Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-30 (of 243 Records) |
Query Trace: Shapiro S[original query] |
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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. |
Understanding three approaches to reporting sudden unexpected infant death in the USA
Erck Lambert AB , Parks S , Bergman K , Cottengim C , Woster A , Shaw E , Ma H , Heitmann R , Riehle-Colarusso T , Shapiro-Mendoza C . Inj Prev 2024 INTRODUCTION: In the USA each year, there are approximately 3400 sudden unexpected infant (<1 year of age) deaths (SUID) which occur without an obvious cause before an investigation. SUID includes the causes of death (COD) undetermined/unknown, sleep-related suffocation/asphyxia and sudden infant death syndrome (SIDS); these are often called SUID subtypes. Three common ways SUID subtypes are grouped (SUID subtype groups) include International Classification of Diseases (ICD) Codes, SUID Case Registry Categories or Child Death Review (CDR)-Assigned Causes. These groups are often used to monitor SUID trends and characteristics at the local, state and national levels. We describe and compare the characteristics of these three SUID subtype groups. DISCUSSION: SUID subtype groups are distinct and not directly interchangeable. They vary in purpose, strengths, limitations, uses, history, data years available, population coverage, assigning entity, guidance documentation and information available to assign subtypes. CONCLUSION: Making informed decisions about which SUID subtype group to use is important for reporting statistics, increasing knowledge of SUID epidemiology and informing prevention strategies. |
A critical review of measures of childhood vaccine confidence
Shapiro GK , Kaufman J , Brewer NT , Wiley K , Menning L , Leask J , BeSD Working Group , Abad N , Jalloh MF . Curr Opin Immunol 12/28/2021 71 34-45 The World Health Organization and global partners sought to identify existing measures of confidence in childhood vaccines, as part of a broader effort to measure the range of behavioural and social drivers of vaccination. We identified 14 confidence measures applicable to childhood vaccination in general, all published between 2010 and 2019. The measures examined 1-5 constructs and included a mean of 12 items. Validation studies commonly examined factor structure, internal consistency reliability, and criterion-related validity. Fewer studies examined convergent and discriminant validity, test-retest reliability, or used cognitive interviewing. Most measures were developed and validated only in high-income countries. These findings highlight the need for a childhood vaccine confidence measure validated for use in diverse global contexts. |
Characteristics of sudden unexpected infant deaths on shared and nonshared sleep surfaces
Erck Lambert AB , Shapiro-Mendoza CK , Parks SE , Cottengim C , Faulkner M , Hauck FR . Pediatrics 2024 OBJECTIVES: Describe characteristics of sudden unexpected infant deaths (SUID) occurring on shared or nonshared sleep surfaces. METHODS: We examined SUID among residents of 23 US jurisdictions who died during 2011 to 2020. We calculated frequencies and percentages of demographic, sleep environment, and other characteristics by sleep surface sharing status and reported differences of at least 5% between surface sharing and nonsharing infants. RESULTS: Of 7595 SUID cases, 59.5% were sleep surface sharing when they died. Compared with nonsharing infants, sharing infants were more often aged 0 to 3 months, non-Hispanic Black, publicly insured, found supine, found in an adult bed or chair/couch, had a higher number of unsafe sleep factors present, were exposed to maternal cigarette smoking prenatally, were supervised by a parent at the time of death, or had a supervisor who was impaired by drugs or alcohol at the time of death. At least 76% of all SUID had multiple unsafe sleep factors present. Among surface-sharing SUID, most were sharing with adults only (68.2%), in an adult bed (75.9%), and with 1 other person (51.6%). Surface sharing was more common among multiples than singletons. CONCLUSIONS: Among SUID, surface sharing and nonsharing infants varied by age at death, race and ethnicity, insurance type, presence of unsafe sleep factors, prenatal smoke exposure, and supervisor impairment. Most SUID, regardless of sleep location, had multiple unsafe sleep factors present, demonstrating the need for comprehensive safe sleep counseling for every family at every encounter. |
