3D printed temporal bones for preoperative simulation and planning.

OBJECTIVE: Demonstrate the utility of 3D printed temporal bone models in individual patient preoperative planning and simulation. METHODS: 3D models of the temporal bone were made from 5 pediatric and adult patients at a tertiary academic hospital with challenging surgical anatomy planned for cochlear implantation or exteriorization of cholesteatoma with complex labyrinthine fistula. The 3D models were created from CT scan used for preoperative planning, simulation and intraoperative reference. The utility of models was assessed for ease of segmentation and production and impact on surgery in regard to reducing intraoperative time and costs, improving safety and efficacy. RESULTS: Three patients received cochlear implants, two exteriorization of advanced cholesteatoma with fistulas (1 internal auditory canal/cochlea, 1 all three semicircular canals). Surgical planning and intraoperative referencing to the simulations by the attending surgeon and trainees significantly altered original surgical plans. In a case of X-linked hereditary deafness, optimal angles and rotation maneuvers for cochlear implant insertion reduced operating time by 93 min compared to the previous contralateral side surgery. Two cochlear implant cases planned for subtotal petrosectomy approach due to aberrant anatomy were successfully approached through routine mastoidectomy. The cholesteatoma cases were successfully exteriorized without necessitating partial labyrinthectomy or labyrinthine injury. There were no complications. CONCLUSION: 3D printed models for simulation training, surgical planning and use intraoperatively in temporal bone surgery demonstrated significant benefits in designing approaches, development of patient-specific techniques, avoidance of potential or actual complications encountered in previous or current surgery, and reduced surgical time and costs.

Setting the Stage: Innovation in Port Access Education for Pediatric Emergency Nurses.

INTRODUCTION: Pediatric port access can be challenging in the emergency department; however, it must be performed promptly and safely. Port education for nurses traditionally includes procedural practice on adult-size, tabletop manikins, which lacks the situational and emotional aspects inherent in pediatrics. The purpose of this foundational study was to describe the knowledge and self-efficacy gain from a simulation curriculum that promotes effective situational dialogue and sterile port access technique, while incorporating a wearable port trainer to enhance simulation fidelity. METHODS: An educational intervention impact study was conducted using a curriculum integrating a comprehensive didactic session with simulation. A unique element included a novel port trainer worn by a standardized patient, along with a second actor portraying a distressed parent at the bedside. Participants completed precourse and postcourse surveys on the day of simulation and a 3-month follow-up survey. Sessions were video recorded for review and content analysis. RESULTS: Thirty-four pediatric emergency nurses participated in the program and demonstrated an overall increase in knowledge and self-efficacy with port access that was sustained at the 3-month follow-up. Data revealed positive feedback regarding the participants' simulation experience. DISCUSSION: Effective port access education for nurses requires a comprehensive curriculum integrating procedural aspects and situational techniques to address the components of a true port access experience involving pediatric patients and families. Our curriculum successfully combined skill-based practice with situational management, and promoted nursing self-efficacy and competence with port access in the pediatric population.

Teaching Unilateral Cleft lip Repair: Lessons from Simulation-Based Mining of Trainee Strengths and Performance Gaps.

OBJECTIVE: To identify specific areas for improvement in cleft lip repair teaching. DESIGN: Secondary analysis of prospectively-collected, blinded data. SETTING: Three residency programs rotating at a single academic children's hospital. PARTICIPANTS: Plastic surgery residents, and craniofacial/pediatric plastic surgery fellows. MAIN OUTCOME MEASURES: Mean scores for each skill in an 18-item Unilateral Cleft Lip Repair competency assessment tool (UCLR) (1-3 scale for each item) were rank ordered. Correlation between level of training (PGY) and performance on steps of the procedure was examined using Pearson R. RESULTS: Simulation participants (n = 26) scored highest on skills in the "Marking" subscale (2.38-2.63 mean score). Procedural steps that scored lowest were: closing the nasal floor (2.00), repairing oral mucosa (2.15) and avoiding over/under-dissection (2.19). Interestingly, none of these skills correlated with PGY, suggesting they do not improve with training. CONCLUSIONS: These results suggest that marking cleft lip repair is taught well in our current teaching environment, while steps like closing the nasal floor and repairing the oral mucosa are taught less well. Improved teaching of these steps could be achieved with deliberate instruction, video, digital simulation, and high fidelity simulation.

