Search

Azithromycin is a common first-line antibiotic for respiratory infection; however, there is conflicting evidence regarding risk of cardiovascular death. We assessed cardiovascular and noncardiovascular mortality associated with azithromycin versus amoxicillin-clavulanate among US Veterans treated for nonear-nose-throat respiratory infection ("respiratory") or ear-nose-throat infection indication.Electronic health record data from the US Veterans Health Administration database were used to identify Veterans (30-74 years) with outpatient dispensings of oral azithromycin versus amoxicillin-clavulanate for respiratory or ear-nose-throat infection (January 01, 2000-December 31, 2014). Outcomes assessed were risk of cardiovascular death and noncardiovascular death within 1-5 and 6-10 days postdispensing. Inverse probability of treatment-weighted proportional hazards models and binomial regression models were used to estimate hazard ratios (HRs) and compute risk differences (RD) per million courses of therapy. Cardiac death (subset of cardiovascular death) was assessed in sensitivity analyses.There were 629 345 azithromycin and 168 429 amoxicillin-clavulanate dispensings for respiratory indications, 143 783 azithromycin, and 203 142 amoxicillin-clavulanate dispensings for ear-nose-throat indications. For respiratory indications, azithromycin was not associated with a significantly different risk of cardiovascular death versus amoxicillin-clavulanate within 1-5 days postdispensing (HR [95% confidence interval (CI)]: 1.12 [0.63, 2.00]; RD [95% CI]: 11 [-43, 64] deaths/million courses of therapy). No elevated risk for azithromycin was found for ear-nose-throat indications. Pooled results for both indications via meta-analysis showed no association between antibiotics and cardiovascular mortality. There was no significant difference in risk of noncardiovascular or cardiac death between antibiotics postdispensing.Azithromycin was not associated with elevated risk of cardiovascular or noncardiovascular death versus amoxicillin-clavulanate among US Veterans.

To compare treatment patterns of United States (US) veterans stable on innovator infliximab (IFX) who switched to an IFX biosimilar (switchers) or remained on innovator IFX (continuers).US Veterans Healthcare Administration data (01/2012-12/2019) were used to identify adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), or Crohn's disease and ulcerative colitis (i.e. inflammatory bowel disease [IBD]), treated with innovator or biosimilar IFX. Index date was the first IFX biosimilar administration for switchers or a random innovator IFX administration for continuers. Patients were required to have ≥5 innovator IFX administrations during the 12 months pre-index (prevalent population). Patients with ≥12 months of observation prior to the first innovator IFX administration were analyzed as the primary population (incident population), and data were assessed from start of innovator IFX. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. Treatment patterns were evaluated post-index; continuers were censored before switching to IFX biosimilar. Discontinuation was defined as switching to another biologic (including innovator IFX) or having ≥120 days between 2 consecutive index treatment records.In the incident population, mean [median] duration of follow-up was 737 [796] days among switchers (Patients switching from innovator to biosimilar IFX were more likely to discontinue treatment and switch to another innovator biologic (notably back to innovator IFX) than those remaining on innovator IFX; however, reasons for discontinuation and switching are unknown.

Objectives We explored factors related to testing positive for severe acute respiratory coronavirus 2 (SARS-CoV-2) to identify populations most at risk for this airborne pathogen. Methods Data were abstracted from the medical record database of the U.S. Department of Veterans Affairs and from public sources. Veterans testing positive were matched in a 1:4 ratio to those at a similar timepoint and local disease burden who remained negative between March 1, 2020, and December 31, 2020. Multivariable logistic regression was used to calculate odds ratios for the association of each potential risk factor with a positive test result. Results A total of 24,843 veterans who tested positive for SARS-CoV-2 were matched with 99,324 controls. Cases and controls were similar in age, sex, ethnicity, and rurality, but cases were more likely to be Black, reside in low-income counties, and suffer from dementia. Multivariable analysis demonstrated highest risk for Black veterans, those with dementia or diabetes, and those living in nursing homes or high-poverty areas. Veterans living in counties likely to be more adherent to public health guidelines were at the lowest risk. Conclusions Our results are similar to those from studies of other populations and add to that work by accounting for several important proxies for risk. In particular, this work has implications for the value of infection control measures at the population level in helping to stem widespread outbreaks of this type.

BackgroundData on effectiveness of sotrovimab preventing COVID-19-related hospitalization or mortality, particularly after the emergence of the Omicron variant, are limited.MethodDetermine the real-world clinical effectiveness of sotrovimab for prevention of 30-day COVID-19 related hospitalization or mortality using a retrospective cohort within the U.S. Department of Veterans Affairs (VA) healthcare system.Veterans aged ≥18 years, diagnosed with COVID-19 between December 1, 2021, and April 4, 2022, were included. Sotrovimab recipients (n=2,816) were exactly matched to untreated controls (n=11,250) on date of diagnosis, vaccination status, and region.The primary outcome was COVID-19-related hospitalization or all-cause mortality within 30 days from diagnosis. Cox proportional hazards modeling estimated the hazard ratios (HR) and 95% Confidence Interval (CI) for the association between receipt of sotrovimab and outcomes.ResultsDuring BA.1 dominance, compared to matched controls, sotrovimab-treated patients had a 70% lower risk hospitalization within 30 days or mortality (HR 0.30; 95%CI, 0.23-0.40), a 66% lower risk of 30-day hospitalization (HR 0.34; 95%CI, 0.25-0.46), and a 77% lower risk of 30-day all-cause mortality (HR 0.23; 95%CI, 0.14-0.38). During BA.2 dominance sotrovimab-treated patients had a 71% (HR .29; 95%CI, 0.08-0.98) lower risk of 30-day COVID-19-related-hospitalization, emergency, or urgent care. Limitations include confounding by indication.ConclusionsUsing national real-world data from high risk and predominantly vaccinated Veterans, administration of sotrovimab, compared with no treatment, was associated with reduced risk of 30-day COVID-19-related hospitalization or all-cause mortality during the Omicron BA.1 period and reduced risk of progression to severe COVID-19 during the BA.2 dominant period.SummaryExamination of national real-world evidence demonstrates sotrovimab is effective in preventing at risk positive COVID-19 cases from progressing to severe SARS-CoV-2 infections compared to matched untreated cases during Delta and early Omicron variant waves in the U.S. Veteran population.

