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How to Quantify and Interpret Treatment Effects in Comparative Clinical Studies of COVID-19
Clinical trials of treatments for coronavirus disease 2019 (COVID-19) draw intense public attention. More than ever, valid, transparent, and intuitive summaries of the treatment effects, including efficacy and harm, are needed. In recently published and ongoing randomized comparative trials evaluating treatments for COVID-19, time to a positive outcome, such as recovery or improvement, has repeatedly been used as either the primary or key secondary end point. Because patients may die before recovery or improvement, data analysis of this end point faces a competing risk problem. Commonly used survival analysis techniques, such as the Kaplan–Meier method, often are not appropriate for such situations. Moreover, almost all trials have quantified treatment effects by using the hazard ratio, which is difficult to interpret for a positive event, especially in the presence of competing risks. Using 2 recent trials evaluating treatments (remdesivir and convalescent plasma) for COVID-19 as examples, a valid, well-established yet underused procedure is presented for estimating the cumulative recovery or improvement rate curve across the study period. Furthermore, an intuitive and clinically interpretable summary of treatment efficacy based on this curve is also proposed. Clinical investigators are encouraged to consider applying these methods for quantifying treatment effects in future studies of COVID-19.
Spatial Inequities in COVID-19 Testing, Positivity, Confirmed Cases, and Mortality in 3 U.S. Cities: An Ecological Study: Annals of Internal Medicine: Vol 174, No 7
Background: Preliminary evidence has shown inequities in coronavirus disease 2019 (COVID-19)–related cases and deaths in the United States. Objective: To explore the emergence of spatial inequities in COVID-19 testing, positivity, confirmed cases, and mortality in New York, Philadelphia, and Chicago during the first 6 months of the pandemic. Design: Ecological, observational study at the ZIP code tabulation area (ZCTA) level from March to September 2020. Setting: Chicago, New York, and Philadelphia. Participants: All populated ZCTAs in the 3 cities. Measurements: Outcomes were ZCTA-level COVID-19 testing, positivity, confirmed cases, and mortality cumulatively through the end of September 2020. Predictors were the Centers for Disease Control and Prevention Social Vulnerability Index and its 4 domains, obtained from the 2014–2018 American Community Survey. The spatial autocorrelation of COVID-19 outcomes was examined by using global and local Moran I statistics, and estimated associations were examined by using spatial conditional autoregressive negative binomial models. Results: Spatial clusters of high and low positivity, confirmed cases, and mortality were found, co-located with clusters of low and high social vulnerability in the 3 cities. Evidence was also found for spatial inequities in testing, positivity, confirmed cases, and mortality. Specifically, neighborhoods with higher social vulnerability had lower testing rates and higher positivity ratios, confirmed case rates, and mortality rates. Limitations: The ZCTAs are imperfect and heterogeneous geographic units of analysis. Surveillance data were used, which may be incomplete. Conclusion: Spatial inequities exist in COVID-19 testing, positivity, confirmed cases, and mortality in 3 large U.S. cities. Primary Funding Source: National Institutes of Health.
Every Body Counts: Measuring Mortality From the COVID-19 Pandemic
As of mid-August 2020, more than 170 000 U.S. residents have died of coronavirus disease 2019 (COVID-19); however, the true number of deaths resulting from COVID-19, both directly and indirectly, is likely to be much higher. The proper attribution of deaths to this pandemic has a range of societal, legal, mortuary, and public health consequences. This article discusses the current difficulties of disaster death attribution and describes the strengths and limitations of relying on death counts from death certificates, estimations of indirect deaths, and estimations of excess mortality. Improving the tabulation of direct and indirect deaths on death certificates will require concerted efforts and consensus across medical institutions and public health agencies. In addition, actionable estimates of excess mortality will require timely access to standardized and structured vital registry data, which should be shared directly at the state level to ensure rapid response for local governments. Correct attribution of direct and indirect deaths and estimation of excess mortality are complementary goals that are critical to our understanding of the pandemic and its effect on human life.
How to Safely Reopen Colleges and Universities During COVID-19: Experiences From Taiwan
Reopening colleges and universities during the coronavirus disease 2019 (COVID-19) pandemic poses a special challenge worldwide. Taiwan is one of the few countries where schools are functioning normally. To secure the safety of students and staff, the Ministry of Education in Taiwan established general guidelines for college campuses. The guidelines delineated creation of a task force at each university; school-based risk screening based on travel history, occupation, contacts, and clusters; measures on self-management of health and quarantine; general hygiene measures (including wearing masks indoors); principles on ventilation and sanitization; regulations on school assemblies; a process for reporting suspected cases; and policies on school closing and make-up classes. It also announced that a class should be suspended if 1 student or staff member in it tested positive and that a school should be closed for 14 days if it had 2 or more confirmed cases. As of 18 June 2020, there have been 7 confirmed cases in 6 Taiwanese universities since the start of the pandemic. One university was temporarily closed, adopted virtual classes, and quickly reopened after 14 days of contact tracing and quarantine of possible contacts. Taiwan's experience suggests that, under certain circumstances, safely reopening colleges and universities this fall may be feasible with a combination of strategies that include containment (access control with contact tracing and quarantine) and mitigation (hygiene, sanitation, ventilation, and social distancing) practices.