Incorporating Cleft Lip Simulation Into a "Bootcamp-Style" Curriculum.

INTRODUCTION: The traditions of surgical education have changed little over the years. However, the increasing focus on patient safety and duty hour restrictions mandates that residents start developing complex skill sets earlier to ensure they graduate with procedural competency. Surgical training is poised to exploit high-fidelity simulation technology to mitigate these pressures. METHODS: By revisiting principles of adult learning theory, the authors created a "bootcamp-style" cleft lip curriculum that sought to (1) maximize educational impact and (2) pilot a high-fidelity procedural trainer permitting resident operative autonomy as part of that curriculum. Trainees participated in small group educational sessions comprised of a standard cleft didactic lecture, augmented by instructional video. Participants immediately processed knowledge from the lecture/video by "operating" on the simulator, allowing opportunities for questions and self-reflection, completing the learning cycle. A self-assessment survey was taken before and after each component of the session, including a self-confidence survey to conclude the session. Anthropometric measures of lip/nasal symmetry were assessed. RESULTS: Sixteen trainees participated in the program. Little increase in self-assessed knowledge/skill was seen after the lecture, but significant increases in most aspects of cleft lip repair were seen after simulation. The greatest increase in self-assessment was seen for the program as a whole, with significant differences across all aspects of the self-assessment. Higher levels of training were associated with both higher self-assessment scores and better lip symmetry. Regardless of level of training, all participants strongly agreed that simulation helped them actively engage in learning and should be a required aspect of training, whereas 94% (n = 15) thought simulation was much more effective than standard preparation alone. CONCLUSIONS: This pilot curriculum illustrates a mechanism to incorporate lessons from adult learning theory into plastic surgery training using a high-fidelity simulator for deliberate practice of cleft lip repair. Further evaluation is warranted to determine whether this didactic model can accelerate the acquisition of the complex skill set required for cleft lip repair and other surgical procedures.

Simulation and Active Learning Decreases Training Time of an Emergency Triage Assessment and Treatment Course in Pilot Study in Malawi: Implications for Increasing Efficiency and Workforce Capacity in Low-Resource Settings.

OBJECTIVES: The aim of the Emergency Triage Assessment and Treatment (ETAT) plus trauma course is to improve the quality of care provided to infants and children younger than 5 years. The curriculum was revised and shortened from 5 to 2.5 days by enhancing simulation and active learning opportunities. The aim of this study was to examine the feasibility and value of the new short-form ETAT course by assessing postcourse knowledge and satisfaction. METHODS: We delivered the short-form ETAT course to a group of interdisciplinary health workers in Malawi. Precourse and postcourse knowledge was assessed using a standardized 20 questions short answer test used previously in the 5-day courses. A 13-statement survey with 2 open-ended questions was used to examine participant satisfaction. RESULTS: Participants' postcourse knowledge improved significantly (P < 0.001) after the shorter ETAT course. Participants reported high levels of satisfaction with the short-form ETAT. CONCLUSIONS: Simulation and other active learning strategies reduced training time by 50% in the short-form ETAT course. Participants with and without previous ETAT training improved their knowledge after participating in the short-form ETAT course. Reduced training time is beneficial in settings already burdened by scarce human resources, may facilitate better access to in-service training, and build capacity while conserving resources in low-resource settings.

Anxiety, distress, and pain in pediatric urodynamics.

