Longitudinal analysis of nursing home residents' T cell responses after SARS-CoV-2 mRNA vaccinations shows influence of biological sex and SARS-CoV-2 infection history.

BACKGROUND: Vaccines and vaccine boosting have blunted excess morbidity and mortality from SARS-CoV-2 infection suffered by older nursing home residents (NHR). However, the impact of repeated vaccination on the T cell response based on biological sex and prior infection of NHR remain understudied. METHODS: We examined T cell responses to mRNA vaccines to SARS-CoV-2 in a cohort of NHR and healthcare workers (HCW) over 2 years. We used IFN-γ ELIspot and flow cytometry to assess T cell response before, two weeks and 6 months after the initial series and each of two booster vaccines. We analyzed these data longitudinally with mixed-effect modeling and also examined subsets of our cohorts for additional changes in T cell effector function. RESULTS: We show that prior SARS-CoV-2 infection and female sex contribute to higher T cell response in NHR but not HCW. When looking across time points, NHR but not HCW with prior infection had significantly higher T cell responses than infection-naive subjects. These patterns of response were maintained across multiple booster vaccinations and suggest that the age, multimorbidity, and/or frailty of the NHR cohort may accentuate sex and infection status differences in T cell response to mRNA vaccination.

Early Mortality After the First Dose of COVID-19 Vaccination: A Target Trial Emulation.

BACKGROUND: Vaccine hesitancy persists alongside concerns about the safety of coronavirus disease 2019 (COVID-19) vaccines. We aimed to examine the effect of COVID-19 vaccination on risk of death among US veterans. METHODS: We conducted a target trial emulation to estimate and compare risk of death up to 60 days under two COVID-19 vaccination strategies: vaccination within 7 days of enrollment versus no vaccination through follow-up. The study cohort included individuals aged ≥18 years enrolled in the Veterans Health Administration system and eligible to receive a COVID-19 vaccination according to guideline recommendations from 1 March 2021 through 1 July 2021. The outcomes of interest included deaths from any cause and excluding a COVID-19 diagnosis. Observations were cloned to both treatment strategies, censored, and weighted to estimate per-protocol effects. RESULTS: We included 3 158 507 veterans. Under the vaccination strategy, 364 993 received vaccine within 7 days. At 60 days, there were 156 deaths per 100 000 veterans under the vaccination strategy versus 185 deaths under the no vaccination strategy, corresponding to an absolute risk difference of -25.9 (95% confidence limit [CL], -59.5 to 2.7) and relative risk of 0.86 (95% CL, .7 to 1.0). When those with a COVID-19 infection in the first 60 days were censored, the absolute risk difference was -20.6 (95% CL, -53.4 to 16.0) with a relative risk of 0.88 (95% CL, .7 to 1.1). CONCLUSIONS: Vaccination against COVID-19 was associated with a lower but not statistically significantly different risk of death in the first 60 days. These results agree with prior scientific knowledge suggesting vaccination is safe with the potential for substantial health benefits.

Comparative safety of tramadol and other opioids following total hip and knee arthroplasty.

BACKGROUND: Tramadol is increasingly used to treat acute postoperative pain among older adults following total hip and knee arthroplasty (THA/TKA). However, tramadol has a complex pharmacology and may be no safer than full opioid agonists. We compared the safety of tramadol, oxycodone, and hydrocodone among opioid-naïve older adults following elective THA/TKA. METHODS: This retrospective cohort included Medicare Fee-for-Service beneficiaries ≥ 65 years with elective THA/TKA between January 1, 2010 and September 30, 2015, 12 months of continuous Parts A and B enrollment, 6 months of continuous Part D enrollment, and no opioid use in the 6 months prior to THA/TKA. Participants initiated single-opioid therapy with tramadol, oxycodone, or hydrocodone within 7 days of discharge from THA/TKA hospitalization, regardless of concurrently administered nonopioid analgesics. Outcomes of interest included all-cause hospitalizations or emergency department visits (serious adverse events (SAEs)) and a composite of 10 surgical- and opioid-related SAEs within 90-days of THA/TKA. The intention-to-treat (ITT) and per-protocol (PP) hazard ratios (HRs) for tramadol versus other opioids were estimated using inverse-probability-of-treatment-weighted pooled logistic regression models. RESULTS: The study population included 2,697 tramadol, 11,407 oxycodone, and 14,665 hydrocodone initiators. Compared to oxycodone, tramadol increased the rate of all-cause SAEs in ITT analyses only (ITT HR 1.19, 95%CLs, 1.02, 1.41; PP HR 1.05, 95%CLs, 0.86, 1.29). Rates of composite SAEs were not significant across comparisons. Compared to hydrocodone, tramadol increased the rate of all-cause SAEs in the ITT and PP analyses (ITT HR 1.40, 95%CLs, 1.10, 1.76; PP HR 1.34, 95%CLs, 1.03, 1.75), but rates of composite SAEs were not significant across comparisons. CONCLUSIONS: Postoperative tramadol was associated with increased rates of all-cause SAEs, but not composite SAEs, compared to oxycodone and hydrocodone. Tramadol does not appear to have a superior safety profile and should not be preferentially prescribed to opioid-naïve older adults following THA/TKA.

