Background Clinicians use fibrosis in a liver biopsy to predict clinical outcomes of chronic liver disease. The performance of non-invasive tests has been evaluated against histological assessment of fibrosis but use of clinical outcomes as the reference standard would be ideal. The enhanced liver fibrosis (ELF) test was derived and validated in a large cohort of patients and shown to have high diagnostic accuracy (area under the curve (AUC)=0.80 95% CI 0.76 to 0.85) in identification of significant fibrosis on biopsy.
Objective To evaluate ELF performance in predicting clinical outcomes by following up the original ELF cohort.
Methods Patients recruited to the ELF study at seven English centres were followed up for liver morbidity and mortality by examination of clinical data. Defaulting/discharged patients were followed up by family practitioner questionnaires. Primary outcome measure was liver-related morbidity/liver-related death.
Results 457 patients were followed up (median 7 years), with ascertainment of clinical status in 92%. There were 61 liver-related outcomes (39 deaths). Survival analysis showed that the ELF score predicts liver outcomes, with people having the highest ELF scores being significantly more likely to have clinical outcomes than those in lower-score groups. A Cox proportional hazards model showed fully adjusted HRs of 75 (ELF score 12.52–16.67), 20 (10.426–12.51) and 5 (8.34–10.425) compared with patients with ELF <8.34. A unit change in ELF is associated with a doubling of risk of liver-related outcome.
Conclusions An ELF test can predict clinical outcomes in patients with chronic liver disease and may be a useful prognostic tool in clinical practice.
- Liver disease
- non-invasive test
- clinical outcome
- ELF test
- chronic liver disease
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Funding Medical Research Council UK provided the salary costs for JPs via a training fellowship. Siemens Healthcare Diagnostics provided financial support for travel and subsistence for researchers collecting data from each centre.
Competing interests Professor William Rosenberg has received research support from Bayer and financial support for lecturing from Siemens Diagnostics.
Ethics approval This study was conducted with the approval of the South West Multi-centre Research Ethics Committee. Study reference: MREC/98/6/08.
Provenance and peer review Not commissioned; externally peer reviewed.