Browsing by Author "Shirey-Rice, Jana"

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    Walk before you run: feasibility challenges and lessons learned from the PROCLAIM Study, a multicenter randomized controlled trial of misoprostol for prevention of recurrent C. difficile during COVID-19
    (Elsevier, 2023) Lavieri, Robert R.; Dubberke, Erik R.; McGill, Sarah K.; Bartelt, Luther; Smith, Stephanie A.; Pandur, Balint K.; Phillips, Sharon E.; Vermillion, Krista; Shirey-Rice, Jana; Pulley, Jill; Xu, Yaomin; Lindsell, Christopher J.; Zaleski, Nicole; Jerome, Rebecca; Doster, Ryan S.; Aronoff, David M.; Medicine, School of Medicine
    We analyzed our challenging experience with a randomized controlled trial of misoprostol for prevention of recurrent C. difficile. Despite careful prescreening and thoughtful protocol modifications to facilitate enrollment, we closed the study early after enrolling just 7 participants over 3 years. We share lessons learned, noting the importance of feasibility studies, inclusion of biomarker outcomes, and dissemination of such findings to inform future research design and implementation successes.