Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
Records 1-30 (of 206 Records) |
Query Trace: Srinivasan A[original query] |
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A framework towards implementation of sequencing for antimicrobial-resistant and other health-care-associated pathogens
Laufer Halpin A , Mathers AJ , Walsh TR , Zingg W , Okeke IN , McDonald LC , Elkins CA , Harbarth S , Peacock SJ , Srinivasan A , Bell M , Pittet D , Cardo D . Lancet Infect Dis 2025 ![]() ![]() ![]() Antimicrobial resistance continues to be a growing threat globally, specifically in health-care settings in which antimicrobial-resistant pathogens cause a substantial proportion of health-care-associated infections (HAIs). Next-generation sequencing (NGS) and the analysis of the data produced therein (ie, bioinformatics) represent an opportunity to enhance our capacity to address these threats. The 3rd Geneva Infection Prevention and Control Think Tank brought together experts to identify gaps, propose solutions, and set priorities for the use of NGS for HAIs and antimicrobial-resistant pathogens. The major deliverable recommendation from this meeting was a proposed framework for implementing the sequencing of HAI pathogens, specifically those harbouring antimicrobial-resistance mechanisms. The key components of the proposed framework relate to wet laboratory quality, sequence data quality, database and tool selection, bioinformatic analyses, data sharing, and NGS data integration, to support public health and actions for infection prevention and control. In this Personal View we detail and discuss the framework in the context of global implementation, specifically in low-income and middle-income countries. |
Benefit of early oseltamivir therapy for adults hospitalized with influenza A: an observational study
Lewis NM , Harker EJ , Grant LB , Zhu Y , Grijalva CG , Chappell JD , Rhoads JP , Baughman A , Casey JD , Blair PW , Jones ID , Johnson CA , Lauring AS , Gaglani M , Ghamande S , Columbus C , Steingrub JS , Shapiro NI , Duggal A , Busse LW , Felzer J , Prekker ME , Peltan ID , Brown SM , Hager DN , Gong MN , Mohamed A , Exline MC , Khan A , Hough CL , Wilson JG , Mosier J , Qadir N , Chang SY , Ginde AA , Martinez A , Mohr NM , Mallow C , Harris ES , Johnson NJ , Srinivasan V , Gibbs KW , Kwon JH , Vaughn IA , Ramesh M , Safdar B , Goyal A , DeLamielleure LE , DeCuir J , Surie D , Dawood FS , Tenforde MW , Uyeki TM , Garg S , Ellington S , Self WH . Clin Infect Dis 2024 BACKGROUND: clinical guidelines recommend initiation of antiviral therapy as soon as possible for patients hospitalized with confirmed or suspected influenza. METHODS: A multicenter US observational sentinel surveillance network prospectively enrolled adults (aged ≥18 years) hospitalized with laboratory-confirmed influenza at 24 hospitals during October 1, 2022-July 21, 2023. A multivariable proportional odds model was used to compare peak pulmonary disease severity (no oxygen support, standard supplemental oxygen, high-flow oxygen/non-invasive ventilation, invasive mechanical ventilation, or death) after the day of hospital admission among patients starting oseltamivir treatment on the day of admission (early) versus those who did not (late or not treated), adjusting for baseline (admission day) severity, age, sex, site, and vaccination status. Multivariable logistic regression models were used to evaluate the odds of intensive care unit (ICU) admission, acute kidney replacement therapy or vasopressor use, and in-hospital death. RESULTS: A total of 840 influenza-positive patients were analyzed, including 415 (49%) who started oseltamivir treatment on the day of admission, and 425 (51%) who did not. Compared with late or not treated patients, those treated early had lower peak pulmonary disease severity (proportional aOR: 0.60, 95% CI: 0.49-0.72), and lower odds of intensive care unit admission (aOR: 0.24, 95% CI: 0.13-0.47), acute kidney replacement therapy or vasopressor use (aOR: 0.40, 95% CI: 0.22-0.67), and in-hospital death (aOR: 0.36, 95% CI: 0.18-0.72). CONCLUSION: Among adults hospitalized with influenza, treatment with oseltamivir on day of hospital admission was associated reduced risk of disease progression, including pulmonary and extrapulmonary organ failure and death. |
CDC's Core Elements to promote diagnostic excellence
Morgan DJ , Singh H , Srinivasan A , Bradford A , McDonald LC , Kutty PK . Diagnosis (Berl) 2024 Nearly a decade after the National Academy of Medicine released the "Improving Diagnosis in Health Care" report, diagnostic errors remain common, often leading to physical, psychological, emotional, and financial harm. Despite a robust body of research on potential solutions and next steps, the translation of these efforts to patient care has been limited. Improvement initiatives are still narrowly focused on selective themes such as diagnostic stewardship, preventing overdiagnosis, and enhancing clinical reasoning without comprehensively addressing vulnerable systems and processes surrounding diagnosis. To close this implementation gap, the US Centers for Disease Control and Prevention (CDC) released the Core Elements of Hospital Diagnostic Excellence programs on September 17, 2024. This initiative aligns with the World Health Organization's (WHO) 2024 World Patient Safety Day focus on improving diagnosis. These Core Elements provide guidance for the formation of hospital programs to improve diagnosis and aim to integrate various disparate efforts in hospitals. By creating a shared mental model of diagnostic excellence, the Core Elements of Diagnostic Excellence supports actions to break down silos, guide hospitals toward multidisciplinary diagnostic excellence teams, and provide a foundation for building diagnostic excellence programs in hospitals. |
Assessment and mitigation of bias in influenza and COVID-19 vaccine effectiveness analyses - IVY Network, September 1, 2022-March 30, 2023
Lewis NM , Harker EJ , Leis A , Zhu Y , Talbot HK , Grijalva CG , Halasa N , Chappell JD , Johnson CA , Rice TW , Casey JD , Lauring AS , Gaglani M , Ghamande S , Columbus C , Steingrub JS , Shapiro NI , Duggal A , Felzer J , Prekker ME , Peltan ID , Brown SM , Hager DN , Gong MN , Mohamed A , Exline MC , Khan A , Wilson JG , Mosier J , Qadir N , Chang SY , Ginde AA , Mohr NM , Mallow C , Harris ES , Johnson NJ , Srinivasan V , Gibbs KW , Kwon JH , Vaughn IA , Ramesh M , Safdar B , DeCuir J , Surie D , Dawood FS , Ellington S , Self WH , Martin ET . Vaccine 2024 43 126492 BACKGROUND: In test-negative studies of vaccine effectiveness (VE), including patients with co-circulating, vaccine-preventable, respiratory pathogens in the control group for the pathogen of interest can introduce a downward bias on VE estimates. METHODS: A multicenter sentinel surveillance network in the US prospectively enrolled adults hospitalized with acute respiratory illness from September 1, 2022-March 31, 2023. We evaluated bias in estimates of VE against influenza-associated and COVID-19-associated hospitalization based on: inclusion vs exclusion of patients with a co-circulating virus among VE controls; observance of VE against the co-circulating virus (rather than the virus of interest), unadjusted and adjusted for vaccination against the virus of interest; and observance of influenza or COVID-19 against a sham outcome of respiratory syncytial virus (RSV). RESULTS: Overall VE against influenza-associated hospitalizations was 6 percentage points lower when patients with COVID-19 were included in the control group, and overall VE against COVID-19-associated hospitalizations was 2 percentage points lower when patients with influenza were included in the control group. Analyses of VE against the co-circulating virus and against the sham outcome of RSV showed that downward bias was largely attributable the correlation of vaccination status across pathogens, but also potentially attributable to other sources of residual confounding in VE models. CONCLUSION: Excluding cases of confounding respiratory pathogens from the control group in VE analysis for a pathogen of interest can reduce downward bias. This real-world analysis demonstrates that such exclusion is a helpful bias mitigation strategy, especially for measuring influenza VE, which included a high proportion of COVID-19 cases among controls. |
