226. PHILOSOPHICAL CONSIDERATIONS IN SURGICAL INNOVATION Free

Innovation in surgery has been viewed as synonymous with progress. This is not always the case as many new innovative processes, devices and techniques do not yield same results in "real world" as they do in the experimental stage. The purpose of this presentation is to discuss the role of philosophical experiment in the process of appraisal of surgical innovation.

A thought experiment was conducted analysing past surgical innovations. Introduction of electrosurgery, laparoscopic cholecystectomy, surgical safety checklist and laparoscopic aortic aneurysm repair were tested. All consequences (known and hypothetical) of these innovations were considered in attempt to establish a more holistic metric of success.

Significant limitations exist in the current assessment methods of innovation "success" which is commonly defined based on the results of a study of chosen pre-set metrics (main outcome). The utility of key metric used to assess innovation (e.g. lengths of hospital stay or visual pain scores) is limited by the choice of these outcomes. This reduces the changes of detecting rate, but possibly, much more significant unintended effects both advantageous and harmful (e.g. discovery of insulin vs thalidomide). The magnitude of detectable change is dictated by practicality of powering controlled studies and exposes results to the sensitivity bias. Unanticipated effects of the innovation are frequently not discovered until it is adopted on a large scale. Various outcomes of innovation are non-commensurable and further complicate the definition of "success".

A novel innovation outcome assessment process is proposed: net global utility, a composite outcome measure which considers all potential effects of innovation (clinical, social, economic, ethical and other). Net global utility is a subjective measure that allows observer to compare non-commensurable values by not using them in isolation. One of the main advantages of net global utility is that it only requires knowledge of available metrics and principles of logical argument, providing an easy assessment tool to boost local oversight of introduction of innovation and policy-making. It includes calculation of risk (probability x consequence) which allows to account for improbable but highly consequential outcomes. Net global utility is compared to the best available alternative and derives internal face validity from this. Net global utility encompasses potential incidental future benefits as well as assessment of innovation against the test of justice.

Defining success in surgical innovation can be challenging. The use of thought experiment and logical argument is described to introduce a novel metric "net global utility" allowing for composite assessment of innovation success. Various previous surgical innovations used to demonstrate the application of the net global utility.