Learning strategies for the advanced trainee in specialist training.

BACKGROUND: A significant factor of clinicians' learning is based on their ability to effectively transfer acquired knowledge, skills, and attitudes from specialty-specific clinical courses to their working environment. MATERIAL AND METHOD: We conducted semi-structured interviews with 20 anaesthesiologist trainees (i.e. residents) in four group and five individual interviews using SRL principles as sensitizing concepts. Data were collected and analyzed iteratively using thematic analysis. RESULTS: Advanced trainees are highly motivated to explore what they have learned in specialty-specific courses, but they often face several barriers in implementing their learning in the workplace environment. Four themes emerged from the interview data: 'Be ready to learn', "Take the 'take-home-messages' home', "Be ready to create your own opportunities', and "Face it, it's not entirely up to you'. Understanding the challenges regarding transferring knowledge from courses to the working environment is an important lesson for assisting trainees set their learning goals, monitor their progress, and re-evaluate their SRL processes. CONCLUSION: Even for advanced trainees, successfully transferring knowledge from specialty-specific courses often requires adequate commitment and support. Medical supervisors and other relevant stakeholders must be aware of their shared responsibility for creating individual environments that support opportunities for trainees to self-regulate their learning.

Preparing for obstetric anaesthesia-An educational randomised controlled trial comparing e-learning to written course material.

BACKGROUND: E-learning is increasingly used in postgraduate medical education. Its numerous benefits include an enhanced learning experience through learning style individualisation, interactive elements, and assessment through tests and quizzes. Current meta-analyses conclude that the overall effectiveness of e-learning is comparable to traditional teaching modalities. However, studies demonstrating its benefits are heterogeneous and of varying quality. This randomised controlled trial aims to investigate whether contemporary e-learning completed prior to a course in obstetric anaesthesia prepares the course participants better than self-study of written course material. METHODS: A randomised controlled trial allocated second-year resident anaesthetists to receive either e-learning in postpartum haemorrhage and written course material in preeclampsia or e-learning in preeclampsia and written course material in postpartum haemorrhage, prior to a compulsory course in obstetric anaesthesia. The primary outcome was knowledge after completion of e-learning before the course, assessed by type X multiple-choice questions with a score ranging from zero to 35. The secondary outcomes were anxiety level before course simulations, performance during course simulations, and knowledge four and 12 weeks after the course. RESULTS: The per protocol analysis of the primary outcome included 45 participants and demonstrated a mean difference of 1.8 (95% CI 0.7-2.9; p = .002) in knowledge after completion of e-learning before the course, in favour of e-learning compared to written course material. There were no statistically significant differences in the secondary outcomes. CONCLUSION: This blinded parallel group randomised controlled trial found a numerically small but statistically significant difference in knowledge favouring e-learning over written course material.

Evaluation of the simulation based training quality assurance tool (SBT-QA10) as a measure of learners' perceptions during the action phase of simulation.

BACKGROUND: In an earlier interview-based study the authors identified that learners experience one or more of eight explicit perceptual responses during the active phase of simulation-based training (SBT) comprising a sense: of belonging to instructor and group, of being under surveillance, of having autonomy and responsibility for patient management, of realism, of an understanding of the scenario in context, of conscious mental effort, of control of attention, and of engagement with task. These were adapted into a ten-item questionnaire: the Simulation Based Training Quality Assurance Tool (SBT-QA10) to allow monitoring of modifiable factors that may impact upon learners' experiences. This study assessed the construct validity evidence of the interpretation of the results when using SBT-QAT10. MATERIALS AND METHODS: Recently graduated doctors and nurses participating in a SBT course on the topic of the deteriorating patient completed the SBT-QAT10 immediately following their participation in the scenarios. The primary outcome measure was internal consistency of the questionnaire items and their correlation to learners' satisfaction scores. A secondary outcome measure compared the impact of allocation to active versus observer role. RESULTS: A total of 349 questionnaires were returned by 96 course learners. The median of the total score for the ten perception items (TPS) was 39 (out of 50), with no significant difference between the scenarios. We identified fair and positive correlations between nine of the 10 items and the SBT-QA10-TPS, the exception being "mental effort". Compared to observers, active learners reported significantly more positive perceptions related to belonging to the team and interaction with the instructor, their sense of acting independently, and being focused. The questionnaire items were poorly correlated with the two measures of global satisfaction. CONCLUSION: Except for the item for mental effort, the QA10-TPS measures learners' experiences during the active phase of simulation scenarios that are associated with a positive learning experience. The tool may have utility to learners, instructors, and course providers by informing subsequent debriefing and reflection upon practice for learners and faculty. The relationship between these perceptions and commonly used measures of satisfaction remains poorly understood raising questions about the value of the latter.