ImportanceThe COVID-19 pandemic had a substantial impact on the overall rate of death in the United States during the first year. It is unclear whether access to comprehensive medical care, such as through the VA healthcare system, altered death rates compared to the US population.ObjectiveQuantify the increase in death rates during the first year of the COVID-19 pandemic in the general US population and among individuals who receive comprehensive medical care through the Department of Veterans Affairs (VA).DesignAnalysis of changes in all-cause death rates by quarter, stratified by age, sex race/ethnicity, and region, based on individual-level data. Hierarchical regression models were fit in a Bayesian setting. Standardized rates were used for comparison between populations.Setting and participantsGeneral population of the United States, enrollees in the VA, and active users of VA healthcare.Exposure and main outcomeChanges in rates of death from any cause during the COVID-19 pandemic in 2020 compared to previous years.ResultsSharp increases were apparent across all of the adult age groups (25 years and older) in both the general US population and the VA populations. Across all of 2020, the relative increase in death rates was similar in the general US population (RR: 1.20 (95% CI: 1.17, 1.22)), VA enrollees (RR: 1.20 (95% CI: 1.14, 1.29)), and VA active users (RR: 1.19 (95% CI: 1.14, 1.26)). Because the pre-pandemic 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 RelevanceDespite access to comprehensive medical care, active users of the VA had similar relative mortality increases from all causes compared with the general US population. Factors that influenced baseline rates of death and that mitigated viral transmission in the community are more likely to have influenced the impact of the pandemic.

ObjectiveTo estimate the effectiveness of messenger RNA (mRNA) booster doses during the period of Delta and Omicron variant dominance.DesignWe conducted a matched test-negative case–control study to estimate the vaccine effectiveness (VE) of three and two doses of mRNA vaccines against infection (regardless of symptoms) and against COVID-19-related hospitalisation and death.SettingVeterans Health Administration.ParticipantsWe used electronic health record data from 114 640 veterans who had a SARS-CoV-2 test during November 2021–January 2022. Patients were largely 65 years or older (52%), male (88%) and non-Hispanic white (59%).Main outcome measuresFirst positive result for a SARS-CoV-2 PCR or antigen test.ResultsAgainst infection, booster doses had higher estimated VE (64%, 95% CI 63 to 65) than two-dose vaccination (12%, 95% CI 10 to 15) during the Omicron period. For the Delta period, the VE against infection was 90% (95% CI 88 to 92) among boosted vaccinees, higher than the VE among two-dose vaccinees (54%, 95% CI 50 to 57). Against hospitalisation, booster dose VE was 89% (95% CI 88 to 91) during Omicron and 94% (95% CI 90 to 96) during Delta; two-dose VE was 63% (95% CI 58 to 67) during Omicron and 75% (95% CI 69 to 80) during Delta. Against death, the VE with a booster dose was 94% (95% CI 90 to 96) during Omicron and 96% (95% CI 87 to 99) during Delta.ConclusionsAmong an older, mostly male, population with comorbidities, we found that an mRNA vaccine booster was highly effective against infection, hospitalisation and death. Although the effectiveness of booster vaccination against infection was moderately higher against Delta than against the Omicron SARS-CoV-2 variant, effectiveness against severe disease and death was similarly high against both variants.

Objectives To determine the association between covid-19 vaccination types and doses with adverse outcomes of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection during the periods of delta (B.1.617.2) and omicron (B.1.1.529) variant predominance. Design Retrospective cohort. Setting US Veterans Affairs healthcare system. Participants Adults (≥18 years) who are affiliated to Veterans Affairs with a first documented SARS-CoV-2 infection during the periods of delta (1 July-30 November 2021) or omicron (1 January-30 June 2022) variant predominance. The combined cohorts had a mean age of 59.4 (standard deviation 16.3) and 87% were male. Interventions Covid-19 vaccination with mRNA vaccines (BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna)) and adenovirus vector vaccine (Ad26.COV2.S (Janssen/Johnson & Johnson)). Main outcome measures Stay in hospital, intensive care unit admission, use of ventilation, and mortality measured 30 days after a positive test result for SARS-CoV-2. Results In the delta period, 95 336 patients had infections with 47.6% having at least one vaccine dose, compared with 184 653 patients in the omicron period, with 72.6% vaccinated. After adjustment for patient demographic and clinical characteristics, in the delta period, two doses of the mRNA vaccines were associated with lower odds of hospital admission (adjusted odds ratio 0.41 (95% confidence interval 0.39 to 0.43)), intensive care unit admission (0.33 (0.31 to 0.36)), ventilation (0.27 (0.24 to 0.30)), and death (0.21 (0.19 to 0.23)), compared with no vaccination. In the omicron period, receipt of two mRNA doses were associated with lower odds of hospital admission (0.60 (0.57 to 0.63)), intensive care unit admission (0.57 (0.53 to 0.62)), ventilation (0.59 (0.51 to 0.67)), and death (0.43 (0.39 to 0.48)). Additionally, a third mRNA dose was associated with lower odds of all outcomes compared with two doses: hospital admission (0.65 (0.63 to 0.69)), intensive care unit admission (0.65 (0.59 to 0.70)), ventilation (0.70 (0.61 to 0.80)), and death (0.51 (0.46 to 0.57)). The Ad26.COV2.S vaccination was associated with better outcomes relative to no vaccination, but higher odds of hospital stay and intensive care unit admission than with two mRNA doses. BNT162b2 was generally associated with worse outcomes than mRNA-1273 (adjusted odds ratios between 0.97 and 1.42). Conclusions In veterans with recent healthcare use and high occurrence of multimorbidity, vaccination was robustly associated with lower odds of 30 day morbidity and mortality compared with no vaccination among patients infected with covid-19. The vaccination type and number of doses had a significant association with outcomes.

ImportanceDuring 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.ObjectiveTo 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 ParticipantsThis 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 MeasuresChanges 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.ResultsThere 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 RelevanceIn 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.

BackgroundLittle is known regarding the effectiveness of tixagevimab/cilgavimab in preventing SARS-CoV-2 infection in this population, particularly after the emergence of the Omicron variant.ObjectiveTo determine the effectiveness of tixagevimab/cilgavimab for prevention of SARS-CoV-2 infection and severe disease among immunocompromised patients.DesignRetrospective cohort study with propensity matching and difference-in-difference analyses.SettingU.S. Department of Veterans Affairs (VA) healthcare system.ParticipantsVeterans age ≥18 years as of January 1, 2022, receiving VA healthcare. We compared a cohort of 1,848 patients treated with at least one dose of intramuscular tixagevimab/cilgavimab to matched controls selected from 251,756 patients who were on immunocompromised or otherwise at high risk for COVID-19. Patients were followed through April 30, 2022, or until death, whichever occurred earlier.Main OutcomesComposite of SARS-CoV-2 infection, COVID-19-related hospitalization, and all-cause mortality. We used cox proportional hazards modelling to estimate the hazard ratios (HR) and 95% CI for the association between receipt of tixagevimab/cilgavimab and outcomes.ResultsMost (69%) tixagevimab/cilgavimab recipients were ≥65 years old, 92% were identified as immunocompromised in electronic data, and 73% had ≥3 mRNA vaccine doses or two doses of Ad26.COV2. Compared to propensity-matched controls, tixagevimab/cilgavimab-treated patients had a lower incidence of the composite COVID-19 outcome (17/1733 [1.0%] vs 206/6354 [3.2%]; HR 0.31; 95%CI, 0.18-0.53), and individually SARS-CoV-2 infection (HR 0.34; 95%CI, 0.13-0.87), COVID-19 hospitalization (HR 0.13; 95%CI, 0.02-0.99), and all-cause mortality (HR 0.36; 95%CI, 0.18-0.73).LimitationsConfounding by indication and immortal time bias.ConclusionsUsing national real-world data from predominantly vaccinated, immunocompromised Veterans, administration of tixagevimab/cilgavimab was associated with lower rates of SARS-CoV-2 infection, COVID-19 hospitalization, and all-cause mortality during the Omicron surge.

