End-User Input into the Design and Validation of a Synthetic Thoracoscopic Esophageal Atresia/Tracheo-Esophageal Fistula Simulator.

Introduction: Thoracoscopic repair of esophageal atresia and tracheo-esophageal fistula (EA/TEF) is challenging. We addressed this by designing a fully synthetic simulator of the procedure and described the design process and how its content validity was assessed. Methods: An iterative design and assessment of content validity was undertaken in three stages. Data were collected from participants who trialed the model and completed a survey of their experience (adapted from Barsness et al.). Results: The model was trialed by participants of varying experience. Each design refinement improved the model's fidelity and validity. For the last iteration of the simulator, the observed averages (out of a maximum of 5) were: value as a training tool 4.8, relevance 4.6, physical attributes 4.5, realism of material 4.25, realism experience 4.17, and ability to perform tasks 3.77. Conclusion: An iterative design process based on end-user feedback has led to a synthetic simulator that has achieved a high level of content validity. This model has advantages over other EA/TEF simulators in that it is relatively inexpensive and does not use animal tissue, thus removing ethical and procurement issues. It was rated highly for its value and relevance to training.

Critical design and validation considerations for the development of neonatal minimally invasive surgery simulators.

BACKGROUND/PURPOSE: Pediatric surgical trainees have limited exposure to advanced minimally invasive surgery (MIS) during their clinical training, particularly for cases such as esophageal atresia/tracheoesophageal fistula (EA/TEF). Simulation on validated neonatal models offers an alternative means of training that may augment traditional forms of training; but to be useful, they must fulfill certain criteria. METHODOLOGY: Review of the currently available MIS, thoracoscopic and laparoscopic, simulators for pediatric surgery, and identification of those factors that contribute to their fidelity and validity as a training tool that must be incorporated in the design of future simulation models. RESULTS: There are few neonatal laparoscopic and thoracoscopic models currently available, or in the research stage. To our knowledge, there is no commercially available, synthetic, high fidelity and low cost thoracoscopic model in existence. Use of animal tissue has disadvantages of ethical dilemmas, cost, and logistic and procurement issues. Newer synthetic models need to be validated for fidelity, to replicate those components of the operation that pose the greatest technical challenge, and incorporate means of measuring acquisition of technical expertise. CONCLUSION: This review describes the principles that need to be considered to develop low cost, validated high-fidelity MIS simulator that can be used for training, and that is capable of measuring the acquisition of the technical skills that can be applied to the repair of complex procedures such as esophageal atresia. Level of evidence III.