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Objective: While the American Diabetes Association (ADA) screening guidelines have been used widely, the way they are implemented and adapted to a particular setting can impact their practical application and usage. Our primary objective was to validate a best practice advisory (BPA) screening algorithm informed by the ADA guidelines to identify patients eligible for hemoglobin a1c (HbA1c) testing in the emergency department (ED). Methods: This cross-sectional study included adults presenting to a large urban medical center’s ED in May 2021. We used sensitivity, specificity, likelihood ratios, and predictive values to estimate the algorithm’s ability to correctly identify patients eligible for diabetes screening, with manual chart review as the reference standard. Eligibility criteria targeted patients at risk for diabetes who were likely unaware of their elevated HbA1c. We also calculated the area under the receiver operating characteristic curve (AUC).  Results: In May 2021, 2,963 (77%) of the 3,850 adults admitted to the ED had a routine lab ordered. Among those, 796 (27%) had a BPA triggered, and of those 631 (79%) had an HbA1c test completed. The algorithm had acceptable sensitivity (0.69, 95% confidence interval [CI] 0.66-0.72), specificity (0.91, CI 0.89-0.92), positive predictive value (0.75, CI 0.72-0.78) and negative predictive value (0.88, CI 0.86-0.89). The positive likelihood ratio (7.39, CI 6.35-8.42 ) was adequate, and the negative likelihood ratio (0.34, CI 0.30-0.37) was informative. The AUC of 0.74 (CI 0.72-0.77) suggests that the algorithm had acceptable accuracy. Conclusion: Findings suggest that an electronic health record-based algorithm informed by the ADA guidelines is a valid tool for identifying patients presenting to the ED who are eligible for HbA1c testing and may be unaware of having prediabetes or diabetes. The ease of workflow integration and high yield of potentially undiagnosed diabetes and prediabetes makes the BPA algorithm an appealing method for diabetes screening within the ED.

This study evaluated whether SARS-CoV-2 infection led to persistent changes in common clinical laboratory tests in people with prior infection compared with those without prior infection and whether people with postacute sequelae of SARS-CoV-2 infection (PASC) have persistent laboratory changes compared with those who are unlikely to have PASC. Visual Abstract. Differentiation of Prior SARS-CoV-2 Infection and Postacute Sequelae by Standard Clinical Laboratory Measurements in the RECOVER Cohort: This study evaluated whether SARS-CoV-2 infection led to persistent changes in common clinical laboratory tests in people with prior infection compared with those without prior infection and whether people with postacute sequelae of SARS-CoV-2 infection (PASC) have persistent laboratory changes compared with those who are unlikely to have PASC. Background: There are currently no validated clinical biomarkers of postacute sequelae of SARS-CoV-2 infection (PASC). Objective: To investigate clinical laboratory markers of SARS-CoV-2 and PASC. Design: Propensity score–weighted linear regression models were fitted to evaluate differences in mean laboratory measures by prior infection and PASC index (≥12 vs. 0). (ClinicalTrials.gov: NCT05172024) Setting: 83 enrolling sites. Participants: RECOVER-Adult cohort participants with or without SARS-CoV-2 infection with a study visit and laboratory measures 6 months after the index date (or at enrollment if >6 months after the index date). Participants were excluded if the 6-month visit occurred within 30 days of reinfection. Measurements: Participants completed questionnaires and standard clinical laboratory tests. Results: Among 10 094 participants, 8746 had prior SARS-CoV-2 infection, 1348 were uninfected, 1880 had a PASC index of 12 or higher, and 3351 had a PASC index of zero. After propensity score adjustment, participants with prior infection had a lower mean platelet count (265.9 × 10 9 cells/L [95% CI, 264.5 to 267.4 × 10 9 cells/L]) than participants without known prior infection (275.2 × 10 9 cells/L [CI, 268.5 to 282.0 × 10 9 cells/L]), as well as higher mean hemoglobin A 1c (HbA 1c) level (5.58% [CI, 5.56% to 5.60%] vs. 5.46% [CI, 5.40% to 5.51%]) and urinary albumin–creatinine ratio (81.9 mg/g [CI, 67.5 to 96.2 mg/g] vs. 43.0 mg/g [CI, 25.4 to 60.6 mg/g]), although differences were of modest clinical significance. The difference in HbA 1c levels was attenuated after participants with preexisting diabetes were excluded. Among participants with prior infection, no meaningful differences in mean laboratory values were found between those with a PASC index of 12 or higher and those with a PASC index of zero. Limitation: Whether differences in laboratory markers represent consequences of or risk factors for SARS-CoV-2 infection could not be determined. Conclusion: Overall, no evidence was found that any of the 25 routine clinical laboratory values assessed in this study could serve as a clinically useful biomarker of PASC. Primary Funding Source: National Institutes of Health. [ABSTRACT FROM AUTHOR]

Importance: Acutely 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 Participants: The 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/mm3 and estimated glomerular filtration rate greater than 30 mL/min/1.73 m2.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 Measures: The 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.Results: On June 18, 2021, the trial data and safety monitoring board recommended early termination because of lower than anticipated event rates; at that time, 657 symptomatic outpatients with COVID-19 had been randomized (median age, 54 years [IQR, 46-59]; 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 Relevance: Among symptomatic clinically stable outpatients with COVID-19, treatment with aspirin or apixaban compared with placebo did not reduce the rate of a composite clinical outcome. However, the study was terminated after enrollment of 9% of participants because of an event rate lower than anticipated.Trial Registration: ClinicalTrials.gov Identifier: NCT04498273. [ABSTRACT FROM AUTHOR]