Notes from the field: Transmission of Mpox to nonsexual close contacts - Two U.S. Jurisdictions, May 1-July 31, 2022
Thomas ES , Madewell ZJ , Still WL , Rowse J , Shapiro B , Gately E , Shaffner J , Mangla AT , Ricaldi JN . MMWR Morb Mortal Wkly Rep 2023 72 (50) 1351-1352 During the 2022 multinational mpox outbreak, U.S. mpox cases primarily occurred among adult gay, bisexual, and other men who have sex with men (1). Among all cases, 94% of patients reported exposure through sexual or other intimate contact (1). Currently, little is known about less common nonsexual mpox transmission. A systematic review of mpox transmission in countries with endemic mpox in Central Africa found that the secondary attack rate among unvaccinated household contacts ranged from 0% to 11%, with a pooled estimate of 8% (2). A better understanding of the risk for nonsexual transmission during the current outbreak in countries where mpox is not endemic is important for developing and implementing future prevention and control strategies. |
Vaccine effectiveness against influenza a-associated hospitalization, organ failure, and death: United States, 2022-2023
Lewis NM , Zhu Y , Peltan ID , Gaglani M , McNeal T , Ghamande S , Steingrub JS , Shapiro NI , Duggal A , Bender WS , Taghizadeh L , Brown SM , Hager DN , Gong MN , Mohamed A , Exline MC , Khan A , Wilson JG , Qadir N , Chang SY , Ginde AA , Mohr NM , Mallow C , Lauring AS , Johnson NJ , Gibbs KW , Kwon JH , Columbus C , Gottlieb RL , Raver C , Vaughn IA , Ramesh M , Johnson C , Lamerato L , Safdar B , Casey JD , Rice TW , Halasa N , Chappell JD , Grijalva CG , Talbot HK , Baughman A , Womack KN , Swan SA , Harker E , Price A , DeCuir J , Surie D , Ellington S , Self WH . Clin Infect Dis 2023 BACKGROUND: Influenza circulation during the 2022-2023 season in the United States largely returned to pre-coronavirus disease 2019 (COVID-19)-pandemic patterns and levels. Influenza A(H3N2) viruses were detected most frequently this season, predominately clade 3C.2a1b.2a, a close antigenic match to the vaccine strain. METHODS: To understand effectiveness of the 2022-2023 influenza vaccine against influenza-associated hospitalization, organ failure, and death, a multicenter sentinel surveillance network in the United States prospectively enrolled adults hospitalized with acute respiratory illness between 1 October 2022, and 28 February 2023. Using the test-negative design, vaccine effectiveness (VE) estimates against influenza-associated hospitalization, organ failures, and death were measured by comparing the odds of current-season influenza vaccination in influenza-positive case-patients and influenza-negative, SARS-CoV-2-negative control-patients. RESULTS: A total of 3707 patients, including 714 influenza cases (33% vaccinated) and 2993 influenza- and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-negative controls (49% vaccinated) were analyzed. VE against influenza-associated hospitalization was 37% (95% confidence interval [CI]: 27%-46%) and varied by age (18-64 years: 47% [30%-60%]; ≥65 years: 28% [10%-43%]), and virus (A[H3N2]: 29% [6%-46%], A[H1N1]: 47% [23%-64%]). VE against more severe influenza-associated outcomes included: 41% (29%-50%) against influenza with hypoxemia treated with supplemental oxygen; 65% (56%-72%) against influenza with respiratory, cardiovascular, or renal failure treated with organ support; and 66% (40%-81%) against influenza with respiratory failure treated with invasive mechanical ventilation. CONCLUSIONS: During an early 2022-2023 influenza season with a well-matched influenza vaccine, vaccination was associated with reduced risk of influenza-associated hospitalization and organ failure. |
Diabetes complications and cognitive function in young adults with youth-onset type 1 or type 2 diabetes: The SEARCH for Diabetes In Youth Study
