Introduction: Simulation has revolutionized surgical training. Randomized trials have demonstrated the efficacy of simulation training in improving procedural skills and safety, and regulatory agencies have strongly advocated for the use of simulators as part of the initial education and credentialing process.1,2,3Although the accumulating evidence supporting the use of simulator-based training to develop highly complex psychomotor skills, only few neurosurgical simulators are available to date. At University of Michigan, we have established a multidisciplinary team that has successfully developed several high-fidelity neurosurgical simulators.4,5,6 Here, we present our strategy and experience on simulators development hoping to encourage further research in the field.

Methods: To gather expertise and resources, senior and in-training neurosurgeons, engineers, and education specialists defined features of “ideal” training tools. Then, digital design, additive manufacturing technologies and novel phantom materials were combined to develop simulator prototypes that were further refined, evaluated for validity, and integrated into comprehensive simulator-based curricula.

Results: “Ideal” neurosurgical simulators were deemed to: -be anatomically accurate and have realistic haptic properties and allow performance of complex psychomotor procedures -be used with real surgical tools -be versatile to explore operative scenarios and contingencies - be custom-made, manufactured from imaging of specific patients allowing high-fidelity pre-surgical training -be easily accessible and affordable -be incorporated into a comprehensive training curriculum. We developed four physical simulators: ventriculostomy placement, endonasal sphenoidotomy, minimally invasive laminectomy and discectomy, and femoral artery access. Validity evidence was evaluated using novel7 and Standard8 sources and further validation is being conducted. Simulator-based training protocols and assessment standards, such as the minimum score to master complex psychomotor skills, are being developed and validated. In order to assure sustained availability and sustainability, partnership with industry was established.

Conclusions: Modern neurosurgical education and credentialing process should include integrated simulator-based comprehensive curricula and global rating matrix. In Michigan, our strategy to develop effective simulators is based on: 1) multidisciplinary team; 2) identification of targeted skills; 3) design, manufacture and refinement of prototype; 4) validation of simulator as training and assessment tool; 5) establishment of a simulator-based curricula in formal resident training; 6) partnership with industry to assure long-lasting availability and sustainability.

Patient Care: We hypothesize that sharing the experience accumulated during the last several years regarding conceptualization, development and implementation of neurosurgical simulator would provide the audience a comprehensive framework to base further simulation research. Improved resident training and credentialing process will translate in more effective and safe patient care.

Learning Objectives: By the conclusion of this session, participants should be able to comprehend the value of simulation-based training and credentialing process to improve patient outcomes with the greatest efficiency and safety. In addition, participants should be able to identify the resources required, discuss niches for development, recognize approaches to overcome obstacles and reflect about pathways that could be employed to develop neurosurgical simulators.

References: 1. Nasca, Thomas J., Susan H. Day, and E. Stephen Amis Jr. "The new recommendations on duty hours from the ACGME Task Force." New England Journal of Medicine 363.2 (2010). 2. Seymour, Neal E., et al. "Virtual reality training improves operating room performance: results of a randomized, double-blinded study." Annals of surgery 236.4 (2002): 458. 3. Gurusamy, K., et al. "Systematic review of randomized controlled trials on the effectiveness of virtual reality training for laparoscopic surgery." British Journal of Surgery 95.9 (2008): 1088-1097. 4. Tai B, Rooney D, Stephenson F, Liao P, Sagher O, Shih A, Savastano LE. “Development of 3D-printing built ventriculostomy placement simulator.” Accepted for publication, Journal of Neurosurgery, November 2014. 5. Tai B, Wang A, Joseph J, Wang P, Sullivan S, McKean E, Shih A, and Deborah Rooney D. “A physical simulator for endoscopic endonasal drilling techniques”. In press, Journal of Neurosurgery, March 2015 6. Rooney DM, Tai BL, PhD, Sagher O, Shih AJ, Wilkinson DA, Savastano LE. A Simulator and two tools: Validation of performance measures from a novel neurosurgery simulator using the current Standards framework. Submitted to Journal of Surgery, March 2015. 7. Seagull, F. Jacob, and Deborah M. Rooney. "Filling a void: Developing a standard subjective assessment tool for surgical simulation through focused review of current practices." Surgery 156.3 (2014): 718-722. 8. American Educational Research Association, American Psychological Association, & National Council on Measurement in Education. (2014) Standards for educational and psychological testing. Washington, DC: American Educational Research.