AIMS: No one has assessed urodynamic studies (UDS) to determine those steps that elicit the greatest anxiety, distress, and pain in children. We sought to systematically evaluate a child's UDS experience to mollify these reactions. METHODS: Prospective study involving children aged ≥5 undergoing UDS over a 6-month period (from 10 December 2018 to 22 May 2019). Upon arrival, patients completed a visual analog scale for anxiety (VAS-A, 0-10) about the upcoming procedure. A research assistant assessed the patient's behavior during each major step of UDS using a validated brief behavioral distress scale. Nursing staff also obtained patients' pain ratings (0-10) for these key elements. Immediately after UDS, each child completed a posttest VAS-A along with a survey about the UDS experience. RESULTS: A total of 76 UDS were observed; almost half included sphincter needle electromyography (EMG). Mean patient VAS-A scores were 2.3 before UDS, compared to 0.8 afterward (P < .001). The highest proportion of distressful behaviors were observed during EMG needle (31%) and urethral catheter (29%) insertion, in agreement with the highest mean pain scores of 3.2 and 2.7, respectively. Fifty-four percent of children reported not being completely aware of what was going to happen before the procedure and 50% of those patients exhibited at least one interfering or potentially interfering behavior. Similarly, 60% of children with no prior history of UDS exhibited at least one interfering or potentially interfering behavior. CONCLUSIONS: EMG needle and urethral catheter placement, initial urodynamic testing and not knowing what to expect were associated with greater pain and distress during pediatric UDS.

Bridging the Stressful Gap Between ICU and Home: Medical Simulation for Pediatric Patients and Their Families.

OBJECTIVES: Introduce an expanding role for pediatric critical care and medical simulation to optimize the care for children with technology dependence. DATA SOURCES: Limited review of literature and practice for current teaching paradigms, vulnerability of the patient population, and efficacy of simulation as a medical educational tool. CONCLUSIONS: In accordance with new care models and patient need, critical care requires parallel evolution of care practices, including new educational and care models, in order to maximally reduce risk, fear, and anxiety and to insure quality and consistent care in the community for patients and families transitioning between the ICU and home environments.

Teaching Incision and Drainage: Perceived Educational Value of Abscess Models.

OBJECTIVES: Incision and drainage (I&D) of skin abscesses is an important procedural skill for pediatric emergency medicine providers. Practical skills training using simulation provides an opportunity to learn and gain confidence with this invasive procedure. Our objective was to assess the perceived educational value of 2 versions of an abscess model as part of an educational workshop for teaching I&D. METHODS: A combined didactic and practical skills workshop was developed for use at 2 national conferences. The didactic content was created through an iterative process. To facilitate hands-on training, 2 versions of an abscess model were created: 1 constructed from a negative mold and the other using a 3-dimensional printer. Participants were surveyed regarding prior experience with I&D, procedural confidence, and perceptions of the educational utility of the models. RESULTS: Seventy physicians and 75 nurse practitioners participated in the study. Procedural confidence improved after training using each version of the model, with the greatest improvements noted among novice learners. Ninety-four percent of physicians, and 99% of nurse practitioners rated the respective models as either "educational" or "very educational," and 97% and 100%, respectively, would recommend the abscess models to others. CONCLUSIONS: A combined didactic and practical skills educational workshop using novel abscess models was effective at improving learners' confidence. Our novel models provide an effective strategy for teaching procedural skills such as I&D and demonstrate a novel use of 3-dimensional printers in medical education. Further study is needed to determine if these educational gains translate into improvement in clinical performance or patient outcomes.

Cost-Benefit Analysis of Three-Dimensional Craniofacial Models for Midfacial Distraction: A Pilot Study.

