Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-30 (of 471 Records) |
Query Trace: Edwards A[original query] |
---|
Detection of a human adenovirus outbreak, including some critical infections, using multipathogen testing at a large university, September 2022-January 2023
Montgomery JP , Marquez JL , Nord J , Stamper AR , Edwards EA , Valentini N , Frank CJ , Washer LL , Ernst RD , Park JI , Price D , Collins J , Smith-jeffcoat sE , Hu f , Knox cL , Khan r , Lu x , Kirking hL , Hsu cH . Open Forum Infect Dis 2024 11 (5) ofae192 BACKGROUND: Human adenoviruses (HAdVs) can cause outbreaks of flu-like illness in university settings. Most infections in healthy young adults are mild; severe illnesses rarely occur. In Fall 2022, an adenovirus outbreak was identified in university students. METHODS: HAdV cases were defined as university students 17-26 years old who presented to the University Health Service or nearby emergency department with flu-like symptoms (eg, fever, cough, headache, myalgia, nausea) and had confirmed adenovirus infections by polymerase chain reaction (PCR). Demographic and clinical characteristics were abstracted from electronic medical records; clinical severity was categorized as mild, moderate, severe, or critical. We performed contact investigations among critical cases. A subset of specimens was sequenced to confirm the HAdV type. RESULTS: From 28 September 2022 to 30 January 2023, 90 PCR-confirmed cases were identified (51% female; mean age, 19.6 years). Most cases (88.9%) had mild illness. Seven cases required hospitalization, including 2 critical cases that required intensive care. Contact investigation identified 44 close contacts; 6 (14%) were confirmed HAdV cases and 8 (18%) reported symptoms but never sought care. All typed HAdV-positive specimens (n = 36) were type 4. CONCLUSIONS: While most students with confirmed HAdV had mild illness, 7 otherwise healthy students had severe or critical illness. Between the relatively high number of hospitalizations and proportion of close contacts with symptoms who did not seek care, the true number of HAdV cases was likely higher. Our findings illustrate the need to consider a wide range of pathogens, even when other viruses are known to be circulating. |
Characteristics of TB cases without documented sputum culture in the United States, 2011-2021
Rautman LH , Kammerer JS , Silk BJ , Marconi VC , Youngblood ME , Edwards JA , Wortham JM , Self JL . Int J Tuberc Lung Dis 2024 28 (5) 231-236 <sec id="st1"><title>BACKGROUND</title>Culture-based diagnostics are the gold standard for diagnosing pulmonary TB (PTB). We characterized culture practices by comparing cases with documented sputum culture to those without.</sec><sec id="st2"><title>METHODS</title>Using multivariable logistic regression, we examined associations between PTB case characteristics and no documented sputum culture reported to the U.S. National TB Surveillance System during 2011-2021.</sec><sec id="st3"><title>RESULTS</title>Among 69,538 PTB cases analyzed, no sputum culture attempt was documented for 5,869 (8%). Non-sputum culture specimens were documented for 54%, 80%, and 89% of cases without documented sputum culture attempts among persons aged <15 years, 15-64, and 65+ years, respectively; bronchial fluid and lung tissue were common non-sputum specimens among cases in persons >15 years old. Having no documented sputum culture was associated with age <15 years (aOR 23.84, 99% CI 20.09-28.27) or ≥65 years (aOR 1.22, 99% CI 1.07-1.39), culture of a non-sputum specimen (aOR 6.57, 99% CI 5.93-7.28), residence in a long-term care facility (aOR 1.58, 99% CI 1.23-2.01), and receiving TB care outside of a health department (aOR 1.79, 99% CI 1.61-1.98).</sec><sec id="st4"><title>CONCLUSIONS</title>Inability to obtain sputum from children and higher diagnostic suspicion for disease processes that require tissue-based diagnostics could explain these findings.</sec>. |
Overview of U.S. COVID-19 vaccine safety surveillance systems
Gee J , Shimabukuro TT , Su JR , Shay D , Ryan M , Basavaraju SV , Broder KR , Clark M , Buddy Creech C , Cunningham F , Goddard K , Guy H , Edwards KM , Forshee R , Hamburger T , Hause AM , Klein NP , Kracalik I , Lamer C , Loran DA , McNeil MM , Montgomery J , Moro P , Myers TR , Olson C , Oster ME , Sharma AJ , Schupbach R , Weintraub E , Whitehead B , Anderson S . Vaccine 2024 The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. Clinical consultation for individual cases of adverse events following vaccination was performed, and monitoring of special populations, such as pregnant persons, was conducted. This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program. |
Prevalence and predictors of colon and prostate cancer screening among volunteer firefighters: The United States Firefighter Cancer Assessment and Prevention Study
Shah NN , Steinberg MB , Calkins MM , Caban-Martinez AJ , Burgess JL , Austin E , Hollerbach BS , Edwards DL , Black TM , Black K , Hinton KM , Kubiel BS , Graber JM . Am J Ind Med 2024 BACKGROUND: Although firefighters have increased risk for colon and prostate cancer, limited information exists on screening practices for these cancers in volunteer firefighters who compose two-thirds of the US fire service. We estimated the prevalence of colon and prostate cancer screening among volunteer firefighters using eligibility criteria from 4 evidence-based screening recommendations and evaluated factors influencing screening. METHODS: We evaluated colon (n = 569) and prostate (n = 498) cancer screening prevalence in a sample of US volunteer firefighters using eligibility criteria from the US Preventive Services Taskforce (USPSTF), National Fire Protection Association, American Cancer Society, and National Comprehensive Cancer Network. We assessed associations with fire service experience, demographics, and cancer risk perception based on USPSTF guidelines. RESULTS: For those eligible based on USPSTF guidelines, colon and prostate cancer screening prevalence was 51.7% (95% CI: 45.7, 57.8) and 48.8% (95% CI: 40.0, 57.6), respectively. Higher odds of colon and prostate cancer screening were observed with older age and with some college education compared to those with less education. Fire service experience and cancer risk perception were not associated with screening practices. CONCLUSION: This is the first large study to assess colon and prostate cancer screening among US volunteer firefighters based on different screening guidelines. Our findings suggest gaps in cancer prevention efforts in the US volunteer fire service. Promoting cancer screening education and opportunities for volunteer firefighters by their fire departments, healthcare professionals, and public health practitioners, may help to address the gaps. |
Hybrid immunity and SARS-CoV-2 antibodies: results of the HEROES-RECOVER prospective cohort study
