Guidance

1 Recommendations

1 Recommendations

1.1 There is not enough evidence to recommend the use of the PredictSURE IBD and IBDX tests. They should only be used in the context of research to help identify people at high risk of a severe course of Crohn's disease and guide treatment.

1.2 Further research is recommended (see section 5) to:

  • assess how accurate the tests are for identifying a low or high risk of a severe course of Crohn's disease

  • understand how the tests affect decisions about treatment

  • assess the clinical outcomes and costs associated with different treatment strategies

  • assess how the tests affect clinical outcomes.

Why the committee made these recommendations

PredictSURE IBD and IBDX are tests that may be able to identify people at high risk of severe Crohn's disease. If people can be identified in this way, clinicians could offer the most appropriate treatment to control symptoms while minimising side effects. 'Top-down' treatment has been suggested to be more effective for people with severe Crohn's disease. This reverses the standard order of treatment, starting with biological therapies such as tumour necrosis factor (TNF)-alpha inhibitors.

The clinical evidence for the tests comes from only a small number of people, which does not give confidence in the results reported. There's also not much evidence on how effective top-down treatment is in people who would be classified as high risk using the test, particularly in the NHS where it is not standard practice.

Because of this and other assumptions made in the economic model, the cost-effectiveness estimates are very uncertain and lack face validity (that is, the results are unexpected). More research is needed to resolve the clinical uncertainties. Therefore, these tests are not recommended for routine use in the NHS.