Versius in urology: an <scp>IDEAL</scp> start

Abstract

The brief report by Reeves et al. [1], who used the IDEAL Framework [2] to guide their initial use of the Versius robotic system in urological surgery, highlights the importance of well-designed evaluation in early clinical research on modern surgical technology. Appropriate evaluation of surgical robotics is a tricky issue because robots are a classic ‘disruptive’ technology [3], changing every aspect of the working environment. Clinical evaluation of safety and effectiveness is only one of numerous dimensions which need to be included in a comprehensive assessment of their overall value. Other important perspectives include engineering, economics, ergonomics, ethics, operator training and the integration of robotics with artificial intelligence, and the complexity of the evaluation challenge has prompted the IDEAL Collaboration to initiate a multidisciplinary discussion about how to integrate these components into a coherent comprehensive assessment [4]. The Reeves case series included four robot-assisted radical prostatectomy procedures, five upper tract procedures and an adrenalectomy, and illustrates the value of transparent reporting of challenges and adaptation during the early clinical study of new techniques and technology (IDEAL Stages 1 and 2a). This stage in the evolution of new devices is characterized by the need to respond to unforeseen challenges, but traditional case reports rarely focus on these. Providing detailed information about the process of discovery clarifies how and why the authors developed their approach as they did. This is an important step up in communication, allowing peers to avoid repeating unsuccessful variation and to understand the empirical basis of the final version described. The reporting and explanation of case selection and team training in this paper highlights their diligent preparation, and the benefits it yielded. The use of simulation and rehearsal to troubleshoot the set-up of the equipment and to re-orient surgeons to Versius after using other technologies was particularly notable. The ergonomics of human–machine interaction is crucial in optimizing complex robotic technology, and the use of non-clinical (IDEAL Stage 0) studies to do this represents an ethically commendable approach to maximizing patient safety. Reporting of outcomes was clear and comprehensive, again providing a high level of transparency. Set-up time was initially long but quickly decreased, illustrating a group learning curve. The problems reported using Versius in patients with low body mass index, due to the design feature forcing 5 cm of penetration into the abdominal cavity before instruments will function, has been noted in reports from other specialities [5], and will undoubtedly be under study by the Versius engineers. Finally, the authors' comments on bedside unit and port site placement suggest that more development work is required to optimize use in some urological procedures. The IDEAL 2a stage ends when a stable version of the technique and device emerges with which the innovators are satisfied. It is important to recognize when this occurs, as attempts at comparative studies are futile until the innovation is a known and stable entity. When that stage is reached, those in the field of urology will need to confront the thorny question of randomized trials for robotic surgery. Where there is no rationale for expecting clinical benefit, a randomized trial arguably represents research waste [4], since most other relevant questions at this stage can be evaluated using IDEAL Stage 2b studies. If promising evidence of clinical benefit of using Versius does not emerge, randomized controlled trials (RCTs) might be necessary only for investigating benefits proposed in other fields, such as economics or the health and welfare of the surgical team [6]. It is important, however, to ensure that the commercial pressures involved in high technology innovation and the unavoidable conflicts of interests of clinical pioneers do not impede RCTs when they are needed – as has happened in previous technological revolutions in surgery. The authors note that patients were informed of the novel nature of the Versius system, an ethically necessary step which is too often omitted in early clinical studies. The IDEAL recommendations suggest patients should be informed not only of known risks, but also of the limited extent of clinical experience of new technology, with an explanation of the consequent uncertainty about as-yet-undiscovered risks (so-called ‘unknown unknowns’). It is not clear if this was done, but the authors clearly went beyond regulatory requirements to inform patients, as this study was registered as an audit. A peculiarity of UK clinical research governance is the artificial separation between ‘research’, which is regulated to a burdensomely excessive degree and ‘audit’ and ‘service improvement’, which are almost completely unregulated. This distinction is unhelpful, wasting the time and money of responsible researchers while allowing less ethically sensitive pioneers the discretion to innovate without oversight, or the need to inform peers or patients. The IDEAL framework emerged because surgeons recognized that surgical research needs rational and ethical guidance on study design and reporting from the first-in-human study onwards. Help from the regulatory authorities in clarifying the responsibilities of surgical innovators during early clinical evaluation would be very valuable. None declared. Abbreviation: RCT, randomized controlled trial.

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