Romine JK , Li H , Coughlin MM , Jones JM , Britton A , Tyner HL , Fuller SB , Bloodworth R , Edwards LJ , Etoule JN , Morrill TC , Newes-Adeyi G , Olsho LEW , Gaglani M , Fowlkes A , Hollister J , Bedrick EJ , Uhrlaub JL , Beitel S , Sprissler RS , Lyski Z , Porter CJ , Rivers P , Lutrick K , Caban-Martinez AJ , Yoon SK , Phillips AL , Naleway AL , Burgess JL , Ellingson KD . Clin Infect Dis 2024 BACKGROUND: There are limited data on whether hybrid immunity differs by count and order of immunity-conferring events (SARS-CoV-2 infection or COVID-19 vaccination). From a cohort of health care personnel, first responders, and other frontline workers in six US states, we examined heterogeneity of the effect of hybrid immunity on SARS-CoV-2 antibody levels. METHODS: Exposures included event-count (sum of infections and vaccine doses) and event-order, categorized into seven permutations of vaccination and/or infection. Outcome was level of serum binding antibodies against receptor binding domain (RBD) of the ancestral SARS-CoV-2 spike protein (total RBD-binding Ig), measured by enzyme-linked immunosorbent assay. Mean antibody levels were examined up to 365 days after each of the 1st-7th events. RESULTS: Analysis included 5,793 participants measured from August 7, 2020 to April 15, 2023. Hybrid immunity from infection before one or two vaccine doses elicited modestly superior antibody responses after the 2nd and 3rd events (compared to infections or vaccine-doses alone). This superiority was not evident after the 4th and 5th events (additional doses). Among adults infected before vaccination, adjusted geometric mean ratios (95% CI) of anti-RBD early response (versus vaccinated-only) were 1.23 (1.14-1.33), 1.09 (1.03-1.14), 0.87 (0.81-0.94), and 0.99 (0.85-1.15) after the 2nd-5th events, respectively. Post-vaccination infections elicited superior responses: adjusted geometric mean ratios (95% CI) of anti-RBD early response (versus vaccinated-only) were: 0.93 (0.75-1.17), 1.11 (1.06-1.16), 1.17 (1.11-1.24), and 1.20 (1.07-1.34) after the 2nd-5th events, respectively. CONCLUSIONS AND RELEVANCE: Findings reflecting heterogeneity in antibody levels by permutations of infection and vaccination history could inform COVID-19 vaccination policy. |
Pharmacokinetics of single dose doxycycline in the rectum, vagina, and urethra: implications for prevention of bacterial sexually transmitted infections
Haaland RE , Fountain J , Edwards TE , Dinh C , Martin A , Omoyege D , Conway-Washington C , Kelley CF , Heneine W . EBioMedicine 2024 101 105037 BACKGROUND: Clinical trials showed a single oral dose of doxycycline taken after sex protects against STIs among men who have sex with men (MSM) but not women. Pharmacokinetic data at vaginal, rectal and penile sites of STI exposure are lacking. We examined vaginal, rectal and urethral doxycycline concentrations in men and women to better inform STI prevention. METHODS: Doxycycline pharmacokinetics in male and female participants 18-59 years of age were evaluated in blood and urine and on rectal and vaginal swabs collected at 1, 2, 4, 8, 24, 48, 72, 96 and 168 h after receiving a 200 mg oral doxycycline dose in a non-randomised single dose open label single centre study in Atlanta, Georgia. Rectal, vaginal, and cervical biopsies and male urethral swabs were collected 24 h after dosing (Trial registration: NCT04860505). Doxycycline was measured by liquid chromatography-mass spectrometry. FINDINGS: Eleven male and nine female participants participated in the study. Doxycycline concentrations on rectal and vaginal swabs collected up to 96 h after dosing were approximately twice those of plasma and remained above minimum inhibitory concentrations (MICs) for at least four, three, and two days for Chlamydia trachomatis, Treponema pallidum, and tetracycline-sensitive Neisseria gonorrhoeae, respectively. Geometric mean doxycycline concentrations in male urethral secretions (1.166 μg/mL; 95% CI 0.568-2.394 μg/mL), male rectal (0.596 μg/g; 0.442-0.803 μg/g), vaginal (0.261 μg/g; 0.098-0.696 μg/g) and cervical tissue (0.410 μg/g; 0.193-0.870 μg/g) in biopsies collected 24 h after dosing exceeded MICs. Plasma and urine doxycycline levels defined adherence markers up to four and seven days postdosing, respectively. No adverse events were reported in this study. INTERPRETATION: Doxycycline efficiently distributes to the rectum, vagina and urethra. Findings can help explain efficacy of STI prevention by doxycycline. FUNDING: Funded by CDC intramural funds, CDC contract HCVJCG-2020-45044 (to CFK). |
Associations between childhood opportunity index and pediatric cardiac surgical outcomes
Kolwaite AR , Edwards JA , Higgins M , Kandaswamy S , Orenstein E , Boughton D , Zinyandu T , Brasher S , Shashidharan S , Thompson LM , Chanani NK . J Pediatr 2024 114000 OBJECTIVE: To assess the relationship between the Childhood Opportunity Index (COI), a comprehensive measurement of social determinants of health (SDOH), and specific COI domains on patient-specific outcomes following congenital cardiac surgery in the metropolitan region of Atlanta, Georgia. STUDY DESIGN: In this retrospective chart review, we included patients who underwent an index operation for congenital heart disease (CHD) between 2010 and 2020 in a single pediatric health care system. Patients' addresses were geocoded and mapped to census tracts. Descriptive statistics, univariable analysis, and multivariable regression models were employed to assess associations between variables and outcomes. RESULTS: Of the 7460 index surgeries, 3798 (51%) met eligibility criteria. Presence of an adverse outcome, defined as either mortality or one of several other major post-operative morbidities, was significantly associated with COI in the univariable model (p=0.008), but not the multivariable regression model (p=0.39). Postoperative hospital length of stay (PHLOS) was significantly associated with COI (p<0.001) in univariable and multivariable regression models. There was no significant association between COI and readmission within 30 days of hospital discharge in univariable (p<0.094) and multivariable (p=0.49) models. CONCLUSION: COI is associated with PHLOS but not all outcomes in patients after congenital heart surgery. By understanding the role of COI in outcomes related to cardiac surgery, targeted interventions can be developed to improve health equity. |
Differences in report of post-covid conditions among adults tested for SARS-cov-2 by race and ethnicity: 2022 Porter Novelli SummerStyles Survey, U.S
Feldstein LR , Edwards D , Cope JR , Hagen MB , Saydah S . AJPM Focus 2024 3 (2) 100181 INTRODUCTION: Since March 2020, Hispanic and Black/African American persons have made up a disproportionate number of COVID-19 cases, hospitalizations, and deaths. However, little is known about whether the prevalence of postacute sequelae or post-COVID conditions differs by race/ethnicity. METHODS: This study used cross-sectional survey data collected by Porter Novelli Public Services to determine the prevalence of ≥1 ongoing symptom lasting ≥4 weeks by SARS-CoV-2 test status and racial/ethnic groups among 2,890 adults in the U.S. RESULTS: Overall, 57% (95% CI=54%, 60%) of respondents with positive SARS-CoV-2 tests reported ≥1 ongoing symptom, compared with 22% (95% CI=20%, 24%) of respondents who tested negative. Among those with positive SARS-CoV-2 tests, Hispanic respondents had higher AORs of experiencing ≥1 ongoing symptom (AOR=1.79, 95% CI=1.27, 2.53) than non-Hispanic White respondents. In addition, Hispanic respondents had significantly higher ORs of experiencing 2 or more ongoing symptoms (AOR=2.03, 95% CI=1.45, 2.86), respiratory/cardiac symptoms (AOR=1.47, 95% CI=1.03, 2.07), neurologic symptoms (AOR=1.77, 95% CI=1.26, 2.48), and other symptoms (AOR=1.53, 95% CI=1.09, 2.14) than non-Hispanic White respondents. Non-Hispanic other respondents who reported at least 1 positive SARS-CoV-2 test had significantly higher ORs of experiencing gastrointestinal symptoms (AOR=4.06, 95% CI=1.78, 8.89) than non-Hispanic White respondents. CONCLUSIONS: These results highlight potential disparities in ongoing symptoms, even after accounting for demographic differences, and reinforce the need for culturally appropriate and targeted strategies to increase access to health care and reduce SARS-CoV-2 infections. |
COVID-19 Vaccine Safety Technical (VaST) work group: Enhancing vaccine safety monitoring during the pandemic
Markowitz LE , Hopkins RH Jr , Broder KR , Lee GM , Edwards KM , Daley MF , Jackson LA , Nelson JC , Riley LE , McNally VV , Schechter R , Whitley-Williams PN , Cunningham F , Clark M , Ryan M , Farizo KM , Wong HL , Kelman J , Beresnev T , Marshall V , Shay DK , Gee J , Woo J , McNeil MM , Su JR , Shimabukuro TT , Wharton M , Keipp Talbot H . Vaccine 2024 During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners. |