OBJECTIVE: Patient-specific three-dimensional (3D) models are increasingly used to virtually plan rare surgical procedures, providing opportunity for preoperative preparation, better understanding of individual anatomy, and implant prefabrication. The purpose of this study was to assess the benefit of 3D models related to patient safety, operative time, and cost. DESIGN: Retrospective review. SETTING: Academic, tertiary care hospital. PATIENTS, PARTICIPANTS: Midfacial distraction was studied as a representative craniofacial operation. A consecutive series of 29 patients who underwent a single type of midfacial distraction was included. INTERVENTION: For a subset of patients, computed tomography-derived 3D models were used to study patient-specific anatomy and precontour hardware. MAIN OUTCOME MEASURES: Complications, operative time, blood loss, and estimated cost. RESULTS: Twenty patients underwent midfacial distraction without and nine with preoperative use of a 3D model. Seven complications occurred in six patients without model use, including premature consolidation (3), cerebrospinal fluid leak (2), and hardware malfunction (2). No complications were reported in the model group. Controlling for surgeon variation, model use resulted in a 31.3-minute (7.8%) reduction in operative time. Time-based cost savings were estimated to be $1036. CONCLUSIONS: Three-dimensional models are valuable for preoperative planning and hardware precontouring in craniofacial surgery, with potential positive effects on complications and operative time. Savings related to operative time and complications may offset much of the cost of the model.

The role of simulation in neurosurgery.

PURPOSE: In an era of residency duty-hour restrictions, there has been a recent effort to implement simulation-based training methods in neurosurgery teaching institutions. Several surgical simulators have been developed, ranging from physical models to sophisticated virtual reality systems. To date, there is a paucity of information describing the clinical benefits of existing simulators and the assessment strategies to help implement them into neurosurgical curricula. Here, we present a systematic review of the current models of simulation and discuss the state-of-the-art and future directions for simulation in neurosurgery. METHODS: Retrospective literature review. RESULTS: Multiple simulators have been developed for neurosurgical training, including those for minimally invasive procedures, vascular, skull base, pediatric, tumor resection, functional neurosurgery, and spine surgery. The pros and cons of existing systems are reviewed. CONCLUSION: Advances in imaging and computer technology have led to the development of different simulation models to complement traditional surgical training. Sophisticated virtual reality (VR) simulators with haptic feedback and impressive imaging technology have provided novel options for training in neurosurgery. Breakthrough training simulation using 3D printing technology holds promise for future simulation practice, proving high-fidelity patient-specific models to complement residency surgical learning.

Pilot testing of a model for insurer-driven, large-scale multicenter simulation training for operating room teams.

OBJECTIVE: To test the feasibility of implementing a standardized teamwork training program with full operating room teams in multiple institutions, driven by malpractice insurer support and incentives. BACKGROUND: Failures in intraoperative teamwork are among the leading causes of preventable patient injury and death in surgical patients. Teamwork training, particularly using simulation, can be an effective intervention but is difficult to scale. METHODS: A malpractice insurer convened a collaborative with 4 Harvard-affiliated simulation programs to develop a standardized operating room teamwork training curriculum, including principles of communication, assertiveness, and use of the World Health Organization Surgical Safety Checklist. Participant teams were compensated for lost operative time via malpractice premium discounts, continuing education credits, and compensation for lost wages. The course was delivered through a simulation program involving the management of intraoperative emergency scenarios. Participants were surveyed for their perceptions of the program and of its impact on clinical practice. RESULTS: A total of 221 active operating room staff members participated in the program. Each team contained at least 1 attending surgeon, 1 attending anesthesiologist, and 1 operating room nurse (mean size per team: 7 ± 2 participants). No study dates were cancelled because of lack of attendance. The survey response rate was 99% (218/221). Overall, the vast majority of participants found the scenarios realistic [94% (95% confidence interval: 90.9%, 97.2%)], appropriately challenging [95.4% (92.6%, 98.2%)], relevant to their practice [96.3% (93.8%, 98.8%)], and found the training would help them provide safer patient care [92.6% (89.1%, 96.1%)]. Surgeons reported their greatest personal deficit as communication skills. Operating room nurses and anesthesiologists reported a greater need than surgeons to work on personal assertiveness. CONCLUSIONS: A standardized multicenter team training program involving full operative teams is feasible with high-fidelity simulation and modest compensation for lost time. The vast majority of the multidisciplinary participants believed the course to have had a meaningful impact on their approach to clinical practice.