Shapiro ALB , Bellatorre A , Dabelea D , Stafford JM , D'Agostino R , Shah AS , Urbina EM , Barrett CE , Pihoker C , Marcovina S , Liese AD , Mottl AK , Jensen ET , Wilkening G . Pediatr Diabetes 2023 2023 Aims/Hypotheses. People with type 1 (T1D) or type 2 diabetes (T2D) who also have diabetes complications can have pronounced cognitive deficits. It remains unknown, however, whether and how multiple diabetes complications co-occur with cognitive dysfunction, particularly in youth-onset diabetes. Methods. Using data from the SEARCH for Diabetes in Youth Study cohort, a prospective longitudinal cohort, we examined clustering of complications and their underlying clinical factors with performance on cognitive tests in young adults with youth-onset T1D or T2D. Cognition was assessed via the NIH Toolbox Cognition Battery. The main cognitive variables were age-corrected scores for composite fluid cognition and associated cognitive subdomains. Diabetes complications included retinopathy, microalbuminuria, and peripheral neuropathy (PN). Lipids, systolic blood pressure (SBP), hemoglobin A1c, and other clinical factors were included in the analyses. Clustering was applied separately to each group (T1D = 646; T2D = 165). A three-cluster (C) solution was identified for each diabetes type. Mean values and frequencies of all factors were compared between resulting clusters. Results. The average age-corrected score for composite fluid cognition differed significantly across clusters for each group (p<0.001). People with T1D and the lowest average fluid cognition scores had the highest frequency of self-reporting at least one episode of hypoglycemia in the year preceding cognitive testing and the highest prevalence of PN. Persons with T2D and the lowest average fluid cognition scores had the highest SBP, the highest central systolic and diastolic blood pressures, and highest prevalence of PN. Conclusions/Interpretations. These findings highlight shared (PN) and unique factors (hypoglycemia in T1D; SBP in T2D) that could be targeted to potentially mitigate cognitive issues in young people with youth-onset diabetes. © 2023 Allison L. B. Shapiro et al. |
Up-to-date breast, cervical, and colorectal cancer screening test use in the United States, 2021
Sabatino SA , Thompson TD , White MC , Villarroel MA , Shapiro JA , Croswell JM , Richardson LC . Prev Chronic Dis 2023 20 E94 INTRODUCTION: We examined national estimates of breast, cervical, and colorectal cancer (CRC) screening test use and compared them with Healthy People 2030 national targets. Test use in 2021 was compared with prepandemic estimates. METHODS: In 2022, we used 2021 National Health Interview Survey (NHIS) data to estimate proportions of adults up to date with US Preventive Services Task Force recommendations for breast (women aged 50-74 y), cervical (women aged 21-65 y), and CRC screening (adults aged 50-75 y) across sociodemographic and health care access variables. We compared age-standardized estimates from the 2021 and 2019 NHIS. RESULTS: Percentages of adults up to date in 2021 were 75.7% (95% CI, 74.4%-76.9%), 75.2% (95% CI, 73.9%-76.4%), and 72.2% (95% CI, 71.2%-73.2%) for breast, cervical, and CRC screening, respectively. Estimates were below 50% among those without a wellness check in 3 years (all screening types), among those without a usual source of care or insurance (aged <65 y) (breast and CRC screening), and among those residing in the US for less than 10 years (CRC screening). Percentages of adults who were up to date with breast and cervical cancer screening and colonoscopy were similar in 2019 and 2021. Fecal occult blood/fecal immunochemical test (FOBT/FIT) use was modestly higher in 2021 (P < .001). CONCLUSIONS: In 2021, approximately 1 in 4 adults of screening age were not up to date with breast, cervical, and CRC screening recommendations, and Healthy People 2030 national targets were not met. Disparities existed across several characteristics, particularly those related to health care access. Breast, cervical, and colonoscopy test use within recommended screening intervals approximated prepandemic levels. FOBT/FIT estimates were modestly higher in 2021. |
Disease severity of respiratory syncytial virus compared with COVID-19 and influenza among hospitalized adults aged ≥60 years - IVY Network, 20 U.S. States, February 2022-May 2023