Author Correction: Ultra-long-acting in-situ forming implants with cabotegravir protect female macaques against rectal SHIV infection
Young IC , Massud I , Cottrell ML , Shrivastava R , Maturavongsadit P , Prasher A , Wong-Sam A , Dinh C , Edwards T , Mrotz V , Mitchell J , Seixas JN , Pallerla A , Thorson A , Schauer A , Sykes C , De la Cruz G , Montgomery SA , Kashuba ADM , Heneine W , Dobard CW , Kovarova M , Garcia JV , Garcίa-Lerma JG , Benhabbour SR . Nat Commun 2024 15 (1) 1054 |
Comparison of factors associated with seasonal influenza and COVID-19 booster vaccination coverage among healthcare personnel working at acute care hospitals during 2021-2022 influenza season, National Healthcare Safety Network, United States
Meng L , Bell J , Soe M , Edwards J , Lymon H , Barbre K , Reses H , Patel A , Wong E , Dudeck M , Huynh CV , Rowe T , Dubendris H , Benin A . Prev Med 2024 179 107852 The simultaneous circulation of seasonal influenza virus and SARS-CoV-2 variants will likely pose unique challenges to public health during the future influenza seasons. Persons who are undergoing treatment in healthcare facilities may be particularly at risk. It is important for healthcare personnel to protect themselves and patients by receiving vaccines. The purpose of this study is to assess coverage of the seasonal influenza vaccine and COVID-19 monovalent booster among healthcare personnel working at acute care hospitals in the United States during the 2021-22 influenza season and to examine the demographic and facility characteristics associated with coverage. A total of 3260 acute care hospitals with over 7 million healthcare personnel reported vaccination data to National Healthcare Safety Network (NHSN) during the 2021-22 influenza season. Two separate negative binomial mixed models were developed to explore the factors associated with seasonal influenza coverage and COVID-19 monovalent booster coverage. At the end of the 2021-2022 influenza season, the overall pooled mean seasonal influenza coverage was 80.3%, and the pooled mean COVID-19 booster coverage was 39.5%. Several demographic and facility-level factors, such as employee type, facility ownership, and geographic region, were significantly associated with vaccination against influenza and COVID-19 among healthcare personnel working in acute care hospitals. Our findings highlight the need to increase the uptake of vaccination among healthcare personnel, particularly non-employees, those working in for-profit and non-medical school-affiliated facilities, and those residing in the South. |
Concurrent transmission of multiple carbapenemases in a long-term acute-care hospital
Rankin DA , Walters MS , Caicedo L , Gable P , Moulton-Meissner HA , Chan A , Burks A , Edwards K , McAllister G , Kent A , Laufer Halpin A , Moore C , McLemore T , Thomas L , Dotson NQ , Chu AK . Infect Control Hosp Epidemiol 2024 1-10 OBJECTIVE: We investigated concurrent outbreaks of Pseudomonas aeruginosa carrying bla(VIM) (VIM-CRPA) and Enterobacterales carrying bla(KPC) (KPC-CRE) at a long-term acute-care hospital (LTACH A). METHODS: We defined an incident case as the first detection of bla(KPC) or bla(VIM) from a patient's clinical cultures or colonization screening test. We reviewed medical records and performed infection control assessments, colonization screening, environmental sampling, and molecular characterization of carbapenemase-producing organisms from clinical and environmental sources by pulsed-field gel electrophoresis (PFGE) and whole-genome sequencing. RESULTS: From July 2017 to December 2018, 76 incident cases were identified from 69 case patients: 51 had bla(KPC,) 11 had bla(VIM,) and 7 had bla(VIM) and bla(KPC). Also, bla(KPC) were identified from 7 Enterobacterales, and all bla(VIM) were P. aeruginosa. We observed gaps in hand hygiene, and we recovered KPC-CRE and VIM-CRPA from drains and toilets. We identified 4 KPC alleles and 2 VIM alleles; 2 KPC alleles were located on plasmids that were identified across multiple Enterobacterales and in both clinical and environmental isolates. CONCLUSIONS: Our response to a single patient colonized with VIM-CRPA and KPC-CRE identified concurrent CPO outbreaks at LTACH A. Epidemiologic and genomic investigations indicated that the observed diversity was due to a combination of multiple introductions of VIM-CRPA and KPC-CRE and to the transfer of carbapenemase genes across different bacteria species and strains. Improved infection control, including interventions that minimized potential spread from wastewater premise plumbing, stopped transmission. |
Redirecting antibody responses from egg-adapted epitopes following repeat vaccination with recombinant or cell culture-based versus egg-based influenza vaccines
Liu F , Gross FL , Joshi S , Gaglani M , Naleway AL , Murthy K , Groom HC , Wesley MG , Edwards LJ , Grant L , Kim SS , Sambhara S , Gangappa S , Tumpey T , Thompson MG , Fry AM , Flannery B , Dawood FS , Levine MZ . Nat Commun 2024 15 (1) 254 Repeat vaccination with egg-based influenza vaccines could preferentially boost antibodies targeting the egg-adapted epitopes and reduce immunogenicity to circulating viruses. In this randomized trial (Clinicaltrials.gov: NCT03722589), sera pre- and post-vaccination with quadrivalent inactivated egg-based (IIV4), cell culture-based (ccIIV4), and recombinant (RIV4) influenza vaccines were collected from healthcare personnel (18-64 years) in 2018-19 (N = 723) and 2019-20 (N = 684) influenza seasons. We performed an exploratory analysis. Vaccine egg-adapted changes had the most impact on A(H3N2) immunogenicity. In year 1, RIV4 induced higher neutralizing and total HA head binding antibodies to cell- A(H3N2) virus than ccIIV4 and IIV4. In year 2, among the 7 repeat vaccination arms (IIV4-IIV4, IIV4-ccIIV4, IIV4-RIV4, RIV4-ccIIV4, RIV4-RIV4, ccIIV4-ccIIV4 and ccIIV4-RIV4), repeat vaccination with either RIV4 or ccIIV4 further improved antibody responses to circulating viruses with decreased neutralizing antibody egg/cell ratio. RIV4 also had higher post-vaccination A(H1N1)pdm09 and A(H3N2) HA stalk antibodies in year 1, but there was no significant difference in HA stalk antibody fold rise among vaccine groups in either year 1 or year 2. Multiple seasons of non-egg-based vaccination may be needed to redirect antibody responses from immune memory to egg-adapted epitopes and re-focus the immune responses towards epitopes on the circulating viruses to improve vaccine effectiveness. |
Progressive massive fibrosis identified at federally funded black lung clinics in the US
Harris DA , Almberg KS , Blackley DJ , Cohen RA , Edwards C , Johnson B , Hall NB . JAMA 2024 This study of US Black Lung Clinics (established to treat coal miners) reports the prevalence of progressive massive fibrosis identified through June 2023. | eng |
The relationship between the intestinal microbiome and body mass index in children with cystic fibrosis
Bernard R , Shilts MH , Strickland BA , Boone HH , Payne DC , Brown RF , Edwards K , Das SR , Nicholson MR . J Cyst Fibros 2023 BACKGROUND: The nutritional status of children with cystic fibrosis (CF), as assessed by their body mass index percentile (BMIp), is a critical determinant of long-term health outcomes. While the intestinal microbiome plays an important role in nutrition, little is known regarding the relationship of the microbiome and BMIp in children with CF. METHODS: Pediatric patients (< 18 years old) with CF and healthy comparison patients (HCs) were enrolled in the study and stool samples obtained. BMIp was categorized as Green Zone (BMIp > 50th), Yellow Zone (BMIp 25th-49th) and Red Zone (BMIp < 25th). Intestinal microbiome assessment was performed via 16S rRNA gene sequencing; microbial richness, diversity, and differential species abundance were assessed. RESULTS: Stool samples were collected from 107 children with CF and 50 age-matched HCs. Compared to HCs, children with CF were found to have lower bacterial richness, alpha-diversity, and a different microbial composition. When evaluating them by their BMIp color zone, richness and alpha-diversity were lowest in those in the Red Zone. In addition, an unclassified amplicon sequence variant (ASV) of Blautia, a known butyrate-producing anaerobe, was of lowest abundance in children in the Red Zone. CONCLUSION: Children with CF have a dysbiotic intestinal microbiome with specific changes that accompany changes in BMIp. Longitudinal assessments of the microbiome and its metabolic activities over time are needed to better understand how improvements in the microbiome may improve nutrition and enhance long-term survival in children with CF. |