Humoral and Cellular Immunity Induced by Adjuvanted and Standard Trivalent Influenza Vaccine in Older Nursing Home Residents.

BACKGROUND: Despite wide use of adjuvanted influenza vaccine in nursing home residents (NHR), little immunogenicity data exist for this population. METHODS: We collected blood from NHR (n = 85) living in nursing homes participating in a cluster randomized clinical trial comparing MF59-adjuvanted trivalent inactivated influenza vaccine (aTIV) with nonadjuvanted vaccine (TIV) (parent trial, NCT02882100). NHR received either vaccine during the 2016-2017 influenza season. We assessed cellular and humoral immunity using flow cytometry and hemagglutinin inhibition, antineuraminidase (enzyme-linked lectin assay), and microneutralization assays. RESULTS: Both vaccines were similarly immunogenic and induced antigen-specific antibodies and T cells, but aTIV specifically induced significantly larger 28 days after vaccination (D28) titers against A/H3N2 neuraminidase than TIV. CONCLUSIONS: NHRs respond immunologically to TIV and aTIV. From these data, the larger aTIV-induced antineuraminidase response at D28 may help explain the increased clinical protection observed in the parent clinical trial for aTIV over TIV in NHR during the A/H3N2-dominant 2016-2017 influenza season. Additionally, a decline back to prevaccination titers at 6 months after vaccination emphasizes the importance of annual vaccination against influenza. CLINICAL TRIALS REGISTRATION: NCT02882100.

SARS-CoV-2 Antibody Responses to the Ancestral SARS-CoV-2 Strain and Omicron BA.1 and BA.4/BA.5 Variants in Nursing Home Residents After Receipt of Bivalent COVID-19 Vaccine - Ohio and Rhode Island, September-November 2022.

Introduction of monovalent COVID-19 mRNA vaccines in late 2020 helped to mitigate disproportionate COVID-19-related morbidity and mortality in U.S. nursing homes (1); however, reduced effectiveness of monovalent vaccines during the period of Omicron variant predominance led to recommendations for booster doses with bivalent COVID-19 mRNA vaccines that include an Omicron BA.4/BA.5 spike protein component to broaden immune response and improve vaccine effectiveness against circulating Omicron variants (2). Recent studies suggest that bivalent booster doses provide substantial additional protection against SARS-CoV-2 infection and severe COVID-19-associated disease among immunocompetent adults who previously received only monovalent vaccines (3).* The immunologic response after receipt of bivalent boosters among nursing home residents, who often mount poor immunologic responses to vaccines, remains unknown. Serial testing of anti-spike protein antibody binding and neutralizing antibody titers in serum collected from 233 long-stay nursing home residents from the time of their primary vaccination series and including any subsequent booster doses, including the bivalent vaccine, was performed. The bivalent COVID-19 mRNA vaccine substantially increased anti-spike and neutralizing antibody titers against Omicron sublineages, including BA.1 and BA.4/BA.5, irrespective of previous SARS-CoV-2 infection or previous receipt of 1 or 2 booster doses. These data, in combination with evidence of low uptake of bivalent booster vaccination among residents and staff members in nursing homes (4), support the recommendation that nursing home residents and staff members receive a bivalent COVID-19 booster dose to reduce associated morbidity and mortality (2).

Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes.