Effectiveness of original monovalent and bivalent COVID-19 vaccines against COVID-19-associated hospitalization and severe in-hospital outcomes among adults in the United States, September 2022-August 2023
DeCuir J , Surie D , Zhu Y , Lauring AS , Gaglani M , McNeal T , Ghamande S , Peltan ID , Brown SM , Ginde AA , Steinwand A , Mohr NM , Gibbs KW , Hager DN , Ali H , Frosch A , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Khan A , Busse LW , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Exline MC , Shapiro NI , Columbus C , Vaughn IA , Ramesh M , Safdar B , Mosier JM , Casey JD , Talbot HK , Rice TW , Halasa N , Chappell JD , Grijalva CG , Baughman A , Womack KN , Rhoads JP , Swan SA , Johnson C , Lewis N , Ellington S , Dawood FS , McMorrow M , Self WH . Influenza Other Respir Viruses 2024 18 (11) e70027 ![]() ![]() BACKGROUND: Assessments of COVID-19 vaccine effectiveness are needed to monitor the protection provided by updated vaccines against severe COVID-19. We evaluated the effectiveness of original monovalent and bivalent (ancestral strain and Omicron BA.4/5) COVID-19 vaccination against COVID-19-associated hospitalization and severe in-hospital outcomes. METHODS: During September 8, 2022 to August 31, 2023, adults aged ≥ 18 years hospitalized with COVID-19-like illness were enrolled at 26 hospitals in 20 US states. Using a test-negative case-control design, we estimated vaccine effectiveness (VE) with multivariable logistic regression adjusted for age, sex, race/ethnicity, admission date, and geographic region. RESULTS: Among 7028 patients, 2924 (41.6%) were COVID-19 case patients, and 4104 (58.4%) were control patients. Compared to unvaccinated patients, absolute VE against COVID-19-associated hospitalization was 6% (-7%-17%) for original monovalent doses only (median time since last dose [IQR] = 421 days [304-571]), 52% (39%-61%) for a bivalent dose received 7-89 days earlier, and 13% (-10%-31%) for a bivalent dose received 90-179 days earlier. Absolute VE against COVID-19-associated invasive mechanical ventilation or death was 51% (34%-63%) for original monovalent doses only, 61% (35%-77%) for a bivalent dose received 7-89 days earlier, and 50% (11%-71%) for a bivalent dose received 90-179 days earlier. CONCLUSION: Bivalent vaccination provided protection against COVID-19-associated hospitalization and severe in-hospital outcomes within 3 months of receipt, followed by a decline in protection to a level similar to that remaining from previous original monovalent vaccination by 3-6 months. These results underscore the benefit of remaining up to date with recommended COVID-19 vaccines. |
Next-generation 3D printed multipurpose prevention intravaginal ring for prevention of HIV, HSV-2, and unintended pregnancy
Dahl DK , Srinivasan P , Janusziewicz R , King JL , Shrivastava R , Zhang J , Little D , Bachman S , Kelley K , Cottrell ML , Schauer AP , Sykes C , Kashuba ADM , Smith J , Benhabbour SR . J Control Release 2024 Globally, nearly half of all pregnancies are unintended, ~1.3 million new human immunodeficiency virus (HIV) infections are reported every year, and more than 500 million people are estimated to have a genital herpes simplex virus (HSV-2) infection. Here we report the first 3D printed multipurpose prevention technology (MPT) intravaginal ring (IVR) for prevention of HIV, HSV-2, and unintended pregnancy. The IVRs were fabricated using state-of-the-art Continuous Liquid Interface Production (CLIP™) 3D printing technology using a biocompatible silicone-urethane based resin. Anti-HIV drug (Dapivirine, DPV), anti-herpes drug (Pritelivir, PTV) and a contraceptive drug (Levonorgestrel, LNG) were loaded in a macaque size IVR (25 mm outer diameter, OD; 6.0 mm cross-section, CS) allometrically scaled from the human size (54 mm OD; 7.6 mm CS) IVR analogue. All three active pharmaceutical ingredients (APIs) were loaded in the IVR using a single-step drug loading process driven by absorption. DPV, PTV, and LNG elicited zero-order release kinetics in vitro in simulated vaginal fluid (SVF) at pH 4 and pH 8 relevant to human and macaque vaginal pH respectively. CLIP 3D printed MPT IVRs remained stable after 6 months of storage at 4 °C with no change in physical, dimensional, or mechanical properties and no change in drug concentration and absence of drug degradation byproducts. The MPT IVRs elicited sustained release of all three APIs in macaques for 28 days with median plasma concentrations of 138 pg/mL (DPV), 18,700 pg/mL (PTV), and 335 pg/mL (LNG). Safety studies demonstrated that the MPT IVRs were safe and well tolerated in the macaques with no observed change or abnormalities in vaginal pH and no significant changes in any of the 22 mucosal cytokines and chemokines tested including pro-inflammatory (IL-1β, IL-6, IL-8, IFN-γ, TNF-α, IL-17, IL-18) and anti-inflammatory (IL-10, IL-12) cytokines while the MPT IVR was in place or after its removal. Additionally, MPT IVRs elicited no observed alterations in systemic CD4+ and CD8+ T cells during the entire study. Collectively, the proposed MPT IVR has potential to expand preventative choices for young women and girls against unintended pregnancy against two highly prevalent sexually transmitted infections (STIs). |
Proposed framework for adopting privacy-preserving record linkage for public health action
Pathak A , Serrer L , Bhalla M , King R , Mirel LB , Srinivasan A , Baier P , Zapata D , David-Ferdon C , Luxenberg S , Gundlapalli AV . J Public Health Manag Pract 2024 OBJECTIVES: To propose a framework for adoption of privacy-preserving record linkage (PPRL) for public health applications. METHODS: Twelve interviews with subject matter experts (SMEs) were conducted virtually and coded using an inductive approach. A collaborative session was conducted with SMEs to identify key steps in the PPRL project lifecycle which informed development of a PPRL implementation checklist. RESULTS: This framework has 2 decision-making levels: the organization level and the project or program level. Organization-level considerations include PPRL governance, the optimal choice among approved PPRL solutions, the need for longitudinal linkages, the potential issue of vendor lock-in, and costs. Program-level considerations include characteristics of the PPRL use case, linkage quality and accuracy, data privacy and use, security thresholds, compatibility with data owners' data architecture, and trade-offs between open-source and commercial PPRL solutions. A PPRL implementation checklist was developed to guide public health practitioners considering PPRL for data linkage. CONCLUSIONS: The framework may be considered by public health entities to guide adoption and implementation of PPRL in public health research and surveillance. Public health experts may refer to this framework and the PPRL implementation checklist when determining the appropriateness of PPRL for specific use cases and implementation planning. |
Expanding the use of mathematical modeling in healthcare epidemiology and infection prevention and control
