# Stratification of Non-alcoholic Fatty Liver Disease using the SAFE Score

> **NIH NIH R01** · STANFORD UNIVERSITY · 2023 · $394,215

## Abstract

Non-alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease with a rapidly increasing public
health burden, affecting a third of American adults. NAFLD represents a spectrum of disorders ranging from simple
steatosis to non-alcoholic steatohepatitis (NASH) which may result in progressive hepatic fibrosis and cirrhosis. While
the majority of NAFLD patients do not develop or succumb to severe liver problems, liver fibrosis, particularly that of
stage 2 or higher is a well-established marker of liver-related morbidity as well as overall mortality. Currently, no
dedicated clinical tool exists to assess future risks and guide management in NAFLD patients in the community.
In this application, we propose a precision tool with which to risk stratify community NAFLD patients so that patients at
risk of developing future complications are directed to specialty care, while others may be monitored without
unnecessary diagnostic testing or interventions. We have recently developed the Steatosis-Associated Fibrosis
Estimator (SAFE) score designed to rule out stage 2 fibrosis in NAFLD patients. In our preliminary assessment of the
model, it had a high negative predictive value – a score of <0 accurately predicted lack of significant fibrosis. The studies
proposed in this application will prospectively test the score in 3 different patient populations (1) NAFLD patients
referred to specialty Hepatology Clinics, (2) NAFLD patients diagnosed in Primary Care Clinics, and (3) type 2 diabetes
patients attending Diabetes Clinics. By comparing the SAFE score and non-invasive indicators of liver fibrosis (i.e., liver
stiffness measurement), we will validate the score’s diagnostic characteristics in these patients when used for one time
risk assessment and for longitudinal follow-up and, if necessary, make further refinements to the score.
With the proposed studies, we will have a well-validated clinical tool with which we will confidently risk-stratify patients
with NAFLD in the community and screen for high risk NAFLD in patient populations at high risk, such as patients with
type 2 diabetes. An effective means to correctly stratify NAFLD patients will improve efficiency of care, optimize
healthcare resource allocation and facilitate clinical research, ultimately benefiting the well-being of patients with the
common condition.

## Key facts

- **NIH application ID:** 10695181
- **Project number:** 5R01DK127224-04
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** W. Ray KIM
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $394,215
- **Award type:** 5
- **Project period:** 2020-09-16 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10695181

## Citation

> US National Institutes of Health, RePORTER application 10695181, Stratification of Non-alcoholic Fatty Liver Disease using the SAFE Score (5R01DK127224-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10695181. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*