The role of central serotonergic markers and estradiol changes in perinatal mental health.

OBJECTIVE: Women have an increased risk for mental distress and depressive symptoms in relation to pregnancy and birth. The serotonin transporter (SERT) may be involved in the emergence of depressive symptoms postpartum and during other sex-hormone transitions. It may be associated with cerebrospinal fluid (CSF) levels of the main serotonin metabolite 5-hydroxyindolacetic acid (5-HIAA). In 100 healthy pregnant women, who were scheduled to deliver by cesarean section (C-section), we evaluated 5-HIAA and estradiol contributions to mental distress 5 weeks postpartum. METHODS: Eighty-two women completed the study. CSF collected at C-section was analyzed for 5-HIAA, with high performance liquid chromatography. Serum estradiol concentrations were quantified by liquid chromatography tandem mass spectrometry before C-section and postpartum. Postpartum mental distress was evaluated with the Edinburgh Postnatal Depression Scale (EPDS). Associations between EPDS, 5-HIAA, and Δestradiol were evaluated in linear regression models adjusted for age, parity and SERT genotype. RESULTS: Higher levels of postpartum mental distress symptoms were negatively associated with a large decrease in estradiol concentrations (ßΔE2  = 0.73, p = 0.007) and, on a trend level, positively associated with high antepartum 5-HIAA levels (ß5-HIAA  = 0.002, p = 0.06). CONCLUSION: In a cohort of healthy pregnant women, postpartum mental distress was higher in women with high antepartum 5-HIAA (trend) and lower in women with a large perinatal estradiol decrease. We speculate that high antepartum 5-HIAA is a proxy of SERT levels, that carry over to the postpartum period and convey susceptibility to mental distress. In healthy women, the postpartum return to lower estradiol concentrations may promote mental well-being.

Hemostatic resuscitation in postpartum hemorrhage - a supplement to surgery.

BACKGROUND: Postpartum hemorrhage is a potentially life-threatening albeit preventable condition that persists as a leading cause of maternal death. Identification of safe and cost-effective hemostatic treatment options remains crucial as a supplement to surgery and uterotonic agents. OBJECTIVE: This review summarizes the background, current evidence and recommendations with regard to the role of fibrinogen, tranexamic acid, prothrombin complex concentrate, desmopressin, and recombinant factor VIIa in the treatment of patients with postpartum hemorrhage. The benefits and evidence behind traditional standard laboratory tests and viscoelastic hemostatic assays, i.e. thromboelastography TEG(®) and thromboelastometry ROTEM(®) , are discussed. In addition we assess and elaborate on the current paradigm and evidence for transfusion of these patients. DATA SOURCES: Publications between 1994 and 2014 were identified from PubMed, EMBASE, Cochrane Library databases, and ClinicalTrial.gov. RESULTS: Viscoelastic hemostatic assays were found to provide a real-time continuum of coagulation and fibrinolysis when introduced as a supplement in transfusion management of postpartum hemorrhage. Fibrinogen should be considered when hypofibrinogenemia is identified. Early administration of 1-2 g tranexamic acid is recommended, followed by an additional dose in cases of ongoing bleeding. Uncontrolled hemorrhage requires early balanced transfusion. CONCLUSION: Despite the lack of conclusive evidence for optimal hemostatic resuscitation in postpartum hemorrhage, the use of viscoelastic hemostatic assays, fibrinogen, tranexamic acid and balanced transfusion therapy may prove to be potentially pivotal in the treatment of postpartum hemorrhage.

Development and Usability of an Inexpensive and Reusable Phantom for Ultrasound-Guided Needle Cannulation.