Surie D , Yuengling KA , DeCuir J , Zhu Y , Gaglani M , Ginde AA , Talbot HK , Casey JD , Mohr NM , Ghamande S , Gibbs KW , Files DC , Hager DN , Ali H , Prekker ME , Gong MN , Mohamed A , Johnson NJ , Steingrub JS , Peltan ID , Brown SM , Leis AM , Khan A , Hough CL , Bender WS , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Exline MC , Lauring AS , Shapiro NI , Columbus C , Vaughn IA , Ramesh M , Safdar B , Halasa N , Chappell JD , Grijalva CG , Baughman A , Rice TW , Womack KN , Han JH , Swan SA , Mukherjee I , Lewis NM , Ellington S , McMorrow ML , Martin ET , Self WH . MMWR Morb Mortal Wkly Rep 2023 72 (40) 1083-1088 On June 21, 2023, CDC's Advisory Committee on Immunization Practices recommended respiratory syncytial virus (RSV) vaccination for adults aged ≥60 years, offered to individual adults using shared clinical decision-making. Informed use of these vaccines requires an understanding of RSV disease severity. To characterize RSV-associated severity, 5,784 adults aged ≥60 years hospitalized with acute respiratory illness and laboratory-confirmed RSV, SARS-CoV-2, or influenza infection were prospectively enrolled from 25 hospitals in 20 U.S. states during February 1, 2022-May 31, 2023. Multivariable logistic regression was used to compare RSV disease severity with COVID-19 and influenza severity on the basis of the following outcomes: 1) standard flow (<30 L/minute) oxygen therapy, 2) high-flow nasal cannula (HFNC) or noninvasive ventilation (NIV), 3) intensive care unit (ICU) admission, and 4) invasive mechanical ventilation (IMV) or death. Overall, 304 (5.3%) enrolled adults were hospitalized with RSV, 4,734 (81.8%) with COVID-19 and 746 (12.9%) with influenza. Patients hospitalized with RSV were more likely to receive standard flow oxygen, HFNC or NIV, and ICU admission than were those hospitalized with COVID-19 or influenza. Patients hospitalized with RSV were more likely to receive IMV or die compared with patients hospitalized with influenza (adjusted odds ratio = 2.08; 95% CI = 1.33-3.26). Among hospitalized older adults, RSV was less common, but was associated with more severe disease than COVID-19 or influenza. High disease severity in older adults hospitalized with RSV is important to consider in shared clinical decision-making regarding RSV vaccination. |
Inferring school district learning modalities during the COVID-19 pandemic with a hidden Markov model
Panaggio MJ , Fang M , Bang H , Armstrong PA , Binder AM , Grass JE , Magid J , Papazian M , Shapiro-Mendoza CK , Parks SE . PLoS One 2023 18 (10) e0292354 During the COVID-19 pandemic, many public schools across the United States shifted from fully in-person learning to alternative learning modalities such as hybrid and fully remote learning. In this study, data from 14,688 unique school districts from August 2020 to June 2021 were collected to track changes in the proportion of schools offering fully in-person, hybrid and fully remote learning over time. These data were provided by Burbio, MCH Strategic Data, the American Enterprise Institute's Return to Learn Tracker and individual state dashboards. Because the modalities reported by these sources were incomplete and occasionally misaligned, a model was needed to combine and deconflict these data to provide a more comprehensive description of modalities nationwide. A hidden Markov model (HMM) was used to infer the most likely learning modality for each district on a weekly basis. This method yielded higher spatiotemporal coverage than any individual data source and higher agreement with three of the four data sources than any other single source. The model output revealed that the percentage of districts offering fully in-person learning rose from 40.3% in September 2020 to 54.7% in June of 2021 with increases across 45 states and in both urban and rural districts. This type of probabilistic model can serve as a tool for fusion of incomplete and contradictory data sources in order to obtain more reliable data in support of public health surveillance and research efforts. |
Comparison of antibiotic prescribing between physicians and advanced practice clinicians
Hersh AL , Shapiro DJ , Sanchez GV , Hicks LA . Infect Control Hosp Epidemiol 2023 1-3 We compared antibiotic prescribing rates for respiratory conditions in a national sample of outpatient visits from 2010 to 2018 between physicians and advanced practice clinicians (APCs). APCs prescribed antibiotics more frequently than physicians (58% vs 52%), but there were no differences in selection of guideline recommended first-line agents between specialties. |
Transmission of yellow fever vaccine virus through blood transfusion and organ transplantation in the USA in 2021: Report of an investigation