Objective To evaluate the effect of a pre-existing posttraumatic stress disorder (PTSD) diagnosis on suicide and non-suicide mortality among men with newly diagnosed prostate cancer, and examine potential mediating factors for the relationship between PTSD and suicide. Methods We used patient-level data from Veterans Health Administration electronic medical records to identify men (age ≥40 years) diagnosed with prostate cancer between 2004-2014. We used Fine and Gray regression to estimate risk for competing mortality outcomes (suicide, non-suicide, alive). We used structural equation models to evaluate mediating factors. Results Our cohort comprised 214,649 men with prostate cancer, of whom 12,208 (5.7%) had a pre-existing PTSD diagnosis. Patients with PTSD compared to those without utilized more health care services and had lower risk cancer at diagnosis. Additionally, they experienced more suicide deaths (N=26, 0.21% vs. N=269, 0.13%) and fewer non-suicide deaths (N=1,399, 11.5% vs. N=45,625, 22.5%). On multivariable analysis, PTSD was an independent suicide risk factor (HR=2.35; 95% CI: 1.16, 4.78). Depression, substance use disorder, and any definitive prostate cancer treatment were partial mediators. However, PTSD was associated with lower non-suicide mortality risk (HR=0.86; 95% CI: 0.77, 0.96). Conclusion Patients with PTSD experienced greater suicide risk even after adjusting for important mediators. They may have experienced lower non-suicide mortality risk due to favorable physical health resulting from greater health care service use and early diagnosis of lower risk cancer. Our findings highlight the importance of considering psychiatric illnesses when treating patients with prostate cancer and the need for interventions to ameliorate suicide risk. This article is protected by copyright. All rights reserved.

OBJECTIVES Applying high-reliability organization (HRO) principles to health care is complex. No consensus exists as to an effective framework for HRO implementation or the direct impact of adoption. METHODS The Veterans Health Administration (VHA) National Center for Patient Safety established the high-reliability hospital (HRH) model for HRO adoption and piloted HRH in collaboration with the Truman VA Medical Center (Truman) during a 3-year intervention period (January 1, 2016-December 31, 2018). High-reliability hospital components are as follows: annual patient safety (PS) assessment, annual PS culture survey, annual root cause analysis training, daily leadership walk-arounds, monthly PS forum, annual processes standardization review, Just Culture training, unit-based Clinical Team Training, unit-based continuous improvement projects, and annual Clinical Team Training simulation education. The impact of HRH was examined using a PS Culture Survey, PS event reporting, and quality outcomes of standardized mortality rate and complication rate. RESULTS Truman internally improved PS culture and PS event reporting rates resulting in outcomes better than all VHA facilities (All VHA; P < 0.001 and P < 0.001, respectively). Low-harm PS event reporting increased (P < 0.001); however, serious safety event rate remained unchanged versus All VHA. Significant improvement in Truman standardized mortality rate and complication rate versus All VHA occurred immediately and were sustained through intervention (slopes, P < 0.001 and P < 0.020; respectively). CONCLUSIONS High-reliability hospital is an effective framework for HRO implementation and will be applied to 18 additional VHA sites. Based on these results, the expected outcome will be improved PS culture and overall PS event reporting. The impact of HRH on serious safety event rate and quality measures requires further study.

INTRODUCTION To provide up-to-date data on fall prevalence and trends in Veterans Health Administration (VHA) hospitals. METHODS Data were collected by the VHA Inpatient Evaluation Center (IPEC) between 2011 and 2017, to establish prevalence and trends of falls and major injuries occurring in acute care/intensive care units (AC/ICU), behavior health (BH), and community living center (CLC)/long-term care, using bed days of care (BDOC) as denominators. RESULTS A total of 204,681 falls were reported (rate = 4.8 falls/1,000 BDOC) during the study period, of which 2,549 (1.2%) resulted in a major injury (rate = 6.0/100,000 BDOC). Fall rates decreased over the 6-year study period for all unit types: 10% decrease for BH (p < .0001), 9% decrease for AC/ICU (p < .0001), and 3% decrease for CLC (p = .0043). Major injury rates remained consistent. CONCLUSIONS In this large descriptive study, fall and major injury rates varied by nursing unit type in VHA hospitals. Over the 6-year study period, a clinically and statistically significant decrease in fall rates for BH and AC/ICU units was observed as well as a small but statistically significant decrease in fall rates for CLC units. No trend was observed for major injury rates.

ImportancePrevious studies have analyzed effectiveness of booster mRNA Covid-19 vaccination and compared it with 2-dose primary series for both Delta and Omicron variants. Observational studies that estimate effectiveness by comparing outcomes among vaccinated and unvaccinated individuals may suffer from residual confounding and exposure misclassification.ObjectiveTo estimate relative effectiveness of booster vaccination versus the 2-dose primary series with self-controlled study designDesign, Setting and ParticipantsWe used the Veterans Health Administration (VHA) Corporate Data Warehouse to identify U.S. Veterans enrolled in care ≥2 years who received the 2-dose primary mRNA Covid-19 vaccine series and a mRNA Covid-19 booster following expanded recommendation for booster vaccination, and who had a positive SARS-CoV-2 test during the Delta (9/23/2021-11/30/2021) or Omicron (1/1/22-3/1/22) predominant period. Among them, we conducted a self-controlled risk interval (SCRI) analysis to compare odds of SARS-CoV-2 infection during a booster exposure interval versus a control interval.Exposurescontrol interval (days 4-6 post-booster vaccination, presumably prior to gain of booster immunity), and booster exposure interval (days 14-16 post-booster vaccination, presumably following gain of booster immunity)Outcomes and MeasuresPositive PCR or antigen SARS-CoV-2 test. Separately for Delta and Omicron periods, we used conditional logistic regression to calculate odds ratios (OR) of a positive test for the booster versus control interval and calculated relative effectiveness of booster versus 2-dose primary series as (1-OR)*100. The SCRI approach implicitly controlled for time-fixed confounders.ResultsWe found 42 individuals with a positive SARS-CoV-2 test in the control interval and 14 in the booster exposure interval during Delta period, and 137 and 66, respectively, in Omicron period. For the booster versus 2-dose primary series, the odds of infection were 70% (95%CI: 42%, 84%) lower during the Delta period and 56% (95%CI: 38%, 67%) lower during Omicron. Results were similar for ages ConclusionsBooster vaccination was more effective relative to a 2-dose primary series, the relative effectiveness was consistent across age groups and was higher during the Delta predominant period than during the Omicron period.