Introduction Ultrasound-guided peripheral venous catheter placement (UG-PVCP) is a key skill for establishing intravenous access, especially in patients with anatomical challenges. Ultrasound is highly operator-dependent, and it is essential to ensure a sufficient level of competence when educating healthcare professionals. Competence can be acquired through simulation-based training (SBT) using phantoms or simulators. We developed a phantom for SBT, and in this study, we explore the phantom's usability and technical fidelity. Methods Novices with no experience in UG-PVCP and experts who routinely performed the procedure were asked to perform three ultrasound-guided catheter placement attempts on the phantom. Afterward, they were asked to complete a usability questionnaire consisting of 14 questions exploring the usability and fidelity of the phantom. Results Fifty-seven participants were included in the study: 29 novices and 28 experts. When assessing positive questions about the frequency of use, ease of use, integration of functionality, quickness to learn, and confidence level, the study showed a median score of 4 to 5 out of 5 in the two groups. The median was 1 to 2 out of 5 for negative questions assessing cumbersomeness, unnecessary complexity, and model inconsistency. In an additional comment textbox, one participant mentioned that the cannulation did not feel realistic but that it was good for cannulation practice. Conclusions We believe the phantom is suitable for an educational curriculum since it shows a high level of usability, scoring high on positive questions while scoring low on negative questions, and having high functional fidelity.

Emotional Activation in Simulation: Measuring the Influence of Participant Roles and Scenario Design.

INTRODUCTION: The degree of emotional activation required for optimal learning in either hands-on or observer roles is unclear, as is the level of stress that impedes learning. Measuring emotional activation is time-consuming, and many scales measure threat or anxiety without considering pleasurable activation. This study examined emotional activation in the observer and hands-on roles in 2 different scenario designs. METHODS: This study was a 2-cohort, parallel study of graduate nurses and doctors completing 2 different courses in managing the deteriorating patient. We examined emotional activation by role across 2 scenario designs. We measured emotional activation on 3 anchored measures scales: the State Trait Anxiety Inventory, Cognitive Appraisal Index, and the Affect Grid with data analysis using analysis of variance and repeated measures. RESULTS: Hands-on learners experienced higher anxiety, threat, and arousal levels and less pleasure than observers in both scenario designs. There were no differences in pre-emotional and postemotional activation in immersive scenarios for either role and increased arousal and decreased threat and anxiety in the hands-on role in the pause-and-discuss scenario design. CONCLUSIONS: Hands-on learners were more emotionally activated than observers in both scenario designs. There was significant perceived anxiety, threat, and pleasurable arousal in both roles and both scenario designs. Pause-and-discuss scenarios demonstrated similar levels of activation as the immersive scenario design. The Affect Grid provided a quick subjective view of arousal and pleasure in simulation participants, potentially providing educators with an indication of whether emotional activation is positive (excitement) or negative (stressful) and may be helpful in educational planning and future research.

Barriers and facilitators among health care professionals in the Emergency Department for treating paediatric patients pain and anxiety. A qualitative survey study.

OBJECTIVE: Pediatric patient's pain and anxiety are insufficiently treated in Emergency Departments (EDs). Implementation of new evidence-based knowledge into paediatric clinical practice is often a protracted process, as the barriers and facilitators among health care professionals for treating pain and anxiety in children are unknown. METHOD: We conducted hypothesis generating interviews with health care professionals and coded the transcriptions into eight main themes. A survey was constructed to test the hypotheses, with one question for each theme. The survey was distributed in two EDs. RESULTS: Barriers: fear of overdose (58.9%) lack of knowledge in different treatment options (56.7%), children or parents cannot cooperate (55%). Facilitators: more education (69.4%), more time to treat every patient (55.2%), standardized treatment regime (50%). CONCLUSION: Our study finds potential barriers and facilitators among health care professionals regarding sufficient treatments of pain and anxiety among paediatric patients in EDs. It suggests that education of health care professionals regarding assessing pain, administrating analgesics and anxiolytics and handling uncooperative children is necessary in order to improve treatment of children in EDs.

[Delivery and analgesia of labouring women with congenital spine abnormalities].

