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Mayo Clin Proc Innov Qual Outcomes ; 6(4): 373-380, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1966937


Objective: To evaluate the impact of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2, on operating room (OR) efficiency for urologic procedures using the concept of fixed OR times. Patients and Methods: Over a 24-month period, urology OR data were prospectively collected. Operations were divided into fixed and variable time points. The fixed OR times were in-roomw to anesthesia-release time, anesthesia-release to cut time, in-room to cut time, and close to wheels-out time. Data from January 1, 2019, to December 31, 2019, were pre-COVID-19 data, and data from April 1, 2020, to December 31, 2020, were post-COVID-19 data. Operations were grouped into endoscopic, implant, major open, and robotic-assisted cases. In the post-COVID-19 era, all patients had a negative polymerase chain reaction test result within 48 hours of operation. The Wilcoxon rank sum test was used to compare the fixed OR times between the pre- and post-COVID-19 eras. Results: A total of 3189 procedures were evaluated: 2058 endoscopic operations (1124 in the pre-COVID-19 era and 934 in the post-COVID-19 era), 343 implant procedures (192 in the pre-COVID-19 era and 151 in the post-COVID-19 era), 222 major open procedures (119 in the pre-COVID-19 era and 103 in the post-COVID-19 era), and 566 robotic-assisted procedures (338 in the pre-COVID-19 era and 228 in the post-COVID-19 era). There were no fixed OR times in any of the examined groups that were negatively impacted by COVID-19. The percentage of the total OR time occupied by fixed OR variables in the pre-COVID-19 era was 40.6% for endoscopic operations, 41.1% for implant procedures, 29.8% for major open procedures, and 21.8% for robotic-assisted procedures. Conclusion: A substantial portion of the total OR time includes fixed time points. Furthermore, COVID-19 did not have a negative impact on fixed OR times in a negative testing environment. Urologic OR efficiency should be maintained in the post-COVID-19 era.

PLoS Med ; 18(12): e1003872, 2021 12.
Article in English | MEDLINE | ID: covidwho-1581903


BACKGROUND: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. METHODS AND FINDINGS: Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. CONCLUSIONS: These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. TRIAL REGISTRATION: NCT#: NCT04338360.

COVID-19/therapy , Compassionate Use Trials/methods , Health Services Needs and Demand/statistics & numerical data , Hospital Distribution Systems/organization & administration , Registries , Transfusion Reaction/complications , Transfusion Reaction/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Ethnic and Racial Minorities , Female , Humans , Immunization, Passive/adverse effects , Immunization, Passive/methods , Inpatients , Male , Medically Underserved Area , Middle Aged , Pandemics , Patient Safety , SARS-CoV-2 , Treatment Outcome , United States