响的方法的论坛。

The Canadian Network for Environmental Scanning in Health (CNESH) identifies information on new, emerging, or new applications of health technologies and shares this information across Canada. 加拿大环境扫描网络(CNESH)确定了新的、新兴的或新的卫生技术应用的信息,并在加拿大分享这些信息。It also develops and promotes methods for identifying, filtering, and setting priorities among new or emerging health technologies. 它还制定和推广了新的或新兴卫生技术中识别,筛选和确定优先顺序的方法。CNESH produces a “top 10” list of new and emerging health technologies in Canada. CNESH发布了在加拿大“十大”新兴卫生技术的榜单。

The Health Policy Advisory Committee on Technology (HealthPACT) provides evidence-based advice about potentially significant new and emerging technologies to health departments in Australia and New Zealand. 卫生政策技术咨询委员会(HealthPACT)向澳大利亚和新西兰卫生部门提供了潜在的、重大的、新兴技术的循证医学的建议。This supports information exchange and evaluation of the potential impact of these technologies on those national health systems, including informing financing decisions and the managed introduction of new technologies.这些建议支持信息交流和评估这些技术对国家卫生系统的潜在影响,包括通知融资决策和管理对新技术的引进。HealthPACT produces New and Emerging Health Technology Reports and Technology Briefs.

The AHRQ Healthcare Horizon Scanning System provides AHRQ with a systematic process to identify and monitor target technologies and create an inventory of those that have the highest potential for impact on clinical care, the health care system, patient outcomes, and costs. AHRQ 卫生水平扫描系统为AHRQ提供了一个系统的过程,用于识别和监控目标技术,并创建对临床护理,卫生系统,患者医疗效果和成本影响最大的潜在技术的库存。This system is also intended to serve as a tool for the public to identify and find information on new health care technologies (ECRI Institute 2013).

EUnetHTA developed a web-based Planned and Ongoing Projects (POP) database to enable HTA agencies to share information about planned and ongoing projects at each agency, with the aim of avoiding duplication and encouraging collaborative efforts (EUnetHTA 2013).

A 2013 systematic review of international health technology horizon scanning activity identified 23 formal programs, most of which are members of EuroScan, along with a variety of other less structured horizon scanning functions of government and private sector organizations. 2013年国际卫生技术水平扫描活动的系统综述确定了23个正式计划,其中大部分是欧洲扫描的成员,以及其他各式各样的政府和私营部门的结构松散的水平扫描功能。Although the formal programs had somewhat varying emphases on target technologies, time horizons of interest, and methods of scanning and assessment, they generally shared the main functions of identification and monitoring of technologies of interest and evaluation of potential impacts of technologies (Sun 2013).

As shown in Box VI-1, a considerable variety of electronic bibliographic databases, newsletters, regulatory documents, and other sources provide streams of information pertaining to new and emerging health care interventions. The AHRQ Horizon Scanning Protocol and Operations Manual provides a detailed list of databases, news sources, and other information sources for horizon scanning, as well as search filters for horizon scanning of PubMed and Embase (ECRI Institute 2013).

Box VI-1. Information Sources for New and Emerging Health Care Interventions

  • Large bibliographic databases (e.g., PubMed, Embase, SciSearch)
  • Specialized bibliographic databases (e.g., CINAHL, PEDro, PsycINFO)
  • Databases of ongoing research and results (e.g., ClinicalTrials.gov, HSRProj)
  • Priority lists and forthcoming assessments from HTA agencies and vendors
  • Cochrane Collaboration protocols (plans for forthcoming/ongoing systematic reviews)
  • Trade publications (e.g., The Pink Sheet, The Gray Sheet, In Vivo, Medtech Insight, Pharmaceutical Approvals Monthly, Medical Device Daily, GenomeWeb Daily News, Telemedicine and e-Health)
  • General news (e.g., PR Newswire, New York Times, Wall Street Journal)
  • General health care/medical journals and specialty health care/medical journals
  • Health professions and industry news (e.g., American Health Line, Medscape, Reuters Health Industry Briefing, , Reuters Health Medical News)
  • Conference abstracts and proceedings of health professions organizations, health industry groups
  • Technology company web sites
  • Industry association (e.g., AdvaMed, BIO, PhRMA) sites (e.g., AdvaMed SmartBrief, PhRMA New Medicines Database)
  • Market research reports (e.g., Frost & Sullivan; GlobalData; IHS Global Insight; Thomson Reuters)
  • Regulatory agency announcements of market approvals, other developments for new pharmaceuticals, biological, and devices (e.g., FDA Advisory Committee Alerts, FDA Approval Alerts, FDA Drug Daily Bulletin, FDA Device Daily Bulletin)
  • Adverse event/alert announcements (e.g., from FDA MedWatch, NIH Clinical Alerts and Advisories, United States Pharmacopeia)
  • Payer policies, notifications (e.g., CMS Updates to Coverage Pages, Aetna Clinical Policy Bulletins)
  • Reports and other sources of information on significant variations in practice, utilization, or payment policies (e.g., The Dartmouth Atlas)
  • Special reports on health care trends and futures (e.g., from Institute for the Future Health Horizons Program; Institute for Healthcare Improvement)

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