Influenza and up-to-date COVID-19 vaccination coverage among health care personnel - National Healthcare Safety Network, United States, 2022-23 Influenza Season
Bell J , Meng L , Barbre K , Haanschoten E , Reses HE , Soe M , Edwards J , Massey J , Tugu Yagama Reddy GR , Woods A , Stuckey MJ , Kuhar DT , Bolden K , Dubendris H , Wong E , Rowe T , Lindley MC , Kalayil EJ , Benin A . MMWR Morb Mortal Wkly Rep 2023 72 (45) 1237-1243 The Advisory Committee on Immunization Practices recommends that health care personnel (HCP) receive an annual influenza vaccine and that everyone aged ≥6 months stay up to date with recommended COVID-19 vaccination. Health care facilities report vaccination of HCP against influenza and COVID-19 to CDC's National Healthcare Safety Network (NHSN). During January-June 2023, NHSN defined up-to-date COVID-19 vaccination as receipt of a bivalent COVID-19 mRNA vaccine dose or completion of a primary series within the preceding 2 months. This analysis describes influenza and up-to-date COVID-19 vaccination coverage among HCP working in acute care hospitals and nursing homes during the 2022-23 influenza season (October 1, 2022-March 31, 2023). Influenza vaccination coverage was 81.0% among HCP at acute care hospitals and 47.1% among those working at nursing homes. Up-to-date COVID-19 vaccination coverage was 17.2% among HCP working at acute care hospitals and 22.8% among those working at nursing homes. There is a need to promote evidence-based strategies to improve vaccination coverage among HCP. Tailored strategies might also be useful to reach all HCP with recommended vaccines and protect them and their patients from vaccine-preventable respiratory diseases. |
Preparing the occupational safety and health workforce for future disruptions
Streit JMK , Felknor SA , Edwards NT , Caruso DL , Howard J . Am J Ind Med 2023 67 (1) 55-72 BACKGROUND: Despite some emerging lessons learned from the COVID-19 pandemic, evidence suggests the world remains largely underprepared for-and vulnerable to-similar threats in the future. METHODS: In 2022, researchers at the US National Institute for Occupational Safety and Health (NIOSH) led a team of volunteers to explore how future disruptions, such as pandemics, might impact work and the practice of occupational safety and health (OSH). This qualitative inquiry was framed as a strategic foresight project and included a series of activities designed to help better understand, prepare for, and influence the future. RESULTS: Findings from a thorough search for indicators of change were synthesized into nine critical uncertainties and four plausible future scenarios. Analysis of these outputs elucidated three key challenges that may impact OSH research, policy, and practice during future disruptions: (1) data access, (2) direct-to-worker communications, and (3) mis- and dis-information management. CONCLUSIONS: A robust strategic response is offered to address these challenges, and next steps are proposed to enhance OSH preparedness and institutionalize strategic foresight across the OSH community. |
Vital signs for pediatric health: High school graduation
Hoagwood K , Walker DK , Edwards A , Kaminski JW , Kelleher KJ , Spandorfer J , Fox EG . NAM Perspect 2023 2023 In 2015, the Institute of Medicine (now the National Academy of Medicine) released the report Vital Signs: Core Metrics for Health and Health Care Progress as a “basic, minimum slate of core metrics for use as sentinel indices of performance at various levels with respect to the key elements of health and health care progress” (IOM, 2015). Although indicators of pediatric health were included in that report as key elements of healthy behaviors, healthy communities, and preventive services, the core measures in the report emphasized indicators of adult health. This series of papers, “Vital Signs for Pediatric Health”, describes four metrics across the pediatric life course, each measuring how well the health care system is building the physical, cognitive, and socio-emotional health of the pediatric population, thereby laying the foundation for life-long health and well-being. The metrics—infant mortality, school readiness, chronic absenteeism, and high school graduation—were selected to focus on four different developmental stages of growth. A standardized set of core metrics to assess pediatric health could provide data to support health systems in identifying important areas for attention among their pediatric population and enable them to respond in a timely way. This rapid response is especially important in pediatric health systems as children undergo rapid development within a short time span. | | This paper discusses one of those four measures—high school graduation—as a pediatric vital sign because it reflects more than a number. Successful completion of high school also reflects the degree to which healthy growth and development has been supported throughout childhood. Earning a high school diploma is a predictor of adult success, including better employment outcomes, better adult physical and mental health, and decreased likelihood of involvement with the criminal justice system (NCES, 2021b; Blackwell et al., 2014; Lochner and Moretti, 2004). Those who do not graduate from high school face a greater likelihood of health risks as adults, including lower life expectancy, limited employment prospects, lower lifetime wages, and increased risk of incarceration (APHA, 2018). | | The remainder of this paper defines high school graduation rate, the selection of the specific measure that can assess high school graduation, and the technical integrity of the measure. The paper also describes disparities by state, race and ethnicity, and socio-economic status and delineates the importance of a high school diploma, including impacts on employment, future earnings, and individual health. It is important to note that the General Equivalency Diploma (GED) is not considered in this paper. Research shows that adults with GEDs have health outcomes more similar to high school dropouts than to graduates and perform at the level of dropouts in the labor market (Zajacova, 2012; Heckman and LaFontaine, 2007). Finally, the paper lays out the challenges in linking education data with health systems data to help communities have a broader impact on improving the health and well-being of their populations, implementation challenges more broadly, and potential ways to improve use of this metric to increase high school graduation rates. |
Vital signs for pediatric health: Chronic absenteeism