Grant R , Rubin M , Abbas M , Pittet D , Srinivasan A , Jernigan JA , Bell M , Samore M , Harbarth S , Slayton RB . Infect Control Hosp Epidemiol 2024 1-6 During the coronavirus disease 2019 pandemic, mathematical modeling has been widely used to understand epidemiological burden, trends, and transmission dynamics, to facilitate policy decisions, and, to a lesser extent, to evaluate infection prevention and control (IPC) measures. This review highlights the added value of using conventional epidemiology and modeling approaches to address the complexity of healthcare-associated infections (HAI) and antimicrobial resistance. It demonstrates how epidemiological surveillance data and modeling can be used to infer transmission dynamics in healthcare settings and to forecast healthcare impact, how modeling can be used to improve the validity of interpretation of epidemiological surveillance data, how modeling can be used to estimate the impact of IPC interventions, and how modeling can be used to guide IPC and antimicrobial treatment and stewardship decision-making. There are several priority areas for expanding the use of modeling in healthcare epidemiology and IPC. Importantly, modeling should be viewed as complementary to conventional healthcare epidemiological approaches, and this requires collaboration and active coordination between IPC, healthcare epidemiology, and mathematical modeling groups. |
Effectiveness of updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination against SARS-CoV-2 Omicron XBB and BA.2.86/JN.1 lineage hospitalization and a comparison of clinical severity-IVY Network, 26 hospitals, October 18, 2023-March 9, 2024
Ma KC , Surie D , Lauring AS , Martin ET , Leis AM , Papalambros L , Gaglani M , Columbus C , Gottlieb RL , Ghamande S , Peltan ID , Brown SM , Ginde AA , Mohr NM , Gibbs KW , Hager DN , Saeed S , Prekker ME , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Khan A , Hough CL , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Parikh B , Exline MC , Vaughn IA , Ramesh M , Safdar B , Mosier J , Harris ES , Shapiro NI , Felzer J , Zhu Y , Grijalva CG , Halasa N , Chappell JD , Womack KN , Rhoads JP , Baughman A , Swan SA , Johnson CA , Rice TW , Casey JD , Blair PW , Han JH , Ellington S , Lewis NM , Thornburg N , Paden CR , Atherton LJ , Self WH , Dawood FS , DeCuir J . Clin Infect Dis 2024 ![]() ![]() BACKGROUND: Assessing variant-specific COVID-19 vaccine effectiveness (VE) and severity can inform public health risk assessments and decisions about vaccine composition. BA.2.86 and its descendants, including JN.1 (referred to collectively as "JN lineages"), emerged in late 2023 and exhibited substantial divergence from co-circulating XBB lineages. METHODS: We analyzed patients hospitalized with COVID-19-like illness at 26 hospitals in 20 U.S. states admitted October 18, 2023-March 9, 2024. Using a test-negative, case-control design, we estimated effectiveness of an updated 2023-2024 (Monovalent XBB.1.5) COVID-19 vaccine dose against sequence-confirmed XBB and JN lineage hospitalization using logistic regression. Odds of severe outcomes, including intensive care unit (ICU) admission and invasive mechanical ventilation (IMV) or death, were compared for JN versus XBB lineage hospitalizations using logistic regression. RESULTS: 585 case-patients with XBB lineages, 397 case-patients with JN lineages, and 4,580 control-patients were included. VE in the first 7-89 days after receipt of an updated dose was 54.2% (95% CI = 36.1%-67.1%) against XBB lineage hospitalization and 32.7% (95% CI = 1.9%-53.8%) against JN lineage hospitalization. Odds of ICU admission (adjusted odds ratio [aOR] 0.80; 95% CI = 0.46-1.38) and IMV or death (aOR 0.69; 95% CI = 0.34-1.40) were not significantly different among JN compared to XBB lineage hospitalizations. CONCLUSIONS: Updated 2023-2024 COVID-19 vaccination provided protection against both XBB and JN lineage hospitalization, but protection against the latter may be attenuated by immune escape. Clinical severity of JN lineage hospitalizations was not higher relative to XBB. |
Privacy preserving record linkage for public health action: opportunities and challenges
Pathak A , Serrer L , Zapata D , King R , Mirel LB , Sukalac T , Srinivasan A , Baier P , Bhalla M , David-Ferdon C , Luxenberg S , Gundlapalli AV . J Am Med Inform Assoc 2024 OBJECTIVES: To understand the landscape of privacy preserving record linkage (PPRL) applications in public health, assess estimates of PPRL accuracy and privacy, and evaluate factors for PPRL adoption. MATERIALS AND METHODS: A literature scan examined the accuracy, data privacy, and scalability of PPRL in public health. Twelve interviews with subject matter experts were conducted and coded using an inductive approach to identify factors related to PPRL adoption. RESULTS: PPRL has a high level of linkage quality and accuracy. PPRL linkage quality was comparable to that of clear text linkage methods (requiring direct personally identifiable information [PII]) for linkage across various settings and research questions. Accuracy of PPRL depended on several components, such as PPRL technique, and the proportion of missingness and errors in underlying data. Strategies to increase adoption include increasing understanding of PPRL, improving data owner buy-in, establishing governance structure and oversight, and developing a public health implementation strategy for PPRL. DISCUSSION: PPRL protects privacy by eliminating the need to share PII for linkage, but the accuracy and linkage quality depend on factors including the choice of PPRL technique and specific PII used to create encrypted identifiers. Large-scale implementations of PPRL linking millions of observations-including PCORnet, National Institutes for Health N3C, and the Centers for Disease Control and Prevention COVID-19 project have demonstrated the scalability of PPRL for public health applications. CONCLUSIONS: Applications of PPRL in public health have demonstrated their value for the public health community. Although gaps must be addressed before wide implementation, PPRL is a promising solution to data linkage challenges faced by the public health ecosystem. |
Stewardship prompts to improve antibiotic selection for pneumonia: The INSPIRE Randomized Clinical Trial
Gohil SK , Septimus E , Kleinman K , Varma N , Avery TR , Heim L , Rahm R , Cooper WS , Cooper M , McLean LE , Nickolay NG , Weinstein RA , Burgess LH , Coady MH , Rosen E , Sljivo S , Sands KE , Moody J , Vigeant J , Rashid S , Gilbert RF , Smith KN , Carver B , Poland RE , Hickok J , Sturdevant SG , Calderwood MS , Weiland A , Kubiak DW , Reddy S , Neuhauser MM , Srinivasan A , Jernigan JA , Hayden MK , Gowda A , Eibensteiner K , Wolf R , Perlin JB , Platt R , Huang SS . Jama 2024 IMPORTANCE: Pneumonia is the most common infection requiring hospitalization and is a major reason for overuse of extended-spectrum antibiotics. Despite low risk of multidrug-resistant organism (MDRO) infection, clinical uncertainty often drives initial antibiotic selection. Strategies to limit empiric antibiotic overuse for patients with pneumonia are needed. OBJECTIVE: To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO infection risk estimates could reduce empiric extended-spectrum antibiotics for non-critically ill patients admitted with pneumonia. DESIGN, SETTING, AND PARTICIPANTS: Cluster-randomized trial in 59 US community hospitals comparing the effect of a CPOE stewardship bundle (education, feedback, and real-time MDRO risk-based CPOE prompts; n = 29 hospitals) vs routine stewardship (n = 30 hospitals) on antibiotic selection during the first 3 hospital days (empiric period) in non-critically ill adults (≥18 years) hospitalized with pneumonia. There was an 18-month baseline period from April 1, 2017, to September 30, 2018, and a 15-month intervention period from April 1, 2019, to June 30, 2020. INTERVENTION: CPOE prompts recommending standard-spectrum antibiotics in patients ordered to receive extended-spectrum antibiotics during the empiric period who have low estimated absolute risk (<10%) of MDRO pneumonia, coupled with feedback and education. MAIN OUTCOMES AND MEASURES: The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy. Secondary outcomes included empiric vancomycin and antipseudomonal days of therapy and safety outcomes included days to intensive care unit (ICU) transfer and hospital length of stay. Outcomes compared differences between baseline and intervention periods across strategies. RESULTS: Among 59 hospitals with 96 451 (51 671 in the baseline period and 44 780 in the intervention period) adult patients admitted with pneumonia, the mean (SD) age of patients was 68.1 (17.0) years, 48.1% were men, and the median (IQR) Elixhauser comorbidity count was 4 (2-6). Compared with routine stewardship, the group using CPOE prompts had a 28.4% reduction in empiric extended-spectrum days of therapy (rate ratio, 0.72 [95% CI, 0.66-0.78]; P < .001). Safety outcomes of mean days to ICU transfer (6.5 vs 7.1 days) and hospital length of stay (6.8 vs 7.1 days) did not differ significantly between the routine and CPOE intervention groups. CONCLUSIONS AND RELEVANCE: Empiric extended-spectrum antibiotic use was significantly lower among adults admitted with pneumonia to non-ICU settings in hospitals using education, feedback, and CPOE prompts recommending standard-spectrum antibiotics for patients at low risk of MDRO infection, compared with routine stewardship practices. Hospital length of stay and days to ICU transfer were unchanged. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03697070. |
