LOCal Assessment and Triage Evaluation of Non-Alcoholic Fatty Liver Disease (LOCATE-NAFLD)


Dataset description

The data are the de-identified individual participant data. They include the participants'questionnaire data at baseline and 12 month follow-up; the data from the Fibroscan; the health data extracted from the participants notes.
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Source Study

Trial acronym


Trial ID





Not Applicable


Government body,National Health and Medical Reserach Council

Scientific enquiries

Prof Adrian Barnett

Brief Summary

LOCATE-NAFLD is a randomised trial, comparing two alternative models of care for NAFLD (usual care versus LOCATE-NAFLD care). Participants randomised to the intervention will be screened in the community with a non-invasive device called a Fibroscan, a scan they may otherwise have waited months to receive. The scan results can then determine if their disease, with high risk patients sent to a specialist, and low-risk patients returned to the care of their GP, reducing unnecessary hospital appoin ....
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Key Inclusion Criteria

Patients will be included if they: • Have had NAFLD diagnosed or suspected by their GP (from a GP referral letter). • Are aged between 18 and 75 years old. • Understand the consent procedures and give their full consent (See Section 13.1.2). • Consent to access of their data from Queensland Health and MBS and PBS.

Key Exclusion Criteria

Patients will be excluded if they: • Are pregnant. • Have advanced cardiac disease or another terminal illness. • Have high current alcohol consumption, defined as two or more standard drinks per day. • Have Hepatitis B or C (extracted from the GP referral letter). • Require priority review at the Hepatology Clinic • Have been evaluated in a specialist hepatology clinic in the previous 12 months. • Have plans to leave the area within the next 12 months.

Can healthy volunteers participate?




Sample Size    98

Min. age    18 Years

Max. age    75 Years

Sex    Both males and females

Condition category    Non-Alcoholic Fatty Liver Disease

Condition code    Oral and Gastrointestinal , Public Health


Intervention code Early detection / Screening

The starting point for patients is when they visit a GP. If the GP has sufficient concerns about the patient’s liver health, they will write a referral letter requesting a specialist hepatology clinic. The GP may also request blood tests, or have already performed those tests. Referral letters will be screened by a hepatologist at the Sunshine Coast and Princess Alexandra Hospitals to identify patients eligible for the study. The details of potential patients will be recorded for potential recru ....
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Control group Active

For those participants randomised to usual care, their referral letters will be dealt with in the usual way, and the patients wait to see a hepatologist at a hospital outpatient clinic, which can have waiting lists of 3 months or longer.


Outcome: Time from baseline to diagnosis of high-risk NAFLD (significant fibrosis result - TE over 8.2 kPa). Fibrosis measurement is provided by the fibroscan results.
Timepoint: On completion of scan

Outcome: Evaluate the cost-effectiveness of the new model of care. This will be measured using hospital data, participant Medicare/Pharmaceutical Benefits Scheme cost and healthcare usage data, and QALYs based on quality of life results from pre- and post- participant screening.
Timepoint: Twelve months post baseline

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

All final non-identifiable data sets will be available once the main papers have been published. All collected data will be shared except MBS and PBS data.

When will data be available?

Ater publication of main papers (approx. June 2022). No end date.

Available to whom?

Available publicly

Available for what types of analyses?

Any purpose

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see