Education on Preventing Early Childhood Injuries Using a Video Game: The VirtualSafeHome Platform.

Poisonings and household injuries are frequent events among toddlers. We developed VirtualSafeHome (VSH)-a novel self-contained, Internet-based home-safety learning tool-to improve awareness of household hazards. Study aims were to investigate VSH usage characteristics. A prototype, screen-based VSH kitchen was built in Unity and delivered through the web using 3DVista and Wix. Players spot and click 21 embedded hazards. A unique feature is the ability to capture the "child's perspective" in identifying hazards. We recruited a convenience sample of adults in 2021-2022. Outcomes included number of hazards discovered, session duration, and pretest/posttest knowledge scores. Twenty-four adults identified a median 15.5 hazards; median playing time was 1022 seconds. Players reported satisfaction with ease of navigation and game features. Mean pretest/posttest knowledge scores rose from 2.0 to 2.79 (P < .035). A web-enabled video game can provide easily accessed, enjoyable training on home safety.

Hazard Assessment and Remediation Tool for Simulation-Based Healthcare Facility Design Testing.

OBJECTIVES: To develop an objective, structured observational tool to enable identification and measurement of hazards in the built environment when applied to audiovisual recordings of simulations by trained raters. BACKGROUND: Simulation-based facility design testing is increasingly used to optimize safety of healthcare environments, often relying on participant debriefing or direct observation by human factors experts. METHODS: Hazard categories were defined through participant debriefing and detailed review of pediatric intensive care unit in situ simulation videos. Categories were refined and operational definitions developed through iterative coding and review. Hazard detection was optimized through the use of structured coding protocols and optimized camera angles. RESULTS: Six hazard categories were defined: (1) slip/trip/fall/injury risk, impaired access to (2) patient or (3) equipment, (4) obstructed path, (5) poor visibility, and (6) infection risk. Analysis of paired and individual coding demonstrated strong overall reliability (0.89 and 0.85, Gwet's AC1). Reliability coefficients for each hazard category were >0.8 for all except obstructed path (0.76) for paired raters. Among individual raters, reliability coefficients were >0.8, except for slip/trip/fall/injury risk (0.68) and impaired access to equipment (0.77). CONCLUSIONS: Hazard Assessment and Remediation Tool (HART) provides a framework to identify and quantify hazards in the built environment. The tool is highly reliable when applied to direct video review of simulations by either paired raters or trained single clinical raters. Subsequent work will (1) assess the tool's ability to discriminate between rooms with different physical attributes, (2) develop strategies to apply HART to improve facility design, and (3) assess transferability to non-ICU acute care environments.

Overcoming roadblocks in clinical innovation via high fidelity simulation: use of a phantom simulator to achieve FDA and IRB approval of a clinical trial of fetal embolization of vein of Galen malformations.

BACKGROUND: Vein of Galen malformation (VOGM) is a rare, life-threatening vascular malformation in neonates and is treated with embolization. However, even at the most experienced centers, patients face high mortality and morbidity. In utero treatment options have been limited by lack of animal models or simulations. OBJECTIVE: To create a novel ultrasound phantom simulator for a preclinical feasibility study of in utero fetal intervention for VOGM. METHODS: Novel phantoms were designed and built in two configurations of spherical and windsock shape from cryogel material to mimic the salient vasculature of the fetal VOGM, based on real-patient fetal MR imaging dimensions. Critical anatomy was realistically mimicked within this model and transtorcular ultrasound-guided coil deployment was simulated. Each phantom model was assessed before and after treatment to evaluate coil mass deposition within the target. RESULTS: The two phantoms underwent pretreatment T2-weighted MR imaging assessment, ultrasound-guided embolization, post-treatment MR and fluoroscopic imaging, and visual inspection of the sliced phantoms for target embolization verification. Postoperative MR scans confirmed realistic compact deposition of the coil masses within the central cavity. Phantom embolization results were submitted as part of the institutional review board and US Food and Drug Administration investigative device exemption approval for a first-in-humans clinical trial of fetal intervention for VOGM. CONCLUSIONS: A phantom simulator for fetal intervention of VOGM produces lifelike results during trial interventions, removing obstacles to feasibility and safety evaluations, typically precluded by non-availability of appropriate animal models. The study provides a proof of concept for potentially wider applications of medical simulation to enable novel procedural advancements in neurointerventions.

