The Development and Evaluation of a Novel Thoracoscopic Diaphragmatic Hernia Repair Simulator

Background: Thoracoscopic diaphragmatic hernia (DH) repair has a high recurrence rate. Effective simulation modeling may improve technical performance for thoracoscopic DH repair. The study purpose was to evaluate measures of validity evidence for a low-cost thoracoscopic DH simulator. Materials and Methods: Synthetic diaphragm/intestine was connected to a to-scale left-sided neonatal rib cage and then covered with synthetic skin. Forty participants evaluated the DH repair simulator, using survey ratings that were analyzed for test content and internal structure validity evidence. Results: Observed averages (on a scale of 0?5) for the domains were 4.6 for Relevance, 4.5 for Value, 4.3 for Physical attributes, 4.0 for Realism of experience, 3.8 for Realism of materials, and 4.2 for Ability to perform. The highest observed averages were ?relevance to practice? and ?value, testing tool,? whereas the lowest ratings were realism, intestines and realism, diaphragm. The observed average of global opinion ratings was 2.84/4.0, indicating the simulator can be considered for teaching thoracoscopic DH repair but could be improved. Experienced surgeons (more than eight DH repairs, at least four thoracoscopic repairs) had higher overall ratings than inexperienced surgeons (4.4 versus 4.1, P=.001). Conclusions: We successfully created a thoracic space relevant to a thoracoscopic DH repair and completed the model using inexpensive, readily accessible materials. After participants performed a simulated thoracoscopic DH repair, their ratings indicated the simulator was relevant to clinical practice and valuable as a learning tool but still requires improvements. Improvements and additional evaluation of validity evidence (content, internal structure, response processes, and relationship to other variables) are necessary prior to full implementation of this model as an educational tool.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/140147/1/lap.2013.0196.pd

The Development and Evaluation of a Novel Thoracoscopic Diaphragmatic Hernia Repair Simulator

Background: Thoracoscopic diaphragmatic hernia (DH) repair has a high recurrence rate. Effective simulation modeling may improve technical performance for thoracoscopic DH repair. The study purpose was to evaluate measures of validity evidence for a low-cost thoracoscopic DH simulator. Materials and Methods: Synthetic diaphragm/intestine was connected to a to-scale left-sided neonatal rib cage and then covered with synthetic skin. Forty participants evaluated the DH repair simulator, using survey ratings that were analyzed for test content and internal structure validity evidence. Results: Observed averages (on a scale of 0?5) for the domains were 4.6 for Relevance, 4.5 for Value, 4.3 for Physical attributes, 4.0 for Realism of experience, 3.8 for Realism of materials, and 4.2 for Ability to perform. The highest observed averages were ?relevance to practice? and ?value, testing tool,? whereas the lowest ratings were realism, intestines and realism, diaphragm. The observed average of global opinion ratings was 2.84/4.0, indicating the simulator can be considered for teaching thoracoscopic DH repair but could be improved. Experienced surgeons (more than eight DH repairs, at least four thoracoscopic repairs) had higher overall ratings than inexperienced surgeons (4.4 versus 4.1, P=.001). Conclusions: We successfully created a thoracic space relevant to a thoracoscopic DH repair and completed the model using inexpensive, readily accessible materials. After participants performed a simulated thoracoscopic DH repair, their ratings indicated the simulator was relevant to clinical practice and valuable as a learning tool but still requires improvements. Improvements and additional evaluation of validity evidence (content, internal structure, response processes, and relationship to other variables) are necessary prior to full implementation of this model as an educational tool.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/140147/1/lap.2013.0196.pd

Evaluation of Three Sources of Validity Evidence for a Laparoscopic Duodenal Atresia Repair Simulator