Stewardship prompts to improve antibiotic selection for urinary tract infection: The INSPIRE Randomized Clinical Trial
Gohil SK , Septimus E , Kleinman K , Varma N , Avery TR , Heim L , Rahm R , Cooper WS , Cooper M , McLean LE , Nickolay NG , Weinstein RA , Burgess LH , Coady MH , Rosen E , Sljivo S , Sands KE , Moody J , Vigeant J , Rashid S , Gilbert RF , Smith KN , Carver B , Poland RE , Hickok J , Sturdevant SG , Calderwood MS , Weiland A , Kubiak DW , Reddy S , Neuhauser MM , Srinivasan A , Jernigan JA , Hayden MK , Gowda A , Eibensteiner K , Wolf R , Perlin JB , Platt R , Huang SS . Jama 2024 IMPORTANCE: Urinary tract infection (UTI) is the second most common infection leading to hospitalization and is often associated with gram-negative multidrug-resistant organisms (MDROs). Clinicians overuse extended-spectrum antibiotics although most patients are at low risk for MDRO infection. Safe strategies to limit overuse of empiric antibiotics are needed. OBJECTIVE: To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO risk estimates could reduce use of empiric extended-spectrum antibiotics for treatment of UTI. DESIGN, SETTING, AND PARTICIPANTS: Cluster-randomized trial in 59 US community hospitals comparing the effect of a CPOE stewardship bundle (education, feedback, and real-time and risk-based CPOE prompts; 29 hospitals) vs routine stewardship (n = 30 hospitals) on antibiotic selection during the first 3 hospital days (empiric period) in noncritically ill adults (≥18 years) hospitalized with UTI with an 18-month baseline (April 1, 2017-September 30, 2018) and 15-month intervention period (April 1, 2019-June 30, 2020). INTERVENTIONS: CPOE prompts recommending empiric standard-spectrum antibiotics in patients ordered to receive extended-spectrum antibiotics who have low estimated absolute risk (<10%) of MDRO UTI, coupled with feedback and education. MAIN OUTCOMES AND MEASURES: The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy. Secondary outcomes included empiric vancomycin and antipseudomonal days of therapy. Safety outcomes included days to intensive care unit (ICU) transfer and hospital length of stay. Outcomes were assessed using generalized linear mixed-effect models to assess differences between the baseline and intervention periods. RESULTS: Among 127 403 adult patients (71 991 baseline and 55 412 intervention period) admitted with UTI in 59 hospitals, the mean (SD) age was 69.4 (17.9) years, 30.5% were male, and the median Elixhauser Comorbidity Index count was 4 (IQR, 2-5). Compared with routine stewardship, the group using CPOE prompts had a 17.4% (95% CI, 11.2%-23.2%) reduction in empiric extended-spectrum days of therapy (rate ratio, 0.83 [95% CI, 0.77-0.89]; P < .001). The safety outcomes of mean days to ICU transfer (6.6 vs 7.0 days) and hospital length of stay (6.3 vs 6.5 days) did not differ significantly between the routine and intervention groups, respectively. CONCLUSIONS AND RELEVANCE: Compared with routine stewardship, CPOE prompts providing real-time recommendations for standard-spectrum antibiotics for patients with low MDRO risk coupled with feedback and education significantly reduced empiric extended-spectrum antibiotic use among noncritically ill adults admitted with UTI without changing hospital length of stay or days to ICU transfers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03697096. |
Severity of respiratory syncytial virus vs COVID-19 and influenza among hospitalized US adults
Surie D , Yuengling KA , DeCuir J , Zhu Y , Lauring AS , Gaglani M , Ghamande S , Peltan ID , Brown SM , Ginde AA , Martinez A , Mohr NM , Gibbs KW , Hager DN , Ali H , Prekker ME , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Leis AM , Khan A , Hough CL , Bender WS , Duggal A , Bendall EE , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Exline MC , Shapiro NI , Columbus C , Vaughn IA , Ramesh M , Mosier JM , Safdar B , Casey JD , Talbot HK , Rice TW , Halasa N , Chappell JD , Grijalva CG , Baughman A , Womack KN , Swan SA , Johnson CA , Lwin CT , Lewis NM , Ellington S , McMorrow ML , Martin ET , Self WH . JAMA Netw Open 2024 7 (4) e244954 IMPORTANCE: On June 21, 2023, the Centers for Disease Control and Prevention recommended the first respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older using shared clinical decision-making. Understanding the severity of RSV disease in adults can help guide this clinical decision-making. OBJECTIVE: To describe disease severity among adults hospitalized with RSV and compare it with the severity of COVID-19 and influenza disease by vaccination status. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, adults aged 18 years and older admitted to the hospital with acute respiratory illness and laboratory-confirmed RSV, SARS-CoV-2, or influenza infection were prospectively enrolled from 25 hospitals in 20 US states from February 1, 2022, to May 31, 2023. Clinical data during each patient's hospitalization were collected using standardized forms. Data were analyzed from August to October 2023. EXPOSURES: RSV, SARS-CoV-2, or influenza infection. MAIN OUTCOMES AND MEASURES: Using multivariable logistic regression, severity of RSV disease was compared with COVID-19 and influenza severity, by COVID-19 and influenza vaccination status, for a range of clinical outcomes, including the composite of invasive mechanical ventilation (IMV) and in-hospital death. RESULTS: Of 7998 adults (median [IQR] age, 67 [54-78] years; 4047 [50.6%] female) included, 484 (6.1%) were hospitalized with RSV, 6422 (80.3%) were hospitalized with COVID-19, and 1092 (13.7%) were hospitalized with influenza. Among patients with RSV, 58 (12.0%) experienced IMV or death, compared with 201 of 1422 unvaccinated patients with COVID-19 (14.1%) and 458 of 5000 vaccinated patients with COVID-19 (9.2%), as well as 72 of 699 unvaccinated patients with influenza (10.3%) and 20 of 393 vaccinated patients with influenza (5.1%). In adjusted analyses, the odds of IMV or in-hospital death were not significantly different among patients hospitalized with RSV and unvaccinated patients hospitalized with COVID-19 (adjusted odds ratio [aOR], 0.82; 95% CI, 0.59-1.13; P = .22) or influenza (aOR, 1.20; 95% CI, 0.82-1.76; P = .35); however, the odds of IMV or death were significantly higher among patients hospitalized with RSV compared with vaccinated patients hospitalized with COVID-19 (aOR, 1.38; 95% CI, 1.02-1.86; P = .03) or influenza disease (aOR, 2.81; 95% CI, 1.62-4.86; P < .001). CONCLUSIONS AND RELEVANCE: Among adults hospitalized in this US cohort during the 16 months before the first RSV vaccine recommendations, RSV disease was less common but similar in severity compared with COVID-19 or influenza disease among unvaccinated patients and more severe than COVID-19 or influenza disease among vaccinated patients for the most serious outcomes of IMV or death. |
