Simulating for Quality: A Centralized Quality Improvement and Patient Safety Simulation Curriculum for Residents and Fellows.

PROBLEM: Requirements for experiential education in quality improvement and patient safety (QI/PS) in graduate medical education (GME) have recently expanded. Major challenges to meeting these requirements include a lack of faculty with the needed expertise, paucity of standardized curricular models allowing for skill demonstration, and inconsistent access to data for iterative improvement. APPROACH: In October 2017, the authors began development of a centralized QI/PS flipped-classroom simulation-based medical education (SBME) curriculum for GME trainees across multiple disciplines at Oregon Health & Science University (OHSU). The curriculum development team included OHSU and Veterans Affairs faculty with experience in QI/PS and SBME, as well as house officers. The curriculum consisted of a preassessment and prework readings and videos (sent 3 weeks before the simulation day) and an 8-hour simulation day, with introductory activities, 4 linked simulation sessions, and concluding activities. The 4 linked sessions followed the same medication error from disclosure and reporting to root cause analysis, iterative implementation of an action plan, and consolidation of lessons learned into routine operations with Lean huddles. OUTCOMES: In academic year 2018-2019, 71 residents and fellows of various postgraduate years from 23 training programs enrolled in 2 pilot sessions. Learners reacted favorably to the simulation curriculum. Learner attitudes, confidence, knowledge, and skills significantly increased across all QI/PS domains studied. NEXT STEPS: This approach focuses a small cadre of educators toward the creation of a centralized resource that, owing to its experiential SBME foundation, can accommodate many learners with data-driven practice-based learning and improvement cycles in a shorter time frame than traditional QI initiatives. Next steps include the addition of a control group, assessment of the sustainability of learner outcomes, translation of learning to behavior change and improvements in patient and health system outcomes, and adapting the materials to include learners from different professions and levels.

Immune Checkpoint Inhibitors in Organ Transplant Patients.

Modulation of T-cell activity through blockade of coinhibitory molecules has revolutionized the treatment of various malignancies. Several immune checkpoint inhibitors are currently Food and Drug Administration approved which target various coinhibitory pathways including cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), programmed death 1 receptor (PD-1), and programmed cell death ligand-1. Clinical trials that lead to the Food and Drug Administration approval of these agents often excluded patients with an organ transplant. Excluding these patients was deliberate due to concern that immune checkpoint inhibitor therapy could lead to graft rejection. The PD-1 and CTLA-4 pathways are essential to downregulate our immune system in the setting of T-cell activation to prevent autoimmunity. Furthermore, both pathways are implicated in transplanted organ tolerance and modulation of the pathways may inadvertently lead to peripheral transplant rejection. Currently, there are no guidelines for the treatment of patients with immune checkpoint inhibitors in the setting of a prior organ transplant. Thus far, there are only 10 reported cases of patients in the literature who were treated in this setting. Two additional cases are reported herein, including 1 patient with a prior cardiac transplant receiving nivolumab for non-small cell lung cancer. Of the 12 cases, 4 patients experienced organ rejection. From these observations, the authors hypothesize factors that affect safety and of this treatment modality in this patient population. These factors include the integral role of the PD-1 pathway compared with the CTLA-4 pathway in organ acceptance, sequential implementation of different immune checkpoint inhibitor classes, length of time with a transplant before therapy, strength of immunosuppressive agents to prevent organ transplant rejection, and immunogenicity of the particular organ grafted. Although limited cases have been reported, there are circumstances in which immune checkpoint inhibitors have been used in the setting of organ transplantation without resulting in organ rejection. A thorough discussion with the patient of the potential risks, including graft rejection, and benefits of this therapy is necessary before beginning this treatment. More research is needed to explore the safety and efficacy of immune checkpoint inhibitors in the setting of organ transplantation.