Abstract：
BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS.
METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements.
RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits.
CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.
METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements.
RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits.
CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.
摘要：
背景：机器人辅助手术（RAS）的健康技术评估（HTAs）在评估机器人手术平台的价值方面面临着一些挑战。由于采用了不同的评估方法，以前的HTAs在评估RAS时得出了不同的结论。虽然可用的系统和外科手术的数量正在快速增长，评估MedTech的现有框架提供了一个起点，但RAS的HTA需要具体考虑，以确保一致的结果。这项工作旨在讨论不同的方法，并为评估RAS提供指导。
方法：采用共识会议研究方法。由14名专家组成的小组具有国际经验，代表相关利益相关者：临床医生，健康经济学家,HTA从业者，政策制定者,和工业。对以前的HTA进行了回顾，并从文献中提取了七个关键主题以供考虑。在五次会议上，小组讨论了关键主题，并制定了共识声明。
结果：总共从25个国家中确定了98个以前的HTA。七个关键主题是证据纳入和排除，患者和临床医生报告的结果，学习曲线，成本分配，适当的时间范围，经济分析方法，和机器人生态系统/更广泛的好处。
结论：机器人手术平台是工具，不是疗法。它们的价值因情况而异，应在治疗领域和利益相关者之间予以考虑。本文提出的原则应有助于各级HTA机构评估RAS。这项工作可以作为MedTech中需要特别考虑HTAs的快速发展领域的案例研究。
方法：采用共识会议研究方法。由14名专家组成的小组具有国际经验，代表相关利益相关者：临床医生，健康经济学家,HTA从业者，政策制定者,和工业。对以前的HTA进行了回顾，并从文献中提取了七个关键主题以供考虑。在五次会议上，小组讨论了关键主题，并制定了共识声明。
结果：总共从25个国家中确定了98个以前的HTA。七个关键主题是证据纳入和排除，患者和临床医生报告的结果，学习曲线，成本分配，适当的时间范围，经济分析方法，和机器人生态系统/更广泛的好处。
结论：机器人手术平台是工具，不是疗法。它们的价值因情况而异，应在治疗领域和利益相关者之间予以考虑。本文提出的原则应有助于各级HTA机构评估RAS。这项工作可以作为MedTech中需要特别考虑HTAs的快速发展领域的案例研究。