Johnson SB , Edwards A , Cheng T , Kelleher KJ , Kaminski J , Fox EG . NAM Perspect 2023 2023 In 2015, the Institute of Medicine (now the National Academy of Medicine) released the report Vital Signs: Core Metrics for Health and Health Care Progress as a “basic, minimum slate of core metrics for use as sentinel indices of performance at various levels with respect to the key elements of health and health care progress” (IOM, 2015). Although indicators of pediatric health were included in that report as key elements of healthy behaviors, healthy communities, and preventive services, the core measures in the report emphasized indicators of adult health. This series of papers, “Vital Signs for Pediatric Health”, describes four metrics across the pediatric life course, each measuring how well the health care system is building the physical, cognitive, and socio-emotional health of the pediatric population, thereby laying the foundation for life-long health and well-being. The metrics—infant mortality, school readiness, chronic absenteeism, and high school graduation—were selected to focus on four different developmental stages of growth. A standardized set of core metrics to assess pediatric health could provide data to support health systems in identifying important areas for attention among their pediatric population and enable them to respond in a timely way. This rapid response is especially important in pediatric health systems as children undergo rapid development within a short time span. | | This paper discusses one of those four measures—chronic absenteeism in middle school—as a developmental target for middle childhood. Middle school may include grades 5 to 9 or a subset of these grades; typically, this includes children who are approximately 10–15 years old. While chronic absenteeism—typically defined as missing 10% or more of enrolled school days—has potential utility as a measure from the time children enter formal schooling in pre-kindergarten through grade 12, measuring chronic absenteeism in middle childhood provides critical information about health and well-being between two key developmental stages captured by other vital signs: early childhood, captured by school readiness, and adolescence, captured by high school graduation. | | Health and educational success are intertwined, as more education has been linked to better health outcomes across the life course (Basch, 2011; Cutler and Lleras-Muney, 2006). Therefore, participation in education is crucial for both developmental and educational progress. Research has documented associations of chronic absenteeism with both acute (e.g., influenza infection, fractures) and chronic (e.g., asthma, type 1 diabetes mellitus) physical health conditions, as well as with mental health disorders and substance use (Allison et al., 2019). Research has also linked chronic absenteeism to poorer educational performance and attainment (Allison et al., 2019). Chronic absenteeism is robustly inversely associated with on-time high school graduation (BERC, 2011). For more information on the importance of high school graduation, refer to “Vital Signs for Pediatric Health: High School Graduation” (Hoagwood et al., 2023). | | Given the links between educational attainment and health, measuring students' chronic absenteeism in middle school may provide a window into physical and mental health in middle childhood and early adolescence, socio-emotional functioning, readiness to learn, family risk and resilience, and potential threats to current and long-term health and well-being (RWJF, 2016). School-level chronic absenteeism, as well as aggregations of multiple schools, such as those served by a particular health system, may also provide an indicator of the adequacy of interventions to promote health and educational equity at the population level. As such, chronic absenteeism could be a vital sign to measure health systems' performance. | | The remainder of this paper defines the chronic absenteeism measure, the selection of the specific measure that assesses chronic absenteeism, and the technical integrity of the measure. The paper also makes clear the links between school attendance and individual health outcomes. The shifting landscape of chronic absenteeism in the COVID-19 global pandemic and its anticipated aftermath are also considered. |
Vital signs for pediatric health: School readiness
Kaminski JW , Barrueco S , Kelleher KJ , Hoagwood K , Edwards A , Fox EG . NAM Perspect 2023 2023 In 2015, the Institute of Medicine (now the National Academy of Medicine) released the report Vital Signs: Core Metrics for Health and Health Care Progress as a “basic, minimum slate of core metrics for use as sentinel indices of performance at various levels with respect to the key elements of health and health care progress” (IOM, 2015). Although indicators of pediatric health were included in that report as key elements of healthy behaviors, healthy communities, and preventive services, the core measures in the report emphasized indicators of adult health. This series of papers, “Vital Signs for Pediatric Health”, describes four metrics across the pediatric life course, each measuring how well the health care system is building the physical, cognitive, and socio-emotional health of the pediatric population, thereby laying the foundation for life-long health and well-being. The metrics—infant mortality, school readiness, chronic absenteeism, and high school graduation—were selected to focus on four different developmental stages of growth. A standardized set of core metrics to assess pediatric health could provide data to support health systems in identifying important areas for attention among their pediatric population and enable them to respond in a timely way. This rapid response is especially important in pediatric health systems as children undergo rapid development within a short time span. | | This paper discusses one of those four measures—school readiness—as a developmental target for early childhood (ages 0 to 5). School readiness could serve as a comprehensive lens for the early development of children across various domains: physical, socio-emotional, language, knowledge, cognition (including early literacy and math), and approaches to learning. Systemic measurement of young children’s school readiness plays a critical role at multiple levels of health and educational systems. At the individual level, comprehensive assessment in early childhood facilitates the early identification of children who would benefit from preventive and intervention services to support their growth and development. At the district level, aggregate indicators can identify where to target resources and interventions within local health and educational systems. At the systems level, understanding current trends in school readiness data can facilitate the development of effective state and federal performance indicators. Ultimately, longitudinal tracking of school readiness could monitor strengths, risks, and the effects of practice and policy changes on meeting the needs of young children over time across districts, states, and the country (Williams et al., 2019). Together, the role of school readiness in the broader picture of child health and development, as well as the identified roles for communities and systems to track school readiness data and intervene with programs and polices when indicated, support the utilization of school readiness as a pediatric vital sign. | | This paper outlines the authors’ definition of school readiness and describes why it is a promising pediatric vital sign. The paper also outlines the importance of school readiness and its impacts on individual health, as well as how a lack of school readiness can lead to health disparities. Finally, the paper lays out the challenges in linking data across health and educational systems to further the capability of communities in improving the health and well-being of their populations. |
Sodium and potassium consumption in Jamaica: National estimates and associated factors from the Jamaica Health and Lifestyle Survey 2016-2017