Key Points Question What was the COVID-19 vaccination coverage and estimated mRNA COVID-19 vaccine effectiveness (VE) among US veterans in the first 3 months following vaccine rollout? Findings In this case-control study including 6 647 733 veterans, 23% of veterans received at least 1 COVID-19 vaccination during the first 3 months of vaccine rollout. VE against infection was estimated to be 95% for full vaccination; estimated VE against COVID-19-related hospitalization was 91%, and there were no COVID-19–related deaths among fully vaccinated veterans. Meaning These findings suggest that early vaccination rollout for veterans was efficient, and estimated VE was high for this diverse US population., This case-control study describes the scope of the mRNA COVID-19 vaccination rollout and estimates the association between vaccination and reductions in SARS-CoV-2 infections among veterans during the first 3 months of vaccine rollout., Importance Effectiveness of mRNA vaccinations in a diverse older population with high comorbidity is unknown. Objectives To describe the scope of the COVID-19 vaccination rollout among US veterans, and to estimate mRNA COVID-19 vaccine effectiveness (VE) as measured by rates of SARS-CoV-2 infection. Design, Setting, and Participants This matched test–negative case-control study was conducted using SARS-CoV-2 test results at Veterans Health Administration sites from December 14, 2020, to March 14, 2021. Vaccine coverage was estimated for all veterans. VE against SARS-CoV-2 infection and COVID-19–related hospitalization and death were estimated using electronic health records from veterans who routinely sought care at a VHA facility and had a test result positive for SARS-CoV-2 (cases) or negative for SARS-CoV-2 (controls). Cases and controls were matched on time of test and geographic region. Data were analyzed from May to July 2021. Exposures Vaccination status, defined as unvaccinated, partially vaccinated (≥14 days after first dose until second dose), or fully vaccinated (≥14 days after second dose), at time of test. Main Outcomes and Measures The main outcome of interest was a positive result for SARS-CoV-2 on a polymerase chain reaction or antigen test. Secondary outcomes included COVID-19–related hospitalization and death, defined by discharge data and proximity of event to positive test result. VE was estimated from odds ratios for SARS-CoV-2 infection with 95% CIs. Results Among 6 647 733 veterans included (3 350 373 veterans [50%] aged ≥65 years; 6 014 798 [90%] men and 632 935 [10%] women; 461 645 Hispanic veterans of any race [7%], 1 102 471 non-Hispanic Black veterans [17%], and 4 361 621 non-Hispanic White veterans [66%]), 1 363 180 (21%) received at least 1 COVID-19 vaccination by March 7, 2021. In this period, during which the share of SARS-CoV-2 variants Alpha, Epsilon, and Iota had started to increase in the US, estimates of COVID-19 VE against infection, regardless of symptoms, was 95% (95% CI, 93%-96%) for full vaccination and 64% (95% CI, 59%-68%) for partial vaccination. Estimated VE against COVID-19–related hospitalization for full vaccination was 91% (95% CI 83%-95%); there were no deaths among veterans who were fully vaccinated. VE against infection was similar across subpopulations (non-Hispanic Black, 94% [95% CI, 88%-97%]; Hispanic [any race], 83% [95% CI, 45%-95%]; non-Hispanic White, 92% [95% CI 88%-94%]; rural, 94% [95% CI, 89%-96%]; urban, 93% 95% CI, 89%-95%]). Conclusions and Relevance For veterans of all racial and ethnic subgroups living in urban or rural areas, mRNA vaccination was associated with substantially decreased risk of COVID-19 infection and hospitalization, with no deaths among fully vaccinated veterans.

BackgroundWith over 40 million cases of SARS-CoV-2 infection reported in the US and discussion of both vaccine mandates as well as boosters ongoing, we aim to examine protection conferred by previous infection compared with vaccination so that citizens and policy makers can make informed decisions.ObjectivesTo compare mRNA COVID-19 vaccine-induced immunity against immunity induced by previous infection with SARS-CoV-2 between June and August 2021 when the Delta variant became dominant in the US.We conducted a retrospective observational study comparing two groups whose incident vaccination or infection occurred within the first two months of 2021: (1) SARS-CoV-2-naive individuals who received a full mRNA vaccination - 2 doses of either Pfizer or Moderna vaccine, (2) newly infected individuals who were subdivided into those have not been vaccinated and those have been vaccinated after their infection. Matched multivariable Cox proportional hazards model was applied. We evaluated laboratory (RT-PCR) confirmed SARS-CoV-2 infection during follow-up, COVID-related hospitalization, and deaths.SettingVeterans Health Administration (VHA).Main outcomesPositive SARS-CoV-2 PCR test, COVID-related hospitalization, and deaths. Protection was estimated from hazard ratios with 95% confidence intervals (CI).ResultsA total of 9,539 patients with SARS-CoV-2 infection during the first two months of 2021 were matched to 14,458 and 23,105 patients fully vaccinated with Moderna and Pfizer mRNA vaccines, during the same two months. 3,917 (41%) of patients with SARS-CoV-2 infection were subsequently vaccinated. We plan to study this group separately. Consequently, protections were estimated among those with infection but were not subsequently vaccinated and those vaccinated with a mRNA vaccine. Among seniors, Moderna and Pfizer mRNA vaccines offered stronger protection against infection, lowering the risk by an additional 66% [HR: 0.34 (95% CI, 0.14-0.78)] and 68% [HR: 0.32 (95% CI, 0.14-0.70)]; stronger protection against hospitalization, lowering the risk by an additional 61% [HR: 0.34 (95% CI, 0.14-0.78)] and 45% [HR: 0.34 (95% CI, 0.14-0.78)]; and stronger protection against deaths lowering the risk by an additional 95% [HR: 0.05 (95% CI, 0.004-0.62)] and 99% [HR: 0.01 (95% CI, 0.001-0.44)]. Among young adults (age < 65), the protections offered by vaccines were statistically equivalent to that provided by previous infection, especially in terms of absolute incidence rate.ConclusionsAmong the elderly (age 65 or older), two-dose mRNA vaccines provided stronger protection against infection, hospitalization, and death, compared to natural immunity. Among young adults (age < 65), the protections offered between natural immunity and vaccine-induced immunity were similar.