Gould CV , Free RJ , Bhatnagar J , Soto RA , Royer TL , Maley WR , Moss S , Berk MA , Craig-Shapiro R , Kodiyanplakkal RPL , Westblade LF , Muthukumar T , Puius YA , Raina A , Hadi A , Gyure KA , Trief D , Pereira M , Kuehnert MJ , Ballen V , Kessler DA , Dailey K , Omura C , Doan T , Miller S , Wilson MR , Lehman JA , Ritter JM , Lee E , Silva-Flannery L , Reagan-Steiner S , Velez JO , Laven JJ , Fitzpatrick KA , Panella A , Davis EH , Hughes HR , Brault AC , St George K , Dean AB , Ackelsberg J , Basavaraju SV , Chiu CY , Staples JE . Lancet Microbe 2023 4 (9) e711-e721 BACKGROUND: In 2021, four patients who had received solid organ transplants in the USA developed encephalitis beginning 2-6 weeks after transplantation from a common organ donor. We describe an investigation into the cause of encephalitis in these patients. METHODS: From Nov 7, 2021, to Feb 24, 2022, we conducted a public health investigation involving 15 agencies and medical centres in the USA. We tested various specimens (blood, cerebrospinal fluid, intraocular fluid, serum, and tissues) from the organ donor and recipients by serology, RT-PCR, immunohistochemistry, metagenomic next-generation sequencing, and host gene expression, and conducted a traceback of blood transfusions received by the organ donor. FINDINGS: We identified one read from yellow fever virus in cerebrospinal fluid from the recipient of a kidney using metagenomic next-generation sequencing. Recent infection with yellow fever virus was confirmed in all four organ recipients by identification of yellow fever virus RNA consistent with the 17D vaccine strain in brain tissue from one recipient and seroconversion after transplantation in three recipients. Two patients recovered and two patients had no neurological recovery and died. 3 days before organ procurement, the organ donor received a blood transfusion from a donor who had received a yellow fever vaccine 6 days before blood donation. INTERPRETATION: This investigation substantiates the use of metagenomic next-generation sequencing for the broad-based detection of rare or unexpected pathogens. Health-care workers providing vaccinations should inform patients of the need to defer blood donation for at least 2 weeks after receiving a yellow fever vaccine. Despite mitigation strategies and safety interventions, a low risk of transfusion-transmitted infections remains. FUNDING: US Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority, and the CDC Epidemiology and Laboratory Capacity Cooperative Agreement for Infectious Diseases. |
Bivalent mRNA vaccine improves antibody-mediated neutralization of many SARS-CoV-2 Omicron lineage variants (preprint)
Jiang N , Wang L , Hatta M , Feng C , Currier M , Lin X , Hossain J , Cui D , Mann BR , Kovacs NA , Wang W , Atteberry G , Wilson M , Chau R , Lacek KA , Paden CR , Hassell N , Rambo-Martin B , Barnes JR , Kondor RJ , Self WH , Rhoads JP , Baughman A , Chappell JD , Shapiro NI , Gibbs KW , Hager DN , Lauring AS , Surie D , McMorrow ML , Thornburg NJ , Wentworth DE , Zhou B . bioRxiv 2023 09 The early Omicron lineage variants evolved and gave rise to diverging lineages that fueled the COVID-19 pandemic in 2022. Bivalent mRNA vaccines, designed to broaden protection against circulating and future variants, were authorized by the U.S. Food and Drug Administration (FDA) in August 2022 and recommended by the U.S. Centers for Disease Control and Prevention (CDC) in September 2022. The impact of bivalent vaccination on eliciting neutralizing antibodies against homologous BA.4/BA.5 viruses as well as emerging heterologous viruses needs to be analyzed. In this study, we analyze the neutralizing activity of sera collected after a third dose of vaccination (2-6 weeks post monovalent booster) or a fourth dose of vaccination (2-7 weeks post bivalent booster) against 10 predominant/recent Omicron lineage viruses including BA.1, BA.2, BA.5, BA.2.75, BA.2.75.2, BN.1, BQ.1, BQ.1.1, XBB, and XBB.1. The bivalent booster vaccination enhanced neutralizing antibody titers against all Omicron lineage viruses tested, including a 10-fold increase in neutralization of BQ.1 and BQ.1.1 viruses that predominated in the U.S. during the last two months of 2022. Overall, the data indicate the bivalent vaccine booster strengthens protection against Omicron lineage variants that evolved from BA.5 and BA.2 progenitors. Copyright The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
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. |
Neutralizing Antibody to Omicron BA.1, BA.2 and BA.5 in COVID-19 Patients (preprint)