Ferguson TS , Younger-Coleman NOM , Webster-Kerr K , Tulloch-Reid MK , Bennett NR , Davidson T , Grant AS , Gordon-Johnson KM , Govia I , Soares-Wynter S , McKenzie JA , Walker E , Cunningham-Myrie CA , Anderson SG , Blake AL , Ho J , Stephenson R , Edwards SE , McFarlane SR , Spence S , Wilks RJ . Medicine (Baltimore) 2023 102 (40) e35308 This study aimed to estimate dietary sodium and potassium consumption among Jamaicans and evaluate associations with sociodemographic and clinical characteristics. A cross-sectional study was conducted using data from the Jamaica Health and Lifestyle Survey 2016-2017. Participants were noninstitutionalized Jamaicans aged ≥15 years. Trained staff collected sociodemographic and health data via interviewer-administered questionnaires and spot urine samples. The Pan American Health Organization formula was used to estimate 24-hour urine sodium and potassium excretion. High sodium level was defined as ≥2000 mg/day, and low potassium levels as <3510 mg/day (World Health Organization criteria). Associations between these outcomes and sociodemographic and clinical characteristics were explored using multivariable ANOVA models using log-transformed 24-hour urine sodium and potassium as outcome variables. Analyses included 1009 participants (368 males, 641 females; mean age 48.5 years). The mean sodium excretion was 3582 mg/day (males 3943 mg/day, females 3245 mg/day, P < .001). The mean potassium excretion was 2052 mg/day (males, 2210 mg/day; females, 1904 mg/day; P = .001). The prevalence of high sodium consumption was 66.6% (males 72.8%, females 60.7%, P < .001) and that of low potassium intake was 88.8% (85.1% males, 92.3% females, P < .001). Sodium consumption was inversely associated with older age, higher education, and low glomerular filtration rate but was directly associated with being male, current smoking, and obesity. Overall, males had higher sodium consumption than women, with the effect being larger among hypertensive men. Women with hypertension had lower sodium consumption than nonhypertensive women; however, hypertensive men had higher sodium consumption than nonhypertensive men. Potassium consumption was higher among men, persons with obesity, and those with high total cholesterol but was lower among men with "more than high school" education compared to men with "less than high school" education. We conclude that most Jamaican adults have diets high in sodium and low in potassium. In this study, sodium consumption was directly associated with male sex, obesity, and current smoking but was inversely associated with older age and higher education. High potassium consumption was associated with obesity and high cholesterol levels. These associations should be further explored in longitudinal studies and population-based strategies should be developed to address these cardiovascular risk factors. |
A review of pediatric central line-associated bloodstream infections reported to the National Healthcare Safety Network: United States, 2016-2022
Prestel C , Fike L , Patel P , Dudeck M , Edwards J , Sinkowitz-Cochran R , Kuhar D . J Pediatric Infect Dis Soc 2023 12 (9) 519-521 Central line-associated bloodstream infections (CLABSIs) are common healthcare-associated infections in pediatrics. Children's hospital CLABSI standardized infection ratios decreased when comparing 2016 to 2019 (-26%, 95% CI [-31%, -20%]), and increased from 2019 and 2022 (18%, 95% CI [9%, 26%]). Resilient pediatric CLABSI prevention initiatives are needed. |
Long COVID and significant activity limitation among adults, by age - United States, June 1-13, 2022, to June 7-19, 2023
Ford ND , Slaughter D , Edwards D , Dalton A , Perrine C , Vahratian A , Saydah S . MMWR Morb Mortal Wkly Rep 2023 72 (32) 866-870 Long COVID is a condition encompassing a wide range of health problems that emerge, persist, or return following COVID-19. CDC analyzed national repeat cross-sectional Household Pulse Survey data to estimate the prevalence of long COVID and significant related activity limitation among U.S. adults aged ≥18 years by age group. Data from surveys completed between June 1-13, 2022, and June 7-19, 2023, indicated that long COVID prevalence decreased from 7.5% (95% CI = 7.1-7.9) to 6.0% (95% CI = 5.7-6.3) among the overall U.S. adult population, irrespective of history of previous COVID-19, and from 18.9% (95% CI = 17.9-19.8) to 11.0% (95% CI = 10.4-11.6) among U.S. adults reporting previous COVID-19. Among both groups, prevalence decreased from June 1-13, 2022, through January 4-16, 2023, before stabilizing. When stratified by age, only adults aged <60 years experienced significant rates of decline (p<0.01). Among adults reporting previous COVID-19, prevalence decreased among those aged 30-79 years through fall or winter and then stabilized. During June 7-19, 2023, 26.4% (95% CI = 24.0-28.9) of adults with long COVID reported significant activity limitation, the prevalence of which did not change over time. These findings help guide the ongoing COVID-19 prevention efforts and planning for long COVID symptom management and future health care service needs. |
SARS-CoV-2 infection and death rates among maintenance dialysis patients during Delta and early Omicron waves - United States, June 30, 2021-September 27, 2022
Navarrete J , Barone G , Qureshi I , Woods A , Barbre K , Meng L , Novosad S , Li Q , Soe MM , Edwards J , Wong E , Reses HE , Guthrie S , Keenan J , Lamping L , Park M , Dumbuya S , Benin AL , Bell J . MMWR Morb Mortal Wkly Rep 2023 72 (32) 871-876 Persons receiving maintenance dialysis are at increased risk for SARS-CoV-2 infection and its severe outcomes, including death. However, rates of SARS-CoV-2 infection and COVID-19-related deaths in this population are not well described. Since November 2020, CDC's National Healthcare Safety Network (NHSN) has collected weekly data monitoring incidence of SARS-CoV-2 infections (defined as a positive SARS-CoV-2 test result) and COVID-19-related deaths (defined as the death of a patient who had not fully recovered from a SARS-CoV-2 infection) among maintenance dialysis patients. This analysis used NHSN dialysis facility COVID-19 data reported during June 30, 2021-September 27, 2022, to describe rates of SARS-CoV-2 infection and COVID-19-related death among maintenance dialysis patients. The overall infection rate was 30.47 per 10,000 patient-weeks (39.64 among unvaccinated patients and 27.24 among patients who had completed a primary COVID-19 vaccination series). The overall death rate was 1.74 per 10,000 patient-weeks. Implementing recommended infection control measures in dialysis facilities and ensuring patients and staff members are up to date with recommended COVID-19 vaccination is critical to limiting COVID-19-associated morbidity and mortality. |
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. |
Association of radiology findings with etiology of community acquired pneumonia among children
Arnold SR , Jain S , Dansie D , Kan H , Williams DJ , Ampofo K , Anderson EJ , Grijalva CG , Bramley AM , Pavia AT , Edwards KM , Nolan VG , McCullers JA , Kaufman RA . J Pediatr 2023 261 113333 OBJECTIVE: To evaluate the association between consolidation on chest radiograph and typical bacterial etiology of childhood community acquired pneumonia (CAP) in the Etiology of Pneumonia in the Community study. STUDY DESIGN: Hospitalized children <18 years of age with CAP enrolled in the Etiology of Pneumonia in the Community study at 3 children's hospitals between January 2010 and June 2012 were included. Testing of blood and respiratory specimens used multiple modalities to identify typical and atypical bacterial, or viral infection. Study radiologists classified chest radiographs (consolidation, other infiltrates [interstitial and/or alveolar], pleural effusion) using modified World Health Organization pneumonia criteria. Infiltrate patterns were compared according to etiology of CAP. RESULTS: Among 2212 children, there were 1302 (59%) with consolidation with or without other infiltrates, 910 (41%) with other infiltrates, and 296 (13%) with pleural effusion. In 1795 children, at least 1 pathogen was detected. Among these patients, consolidation (74%) was the most frequently observed pattern (74% in typical bacterial CAP, 58% in atypical bacterial CAP, and 54% in viral CAP). Positive and negative predictive values of consolidation for typical bacterial CAP were 12% (95% CI 10%-15%) and 96% (95% CI 95%-97%) respectively. In a multivariable model, typical bacterial CAP was associated with pleural effusion (OR 7.3, 95% CI 4.7-11.2) and white blood cell ≥15 000/mL (OR 3.2, 95% CI 2.2-4.9), and absence of wheeze (OR 0.5, 95% CI 0.3-0.8) or viral detection (OR 0.2, 95% CI 0.1-0.4). CONCLUSIONS: Consolidation predicted typical bacterial CAP poorly, but its absence made typical bacterial CAP unlikely. Pleural effusion was the best predictor of typical bacterial infection, but too uncommon to aid etiology prediction. |
