Browsing by Author "Krucoff, Mitchell"
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Item Open Access Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN).(BMJ surgery, interventions, & health technologies, 2022-01) Long, Cynthia; Tcheng, James E; Marinac-Dabic, Danica; Iorga, Andrea; Krucoff, Mitchell; Fisher, DeborahObesity continues to be a major public health issue, with more than two-thirds of adults in the USA categorized as overweight or obese. Bariatric surgery is effective and yields durable weight loss; however, few qualified candidates choose to undergo surgical treatment. Less-invasive alternatives to bariatric surgery are being developed to bridge the treatment gap. Recognizing the burden of conducting pivotal clinical trials and traditional post-approval studies for medical devices, the Food and Drug Administration (FDA) Center for Devices and Radiological Health has encouraged the development of real-world data content and quality that is sufficient to provide evidence for Total Product Life Cycle medical device evaluation. A key first step is to establish a minimum core data structure that provides a common lexicon for endoscopic obesity devices and its corresponding interoperable data elements. Such a structure would facilitate data capture across existing workflow with a 'coordinated registry network' capability. On July 29, 2016, a workshop entitled, 'GI Coordinated Registry Network: A Case for Obesity Devices' was held at the FDA White Oak Campus by the Medical Device Epidemiology Network public-private partnership and FDA to initiate the work of developing a common lexicon and core data elements in the metabolic device space, which marked the inauguration of the Gastrointestinal Coordinated Registry Network project. Several work groups were subsequently formed to address clinical issues, data quality issues, registry participation, and data sharing.Item Open Access Teaching yoga to seniors: essential considerations to enhance safety and reduce risk in a uniquely vulnerable age group.(J Altern Complement Med, 2010-08) Krucoff, Carol; Carson, Kimberly; Peterson, Matthew; Shipp, Kathy; Krucoff, MitchellBACKGROUND: Seniors age 65 and older represent the fastest-growing sector of the population and, like many Americans, are increasingly drawn to yoga. This presents both an extraordinary opportunity and a serious challenge for yoga instructors who must be both a resource and guardians of safety for this uniquely vulnerable group. A typical class of seniors is likely to represent the most diverse mix of abilities of any age group. While some may be exceedingly healthy, most fit the profile of the average older adult in America, 80% of whom have at least one chronic health condition and 50% of whom have at least two. OBJECTIVES: This article discusses the Therapeutic Yoga for Seniors program, offered since 2007 at Duke Integrative Medicine to fill a critical need to help yoga instructors work safely and effectively with the increasing number of older adults coming to yoga classes, and explores three areas that pose the greatest risk of compromise to older adult students: sedentary lifestyle, cardiovascular disease, and osteoporosis. To provide a skillful framework for teaching yoga to seniors, we have developed specific Principles of Practice that integrate the knowledge gained from Western medicine with yogic teachings.