A Taiwanese cohort study found that symptomatic herpes simplex virus (HSV) infection was associated with a threefold increased risk of developing dementia; however, antiherpetic medication reduced the risk by 90%. Our aim was to verify and further investigate this finding in the US Veteran population using comprehensive electronic medical records from the Veterans Health Administration (VHA). Eighty-seven thousand six hundred eighty-seven Veterans aged 50 or older with symptomatic HSV-1/HSV-2 infection and 217,895 matched controls were identified in VHA data between January 1, 2001, and December 31, 2014, and followed until December 31, 2019. International Classification of Diseases (ICD) codes, ninth and tenth revisions, were used to define dementia. To define HSV infection, we utilized VHA data on antiherpetic medications and laboratory tests in addition to ICD codes. Cox proportional hazards models were used to analyze the effects of HSV infection and antiherpetic medication on the risk of developing dementia. The analysis revealed an adjusted HR of 0.80 (95% CI, 0.78–0.83) for the development of dementia among those with symptomatic HSV relative to those without. Among the 61,776 HSV-1/HSV-2 patients who were treated with antiherpetic medication, 4836 patients (7.8%) developed dementia (adjusted HR = 0.75; 95% CI, 0.72–0.78); this translated to a population average of one additional year of being dementia free in those who were taking antiherpetic medication. In contrast to Tzeng et al. we did not find that HSV infection was associated with an increased risk of dementia. Like their findings, we found that antiherpetic medication was associated with a protective effect against dementia. Future prospective studies are needed to further investigate this effect. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13311-021-01084-9.

Background Unmeasured confounders are commonplace in observational studies conducted using real-world data. Prior event rate ratio (PERR) adjustment is a technique shown to perform well in addressing such confounding. However, it has been demonstrated that, in some circumstances, the PERR method actually increases rather than decreases bias. In this work, we seek to better understand the robustness of PERR adjustment. Methods We begin with a Bayesian network representation of a generalized observational study, which is subject to unmeasured confounding. Previous work evaluating PERR performance used Monte Carlo simulation to calculate joint probabilities of interest within the study population. Here, we instead use a Bayesian networks framework. Results Using this streamlined analytic approach, we are able to conduct probabilistic bias analysis (PBA) using large numbers of combinations of parameters and thus obtain a comprehensive picture of PERR performance. We apply our methodology to a recent study that used the PERR in evaluating elderly-specific high-dose (HD) influenza vaccine in the US Veterans Affairs population. That study obtained an HD relative effectiveness of 25% (95% CI: 2%-43%) against influenza- and pneumonia-associated hospitalization, relative to standard-dose influenza vaccine. In this instance, we find that the PERR-adjusted result is more like to underestimate rather than to overestimate the relative effectiveness of the intervention. Conclusions Although the PERR is a powerful tool for mitigating the effects of unmeasured confounders, it is not infallible. Here, we develop some general guidance for when a PERR approach is appropriate and when PBA is a safer option.

Aims: To reduce preventable falls and fall related injuries in State Veterans Homes (SVHs), we conducted a virtual breakthrough series (VBTS) quality improvement collaborative.Methods: Participatin...

Objective To compare the economic impact of high-dose trivalent (HD) versus standard-dose trivalent (SD) influenza vaccination on direct medical costs for cardio-respiratory hospitalizations in adults aged 65 years or older enrolled in the United States (US) Veteran’s Health Administration (VHA). Methods Leveraging a relative vaccine effectiveness study of HD versus SD over five respiratory seasons (2010/11 through 2014/15), we collected cost data for healthcare provided to the same study population both at VHA and through Medicare services. Our economic assessment compared the costs of vaccination and hospital care for patients experiencing acute cardio-vascular or respiratory illness. Results We analyzed 3.5 million SD and 158,636 HD person-seasons. The average cost of HD and SD vaccination was $23.48 (95% CI: $21.29 - $25.85) and $12.21 (95% CI: $11.49 - $13.00) per recipient, respectively, while the hospitalization rates for cardio-respiratory disease in HD and SD recipients were 0.114 (95% CI: 0.108–0.121) and 0.132 (95% CI: 0.132–0.133) per person-season, respectively. Attributing the average cost per hospitalization of $11,796 (95% CI: $11,685 - $11,907) to the difference in hospitalization rates, we estimated savings attributable to HD to be $202 (95% CI: $115 – $280) per vaccinated recipient. Conclusions For the five-season period of 2010/11 through 2014/15, HD influenza vaccination was associated with net cost savings due to fewer hospitalizations, and therefore lower direct medical costs, for cardio-respiratory disease as compared to SD influenza vaccination in the senior US VHA population.

Importance The scope of vaccination rollout and effectiveness of mRNA SARS-CoV-2 vaccines in the United States (US), and US Veterans specifically, has not been fully assessed. Objective To estimate receipt of SARS-CoV-2 vaccines, and vaccine effectiveness (VE) against SARS-CoV-2 infection, subsequent disease-related severity and mortality. Design, Setting, and Participants First, receipt of any SARS-CoV-2 vaccine by March 7, 2021 was described for all enrolled and alive Veterans within the Veterans Health Administration (VHA). Second, to evaluate mRNA SARS-CoV-2 VE, a matched test negative case-control evaluation was conducted across all VHA facilities utilizing SARS-CoV-2 positive (cases [n=16,690]) and negative (controls [n=61,610]) tests from Veterans aged ≥18 years old who routinely sought care at a VHA facility and were tested for SARS-CoV-2 from December 14, 2020, through March 14, 2021. Exposures Vaccination histories were obtained from pharmacy and medical records to determine if patients were unvaccinated, partially vaccinated (from 7 days after first dose until day of second dose of mRNA SARS-CoV-2 vaccine), or fully vaccinated (from 7 days after second dose of mRNA SARS-CoV-2 vaccine) at time of SARS-CoV-2 test. Main Outcome Measures Primary outcomes were (1) vaccine receipt among Veterans and specific subpopulations, (2) VE calculated from odds ratios (ORs) with 95% confidence intervals (95% CI) for the association between SARS-CoV-2 infection and full vs. no vaccination, and (3) VE against infection for partial vs. no vaccination. VE against COVID-19-related hospitalization and death were also estimated. Results By March 7, 2020, among 6,170,750 Veterans, 1,547,045 (23.1%) received at least one SARS-CoV-2 vaccine. Based on the analysis of mRNA SARS-CoV-2 vaccines, VE against infection was 93.7% (95% CI 92.0-95.0) and 57.7% (95% CI 53.5-61.5) for full and partial vaccination (vs. no vaccination), respectively. VE was similar for subpopulations. VE against COVID-19-related hospitalization and death for full vs. no vaccination was 90.7% (95% CI 90.0-91.3) and 94.7% (95% CI 91.3-98.1), respectively. Conclusion and Relevance Vaccines are effective in reducing SARS-CoV-2 infections and disease-related severity and mortality in the Veteran population. Effective vaccine, as well as their efficient and equitable distribution, are important for reducing COVID-19 disease burden among Veterans. Key Points Question What is the scope of VHA vaccination rollout and the impact of mRNA SARS-CoV-2 vaccination among Veterans? Findings Vaccination rollout reached all Veteran subpopulations in the first three months. Effectiveness of full vaccination with mRNA SARS-CoV-2 vaccines was 93.7% for preventing infection, comparable to that demonstrated in clinical trials. Effectiveness was similarly high for the elderly, ethnic and racial minorities, individuals with low income, homeless persons, and immunocompromised Veterans. Meaning Effective vaccines and their efficient and equitable distribution helped the VHA to reduce COVID-19 disease burden and disparities among Veterans within the first three months of vaccine distribution.