Congenital spine abnormalities are common. These anomalies can be associated with other anomalies and different degrees of symptom severity. In pregnant women multidisciplinary planning and considerations of special needs may be necessary as summarised in this review. Recommendation for caesarean section should, for most parts, be made on obstetric indication only. Neuroaxial analgesia during birth and anaesthesia for caesarean section is seldom contraindicated in women with back abnormalities. However, in tethered cord, it is important to avoid iatrogenic damage to the conus when placing spinal anaesthesia.

Adherence to guidelines on red blood cell transfusions in women having post-partum haemorrhage.

INTRODUCTION: Transfusion of blood products occurs frequently as part of the treatment of post-partum haemorrhage, but since it is both expensive and has potentially severe complications, prescription of blood products should be restricted. The aim of this study was to examine if restrictive red blood cell transfusion (RBC-T) practice for obstetric patients was in line with national Danish guidelines. METHODS: A retrospective quality assurance study was conducted at Rigshospitalet, Denmark. The study counted the participation of the Department of Anaesthesiology and Surgery, the Juliane Marie Centre, the Danish Blood Bank and the Department of Obstetrics. Patients were identified via the patient database of the Danish Blood Bank in 2015-2017, and patient files were read. RESULTS: Out of 16,698 delivering women, 196 (1.2%) received one or more RBC-T from 2015 to 2017. A total of 133 women (67.9%) received more than one RBC-T and the median was two. The most common reason for RBC-T was a "low haemoglobin level (Hb) + anaemic symptoms" (37.0%). A total of 20.3% of all RBC-Ts were prescribed based simply on a low Hb. The most common symptom of anaemia was dizziness. CONCLUSIONS: The majority of RBC-Ts for obstetric patients were conducted in line with the guidelines. However, 6.0% of RBC-Ts were registered to be in discrepancy with the guidelines and 20.3% of RBC-Ts were prescribed on the "low Hb" criterium solely. It is possible, though, that the 20.3% is overestimated due to insufficient descriptions of indications for RBC-T in patient files. FUNDING: none. TRIAL REGISTRATION: The study was approved by the management at Rigshospitalet.

Clinical and microbiological characteristics of severe Streptococcus pyogenes disease in Europe.

In an attempt to compare the epidemiology of severe Streptococcus pyogenes infection within Europe, prospective data were collected through the Strep-EURO program. Surveillance for severe cases of S. pyogenes infection diagnosed during 2003 and 2004 was undertaken in 11 countries across Europe by using a standardized case definition and questionnaire. Patient data as well as bacterial isolates were collected and characterized by T and M/emm typing, and selected strains were analyzed for the presence of superantigen genes. Data were analyzed to compare the clinical and microbiological patterns of the infections across the participating countries. A total of 4,353 isolates were collected from 5,521 cases with severe S. pyogenes infections who were identified. A wide diversity of M/emm types (n = 104) was found among the S. pyogenes clinical isolates, but the M/emm type distribution varied broadly between participating countries. The 10 most predominant M/emm types were M/emm type 1 (M/emm1), M/emm28, M/emm3, M/emm89, M/emm87, M/emm12, M/emm4, M/emm83, M/emm81, and M/emm5, in descending order. A correlation was found between some specific disease manifestations, the age of the patients, and the emm types. Although streptococcal toxic shock syndrome and necrotizing fasciitis were caused by a large number of types, they were particularly associated with M/emm1 and M/emm3. The emm types included in the 26-valent vaccine under development were generally well represented in the present material; 16 of the vaccine types accounted for 69% of isolates. The Strep-EURO collaborative program has contributed to enhancement of the knowledge of the spread of invasive disease caused by S. pyogenes within Europe and encourages future surveillance by the notification of cases and the characterization of strains, which are important for vaccination strategies and other health care issues.

[Failed epidural analgesia during birth].

Epidural analgesia is regarded as the most effective pain relief option, and it is used in 25% of all child births in Denmark. Despite the large number of epidural blocks, there is no consensus on, how failed epidural analgesia (FEA) should be defined. There are several different definitions and probably therefore a wide incidence (8.5-23%). In this review, we attempt to provide an overview of the many definitions of FEA and to identify the risk factors. In addition, we suggest recommendations on how to reduce the number of FEA in the future.

