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1.  Clarifying the learning experiences of healthcare professionals with in situ and off-site simulation-based medical education: a qualitative study 
BMJ Open  2015;5(10):e008345.
To examine how the setting in in situ simulation (ISS) and off-site simulation (OSS) in simulation-based medical education affects the perceptions and learning experience of healthcare professionals.
Qualitative study using focus groups and content analysis.
Twenty-five healthcare professionals (obstetricians, midwives, auxiliary nurses, anaesthesiologists, a nurse anaesthetist and operating theatre nurse) participated in four focus groups and were recruited due to their exposure to either ISS or OSS in multidisciplinary obstetric emergencies in a randomised trial.
Departments of obstetrics and anaesthesia, Rigshospitalet, Copenhagen, Denmark.
Initially participants preferred ISS, but this changed after the training when the simulation site became of less importance. There was a strong preference for simulation in authentic roles. These perceptions were independent of the ISS or OSS setting. Several positive and negative factors in simulation were identified, but these had no relation to the simulation setting. Participants from ISS and OSS generated a better understanding of and collaboration with the various health professionals. They also provided individual and team reflections on learning. ISS participants described more experiences that would involve organisational changes than the OSS participants did.
Many psychological and sociological aspects related to the authenticity of the learning experience are important in simulation, but the physical setting of the simulation as an ISS and OSS is the least important. Based on these focus groups OSS can be used provided that all other authenticity elements are taken into consideration and respected. The only difference was that ISS had an organisational impact and ISS participants talked more about issues that would involve practical organisational changes. ISS and OSS participants did, however, go through similar individual and team learning experiences.
PMCID: PMC4608174  PMID: 26443655
2.  Simulation-based multiprofessional obstetric anaesthesia training conducted in situ versus off-site leads to similar individual and team outcomes: a randomised educational trial 
BMJ Open  2015;5(10):e008344.
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.
Investigator-initiated single-centre randomised superiority educational trial.
Obstetrics and anaesthesiology departments, Rigshospitalet, University of Copenhagen, Denmark.
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.
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.
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.
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
PMCID: PMC4611309  PMID: 26443654
OBSTETRICS; MEDICAL EDUCATION & TRAINING; patient simulation; in situ simulation; interprofessional
3.  Procedural specificity in laparoscopic simulator training: protocol for a randomised educational superiority trial 
BMC Medical Education  2014;14:215.
The use of structured curricula for minimally invasive surgery training is becoming increasingly popular. However, many laparoscopic training programs still use basic skills and isolated task training, despite increasing evidence to support the use of training models with higher functional resemblance, such as whole procedural modules. In contrast to basic skills training, procedural training involves several cognitive skills such as elements of planning, movement integration, and how to avoid adverse events. The objective of this trial is to investigate the specificity of procedural practice in laparoscopic simulator training.
A randomised single-centre educational superiority trial. Participants are 96 surgical novices (medical students) without prior laparoscopic experience. Participants start by practicing a series of basic skills tasks to a predefined proficiency level on a virtual reality laparoscopy simulator. Upon reaching proficiency, the participants are randomised to either the intervention group, which practices two procedures (an appendectomy followed by a salpingectomy) or to the control group, practicing only one procedure (a salpingectomy) on the simulator. 1:1 central randomisation is used and participants are stratified by sex and time to complete the basic skills. Data collection is done at a surgical skills centre.
The primary outcome is the number of repetitions required to reach a predefined proficiency level on the salpingectomy module. The secondary outcome is the total training time to proficiency. The improvement in motor skills and effect on cognitive load are also explored.
The results of this trial might provide new knowledge on how the technical part of surgical training curricula should be comprised in the future. To examine the specificity of practice in procedural simulator training is of great importance in order to develop more comprehensive surgical curricula.
Trial registration NCT02069951
PMCID: PMC4201735  PMID: 25304939
Laparoscopy; Specificity; Procedural training; Simulation; Virtual reality training
4.  '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 
Trials  2013;14:220.
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.
The perspective is to provide new knowledge on contextual effects of different simulation settings.
Trial registration NCT01792674.
PMCID: PMC3716971  PMID: 23870501
Simulation; In situ simulation; Randomized trial; Obstetric emergencies; Multi-professional education; Stress
5.  International Multispecialty Consensus on How to Evaluate Ultrasound Competence: A Delphi Consensus Survey 
PLoS ONE  2013;8(2):e57687.
To achieve international consensus across multiple specialties on a generic ultrasound rating scale using a Delphi technique.
