Comparative mRNA booster effectiveness against death or hospitalization with COVID-19 pneumonia across at-risk US Veteran populations.

Studies of comparative mRNA booster effectiveness among high-risk populations can inform mRNA booster-specific guidelines. The study emulated a target trial of COVID-19 vaccinated U.S. Veterans who received three doses of either mRNA-1273 or BNT162b2 vaccines. Participants were followed for up to 32 weeks between July 1, 2021 to May 30, 2022. Non-overlapping populations were average and high risk; high-risk sub-groups were age ≥65 years, high-risk co-morbid conditions, and immunocompromising conditions. Of 1,703,189 participants, 10.9 per 10,000 persons died or were hospitalized with COVID-19 pneumonia over 32 weeks (95% CI: 10.2, 11.8). Although relative risks of death or hospitalization with COVID-19 pneumonia were similar across at-risk groups, absolute risk varied when comparing three doses of BNT162b2 with mRNA-1273 (BNT162b2 minus mRNA-1273) between average-risk and high-risk populations, confirmed by the presence of additive interaction. The risk difference of death or hospitalization with COVID-19 pneumonia for high-risk populations was 2.2 (0.9, 3.6). Effects were not modified by predominant viral variant. In this work, the risk of death or hospitalization with COVID-19 pneumonia over 32 weeks was lower among high-risk populations who received three doses of mRNA-1273 vaccine instead of BNT162b2 vaccine; no difference was found among the average-risk population and age >65 sub-group.

Impact of the coronavirus disease-2019 pandemic on Veterans Health Administration Sleep Services.

Objectives: To understand the impact of the coronavirus disease-2019 pandemic on sleep services within the United States Department of Veterans Affairs using separate surveys from "pre-COVID" and pandemic periods. Methods: Data from a pre-pandemic survey (September to November 2019) were combined with data from a pandemic-period survey (August to November 2020) to Veterans Affairs sleep medicine providers about their local sleep services within 140 Veterans Affairs facilities). Results: A total of 67 (47.9%) facilities responded to the pandemic online survey. In-lab diagnostic and titration sleep studies were stopped at 91.1% of facilities during the pandemic; 76.5% of facilities resumed diagnostic studies and 60.8% resumed titration studies by the time of the second survey. Half of the facilities suspended home sleep testing; all facilities resumed these services. In-person positive airway pressure clinics were stopped at 76.3% of facilities; 46.7% resumed these clinics. Video telehealth was either available or in development at 86.6% of facilities and was considered a lasting addition to sleep services. Coronavirus disease-2019 transmission precautions occurred at high rates. Sleep personnel experienced high levels of stress, anxiety, fear, and burnout because of the pandemic and in response to unexpected changes in sleep medicine care delivery. Conclusions: Sleep medicine services within the Veterans Affairs evolved during the pandemic with many key services being interrupted, including in-lab studies and in-person positive airway pressure clinics. Expansion and initiation of telehealth sleep services occurred commonly. The pandemic adversely affected sleep medicine personnel as they sought to maintain access to care.

The impact of the COVID-19 pandemic on blood pressure control after a stroke or transient ischemic attack among patients at VA medical centers.

OBJECTIVE: To study factors associated with systolic blood pressure(SBP) control for patients post-discharge from an ischemic stroke or transient ischemic attack(TIA) during the early months of the COVID-19 pandemic compared to pre-pandemic periods within the Veterans Health Administration(VHA). MATERIALS AND METHODS: We analyzed retrospective data from patients discharged from Emergency Departments or inpatient admissions after an ischemic stroke or TIA. Cohorts consisted of 2,816 patients during March-September 2020 and 11,900 during the same months in 2017-2019. Outcomes included primary care or neurology clinic visits, recorded blood pressure readings and average blood pressure control in the 90-days post-discharge. Random effect logit models were used to compare clinical characteristics of the cohorts and relationships between patient characteristics and outcomes. RESULTS: The majority (73%) of patients with recorded readings during the COVID-19 period had a mean post-discharge SBP within goal (<140 mmHg); this was slightly lower than the pre-COVID-19 period (78%; p=0.001). Only 38% of the COVID-19 cohort had a recorded SBP in the 90-days post-discharge compared with 83% of patients during the pre-pandemic period (p=0.001). During the pandemic period, 29% did not have follow-up primary care or neurologist visits, and 33% had a phone or video visit without a recorded SBP reading. CONCLUSIONS: Patients with an acute cerebrovascular event during the initial COVID-19 period were less likely to have outpatient visits or blood pressure measurements than during the pre-pandemic period; patients with uncontrolled SBP should be targeted for follow-up hypertension management.

