Do racial and ethnic disparities in following stay-at-home orders influence COVID-19 health outcomes? A mediation analysis approach.

Racial/ethnic disparities are among the top-selective underlying determinants associated with the disproportional impact of the COVID-19 pandemic on human mobility and health outcomes. This study jointly examined county-level racial/ethnic differences in compliance with stay-at-home orders and COVID-19 health outcomes during 2020, leveraging two-year geo-tracking data of mobile devices across ~4.4 million point-of-interests (POIs) in the contiguous United States. Through a set of structural equation modeling, this study quantified how racial/ethnic differences in following stay-at-home orders could mediate COVID-19 health outcomes, controlling for state effects, socioeconomics, demographics, occupation, and partisanship. Results showed that counties with higher Asian populations decreased most in their travel, both in terms of reducing their overall POIs' visiting and increasing their staying home percentage. Moreover, counties with higher White populations experienced the lowest infection rate, while counties with higher African American populations presented the highest case-fatality ratio. Additionally, control variables, particularly partisanship, median household income, percentage of elders, and urbanization, significantly accounted for the county differences in human mobility and COVID-19 health outcomes. Mediation analyses further revealed that human mobility only statistically influenced infection rate but not case-fatality ratio, and such mediation effects varied substantially among racial/ethnic compositions. Last, robustness check of racial gradient at census block group level documented consistent associations but greater magnitude. Taken together, these findings suggest that US residents' responses to COVID-19 are subject to an entrenched and consequential racial/ethnic divide.

Characteristics and Outcomes Among US Patients Hospitalized for Ischemic Stroke Before vs During the COVID-19 Pandemic.

Importance: After the emergence of COVID-19, studies reported a decrease in hospitalizations of patients with ischemic stroke (IS), but there are little to no data regarding hospitalizations for the remainder of 2020, including outcome data from a large cohort of patients with IS and comorbid COVID-19. Objective: To assess hospital discharge rates, demographic factors, and outcomes of hospitalization associated with the COVID-19 pandemic among US patients with IS before vs during the COVID-19 pandemic. Design, Setting, and Participants: This retrospective cohort study used data from the Vizient Clinical Data Base on 324 013 patients with IS at 478 nonfederal hospitals in 43 US states between January 1, 2019, and December 31, 2020. Patients were eligible if they were admitted to the hospital on a nonelective basis and were not receiving hospice care at the time of admission. A total of 41 166 discharged between January and March 2020 were excluded from the analysis because they had unreliable data on COVID-19 status, leaving 282 847 patients for the study. Exposure: Ischemic stroke and laboratory-confirmed COVID-19. Main Outcomes and Measures: Monthly counts of discharges among patients with IS in 2020. Demographic characteristics and outcomes, including in-hospital death, among patients with IS who were discharged in 2019 (control group) were compared with those of patients with IS with or without comorbid COVID-19 (COVID-19 and non-COVID-19 groups, respectively) who were discharged between April and December 2020. Results: Of the 282 847 patients included in the study, 165 912 (50.7% male; 63.4% White; 26.3% aged ≥80 years) were allocated to the control group; 111 418 of 116 935 patients (95.3%; 51.9% male; 62.8% White; 24.6% aged ≥80 years) were allocated to the non-COVID-19 group and 5517 of 116 935 patients (4.7%; 58.0% male; 42.5% White; 21.3% aged ≥80 years) to the COVID-19 group. A mean (SD) of 13 846 (553) discharges per month among patients with IS was reported in 2019. Discharges began decreasing in February 2020, reaching a low of 10 846 patients in April 2020 before returning to a prepandemic level of 13 639 patients by July 2020. A mean (SD) of 13 492 (554) discharges per month was recorded for the remainder of 2020. Black and Hispanic patients accounted for 21.4% and 7.0% of IS discharges in 2019, respectively, but accounted for 27.5% and 16.0% of those discharged with IS and comorbid COVID-19 in 2020. Compared with patients in the control and non-COVID-19 groups, those in the COVID-19 group were less likely to smoke (16.0% vs 17.2% vs 6.4%, respectively) and to have hypertension (73.0% vs 73.1% vs 68.2%) or dyslipidemia (61.2% vs 63.2% vs 56.6%) but were more likely to have diabetes (39.8% vs 40.5% vs 53.0%), obesity (16.2% vs 18.4% vs 24.5%), acute coronary syndrome (8.0% vs 9.2% vs 15.8%), or pulmonary embolus (1.9% vs 2.4% vs 6.8%) and to require intubation (11.3% vs 12.3% vs 37.6%). After adjusting for baseline factors, patients with IS and COVID-19 were more likely to die in the hospital than were patients with IS in 2019 (adjusted odds ratio, 5.17; 95% CI, 4.83-5.53; National Institutes of Health Stroke Scale adjusted odds ratio, 3.57; 95% CI, 3.15-4.05). Conclusions and Relevance: In this cohort study, after the emergence of COVID-19, hospital discharges of patients with IS decreased in the US but returned to prepandemic levels by July 2020. Among patients with IS between April and December 2020, comorbid COVID-19 was relatively common, particularly among Black and Hispanic populations, and morbidity was high.