High-Fidelity Cleft Simulation Maintains Improvements in Performance and Confidence: A Prospective Study.

OBJECTIVE: High-fidelity simulation has a growing role in plastic surgical education. This study tests the hypothesis that cleft lip repair simulation followed by structured debriefing improves performance and self-confidence and that gains are maintained. DESIGN: Prospective, single-blinded interventional study with repeated measures. Trainees performed cleft lip repair on a high-fidelity simulator followed by debriefing, immediately completed a second repair, and returned 3 months later for a third session. Anonymized simulation videos were rated using the modified Objective Structured Assessment of Technical Skills (OSATS) and the Unilateral Cleft Lip Repair competency assessment tool (UCLR). Self-assessed cleft lip knowledge/confidence and procedural self-confidence were surveyed after each simulation. SETTING: Boston Children's Hospital, a tertiary care academic hospital in Boston, MA, USA. PARTICIPANTS: All trainees rotating through the study setting were eligible. Twenty-six participated; 21 returned for follow-up. RESULTS: Significant improvements (p < 0.05) occurred between the first and second simulations for OSATS, UCLR, and procedural self-confidence. Significant improvement occurred between the second and third simulations cleft lip knowledge/confidence. Compared to the first simulation, improvements were maintained at the third simulation for all variables. Training level moderately correlated with score for UCLR for the first simulation (r = 0.55, p < 0.01), deteriorated somewhat with the second (r = 0.35, p = 0.08), and no longer corelated by the third (r = 0.02, p = 0.92). CONCLUSIONS: Objective performance and subjective self-assessed knowledge and confidence improve with high-fidelity simulation plus structured debriefing and improvement is maintained. Differences in procedure-specific performance seen with increasing training level are reduced with simulation, suggesting it may accelerate knowledge and skill acquisition.

A Multimodal Approach to Training Coronavirus Disease (COVID-19) Processes Across Four Intensive Care Units.

Background: Coronavirus disease (COVID-19) required innovative training strategies for emergent aerosol generating procedures in intensive care units. This manuscript summarizes institutional operationalization of COVID-specific training, standardized across four intensive care units. Methods & Results: An interdisciplinary team collaborated with the Simulator Program and OpenPediatrics refining logistics using process maps, walkthroughs and simulation. A multimodal approach to information dissemination, high-volume team training in modified resuscitation practices and technical skill acquisition included instructional videos, training superusers, small-group simulation using a flipped classroom approach with rapid cycle deliberate practice, interactive webinars, and cognitive aids. Institutional data on application of this model are presented. Conclusion: Success was founded in interdisciplinary collaboration, resource availability and institutional buy in.

Creation of a Novel Child Simulator and Curriculum to Optimize Administration of Seizure Rescue Medication.