Ultrasound experts from Obstetrics-Gynaecology, Surgery, Urology, Radiology, Rheumatology, Emergency Medicine, and Gastro-Enterology representing North America, Australia, and Europe were identified. A multi-round survey was conducted to obtain consensus between these experts. Of 60 invited experts, 44 experts agreed to participate in the first Delphi round, 41 remained in the second round, and 37 completed the third Delphi round. Seven key elements of the ultrasound examination were identified from existing literature and recommendations from international ultrasound societies. All experts rated the importance of these seven elements on a five-point Likert scale in the first round and suggested potential new elements for the assessment of ultrasound skills. In the second round, the experts re-rated all elements and a third round was conducted to allow final comments. Agreement on which elements to include in the final rating scale was pre-defined as more than 80% of the experts rating an element four or five, on importance to the ultrasound examination.
Two additional elements were suggested by more than 10% of the experts in the first Delphi round. Consensus was obtained to include these two new elements along with five of the original elements in the final assessment instrument: 1) Indication for the examination 2) Applied knowledge of ultrasound equipment 3) Image optimization 4) Systematic examination 5) Interpretation of images 6) Documentation of examination and 7) Medical decision making.
International multispecialty consensus was achieved on the content of a generic ultrasound rating scale. This is the first step to ensure valid assessment of clinicians in different medical specialties using ultrasound.
PMCID: PMC3585207  PMID: 23469051
6.  Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial 
Several studies have found a positive effect on the learning curve as well as the improvement of basic psychomotor skills in the operating room after virtual reality training. Despite this, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training. This is mainly due to lack of knowledge concerning the time and human resources needed to train novice surgeons to an adequate level. The purpose of this trial is to investigate the impact of instructor feedback regarding time, repetitions and self-perception when training complex operational tasks on a virtual reality simulator.
The study population consists of medical students on their 4th to 6th year without prior laparoscopic experience. The study is conducted in a skills laboratory at a centralized university hospital. Based on a sample size estimation 98 participants will be randomized to an intervention group or a control group. Both groups have to achieve a predefined proficiency level when conducting a laparoscopic salpingectomy using a surgical virtual reality simulator. The intervention group receives standardized instructor feedback of 10 to 12 min a maximum of three times. The control group receives no instructor feedback. Both groups receive the automated feedback generated by the virtual reality simulator. The study follows the CONSORT Statement for randomized trials. Main outcome measures are time and repetitions to reach the predefined proficiency level on the simulator. We include focus on potential sex differences, computer gaming experience and self-perception.
The findings will contribute to a better understanding of optimal training methods in surgical education.
Trial Registration
PMCID: PMC3311079  PMID: 22373062
Virtual reality simulation; Laparoscopy; Training; Salpingectomy; Feedback
7.  Obstetric risk indicators for labour dystocia in nulliparous women: A multi-centre cohort study 
In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria.
A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given.
The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix < 4 cm (1.63, 1.38–1.92), tense cervix (1.31, 1.04–1.65), thick lower segment (1.32, 1.09–1.61), fetal head above the inter-spinal diameter (2.29, 1.80–2.92) and poor fetal head-to-cervix contact (1.83, 1.31–2.56). The use of epidural analgesia (5.65, 4.33–7.38) was also associated with dystocia.
Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern.
PMCID: PMC2569907  PMID: 18837972
8.  Effect of virtual reality training on laparoscopic surgery: randomised controlled trial 
Objective To assess the effect of virtual reality training on an actual laparoscopic operation.
Design Prospective randomised controlled and blinded trial.
Setting Seven gynaecological departments in the Zeeland region of Denmark.
Participants 24 first and second year registrars specialising in gynaecology and obstetrics.
Interventions Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls).
Main outcome measure The main outcome measure was technical performance assessed by two independent observers blinded to trainee and training status using a previously validated general and task specific rating scale. The secondary outcome measure was operation time in minutes.
Results The simulator trained group (n=11) reached a median total score of 33 points (interquartile range 32-36 points), equivalent to the experience gained after 20-50 laparoscopic procedures, whereas the control group (n=10) reached a median total score of 23 (22-27) points, equivalent to the experience gained from fewer than five procedures (P<0.001). The median total operation time in the simulator trained group was 12 minutes (interquartile range 10-14 minutes) and in the control group was 24 (20-29) minutes (P<0.001). The observers’ inter-rater agreement was 0.79.
Conclusion Skills in laparoscopic surgery can be increased in a clinically relevant manner using proficiency based virtual reality simulator training. The performance level of novices was increased to that of intermediately experienced laparoscopists and operation time was halved. Simulator training should be considered before trainees carry out laparoscopic procedures.
Trial registration NCT00311792.
PMCID: PMC3273782  PMID: 19443914

Results 1-8 (8)