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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

    Could the period while surgeons are learning to use the technologies have a significant impact on the clinical and cost-effectiveness of them?

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 company 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 benefits of the technologies.

Essential evidence for future committee decision making

Impact on patient quality of life

The impact of robot-assisted surgery (RAS) on people's daily lives in comparison with conventional surgery is uncertain. Information about the impact that RAS has on people's symptoms and quality of life should be recorded using appropriate patient-reported outcome measures, for example those outlined in section 3.4.

Resource use

More information on how RAS would affect resource use during and after implementation is needed to help the committee understand RAS's clinical and cost effectiveness. For example, the technologies could reduce the number of follow-up physiotherapy appointments, length of hospital stays and readmission rates.

Resource estimates should include:

  • the immediate impact of RAS on surgical theatres, for example the number of procedures per day, staffing (number and grade) and total surgery and theatre time, and the cost of any associated consumables

  • the use of post-surgery NHS services, for example the number of revisions, hospital readmissions and physiotherapy sessions (see section 3.4).

Further evidence about this will support future economic evaluations in estimating the impact of RAS on consumables, surgical capacity and use of other post-surgery NHS services.

Evidence that further supports committee decision making

Clinical impact in different subgroups

There is limited evidence on the clinical impact of RAS in different subgroups. Most of the evidence for RAS is in young people with normal body mass indexes. There may be more complications during surgery in older people and people who are overweight or have obesity. So, further evidence is needed to assess the clinical impact of RAS in these subgroups. The committee heard that people from a Southeast Asian background may benefit more from RAS for knee replacements because of anatomical differences that can cause poor alignment with conventional surgery.

The impact of RAS in people with more complex surgical requirements is uncertain. The committee heard that evidence showing the benefits of using RAS in these subgroups would support future clinical and cost-effectiveness modelling.