Based on an international consensus conference held in Copenhagen in the autumn of 1994, a set of guidelines for Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents are presented. The guidelines are intended to be a help for people working in this research field, and it is hoped that the guidelines will assist researchers, editors, and drug companies to enhance the quality of their pharmacodynamic studies of neuromuscular blocking agents.

At doses of 2.0 mg/kg or greater, sugammadex safely reversed 0.6 mg/kg rocuronium-induced neuromuscular block in a dose-dependent manner. Sugammadex enhanced renal excretion of rocuronium and was excreted unchanged by the kidneys.

BackgroundSimulation-based medical education (SBME) has traditionally been conducted as off-site simulation in simulation centres. Some hospital departments also provide off-site simulation using in-house training room(s) set up for simulation away from the clinical setting, and these activities are called in-house training. In-house training facilities can be part of hospital departments and resemble to some extent simulation centres but often have less technical equipment. In situ simulation, introduced over the past decade, mainly comprises of team-based activities and occurs in patient care units with healthcare professionals in their own working environment. Thus, this intentional blend of simulation and real working environments means that in situ simulation brings simulation to the real working environment and provides training where people work. In situ simulation can be either announced or unannounced, the latter also known as a drill. This article presents and discusses the design of SBME and the advantage and disadvantage of the different simulation settings, such as training in simulation-centres, in-house simulations in hospital departments, announced or unannounced in situ simulations.DiscussionNon-randomised studies argue that in situ simulation is more effective for educational purposes than other types of simulation settings. Conversely, the few comparison studies that exist, either randomised or retrospective, show that choice of setting does not seem to influence individual or team learning. However, hospital department-based simulations, such as in-house simulation and in situ simulation, lead to a gain in organisational learning. To our knowledge no studies have compared announced and unannounced in situ simulation. The literature suggests some improved organisational learning from unannounced in situ simulation; however, unannounced in situ simulation was also found to be challenging to plan and conduct, and more stressful among participants. The importance of setting, context and fidelity are discussed.SummaryBased on the current limited research we suggest that choice of setting for simulations does not seem to influence individual and team learning. Department-based local simulation, such as simulation in-house and especially in situ simulation, leads to gains in organisational learning. The overall objectives of simulation-based education and factors such as feasibility can help determine choice of simulation setting.

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Objectives: Describing what simulation centre leaders see as the ideal debriefing for different simulator courses (medical vs. crisis resource management (CRM)-oriented). Describing the practice of debriefing based on interactions between instructors and training participants. Methods: Study 1 -Electronic questionnaire on the relevance of different roles of the medical teacher for debriefing (facilitator, role model, information provider, assessor, planner, resource developer) sent to simulation centre leaders. Study 2 -Observation study using a paper-and-pencil tool to code interactions during debriefings in simulation courses for CRM for content (medical vs. CRM-oriented) and type (question vs. utterance). Results: Study 1 -The different roles were seen as equally important for both course types with the exception of 'information provider' which was seen as more relevant for medical courses. Study 2 -There were different interaction patterns during debriefings: line -involving mostly the instructor and one course participant, triangle -instructor and two participants, faninstructor and all participants in a dyadic form and net -all participants and the instructor with cross references. Conclusion: What simulation centre heads think is important for the role mix of simulation instructors is (at least partly) not reflected in debriefing practice.

ObjectiveTo investigate the effect of in situ simulation (ISS) versus off-site simulation (OSS) on knowledge, patient safety attitude, stress, motivation, perceptions of simulation, team performance and organisational impact.DesignInvestigator-initiated single-centre randomised superiority educational trial.SettingObstetrics and anaesthesiology departments, Rigshospitalet, University of Copenhagen, Denmark.Participants100 participants in teams of 10, comprising midwives, specialised midwives, auxiliary nurses, nurse anaesthetists, operating theatre nurses, and consultant doctors and trainees in obstetrics and anaesthesiology.InterventionsTwo multiprofessional simulations (clinical management of an emergency caesarean section and a postpartum haemorrhage scenario) were conducted in teams of 10 in the ISS versus the OSS setting.Primary outcomeKnowledge assessed by a multiple choice question test.Exploratory outcomesIndividual outcomes: scores on the Safety Attitudes Questionnaire, stress measurements (State-Trait Anxiety Inventory, cognitive appraisal and salivary cortisol), Intrinsic Motivation Inventory and perceptions of simulations. Team outcome: video assessment of team performance. Organisational impact: suggestions for organisational changes.ResultsThe trial was conducted from April to June 2013. No differences between the two groups were found for the multiple choice question test, patient safety attitude, stress measurements, motivation or the evaluation of the simulations. The participants in the ISS group scored the authenticity of the simulation significantly higher than did the participants in the OSS group. Expert video assessment of team performance showed no differences between the ISS versus the OSS group. The ISS group provided more ideas and suggestions for changes at the organisational level.ConclusionsIn this randomised trial, no significant differences were found regarding knowledge, patient safety attitude, motivation or stress measurements when comparing ISS versus OSS. Although participant perception of the authenticity of ISS versus OSS differed significantly, there were no differences in other outcomes between the groups except that the ISS group generated more suggestions for organisational changes.Trial registration numberNCT01792674.

Trauma resuscitation is a complex situation, and most organisations have multi-professional trauma teams. Non-technical skills are challenged during trauma resuscitation, and they play an important role in the prevention of critical incidents. Simulation-based training of these is recommended. Our research question was: Does simulation-based trauma team training of non-technical skills have effect on reaction, learning, behaviour or patient outcome? The authors searched PubMed, EMBASE and the Cochrane Library and found 13 studies eligible for analysis. We described and compared the educational interventions and the evaluations of effect according to the four Kirkpatrick levels: reaction, learning (knowledge, skills, attitudes), behaviour (in a clinical setting) and patient outcome. No studies were randomised, controlled and blinded, resulting in a moderate to high risk of bias. The multi-professional trauma teams had positive reactions to simulation-based training of non-technical skills. Knowledge and skills improved in all studies evaluating the effect on learning. Three studies found improvements in team performance (behaviour) in the clinical setting. One of these found difficulties in maintaining these skills. Two studies evaluated on patient outcome, of which none showed improvements in mortality, complication rate or duration of hospitalisation. A significant effect on learning was found after simulation-based training of the multi-professional trauma team in non-technical skills. Three studies demonstrated significantly increased clinical team performance. No effect on patient outcome was found. All studies had a moderate to high risk of bias. More comprehensive randomised studies are needed to evaluate the effect on patient outcome.

With the risk of bias in mind, it is concluded that more than half of the RCARs described erroneous verbal communication between staff members as root causes of or contributing factors of severe patient safety incidents. The RCARs rich descriptions of the incidents revealed the organisational factors and needs related to these errors.