Reflex testing for metabolic-associated fatty liver disease in patients with type 2 diabetes

Approved 02/08/2023, West of Scotland REC 3 (Ground Floor Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0212; WoSREC3@ggc.scot.nhs.uk), ref: 23/WS/0102

Current primary outcome measure as of 07/02/2025:
The number of participants referred to specialist services with suspected liver disease within 12 months of randomisation who are subsequently enrolled in HCC surveillance. The clinical decision to refer for HCC surveillance is made by hospital-based specialists who are independent of the research team.

Previous primary outcome measure:
1. The number of patients diagnosed with moderate or significant liver disease within a year of randomisation (defined as ≥8.2 kPa on VCTE)
2. The number of patients with significant liver disease (defined as ≥12.1 kPa* on VCTE) and referred for HCC surveillance

Both measured using vibration-controlled transient elastography (VCTE) at the following timepoints:
Intervention arm: one time only, at the time of liver assessment, there is no additional follow-up
Control arm: 12 months after consent (via patient records, one time only)

Current secondary outcome measures as of 07/02/2025:
1. The test or combination of tests for liver cirrhosis with the lowest cost per case diagnosed*
2. The sub-group with the lowest cost per case diagnosed*
3. The incremental cost-effectiveness ratio (ICER) of screening for liver cirrhosis in people with T2DM (incremental cost-effectiveness is calculated from a Markov model)
4. The number of cancer deaths avoided by screening (as per Markov modelling)
5. The number of patients diagnosed on VCTE at baseline with ≥F2 disease (liver stiffness is measured in kPa using VCTE, ≥F2 is measured as a liver stiffness of ≥8.2 kPa)

*Measured using micro-costs in pound sterling (£) of the following components of the pathway:
1. Item costs for ELF™ & FIB-4 tests and venepuncture cost
2. Nursing time for venepuncture, VCTE, results delivery and onward referral
3. Cost per VCTE assessment including equipment, equipment servicing and training
4. Community venue hire for liver assessment


Previous secondary outcome measures:
1. ‘Costs per case’ of moderate and significant liver disease identified via reflex testing (i.e. testing all people living with T2DM as part of their routine diabetes care) for liver disease and usual care
2. The test or combination of tests for liver fibrosis with the lowest cost per case
3. The incremental cost-effectiveness ratio (ICER) of reflex testing and HCC surveillance for liver disease in people living with T2DM

Measured using micro-costs in pound sterling (£) of the following components of the pathway:
1. Item costs for ELF™ & FIB-4 tests and venepuncture cost
2. Nursing time for venepuncture, VCTE, results delivery and onward referral
3. Cost per VCTE assessment including equipment, equipment servicing and training
4. Community venue hire for liver assessment

Analysed 12 months after the last patient is recruited to the control arm.