Incidence of Severe COVID-19 Illness Following Vaccination and Booster With BNT162b2, mRNA-1273, and Ad26.COV2.S Vaccines.

Importance: Evidence describing the incidence of severe COVID-19 illness following vaccination and booster with BNT162b2, mRNA-1273, and Ad26.COV2.S vaccines is needed, particularly for high-risk populations. Objective: To describe the incidence of severe COVID-19 illness among a cohort that received vaccination plus a booster vaccine dose. Design, Setting, and Participants: Retrospective cohort study of adults receiving care at Veterans Health Administration facilities across the US who received a vaccination series plus 1 booster against SARS-CoV-2, conducted from July 1, 2021, to May 30, 2022. Patients were eligible if they had received a primary care visit in the prior 2 years and had documented receipt of all US Food and Drug Administration-authorized doses of the initial mRNA vaccine or viral vector vaccination series after December 11, 2020, and a subsequent documented booster dose between July 1, 2021, and April 29, 2022. The analytic cohort consisted of 1 610 719 participants. Exposures: Receipt of any combination of mRNA-1273 (Moderna), BNT162b2 (Pfizer-BioNTech), and Ad26.COV2.S (Janssen/Johnson & Johnson) primary vaccination series and a booster dose. Main Outcomes and Measures: Outcomes were breakthrough COVID-19 (symptomatic infection), hospitalization with COVID-19 pneumonia and/or death, and hospitalization with severe COVID-19 pneumonia and/or death. A subgroup analysis of nonoverlapping populations included those aged 65 years or older, those with high-risk comorbid conditions, and those with immunocompromising conditions. Results: Of 1 610 719 participants, 1 100 280 (68.4%) were aged 65 years or older and 132 243 (8.2%) were female; 1 133 785 (70.4%) had high-risk comorbid conditions, 155 995 (9.6%) had immunocompromising conditions, and 1 467 879 (91.1%) received the same type of mRNA vaccine (initial series and booster). Over 24 weeks, 125.0 (95% CI, 123.3-126.8) per 10 000 persons had breakthrough COVID-19, 8.9 (95% CI, 8.5-9.4) per 10 000 persons were hospitalized with COVID-19 pneumonia or died, and 3.4 (95% CI, 3.1-3.7) per 10 000 persons were hospitalized with severe pneumonia or died. For high-risk populations, incidence of hospitalization with COVID-19 pneumonia or death was as follows: aged 65 years or older, 1.9 (95% CI, 1.4-2.6) per 10 000 persons; high-risk comorbid conditions, 6.7 (95% CI, 6.2-7.2) per 10 000 persons; and immunocompromising conditions, 39.6 (95% CI, 36.6-42.9) per 10 000 persons. Subgroup analyses of patients hospitalized with COVID-19 pneumonia or death by time after booster demonstrated similar incidence estimates among those aged 65 years or older and with high-risk comorbid conditions but not among those with immunocompromising conditions. Conclusions and Relevance: In a US cohort of patients receiving care at Veterans Health Administration facilities during a period of Delta and Omicron variant predominance, there was a low incidence of hospitalization with COVID-19 pneumonia or death following vaccination and booster with any of BNT162b2, mRNA-1273, or Ad26.COV2.S vaccines.

Quality of Care and Outcomes for Patients with Acute Ischemic Stroke and Transient Ischemic Attack During the COVID-19 Pandemic.

