Developing entrustable professional activities as the basis for assessment of competence in an internal medicine residency: a feasibility study.

BACKGROUND: Graduate medical education programs assess trainees' performance to determine readiness for unsupervised practice. Entrustable professional activities (EPAs) are a novel approach for assessing performance of core professional tasks. AIM: To describe a pilot and feasibility evaluation of two EPAs for competency-based assessment in internal medicine (IM) residency. SETTING/PARTICIPANTS: Post-graduate year-1 interns (PGY-1s) and attendings at a large internal medicine (IM) residency program. PROGRAM DESCRIPTION: Two Entrustable professional activities (EPA) assessments (Discharge, Family Meeting) were piloted. PROGRAM FEASIBILITY EVALUATION: Twenty-eight out of 43 (65.1 %) PGY-1 s and 32/43 (74.4 %) attendings completed surveys about the Discharge EPA experience. Most who completed the EPA assessment (10/12, 83.8 %, PGY-1s; 9/11, 83.3 %, attendings) agreed it facilitated useful feedback discussions. For the Family Meeting EPA, 16/26 (61.5 %) PGY-1s completed surveys, and most who participated (9/12 PGY1s, 75 %) reported it improved attention to family meeting education, although only half recommended continuing the EPA assessment. DISCUSSION: From piloting two EPA assessments in a large IM residency, we recognized our reminder systems and time dedicated for completing EPA requirements as inadequate. Collaboration around patient safety and palliative care with relevant clinical services has enhanced implementation and buy-in. We will evaluate how well EPA-based assessment serves the intended purpose of capturing trainees' trustworthiness to conduct activities unsupervised.

Off-label use of rituximab in a multipayer insurance system.

PURPOSE: Off-label prescribing in oncology is common and unregulated. The aim of this study was to describe the off-label use of rituximab, a novel anti-CD20 antibody, among patients from a large proprietary insurance database to understand how frequently and appropriately off-label prescribing occurs for this medication. PATIENTS AND METHODS: In this descriptive study, 11,232,642 patients were enrolled in the D2 Hawkeye commercial insurance database between 2001 and 2007, and 2,782 patients received rituximab. The main outcome measures were quantity and type of off-label usage, and expenditures for off-label usage. RESULTS: Seven hundred five (25.3%) patients received rituximab for off-label indications, and of those, 332 (47.1%) received rituximab for uncertain or inadequate evidence-based diagnoses. Expenditures for off-label indications were 17.1% of expenditures for rituximab usage. CONCLUSION: The frequent use of rituximab for off-label indications should lead to improved postapproval surveillance of biologics by the US Food and Drug Administration, so that use can be adequately studied. This will also facilitate improved regulatory mechanisms to ensure evidence-based use.