BACKGROUND/AIMS: When the randomized clusters in a cluster randomized trial are selected based on characteristics that influence treatment effectiveness, results from the trial may not be directly applicable to the target population. We used data from two large nursing home-based pragmatic cluster randomized trials to compare nursing home and resident characteristics in randomized facilities to eligible non-randomized and ineligible facilities. METHODS: We linked data from the high-dose influenza vaccine trial and the Music & Memory Pragmatic TRIal for Nursing Home Residents with ALzheimer's Disease (METRICaL) to nursing home assessments and Medicare fee-for-service claims. The target population for the high-dose trial comprised Medicare-certified nursing homes; the target population for the METRICaL trial comprised nursing homes in one of four US-based nursing home chains. We used standardized mean differences to compare facility and individual characteristics across the three groups and logistic regression to model the probability of nursing home trial participation. RESULTS: In the high-dose trial, 4476 (29%) of the 15,502 nursing homes in the target population were eligible for the trial, of which 818 (18%) were randomized. Of the 1,361,122 residents, 91,179 (6.7%) were residents of randomized facilities, 463,703 (34.0%) of eligible non-randomized facilities, and 806,205 (59.3%) of ineligible facilities. In the METRICaL trial, 160 (59%) of the 270 nursing homes in the target population were eligible for the trial, of which 80 (50%) were randomized. Of the 20,262 residents, 973 (34.4%) were residents of randomized facilities, 7431 (36.7%) of eligible non-randomized facilities, and 5858 (28.9%) of ineligible facilities. In the high-dose trial, randomized facilities differed from eligible non-randomized and ineligible facilities by the number of beds (132.5 vs 145.9 and 91.9, respectively), for-profit status (91.8% vs 66.8% and 68.8%), belonging to a nursing home chain (85.8% vs 49.9% and 54.7%), and presence of a special care unit (19.8% vs 25.9% and 14.4%). In the METRICaL trial randomized facilities differed from eligible non-randomized and ineligible facilities by the number of beds (103.7 vs 110.5 and 67.0), resource-poor status (4.6% vs 10.0% and 18.8%), and presence of a special care unit (26.3% vs 33.8% and 10.9%). In both trials, the characteristics of residents in randomized facilities were similar across the three groups. CONCLUSION: In both trials, facility-level characteristics of randomized nursing homes differed considerably from those of eligible non-randomized and ineligible facilities, while there was little difference in resident-level characteristics across the three groups. Investigators should assess the characteristics of clusters that participate in cluster randomized trials, not just the individuals within the clusters, when examining the applicability of trial results beyond participating clusters.

Barriers and facilitators to interprofessional collaborative practice for community-dwelling older adults: An integrative review.

AIMS AND OBJECTIVES: The aim of this integrative review was to synthesise empirical reports of interprofessional collaborative practice (IPCP) for community-dwelling older adults and uncover barriers and facilitators related to its success as a model of care for this population. BACKGROUND: IPCP is a model of care that has demonstrated positive outcomes for community-dwelling older adults. However, a summary of barriers and facilitators to IPCP models has not been presented. METHODS: An integrative review using the method posited by Whittemore and Knafl was completed to identify barriers and facilitators to IPCP for community-dwelling older adults. The literature search was reported following PRISMA guidelines. RESULTS: Four themes emerged as barriers to IPCP: (1) A (Potential) Logistical Nightmare, (2) All About the Money, (3) If We Can't Test It, Can We Recommend It? and (4) Challenging for the Team, Challenging for the Client. Three themes emerged as facilitators to IPCP: (1) Reducing Resource Waste, (2) The "C" in IPCP and (3) What Matters Most. CONCLUSIONS: IPCP models for community-dwelling older adults must adapt to the setting of care and client needs. Interprofessional education opportunities for team members facilitate effective IPCP. Healthcare policies and funding structures need to address IPCP for community-dwelling older adults for this model to be successful and sustainable. RELEVANCE TO CLINICAL PRACTICE: Nurses participate on and lead IPCP teams caring for community-dwelling older adults and, therefore, need to be aware of barriers and facilitators to this model of care.

Identifying strategies that promote staff and resident influenza and COVID-19 vaccination in nursing homes: Perspectives from nursing home staff.

