Excess Mortality Among Patients in the Veterans Affairs Health System Compared With the Overall US Population During the First Year of the COVID-19 Pandemic.

Importance: During the first year of the COVID-19 pandemic, there was a substantial increase in the rate of death in the United States. It is unclear whether those who had access to comprehensive medical care through the Department of Veterans Affairs (VA) health care system had different death rates compared with the overall US population. Objective: To quantify and compare the increase in death rates during the first year of the COVID-19 pandemic between individuals who received comprehensive medical care through the VA health care system and those in the general US population. Design, Setting, and Participants: This cohort study compared 10.9 million enrollees in the VA, including 6.8 million active users of VA health care (those with a visit in the last 2 years), with the general population of the US, with deaths occurring from January 1, 2014, to December 31, 2020. Statistical analysis was conducted from May 17, 2021, to March 15, 2023. Main Outcomes and Measures: Changes in rates of death from any cause during the COVID-19 pandemic in 2020 compared with previous years. Changes in all-cause death rates by quarter were stratified by age, sex, race and ethnicity, and region, based on individual-level data. Multilevel regression models were fit in a bayesian setting. Standardized rates were used for comparison between populations. Results: There were 10.9 million enrollees in the VA health care system and 6.8 million active users. The demographic characteristics of the VA populations were predominantly male (>85% in the VA health care system vs 49% in the general US population), older (mean [SD], 61.0 [18.2] years in the VA health care system vs 39.0 [23.1] years in the US population), and had a larger proportion of patients who were White (73% in the VA health care system vs 61% in the US population) or Black (17% in the VA health care system vs 13% in the US population). Increases in death rates were apparent across all of the adult age groups (≥25 years) in both the VA populations and the general US population. Across all of 2020, the relative increase in death rates compared with expected values was similar for VA enrollees (risk ratio [RR], 1.20 [95% CI, 1.14-1.29]), VA active users (RR, 1.19 [95% CI, 1.14-1.26]), and the general US population (RR, 1.20 [95% CI, 1.17-1.22]). Because the prepandemic standardized mortality rates were higher in the VA populations prior to the pandemic, the absolute rates of excess mortality were higher in the VA populations. Conclusions and Relevance: In this cohort study, a comparison of excess deaths between populations suggests that active users of the VA health system had similar relative increases in mortality compared with the general US population during the first 10 months of the COVID-19 pandemic.

Defining Essential Surgery in the US During the COVID-19 Pandemic Response.

This cohort study compares the volume of performed surgical procedures classified as essential, urgent, and nonurgent before and after elective surgeries were restricted during the COVID-19 pandemic in the US.

Trends in US Surgical Procedures and Health Care System Response to Policies Curtailing Elective Surgical Operations During the COVID-19 Pandemic.

Importance: The COVID-19 pandemic has affected every aspect of medical care, including surgical treatment. It is critical to understand the association of government policies and infection burden with surgical access across the United States. Objective: To describe the change in surgical procedure volume in the US after the government-suggested shutdown and subsequent peak surge in volume of patients with COVID-19. Design, Setting, and Participants: This retrospective cohort study was conducted using administrative claims from a nationwide health care technology clearinghouse. Claims from pediatric and adult patients undergoing surgical procedures in 49 US states within the Change Healthcare network of health care institutions were used. Surgical procedure volume during the 2020 initial COVID-19-related shutdown and subsequent fall and winter infection surge were compared with volume in 2019. Data were analyzed from November 2020 through July 2021. Exposures: 2020 policies to curtail elective surgical procedures and the incidence rate of patients with COVID-19. Main Outcomes and Measures: Incidence rate ratios (IRRs) were estimated from a Poisson regression comparing total procedure counts during the initial shutdown (March 15 to May 2, 2020) and subsequent COVID-19 surge (October 22, 2020-January 31, 2021) with corresponding 2019 dates. Surgical procedures were analyzed by 11 major procedure categories, 25 subcategories, and 12 exemplar operative procedures along a spectrum of elective to emergency indications. Results: A total of 13 108 567 surgical procedures were identified from January 1, 2019, through January 30, 2021, based on 3498 Current Procedural Terminology (CPT) codes. This included 6 651 921 procedures in 2019 (3 516 569 procedures among women [52.9%]; 613 192 procedures among children [9.2%]; and 1 987 397 procedures among patients aged ≥65 years [29.9%]) and 5 973 573 procedures in 2020 (3 156 240 procedures among women [52.8%]; 482 637 procedures among children [8.1%]; and 1 806 074 procedures among patients aged ≥65 years [30.2%]). The total number of procedures during the initial shutdown period and its corresponding period in 2019 (ie, epidemiological weeks 12-18) decreased from 905 444 procedures in 2019 to 458 469 procedures in 2020, for an IRR of 0.52 (95% CI, 0.44 to 0.60; P < .001) with a decrease of 48.0%. There was a decrease in surgical procedure volume across all major categories compared with corresponding weeks in 2019. During the initial shutdown, otolaryngology (ENT) procedures (IRR, 0.30; 95% CI, 0.13 to 0.46; P < .001) and cataract procedures (IRR, 0.11; 95% CI, -0.11 to 0.32; P = .03) decreased the most among major categories. Organ transplants and cesarean deliveries did not differ from the 2019 baseline. After the initial shutdown, during the ensuing COVID-19 surge, surgical procedure volumes rebounded to 2019 levels (IRR, 0.97; 95% CI, 0.95 to 1.00; P = .10) except for ENT procedures (IRR, 0.70; 95% CI, 0.65 to 0.75; P < .001). There was a correlation between state volumes of patients with COVID-19 and surgical procedure volume during the initial shutdown (r = -0.00025; 95% CI, -0.0042 to -0.0009; P = .003), but there was no correlation during the COVID-19 surge (r = -0.00034; 95% CI, -0.0075 to 0.00007; P = .11). Conclusions and Relevance: This study found that the initial shutdown period in March through April 2020, was associated with a decrease in surgical procedure volume to nearly half of baseline rates. After the reopening, the rate of surgical procedures rebounded to 2019 levels, and this trend was maintained throughout the peak burden of patients with COVID-19 in fall and winter; these findings suggest that after initial adaptation, health systems appeared to be able to self-regulate and function at prepandemic capacity.