Linderman SL , Lai L , Bocangel Gamarra EL , Mohr NM , Gibbs KW , Steingrub JS , Exline MC , Shapiro NI , Frosch AE , Qadir N , Edupuganti S , Surie D , Tenforde MW , Davis-Gardner ME , Chappell JD , Lau MSY , McElrath MJ , Lauring AS , Suthar MS , Patel MM , Self WH , Ahmed R . medRxiv 2022 22 Neutralizing antibody plays a key role in protective immunity against COVID-19. As increasingly distinct variants circulate, debate continues regarding the value of adding novel variants to SARS-CoV-2 vaccines. In this study, we have analyzed live virus neutralization titers against WA1, Delta, BA.1, BA.2, and BA.5 in 187 hospitalized patients infected with Delta or Omicron strains. This information will be useful in selection of the SARS-CoV-2 strains to include in an updated vaccine. Our results show that unvaccinated Delta infected patients made a highly biased neutralizing antibody response towards the infecting Delta strain with slightly lower responses against the WA1 strain, but with strikingly lower titers against BA.1, BA.2, and BA.5. Delta infected patients that had been previously vaccinated with the WA1 containing COVID vaccine made equivalent responses to WA1 and Delta strains, but still had very low neutralizing antibody responses to Omicron strains. In striking contrast, both unvaccinated and vaccinated Omicron patients exhibited a more balanced ratio of Omicron virus neutralization compared to neutralization of ancestral strains. Interestingly, Omicron patients infected with BA.1 or BA.2 had detectable neutralizing antibody titers to BA.5, but these titers were lower than neutralization titers to BA.1 and BA.2. Taken together, these results suggest that inclusion of the Omicron BA.5 strain in a SARS-CoV-2 vaccine would be beneficial in protection against the widely circulating BA.5 variant. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license. |
Effectiveness of SARS-CoV-2 mRNA Vaccines for Preventing Covid-19 Hospitalizations in the United States (preprint)
Tenforde MW , Patel MM , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , Zepeski A , Gaglani M , McNeal T , Ghamande S , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Exline MC , Gong MN , Mohamed A , Henning DJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Hough CT , Busse L , Lohuis CCT , Duggal A , Wilson JG , Gordon AJ , Qadir N , Chang SY , Mallow C , Gershengorn HB , Babcock HM , Kwon JH , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Olson SM , Stephenson M , Schrag SJ , Kobayashi M , Verani JR , Self WH . medRxiv 2021 BACKGROUND: As SARS-CoV-2 vaccination coverage increases in the United States (US), there is a need to understand the real-world effectiveness against severe Covid-19 and among people at increased risk for poor outcomes. METHODS: In a multicenter case-control analysis of US adults hospitalized March 11 - May 5, 2021, we evaluated vaccine effectiveness to prevent Covid-19 hospitalizations by comparing odds of prior vaccination with an mRNA vaccine (Pfizer-BioNTech or Moderna) between cases hospitalized with Covid-19 and hospital-based controls who tested negative for SARS-CoV-2. RESULTS: Among 1210 participants, median age was 58 years, 22.8% were Black, 13.8% were Hispanic, and 20.6% had immunosuppression. SARS-CoV-2 lineage B.1.1.7 was most common variant (59.7% of sequenced viruses). Full vaccination (receipt of two vaccine doses ≥14 days before illness onset) had been received by 45/590 (7.6%) cases and 215/620 (34.7%) controls. Overall vaccine effectiveness was 86.9% (95% CI: 80.4 to 91.2%). Vaccine effectiveness was similar for Pfizer-BioNTech and Moderna vaccines, and highest in adults aged 18-49 years (97.3%; 95% CI: 78.9 to 99.7%). Among 45 patients with vaccine-breakthrough Covid hospitalizations, 44 (97.8%) were ≥50 years old and 20 (44.4%) had immunosuppression. Vaccine effectiveness was lower among patients with immunosuppression (59.2%; 95% CI: 11.9 to 81.1%) than without immunosuppression (91.3%; 95% CI: 85.5 to 94.7%). CONCLUSION: During March-May 2021, SARS-CoV-2 mRNA vaccines were highly effective for preventing Covid-19 hospitalizations among US adults. SARS-CoV-2 vaccination was beneficial for patients with immunosuppression, but effectiveness was lower in the immunosuppressed population. |
Differential neutralization and inhibition of SARS-CoV-2 variants by antibodies elicited by COVID-19 mRNA vaccines (preprint)