Resident and staff influenza and COVID-19 vaccination are critical components of infection prevention in nursing homes. Our study sought to characterize strategies that nursing home staff use to promote vaccination. Twenty-six telephone/videoconference interviews were conducted with administrators, directors of nursing, infection preventionists, and Minimum Data Set coordinators at 14 nursing homes across the US. Transcripts were analyzed using content analysis and a detailed audit trail was maintained. Staff described resident and staff influenza and COVID-19 vaccine hesitancy and confidence as well as varying approaches to promote vaccination. These included incentives, education efforts, and having a "vaccine champion" responsible for vaccine promotion. While many strategies had been in place prior to COVID-19 in support of improving influenza vaccination, participants reported implementing additional approaches to promote COVID-19 vaccination. Findings may inform future efforts to promote vaccination, which will be critical to mitigate the burden of influenza and COVID-19 in nursing homes.

Significant Reduction in Vaccine-Induced Antibody Levels and Neutralization Activity Among Healthcare Workers and Nursing Home Residents 6 Months Following Coronavirus Disease 2019 BNT162b2 mRNA Vaccination.

Antibody decline occurred from 2 weeks to 6 months post-BNT162b2 mRNA vaccination in nursing home (NH) residents and healthcare workers. Antispike, receptor-binding domain, and neutralization levels dropped >81% irrespective of prior infection. Notably, 69% of infection-naive NH residents had neutralizing antibodies at or below the assay's limit of detection.

Effectiveness of a Second COVID-19 Vaccine Booster Dose Against Infection, Hospitalization, or Death Among Nursing Home Residents - 19 States, March 29-July 25, 2022.

Nursing home residents continue to experience significant COVID-19 morbidity and mortality (1). On March 29, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended a second mRNA COVID-19 vaccine booster dose for adults aged ≥50 years and all immunocompromised persons who had received a first booster ≥4 months earlier.* On September 1, 2022, ACIP voted to recommend bivalent mRNA COVID-19 vaccine boosters for all persons aged ≥12 years who had completed the primary series using monovalent vaccines ≥2 months earlier (2). Data on COVID-19 booster dose vaccine effectiveness (VE) in the nursing home population are limited (3). For this analysis, academic, federal, and private partners evaluated routine care data collected from 196 U.S. community nursing homes to estimate VE of a second mRNA COVID-19 vaccine booster dose among nursing home residents who had received 3 previous COVID-19 vaccine doses (2 primary series doses and 1 booster dose). Residents who received second mRNA COVID-19 vaccine booster doses during March 29-June 15, 2022, with follow-up through July 25, 2022, were found to have 60-day VE of 25.8% against SARS-CoV-2 (the virus that causes COVID-19 infection), 73.9% against severe COVID-19 outcomes (a combined endpoint of COVID-19-associated hospitalizations or deaths), and 89.6% against COVID-19-associated deaths alone. During this period, subvariants BA.2 and BA.2.12.1 (March-June 2022), and BA.4 and BA.5 (July 2022) of the B.1.1.529 and BA.2 (Omicron) variant were predominant. These findings suggest that among nursing home residents, second mRNA COVID-19 vaccine booster doses provided additional protection over first booster doses against severe COVID-19 outcomes during a time of emerging Omicron variants. Facilities should continue to ensure that nursing home residents remain up to date with COVID-19 vaccination, including bivalent vaccine booster doses, to prevent severe COVID-19 outcomes.

Development of MDS-Based Predication Model for COPD Severity in Nursing Home Residents.

BACKGROUND: Assessing chronic obstructive pulmonary disease (COPD) severity is challenging in nursing home (NH) residents due to incomplete symptom assessments and exacerbation history. OBJECTIVE: The objective of this study was to predict COPD severity in NH residents using the Minimum Data Set (MDS), a clinical assessment of functional capabilities and health needs. METHODS: A cohort analysis of prospectively collected longitudinal data was conducted. Residents from geographically varied Medicare-certified NHs with age ≥60 years, COPD diagnosis, and ≥6 months NH residence at enrollment were included. Residents with severe cognitive impairment were excluded. Demographic characteristics, medical history, and MDS variables were extracted from medical records. The care provider-completed COPD Assessment Test (CAT) and COPD exacerbation history were used to categorize residents by Global Initiative for Chronic Lung Disease (GOLD) A to D groups. Multivariate multinomial logit models mapped the MDS to GOLD A to D groups with stepwise selection of variables. RESULTS: Nursing home residents (N = 175) were 64% women and had a mean age of 77.9 years. Among residents, GOLD B was most common (A = 13.1%; B = 44.0%; C = 5.7%; D = 37.1%). Any long-acting bronchodilator (LABD) use and any dyspnea were significant predictors of GOLD A to D groups. The predicted MDS-GOLD group (A = 6.9%; B = 52.6%; C = 4.6%; D = 36.0%) showed good model fit (correctly predicted = 60.6%). Nursing home residents may underuse group-recommended LABD treatment (no LABD: B = 53.2%; C = 80.0%; D = 40.0%). CONCLUSION AND RELEVANCE: The MDS, completed routinely for US NH residents, could potentially be used to estimate COPD severity. Predicted COPD severity with additional validation could provide a map to evidence-based treatment guidelines and may help to individualize treatment pathways for NH residents.

