Evidence generation plan for robot-assisted surgery for soft tissue procedures
2 Evidence gaps
This section describes the evidence gaps, why they need to be addressed and their relative importance for future committee decision making.
The committee will not be able to make a positive recommendation without the essential evidence gaps (see section 2.1) being addressed. The companies can strengthen the evidence base by also addressing as many other evidence gaps (see section 2.2) as possible. This will help the committee to make a recommendation by ensuring it has a better understanding of the patient or healthcare system impact of the technologies.
2.1 Essential evidence for future committee decision making
Understanding the learning curve associated with RAS introduction
Evidence considered by the committee indicates that there is a substantial learning curve when robot-assisted surgery (RAS) technologies are implemented. Further surgeon information and outcomes characterising the learning curve are necessary to help the committee to understand the short- and long-term clinical effectiveness of the technologies.
Resource use
More information on how using the technology would affect resource use during and after implementation is needed to help the committee understand long-term cost effectiveness of the technologies. Key areas that will help to address this evidence gap are:
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technology acquisition and payment model used, and set-up costs
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implementation costs, for example, training costs and staff time needed to support the service, as well as any training costs after completion of initial training
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technology maintenance and component (for example, surgical blades) costs
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the short- and long-term impact of RAS on surgical theatre scheduling, for example, length of surgery, the number and type of procedures done and any change in capacity
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the downstream use of NHS services, for example, number of hospital readmissions.
Clinical impact of RAS
The committee noted that the current evidence comparing clinical effectiveness outcomes against standard care in the NHS is limited. The current evidence was also not available for a sufficient time horizon of at least 12 months. This information will be needed to recommend RAS implementation in the NHS. For example, further information is needed on:
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rates of conversion from minimally invasive surgery to open surgery with and without RAS
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adverse events and complications
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patient outcomes such as length of hospital stay, and long-term outcomes, survival (when appropriate), need for follow-up surgery, and, ideally, health-related quality of life.
2.2 Evidence that further supports committee decision making
Surgeon experience of RAS
Evidence on ergonomics for the surgeon, procedure-related discomfort and uptake rates will help the committee understand how the technologies are viewed by surgeons and assess the real-world uptake of the technologies.
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