Simulation training in critical care: does practice make perfect?

BACKGROUND: Few data exist regarding the effectiveness of simulation in resident education in critical care. The purpose of this study was to determine whether multiple-simulation exposure (MSE) or single-simulation exposure (SSE) improved residents' recognition of shock and initial management of the critically ill simulated surgical patient. METHODS: Data were collected at a level 1 trauma center. Surgery, anesthesiology, and emergency medicine residents were given a multiple-choice question (MCQ) pretest before a tutorial on the recognition and management of shock followed by high-fidelity simulation/debriefing and MCQ post-test. MSE residents had 1.5 hours of simulation per resident over 3 days, and SSE residents had 1.5 hours of simulation as a group in 1 day. Pre- and posttest comparisons overall and subgroup analysis for MSE versus SSE were performed. RESULTS: Data was available for 45 MSE residents and 15 SSE residents. Overall posttest percent correct was greater than pretest percent correct (81% ± 9% vs 75% ± 13%, post- versus pre-, P = .01). Subgroup analysis demonstrated significantly improved post- versus pretest performance for MSE residents only. There were no differences in pre- or posttest performance for MSE residents during the first 4 months of the academic year versus the last 4 months. Pretest performance over 12 months of observation for MSE residents showed no significant differences. CONCLUSION: Repeated simulation exposure was more effective than single simulation exposure at improving MCQ performance designed to measure the recognition and management of shock in the critically ill simulated surgical patient. Duration of training did not impact MCQ performance.

Steady-state pharmacokinetics of a novel extended-release metformin formulation.

BACKGROUND AND OBJECTIVE: Metformin is an effective treatment for type 2 diabetes mellitus. The pharmacokinetic characteristics of the conventional immediate-release (IR) formulation of metformin (Glucophage), however, necessitate two- or three-times-daily dosing. Development of a novel extended-release (XR) formulation of metformin (Glucophage XR) using GelShield Diffusion System technology provides a once-daily dosing option. The objective of this study was to assess the steady-state pharmacokinetics of metformin XR tablets. STUDY DESIGN: This was an open-label, multiple-dose, five-regimen, two-sequence clinical study lasting 5 weeks. METHODS: Subjects were 16 healthy volunteers aged 18-40 years. Three 1-week regimens of metformin XR (500, 1000 and 1500 mg once daily) were administered sequentially. Subjects were alternately given either metformin XR 2000 mg once daily or metformin IR 1000 mg twice daily during weeks 4 and 5. The pharmacokinetic properties of metformin XR were assessed on two separate days at steady state and compared with those of metformin IR. RESULTS: Absorption of metformin XR was slower than that of metformin IR (time to maximum plasma concentration = 7 versus 3 hours). Maximum plasma concentrations (Cmax) following the administration of metformin XR 2000 mg once daily was 36% higher than that following the evening dose of metformin IR 1000 mg twice daily. The extent of absorption, determined by area under the plasma concentration-time curve (AUC), was equivalent for both formulations. The mean accumulation ratio of metformin XR was 1.0, indicating no accumulation with multiple-dose administration. Intrasubject variabilities in Cmax and AUC of metformin were comparable between metformin XR and metformin IR. This novel formulation of metformin XR was well tolerated at single doses up to 2000 mg once daily for 7 days, and adverse events were similar to those reported with metformin IR. CONCLUSION: The pharmacokinetic parameters of metformin XR tablet using GelShield Diffusion System technology were similar to those of metformin IR. Metformin XR was well tolerated at single doses up to 2000 mg once daily.