BACKGROUND AND AIMS Recently, the American Gastroenterological Association (AGA) and American Association for the Study of Liver Diseases (AASLD) developed clinical pathways to evaluate populations at high-risk for nonalcoholic fatty liver disease (NAFLD). We assessed the diagnostic performance of the new guidance in a well-phenotyped cohort of patients with Type 2 diabetes mellitus (T2DM). APPROACH AND RESULTS This prospective study enrolled adults age ≥50 years with T2DM. Participants underwent a standardized clinical research visit with magnetic resonance imaging (MRI) and ultrasound-based assessment of liver fat and stiffness and ELF testing. Of 417 participants (36% men) with T2DM with FIB-4 and MRE data, the prevalence of NAFLD was 64% and 12% had advanced fibrosis (MRE≥3.63 kPa). Applying the AGA pathway of FIB-4 and vibration controlled transient elastography (VCTE) the false negative rate was 3.3% and 18% would qualify for specialty referral. Applying FIB-4 + ELF AASLD pathway the false negative rate was 4.5% but 50% would qualify specialty referral. Applying higher ELF cut points improved the pathway yielding a similar false negative rate of 4.9% but decreased specialty referral to 27%. CONCLUSION Validation of the AGA clinical pathway in a prospectively recruited cohort with T2DM revealed a low false negative rate and avoided specialty referral in a large percentage of patients. The AASLD pathway with FIB-4 + ELF resulted in a high rate of specialty referral, which improved with utilization of higher ELF cut-points and may serve as an alternative for primary care and endocrinology clinics without access to VCTE.

中文翻译：

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在 2 型糖尿病患者前瞻性队列中验证 AGA 临床护理路径和 AASLD 实践指南对非酒精性脂肪性肝病的影响。

背景和目标 最近，美国胃肠病学协会 (AGA) 和美国肝病研究协会 (AASLD) 开发了临床路径来评估非酒精性脂肪肝 (NAFLD) 高危人群。我们在一组表型良好的 2 型糖尿病 (T2DM) 患者中评估了新指南的诊断性能。方法和结果 这项前瞻性研究招募了年龄≥50 岁的 T2DM 成年人。参与者接受了标准化临床研究访问，包括磁共振成像 (MRI) 和基于超声的肝脏脂肪和硬度评估以及 ELF 测试。在具有 FIB-4 和 MRE 数据的 417 名 T2DM 参与者（36% 男性）中，NAFLD 患病率为 64%，12% 患有晚期纤维化（MRE≥3.63 kPa）。应用 FIB-4 的 AGA 途径和振动控制瞬态弹性成像 (VCTE) 的假阴性率为 3.3%，18% 符合专业转诊资格。应用 FIB-4 + ELF AASLD 途径，假阴性率为 4.5%，但 50% 符合专业转诊资格。应用更高的 ELF 切点改善了路径，产生了 4.9% 的类似假阴性率，但将专业转诊率降低至 27%。结论 在前瞻性招募的 T2DM 队列中对 AGA 临床路径的验证显示，假阴性率较低，并且大部分患者避免了专科转诊。采用 FIB-4 + ELF 的 AASLD 途径带来了较高的专科转诊率，随着使用更高的 ELF 切点，这种转诊率得到了改善，并且可以作为无法获得 VCTE 的初级保健和内分泌诊所的替代方案。