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Background: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has long recognized and championed increasing diversity within the surgical workplace. SAGES initiated the Fundamentals of Leadership Development (FLD) Curriculum to address these needs and to provide surgeon leaders with the necessary tools and skills to promote diversity, equity, and inclusion (DEI) in surgical practice. In 2019, the American College of Surgeons issued a request for anti-racism initiatives which lead to the partnering of the two societies. The primary goal of FLD was to create the first surgeon-focused leadership curriculum dedicated to DEI. The rationale/development of this curriculum and its evaluation/feedback methods are detailed in this White Paper. Methods: The FLD curriculum was developed by a multidisciplinary task force that included surgeons, education experts, and diversity consultants. The curriculum development followed the Analysis, Design, Development, Implementation and Evaluation (ADDIE) instructional design model and utilized a problem-based learning approach. Competencies were identified, and specific learning objectives and assessments were developed. The implementation of the curriculum was designed to be completed in short intervals (virtual and in-person). Post-course surveys used the Kirkpatrick's model to evaluate the curriculum and provide valuable feedback. Results: The curriculum consisted of interactive online modules, an online discussion forum, and small group interactive sessions focused in three key areas: (1) increasing pipeline of underrepresented individuals in surgical leadership, (2) healthcare equity, and (3) conflict negotiation. By focusing on positive action items and utilizing a problem-solving approach, the curriculum aimed to provide a framework for surgical leaders to make meaningful changes in their institutions and organizations. Conclusion: The FLD curriculum is a novel leadership curriculum that provided surgeon leaders with the knowledge and tools to improve diversity in three areas: pipeline improvement, healthcare equity, and conflict negotiation. Future directions include using pilot course feedback to enhance curricular effectiveness and delivery. [ABSTRACT FROM AUTHOR]

Background: Spontaneous reporting of adverse drug reactions (ADRs) is essential for the post-marketing safety evaluation of drugs. Therefore, good monitoring of ADRs is vital for strengthening drug supervision, management, and guiding rational drug use. Chinese medical institutions are the primary source of ADR case reports, but the proportion of the reports in grade IIIA hospitals is still low due to serious under-reporting. The 3rd Affiliated Hospital of Chengdu Medical College, Chengdu Pidu District People's Hospital, also has such a problem. Objective: To improve the quantity and quality of ADR reports and enhance the level of pharmacovigilance in hospitals, the Third Affiliated Hospital of Chengdu Medical College, People's Hospital of Chengdu Pidu District experienced 10 years to gradually establish a management model to improve the medical staff's reporting rate of spontaneous reporting of ADRs. The management model is led by clinical pharmacists and combines the PDCA with Teach-back methods. The purpose of this paper is to introduce the management model and discuss its advantages and shortcomings of this model. Methods: This study was conducted at the Third Affiliated Hospital of Chengdu Medical College—Chengdu Pidu District People's Hospital. From 2016, the daily management of reporting, auditing, and data improvement of adverse drug reactions in the hospital was carried out by clinical pharmacists, who used the PDCA method combined with the Teach-back method to continuously improve the reporting program of ADRs in the hospital during 2016–2021. Then, the proportion of spontaneous reports of total, new, and serious ADRs was compared before and after the intervention. Also, we performed a time series analysis using an autoregressive moving average model to assess changes in the total number of spontaneous ADR reports before the intervention (2013–2015), the first intervention (2016–2018), and the second intervention (2019–2021). Results: After the combined PDCA and Teach-back method intervention, the median number of reported ADRs per year increased from 50 (range 37–55) in the pre-intervention period to 88 (range 83–162) in the first intervention period and to 374 in the second (range 312–566). Breakpoint regression analysis of the spontaneous reporting rate of ADRs showed that the instantaneous increase after the first intervention was not statistically significant (P = 0.526). However, the reporting rate of ADRs increased at a month-by-month growth rate during the second intervention compared to the first intervention. Its spontaneous reporting rate improved 1.034 times (P = 0.002). After the second intervention, the spontaneous reporting rate of ADRs transiently increased 6.111-fold (P < 0.001), and the month-to-month growth rate increased 1.024-fold (P < 0.001) again. Conclusion: The management model that combines the PDCA and the Teach-back method significantly improves the reporting rate of adverse drug reactions. [ABSTRACT FROM AUTHOR]