Purpose: Laparoscopic duodenal atresia (DA) repair is a relatively uncommon pediatric operation requiring advanced minimally invasive skills. Currently, there are no commercial simulators available that address surgeons' needs for refining skills associated with this procedure. The purposes of this study were (1) to create an anatomically correct, size-relevant model and (2) to evaluate the content validity of the simulator. Materials and Methods: Radiologic images were used to create an abdominal domain consistent with a full-term infant. Fetal bovine tissue was used to complete the simulator. Following Institutional Review Board exempt determination, 18 participants performed the simulated laparoscopic DA repair. Participants completed a self-report, six-domain, 24-item instrument consisting of 4-point rating scales (from 1=not realistic to 4=highly realistic). Validity evidence relevant to test content and response processes was evaluated using the many-facet Rasch model, and evidence of internal structure (inter-item consistency) was estimated using Cronbach's alpha. Results: The highest observed averages were for ?Value as a training and testing tool? (both observed averages=3.9), whereas the lowest ratings were ?Palpation of liver? (observed average=3.3) and ?Realism of skin? (observed average=3.2). The Global opinion rating was 3.2, indicating the simulator can be considered for use as is, but could be improved slightly. Inter-item consistency was high (α=0.89). Conclusions: We have successfully created a size-appropriate laparoscopic DA simulator. Participants agreed that the simulator was relevant and valuable as a learning/testing tool. Prior to implementing this simulator as a training tool, minor improvements should be made, with subsequent evaluation of additional validation evidence.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/140148/1/lap.2014.0358.pd

Preliminary Evaluation of a Novel Thoracoscopic Infant Lobectomy Simulator

Purpose: Thoracoscopic lobectomy in infants requires advanced minimally invasive skills. Simulation-based education has the potential to improve complex procedural skills without exposing the patient to undue risks. The study purposes were (1) to create a size-appropriate infant lobectomy simulator and (2) to evaluate validity evidence to support or refute its use in surgical education. Materials and Methods: In this Institutional Review Board-exempt study, a size-appropriate rib cage for a 3-month-old infant was created. Fetal bovine tissue completed the simulator. Thirty-three participants performed the simulated thoracoscopic lobectomy. Participants completed a self-report, 26-item instrument consisting of 25 4-point rating scales (from 1=not realistic to 4=highly realistic) and a one 4-point Global Rating Scale. Validity evidence relevant to test content and response processes was evaluated using the many-facet Rasch model, and evidence of internal structure (inter-item consistency) was estimated using Cronbach's alpha. Results: Experienced surgeons (observed average=3.6) had slightly higher overall rating than novice surgeons (observed average=3.4, P=.001). The highest combined observed averages were for the domain Physical Attributes (3.7), whereas the lowest ratings were for the domains Realism of Experience and Ability to Perform Tasks (3.4). The global rating was 2.9, consistent with ?this simulator can be considered for use in infant lobectomy training, but could be improved slightly.? Inter-item consistency for items used to evaluate the simulator's quality was high (α=0.90). Conclusions: With ratings consistent with high physical attributes and realism, we successfully created an infant lobectomy simulator, and preliminary evidence relevant to test content, response processes, and internal structure was supported. Participants rated the model as realistic, relevant to clinical practice, and valuable as a learning tool. Minor improvements were suggested prior to its full implementation as an educational and testing tool.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/140149/1/lap.2014.0364.pd

Evaluation of Three Sources of Validity Evidence for a Synthetic Thoracoscopic Esophageal Atresia/Tracheoesophageal Fistula Repair Simulator

