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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 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?

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 technology.

2.1 Essential evidence for future committee decision making

Improvement in adenoma detection rate (ADR) by polyp type and size

The committee said that evidence showed that the 5 AI software technologies significantly increase adenoma detection rate (ADR). But it concluded that there was not enough evidence to determine whether the software increases detection of advanced adenomas or sessile serrated lesions (SSLs). This is important because these polyps are more likely to develop into cancer. The committee needs more evidence, categorised by polyp type and size, on whether using the software leads to an improvement in ADR for advanced adenomas and SSLs.

Change in post-colonoscopy colorectal cancer rates

While a significant increase in ADR was seen when AI software was used, it was not clear if this translated into a change in the number of cases of colorectal cancer detected post colonoscopy. The committee said that there was not enough evidence on the type and size of adenomas that the software helped to detect. This means that the improved ADR may be caused by increased numbers of small adenomas being detected. Small adenomas are less likely to develop into colorectal cancer. The committee would like more evidence on whether using these AI software technologies leads to changes in post-colonoscopy colorectal cancer rates.

Impact on clinical management

The committee noted that there was a lack of data about how the increased identification and removal of polyps may impact on costs and surveillance intervals. It was concerned that it could lead to an increase in the overall number of colonoscopies with no clear corresponding clinical benefit. The committee concluded that more evidence is needed on the impact of introducing the AI software on clinical management following polyp identification. More evidence is particularly needed on the effect of the software on decisions made about follow up, surveillance intervals and additional excision and testing of polyps.