Introduction Early identification of patients with coronavirus disease 2019 (COVID-19) who are at risk for hospitalization may help to mitigate disease burden by allowing healthcare systems to conduct sufficient resource and logistical planning in the event of case surges. We sought to develop and validate a clinical risk score that uses readily accessible information at testing to predict individualized 30-day hospitalization risk following COVID-19 diagnosis. Methods We assembled a retrospective cohort of U.S. Veterans Health Administration patients (age ≥ 18 years) diagnosed with COVID-19 between March 1, 2020, and December 31, 2020. We screened patient characteristics using Least Absolute Shrinkage and Selection Operator logistic regression and constructed the risk score using characteristics identified as most predictive for hospitalization. Patients diagnosed before November 1, 2020, comprised the development cohort, while those diagnosed on or after November 1, 2020, comprised the validation cohort. We assessed risk score discrimination by calculating the area under the receiver operating characteristic (AUROC) curve and calibration using the Hosmer–Lemeshow (HL) goodness-of-fit test. This study was approved by the Veteran’s Institutional Review Board of Northern New England at the White River Junction Veterans Affairs Medical Center (Reference no.:1473972-1). Results The development and validation cohorts comprised 11,473 and 12,970 patients, of whom 4,465 (38.9%) and 3,669 (28.3%) were hospitalized, respectively. The independent predictors for hospitalization included in the risk score were increasing age, male sex, non-white race, Hispanic ethnicity, homelessness, nursing home/long-term care residence, unemployed or retired status, fever, fatigue, diarrhea, nausea, cough, diabetes, chronic kidney disease, hypertension, and chronic obstructive pulmonary disease. Model discrimination and calibration was good for the development (AUROC = 0.80; HL P-value = .05) and validation (AUROC = 0.80; HL P-value = .31) cohorts. Conclusions The prediction tool developed in this study demonstrated that it could identify patients with COVID-19 who are at risk for hospitalization. This could potentially inform clinicians and policymakers of patients who may benefit most from early treatment interventions and help healthcare systems anticipate capacity surges.

To quantify the association between dose reductions of abiraterone acetate plus prednisone (AAP) or enzalutamide and prostate-specific antigen (PSA) progression in patients with metastatic castration-resistant prostate cancer (mCRPC). Changes in medication-taking patterns of AAP or enzalutamide may arise due to clinical (e.g. toxicity) and non-clinical (e.g. patient compliance) reasons in men with mCRPC. However, it is unclear how this affects PSA progression.Veterans Health Administration electronic health record database was used to identify Veterans diagnosed with prostate cancer who initiated AAP or enzalutamide (index) from April 2010 to December 2016. PSA progression was defined as the first rise in PSA of ≥2 ng/mL and ≥25% above nadir. The relative dose intensity (RDI) was defined as the ratio of the total dispensed dose over the last two months to the standard recommended dose and was updated monthly. Dose reduction was assessed using a threshold of RDI80%.The cohort included 6069 Veterans aged 74.6 years on average. Mean follow-up was 12.3 months. PSA progression occurred in 62.7% of patients. About 63.6% of AAP- and 67.2% of enzalutamide-treated patients had ≥1 occurrence of RDI 80%. RDI 80% was associated with an 8.8% higher risk of PSA progression (hazard ratio [HR] = 1.088;Dose reduction was observed in most patients and was associated with significantly higher risk of PSA progression in men with mCRPC. These results suggest future efforts to minimize dose reductions for non-clinical reasons are warranted and that patient adherence should be encouraged to limit the risk of PSA progression.

OBJECTIVEWe explored longitudinal trends in sociodemographic characteristics, reported symptoms, laboratory findings, pharmacological and non-pharmacological treatment, comorbidities, and 30-day in-hospital mortality among hospitalized patients with coronavirus disease 2019 (COVID-19).METHODSThis retrospective cohort study included 43,267 patients diagnosed with COVID-19 in the Veterans Health Administration between 03/01/20 and 08/31/20 and followed until 09/30/20. We focused our analysis on patients that were subsequently hospitalized, and categorized them into groups based on the month of hospitalization. We summarized our findings through descriptive statistics. We used a nonparametric rank-sum test for trend to examine any differences in the distribution of our study variables across the six months.RESULTSDuring our study period, 8,240 patients were hospitalized, and 1,081 (13.1%) died within 30 days of admission. Hospitalizations increased over time, but the proportion of patients that died consistently declined from March (N=221/890, 24.8%) to August (N=111/1,396, 8.0%). Patients hospitalized in March compared to August were younger on average, mostly black, and symptomatic. They also had a higher frequency of baseline comorbidities, including hypertension and diabetes, and were more likely to present with abnormal laboratory findings including low lymphocyte counts and elevated creatinine. Lastly, receipt of mechanical ventilation and Hydroxychloroquine declined from March to August, while treatment with Dexamethasone and Remdesivir increased.CONCLUSIONWe found evidence of declining COVID-19 severity and fatality over time within a national health care system.

Applying high-reliability organization (HRO) principles to health care is complex. No consensus exists as to an effective framework for HRO implementation or the direct impact of adoption.The Veterans Health Administration (VHA) National Center for Patient Safety established the high-reliability hospital (HRH) model for HRO adoption and piloted HRH in collaboration with the Truman VA Medical Center (Truman) during a 3-year intervention period (January 1, 2016-December 31, 2018). High-reliability hospital components are as follows: annual patient safety (PS) assessment, annual PS culture survey, annual root cause analysis training, daily leadership walk-arounds, monthly PS forum, annual processes standardization review, Just Culture training, unit-based Clinical Team Training, unit-based continuous improvement projects, and annual Clinical Team Training simulation education. The impact of HRH was examined using a PS Culture Survey, PS event reporting, and quality outcomes of standardized mortality rate and complication rate.Truman internally improved PS culture and PS event reporting rates resulting in outcomes better than all VHA facilities (All VHA; P0.001 and P0.001, respectively). Low-harm PS event reporting increased (P0.001); however, serious safety event rate remained unchanged versus All VHA. Significant improvement in Truman standardized mortality rate and complication rate versus All VHA occurred immediately and were sustained through intervention (slopes, P0.001 and P0.020; respectively).High-reliability hospital is an effective framework for HRO implementation and will be applied to 18 additional VHA sites. Based on these results, the expected outcome will be improved PS culture and overall PS event reporting. The impact of HRH on serious safety event rate and quality measures requires further study.