Correlation of long-term care facility vaccination practices between seasons and resident types.

BACKGROUND: Influenza vaccination varies widely across long-term care facilities (LTCFs) due to staff behaviors, LTCF practices, and patient factors. It is unclear how seasonal LTCF vaccination varies between cohabitating but distinct short-stay and long-stay residents. Thus, we assessed the correlation of LTCF vaccination between these populations and across seasons. METHODS: The study design is a national retrospective cohort using Medicare and Minimum Data Set (MDS) data. Participants include U.S. LTCFs. Short-stay and long-stay Medicare-enrolled residents age ≥ 65 in U.S. LTCFs from a source population of residents during October 1st-March 31st in 2013-2014 (3,042,881 residents; 15,683 LTCFs) and 2014-2015 (3,143,174, residents; 15,667 LTCFs). MDS-assessed influenza vaccination was the outcome. Pearson correlation coefficients were estimated to assess seasonal correlations between short-stay and long-stay resident vaccination within LTCFs. RESULTS: The median proportion of short-stay residents vaccinated across LTCFs was 70.4% (IQR, 50.0-82.7%) in 2013-2014 and 69.6% (IQR, 50.0-81.6%) in 2014-2015. The median proportion of long-stay residents vaccinated across LTCFs was 85.5% (IQR, 78.0-90.9%) in 2013-2014 and 84.6% (IQR, 76.6-90.3%) in 2014-2015. Within LTCFs, there was a moderate correlation between short-stay and long-stay vaccination in 2013-2014 (r = 0.50, 95%CI: 0.49-0.51) and 2014-2015 (r = 0.53, 95%CI: 0.51-0.54). Across seasons, there was a moderate correlation for LTCFs with short-stay residents (r = 0.54, 95%CI: 0.53-0.55) and a strong correlation for those with long-stay residents (r = 0.68, 95%CI: 0.67-0.69). CONCLUSIONS: In LTCFs with inconsistent influenza vaccination across seasons or between populations, targeted vaccination protocols for all residents, regardless of stay type, may improve successful vaccination in this vulnerable patient population.

Self-reported measures of limitation in physical function in late midlife are associated with incident Alzheimer's disease and related dementias.

BACKGROUND: Even small improvements in modifiable Alzheimer's disease and related dementias (ADRD) risk factors could lead to a substantial reduction of dementia cases. AIMS: To determine if self-reported functional limitation associates with ADRD symptoms 4-18 years later. METHODS: We conducted a prospective longitudinal study using the Health and Retirement Study of adults aged 51-59 years in 1998 without symptoms of ADRD by 2002 and followed them to 2016. Main exposure variables were difficulty with activities of daily living, mobility, large muscle strength, gross motor and upper limb activities. The outcome was incident ADRD identified by the Lange-Weir algorithm, death, or alive without ADRD. We fit two GEE multinomial models for each measure: (1) baseline measure of function and (2) change in function over time. RESULTS: In the model with baseline only and outcome, only difficulty with mobility associated with future ADRD across levels of difficulty with near dose-response effect (risk ratios (RR) difficulty with 1-5 functions respectively, compared with no difficulty: 1.82; 2.70; 1.73 2.81; 4.03). Mobility also significantly associated with ADRD when allowing for change over time among those with 3, 4 or 5 versus no mobility limitations (RR 1.76; 2.36; 2.37). DISCUSSION: The results infer that an adult in midlife reporting difficulty with mobility as well as those with no mobility limitations in midlife but who later report severe limitations may be at increased risk of incident ADRD. CONCLUSIONS: Self-reported measures of mobility limitation may be early indicators of ADRD and may be useful for public health planning.