BACKGROUND AND PURPOSE: Hospitalizations for acute ischemic stroke (AIS) and transient ischemic attack (TIA) decreased during the COVID-19 pandemic. We compared the quality of care and outcomes for patients with AIS/TIA before vs. during the COVID-19 pandemic across the United States Department of Veterans Affairs healthcare system. METHODS: This retrospective cohort study compared AIS/TIA care quality before (March-September 2019) vs. during (March-September 2020) the pandemic. Electronic health record data were used to identify patient characteristics, quality of care and outcomes. The without-fail rate was a composite measure summarizing whether an individual patient received all of the seven processes for which they were eligible. Mixed effects logistic regression modeling was used to assess differences between the two periods. RESULTS: A decrease in presentations occurred during the pandemic (N = 4360 vs. N = 5636 patients; p = 0.003) and was greater for patients with TIA (-30.4%) than for AIS (-18.7%). The without-fail rate improved during the pandemic (56.2 vs. before 50.1%). The use of high/moderate potency statins increased among AIS patients (OR 1.26 [1.06-1.48]) and remained unchanged among those with TIA (OR 1.04 [0.83,1.29]). Blood pressure measurement within 90-days of discharge was less frequent during the pandemic (57.8 vs. 89.2%, p < 0.001). Hypertension control decreased among patients with AIS (OR 0.73 [0.60-0.90]) and TIA (OR 0.72 [0.54-0.96]). The average systolic and diastolic blood pressure was 1.9/1.4 mmHg higher during the pandemic than before (p < 0.001). Compared to before, during the pandemic fewer AIS patients had a primary care visit (52.5% vs. 79.8%; p = 0.0001) or a neurology visit (27.9 vs. 41.1%; p = 0.085). Both 30- and 90-day unadjusted all-cause mortality rates were higher in 2020 (3.6% and 6.7%) vs. 2019 (2.9, 5.4%; p = 0.041 and p = 0.006); but these differences were not statistically significant after risk adjustment. CONCLUSIONS: Overall quality of care for patients with AIS/TIA did not decline during the COVID-19 pandemic.

Association of Social and Behavioral Risk Factors With Mortality Among US Veterans With COVID-19.

Importance: The US Department of Veterans Affairs (VA) offers programs that reduce barriers to care for veterans and those with housing instability, poverty, and substance use disorder. In this setting, however, the role that social and behavioral risk factors play in COVID-19 outcomes is unclear. Objective: To examine whether social and behavioral risk factors were associated with mortality among US veterans with COVID-19 and whether this association might be modified by race/ethnicity. Design, Setting, and Participants: This cohort study obtained data from the VA Corporate Data Warehouse to form a cohort of veterans who received a positive COVID-19 test result between March 2 and September 30, 2020, in a VA health care facility. All veterans who met the inclusion criteria were eligible to participate in the study, and participants were followed up for 30 days after the first SARS-CoV-2 or COVID-19 diagnosis. The final follow-up date was October 31, 2020. Exposures: Social risk factors included housing problems and financial hardship. Behavioral risk factors included current tobacco use, alcohol use, and substance use. Main Outcomes and Measures: The primary outcome was all-cause mortality in the 30-day period after the SARS-CoV-2 or COVID-19 diagnosis date. Multivariable logistic regression was used to estimate odds ratios, clustering for health care facilities and adjusting for age, sex, race, ethnicity, marital status, clinical factors, and month of COVID-19 diagnosis. Results: Among 27 640 veterans with COVID-19 who were included in the analysis, 24 496 were men (88.6%) and the mean (SD) age was 57.2 (16.6) years. A total of 3090 veterans (11.2%) had housing problems, 4450 (16.1%) had financial hardship, 5358 (19.4%) used alcohol, and 3569 (12.9%) reported substance use. Hospitalization occurred in 7663 veterans (27.7%), and 1230 veterans (4.5%) died. Housing problems (adjusted odds ratio [AOR], 0.96; 95% CI, 0.77-1.19; P = .70), financial hardship (AOR, 1.13; 95% CI, 0.97-1.31; P = .11), alcohol use (AOR, 0.82; 95% CI, 0.68-1.01; P = .06), current tobacco use (AOR, 0.85; 95% CI, 0.68-1.06; P = .14), and substance use (AOR, 0.90; 95% CI, 0.71-1.15; P = .41) were not associated with higher mortality. Interaction analyses by race/ethnicity did not find associations between mortality and social and behavioral risk factors. Conclusions and Relevance: Results of this study showed that, in an integrated health system such as the VA, social and behavioral risk factors were not associated with mortality from COVID-19. Further research is needed to substantiate the potential of an integrated health system to be a model of support services for households with COVID-19 and populations who are at risk for the disease.

Heterogeneity in COVID-19 patient volume, characteristics and outcomes across US Department of Veterans Affairs facilities: an observational cohort study.