Clinical and epidemiological aspects of invasive Streptococcus pyogenes infections in Denmark during 2003 and 2004.

Active surveillance of invasive group A streptococcal (GAS) infections was conducted in Denmark during 2003 and 2004 as a part of the Strep-EURO initiative. The main objective was to improve understanding of the epidemiology of invasive GAS disease in Denmark. During the 2 years, 278 cases were reported, corresponding to a mean annual incidence of 2.6 cases per 100,000 inhabitants. The vast majority of isolates, 253 (91%), were from blood, with the remaining 25 (9%) being from cerebrospinal fluid, joints, or other normally sterile sites. The mean case fatality rate (CFR) was 20%, with the rate being higher in patients more than 70 years of age (36.5%). For streptococcal toxic shock syndrome (STSS) and necrotizing fasciitis the CFRs were 53% and 25%, respectively. Out of 16 T types recorded, three predominated: T28 (23%), T1 (22%), and the cluster T3/13/B3264 (14%). Among 29 different emm types, emm28 and emm1 accounted for 51% of strains, followed by emm3 (11%), emm89 (7%), and emm12 (5.5%). Low resistance rates were detected for macrolide-lincosamide-streptogramin B (MLS(B)) antibiotics (3%) and tetracycline (8%); two isolates exhibited coresistance to tetracycline and macrolides. Of nine pyrogenic exotoxin (superantigen) genes examined, speA and speC were identified in 58% and 40% of the strains, respectively; either of the genes was present in all strains causing STSS. Most strains harbored speG (99%). ssa was present in 14% of the isolates only. In Denmark, as in comparable countries, GAS invasive disease shows a sustained, high endemicity, with involvement of both established and emerging streptococcal emm and T types.

Epidemiology of severe Streptococcus pyogenes disease in Europe.

The past 2 decades have brought worrying increases in severe Streptococcus pyogenes diseases globally. To investigate and compare the epidemiological patterns of these diseases within Europe, data were collected through a European Union FP-5-funded program (Strep-EURO). Prospective population-based surveillance of severe S. pyogenes infection diagnosed during 2003 and 2004 was undertaken in 11 countries across Europe (Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Romania, Sweden, and the United Kingdom) using a standardized case definition. A total of 5,522 cases were identified across the 11 countries during this period. Rates of reported infection varied, reaching 3/100,000 population in the northern European countries. Seasonal patterns of infection showed remarkable congruence between countries. The risk of infection was highest among the elderly, and rates were higher in males than in females in most countries. Skin lesions/wounds were the most common predisposing factor, reported in 25% of cases; 21% had no predisposing factors reported. Skin and soft tissue were the most common foci of infection, with 32% of patients having cellulitis and 8% necrotizing fasciitis. The overall 7-day case fatality rate was 19%; it was 44% among patients who developed streptococcal toxic shock syndrome. The findings from Strep-EURO confirm a high incidence of severe S. pyogenes disease in Europe. Furthermore, these results have identified targets for public health intervention, as well as raising awareness of severe S. pyogenes disease across Europe.

[Advanced labour pain relief].

Delivery and labour pain is normally the most painful event in a woman's lifetime. Physical and psychological factors may influence the severity of labour pain, and labour pain relief is an important issue for the obstetric anaesthetist. We describe the current most effective pharmacological techniques used for labour analgesia: systemically with remifentanil and regionally with epidural analgesia.

[Sectio and Brugada syndrome].

Brugada syndrome (BS) is an inherited cardiac disease with increased risk of ventricular tachyarrythmias, cardiac arrest and sudden death. BS is diagnosed on various criteria including specific electrocardiographic abnormalities in a structurally normal heart. Many drugs have been reported to induce fatal arrhythmias in patients with BS and in particular sodium channel blockers i.e. local anaesthetics such as bupivacaine. We report the anaesthetic management of two women with BS during caesarean section and provide a general discussion on the use of bupivacain for neuraxial blockade for patients with BS.

Simulation-based multiprofessional obstetric anaesthesia training conducted in situ versus off-site leads to similar individual and team outcomes: a randomised educational trial.

