Centre for Ethics in Medicine, University of Bristol, Canynge Hall, Bristol, UK.
Centre for Surgical Research, University of Bristol, Canynge Hall, Bristol, UK.
Health Care Anal. 2020 Mar;28(1):73-97. doi: 10.1007/s10728-019-00380-y.
Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (surgical) innovation, that we categorised alliteratively under the themes of "purpose" (about drivers of innovation), "place" (about contexts of innovation), "process" (about differentiating innovation), "product" (about tangible and intangible results of innovation) and "person" (about personal factors and viewpoint). These conceptual areas are used in varying-sometimes contradictory-ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term "innovation" carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term "innovation" from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery.
改进手术干预措施是改善手术效果的关键。确保这些改进措施安全透明地转化至关重要。评估和治理举措，包括 IDEAL 框架和麦考瑞外科创新识别工具，已经开始着手解决这个问题。然而，如果没有一个能够让非外科医生识别创新发生的定义，这些举措的价值就很有限。似乎很难定义创新，因此我们对外科创新进行了概念研究。这表明在（外科）创新讨论中有共同的概念领域，我们将这些领域按主题分类，分别是“目的”（关于创新的驱动力）、“地点”（关于创新的背景）、“过程”（关于创新的区别）、“产品”（关于创新的有形和无形结果）和“人”（关于个人因素和观点）。这些概念领域在不同的讨论中以不同的、有时是矛盾的方式使用。强调这些外科创新的概念领域可能有助于澄清在创新登记处应报告的内容。然而，我们更广泛的结论是，“创新”一词概念包袱太重，无法为外科实践的规范研究提供信息。相反，我们建议在旨在评估和规范外科手术的严肃讨论中，不再使用“创新”一词。在我们看来，研究人员、哲学家和政策制定者应该考虑需要关注外科活动的哪些方面，并制定出可靠的定义来识别这些方面：就我们自己对透明度和安全性的关注而言，这意味着需要找到能够在手术发展过程中客观识别某些风险特征的标准。
