The coronavirus disease 2019 (COVID-19) pandemic has underscored the structural inequities facing communities of color and its consequences in lives lost. However, little is known about the COVID-related disparities facing Asian Americans amidst the heightened racism and violence against this community. We analyze the mortality toll of COVID-19 on Asian Americans using multiple measures. In 2020, one in seven Asian American deaths was attributable to COVID-19. We find that while Asian Americans make up a small proportion of COVID-19 deaths in the USA, they experience significantly higher excess all-cause mortality (3.1 times higher), case fatality rate (as high as 53% higher), and percentage of deaths attributed to COVID-19 (2.1 times higher) compared to non-Hispanic Whites. Mounting evidence suggest that disproportionately low testing rates, greater disease severity at care presentation, socioeconomic factors, and racial discrimination contribute to the observed disparities. Improving data reporting and uniformly confronting racism are key components to addressing health inequities facing communities of color.

ObjeCtiveTo investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk cardiovascular devices compared with the characteristics and results reported in peer reviewed publications. DesignA search of the publicly available FDA database was performed for all cardiovascular devices that received premarket approval from 1 January 2000 to 31 December 2010. For each study listed in the premarket approval documents, a Medline search was conducted to obtain the corresponding publication. Main OutCOMe MeasuresClinical trial characteristics, primary endpoints, and safety and efficacy results in the FDA documents and corresponding publications. results 106 cardiovascular devices received premarket approval from 1 January 2000 to 31 December 2010. FDA premarket approval documents for these devices contained 177 studies, of which 86 (49%) had been published by 1 January 2013. These 86 publications corresponded to 60 distinct devices. The mean time from FDA approval to publication in a peer reviewed journal was 6.5 months (range −4.8-7.5 years). In 22 (26%) of the 86 compared studies the number of participants enrolled in the study differed in the FDA summary and the corresponding publications. Of 152 primary endpoints identified in the FDA documents, in the corresponding publications three (2%) were labeled as secondary, 43 (28%) were unlabeled, and 15 (10%) were not found. Among the primary results, 69 (45%) were identical, 35 (23%) were similar, 17 (11%) were substantially different, and 31 (20%) could not be compared. COnClusiOnsMany clinical trials for high risk cardiovascular devices approved by the FDA remain unpublished. Even when trials are published, the study population, primary endpoints, and results can differ substantially from data submitted to the FDA. IntroductionAs medical devices play an important role in healthcare, the quality of clinical trial evidence supporting their use is critical to patients' health and safety. In the United States between 1990 and 2002, over 17 000 pacemakers and implantable cardioverter defibrillators were removed and over 60 deaths were attributed to confirmed device malfunctions. 1 Manufacturers of new high risk devices, including many used to treat cardiovascular disease, are often required to submit clinical trial data to the US Food and Drug Administration (FDA) for evaluation of safety and effectiveness via the premarket approval process. 2 A review of recently approved high risk cardiovascular devices showed that they are often approved on the basis of a single study, most of which are not randomized and lack prospective controls. 3 4 FDA documents containing the evidence to support approval of devices are available but are not easy to access. For informed clinical decision making, the trial data that the FDA reviews should be accessible to clinicians in peer reviewed publications. Previous work has found that when clinical trial information in F...

Background Recent guidelines include aspirin as an option to prevent venous thromboembolism (VTE) in selected patients undergoing hip or knee replacement surgery. However, the efficacy of aspirin after arthroplasty has not been well-defined, particularly in more contemporary patient populations. We compared rates of post-operative VTE between patients who received aspirin-only versus anticoagulants after hip or knee arthroplasty, using data from a large US-based administrative database. Materials and Methods We conducted a retrospective cohort study of 231,780 adults who underwent total knee arthroplasty and 110,621 who underwent total hip arthroplasty in 2009–2012 and who received pharmacologic VTE prophylaxis (aspirin or anticoagulant) within the first 7 days after surgery. We compared the risk of post-operative VTE between patients receiving aspirin-only vs. anticoagulants, controlling for clinical and hospital characteristics using multivariable logistic regression with propensity score adjustment. Results Aspirin-only prophylaxis was administered to 7.5% of patients after knee arthroplasty and 8.0% after hip arthroplasty. Post-operative VTE was diagnosed in 2,217 (0.96%) patients after knee arthroplasty and 454 (0.41%) after hip arthroplasty. Compared to anticoagulants, aspirin was not associated with a higher risk for post-operative VTE either after knee arthroplasty (adjusted odds ratio and 95% confidence interval [OR] 0.34 [0.24–0.48]) or hip arthroplasty (OR 0.82 [0.45–1.51]). Conclusions Aspirin was uncommonly administered as the sole prophylactic agent after hip or knee arthroplasty in this study. However, patients who received aspirin-only had similar rates of post-operative VTE compared to patients who received anticoagulants. Further research should focus on distinguishing which patients benefit more from anticoagulants versus aspirin after arthroplasty.

Background The COVID-19 pandemic led to a significant increase in ambulatory virtual care, threatening access to care for older adults with lower digital literacy. In this report, we describe the Video Visits for Elders Project (VVEP), a quality improvement effort to help older adults access video visits at an academic primary care practice. Methods We reached out to empaneled older adults (≥ 65 years) who had a scheduled visit between March 30 and June 12, 2020. We assessed patients’ readiness to engage in a virtual visit and offered to walk them through accessing the platform if they owned a compatible device. We evaluated outcomes of those phone calls and actual visit completion. Results Between March 26 and June 3, 2020, we called 1,427 patients, reaching 1,025 (72%). Of those reached (mean age 75.6 years), 312 (30%) were already video-enabled, 192 (19%) asked for technical assistance, 185 (18%) did not have access to an electronic device, and 336 (33%) declined assistance. Of those reached, 40% completed their visit by video, 27% by telephone, and 1% by in-person visit, while 30% canceled and 2% no-showed. Conclusions VVEP successfully innovated to promote equitable access to telemedicine for vulnerable older patients in a time of crisis. Almost half required technical assistance or did not have access to a compatible device to engage in virtual care. As telemedicine will continue to play an important role in access to clinical care even in a post-pandemic world, it is imperative for health systems to focus on technological need to promote equitable access to care for all patients.