INTRODUCTION: Although most cases of pediatric convulsive status epilepticus start in the prehospital setting, many patients do not receive treatment. The use of prehospital seizure rescue medications by caregivers is crucial, but studies suggest a lack of proper training on medication use. METHODS: We created a novel proof of principle mannequin and simulation for training proper administration of rectal diazepam, with a scoring paradigm to standardize and assess the educational process. RESULTS: Twenty-three health care providers (nurses and nurse practitioners, residents/fellows, and attending physicians) and 5 patient guardians/parents were included in the study. The rectal diazepam simulator displayed a high degree of physical and emotional realism (mean ≥ 4/5 on Likert scale survey) that effectively decreased time to treatment (-12.3 seconds; SD, 16.3) and improved the accuracy of medication delivery in a simulation setting (-4.2 points; SD, 3.1). The scoring technique had appropriate interrater reliability (≥86% on all but 2 prompts) and was a feasible instrument to assess the effectiveness of the educational intervention. CONCLUSIONS: A unique procedure-focused child simulator and rescue medication score offer an innovative and effective means to train caregivers on the use of lifesaving seizure rescue medications.

Quality Improvement Initiative Using Blended In Situ Simulation Training on Procedural Sedation and Analgesia in a Pediatric Emergency Department: Better Patient Care at Lower Costs.

INTRODUCTION: There is evidence in the literature for high-fidelity in situ simulation training programs being an effective modality for physicians training. This quality initiative focused on implementation of the procedural sedation and analgesia (PSA) in our pediatric emergency department (PED). The primary outcomes of this study were to evaluate the impact of blended in situ simulation training (BST) program on PSA for closed forearm fracture reduction in the PED and to assess its cost-effectiveness. The secondary outcomes were to estimate this change on PSA's clinical efficacy and safety. METHODS: Between 2014 and 2018, a single-center, quasi-experimental, uncontrolled before and after study on forearm fracture reduction management was conducted. To assess the impact of our BST-PSA course, both historical control and prospective analyses were performed. Statistical significance was based on Fisher exact test or Pearson χ 2 test. RESULTS: Eight hundred eighty-five children met inclusion criteria. A significant difference in the number of PSAs performed in the PED, before and after BST, was found (37% vs. 85.3%, P < 0.001). Furthermore, a reduction in the number of hospitalizations for closed fracture reduction was measured (68.2% vs. 31.8%, P < 0.001). The overall cost savings from the BST-enabled increase in PSAs carried out in the PED was €370,714 ($440,838) with a return on investment of 64:1. No significant increase of PSA-related adverse events was found, and no serious adverse events occurred. CONCLUSIONS: Findings provide evidence of the benefits of implementing BST to enable PSA use in the PED, with an improved patient flow and significant cost savings from avoiding unnecessary hospitalizations.

Cleft Lip Repair Competence Can Be Evaluated with High-fidelity Simulation.

Background: Demonstrating competency before independent practice is increasingly important in surgery. This study tests the hypothesis that a high-fidelity cleft lip simulator can be used to discriminate performance between training levels, demonstrating its utility for assessing procedural competence. Methods: During this prospective cohort study, participants performed a unilateral cleft lip repair on a high-fidelity simulator. Videos were blindly rated using the Objective Structured Assessment of Technical Skills (OSATS) and the Unilateral Cleft Lip Repair Competency Assessment Tool (UCLR). Digital measurement of symmetry was estimated. Influence of training level and cumulative prior experience on each score was estimated using Pearson r. Results: Participants (n = 26) ranged from postgraduate year 3 to craniofacial fellow. Training level correlated best with UCLR (R = 0.4842, P = 0.0122*) and more weakly with OSATS (R = 0.3645, P = 0.0671), whereas cumulative prior experience only weakly correlated with UCLR (R = 0.3450, P = 0.0843) and not with OSATS (R = 0.1609, P = 0.4323). UCLR subscores indicated marking the repair had little correlation with training level (R = 0.2802, P = 0.1656), whereas performance and result did (R = 0.5152, P = 0.0071*, R = 0.4226, P = 0.0315*, respectively). Correlation between symmetry measures and training level was weak. Conclusions: High-fidelity simulation paired with an appropriate procedure-specific assessment tool has the construct validity to evaluate performance for cleft lip repair. Simply being able to mark a cleft lip repair is not an accurate independent assessment method nor is symmetry of the final result.