26 research outputs found

    Modified-Release Tacrolimus

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    Surgical Crisis Management Skills Training and Assessment: A Stimulation-Based Approach to Enhancing Operating Room Performance

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    BACKGROUND: Intraoperative surgical crisis management is learned in an unstructured manner. In aviation, simulation training allows aircrews to coordinate and standardize recovery strategies. Our aim was to develop a surgical crisis simulation and evaluate its feasibility, realism, and validity of the measures used to assess performance. METHODS: Surgical trainees were exposed to a bleeding crisis in a simulated operating theater. Assessment of performance consisted of a trainee’s technical ability to control the bleeding and of their team/human factors skills. This assessment was performed in a blinded manner by 2 surgeons and one human factors expert. Other measures consisted of time measures such as time to diagnose the bleeding (TD), inform team members (TT), achieve control (TC), and close the laceration (TL). Blood loss was used as a surrogate outcome measures. RESULTS: There were considerable variations within both senior (n = 10) and junior (n = 10) trainees for technical and team skills. However, while the senior trainees scored higher than the juniors for technical skills (P = 0.001), there were no differences in human factors skills. There were also significant differences between the 2 groups for TD (P = 0.01), TC (P = 0.001), and TL (0.001). The blood loss was higher in the junior group. CONCLUSIONS: We have described the development of a novel simulated setting for the training of crisis management skills and the variability in performance both in between and within the 2 groups

    Efficacy, safety, and immunosuppressant adherence in stable liver transplant patients converted from a twice-daily tacrolimus-based regimen to once-daily tacrolimus extended-release formulation

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    The aim of this study was to determine the efficacy, safety, and immunosuppressant adherence in 125 stable liver transplant (LT) patients converted from twice-daily tacrolimus (TAC BID) to once-daily TAC (TAC OD). Tacrolimus trough levels, laboratory parameters, metabolic disorders, selected patient reported outcomes, and adverse events were assessed. Mean TAC trough level concentration was 6.1 ± 2.3 ng/ml at study entry, decreased to 5.5 ± 2.1 ng/ml (P = 0.016) and 5.5 ± 2.2 ng/ml (P = 0.019) after 1 and 2 weeks, respectively, and tended to equal the baseline value during further follow-up. At week 1, TAC concentrations were lower in 62.4% of patients and higher in 36.0% when compared with baseline. Renal and cardiovascular risk factors remained stable and no rejection episodes occurred over 12 months. Adverse events were consistent with the safety profile known from previous studies with TAC BID. Nonadherence measured by the "Basel Assessment of Adherence Scale to Immunosuppressives" was evident in 66.4% at study entry and decreased to 30.9% postconversion (P > 0.0001). Prevalence of nonadherence at baseline was significantly higher in patients converted <2 years after LT and in those ?60 years of age. Conversion to TAC OD is safe, enhances immunosuppressant adherence and should be accompanied by a close TAC level monitoring during the initial period
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