The effect of age on fever response among nursing home residents with SARS-COV-2 infection.

Over 15,000 veterans in 135 VA nursing homes were systematically tested for SARS-CoV-2 and had daily temperatures assessed from March to August, 2020. Lower baseline temperatures, and in SARS-CoV-2+ , lower maximum temperatures were observed with advancing age. Clinicians should be aware of the potential diminished fever response in the elderly with SARS-CoV-2.

Pragmatic trials in long-term care: Research challenges and potential solutions in relation to key areas of care.

As a method of research, pragmatic trials are recommended so as to generate results that are applicable to real-world care. This intent is especially important for the millions of older adults who receive long-term care in thousands of nursing homes and assisted living communities across the country-and many millions more around the globe. This article presents key points raised by experts participating in a conference funded by the National Institute of Aging held at the 2021 conference of the Society for Post-Acute and Long-term Care Medicine. The purpose of the conference was to convene leading clinicians, researchers, and industry partners to address special considerations of pragmatic trials in long-term care. Cross-cutting and unique challenges and solutions to conducting pragmatic trials were discussed focusing on 3 areas of clinical relevance to long-term care: (1) functional care and outcomes, (2) psychosocial care and quality of life, and (3) medical care and outcomes, with a special focus on persons with dementia. Challenges and innovative solutions were organized across the 9 domains of the revised Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Tool, and future research recommendations for pragmatic trials in long-term care were identified.

On Setting Expectations for a Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine.

The global coronavirus pandemic is unlike any other since 1918. A century of dramatic medical advances has produced a public expectation that the medical field will rapidly provide solutions to restore normalcy. In less than 6 months, since severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified, the massive international effort to develop a SARS-CoV-2 vaccine has generated more than 140 vaccines in different stages of development, with 9 already recruiting into clinical trials posted on ClinicalTrials.gov. The long-term strategy to handle coronavirus disease 2019 (COVID-19) will almost certainly rely on vaccines. But what type of protection can we realistically expect to achieve from vaccines and when?

Cluster-randomized Trial of Adjuvanted Versus Nonadjuvanted Trivalent Influenza Vaccine in 823 US Nursing Homes.

BACKGROUND: Influenza leads in preventable infection-related hospitalization in nursing home (NH) residents. The adjuvanted trivalent influenza vaccine (aTIV) is more immunogenic than similarly dosed nonadjuvanted trivalent influenza vaccine (TIV), and observational studies suggest aTIV better prevents hospitalizations in older adults. We prospectively tested this in an NH setting. METHODS: NHs with ≥50 long-stay residents aged ≥65 years were randomized to offer aTIV or TIV for residents for the 2016-2017 influenza season. Using intent-to-treat resident-level analysis with Cox proportional hazards regression models adjusted for clustering by facility and a priori baseline covariates (eg, age, heart failure, and facility-level characteristics), we assessed relative aTIV:TIV effectiveness for hospitalization (ie, all-cause, respiratory, and pneumonia and influenza [P&I]). RESULTS: We randomized 823 NHs, housing 50 012 eligible residents, to aTIV or TIV. Residents were similar between groups by age (mean, ~79 years), heart failure, lung disease, and influenza and pneumococcal vaccine uptake, except aTIV homes housed fewer Black residents (14.5 vs 18.9%). Staff vaccine uptake was similar (~55%). P&I and all-cause resident hospitalization rates were lower (adjusted HR [aHR], .80 [95% CI, .66-.98; P = .03] and .94 [.89-.99; P = .02], respectively) for aTIV versus TIV, while the respiratory hospitalization rate was similar, in a season where vaccine effectiveness was considered poor. CONCLUSIONS: aTIV was more effective than TIV in preventing all-cause and P&I hospitalization from NHs during an A/H3N2-predominant season when TIV was relatively ineffective. CLINICAL TRIALS REGISTRATION: NCT02882100.

Adjuvanted Influenza Vaccine and Influenza Outbreaks in US Nursing Homes: Results From a Pragmatic Cluster-Randomized Clinical Trial.

