IMPORTANCEAcutely ill inpatients with COVID-19 typically receive antithrombotic therapy, although the risks and benefits of this intervention among outpatients with COVID-19 have not been established. OBJECTIVE To assess whether anticoagulant or antiplatelet therapy can safely reduce major adverse cardiopulmonary outcomes among symptomatic but clinically stable outpatients with COVID-19. DESIGN, SETTING, AND PARTICIPANTSThe ACTIV-4B Outpatient Thrombosis Prevention Trial was designed as a minimal-contact, adaptive, randomized, double-blind, placebo-controlled trial to compare anticoagulant and antiplatelet therapy among 7000 symptomatic but clinically stable outpatients with COVID-19. The trial was conducted at 52 US sites between September 2020 and June 2021; final follow-up was August 5, 2021. Prior to initiating treatment, participants were required to have platelet count greater than 100 000/mm 3 and estimated glomerular filtration rate greater than 30 mL/min/1.73 m 2 .INTERVENTIONS Random allocation in a 1:1:1:1 ratio to aspirin (81 mg orally once daily; n = 164), prophylactic-dose apixaban (2.5 mg orally twice daily; n = 165), therapeutic-dose apixaban (5 mg orally twice daily; n = 164), or placebo (n = 164) for 45 days. MAIN OUTCOMES AND MEASURESThe primary end point was a composite of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary cause. The primary analyses for efficacy and bleeding events were limited to participants who took at least 1 dose of trial medication. RESULTSOn June 18, 2021, the trial data and safety monitoring board recommended early terminationbecauseoflowerthananticipatedeventrates;atthattime,657symptomaticoutpatients with COVID-19 had been randomized (median age, 54 years [IQR,[46][47][48][49][50][51][52][53][54][55][56][57][58][59]; 59% women). The median times from diagnosis to randomization and from randomization to initiation of study treatment were 7 days and 3 days, respectively. Twenty-two randomized participants (3.3%) were hospitalized for COVID-19 prior to initiating treatment. Among the 558 patients who initiated treatment, the adjudicated primary composite end point occurred in 1 patient (0.7%) in the aspirin group, 1 patient (0.7%) in the 2.5-mg apixaban group, 2 patients (1.4%) in the 5-mg apixaban group, and 1 patient (0.7%) in the placebo group. The risk differences compared with placebo for the primary end point were 0.0% (95% CI not calculable) in the aspirin group, 0.7% (95% CI, -2.1% to 4.1%) in the 2.5-mg apixaban group, and 1.4% (95% CI, -1.5% to 5.0%) in the 5-mg apixaban group. Risk differences compared with placebo for bleeding events were 2.0% (95% CI, -2.7% to 6.8%), 4.5% (95% CI, -0.7% to 10.2%), and 6.9% (95% CI, 1.4% to 12.9%) among participants who initiated therapy in the aspirin, prophylactic apixaban, and therapeutic apixaban groups, respectively, although none were major. Findings inclusive of all randomized patients were similar.CONCLUSIONS AND RELEV...
Background Pain is one of the most common complaints that patients present to the emergency department for; emergency medicine providers are tasked with providing appropriate pain relief while simultaneously limiting the risk of personal and societal harm that may result from opioid misuse. The Lakeland Regional Medical Center developed a medical management program that identified frequent emergency department visitors with a chief complaint of pain. Individualized care plans were developed for these patients. A retrospective review was then conducted to assess the efficacy of these care plans in reducing the number of emergency department visits for pain-related complaints by the patients entered into the medical management program. Results There were 294 patients; 65% were male, and the median age was 41 (interquartile range: 33 to 51). A total of 80% percent of the patients were white, and the payors were as follows: 53% were self-pay, 42% were government programs, and 5% had private insurance. The three most common chronic pain complaints were 39% abdominal pain, 24% back/neck pain, and 23% headache/migraine (patients could have more than one area of pain). A total of 60% of the patients had a primary care provider, and another 18% had a pain management provider in addition to primary care. Post plan admissions were significantly reduced to a median of 1 (IQR 0 to 3) with the Wilcoxon signed-rank test’s p-value of less than 0.001. Conclusion The authors describe their experience with a quality improvement initiative that identifies frequent emergency department visitors with a chief complaint of pain and provides individualized care plans to these patients. The goals of the program are to improve patient’s quality and consistency of care, through interventions that eliminate the prescribing of opioids while providing non-opioid alternatives.
