Development of a Simulation Surgical Cricothyroidotomy Curriculum for Novice Providers: A Learning Curve Study.

INTRODUCTION: Airway obstruction is the third most common cause of preventable death on the battlefield, accounting for 1%-2% of total combat fatalities. No previous surgical cricothyroidotomy (SC) studies have analyzed the learning curve required to obtain proficiency despite being studied in numerous other surgical technique training experiments. The aims of this study were to establish expert SC performance criteria, develop a novel standardized SC curriculum, and determine the necessary number of practice iterations required by a novice to reach this pre-determined performance goal. MATERIALS AND METHODS: A standardized checklist and SC performance standards were established based on the performance of 12 board certified Military Health System surgeons with prior experience on performing a SC using a simulated trauma mannequin. Expert-level criteria were defined as a SC time to completion of 40 s or less and checklist score of at least 9/10, including all critical steps. Study subjects included 89 novice providers (54 active-duty first- and second-year medical students and 35 Navy corpsmen). Subjects received instruction on performing a SC using the principles of mastery learning and performed a final test of SC proficiency on a trauma mannequin within a realistic simulated MEDEVAC helicopter. The total number of subject practice attempts, checklist scores, and time to completion were measured and/or blindly scored. Learning curve and exponential plateau equations were used to characterize their improvement in mean time to SC completion and checklist scores. RESULTS: Mean pre-test knowledge scores for the entire group were 11.8 ± 3.1 out of 24 points. Total mean practice learning plateaued at checklist scores of 9.9/10 after 7 iterations and at a mean completion time of 30.4 s after 10 iterations. During the final test performance in the helicopter, 67.4% of subjects achieved expert-level performance on the first attempt. All subjects achieved expert-level performance by the end of two additional attempts. While a significantly larger proportion of medical students (79.9%) successfully completed the helicopter test on the first attempt compared to corpsmen (54.3%), there were no statistically significant differences in mean SC completion times and checklist scores between both groups (P > 0.05). Medical students performed a SC only 1.3 s faster and scored only 0.16 points higher than corpsmen. The effect size for differences were small to negligible (Cohen's d range 0.18-0.33 for SC completion time; Cohen's d range 0.45-0.46 for checklist scores). CONCLUSION: This study successfully defined SC checklist scores and completion times based on the performance of experienced surgeons on a simulator. Using these criteria and the principles of mastery learning, novices with little knowledge and experience in SC were successfully trained to the level of experienced providers. All subjects met performance targets after training and overall performance plateaued after approximately seven iterations. Over two-thirds of subjects achieved the performance target on the first testing attempt in a simulated helicopter environment. Performance was comparable between medical student and corpsmen subgroups. Further research will assess the durability of maintaining SC skills and the timing for introducing refresher courses after initial skill acquisition.

Accrual-Monitoring Practices for Various Disease Trials among AACI Member Cancer Centers.

Progress in the management of rare diseases, including rare cancers, is dependent upon clinical trials; however, as many as 32% of rare-disease trials go uncompleted or unpublished due to insufficient accrual. Monitoring practices may differ between institutions. We sought to survey the regulatory standards for various trial types among major U.S. cancer centers. A 10-question survey was designed using Qualtrics assessment software. The survey was sent via email to an internal server of member institutions of the Association of American Cancer Institutes (AACI). Of 103 AACI centers, 31% completed the survey (n = 32). Respondents differed in their definitions of a rare disease, minimum expectations for rare tumor studies, and frequency of accrual monitoring by their institutional Protocol Review and Monitoring Committee. Seventy-three percent of respondents did not close trials based on low accrual. Strategies to optimize accrual included investigator incentives for high accrual and penalties for low accrual in 37% and 13% of respondents, respectively.