Purpose: Thoracoscopic esophageal atresia (EA)/tracheoesophageal fistula (TEF) repair is technically challenging. We have previously reported our experiences with a high-fidelity hybrid model for simulation-based educational instruction in thoracoscopic EA/TEF, including the high cost of the tissue for these models. The purposes of this study were (1) to create a low-cost synthetic tissue EA/TEF repair simulation model and (2) to evaluate the content validity of the synthetic tissue simulator. Materials and Methods: Review of the literature and computed tomography images were used to create computer-aided drawings (CAD) for a synthetic, size-appropriate EA/TEF tissue insert. The inverse of the CAD image was then printed in six different sections to create a mold that could be filled with platinum-cured silicone. The silicone EA/TEF insert was then placed in a previously described neonatal thorax and covered with synthetic skin. Following institutional review board?exempt determination, 47 participants performed some or all of a simulated thoracoscopic EA/TEF during two separate international meetings (International Pediatric Endosurgery Group [IPEG] and World Federation of Associations of Pediatric Surgeons [WOFAPS]). Participants were identified as ?experts,? having 6?50 self-reported thoracoscopic EA/TEF repairs, and ?novice,? having 0?5 self-reported thoracoscopic EA/TEF repairs. Participants completed a self-report, six-domain, 24-item instrument consisting of 23 5-point rating scales and one 4-point Global Rating Scale. Validity evidence relevant to test content and response processes was evaluated using the many-facet Rasch model, and evidence of internal structure (interitem consistency) was estimated using Cronbach's alpha. Results: A review of the participants' ratings indicates there were no overall differences across sites (IPEG versus WOFAPS, P=.84) or experience (expert versus novice, P=.17). The highest observed averages were 4.4 (Value of Simulator as a Training Tool), 4.3 (Physical Attributes?chest circumference, chest depth, and intercostal space), and 4.3 (Realism of Experience?fistula location). The lowest observed averages were 3.5 (Ability to Perform?closure of fistula), 3.7 (Ability to Perform?acquisition target trocar sites), 3.8 (Physical Attributes?landmark visualization), 3.8 (Ability to Perform?anastomosis and dissection of upper pouch), and 3.9 (Realism of Materials?skin). The Global Rating Scale was 2.9, coinciding with a response of ?this simulator can be considered for use in neonatal TEF repair training, but could be improved slightly.? Material costs for the synthetic EA/TEF inserts were less than $2 U.S. per insert. Conclusions: We have successfully created a low-cost synthetic EA/TEF tissue insert for use in a neonatal thoracoscopic EA/TEF repair simulator. Analysis of the participants' ratings of the synthetic EA/TEF simulation model indicates that it has value and can be used to train pediatric surgeons, especially those early in their learning curve, to begin to perform a thoracoscopic EA/TEF repair. Areas for model improvement were identified, and these areas will be the focus for future modifications to the synthetic EA/TEF repair simulator.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/140150/1/lap.2014.0370.pd

Preliminary Evaluation of a Laparoscopic Common Bile Duct Simulator for Pediatric Surgical Education

Purpose: Laparoscopic common bile duct exploration (LCBDE) decreases overall costs and length of stay in patients with choledocolithiasis. However, utilization of LCBDE remains low. We sought to evaluate a previously developed general surgery LCBDE simulator among a cohort of pediatric surgical trainees. The study purpose was to evaluate the content validity of an LCBDE simulator to support or refute its use in pediatric surgery education. Materials and Methods: After IRB exempt determination, 30 participants performed a transcystic LCBDE using a previously developed simulator and evaluated the simulator using a self-reported 28-item instrument. The instrument consisted of two primary domains (Quality and Ability to Perform) that were rated using twenty-five 4-point rating scales and one 4-point global rating scale. Validity evidence relevant to test content was evaluated using a many-facet Rasch model. Interitem consistency was estimated using Cronbach's alpha. P?Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/140153/1/lap.2016.0248.pd

Simulation‐Based Medical Emergencies Education for Dental Students: A Three‐Year Evaluation

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/153561/1/jddjde019084.pd

Assessing anesthesiology residents’ out-of-the-operating-room (OOOR) emergent airway management

Abstract Background At many academic institutions, anesthesiology residents are responsible for managing emergent intubations outside of the operating room (OOOR), with complications estimated to be as high as 39%. In order to create an OOOR training curriculum, we evaluated residents’ familiarity with the content and correct adherence to the American Society of Anesthesiologists’ Difficult Airway Algorithm (ASA DAA). Methods Residents completed a pre-simulation multiple-choice survey measuring their understanding and use of the DAA. Residents then managed an emergent, difficult OOOR intubation in the simulation center, where two trained reviewers assessed performance using checklists. Post-simulation, the residents completed a survey rating their behaviors during the simulation. The primary outcome was comprehension and adherence to the DAA as assessed by survey responses and behavior in the simulation. Results Sixty-three residents completed both surveys and the simulation. Post-survey responses indicated a shift toward decreased self-perceived familiarity with the DAA content compared to pre-survey responses. During the simulation, 22 (35%) residents were unsuccessful with intubation. Of these, 46% placed an LMA and 46% prepared for cricothyroidotomy. Nineteen residents did not attempt intubation. Of these, only 31% considered LMA placement, and 26% initiated cricothyroidotomy. Conclusions Many anesthesiology residency training programs permit resident autonomy in managing emergent intubations OOOR. Residents self-reported familiarity with the content of and adherence to the DAA was higher than that observed during the simulation. Curriculum focused on comprehension of the DAA, as well as improving communication with higher-level physicians and specialists, may improve outcomes during OOORs.https://deepblue.lib.umich.edu/bitstream/2027.42/137699/1/12871_2017_Article_387.pd