Model-Based Estimation of Colorectal Cancer Screening and Outcomes During the COVID-19 Pandemic.

Importance: COVID-19 has decreased colorectal cancer screenings. Objective: To estimate the degree to which expanding fecal immunochemical test-based colorectal cancer screening participation during the COVID-19 pandemic is associated with clinical outcomes. Design, Setting, and Participants: A previously developed simulation model was adopted to estimate how much COVID-19 may have contributed to colorectal cancer outcomes. The model included the US population estimated to have completed colorectal cancer screening pre-COVID-19 according the American Cancer Society. The model was designed to estimate colorectal cancer outcomes between 2020 and 2023. This analysis was completed between July and December 2020. Exposures: Adults screened for colorectal cancer and colorectal cancer cases detected by stage. Main Outcomes and Measures: Estimates of colorectal cancer outcomes across 4 scenarios: (1) 9 months of 50% colorectal cancer screenings followed by 21 months of 75% colorectal cancer screenings; (2) 18 months of 50% screening followed by 12 months of 75% screening; (3) scenario 1 with increased use of fecal immunochemical tests; and (4) scenario 2 with increased use of fecal immunochemical tests. Results: In our simulation model, COVID-19-related reductions in care utilization resulted in an estimated 1 176 942 to 2 014 164 fewer colorectal cancer screenings, 8346 to 12 894 fewer colorectal cancer diagnoses, and 6113 to 9301 fewer early-stage colorectal cancer diagnoses between 2020 and 2023. With an abbreviated period of reduced colorectal cancer screenings, increasing fecal immunochemical test use was associated with an estimated additional 588 844 colorectal cancer screenings and 2836 colorectal cancer diagnoses, of which 1953 (68.9%) were early stage. In the event of a prolonged period of reduced colorectal cancer screenings, increasing fecal immunochemical test use was associated with an estimated additional 655 825 colorectal cancer screenings and 2715 colorectal cancer diagnoses, of which 1944 (71.6%) were early stage. Conclusions and Relevance: These results suggest that the increased use of fecal immunochemical tests during the COVID-19 pandemic was associated with increased colorectal cancer screening participation and more colorectal cancer diagnoses at earlier stages. If our estimates are borne out in real-world clinical practice, increasing fecal immunochemical test-based colorectal cancer screening participation during the COVID-19 pandemic could mitigate the consequences of reduced screening rates during the pandemic for colorectal cancer outcomes.

COVID-19 International Collaborative Research by the Health Insurance Review and Assessment Service Using Its Nationwide Real-world Data: Database, Outcomes, and Implications.

This article aims to introduce the inception and operation of the COVID-19 International Collaborative Research Project, the world's first coronavirus disease 2019 (COVID-19) open data project for research, along with its dataset and research method, and to discuss relevant considerations for collaborative research using nationwide real-world data (RWD). COVID-19 has spread across the world since early 2020, becoming a serious global health threat to life, safety, and social and economic activities. However, insufficient RWD from patients was available to help clinicians efficiently diagnose and treat patients with COVID-19, or to provide necessary information to the government for policy-making. Countries that saw a rapid surge of infections had to focus on leveraging medical professionals to treat patients, and the circumstances made it even more difficult to promptly use COVID-19 RWD. Against this backdrop, the Health Insurance Review and Assessment Service (HIRA) of Korea decided to open its COVID-19 RWD collected through Korea's universal health insurance program, under the title of the COVID-19 International Collaborative Research Project. The dataset, consisting of 476 508 claim statements from 234 427 patients (7590 confirmed cases) and 18 691 318 claim statements of the same patients for the previous 3 years, was established and hosted on HIRA's in-house server. Researchers who applied to participate in the project uploaded analysis code on the platform prepared by HIRA, and HIRA conducted the analysis and provided outcome values. As of November 2020, analyses have been completed for 129 research projects, which have been published or are in the process of being published in prestigious journals.

