Longitudinal Validation of Clinical Care Pathways for Metabolic Dysfunction-Associated Steatotic Liver Disease in a Prospective Cohort of Individuals With Type 2 Diabetes.
The American Gastroenterological Association (AGA) Clinical Care Pathway provides a tiered, noninvasive algorithm for fibrosis risk stratification in populations at high risk for metabolic dysfunction-associated steatotic liver disease (MASLD). We assessed the 2-year longitudinal performance of the AGA pathway using magnetic resonance elastography (MRE) as the reference.
This prospective cohort study enrolled adults aged 50-79 years with type 2 diabetes mellitus from ambulatory care clinics between the dates of February 2016 and February 2025. Participants underwent a standardized clinical research visit with Fibrosis-4 index (FIB-4), vibration-controlled transient elastography (VCTE), and MRE at baseline and at a 2-year interval at the UCSD MASLD Research Center.
Of 626 participants with a baseline assessment, 209 had longitudinal follow-up assessment and were included in the study. The prevalence of MASLD was 69.9%, and 19.0% had significant fibrosis at baseline (MRE ≥3.30 kPa). Applying the AGA pathway of FIB-4 and VCTE, the false negative rate (low risk by pathway with MRE ≥3.30 kPa) at baseline was 7% with 17.6% of participants qualifying for specialty referral. At 2-year follow-up, the false negative rate decreased to 3% and an additional 7%, respectively qualified for specialty referral. Applying a FIB-4 cut point of 1.0 decreased the false negative rate to 0%; however, the number of patients requiring VCTE increased by 54% over 2-years.
Longitudinal reassessment of patients initially classified as low risk by the AGA Clinical Care Pathway substantially reduced misclassification of significant fibrosis, while maintaining a low rate of specialty referral. These findings support serial re-evaluation as a key component of noninvasive fibrosis risk stratification in at-risk populations.
This prospective cohort study enrolled adults aged 50-79 years with type 2 diabetes mellitus from ambulatory care clinics between the dates of February 2016 and February 2025. Participants underwent a standardized clinical research visit with Fibrosis-4 index (FIB-4), vibration-controlled transient elastography (VCTE), and MRE at baseline and at a 2-year interval at the UCSD MASLD Research Center.
Of 626 participants with a baseline assessment, 209 had longitudinal follow-up assessment and were included in the study. The prevalence of MASLD was 69.9%, and 19.0% had significant fibrosis at baseline (MRE ≥3.30 kPa). Applying the AGA pathway of FIB-4 and VCTE, the false negative rate (low risk by pathway with MRE ≥3.30 kPa) at baseline was 7% with 17.6% of participants qualifying for specialty referral. At 2-year follow-up, the false negative rate decreased to 3% and an additional 7%, respectively qualified for specialty referral. Applying a FIB-4 cut point of 1.0 decreased the false negative rate to 0%; however, the number of patients requiring VCTE increased by 54% over 2-years.
Longitudinal reassessment of patients initially classified as low risk by the AGA Clinical Care Pathway substantially reduced misclassification of significant fibrosis, while maintaining a low rate of specialty referral. These findings support serial re-evaluation as a key component of noninvasive fibrosis risk stratification in at-risk populations.
Authors
Dounel Dounel, Díaz Díaz, Bettencourt Bettencourt, Tavaglione Tavaglione, Madamba Madamba, Richards Richards, Loomba Loomba, Ajmera Ajmera
View on Pubmed