Roberts Derek J, Zygun David A, Ball Chad G, Kirkpatrick Andrew W, Faris Peter D, James Matthew T, Mrklas Kelly J, Hemmelgarn Brenda D, Manns Braden, Stelfox Henry T
Division of Vascular and Endovascular Surgery, Department of Surgery, University of Ottawa, The Ottawa Hospital, Civic Campus, Room A280, 1053 Carling Avenue, Ottawa, Ontario, K1Y 4E9, Canada.
Division of Critical Care Medicine, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
BMC Surg. 2019 Aug 27;19(1):119. doi: 10.1186/s12893-019-0586-5.
As it may be argued that many surgical interventions provide obvious patient benefits, formal, staged assessment of the efficacy and safety of surgical procedures has historically been and remains uncommon. The majority of innovative surgical procedures have therefore often been developed based on anatomical and pathophysiological principles in an attempt to better manage clinical problems.
In this manuscript, we sought to review and contrast the models for pharmaceutical and surgical innovation in North America, including their stages of development and methods of evaluation, monitoring, and regulation. We also aimed to review the present structure of academic surgery, the role of methodological experts and funding in conducting surgical research, and the current system of regulation of innovative surgical procedures. Finally, we highlight the influence that evidence and surgical history, education, training, and culture have on elective and emergency surgical decision-making. The above discussion is used to support the argument that the model used for assessment of innovative pharmaceuticals cannot be applied to that for evaluating surgical innovations. It is also used to support our position that although the evaluation and monitoring of innovative surgical procedures requires a rigorous, fit-for-purpose, and formal system of assessment to protect patient safety and prevent unexpected adverse health outcomes, it will only succeed if it is supported and championed by surgical practice leaders and respects surgical history, education, training, and culture.
We conclude the above debate by providing a recommended approach to the evaluation, monitoring, and regulation of surgical innovations, which we hope may be used as a guide for all stakeholders involved in interpreting and/or conducting future surgical research.
由于可以认为许多外科手术干预能为患者带来明显益处，因此，对手术程序的疗效和安全性进行正式的、分阶段评估在历史上并不常见，现在依然如此。因此，大多数创新性手术程序往往是基于解剖学和病理生理学原理开发的，旨在更好地处理临床问题。
在本论文中，我们试图回顾和对比北美的药物和手术创新模式，包括其发展阶段以及评估、监测和监管方法。我们还旨在回顾学术外科的当前结构、方法学专家和资金在开展外科研究中的作用，以及创新性手术程序的现行监管体系。最后，我们强调证据、手术史、教育、培训和文化对外科择期手术和急诊手术决策的影响。上述讨论用于支持以下观点：用于评估创新药物的模式不能应用于评估手术创新。它还用于支持我们的立场，即尽管对创新性手术程序的评估和监测需要一个严格、适用且正式的评估体系，以保护患者安全并防止意外的不良健康后果，但只有在外科实践领导者的支持和倡导下，并尊重手术史、教育、培训和文化，该体系才能成功。
我们通过提供一种推荐的手术创新评估、监测和监管方法来结束上述辩论，我们希望该方法可作为所有参与解释和/或开展未来外科研究的利益相关者的指南。