Background Recombinant, monoclonal antibody therapies have been utilized under emergency use authorization (EUA) for the prevention of clinical decompensation in high-risk COVID-19 positive patients for up to 10 days from symptom onset. The purpose of this study was to determine the impact of the timing of the monoclonal antibody, bamlanivimab, on clinical outcomes in high-risk COVID-19 positive patients. Methods This was an IRB-approved, retrospective evaluation of adult patients who received bamlanivimab per EUA criteria in the emergency department (ED). Patients were dichotomized into two groups– 3 days of symptoms or less ( early ) versus 4 to 10 days ( late ). The primary outcome was hospitalization for COVID-related illness at 28 days (or treatment failure). Secondary outcomes were COVID-related ED visits at 28 days, hospital and intensive care unit (ICU) length of stay (LOS), and in-hospital mortality at 28 days. Results A total of 839 patients were included in the analysis. There was no difference observed in COVID-related hospitalization rates within 28 days between the early and late bamlanivimab administration groups (7.5% vs. 8.2%, p = 0.71). There was no difference in COVID-related ED visits within 28 days with 13% of patients returning to the ED. Conclusions In conclusion, there were no differences in the rates of hospitalization at 28 days when bamlanivimab was administered in the first 3 days of illness versus days 4 to 10. Future prospective studies are warranted to expand upon the characteristics of patients that may or may not benefit from monoclonal antibody therapy.
Background: There have been many perceived barriers to the implementation of the mass use of monoclonal antibody therapy following the Food and Drug Administration’s Emergency Use Authorization in November 2020. These barriers include identifying eligible patients, physical resources including trained staff members, space, and materials for the administration away from others to reduce transmission, and cost of the resources. However, Lakeland Regional Health was able to create a safe and efficient protocol to administer Bamlanivimab in the treatment of high risk COVID positive patients and initiate this proposed pathway within 24 hours of receipt of the first shipment of medication.Methods: Critical to the development and success of this protocol was a multi-disciplinary approach focused on identifying and utilizing preexisting resources to ensure safe and efficient administration of this treatment to as many eligible patients as possible. Another crucial aspect was the utilization of the emergency department providers for identifying high risk eligible patients and as a safe and effective treatment setting.Results: This article is intended to demonstrate a best practice pathway to identify and administer Bamlanivimab, or similar treatments, and will not discuss outcomes or efficacy of the medication. To date Lakeland Regional Health has successfully treated over 1,000 high risk COVID-19 positive patients within our community.Conclusions: By identifying and utilizing similar resources and pathways available at individual medical centers, it is possible to safely and efficiently treat high risk COVID positive patients with monoclonal antibody therapy on a large scale.
A ccording to the most recent Annual Report of the American Association of Poison Control Centers' National Poison Data System, there were 51,081 patient exposures to acetaminophen or acetaminophen-containing products treated in a healthcare facility in 2018. 1 The toxicity of acetaminophen is mediated by its metabolism into the electrophile N-acetyl-p-benzoquinone imine (NAPQI). 2 If the amount of acetaminophen ingested is higher than recommended dosages, glutathione stores may become depleted as the liver tries to detoxify NAPQI and may no longer able to keep up with the demand. As the patient progresses 24 to 36 hours after ingestion, the onset of hepatic injury becomes apparent with elevations in aspartate aminotransferase (AST). AST elevations, should they occur, are almost always present by 36 hours. 2 Maximum hepatic dysfunction, as well as elevations in prothrombin time, bilirubin, and serum creatinine, occurs 72 to 96 hours after a toxic ingestion. As a result of marked age-associated differences in the process of conjugating acetaminophen metabolites, infants and young children may be less susceptible to acetaminophen-associated hepatotoxicity, compared with their adult counterparts. 3,4 This clinical progress note addresses acetaminophen toxicity treatment, focusing on N-acetylcysteine (NAC) dosing protocols and the 2017 American College of Medical Toxicology (ACMT) position statement, Duration of Intravenous Acetylcysteine Therapy Following Acetaminophen Overdose. 5 We conducted a literature search via the PubMed database. The authors began by using the following Medical Subject Headings terms "acetaminophen overdose [title]," which yielded 299 articles, "acetaminophen hepatotoxicity [title]," which yielded 283 articles, and "acetaminophen N-acetylcysteine [title]," which yielded 335 titles. Variations of these terms were used to ensure exhaustive search results. The search results were reviewed for applicability to acetaminophen poisoning and especially goal-directed N-acetylcysteine treatment strategies.
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