Multicenter Pragmatic Clinical Trials in Emergency Medicine: Design and Applied Implementation Strategies for Large-Scale Comparative Effectiveness Research

  • Richard E. Rothman, MD, PhD

  • Jason Haukoos, MD, MSc

  • Michael Lyons, MD, MPH

    Associate Professor of Emergency Medicine

    University of Cincinnati

    Michael S. Lyons, MD, MPH has been a transformative and nationally recognized leader at the intersection of emergency medicine and public health for nearly 20 years, most predominantly in the areas of transmissible infectious diseases and substance use disorders. After completing his undergraduate degree at Northwestern University, he attended Duke Medical School with election to AOA and then served as Resident and Chief Resident at the University of Cincinnati (UC), where he is now Associate Professor. As faculty, Dr. Lyons completed a Master of Public Health degree at Emory University and has headed the Division of Public Health and Health Services Research since 2002. Dr. Lyons has worked tirelessly to reduce fragmentation that divides emergency medicine from public health and other healthcare entities. In particular, he leads the UC Early Intervention Program (EIP), an ever-expanding array of clinical prevention services continuously funded for two decades by a variety of public health, community, healthcare, and industry sponsors. The EIP was the first and most notable example of health departments directly funding prevention programs in EDs and innovates operational changes to advance public health practice in healthcare settings that do not require external funding. EIP is also active in the community, most recently operating a massive $multi-million countywide COVID screening effort. Over 100 nurses, physicians, researchers, and other allied health professionals began their careers as EIP service providers, and Dr. Lyons has directly mentored countless others in projects and clinical practice. This body of clinical, educational, and administrative work directly informs Dr. Lyons’ research, which has been variously funded by NIH, CDC, AHRQ, EMF, and SAMHSA and required leadership of multi-disciplinary collaborations involving infectious diseases, gastroenterology, virology, addiction and mental health, communications, sociology, economics, healthcare informatics, and operations simulation. Dr. Lyons has authored multiple seminal papers involving ED screening and linkageto-care practices, led the planning and evaluation of the nation’s largest per capita regional naloxone distribution effort, and is currently honored to serve as co-lead of Ohio’s “Intervention Operations Core” in the unprecedented $350 million NIH/SAMHSA HEALing Communities Study, promoting multisector system and practice change to substantially reduce opioid overdose deaths. He has also played a leading role in development of the EM Transmissible Infectious Diseases and Epidemics (EMTIDE) SAEM interest group, served as an invited co-editor for special supplement issues to Annals of Emergency Medicine and Public Health Reports, and was an invited speaker for an American Association of Medical Colleges (AAMC) Congressional Briefing on the role medical colleges can play in community health. 
  • Douglas A.E. White, MD