The role of stroke care infrastructure on the effectiveness of a hub-and-spoke telestroke model in South Carolina
Srinivasan M , Scott A , Soo J , Sreedhara M , Popat S , Beasley KL , Jackson TN , Abbas A , Keaton WA , Holmstedt C , Harvey J , Kruis R , McLeod S , Ahn R . J Stroke Cerebrovasc Dis 2024 107702 OBJECTIVE: To examine the relationship between stroke care infrastructure and stroke quality-of-care outcomes at 29 spoke hospitals participating in the <name concealed for blinding purposes> hub-and-spoke telestroke network. MATERIALS AND METHODS: Encounter-level data from <name concealed for blinding purposes> telestroke patient registry were filtered to include encounters during 2015-2022 for patients aged 18 and above with a clinical diagnosis of acute ischemic stroke, and who received intravenous tissue plasminogen activator. Unadjusted and adjusted generalized estimating equations assessed associations between time-related stroke quality-of-care metrics captured during the encounter and the existence of the two components of stroke care infrastructure-stroke coordinators and stroke center certifications-across all hospitals and within hospital subgroups defined by size and rurality. RESULTS: Telestroke encounters at spoke hospitals with stroke coordinators and stroke center certifications were associated with shorter door-to-needle (DTN) times (60.9 min for hospitals with both components and 57.3 min for hospitals with one, vs. 81.2 min for hospitals with neither component, p <.001). Similar patterns were observed for the percentage of encounters with DTN time of ≤60 min (63.8% and 68.9% vs. 32.0%, p <.001) and ≤45 min (34.0% and 38.4% vs. 8.42%, p <.001). Associations were similar for other metrics (e.g., door-to-registration time), and were stronger for smaller (vs. larger) hospitals and rural (vs. urban) hospitals. CONCLUSIONS: Stroke coordinators or stroke center certifications may be important for stroke quality of care, especially at spoke hospitals with limited resources or in rural areas. |
Interim effectiveness of updated 2023-2024 (monovalent xbb.1.5) COVID-19 vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalization among immunocompetent adults aged ≥18 years - VISION and IVY Networks, September 2023-January 2024
DeCuir J , Payne AB , Self WH , Rowley EAK , Dascomb K , DeSilva MB , Irving SA , Grannis SJ , Ong TC , Klein NP , Weber ZA , Reese SE , Ball SW , Barron MA , Naleway AL , Dixon BE , Essien I , Bride D , Natarajan K , Fireman B , Shah AB , Okwuazi E , Wiegand R , Zhu Y , Lauring AS , Martin ET , Gaglani M , Peltan ID , Brown SM , Ginde AA , Mohr NM , Gibbs KW , Hager DN , Prekker M , Mohamed A , Srinivasan V , Steingrub JS , Khan A , Busse LW , Duggal A , Wilson JG , Chang SY , Mallow C , Kwon JH , Exline MC , Columbus C , Vaughn IA , Safdar B , Mosier JM , Harris ES , Casey JD , Chappell JD , Grijalva CG , Swan SA , Johnson C , Lewis NM , Ellington S , Adams K , Tenforde MW , Paden CR , Dawood FS , Fleming-Dutra KE , Surie D , Link-Gelles R . MMWR Morb Mortal Wkly Rep 2024 73 (8) 180-188 In September 2023, CDC's Advisory Committee on Immunization Practices recommended updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. However, few estimates of updated vaccine effectiveness (VE) against medically attended illness are available. This analysis evaluated VE of an updated COVID-19 vaccine dose against COVID-19-associated emergency department (ED) or urgent care (UC) encounters and hospitalization among immunocompetent adults aged ≥18 years during September 2023-January 2024 using a test-negative, case-control design with data from two CDC VE networks. VE against COVID-19-associated ED/UC encounters was 51% (95% CI = 47%-54%) during the first 7-59 days after an updated dose and 39% (95% CI = 33%-45%) during the 60-119 days after an updated dose. VE estimates against COVID-19-associated hospitalization from two CDC VE networks were 52% (95% CI = 47%-57%) and 43% (95% CI = 27%-56%), with a median interval from updated dose of 42 and 47 days, respectively. Updated COVID-19 vaccine provided increased protection against COVID-19-associated ED/UC encounters and hospitalization among immunocompetent adults. These results support CDC recommendations for updated 2023-2024 COVID-19 vaccination. All persons aged ≥6 months should receive updated 2023-2024 COVID-19 vaccine. |
Dr. Arjun Srinivasan on being pathogen agnostic, following his passion, and knowing when to lead and when to follow
Srinivasan A . Antimicrob Steward Healthc Epidemiol 2024 4 (1) e25 |
An update from the National Healthcare Safety Network on hospital antibiotic stewardship programs in the United States, 2014-2021
O'Leary EN , Neuhauser MM , McLees A , Paek M , Tappe J , Srinivasan A . Open Forum Infect Dis 2024 11 (2) ofad684 BACKGROUND: In 2014, the Centers for Disease Control and Prevention (CDC) released the Core Elements of Hospital Antibiotic Stewardship Programs (ASPs) and began monitoring uptake through the National Healthcare Safety Network (NHSN) Annual Hospital Survey. In 2019, CDC updated the Core Elements and in 2022 released the Priorities for Hospital Core Element Implementation. We describe Core Element uptake from 2014 to 2021, provide a snapshot of specific ASP practices in acute care hospitals in 2021, and describe how we plan to monitor stewardship moving forward. METHODS: We used the NHSN Annual Hospital Survey to summarize facility demographics and ASP practices and to monitor uptake of Core Elements. Questions have been updated over time, so not all data could be compared across years. RESULTS: Uptake of all 7 Core Elements increased from 41% in 2014 to 95% in 2021. Uptake of all 6 Priority Elements was 10% in 2021, though 46% of hospitals met 4 or 5 of the possible 6 elements. Antibiotic stewardship was specifically listed in a contract or job description for about 60% of program leaders. The percentage of physician-pharmacist co-led programs rose from 23% to 64%. Seventy-six percent of hospitals reported implementing audit with feedback interventions. CONCLUSIONS: With nearly all acute care hospitals reporting uptake of the 7 Core Elements in 2021, and with more evidence for which ASP practices are most effective, the Priorities for Hospital Core Element Implementation were released in 2022 to help enhance the quality and impact of existing ASPs. |
Challenges and opportunities during the COVID-19 vaccination efforts in long-term care
Stone ND , Parker Fiebelkorn A , Guo A , Mothershed E , Moccia L , Bell J , Yassanye D , Hall E , Duggar C , Srinivasan A , Meyer SA , Link-Gelles R . Vaccine 2024 From December 2020 through March 2023, the COVID-19 vaccination efforts in long-term care (LTC) settings, identified many gaps and opportunities to improve public health capacity to support vaccine distribution, education, and documentation of COVID-19 vaccines administered to LTC residents and staff. Partner engagement at the local, state, and federal levels helped establish pathways for dissemination of information, improve access and delivery of vaccines, and expand reporting of vaccine administration data to monitor the impact of COVID-19 vaccination in LTC settings. Sustaining the improvements to the vaccine infrastructure in LTC settings that were created or enhanced during the COVID-19 vaccination efforts is critical for the protection of residents and staff against COVID-19 and other vaccine preventable respiratory outbreaks in the future. |
Coverage with influenza, respiratory syncytial virus, and updated COVID-19 vaccines among nursing home residents - National Healthcare Safety Network, United States, December 2023