Ten Rules for Conducting Retrospective Pharmacoepidemiological Analyses: Example COVID-19 Study.

Since the beginning of the COVID-19 pandemic, pharmaceutical treatment hypotheses have abounded, each requiring careful evaluation. A randomized controlled trial generally provides the most credible evaluation of a treatment, but the efficiency and effectiveness of the trial depend on the existing evidence supporting the treatment. The researcher must therefore compile a body of evidence justifying the use of time and resources to further investigate a treatment hypothesis in a trial. An observational study can provide this evidence, but the lack of randomized exposure and the researcher's inability to control treatment administration and data collection introduce significant challenges. A proper analysis of observational health care data thus requires contributions from experts in a diverse set of topics ranging from epidemiology and causal analysis to relevant medical specialties and data sources. Here we summarize these contributions as 10 rules that serve as an end-to-end introduction to retrospective pharmacoepidemiological analyses of observational health care data using a running example of a hypothetical COVID-19 study. A detailed supplement presents a practical how-to guide for following each rule. When carefully designed and properly executed, a retrospective pharmacoepidemiological analysis framed around these rules will inform the decisions of whether and how to investigate a treatment hypothesis in a randomized controlled trial. This work has important implications for any future pandemic by prescribing what we can and should do while the world waits for global vaccine distribution.

Short-term Effects of Canceled Elective Procedures Due to COVID-19: Evidence From the Veterans Affairs Healthcare System.

OBJECTIVE: To determine whether delayed or canceled elective procedures due to COVID-19 resulted in higher rates of ED utilization and/or increased mortality. SUMMARY OF BACKGROUND DATA: On March 15, 2020, the VA issued a nationwide order to temporarily pause elective cases due to COVID-19. The effects of this disruption on patient outcomes are not yet known. METHODS: This retrospective cohort study used data from the VA Corporate Data Warehouse. Surgical procedures canceled due to COVID-19 in 2020 (n = 3326) were matched to similar completed procedures in 2018 (n = 151,863) and 2019 (n = 146,582). Outcome measures included 30- and 90-day VA ED use and mortality in the period following the completed or canceled procedure. We used exact matching on surgical procedure category and nearest neighbor matching on patient characteristics, procedure year, and facility. RESULTS: Patients with elective surgical procedures canceled due to COVID-19 were no more likely to have an ED visit in the 30- [Difference: -4.3% pts; 95% confidence interval (CI): -0.078, -0.007] and 90 days (-0.9% pts; 95% CI: -0.068, 0.05) following the expected case date. Patients with cancellations had no difference in 30- (Difference: 0.1% pts; 95% CI: -0.008, 0.01) and 90-day (Difference: -0.4% pts; 95% CI: -0.016, 0.009) mortality rates when compared to similar patients with similar procedures that were completed in previous years. CONCLUSIONS: The pause in elective surgical cases was not associated with short-term adverse outcomes in VA hospitals, suggesting appropriate surgical case triage and management. Further study will be essential to determine if the delayed cases were associated with longer-term effects.

The Association Between Alpha-1 Adrenergic Receptor Antagonists and In-Hospital Mortality From COVID-19.

Effective therapies for coronavirus disease 2019 (COVID-19) are urgently needed, and pre-clinical data suggest alpha-1 adrenergic receptor antagonists (α1-AR antagonists) may be effective in reducing mortality related to hyperinflammation independent of etiology. Using a retrospective cohort design with patients in the Department of Veterans Affairs healthcare system, we use doubly robust regression and matching to estimate the association between baseline use of α1-AR antagonists and likelihood of death due to COVID-19 during hospitalization. Having an active prescription for any α1-AR antagonist (tamsulosin, silodosin, prazosin, terazosin, doxazosin, or alfuzosin) at the time of admission had a significant negative association with in-hospital mortality (relative risk reduction 18%; odds ratio 0.73; 95% CI 0.63-0.85; p ≤ 0.001) and death within 28 days of admission (relative risk reduction 17%; odds ratio 0.74; 95% CI 0.65-0.84; p ≤ 0.001). In a subset of patients on doxazosin specifically, an inhibitor of all three alpha-1 adrenergic receptors, we observed a relative risk reduction for death of 74% (odds ratio 0.23; 95% CI 0.03-0.94; p = 0.028) compared to matched controls not on any α1-AR antagonist at the time of admission. These findings suggest that use of α1-AR antagonists may reduce mortality in COVID-19, supporting the need for randomized, placebo-controlled clinical trials in patients with early symptomatic infection.