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Surgical improvisation, innovation or research...

The importance of 3rd party oversight

Bariatric-metabolic (BM) surgery delivers extraordinary outcomes, excellent sustained weight loss, saves lives, improves quality of life and improves weight-related comorbidity. Improvements in efficacy, and in particular safety, have been evident over the last decade. Innovation has always been a major part of surgery and, consequently, new techniques and procedures emerge without the rigorous evaluation that is generally required for the approval of drugs and devices. The excitement of innovation is lauded by surgeons, their institutions, and industry, and consumers may feel that “new” is synonymous with improved.

At BM surgical meetings we are enticed by future opportunities - the simplicity of gastric plication; the opportunity to develop a diabetes-specific procedure without the need for weight loss; novel modifications to established procedures to reduce complications; and novel combinations of procedures to reduce risk and improve efficacy.  These surgical “improvements” are often promoted enthusiastically from the podium and there can be urgency for a range of stakeholders to promote local or regional expertise, encourage champions to innovation and encourage an early uptake of innovative change. This rapid sequence of change is associated with considerable risk and, by the very nature of BM surgery; it will take many years, not days or months, to evaluate the outcomes.

The concept of “innovation” in surgery is itself difficult to define and can vary from minor personal improvisation or variations in clinical practice, to more fundamental changes in technique or procedure, which should involve rigorous processes of documentation and oversight. Indeed, the terms “improvisation”, “innovation” and “surgical research” are often used interchangeably, even though they can in reality refer to very different things. A clear definition is important for all stakeholders, especially the patient. Surgeons argue that oversight is not needed as it is tedious and time consuming, and will reduce innovation and slow the progress in the evolution of surgery. I will argue that a low threshold for rigorous documentation and oversight is essential, and indeed is required by the World Medical Society Declaration of Helsinki, as modified in 2008, Seoul, South Korea.

Surgeons often face a dilemma between their duties to act in the best interests of individual patients and to improve surgical standards – a process that inevitably exposes some patients to risk. The classical textbook Bailey and Love’s Short Practice of Surgery suggests a simple test to define innovation as distinct from experimental research: is the innovation an incremental change in personal clinical practice, or does it depart more radically from this? It should be considered that incremental change in personal practice cannot contribute to broader knowledge or enhance surgical training. Put simply, if you want your innovation to inform others or advance surgical practice, then your innovation needs to be rigorously evaluated with appropriate third party oversight.

Why? Johnson and Rogers (J Med Ethics 2012:38(1): 9-12) discuss 4 main reasons for concern.

  • Any innovation has the potential to cause harm
    • In the case of bariatric surgery the harm may come years later.
  • There is a need for informed consent
    • But the risk and benefits of the innovation are not known, and so oversight is required to provide a balanced view of risks and benefits.
  • The role of clinician-researcher is a clear example of conflict of interest
    • Innovative surgeons have status, prestige, and enhanced career and practice opportunities.
    • The price can be an influence on judgement and a distorted consent process. Can the surgeon provide open and objective counselling about their own innovation?
  • Innovation is often expensive, not of proven value and must compete for precious health care resources
    • Surgeons, Institutions and industry can have overly optimistic views of innovations that they support.

Clearly, independent oversight of this process is necessary. Responsibility for such review is granted to ethics committees. These committees address the issues of the justification, design and conduct of the research, the balance between potential risks and likely benefits, consent processes, data management, the distribution of resources, and the management of dualities and conflicts of interests. This modern approach to the regulation and oversight of research has not limited innovation or experimentation; rather, it has supported creative endeavour, ensured the rigor and trustworthiness of data and sustained the confidence of patients and the wider public (Dixon J, Logue J, and Komesaroff P, Promises and Ethical Pitfalls of Surgical Innovation: the Case of Bariatric Surgery. Obesity Surgery 2013).