Reses HE , Dubendris H , Haas L , Barbre K , Ananth S , Rowe T , Mothershed E , Hall E , Wiegand RE , Lindley MC , Meyer S , Patel SA , Benin A , Kroop S , Srinivasan A , Bell JM . MMWR Morb Mortal Wkly Rep 2023 72 (51) 1371-1376 Nursing home residents are at risk for becoming infected with and experiencing severe complications from respiratory viruses, including SARS-CoV-2, influenza, and respiratory syncytial virus (RSV). Fall 2023 is the first season during which vaccines are simultaneously available to protect older adults in the United States against all three of these respiratory viruses. Nursing homes are required to report COVID-19 vaccination coverage and can voluntarily report influenza and RSV vaccination coverage among residents to CDC's National Healthcare Safety Network. The purpose of this study was to assess COVID-19, influenza, and RSV vaccination coverage among nursing home residents during the current 2023-24 respiratory virus season. As of December 10, 2023, 33.1% of nursing home residents were up to date with vaccination against COVID-19. Among residents at 20.2% and 19.4% of facilities that elected to report, coverage with influenza and RSV vaccines was 72.0% and 9.8%, respectively. Vaccination varied by U.S. Department of Health and Human Services region, social vulnerability index level, and facility size. There is an urgent need to protect nursing home residents against severe outcomes of respiratory illnesses by continuing efforts to increase vaccination against COVID-19 and influenza and discussing vaccination against RSV with eligible residents during the ongoing 2023-24 respiratory virus season. |
Monitoring and reporting the US COVID-19 vaccination effort
Scharf LG , Adeniyi K , Augustini E , Boyd D , Corvin L , Kalach RE , Fast H , Fath J , Harris L , Henderson D , Hicks-Thomson J , Jones-Jack N , Kellerman A , Khan AN , McGarvey SS , McGehee JE , EMiner C , Moore LB , Murthy BP , Myerburg S , Neuhaus E , Nguyen K , Parker M , Pierce-Richards S , Samchok D , Shaw LK , Spoto S , Srinivasan A , Stearle C , Thomas J , Winarsky M , Zell E . Vaccine 2023 Immunizations are an important tool to reduce the burden of vaccine preventable diseases and improve population health.(1) High-quality immunization data is essential to inform clinical and public health interventions and respond to outbreaks of vaccine-preventable diseases. To track COVID-19 vaccines and vaccinations, CDC established an integrated network that included vaccination provider systems, health information exchange systems, immunization information systems, pharmacy and dialysis systems, vaccine ordering systems, electronic health records, and tools to support mass vaccination clinics. All these systems reported data to CDC's COVID-19 response system (either directly or indirectly) where it was processed, analyzed, and disseminated. This unprecedented vaccine tracking effort provided essential information for public health officials that was used to monitor the COVID-19 response and guide decisions. This paper will describe systems, processes, and policies that enabled monitoring and reporting of COVID-19 vaccination efforts and share challenges and lessons learned for future public health emergency responses. |
National Healthcare Safety Network Antimicrobial Use Option reporting .. finding the path forward
Neuhauser MM , Webb AK , Srinivasan A . Antimicrob Steward Healthc Epidemiol 2023 3 (1) e183 Through the Centers for Medicare and Medicaid Services Promoting Interoperability Program, more hospitals will be reporting to the National Healthcare Safety Network Antimicrobial Use (AU) Option. We highlight the next steps and opportunities for measurement of AU to optimize prescribing. © Society for Healthcare Epidemiology of America, 2023. |
Defining access without excess: expanding appropriate use of antibiotics targeting multidrug-resistant organisms
Patel TS , Sati H , Lessa FC , Patel PK , Srinivasan A , Hicks LA , Neuhauser MM , Tong D , van der Heijden M , Alves SC , Getahun H , Park BJ . Lancet Microbe 2023 Antimicrobial resistance remains a significant global public health threat. Although development of novel antibiotics can be challenging, several new antibiotics with improved activity against multidrug-resistant Gram-negative organisms have recently been commercialised. Expanding access to these antibiotics is a global public health priority that should be coupled with improving access to quality diagnostics, health care with adequately trained professionals, and functional antimicrobial stewardship programmes. This comprehensive approach is essential to ensure responsible use of these new antibiotics. |
Sepsis program activities in acute care hospitals - National Healthcare Safety Network, United States, 2022
Dantes RB , Kaur H , Bouwkamp BA , Haass KA , Patel P , Dudeck MA , Srinivasan A , Magill SS , Wilson WW , Whitaker M , Gladden NM , McLaughlin ES , Horowitz JK , Posa PJ , Prescott HC . MMWR Morb Mortal Wkly Rep 2023 72 (34) 907-911 Sepsis, life-threatening organ dysfunction secondary to infection, contributes to at least 1.7 million adult hospitalizations and at least 350,000 deaths annually in the United States. Sepsis care is complex, requiring the coordination of multiple hospital departments and disciplines. Sepsis programs can coordinate these efforts to optimize patient outcomes. The 2022 National Healthcare Safety Network (NHSN) annual survey evaluated the prevalence and characteristics of sepsis programs in acute care hospitals. Among 5,221 hospitals, 3,787 (73%) reported having a committee that monitors and reviews sepsis care. Prevalence of these committees varied by hospital size, ranging from 53% among hospitals with 0-25 beds to 95% among hospitals with >500 beds. Fifty-five percent of all hospitals provided dedicated time (including assigned protected time or job description requirements) for leaders of these committees to manage a program and conduct daily activities, and 55% of committees reported involvement with antibiotic stewardship programs. These data highlight opportunities, particularly in smaller hospitals, to improve the care and outcomes of patients with sepsis in the United States by ensuring that all hospitals have sepsis programs with protected time for program leaders, engagement of medical specialists, and integration with antimicrobial stewardship programs. CDC's Hospital Sepsis Program Core Elements provides a guide to assist hospitals in developing and implementing effective sepsis programs that complement and facilitate the implementation of existing clinical guidelines and improve patient care. Future NHSN annual surveys will monitor uptake of these sepsis core elements. |
Impact of the COVID-19 pandemic on inpatient antibiotic use in the United States, January 2019 through July 2022
O'Leary EN , Neuhauser MM , Srinivasan A , Dubendris H , Webb AK , Soe MM , Hicks LA , Wu H , Kabbani S , Edwards JR . Clin Infect Dis 2023 Antimicrobial use (AU) data reported to the National Healthcare Safety Network's Antimicrobial Use and Resistance Module between January 2019 and July 2022 were analyzed to assess the impact of the COVID-19 pandemic on inpatient antimicrobial use. |
Antibiotic stewardship: A decade of progress
Cosgrove SE , Srinivasan A . Infect Dis Clin North Am 2023 37 (4) 659-667 Antibiotic stewardship has seen transformative change over the past decade. Antibiotic stewardship infrastructure has grown significantly across the spectrum of health care in hospitals, nursing homes, and ambulatory settings, and issues related to improving antibiotic use have become central to high-level policy discussions, regulations, and legislation. Herein we review important events and developments in stewardship across the spectrum of care with a focus on (1) infrastructure and implementation, (2) requirement and regulation, and (3) measurement of antibiotic use and other outcomes. |
Next generation 3D-printed intravaginal ring for prevention of HIV and unintended pregnancy
