Mayo Clinic proceedings
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Mayo Clinic proceedings · Nov 2023
ReviewGuidelines for Data and Safety Monitoring in Pragmatic Randomized Clinical Trials Using Case Studies.
Pragmatic randomized clinical trials (pRCTs) have a unique set of considerations for data and safety monitoring. Because of their unconventional trial designs coupled with collection of multilevel data and implementation outcomes in real-world settings, thoughtful consideration is needed on the presentation of the trial design and accruing data to facilitate review and decision-making by the trial's data and safety monitoring board (DSMB). ⋯ In considering these questions, we provide tabular and graphical illustrations of how data can be presented to the DSMB while drawing attention to those areas that the DSMB should focus on in its review of the trial. The strategies and viewpoints discussed herein provide practical guidelines and can serve as a resource for the generalist conducting pRCTs.
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Mayo Clinic proceedings · Nov 2023
Mayo Clinic Consensus Report on Membranous Nephropathy: Proposal for a Novel Classification.
Membranous nephropathy (MN) is a pattern of injury caused by autoantibodies binding to specific target antigens, with accumulation of immune complexes along the subepithelial region of glomerular basement membranes. The past 20 years have brought revolutionary advances in the understanding of MN, particularly via the discovery of novel target antigens and their respective autoantibodies. These discoveries have challenged the traditional classification of MN into primary and secondary forms. ⋯ The second step is the search for a potential underlying disease or associated condition, which is particularly relevant when knowledge of the target antigen is available to direct it. The meeting acknowledges that the resources and equipment required to perform the proposed testing may not be generally available. However, the meeting consensus was that the time has come to adopt an antigen-based classification of MN because this approach will allow for accurate and specific MN diagnosis, with significant implications for patient management and targeted treatment.
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Mayo Clinic proceedings · Nov 2023
Politicization of Medical Care, Burnout, and Professionally Conflicting Emotions Among Physicians During COVID-19.
To evaluate the association of politicization of medical care with burnout, professional fulfillment, and professionally conflicting emotions (eg, less empathy, compassion; more anger, frustration, resentment). ⋯ Most physicians experienced intrusion of politics into medical care during the pandemic. These experiences are associated with professionally conflicting emotions, including less compassion and empathy, greater frustration, and resentment. COVID-19-related moral distress and compromised integrity were also associated with less professional fulfillment and greater occupational burnout.