BACKGROUND: Influenza outbreaks in nursing homes pose a threat to frail residents and occur even in vaccinated populations. We conducted a pragmatic cluster-randomized trial comparing adjuvanted trivalent influenza vaccine (aTIV) versus trivalent influenza vaccine (TIV). We report an exploratory analysis to compare the effect of aTIV versus TIV on facility-reported influenza outbreaks. METHODS: We evaluated the impact of the intent-to-treat vaccine assignment on outbreaks reported from November 2016 to March 2017. We collected data according to standard CDC definitions for both suspected outbreaks and those with a laboratory-confirmed case and adjusted for facility-level vaccination rates and resident characteristics in nursing homes. RESULTS: Of 823 randomized nursing homes, 777 (aTIV, n = 387; TIV, n = 390) reported information on influenza outbreaks. Treatment groups had similar characteristics at baseline except for race/ethnicity: homes assigned to TIV had a higher percentage of African-American residents (18.0% vs 13.7%). There were 133 versus 162 facility-reported suspected influenza outbreaks in aTIV versus TIV facilities, respectively; of these, 115 versus 140 were laboratory confirmed. The aTIV group experienced a 17% reduction in suspected (rate ratio, .83; 95% confidence interval, .65-1.05) and laboratory-confirmed (.83; .63-1.06) influenza outbreaks. Covariate adjustment increased the estimated reduction for suspected outbreaks to 21% (.79; .61-.99) and 22% for laboratory-confirmed outbreaks (.78; .60-1.02). CONCLUSIONS: In an exploratory analysis of a cluster-randomized trial we observed 17-21% fewer outbreaks with aTIV than TIV. Clinical Trials Registration. (NCT02882100).

Epidemiology of Escherichia coli Bacteremia: A Systematic Literature Review.

BACKGROUND: Escherichia coli is the most common cause of bacteremia in high-income countries. To enable the development and implementation of effective prevention strategies, a better understanding of the current epidemiology of invasive E. coli infections is needed. METHODS: A systematic review of literature published between 1 January 2007 and 31 March 2018 on the burden and epidemiology of E. coli bacteremia in populations that include adults in high-income countries was conducted. Meta-analysis was performed for descriptive purposes. RESULTS: During the studied time interval, the estimated incidence rate of E. coli bacteremia was 48 per 100 000 person-years, but this increased considerably with age: rates per 100 000 person-years were >100 in 55-to-75-year-olds and >300 in 75-to-85-year-olds. Overall, E. coli accounted for 27% of documented bacteremia episodes: 18% if hospital acquired, 32% if community-onset healthcare associated, and 33% if community acquired. The estimated case fatality rate was 12%. Approximately 44% of episodes were community acquired, 27% community-onset healthcare associated, and 27% hospital acquired. Urinary tract infection (UTI) was the primary source for 53% of episodes. CONCLUSIONS: This systematic review confirms the substantial burden of E. coli bacteremia in older adults and justifies the implementation of community-level programs to prevent E. coli bacteremia and ideally UTI in this age group.

Persistence of Racial Inequities in Receipt of Influenza Vaccination Among Nursing Home Residents in the United States.

BACKGROUND: We sought to determine if racial differences in influenza vaccination among nursing home (NH) residents during the 2008-2009 influenza season persisted in 2018-2019. METHODS: We conducted a cross-sectional study of NHs certified by the Centers for Medicare & Medicaid Services during the 2018-2019 influenza season in US states with ≥1% Black NH residents and a White-Black gap in influenza vaccination of NH residents (N = 2 233 392) of at least 1 percentage point (N = 40 states). NH residents during 1 October 2018 through 31 March 2019 aged ≥18 years and self-identified as being of Black or White race were included. Residents' influenza vaccination status (vaccinated, refused, and not offered) was assessed. Multilevel modeling was used to estimate facility-level vaccination status and inequities by state. RESULTS: The White-Black gap in influenza vaccination was 9.9 percentage points. In adjusted analyses, racial inequities in vaccination were more prominent at the facility level than at the state level. Black residents disproportionately lived in NHs that had a majority of Blacks residents, which generally had the lowest vaccination. Inequities were most concentrated in the Midwestern region, also the most segregated. Not being offered the vaccine was negligible in absolute percentage points between White residents (2.6%) and Black residents (4.8%), whereas refusals were higher among Black (28.7%) than White residents (21.0%). CONCLUSIONS: The increase in the White-Black vaccination gap among NH residents is occurring at the facility level in more states, especially those with the most segregation.