在模拟环境中重新检验一项临床随机对照试验的假设，以验证麻醉模拟在错误研究中的有效性（VASER研究）。

Retesting the Hypothesis of a Clinical Randomized Controlled Trial in a Simulation Environment to Validate Anesthesia Simulation in Error Research (the VASER Study).

作者信息

Merry Alan F, Hannam Jacqueline A, Webster Craig S, Edwards Kylie-Ellen, Torrie Jane, Frampton Chris, Wheeler Daniel W, Gupta Arun K, Mahajan Ravi P, Evley Rachel, Weller Jennifer M

机构信息

From the Department of Anaesthesiology, Faculty of Medical and Health Sciences (A.F.M., J.A.H., J.T.), Centre for Medical and Health Sciences Education, Faculty of Medical and Health Sciences (C.S.W., J.M.W.), University of Auckland, Auckland, New Zealand; Anaesthetic Department, St Mary's Hospital, London, United Kingdom (K.-E.E.); Department of Medicine, Christchurch School of Medicine and Health Sciences, University of Otago, New Zealand (C.F.); University Division of Anaesthesia, University of Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom (D.W.W.); Department of Anaesthesia, Cambridge University Hospitals, Cambridge, United Kingdom (A.K.G.); and Anaesthesia and Critical Care, Division of Clinical Neuroscience, University of Nottingham, Nottingham, United Kingdom (R.P.M., R.E.).

出版信息

Anesthesiology. 2017 Mar;126(3):472-481. doi: 10.1097/ALN.0000000000001514.

DOI:10.1097/ALN.0000000000001514

PMID:28079566

Abstract

BACKGROUND

Simulation has been used to investigate clinical questions in anesthesia, surgery, and related disciplines, but there are few data demonstrating that results apply to clinical settings. We asked "would results of a simulation-based study justify the same principal conclusions as those of a larger clinical study?"

METHODS

We compared results from a randomized controlled trial in a simulated environment involving 80 cases at three centers with those from a randomized controlled trial in a clinical environment involving 1,075 cases. In both studies, we compared conventional methods of anesthetic management with the use of a multimodal system (SAFERsleep; Safer Sleep LLC, Nashville, Tennessee) designed to reduce drug administration errors. Forty anesthesiologists each managed two simulated scenarios randomized to conventional methods or the new system. We compared the rate of error in drug administration or recording for the new system versus conventional methods in this simulated randomized controlled trial with that in the clinical randomized controlled trial (primary endpoint). Six experts were asked to indicate a clinically relevant effect size.

RESULTS

In this simulated randomized controlled trial, mean (95% CI) rates of error per 100 administrations for the new system versus conventional groups were 6.0 (3.8 to 8.3) versus 11.6 (9.3 to 13.8; P = 0.001) compared with 9.1 (6.9 to 11.4) versus 11.6 (9.3 to 13.9) in the clinical randomized controlled trial (P = 0.045). A 10 to 30% change was considered clinically relevant. The mean (95% CI) difference in effect size was 27.0% (-7.6 to 61.6%).

CONCLUSIONS

The results of our simulated randomized controlled trial justified the same primary conclusion as those of our larger clinical randomized controlled trial, but not a finding of equivalence in effect size.

摘要

背景

模拟已被用于研究麻醉、手术及相关学科中的临床问题，但鲜有数据表明研究结果适用于临床环境。我们提出疑问：“基于模拟的研究结果能否支持与大型临床研究相同的主要结论？”

方法

我们将三个中心进行的一项涉及80例病例的模拟环境随机对照试验结果，与一项涉及1075例病例的临床环境随机对照试验结果进行了比较。在这两项研究中，我们将传统麻醉管理方法与使用旨在减少用药错误的多模式系统（SAFERsleep；Safer Sleep LLC，田纳西州纳什维尔）进行了比较。40名麻醉医生每人管理两个随机分配至传统方法或新系统的模拟场景。我们将此模拟随机对照试验中使用新系统与传统方法相比的用药或记录错误率，与临床随机对照试验中的错误率（主要终点）进行了比较。6名专家被要求指出具有临床意义的效应大小。

结果

在这项模拟随机对照试验中，新系统组与传统组每100次给药的平均（95%CI）错误率分别为6.0（3.8至8.3）和11.6（9.3至13.8；P = 0.001），而在临床随机对照试验中分别为9.1（6.9至11.4）和11.6（9.3至13.9）（P = 0.045）。10%至30%的变化被认为具有临床意义。效应大小的平均（95%CI）差异为27.0%（-7.6至61.6%）。