Articles: pandemics.
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Randomized Controlled Trial Multicenter Study
Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.
The ORCHID (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with coronavirus disease (COVID-19). This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multicenter, randomized trial during a pandemic, including 1) widespread, off-label use of the study drug before the availability of safety and efficacy data; 2) the need to adapt traditional procedures for documentation of informed consent during an infectious pandemic; 3) developing a flexible and robust Bayesian analysis incorporating significant uncertainty about the disease, outcomes, and treatment; 4) obtaining indistinguishable drug and placebo without delaying enrollment; and 5) rapidly obtaining administrative and regulatory approvals. ⋯ We describe lessons learned to improve the efficiency of future clinical trials, particularly in the setting of pandemics. The ORCHID trial will provide high-quality, clinically relevant data on the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults. Clinical trial registered with www.clinicaltrials.gov (NCT04332991).
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Multicenter Study
The impact of the COVID-19 pandemic on emergency department visits and patient safety in the United States.
COVID-19 pandemic effects are still being elucidated. Stay-at-home orders and social distancing compounded with COVID-19 concerns have caused significant disruptions in daily life. One notable effect of these variables may be a change in the number of emergency department (ED) visits. This study aims to investigate the effects of COVID-19 on ED visits, and possible reasons for changes. ⋯ A number of factors have likely contributed to the substantial decrease in ED visits observed in this study. In light of these findings, it is important to raise patient awareness regarding acute conditions that are deadlier than COVID-19 and require immediate medical intervention to ensure recovery.
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Int J Colorectal Dis · Sep 2020
Multicenter StudyFrom high volume to "zero" proctology: Italian experience in the COVID era.
The coronavirus disease 2019 (COVID-19) pandemic hit Italy early and strongly, challenging the whole health care system. Proctological patients and surgeons are experiencing a previously unseen change in care with unknown repercussion. Here we discuss the proctological experience of 4 Italian hospitals during the COVID-19 pandemic. ⋯ In the absence of scientific evidence, these practical considerations may be valuable to proctological surgeons starting to face the COVID-19 pandemics. Beside the more clinical considerations, this crisis produced unexpected consequences such as an improvement of the therapeutic alliance and a shift towards telemedicine that may be worth exploring also in the post-COVID-19 era.
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Clin. Gastroenterol. Hepatol. · Sep 2020
Multicenter StudyPlans to Reactivate Gastroenterology Practices Following the COVID-19 Pandemic: A Survey of North American Centers.
Practices dramatically reduced endoscopy services due to the COVID-19 pandemic. Because practices now are considering reintroduction of elective endoscopy, we conducted a survey of North American practices to identify reactivation barriers and strategies. ⋯ This survey highlights barriers and variable strategies for reactivation of elective endoscopy services after the COVID-19 pandemic. Our results suggest that more widespread access to preprocedure SARS-CoV-2 tests with superior performance characteristics is needed to increase provider and patient comfort in proceeding with elective endoscopy.
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Multicenter Study
Telemedicine During COVID-19 for Outpatient Sports and Musculoskeletal Medicine Physicians.
The global pandemic due to SARS-CoV-2 has resulted in an expansion of telemedicine. Measures of quality and barriers for rapid use by patients and physicians are not well described. ⋯ In summary, rapid expansion of telemedicine during the COVID-19 pandemic was well-received by a majority of patients and physicians. This suggests feasibility in rapid expansion of telemedicine for other outpatient sports medicine practices.