OBJECTIVE Assess the prevalence of nonalcoholic fatty liver disease (NAFLD) and of liver fibrosis associated with nonalcoholic steatohepatitis in unselected patients with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS A total of 561 patients with T2DM (age: 60 ± 11 years; BMI: 33.4 ± 6.2 kg/m2; and HbA1c: 7.5 ± 1.8%) attending primary care or endocrinology outpatient clinics and unaware of having NAFLD were recruited. At the visit, volunteers were invited to be screened by elastography for steatosis and fibrosis by controlled attenuation parameter (≥274 dB/m) and liver stiffness measurement (LSM; ≥7.0 kPa), respectively. Secondary causes of liver disease were ruled out. Diagnostic panels for prediction of advanced fibrosis, such as AST-to-platelet ratio index (APRI) and Fibrosis-4 (FIB-4) index, were also measured. A liver biopsy was performed if results were suggestive of fibrosis. RESULTS The prevalence of steatosis was 70% and of fibrosis 21% (LSM ≥7.0 kPa). Moderate fibrosis (F2: LSM ≥8.2 kPa) was present in 6% and severe fibrosis or cirrhosis (F3–4: LSM ≥9.7 kPa) in 9%, similar to that estimated by FIB-4 and APRI panels. Noninvasive testing was consistent with liver biopsy results. Elevated AST or ALT ≥40 units/L was present in a minority of patients with steatosis (8% and 13%, respectively) or with liver fibrosis (18% and 28%, respectively). This suggests that AST/ALT alone are insufficient as initial screening. However, performance may be enhanced by imaging (e.g., transient elastography) and plasma diagnostic panels (e.g., FIB-4 and APRI). CONCLUSIONS Moderate-to-advanced fibrosis (F2 or higher), an established risk factor for cirrhosis and overall mortality, affects at least one out of six (15%) patients with T2DM. These results support the American Diabetes Association guidelines to screen for clinically significant fibrosis in patients with T2DM with steatosis or elevated ALT.

<b>Objective:</b> Assess the prevalence of NAFLD and of liver fibrosis associated with nonalcoholic steatohepatitis (NASH) in unselected patients with T2DM. <p><b>Research Design and Methods:</b> 561 patients with T2DM (age: 60±11; BMI: 33.4±6.2 kg/m²; HbA1c: 7.5±1.8%) attending primary care or endocrinology outpatient clinics and unaware of having NAFLD. At the visit, volunteers were invited to be screened by elastography for steatosis and fibrosis by CAP (≥274 dB/m) and LSM (≥7.0 kPa), respectively. Secondary causes of liver disease were ruled out. Diagnostic panels for prediction of advanced fibrosis, such as APRI and FIB-4, were also measured. A liver biopsy was performed if results were suggestive of fibrosis.</p> <p><b>Results:</b> The prevalence of steatosis was 70% and of fibrosis 21% (LSM≥7.0 kPa). Moderate fibrosis (F2: LSM≥8.2 kPa) was present in 6% and severe fibrosis or cirrhosis (F3-4: LSM≥9.7 kPa) in 9%, similar to that estimated by FIB-4 and APRI panels. Non-invasive testing was consistent with liver biopsy results. Elevated AST or ALT ≥40 U/L were present in a minority of patients with steatosis (8% and 13%, respectively) or with liver fibrosis (18% and 28%, respectively). This suggests that AST/ALT alone are insufficient as initial screening. However, performance may be enhanced by imaging (e.g., transient elastography) and plasma diagnostic panels (e.g., FIB-4, APRI).</p> <p><b>Conclusions: </b>Moderate-to-advanced fibrosis (F≥2), an established risk factor for cirrhosis and overall mortality, affects at least one-out-of-six (15%) patients with T2DM. These results support the ADA guidelines to screen for clinically significant fibrosis in patients with T2DM with steatosis or elevated ALT.</p>

Purpose PCORnet, the National Patient‐Centered Clinical Research Network, represents an innovative system for the conduct of observational and pragmatic studies. We describe the identification and validation of a retrospective cohort of patients with type 2 diabetes (T2DM) from four PCORnet sites. Methods We adapted existing computable phenotypes (CP) for the identification of patients with T2DM and evaluated their performance across four PCORnet sites (2012‐2016). Patients entered the cohort on the earliest date they met one of three CP categories: (CP1) coded T2DM diagnosis (ICD‐9/ICD‐10) and an antidiabetic prescription, (CP2) diagnosis and glycosylated hemoglobin (HbA1c) ≥6.5%, or (CP3) an antidiabetic prescription and HbA1c ≥6.5%. We required evidence of health care utilization in each of the 2 prior years for each patient, as we also developed an incident T2DM CP to identify the subset of patients without documentation of T2DM in the 365 days before t0. Among a systematic sample of patients, we calculated the positive predictive value (PPV) for the T2DM CP and incident‐T2DM CP using electronic health record (EHR) review as reference. Results The CP identified 50 657 patients with T2DM. The PPV of patients randomly selected for validation was 96.2% (n = 1572; CI:95.1‐97.0) and was consistently high across sites. The PPV for the incident‐T2DM CP was 5.8% (CI:4.5‐7.5). Conclusions The T2DM CP accurately and efficiently identified patients with T2DM across multiple sites that participate in PCORnet, although the incident T2DM CP requires further study. PCORnet is a valuable data source for future epidemiological and comparative effectiveness research among patients with T2DM.

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<b>Objective:</b> Assess the prevalence of NAFLD and of liver fibrosis associated with nonalcoholic steatohepatitis (NASH) in unselected patients with T2DM. <p><b>Research Design and Methods:</b> 561 patients with T2DM (age: 60±11; BMI: 33.4±6.2 kg/m²; HbA1c: 7.5±1.8%) attending primary care or endocrinology outpatient clinics and unaware of having NAFLD. At the visit, volunteers were invited to be screened by elastography for steatosis and fibrosis by CAP (≥274 dB/m) and LSM (≥7.0 kPa), respectively. Secondary causes of liver disease were ruled out. Diagnostic panels for prediction of advanced fibrosis, such as APRI and FIB-4, were also measured. A liver biopsy was performed if results were suggestive of fibrosis.</p> <p><b>Results:</b> The prevalence of steatosis was 70% and of fibrosis 21% (LSM≥7.0 kPa). Moderate fibrosis (F2: LSM≥8.2 kPa) was present in 6% and severe fibrosis or cirrhosis (F3-4: LSM≥9.7 kPa) in 9%, similar to that estimated by FIB-4 and APRI panels. Non-invasive testing was consistent with liver biopsy results. Elevated AST or ALT ≥40 U/L were present in a minority of patients with steatosis (8% and 13%, respectively) or with liver fibrosis (18% and 28%, respectively). This suggests that AST/ALT alone are insufficient as initial screening. However, performance may be enhanced by imaging (e.g., transient elastography) and plasma diagnostic panels (e.g., FIB-4, APRI).</p> <p><b>Conclusions: </b>Moderate-to-advanced fibrosis (F≥2), an established risk factor for cirrhosis and overall mortality, affects at least one-out-of-six (15%) patients with T2DM. These results support the ADA guidelines to screen for clinically significant fibrosis in patients with T2DM with steatosis or elevated ALT.</p>