Limiting weight gain in overweight and obese women during pregnancy to improve health outcomes: the LIMIT randomised controlled trial

Extent: 5p.Background: Obesity is a significant global health problem, with the proportion of women entering pregnancy with a body mass index greater than or equal to 25 kg/m2 approaching 50%. Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant, however there is more limited information available regarding effective interventions to improve health outcomes. The aims of this randomised controlled trial are to assess whether the implementation of a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit gestational weight gain is effective in improving maternal, fetal and infant health outcomes. Methods/Design: Design: Multicentred randomised, controlled trial. Inclusion Criteria: Women with a singleton, live gestation between 10+0-20+0 weeks who are obese or overweight (defined as body mass index greater than or equal to 25 kg/m2), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10+0 and 20+0 weeks gestation using a central telephone randomisation service, and randomisation schedule prepared by non-clinical research staff with balanced variable blocks. Stratification will be according to maternal BMI at trial entry, parity, and centre where planned to give birth. Treatment Schedules: Women randomised to the Dietary and Lifestyle Advice Group will receive a series of inputs from research assistants and research dietician to limit gestational weight gain, and will include a combination of dietary, exercise and behavioural strategies. Women randomised to the Standard Care Group will continue to receive their pregnancy care according to local hospital guidelines, which does not currently include routine provision of dietary, lifestyle and behavioural advice. Outcome assessors will be blinded to the allocated treatment group. Primary Study Outcome: infant large for gestational age (defined as infant birth weight ≥ 90th centile for gestational age). Sample Size: 2,180 women to detect a 30% reduction in large for gestational age infants from 14.40% (p = 0.05, 80% power, two-tailed). Discussion This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines.Jodie M Dodd, Deborah A Turnbull, Andrew J McPhee, Gary Wittert, Caroline A Crowther and Jeffrey S Robinso

Basic science232. Certolizumab pegol prevents pro-inflammatory alterations in endothelial cell function

Background: Cardiovascular disease is a major comorbidity of rheumatoid arthritis (RA) and a leading cause of death. Chronic systemic inflammation involving tumour necrosis factor alpha (TNF) could contribute to endothelial activation and atherogenesis. A number of anti-TNF therapies are in current use for the treatment of RA, including certolizumab pegol (CZP), (Cimzia ®; UCB, Belgium). Anti-TNF therapy has been associated with reduced clinical cardiovascular disease risk and ameliorated vascular function in RA patients. However, the specific effects of TNF inhibitors on endothelial cell function are largely unknown. Our aim was to investigate the mechanisms underpinning CZP effects on TNF-activated human endothelial cells. Methods: Human aortic endothelial cells (HAoECs) were cultured in vitro and exposed to a) TNF alone, b) TNF plus CZP, or c) neither agent. Microarray analysis was used to examine the transcriptional profile of cells treated for 6 hrs and quantitative polymerase chain reaction (qPCR) analysed gene expression at 1, 3, 6 and 24 hrs. NF-κB localization and IκB degradation were investigated using immunocytochemistry, high content analysis and western blotting. Flow cytometry was conducted to detect microparticle release from HAoECs. Results: Transcriptional profiling revealed that while TNF alone had strong effects on endothelial gene expression, TNF and CZP in combination produced a global gene expression pattern similar to untreated control. The two most highly up-regulated genes in response to TNF treatment were adhesion molecules E-selectin and VCAM-1 (q 0.2 compared to control; p > 0.05 compared to TNF alone). The NF-κB pathway was confirmed as a downstream target of TNF-induced HAoEC activation, via nuclear translocation of NF-κB and degradation of IκB, effects which were abolished by treatment with CZP. In addition, flow cytometry detected an increased production of endothelial microparticles in TNF-activated HAoECs, which was prevented by treatment with CZP. Conclusions: We have found at a cellular level that a clinically available TNF inhibitor, CZP reduces the expression of adhesion molecule expression, and prevents TNF-induced activation of the NF-κB pathway. Furthermore, CZP prevents the production of microparticles by activated endothelial cells. This could be central to the prevention of inflammatory environments underlying these conditions and measurement of microparticles has potential as a novel prognostic marker for future cardiovascular events in this patient group. Disclosure statement: Y.A. received a research grant from UCB. I.B. received a research grant from UCB. S.H. received a research grant from UCB. All other authors have declared no conflicts of interes