Young IC , Srinivasan P , Shrivastava R , Janusziewicz R , Thorson A , Cottrell ML , Sellers RS , Sykes C , Schauer A , Little D , Kelley K , Kashuba ADM , Katz D , Pyles RB , García-Lerma JG , Vincent KL , Smith J , Benhabbour SR . Biomaterials 2023 301 122260 Globally, there are 20 million adolescent girls and young women living with HIV who have limited access to long-acting, effective, women-controlled preventative methods. Additionally, although there are many contraceptive methods available, globally, half of all pregnancies remain unintended. Here we report the first 3D-printed multipurpose prevention technology (MPT) intravaginal ring (IVR) for HIV prevention and contraception. We utilized continuous liquid interface production (CLIP™) to fabricate MPT IVRs in a biocompatible silicone-based resin. Etonogestrel (ENG), ethinyl estradiol (EE), and islatravir (ISL) were loaded into the silicone poly(urethane) IVR in a controlled single step drug loading process driven by absorption. ENG/EE/ISL IVR promoted sustained release of drugs for 150 days in vitro and 14 days in sheep. There were no adverse MPT IVR-related findings of cervicovaginal toxicity or changes in vaginal biopsies or microbiome community profiles evaluated in sheep. Furthermore, ISL IVR in macaques promoted sustained release for 28 days with ISL-triphosphate levels above the established pharmacokinetic benchmark of 50-100 fmol/10(6) PBMCs. The ISL IVR was found to be safe and well tolerated in the macaques with no observed mucosal cytokine changes or alterations in peripheral CD4 T-cell populations. Collectively, the proposed MPT IVR has potential to expand preventative choices for young women and girls. |
Modeling effectiveness of testing strategies to prevent COVID-19 in nursing homes —United States, 2020 (preprint)
See I , Paul P , Slayton RB , Steele MK , Stuckey MJ , Duca L , Srinivasan A , Stone N , Jernigan JA , Reddy SC . medRxiv 2021 2020.12.18.20248255 Background SARS-CoV-2 outbreaks in nursing homes can be large with high case fatality. Identifying asymptomatic individuals early through serial testing is recommended to control COVID-19 in nursing homes, both in response to an outbreak (“outbreak testing” of residents and healthcare personnel) and in facilities without outbreaks (“non-outbreak testing” of healthcare personnel). The effectiveness of outbreak testing and isolation with or without non-outbreak testing was evaluated.Methods Using published SARS-CoV-2 transmission parameters, the fraction of SARS-CoV-2 transmissions prevented through serial testing (weekly, every three days, or daily) and isolation of asymptomatic persons compared to symptom-based testing and isolation was evaluated through mathematical modeling using a Reed-Frost model to estimate the percentage of cases prevented (i.e., “effectiveness”) through either outbreak testing alone or outbreak plus non-outbreak testing. The potential effect of simultaneous decreases (by 10%) in the effectiveness of isolating infected individuals when instituting testing strategies was also evaluated.Results Modeling suggests that outbreak testing could prevent 54% (weekly testing with 48-hour test turnaround) to 92% (daily testing with immediate results and 50% relative sensitivity) of SARS-CoV-2 infections. Adding non-outbreak testing could prevent up to an additional 8% of SARS-CoV-2 infections (depending on test frequency and turnaround time). However, added benefits of non-outbreak testing were mostly negated if accompanied by decreases in infection control practice.Conclusions When combined with high-quality infection control practices, outbreak testing could be an effective approach to preventing COVID-19 in nursing homes, particularly if optimized through increased test frequency and use of tests with rapid turnaround.Summary Mathematical modeling evaluated the effectiveness of serially testing asymptomatic persons in a nursing home in response to a SARS-CoV-2 outbreak with or without serial testing of asymptomatic staff in the absence of known SARS-CoV-2 infections.Competing Interest StatementThe authors have declared no competing interest.Funding StatementNo external funding was received. All work was conducted as part of government duties.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy (see e.g., 45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C 552a; 44 U.S.C. 351 et seq.).All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData provided in supplemental materials or publicly available through links in the manuscript. https://github.com/cdcepi/Nursing-home-SARS-CoV-2-testing-model/ |
Vaccine Effectiveness of Primary Series and Booster Doses against Omicron Variant COVID-19-Associated Hospitalization in the United States (preprint)
Adams K , Rhoads JP , Surie D , Gaglani M , Ginde AA , McNeal T , Ghamande S , Huynh D , Talbot HK , Casey JD , Mohr NM , Zepeski A , Shapiro NI , Gibbs KW , Files DC , Hicks M , Hager DN , Ali H , Prekker ME , Frosch AE , Exline MC , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Lauring AS , Khan A , Hough CL , Busse LW , ten Lohuis CC , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Chappell JD , Halasa N , Grijalva CG , Rice TW , Stubblefield WB , Baughman A , Lindsell CJ , Hart KW , Lester SN , Thornburg NJ , Park S , McMorrow ML , Patel MM , Tenforde MW , Self WH . medRxiv 2022 14 Objectives: To compare the effectiveness of a primary COVID-19 vaccine series plus a booster dose with a primary series alone for the prevention of Omicron variant COVID-19 hospitalization. Design(s): Multicenter observational case-control study using the test-negative design to evaluate vaccine effectiveness (VE). Setting(s): Twenty-one hospitals in the United States (US). Participant(s): 3,181 adults hospitalized with an acute respiratory illness between December 26, 2021 and April 30, 2022, a period of SARS-CoV-2 Omicron variant (BA.1, BA.2) predominance. Participants included 1,572 (49%) case-patients with laboratory confirmed COVID-19 and 1,609 (51%) control patients who tested negative for SARS-CoV-2. Median age was 64 years, 48% were female, and 21% were immunocompromised; 798 (25%) were vaccinated with a primary series plus booster, 1,326 (42%) were vaccinated with a primary series alone, and 1,057 (33%) were unvaccinated. Main Outcome Measure(s): VE against COVID-19 hospitalization was calculated for a primary series plus a booster and a primary series alone by comparing the odds of being vaccinated with each of these regimens versus being unvaccinated among cases versus controls. VE analyses were stratified by immune status (immunocompetent; immunocompromised) because the recommended vaccine schedules are different for these groups. The primary analysis evaluated all COVID-19 vaccine types combined and secondary analyses evaluated specific vaccine products. Result(s): Among immunocompetent patients, VE against Omicron COVID-19 hospitalization for a primary series plus one booster of any vaccine product dose was 77% (95% CI: 71-82%), and for a primary series alone was 44% (95% CI: 31-54%) (p<0.001). VE was higher for a boosted regimen than a primary series alone for both mRNA vaccines used in the US (BNT162b2: primary series plus booster VE 80% (95% CI: 73-85%), primary series alone VE 46% (95% CI: 30-58%) [p<0.001]; mRNA-1273: primary series plus booster VE 77% (95% CI: 67-83%), primary series alone VE 47% (95% CI: 30-60%) [p<0.001]). Among immunocompromised patients, VE for a primary series of any vaccine product against Omicron COVID-19 hospitalization was 60% (95% CI: 41-73%). Insufficient sample size has accumulated to calculate effectiveness of boosted regimens for immunocompromised patients. Conclusion(s): Among immunocompetent people, a booster dose of COVID-19 vaccine provided additional benefit beyond a primary vaccine series alone for preventing COVID-19 hospitalization due to the Omicron variant. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. |
Effectiveness of a Third Dose of Pfizer-BioNTech and Moderna Vaccines in Preventing COVID-19 Hospitalization Among Immunocompetent and Immunocompromised Adults - United States, August-December 2021.
