ATS 2019 Virtual Final Program

6,000 participants, including new enrolled subjects from centers across the US. This session will outline specifically the value of the combined resource from the perspective of the investigators, and how it can be used for the advancement of understanding and treatment of HIV-driven pulmonary complications in PLWH. Chairing: K.M. Kunisaki, MD, MSCR, Minneapolis, MN E. Caler, PhD, Bethesda, MD 12:15 Leveraging MACS and WIHS for Mechanistic Studies A.M. Morris, MD, MS, Pittsburgh, PA 12:27 Published Results Regarding Respiratory Disease in the MACS and WIHS Cohorts K.M. Kunisaki, MD, MSCR, Minneapolis, MN 12:51 Potential for Analyses of Lung Function Across Macs/WIHS Cohorts M.B. Drummond, MHS, MD, ATSF, Chapel Hill, NC 1:03 Lessons Learned and Future Opportunities for Cardiometabolic Research in the Combined MACS/WIHS Cohort P. Tien, MD, San Francisco, CA DIVISION OF LUNG DISEASES, NHLBI/NIH L18 RESIDENT DUTY HOURS, PATIENT SAFETY, AND RESIDENT SLEEP: RESULTS OF THE ROSTERS AND ICOMPARE TRIALS 12:15 p.m. - 1:15 p.m. KBHCCD Room D221/D225/D226 (Level 2) Target Audience Sleep clinicians and researchers, clinicians involved in graduate medical education, and clinical researchers would benefit from this session. This includes students, residents, fellows, and other medical professionals. Objectives At the conclusion of this session, the participant will be able to: • understand questions being addressed by ROSTERS and iCOMPARE, and the study designs; • learn and understand how resident duty hours affect resident sleep; • understand how resident duty hours affect patient outcomes. This session will discuss two NHLBI-funded trials examining the effect of resident duty hours on patient safety and resident sleep. The Multi-center Clinical Trial of Limiting Resident Work Hours on ICU Patient Safety (ROSTERS) examines the effect of two different resident work hour schedules on patient safety, resident safety, resident performance, and resident sleep in the pediatric intensive care unit setting. The Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial examines the effect of two internal medicine resident duty hour standards on patient safety, resident education and resident sleep. Study results will be presented. Chairing: L. Reineck, MD, Bethesda, MD M. Twery, PhD, Bethesda, MD 12:15 Overview of Rosters and iCOMPARE Trials L. Reineck, MD, Bethesda, MD 12:25 ROSTERS Overview, Design and Outcomes C. Czeisler, PhD, MD, Boston, MA 12:45 iCOMPARE Overview, Design and Outcomes L. Bellini, MD, Philadelphia, PA 1:05 Question and Answer U.S. FOOD AND DRUG ADMINISTRATION L19 NICOTINE AND THE FDA PERSPECTIVE: REGULATION, SCIENCE, PATIENT EDUCATION, AND CLINICAL PRACTICE 12:15 p.m. - 1:15 p.m. KBHCCD Room C155-C156 (Level 1) Target Audience Clinicians trying to help adult smokers quit and those trying to educate youth and others about nicotine and tobacco products, smoking cessation counselors trying to motivate current smokers to quit Objectives At the conclusion of this session, the participant will be able to: • improve understanding of FDA policies related to nicotine; • better advise patients of the addictiveness of nicotine and the dangers of newer tobacco products; • refer patients for smoking cessation counseling and treatments earlier and more consistently. We will focus on nicotine from the FDA perspective; specifically, the science of nicotine and how this affects FDA policy and regulation. We will describe FDA’s “The Real Cost” and “The Fresh Empire” campaigns which focused on helping youth understand the dangers of tobacco use including addiction to nicotine and provide data on the campaigns’ effectiveness. We will describe FDA’s new campaign designed to help motivate current smokers to quit and conclude with a discussion of the applicability of the information to clinical practice. Eliminating use of tobacco products in the United States requires a multifaceted approach and team effort. Chairing: P. Callahan-Lyon, MD, Silver Spring, MD 12:15 Nicotine: FDA Policy and Regulation M. Zeller, JD, Silver Spring, MD 12:35 Nicotine: The Science Behind the Products and the Policies P. Callahan-Lyon, MD, Silver Spring, MD 12:55 FDA’s Public Education Campaigns to Prevent Initiation and Encourage Cessation M. Zeller, JD, Silver Spring, MD ATS 2019 • Dallas, TX MONDAY • MAY 20 195 MONDAY MID-DAY

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