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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?

  • Question on Document

    Is there any ongoing study in addition to the REINFORCE trial and the MASTERY cohort study that we may have missed and could be used to address any evidence gaps?
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Evidence generation plan

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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 robot-assisted surgery (RAS) introduction

Evidence considered by the committee indicates that there is a substantial learning curve when RAS technologies are implemented. Further information characterising the learning curve is 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:

  • technology acquisition and payment model used, and set up costs

  • 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

  • technology maintenance and component (for example, surgical blades) costs

  • the short- and long-term impact of RAS on surgical theatres, for example, length of surgery, the number of procedures done and any change in capacity

  • 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:

  • rates of conversion from minimally invasive surgery to open surgery with and without RAS

  • adverse events and complications

  • patient outcomes such as length of hospital stay, and long-term outcomes including return to normal activities, survival, need for follow-up surgery, and health-related quality of life.

2.2 Evidence that further supports committee decision making

Surgeon opinion of RAS

Evidence on surgeon preference, opinion 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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