OBJECTIVE: To 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. DESIGN: Investigator-initiated single-centre randomised superiority educational trial. SETTING: Obstetrics and anaesthesiology departments, Rigshospitalet, University of Copenhagen, Denmark. PARTICIPANTS: 100 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. INTERVENTIONS: Two 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 OUTCOME: Knowledge assessed by a multiple choice question test. EXPLORATORY OUTCOMES: Individual 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. RESULTS: The 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. CONCLUSIONS: In 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 NUMBER: NCT01792674.

Tetracycline and macrolide co-resistance in Streptococcus pyogenes: co-selection as a reason for increase in macrolide-resistant S. pyogenes?

In Denmark, tetracycline resistance in Streptococcus pyogenes is frequent (>30%) whereas macrolide resistance is low (<5%). The aim of this study was to investigate the genetic background of tetracycline- and macrolide resistance in macrolide-resistant S. pyogenes (MRSP) and to investigate the correlation between the use of macrolide and tetracycline and macrolide resistance using international data. A total of 133 MRSP isolates were received at Statens Serum Institut from nine Danish clinical microbiology laboratories between. November 2000, and November 2002. The macrolide-resistance genes, erm(B), erm(A), and mef(A) were detected in 46%, 18%, and 32% of the tested MRSP isolates, respectively. In 4% of MRSP isolates, none of the MR genes were detected. Tetracycline resistance was found in 52% of MRSP. Tetracycline resistance was encoded by either tet(M) or tet(O). erm(B) and mef(A) were associated with tet(M). Sixteen different T types were detected among the 133 MRSP. Analysis of the importance of antibiotic use for development of macrolide resistance in S. pyogenes showed no correlation with macrolide use alone (p = 0.15) but a significant correlation (p = 0.03) for the combination of macrolide and tetracycline use. The frequency of macrolide resistance in Danish S. pyogenes was low and mainly due to erm genes. A high frequency of macrolide-tetracycline coresistance in S. pyogenes is found in many countries including Denmark, hence tetracycline use must be considered as a co-factor in selection of MRSP.

[Lactic acidosis in a patient with exercabation of asthma receiving inhalation therapy]. / Laktatacidose som komplikation til inhalationsbehandling hos patient med astmaeksacerbation.

We present a case of severe lactic acidosis due to exacerbation of asthma in presence of normal tissue perfusion and oxygenation in a 35-year-old woman with poorly controlled asthma. After admission, she was treated continuously with inhalation of salbutamol (a beta-agonist) resulting in lactic acidosis, which was misinterpreted as treatment failure. The lactic acidosis reversed on discontinuation of the inhalation therapy. Although lactic acidosis is a rare complication to inhalation of beta-agonists, it is important for the clinicians to recognize this.

'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial.

BACKGROUND: Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improved learner outcomes. However, many questions on how SBME can be optimized remain unanswered. One unresolved issue is how 'in situ simulation' (ISS) versus 'off site simulation' (OSS) impact learning. ISS means simulation-based training in the actual patient care unit (in other words, the labor room and operating room). OSS means training in facilities away from the actual patient care unit, either at a simulation centre or in hospital rooms that have been set up for this purpose. METHODS AND DESIGN: The objective of this randomized trial is to study the effect of ISS versus OSS on individual learning outcome, safety attitude, motivation, stress, and team performance amongst multi-professional obstetric-anesthesia teams.The trial is a single-centre randomized superiority trial including 100 participants. The inclusion criteria were health-care professionals employed at the department of obstetrics or anesthesia at Rigshospitalet, Copenhagen, who were working on shifts and gave written informed consent. Exclusion criteria were managers with staff responsibilities, and staff who were actively taking part in preparation of the trial. The same obstetric multi-professional training was conducted in the two simulation settings. The experimental group was exposed to training in the ISS setting, and the control group in the OSS setting. The primary outcome is the individual score on a knowledge test. Exploratory outcomes are individual scores on a safety attitudes questionnaire, a stress inventory, salivary cortisol levels, an intrinsic motivation inventory, results from a questionnaire evaluating perceptions of the simulation and suggested changes needed in the organization, a team-based score on video-assessed team performance and on selected clinical performance. DISCUSSION: The perspective is to provide new knowledge on contextual effects of different simulation settings. TRIAL REGISTRATION: ClincialTrials.gov NCT01792674.