Operationalizing the Centers for Disease Control and Prevention's Vaccinate with Confidence framework during the COVID-19 emergency response in the United States
Holmes K , Gutierrez-Nkomo M , Donovan J , Manns BJ , Griswold S , Edwards R , Flores SA , Parker Fiebelkorn A . Health Promot Pract 2023 15248399231188106 In December 2020, 11 months after identifying the first laboratory-confirmed case of COVID-19 in the United States, the U.S. Food and Drug Administration authorized emergency use of two COVID-19 vaccines. To prepare the public for a large-scale vaccination campaign and build confidence in COVID-19 vaccines, the U.S. Centers for Disease Control and Prevention (CDC) funded more than 200 partners and developed a national Vaccinate with Confidence (VwC) COVID-19 framework to support Americans in their decision to get vaccinated. The evolving nature of the pandemic and highly variable confidence in vaccines across populations has resulted in many unique complexities and challenges to reaching universally high vaccination coverage. Here, we describe how 23 professional health associations and national partner organizations, focused solely on building vaccine confidence, operationalized CDC's VwC COVID-19 framework from February 2021 to March 2022. Capturing how partners deployed and adapted their activities to meet a shifting pandemic landscape, which began with high demand for vaccines that waned over time, is an important first step to understanding how this new strategy was utilized and could be implemented for future surges in COVID-19 cases and other routine immunization efforts. Going forward, evaluation of partner activities should be prioritized to capture learnings and assess VwC program effectiveness. |
Neutralizing Antibody Response to Pseudotype SARS-CoV-2 Differs between mRNA-1273 and BNT162b2 COVID-19 Vaccines and by History of SARS-CoV-2 Infection (preprint)
Tyner HL , Burgess JL , Grant L , Gaglani M , Kuntz JL , Naleway AL , Thornburg NJ , Caban-Martinez AJ , Yoon SK , Herring MK , Beitel SC , Blanton L , Nikolich-Zugich J , Thiese MS , Pleasants JF , Fowlkes AL , Lutrick K , Dunnigan K , Yoo YM , Rose S , Groom H , Meece J , Wesley MG , Schaefer-Solle N , Louzado-Feliciano P , Edwards LJ , Olsho LEW , Thompson MG . medRxiv 2021 2021.10.20.21265171 Background Data on the development of neutralizing antibodies against SARS-CoV-2 after SARS-CoV-2 infection and after vaccination with messenger RNA (mRNA) COVID-19 vaccines are limited.Methods From a prospective cohort of 3,975 adult essential and frontline workers tested weekly from August, 2020 to March, 2021 for SARS-CoV-2 infection by Reverse Transcription- Polymerase Chain Reaction (RT-PCR) assay irrespective of symptoms, 497 participants had sera drawn after infection (170), vaccination (327), and after both infection and vaccination (50 from the infection population). Serum was collected after infection and each vaccine dose. Serum- neutralizing antibody titers against USA-WA1/2020-spike pseudotype virus were determined by the 50% inhibitory dilution. Geometric mean titers (GMTs) and corresponding fold increases were calculated using t-tests and linear mixed effects models.Results Among 170 unvaccinated participants with SARS-CoV-2 infection, 158 (93%) developed neutralizing antibodies (nAb) with a GMT of 1,003 (95% CI=766-1,315). Among 139 previously uninfected participants, 138 (99%) developed nAb after mRNA vaccine dose-2 with a GMT of 3,257 (95% CI = 2,596-4,052). GMT was higher among those receiving mRNA-1273 vaccine (GMT =4,698, 95%CI= 3,186-6,926) compared to BNT162b2 vaccine (GMT=2,309, 95%CI=1,825-2,919). Among 32 participants with prior SARS-CoV-2 infection, GMT was 21,655 (95%CI=14,766-31,756) after mRNA vaccine dose-1, without further increase after dose- 2.Conclusions A single dose of mRNA vaccine after SARS-CoV-2 infection resulted in the highest observed nAb response. Two doses of mRNA vaccine in previously uninfected participants resulted in higher nAb to SARS-CoV-2 than after one dose of vaccine or SARS- CoV-2 infection alone. Neutralizing antibody response also differed by mRNA vaccine product.Main Point Summary One dose of mRNA COVID-19 vaccine after previous SARS-CoV-2 infection produced the highest neutralizing antibody titers; among those without history of infection, two doses of mRNA vaccine produced the most robust response.Competing Interest StatementAllison Naleway receives research funding from Pfizer and Vir Biotechnology and Jennifer Kuntz receives research funding from Pfizer, Novartis, and Vir Biotechnology for unrelated studies. All other authors: No conflicts. Funding StatementThis work was supported by the Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases [contracts 75D30120R68013 to Marshfield Clinic Research Institute, 75D30120C08379 to the University of Arizona, and 75D30120C08150 to Abt Associates].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 study is governed by Centers for Disease Control and Prevention IRB review board and gave ethical approval for this work.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.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.YesAll data produced in the pres nt work are contained in the manuscript |
Prevention and Attenuation of COVID-19 by BNT162b2 and mRNA-1273 Vaccines (preprint)
Thompson MG , Burgess JL , Naleway AL , Tyner H , Yoon SK , Meece J , Olsho LEW , Caban-Martinez AJ , Fowlkes AL , Lutrick K , Groom HC , Dunnigan K , Odean MJ , Hegmann K , Stefanski E , Edwards LJ , Schaefer-Solle N , Grant L , Ellingson K , Kuntz JL , Zunie T , Thiese MS , Ivacic L , Wesley MG , Mayo Lamberte J , Sun X , Smith ME , Phillips AL , Groover KD , Yoo YM , Gerald J , Brown RT , Herring MK , Joseph G , Beitel S , Morrill TC , Mak J , Rivers P , Poe BP , Lynch B , Zhou Y , Zhang J , Kelleher A , Li Y , Dickerson M , Hanson E , Guenther K , Tong S , Bateman A , Reisdorf E , Barnes J , Azziz-Baumgartner E , Hunt DR , Arvay ML , Kutty P , Fry AM , Gaglani M . medRxiv 2021 2021.06.01.21257987 BACKGROUND Information is limited on messenger RNA (mRNA) BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccine effectiveness (VE) in preventing SARS-CoV-2 infection or attenuating disease when administered in real-world conditions.METHODS Prospective cohorts of 3,975 healthcare personnel, first responders, and other essential and frontline workers completed weekly SARS-CoV-2 testing during December 14 2020—April 10 2021. Self-collected mid-turbinate nasal swabs were tested by qualitative and quantitative reverse-transcription–polymerase-chain-reaction (RT-PCR). VE was calculated as 100%×(1−hazard ratio); adjusted VE was calculated using vaccination propensity weights and adjustments for site, occupation, and local virus circulation.RESULTS SARS-CoV-2 was detected in 204 (5.1%) participants; 16 were partially (≥14 days post-dose-1 to 13 days after dose-2) or fully (≥14 days post-dose-2) vaccinated, and 156 were unvaccinated; 32 with indeterminate status (<14 days after dose-1) were excluded. Adjusted mRNA VE of full vaccination was 91% (95% confidence interval [CI]=76%–97%) against symptomatic or asymptomatic SARS-CoV-2 infection; VE of partial vaccination was 81% (95% CI=64%-90%). Among partially or fully vaccinated participants with SARS-CoV-2 infection, mean viral RNA load (Log10 copies/mL) was 40% lower (95% CI=16%-57%), the risk of self-reported febrile COVID-19 was 58% lower (Risk Ratio=0.42, 95% CI=0.18-0.98), and 2.3 fewer days (95% CI=0.8-3.7) were spent sick in bed compared to unvaccinated infected participants.CONCLUSIONS Authorized mRNA vaccines were highly effective among working-age adults in preventing SARS-CoV-2 infections when administered in real-world conditions and attenuated viral RNA load, febrile symptoms, and illness duration among those with breakthrough infection despite vaccination.Competing Interest StatementAllison L. Naleway reported funding from Pfizer for a meningococcal B vaccine study unrelated to the submitted work. Kurt T. Hegmann serves at the Editor of the American College of Occupational and Environmental Medicine evidence-based practice guidelines. Matthew S. These reported grants and personal fees from Reed Group and the American College of Occupational and Environmental Medicine, outside the submitted work. Other authors have reported no conflicts of interest.Funding StatementFunding provided in whole or in part by federal funds from the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention under contract numbers 75D30120R68013 awarded to Marshfield Clinic Research Laboratory, 75D30120C08379 to University of Arizona, and 75D30120C08150 awarded to Abt Associates, Inc.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 study was reviewed and approved by the University of Arizona IRB as the single IRB for this studyAll 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.YesSummary data will be available once all study objectives are met. |
Improving reporting standards for polygenic scores in risk prediction studies (preprint)
Wand H , Lambert SA , Tamburro C , Iacocca MA , O'Sullivan JW , Sillari C , Kullo IJ , Rowley R , Dron JS , Brockman D , Venner E , McCarthy MI , Antoniou AC , Easton DF , Hegele RA , Khera AV , Chatterjee N , Kooperberg C , Edwards K , Vlessis K , Kinnear K , Danesh JN , Parkinson H , Ramos EM , Roberts MC , Ormond KE , Khoury MJ , Janssens Acjw , Goddard KAB , Kraft P , MacArthur JAL , Inouye M , Wojcik GL . medRxiv 2020 2020.04.23.20077099 Polygenic risk scores (PRS), often aggregating the results from genome-wide association studies, can bridge the gap between the initial discovery efforts and clinical applications for disease risk estimation. However, there is remarkable heterogeneity in the reporting of these risk scores. This lack of adherence to reporting standards hinders the translation of PRS into clinical care. The ClinGen Complex Disease Working Group, in a collaboration with the Polygenic Score (PGS) Catalog, have updated the Genetic Risk Prediction (GRIPS) Reporting Statement to the current state of the field and to enable downstream utility. Drawing upon experts in epidemiology, statistics, disease-specific applications, implementation, and policy, this 22-item reporting framework defines the minimal information needed to interpret and evaluate a PRS, especially with respect to any downstream clinical applications. Items span detailed descriptions of the study population (recruitment method, key demographic and clinical characteristics, inclusion/exclusion criteria, and outcome definition), statistical methods for both PRS development and validation, and considerations for potential limitations of the published risk score and downstream clinical utility. Additionally, emphasis has been placed on data availability and transparency to facilitate reproducibility and benchmarking against other PRS, such as deposition in the publicly available PGS Catalog. By providing these criteria in a structured format that builds upon existing standards and ontologies, the use of this framework in publishing PRS will facilitate translation of PRS into clinical care and progress towards defining best practices.Summary In recent years, polygenic risk scores (PRS) have increasingly been used to capture the genome-wide liability underlying many human traits and diseases, hoping to better inform an individual’s genetic risk. However, a lack of adherence to existing reporting standards has hindered the translation of this important tool into clinical and public health practice; in particular, details necessary for benchmarking and reproducibility are underreported. To address this gap, the ClinGen Complex Disease Working Group and Polygenic Score (PGS) Catalog have updated the Genetic Risk Prediction (GRIPS) Reporting Statement into the 22-item Polygenic Risk Score Reporting Statement (PRS-RS). This framework provides the minimal information expected of authors to promote the validity, transparency, and reproducibility of PRS by encouraging authors to detail the study population, statistical methods, and potential clinical utility of a published score. The widespread adoption of this framework will encourage rigorous methodological consideration and facilitate benchmarking to ensure high quality scores are translated into the clinic.Competing Interest StatementMIM is on the advisory panels Pfizer, Novo Nordisk, and Zoe Global; Honoraria: Merck, Pfizer, Novo Nordisk, and Eli Lilly; Research funding: Abbvie, Astra Zeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novo Nordisk, Pfizer, Roche, Sanofi Aventis, Servier & Takeda. As of June 2019, he is an employee of Genentech with stock and stock options in Roche. No other authors have competing interests to declare.Funding StatementClinGen is primarily funded by the National Human Genome Research Institute (NHGRI), through the following three grants: U41HG006834, U41HG009649, U41HG009650. ClinGen also receives support for content curation from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through the following three grants: U24HD093483, U24HD093486, U24HD093487. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Additionally, the views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health. Research reported in this publication was supported by the National Human Genome Research Institute of the National Institutes of Health under Award Number U41HG007823 (EBI-NHGRI GWAS Catalog, PGS Catalog). In addition, we acknowledge funding from the European Molecular Biology Laboratory. Individuals were funded from the following sources: MIM was a Wellcome Investigator and an NIHR Senior Investigator with funding from NIDDK (U01-DK105535); Wellcome (090532, 098381, 106130, 203141, 212259). MI, SAL, and JD were supported by core funding from: the UK Medical Research Council (MR/L003120/1), the British Heart Foundation (RG/13/13/30194; RG/18/13/33946) and the National Institute for Health Research (Cambridge Biomedical Research Centre at the Cambridge University Hospitals NHS Foundation Trust). SAL is supported by a Canadian Institutes of Health Research postdoctoral fellowship (MFE-171279). JD holds a British Heart Foundation Personal Chair and a National Institute for Health Research Senior Investigator Award. This work was also supported by Health Data Research UK, which is funded by the UK Medical Research Council, Engineering and Physical Sciences Research Council, Economic and Social Research Council, Department of Health and Social Care (England), Chief Scientist Office of the Scottish Government Health and Social Care Directorates, Health and Social Care Research and Development Division (Welsh Government), Public Health Agency (Northern Ireland), British Heart Foundation and Wellcome.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:N/AAll 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.YesN/A |
- Page last reviewed:Feb 1, 2024
- Page last updated:May 06, 2024
- Content source:
- Powered by CDC PHGKB Infrastructure