Wang L , Kainulainen MH , Jiang N , Di H , Bonenfant G , Mills L , Currier M , Shrivastava-Ranjan P , Calderon BM , Sheth M , Hossain J , Lin X , Lester S , Pusch E , Jones J , Cui D , Chatterjee P , Jenks HM , Morantz E , Larson G , Hatta M , Harcourt J , Tamin A , Li Y , Tao Y , Zhao K , Burroughs A , Wong T , Tong S , Barnes JR , Tenforde MW , Self WH , Shapiro NI , Exline MC , Files DC , Gibbs KW , Hager DN , Patel M , Laufer Halpin AS , Lee JS , Xie X , Shi PY , Davis CT , Spiropoulou CF , Thornburg NJ , Oberste MS , Dugan V , Wentworth DE , Zhou B , Batra D , Beck A , Caravas J , Cintron-Moret R , Cook PW , Gerhart J , Gulvik C , Hassell N , Howard D , Knipe K , Kondor RJ , Kovacs N , Lacek K , Mann BR , McMullan LK , Moser K , Paden CR , Martin BR , Schmerer M , Shepard S , Stanton R , Stark T , Sula E , Tymeckia K , Unoarumhi Y . bioRxiv 2021 30 The evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in the emergence of many new variant lineages that have exacerbated the COVID-19 pandemic. Some of those variants were designated as variants of concern/interest (VOC/VOI) by national or international authorities based on many factors including their potential impact on vaccines. To ascertain and rank the risk of VOCs and VOIs, we analyzed their ability to escape from vaccine-induced antibodies. The variants showed differential reductions in neutralization and replication titers by post-vaccination sera. Although the Omicron variant showed the most escape from neutralization, sera collected after a third dose of vaccine (booster sera) retained moderate neutralizing activity against that variant. Therefore, vaccination remains the most effective strategy to combat the COVID-19 pandemic. |
Comparison of mRNA vaccine effectiveness against COVID-19-associated hospitalization by vaccination source: Immunization information systems, electronic medical records, and self-report-IVY Network, February 1-August 31, 2022
Surie D , Bonnell LN , DeCuir J , Gaglani M , McNeal T , Ghamande S , Steingrub JS , Shapiro NI , Busse LW , Prekker ME , Peltan ID , Brown SM , Hager DN , Ali H , Gong MN , Mohamed A , Khan A , Wilson JG , Qadir N , Chang SY , Ginde AA , Huynh D , Mohr NM , Mallow C , Martin ET , Lauring AS , Johnson NJ , Casey JD , Gibbs KW , Kwon JH , Baughman A , Chappell JD , Hart KW , Grijalva CG , Rhoads JP , Swan SA , Keipp Talbot H , Womack KN , Zhu Y , Tenforde MW , Adams K , Self WH , McMorrow ML . Vaccine 2023 41 (29) 4249-4256 BACKGROUND: Accurate determination of COVID-19 vaccination status is necessary to produce reliable COVID-19 vaccine effectiveness (VE) estimates. Data comparing differences in COVID-19 VE by vaccination sources (i.e., immunization information systems [IIS], electronic medical records [EMR], and self-report) are limited. We compared the number of mRNA COVID-19 vaccine doses identified by each of these sources to assess agreement as well as differences in VE estimates using vaccination data from each individual source and vaccination data adjudicated from all sources combined. METHODS: Adults aged ≥18 years who were hospitalized with COVID-like illness at 21 hospitals in 18 U.S. states participating in the IVY Network during February 1-August 31, 2022, were enrolled. Numbers of COVID-19 vaccine doses identified by IIS, EMR, and self-report were compared in kappa agreement analyses. Effectiveness of mRNA COVID-19 vaccines against COVID-19-associated hospitalization was estimated using multivariable logistic regression models to compare the odds of COVID-19 vaccination between SARS-CoV-2-positive case-patients and SARS-CoV-2-negative control-patients. VE was estimated using each source of vaccination data separately and all sources combined. RESULTS: A total of 4499 patients were included. Patients with ≥1 mRNA COVID-19 vaccine dose were identified most frequently by self-report (n = 3570, 79 %), followed by IIS (n = 3272, 73 %) and EMR (n = 3057, 68 %). Agreement was highest between IIS and self-report for 4 doses with a kappa of 0.77 (95 % CI = 0.73-0.81). VE point estimates of 3 doses against COVID-19 hospitalization were substantially lower when using vaccination data from EMR only (VE = 31 %, 95 % CI = 16 %-43 %) than when using all sources combined (VE = 53 %, 95 % CI = 41 %-62%). CONCLUSION: Vaccination data from EMR only may substantially underestimate COVID-19 VE. |
Changing severity and epidemiology of adults hospitalized with coronavirus disease 2019 (COVID-19) in the United States after introduction of COVID-19 vaccines, March 2021-August 2022
