Nonalcoholic steatohepatitis, a chronic liver disease without an approved therapy, is associated with lipotoxicity and insulin resistance and is a major cause of cirrhosis and hepatocellular carcinoma.Aramchol, a partial inhibitor of hepatic stearoyl-CoA desaturase (SCD1) improved steatohepatitis and fibrosis in rodents and reduced steatosis in an early clinical trial. ARREST, a 52-week, doubleblind, placebo-controlled, phase 2b trial randomized 247 non-alcoholic steatohepatitis (NASH) patients (101, 98, 48 in aramchol 400mg, 600mg, placebo, respectively; NCT 02279524). The primary endpoint was a decrease in hepatic triglycerides by magnetic resonance spectroscopy at 52 weeks with a dose of 600 mg of aramchol. Key secondary endpoints included liver histology and ALT. Aramchol 600 mg produced a placebo-corrected decrease in liver triglycerides without meeting the prespecified significance (-3.1, 95%CI -6.4 to 0.2, p=0.06), precluding further formal statistical analysis. NASH resolution without worsening fibrosis was achieved in 16.7% (13/78) of aramchol 600 mg versus 5% (2/40) of the placebo arm (OR=4.74, 95% CI:0.1-22.7) and fibrosis improvement Vlad Ratziu, Study Design, Patient Recruitment and Treatment, Data Analyses and Interpretation, member of study advisory committee, Manuscript Writing
BackgroundPoint‐of‐care ultrasound (POCUS) competence consists of image acquisition, image interpretation, and clinical integration. Limited data exist on POCUS usage patterns and clinical integration by emergency medicine (EM) residents. We sought to determine actual POCUS usage and clinical integration patterns by EM residents and to explore residents' perspectives on POCUS clinical integration.MethodsWe conducted an explanatory sequential mixed‐methods study at a 4‐year EM residency program. In phase 1, EM ultrasound (US) attendings observed PGY‐4 EM residents' clinical integration of POCUS in real time while on shift in the emergency department (ED). EM US attendings evaluated residents on their intent to perform POCUS, actual POCUS usage, and competence per patient encounter. We used logistic regression to analyze these parameters. In phase 2, we conducted semi‐structured interviews with the observed PGY‐4 residents regarding POCUS usage and clinical integration in the ED. We analyzed qualitative data for themes.ResultsEmergency medicine US attendings observed 10 PGY‐4 EM residents during 254 high‐acuity patient encounters from December 2018 to March 2019. EM US attendings considered POCUS indicated for 26% (66/254) of patients, possibly indicated for 12% (30/254) and not indicated for 62% (158/254). Of the 66 patients for whom EM US attendings considered POCUS indicated, PGY‐4s intended to perform POCUS for patient management 61% (40/66) of the time. PGY‐4s subsequently incorporated POCUS into patient management 73% (48/66) of the time. EM US attendings considered PGY‐4s entrustable to perform POCUS independently 81% (206/254) of the time. We did not find a statistically significant association between shift volume, shift type, or POCUS application, and resident intent to perform POCUS nor competence. Interviews identified three factors that influence PGY‐4's POCUS clinical integration: motivations to use POCUS, barriers to utilization, and POCUS educational methods.ConclusionsThis mixed‐methods study identified a significant gap in POCUS utilization and clinical integration by PGY‐4 EM residents for clinically indicated cases identified by EM US attendings. As clinical integration is a cornerstone of POCUS competence, it is important to ensure that EM resident POCUS curricula emphasize training on clinical utilization and indications for POCUS while on shift in the ED.
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