Background Pressure injury prevention is a persistent concern in nursing. The Veterans Health Administration implemented a creative approach with successful outcomes across the United States. Problem Pressure injury prevention is a measure of nursing quality of care and a high priority in the Veterans Health Administration. Methods A 12-month Virtual Breakthrough Series Collaborative utilizing coaching and group calls was conducted to assist long-term and acute care teams with preventing pressure injuries. Interventions Interventions from the Veterans Health Administration Skin Bundle were implemented, including pressure-relieving surfaces, novel turning techniques, specialized dressings, and emollients to prevent skin breakdown. Results The aggregated pressure injury rate for all teams decreased from Prework to the Action phase from 1.0 to 0.8 per 1000 bed days of care (P = .01). The aggregated pressure injury rates for long-term care units decreased from Prework to Continuous Improvement from 0.8 to 0.4 per 1000 bed days of care (P = .021). Conclusion The Virtual Breakthrough Series helped reduce pressure injuries.

Introduction It is unclear whether high-dose influenza vaccine (HD) is more effective at reducing mortality among seniors. Aim This study aimed to evaluate the relative vaccine effectiveness (rVE) of HD. Methods We linked electronic medical record databases in the Veterans Health Administration (VHA) and Medicare administrative files to examine the rVE of HD vs standard-dose influenza vaccines (SD) in preventing influenza/pneumonia-associated and cardiorespiratory mortality among VHA-enrolled veterans 65 years or older during the 2012/13, 2013/14 and 2014/15 influenza seasons. A multivariable Cox proportional hazards model was performed on matched recipients of HD vs SD, based on vaccination time, location, age, sex, ethnicity and VHA priority level. Results Among 569,552 person-seasons of observation, 207,574 (36%) were HD recipients and 361,978 (64%) were SD recipients, predominantly male (99%) and white (82%). Pooling findings from all three seasons, the adjusted rVE estimate of HD vs SD during the high influenza periods was 42% (95% confidence interval (CI): 24–59) against influenza/pneumonia-associated mortality and 27% (95% CI: 23–32) against cardiorespiratory mortality. Residual confounding was evident in both early and late influenza periods despite matching and multivariable adjustment. Excluding individuals with high 1-year predicted mortality at baseline reduced the residual confounding and yielded rVE of 36% (95% CI: 10–62) and 25% (95% CI: 12–38) against influenza/pneumonia-associated and cardiorespiratory mortality, respectively. These were confirmed by results from two-stage residual inclusion estimations. Discussion The HD was associated with a lower risk of influenza/pneumonia-associated and cardiorespiratory death in men during the high influenza period.

The objective of this study was to evaluate the association of prostate-specific antigen doubling time (PSADT) with metastasis-free survival (MFS) and overall survival (OS), and to describe healthcare resource utilization (HRU) and costs among patients with non-metastatic castrate-resistant prostate cancer (nmCRPC) in the Veterans Health Administration setting.Patients with nmCRPC were identified from the Veterans Health Administration electronic health record database (1/2007-8/2017). PSADT was categorized as3 months, 3 to 9 months, 9 to 15 months, ≥15 months, and unknown. MFS and OS were assessed using multivariable Cox proportional hazards regression, including PSADT as a predictor. HRU and costs were described per-patient-per-year (PPPY).Among 12,083 patients in the study, shorter PSADT was associated with shorter MFS and OS (PSADT3 months vs. PSADT ≥15 months hazard ratio [HR] [95% confidence interval (CI)] = 0.307 [0.281, 0.335] and 0.371 [0.335, 0.410], respectively). Patients who developed metastasis had a 3-fold higher risk of death compared to those without metastasis (HR [95% CI] = 2.933 [2.763, 3.113]). Mean HRU increased following the onset of nmCRPC and metastatic castrate-resistant prostate cancer (mCRPC); mean inpatient stays more than doubled (0.2 vs. 0.5 and 0.6 vs. 2.8 PPPY, respectively). Similar increases in healthcare costs were observed; pharmacy costs more than tripled following nmCRPC ($2,074 vs. $6,839 PPPY). From nmCRPC to mCRPC, large increases were observed for inpatient costs ($7,257-$61,691), emergency room costs ($844-$1,958), and pharmacy costs ($4,115-$26,279) PPPY.In Veterans with nmCRPC, shorter PSADT was significantly associated with shorter MFS and OS. Onset of nmCRPC and mCRPC was associated with substantial HRU and cost increases.

OBJECTIVE Fluoxetine, paroxetine, sertraline, topiramate, and venlafaxine have previously shown efficacy for posttraumatic stress disorder (PTSD). One prior study using US Department of Veterans Affairs (VA) medical records data to compare these agents found no differences in symptom reduction in clinical practice. The current study addresses several weaknesses in that study, including limited standardization of treatment duration, inability to account for prior treatment receipt, use of an outdated symptomatic assessment for PTSD, and lack of functional outcome. METHODS A total of 834 VA outpatients were identified with DSM-5 clinical diagnoses of PTSD between October 2016 and March 2018 who initiated one of the medications and met prespecified criteria for treatment duration and dose, combined with baseline and endpoint DSM-5 PTSD Checklist (PCL-5) measurements. Twelve-week acute-phase changes in PCL-5 score and remission of PTSD symptoms were compared among patients receiving the different medications, as was use of acute psychiatric services in the subsequent 6-month continuation phase. RESULTS In the acute phase, patients improved by a mean of 6.8-10.1 points on the PCL-5 and 0.0%-10.9% achieved remission of PTSD symptoms. Those taking venlafaxine were significantly more likely to achieve remission (P = .008 vs fluoxetine and P < .0001 vs paroxetine, sertraline, and topiramate). In the continuation phase, there were no differences in acute psychiatric care use between medications. Those who continued their medication were less likely to use acute psychiatric services (HR = 0.55; P = .03). CONCLUSIONS There may be an advantage to venlafaxine over other agents in achieving acute-phase remission for DSM-5 PTSD in routine clinical practice, but this finding requires further study. Regardless of the agent chosen, medication cessation during the continuation phase is associated with a higher risk of acute psychiatric care use.