Kojima N , Adams K , Self WH , Gaglani M , McNeal T , Ghamande S , Steingrub JS , Shapiro NI , Duggal A , Busse LW , Prekker ME , Peltan ID , Brown SM , Hager DN , Ali H , Gong MN , Mohamed A , Exline MC , Khan A , Wilson JG , Qadir N , Chang SY , Ginde AA , Withers CA , Mohr NM , Mallow C , Martin ET , Lauring AS , Johnson NJ , Casey JD , Stubblefield WB , Gibbs KW , Kwon JH , Baughman A , Chappell JD , Hart KW , Jones ID , Rhoads JP , Swan SA , Womack KN , Zhu Y , Surie D , McMorrow ML , Patel MM , Tenforde MW . Clin Infect Dis 2023 77 (4) 547-557 INTRODUCTION: Understanding the changing epidemiology of adults hospitalized with coronavirus disease 2019 (COVID-19) informs research priorities and public health policies. METHODS: Among adults (≥18 years) hospitalized with laboratory-confirmed, acute COVID-19 between 11 March 2021, and 31 August 2022 at 21 hospitals in 18 states, those hospitalized during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron-predominant period (BA.1, BA.2, BA.4/BA.5) were compared to those from earlier Alpha- and Delta-predominant periods. Demographic characteristics, biomarkers within 24 hours of admission, and outcomes, including oxygen support and death, were assessed. RESULTS: Among 9825 patients, median (interquartile range [IQR]) age was 60 years (47-72), 47% were women, and 21% non-Hispanic Black. From the Alpha-predominant period (Mar-Jul 2021; N = 1312) to the Omicron BA.4/BA.5 sublineage-predominant period (Jun-Aug 2022; N = 1307): the percentage of patients who had ≥4 categories of underlying medical conditions increased from 11% to 21%; those vaccinated with at least a primary COVID-19 vaccine series increased from 7% to 67%; those ≥75 years old increased from 11% to 33%; those who did not receive any supplemental oxygen increased from 18% to 42%. Median (IQR) highest C-reactive protein and D-dimer concentration decreased from 42.0 mg/L (9.9-122.0) to 11.5 mg/L (2.7-42.8) and 3.1 mcg/mL (0.8-640.0) to 1.0 mcg/mL (0.5-2.2), respectively. In-hospital death peaked at 12% in the Delta-predominant period and declined to 4% during the BA.4/BA.5-predominant period. CONCLUSIONS: Compared to adults hospitalized during early COVID-19 variant periods, those hospitalized during Omicron-variant COVID-19 were older, had multiple co-morbidities, were more likely to be vaccinated, and less likely to experience severe respiratory disease, systemic inflammation, coagulopathy, and death. |
Risk factors for suffocation and unexplained causes of infant deaths
Parks SE , DeSisto CL , Kortsmit K , Bombard JM , Shapiro-Mendoza CK . Pediatrics 2023 151 (1) BACKGROUND: Observational studies have improved our understanding of the risk factors for sudden infant death syndrome, but separate examination of risk for sleep-related suffocation and unexplained infant deaths has been limited. We examined the association between unsafe infant sleep practices and sudden infant deaths (sleep-related suffocation and unexplained causes including sudden infant death syndrome). METHODS: We conducted a population-based case-control study using 2016 to 2017 Centers for Disease Control and Prevention data. Controls were liveborn infants from the Pregnancy Risk Assessment Monitoring System; cases were from the Sudden Unexpected Infant Death Case Registry. We calculated risk factor prevalence among cases and controls and crude and adjusted odds ratios. RESULTS: We included 112 sleep-related suffocation cases with 448 age-matched controls and 300 unexplained infant death cases with 1200 age-matched controls. Adjusted odds for sleep-related suffocation ranged from 18.7 (95% confidence interval [CI]: 6.8-51.3) among infants not sharing a room with their mother or caregiver to 1.9 (95% CI: 0.9-4.1) among infants with nonsupine sleep positioning. Adjusted odds for unexplained death ranged from 7.6 (95% CI: 4.7-12.2) among infants not sharing a room with their mother or caregiver to 1.6 (95% CI: 1.1-2.4) among nonsupine positioned infants. COCLUSIONS: We confirmed previously identified risk factors for unexplained infant death and independently estimated risk factors for sleep-related suffocation. Significance of associations for suffocation followed similar patterns but was of larger magnitude. This information can be used to improve messaging about safe infant sleep. |
Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitalizations Among Adults - United States, March-July 2021.
Tenforde MW , Self WH , