Confidence-Based Surgical Innovation is a framework that promotes responsible surgical innovation by combining evidence-based medicine and philosophical reasoning to provide surgeons with a step-by-step guide to thinking clearly about innovation that aligns with their legal and professional obligations. Using this framework addresses the problems faced by surgical innovation related to surgeons’ obligations and clinical decision-making behaviours that I identify from Australian examples.
Surgical innovation is an essential part of surgical practice, but it is inherently risky. Despite a long history of innovation in surgery and many extraordinary advances in patient care, patients can be harmed by surgical innovation. While it is appropriate to approach innovative surgery with caution in the interests of patient safety, this must be balanced with active promotion of responsible innovation.
Having analysed the legal and professional obligations of surgeons in Australia, I find that existing obligations do not support surgical innovation. Surgeons have legal and professional obligations with respect to their care of patients. These obligations apply to all care provided to patients, whether the care is innovative or not and require surgeons to have a rational basis for the treatment they offer. Usually, the rational basis for treatment arises from clinical evidence and peer professional support. However, clinical evidence and peer support may be limited or lacking for surgical innovation, and in such circumstances is not clear how to proceed so that obligations are met. This culminates in general uncertainty around surgeons’ obligations, which leads to two problems for surgical innovation – first, that much-needed surgical innovation is at risk of not happening when it should, and, second, that when it is undertaken it is not reliably undertaken responsibly.
To address this, I propose a framework to provide surgeons with a clear, stepwise approach to good reasoning about surgical innovation that meets their obligations and promotes responsible implementation of innovation. This framework combines well-established evidence-based medicine principles with philosophical reasoning. The framework, which I have called Confidence-Based Surgical Innovation, provides a structured approach to therapeutic reasoning that has to date been missing. I argue that by using philosophical reasoning alongside evidence-based medicine, we can formalise and defend conclusions about safety and efficacy of surgical innovation. Ultimately resulting in responsible innovation being offered to patients and implemented in ways that more autonomy-enhancing and more defensible in legal and disciplinary proceedings.