Abstract
BackgroundAs 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.Main BodyIn 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.ConclusionWe 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.
Highlights
Approval and monitoring of innovative pharmaceuticals in North America and the central role of the industryfunded, placebo-controlled randomized controlled trial (RCT) Assessment of innovative pharmaceuticals within the United States and Canada occurs within a highly structured model regulated by the U.S Food and Drug Administration (FDA) and Health Canada, respectively [5]
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
We 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
Summary
A recommended approach to the evaluation, monitoring, and regulation of innovative surgical procedures As the development of innovative surgical procedures continues to occur long after its initial use among humans, the approval and monitoring of innovative surgical procedures cannot occur in sequential stages as in the model of pharmaceutical regulation and monitoring [1, 7]. As “unrealistically demanding standards could hinder surgical innovation,” the requirement for large RCTs demonstrating efficacy/effectiveness and safety prior to their use in clinical practice may have a detrimental influence on surgical progress [7]. The evaluation and subsequent monitoring of innovative surgical procedures requires a formal system to prevent recurrent mistakes and protect patients [7]. Surgical innovations should be first reported in case reports and case series and subsequently evaluated in cohort studies followed by RCTs and economic analyses. RCTs are recommended for evaluating surgical innovations by IDEAL, the conduct of these trials may be limited by methodological and technical challenges as well as issues related to external validity and cost. If RCTs are to be viewed as an ideal
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