Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model.

BACKGROUND/OBJECTIVES: The US Food and Drug Administration (FDA) is responsible for assessing safety (risks) and effectiveness (benefits) of new drug products using the data provided in a Sponsor's new drug product marketing application before they can be marketed. The FDA forms cross-disciplinary review teams to conduct these assessments. Recently, the FDA began implementing more interdisciplinary approaches to its assessments, reducing redundancy in review processes and documentation by increasing team integration around review issues. METHODS: Through a phenomenological descriptive comparative case study, the impact of FDA's new interdisciplinary approach on review team integration was compared with its traditional multidisciplinary review approach. RESULTS: We identified collaborative integration occurring in one FDA review team using the new interdisciplinary review and another team using the traditional review and then modeled and analyzed the collaborative, cross-disciplinary integration in each case using an input-process-output (IPO) model drawn from the Science-of-Team-Science (SciTS). CONCLUSION: This study provides a systematic method for understanding and visualizing integration in each type of review previously and presently used at FDA and illustrates how the new interdisciplinary approach can ensure more integration than more traditional approaches previously used. In addition, our study suggests that an IPO model of integration can characterize how effectively FDA review teams are integrating around issues and assist in the evaluation of differences in integration between FDA's new interdisciplinary review and the existing multidisciplinary approach. The approach used here is a new application of SciTS scholarship in a unique sector, and it also serves as an example for measuring review team effectiveness.

Comparing student outcomes in traditional vs intensive, online graduate programs in health professional education.

BACKGROUND: Health professions' education programs are undergoing enormous changes, including increasing use of online and intensive, or time reduced, courses. Although evidence is mounting for online and intensive course formats as separate designs, literature investigating online and intensive formats in health professional education is lacking. The purpose of the study was to compare student outcomes (final grades and course evaluation ratings) for equivalent courses in semester long (15-week) versus intensive (7-week) online formats in graduate health sciences courses. METHODS: This retrospective, observational study compared satisfaction and performance scores of students enrolled in three graduate health sciences programs in a large, urban US university. Descriptive statistics, chi square analysis, and independent t-tests were used to describe student samples and determine differences in student satisfaction and performance. RESULTS: The results demonstrated no significant differences for four applicable items on the final student course evaluations (p values range from 0.127 to 1.00) between semester long and intensive course formats. Similarly, student performance scores for final assignment and final grades showed no significant differences (p = 0.35 and 0.690 respectively) between semester long and intensive course formats. CONCLUSION: Findings from this study suggest that 7-week and 15-week online courses can be equally effective with regard to student satisfaction and performance outcomes. While further study is recommended, academic programs should consider intensive online course formats as an alternative to semester long online course formats.

Design for success: Identifying a process for transitioning to an intensive online course delivery model in health professions education.

Intensive courses (ICs), or accelerated courses, are gaining popularity in medical and health professions education, particularly as programs adopt e-learning models to negotiate challenges of flexibility, space, cost, and time. In 2014, the Department of Clinical Research and Leadership (CRL) at the George Washington University School of Medicine and Health Sciences began the process of transitioning two online 15-week graduate programs to an IC model. Within a year, a third program also transitioned to this model. A literature review yielded little guidance on the process of transitioning from 15-week, traditional models of delivery to IC models, particularly in online learning environments. Correspondingly, this paper describes the process by which CRL transitioned three online graduate programs to an IC model and details best practices for course design and facilitation resulting from our iterative redesign process. Finally, we present lessons-learned for the benefit of other medical and health professions' programs contemplating similar transitions. ABBREVIATIONS: CRL: Department of Clinical Research and Leadership; HSCI: Health Sciences; IC: Intensive course; PD: Program director; QM: Quality Matters.