Background Clostridioides difficile infection (CDI) is an important cause of diarrheal disease associated with increasing morbidity and mortality. Efforts to develop a preventive vaccine are ongoing. The goal of this study was to develop an algorithm to identify patients at high risk of CDI for enrollment in a vaccine efficacy trial. Methods We conducted a 2-stage retrospective study of patients aged ≥ 50 within the US Department of Veterans Affairs Health system between January 1, 2009 and December 31, 2013. Included patients had at least 1 visit in each of the 2 years prior to the study, with no CDI in the past year. We used multivariable logistic regression with elastic net regularization to identify predictors of CDI in months 2–12 (i.e., days 31 – 365) to allow time for antibodies to develop. Performance was measured using the positive predictive value (PPV) and the area under the curve (AUC). Results Elements of the predictive algorithm included age, baseline comorbidity score, acute renal failure, recent infections or high-risk antibiotic use, hemodialysis in the last month, race, and measures of recent healthcare utilization. The final algorithm resulted in an AUC of 0.69 and a PPV of 3.4%. Conclusions We developed a predictive algorithm to identify a patient population with increased risk of CDI over the next 2–12 months. Our algorithm can be used prospectively with clinical and administrative data to facilitate the feasibility of conducting efficacy studies in a timely manner in an appropriate population.

This case-control study examines estimated COVID-19 messenger RNA vaccination effectiveness against SARS-CoV-2 infection from January to September 2021 among fully vaccinated male veterans aged 65 years or older.

Objective We explored longitudinal trends in sociodemographic characteristics, reported symptoms, laboratory findings, pharmacological and non-pharmacological treatment, comorbidities, and 30-day in-hospital mortality among hospitalized patients with coronavirus disease 2019 (COVID-19). Methods This retrospective cohort study included patients diagnosed with COVID-19 in the United States Veterans Health Administration between 03/01/20 and 08/31/20 and followed until 09/30/20. We focused our analysis on patients that were subsequently hospitalized, and categorized them into groups based on the month of hospitalization. We summarized our findings through descriptive statistics. We used Cuzick’s Trend Test to examine any differences in the distribution of our study variables across the six months. Results During our study period, we identified 43,267 patients with COVID-19. A total of 8,240 patients were hospitalized, and 13.1% (N = 1,081) died within 30 days of admission. Hospitalizations increased over time, but the proportion of patients that died consistently declined from 24.8% (N = 221/890) in March to 8.0% (N = 111/1,396) in August. Patients hospitalized in March compared to August were younger on average, mostly black, urban-dwelling, febrile and dyspneic. They also had a higher frequency of baseline comorbidities, including hypertension and diabetes, and were more likely to present with abnormal laboratory findings including low lymphocyte counts and elevated creatinine. Lastly, there was a decline from March to August in receipt of mechanical ventilation (31.4% to 13.1%) and hydroxychloroquine (55.3% to Conclusion Among hospitalized patients with COVID-19, we observed a trend towards decreased disease severity and mortality over time.

BackgroundFew randomised controlled trials (RCTs) have shown decreases in suicide.AimsTo identify interventions for preventing suicide.MethodWe searched EMBASE and Medline from inception until 31 December 2015. We included RCTs comparing prevention strategies with control. We pooled odds ratios (ORs) for suicide using the Peto method.ResultsAmong 8647 citations, 72 RCTs and 6 pooled analyses met inclusion criteria. Three RCTs (n= 2028) found that the World Health Organization (WHO) brief intervention and contact (BIC) was associated with significantly lower odds of suicide (OR = 0.20, 95% CI 0.09–0.42). Six RCTs (n= 1040) of cognitive–behavioural therapy (CBT) for suicide prevention and six RCTs of lithium (n = 619) yielded non-significant findings (OR = 0.34, 95% CI 0.12–1.03 and OR = 0.23, 95% CI 0.05–1.02, respectively).ConclusionsThe WHO BIC is a promising suicide prevention strategy. No other intervention showed a statistically significant effect in reducing suicide.

Background Seasonal influenza poses a substantial clinical and economic burden, despite influenza vaccination efforts. This study evaluates healthcare resource utilization attributable to influenza in elderly populations at increased risk of influenza-related complications. Methods Elderly (≥ 65 years of age) patients (pts) with ≥ 1 influenza diagnosis (Dx) during influenza seasons from October 1, 2014 – March 1, 2019 were identified in the IQVIA PharMetrics® Plus claims database. The earliest influenza Dx was the index date and pts had evidence of pulmonary, cardiovascular, or renal disease before index. Pts had ≥ 12 months continuous enrollment (baseline before index) and ≥ 30 days follow-up after index. Medically-attended influenza cases were identified by primary influenza Dx codes or any influenza Dx with a record of an influenza test within ±14 days. Influenza pts were 1:1 propensity score matched to pts without influenza using baseline demographic and clinical characteristics and baseline healthcare costs. All-cause hospital and emergency department (ED) visits and total healthcare costs during follow-up (30-day and in the index influenza season) were compared in the matched cohorts. Results Baseline characteristics were balanced after matching. Elderly influenza pts had 3 to 7 times higher 30-day hospitalization rates compared to pts without influenza, including pts with congestive heart failure (41% vs. 8%), chronic obstructive pulmonary disease (35% vs. 6%), coronary artery disease (23% vs. 4%), and stage 5/end stage renal disease (ESRD)/dialysis (44% vs. 13%; all p< .05; Figure). Hospital and ED visit rates in the influenza season were 2 to 3 times higher in pts with vs. without influenza; ED visit rates were 49% vs. 23%, 44% vs. 18%, 37% vs. 14%, and 60% vs. 28% for the above cohorts, respectively (all p< .05). Mean total healthcare costs per patient per season were $3,299 to $12,398 higher in pts with vs. without influenza (all p< .05, except myocardial infarction and stage 5/ESRD/dialysis pts). Figure. All-cause 30-day hospitalization rates in matched cohorts of elderly patients with baseline comorbidities with and without influenza Conclusion Hospitalizations, ED visits, and total healthcare costs are elevated in the elderly after evidence of medically-attended influenza, but to varying degrees depending on baseline comorbidities. Continued efforts to reduce influenza burden in high-risk populations are needed. Disclosures Aimee Near, MPH, Employee of IQVIA; IQVIA paid by VIR Bio to complete research project (Consultant) Jenny Tse, MS, Vir Biotechnology, Inc. (Other Financial or Material Support, I am employed by IQVIA which was paid by Vir Biotechnology, Inc. to complete this study.) David K. Hong, MD, Vir Biotechnology (Employee) Carolina M. Reyes, PhD, Vir Biotechnology (Employee, Shareholder)