OBJECTIVE: Studies describe COVID-19 patient characteristics and outcomes across populations, but reports of variation across healthcare facilities are lacking. The objectives were to examine differences in COVID-19 patient volume and mortality across facilities, and understand whether facility variation in mortality was due primarily to differences in patient versus facility characteristics. DESIGN: Observational cohort study with multilevel mixed effects logistic regression modelling. SETTING: The Veterans Health Administration (VA) is the largest healthcare system in the USA. PARTICIPANTS: Patients with COVID-19. MAIN OUTCOME: All-cause mortality within 45 days after COVID-19 testing (March-May, follow-up through 16 July 2020). RESULTS: Among 13 510 patients with COVID-19, 3942 (29.2%) were admitted (2266/3942 (57.5%) ward; 1676/3942 (42.5%) intensive care unit (ICU)) and 679/3942 (17.2%) received mechanical ventilation. Marked heterogeneity was observed across facilities in median age (range: 34.3-83.9 years; facility mean: 64.7, SD 7.2 years); patient volume (range: 1-737 at 160 facilities; facility median: 48.5, IQR 14-105.5); hospital admissions (range: 1-286 at 133 facilities; facility median: 11, IQR 1-26.5); ICU caseload (range: 1-85 at 115 facilities; facility median: 4, IQR 0-12); and mechanical ventilation (range: 1-53 at 90 facilities; facility median: 1, IQR 0-5). Heterogeneity was also observed in facility mortality for all patients with COVID-19 (range: 0%-29.7%; facility median: 8.9%, IQR 2.4%-13.7%); inpatients (range: 0%-100%; facility median: 18.0%, IQR 5.6%-28.6%); ICU patients (range: 0%-100%; facility median: 28.6%, IQR 14.3%-50.0%); and mechanical ventilator patients (range: 0%-100%; facility median: 52.7%, IQR 33.3%-80.6%). The majority of variation in facility mortality was attributable to differences in patient characteristics (eg, age). CONCLUSIONS: Marked heterogeneity in COVID-19 patient volume, characteristics and mortality were observed across VA facilities nationwide. Differences in patient characteristics accounted for the majority of explained variation in mortality across sites. Variation in unadjusted COVID-19 mortality across facilities or nations should be considered with caution.

Association of Intensive Care Unit Patient Load and Demand With Mortality Rates in US Department of Veterans Affairs Hospitals During the COVID-19 Pandemic.

Importance: Although strain on hospital capacity has been associated with increased mortality in nonpandemic settings, studies are needed to examine the association between coronavirus disease 2019 (COVID-19) critical care capacity and mortality. Objective: To examine whether COVID-19 mortality was associated with COVID-19 intensive care unit (ICU) strain. Design, Setting, and Participants: This cohort study was conducted among veterans with COVID-19, as confirmed by polymerase chain reaction or antigen testing in the laboratory from March through August 2020, cared for at any Department of Veterans Affairs (VA) hospital with 10 or more patients with COVID-19 in the ICU. The follow-up period was through November 2020. Data were analyzed from March to November 2020. Exposures: Receiving treatment for COVID-19 in the ICU during a period of increased COVID-19 ICU load, with load defined as mean number of patients with COVID-19 in the ICU during the patient's hospital stay divided by the number of ICU beds at that facility, or increased COVID-19 ICU demand, with demand defined as mean number of patients with COVID-19 in the ICU during the patient's stay divided by the maximum number of patients with COVID-19 in the ICU. Main Outcomes and Measures: All-cause mortality was recorded through 30 days after discharge from the hospital. Results: Among 8516 patients with COVID-19 admitted to 88 VA hospitals, 8014 (94.1%) were men and mean (SD) age was 67.9 (14.2) years. Mortality varied over time, with 218 of 954 patients (22.9%) dying in March, 399 of 1594 patients (25.0%) dying in April, 143 of 920 patients (15.5%) dying in May, 179 of 1314 patients (13.6%) dying in June, 297 of 2373 patients (12.5%) dying in July, and 174 of 1361 (12.8%) patients dying in August (P < .001). Patients with COVID-19 who were treated in the ICU during periods of increased COVID-19 ICU demand had increased risk of mortality compared with patients treated during periods of low COVID-19 ICU demand (ie, demand of ≤25%); the adjusted hazard ratio for all-cause mortality was 0.99 (95% CI, 0.81-1.22; P = .93) for patients treated when COVID-19 ICU demand was more than 25% to 50%, 1.19 (95% CI, 0.95-1.48; P = .13) when COVID-19 ICU demand was more than 50% to 75%, and 1.94 (95% CI, 1.46-2.59; P < .001) when COVID-19 ICU demand was more than 75% to 100%. No association between COVID-19 ICU demand and mortality was observed for patients with COVID-19 not in the ICU. The association between COVID-19 ICU load and mortality was not consistent over time (ie, early vs late in the pandemic). Conclusions and Relevance: This cohort study found that although facilities augmented ICU capacity during the pandemic, strains on critical care capacity were associated with increased COVID-19 ICU mortality. Tracking COVID-19 ICU demand may be useful to hospital administrators and health officials as they coordinate COVID-19 admissions across hospitals to optimize outcomes for patients with this illness.