Tenforde MW , Patel MM , Gaglani M , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , McNeal T , Ghamande S , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Gong MN , Mohamed A , Johnson NJ , Srinivasan V , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CL , Busse LW , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Rivas C , Babcock HM , Kwon JH , Exline MC , Botros M , Lauring AS , Shapiro NI , Halasa N , Chappell JD , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Rhoads JP , Lindsell CJ , Hart KW , Zhu Y , Naioti EA , Adams K , Lewis NM , Surie D , McMorrow ML , Self WH , IVY Network . MMWR Morb Mortal Wkly Rep 2022 71 (4) 118-124 COVID-19 mRNA vaccines (BNT162b2 [Pfizer-BioNTech] and mRNA-1273 [Moderna]) provide protection against infection with SARS-CoV-2, the virus that causes COVID-19, and are highly effective against COVID-19-associated hospitalization among eligible persons who receive 2 doses (1,2). However, vaccine effectiveness (VE) among persons with immunocompromising conditions* is lower than that among immunocompetent persons (2), and VE declines after several months among all persons (3). On August 12, 2021, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a third mRNA vaccine dose as part of a primary series ≥28 days after dose 2 for persons aged ≥12 years with immunocompromising conditions, and, on November 19, 2021, as a booster dose for all adults aged ≥18 years at least 6 months after dose 2, changed to ≥5 months after dose 2 on January 3, 2022 (4,5,6). Among 2,952 adults (including 1,385 COVID-19 case-patients and 1,567 COVID-19-negative controls) hospitalized at 21 U.S. hospitals during August 19-December 15, 2021, effectiveness of mRNA vaccines against COVID-19-associated hospitalization was compared between adults eligible for but who had not received a third vaccine dose (1,251) and vaccine-eligible adults who received a third dose ≥7 days before illness onset (312). Among 1,875 adults without immunocompromising conditions (including 1,065 [57%] unvaccinated, 679 [36%] 2-dose recipients, and 131 [7%] 3-dose [booster] recipients), VE against COVID-19 hospitalization was higher among those who received a booster dose (97%; 95% CI = 95%-99%) compared with that among 2-dose recipients (82%; 95% CI = 77%-86%) (p <0.001). Among 1,077 adults with immunocompromising conditions (including 324 [30%] unvaccinated, 572 [53%] 2-dose recipients, and 181 [17%] 3-dose recipients), VE was higher among those who received a third dose to complete a primary series (88%; 95% CI = 81%-93%) compared with 2-dose recipients (69%; 95% CI = 57%-78%) (p <0.001). Administration of a third COVID-19 mRNA vaccine dose as part of a primary series among immunocompromised adults, or as a booster dose among immunocompetent adults, provides improved protection against COVID-19-associated hospitalization. |
Measuring the burden of infodemics: Summary of the methods and results of the Fifth WHO Infodemic Management Conference
Wilhelm E , Ballalai I , Belanger ME , Benjamin P , Bertrand-Ferrandis C , Bezbaruah S , Briand S , Brooks I , Bruns R , Bucci LM , Calleja N , Chiou H , Devaria A , Dini L , D'Souza H , Dunn AG , Eichstaedt JC , Evers Smaa , Gobat N , Gissler M , Gonzales IC , Gruzd A , Hess S , Ishizumi A , John O , Joshi A , Kaluza B , Khamis N , Kosinska M , Kulkarni S , Lingri D , Ludolph R , Mackey T , Mandić-Rajčević S , Menczer F , Mudaliar V , Murthy S , Nazakat S , Nguyen T , Nilsen J , Pallari E , Pasternak Taschner N , Petelos E , Prinstein MJ , Roozenbeek J , Schneider A , Srinivasan V , Stevanović A , Strahwald B , Syed Abdul S , Varaidzo Machiri S , van der Linden S , Voegeli C , Wardle C , Wegwarth O , White BK , Willie E , Yau B , Purnat TD . JMIR Infodemiology 2023 3 e44207 BACKGROUND: An infodemic is excess information, including false or misleading information, that spreads in digital and physical environments during a public health emergency. The COVID-19 pandemic has been accompanied by an unprecedented global infodemic that has led to confusion about the benefits of medical and public health interventions, with substantial impact on risk-taking and health-seeking behaviors, eroding trust in health authorities and compromising the effectiveness of public health responses and policies. Standardized measures are needed to quantify the harmful impacts of the infodemic in a systematic and methodologically robust manner, as well as harmonizing highly divergent approaches currently explored for this purpose. This can serve as a foundation for a systematic, evidence-based approach to monitoring, identifying, and mitigating future infodemic harms in emergency preparedness and prevention. OBJECTIVE: In this paper, we summarize the Fifth World Health Organization (WHO) Infodemic Management Conference structure, proceedings, outcomes, and proposed actions seeking to identify the interdisciplinary approaches and frameworks needed to enable the measurement of the burden of infodemics. METHODS: An iterative human-centered design (HCD) approach and concept mapping were used to facilitate focused discussions and allow for the generation of actionable outcomes and recommendations. The discussions included 86 participants representing diverse scientific disciplines and health authorities from 28 countries across all WHO regions, along with observers from civil society and global public health-implementing partners. A thematic map capturing the concepts matching the key contributing factors to the public health burden of infodemics was used throughout the conference to frame and contextualize discussions. Five key areas for immediate action were identified. RESULTS: The 5 key areas for the development of metrics to assess the burden of infodemics and associated interventions included (1) developing standardized definitions and ensuring the adoption thereof; (2) improving the map of concepts influencing the burden of infodemics; (3) conducting a review of evidence, tools, and data sources; (4) setting up a technical working group; and (5) addressing immediate priorities for postpandemic recovery and resilience building. The summary report consolidated group input toward a common vocabulary with standardized terms, concepts, study designs, measures, and tools to estimate the burden of infodemics and the effectiveness of infodemic management interventions. CONCLUSIONS: Standardizing measurement is the basis for documenting the burden of infodemics on health systems and population health during emergencies. Investment is needed into the development of practical, affordable, evidence-based, and systematic methods that are legally and ethically balanced for monitoring infodemics; generating diagnostics, infodemic insights, and recommendations; and developing interventions, action-oriented guidance, policies, support options, mechanisms, and tools for infodemic managers and emergency program managers. |
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