Impact of COVID-19 Outbreak through Telemedicine Implementation on Data Reporting During Oncology Clinical Trials.

Coronavirus disease outbreak has affected all aspect of clinical care including cancer clinical trials. To minimize exposure of frail cancer patients, an implementation of telemedicine was retained. The impact of this implementation on primary and secondary endpoints criteria of ongoing clinical trials was analyzed. Out of 128 oncology clinical trials, 25 (19%) had an implementation of teleconsultation. Poor data reporting induced mainly a bias on qualitative and descriptive primary endpoints than those assessing efficacy (80% vs 20%; p < 0.001). The integration of telemedicine and E-technologies in the medical practices and clinical trials must be designed and validated.

Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery.

OBJECTIVES: Respiratory failure, multiple organ failure, shortness of breath, recovery, and mortality have been identified as critically important core outcomes by more than 9300 patients, health professionals, and the public from 111 countries in the global coronavirus disease 2019 core outcome set initiative. The aim of this project was to establish the core outcome measures for these domains for trials in coronavirus disease 2019. DESIGN: Three online consensus workshops were convened to establish outcome measures for the four core domains of respiratory failure, multiple organ failure, shortness of breath, and recovery. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Respiratory failure, assessed by the need for respiratory support based on the World Health Organization Clinical Progression Scale, was considered pragmatic, objective, and with broad applicability to various clinical scenarios. The Sequential Organ Failure Assessment was recommended for multiple organ failure, because it was routinely used in trials and clinical care, well validated, and feasible. The Modified Medical Research Council measure for shortness of breath, with minor adaptations (recall period of 24 hr to capture daily fluctuations and inclusion of activities to ensure relevance and to capture the extreme severity of shortness of breath in people with coronavirus disease 2019), was regarded as fit for purpose for this indication. The recovery measure was developed de novo and defined as the absence of symptoms, resumption of usual daily activities, and return to the previous state of health prior to the illness, using a 5-point Likert scale, and was endorsed. CONCLUSIONS: The coronavirus disease 2019 core outcome set recommended core outcome measures have content validity and are considered the most feasible and acceptable among existing measures. Implementation of the core outcome measures in trials in coronavirus disease 2019 will ensure consistency and relevance of the evidence to inform decision-making and care of patients with coronavirus disease 2019.

Cardiac involvement at presentation in patients hospitalized with COVID-19 and their outcome in a tertiary referral hospital in Northern Italy.

The correlation between myocardial injury and clinical outcome in COVID-19 patients is gaining attention in the literature. The aim of the present study was to evaluate the role of cardiac involvement and of respiratory failure in a cohort of COVID-19 patients hospitalized in an academic hospital in Lombardy, one of the most affected Italian (and worldwide) regions by the epidemic. The study included 405 consecutive patients with confirmed COVID-19 admitted to a medical ward from February 25th to March 31st, 2020. Follow-up of surviving patients ended either at hospital discharge or by July 30th, 2020. Myocardial injury was defined on the basis of the presence of blood levels of hs-TnI above the 99th percentile upper reference limit. Respiratory function was assessed as PaO2/FiO2 (P/F) ratio. The primary end-point was death for any cause. During hospitalization, 124 patients died. Death rate increased from 7.9% in patients with normal hs-TnI plasma levels and no cardiac comorbidity to 61.5% in patients with elevated hs-TnI and cardiac involvement (p < 0.001). At multivariable analysis, older age, P/F ratio < 200 (both p < 0.001) and hs-TnI plasma levels were independent predictors of death. However, it must be emphasized that the median values of hs-TnI were within normal range in non-survivors. Cardiac involvement at presentation was associated with poor prognosis in COVID-19 patients, but, even in a population of COVID-19 patients who did not require invasive ventilation at hospital admission, mortality was mainly driven by older age and respiratory failure.

A minimal common outcome measure set for COVID-19 clinical research.

Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.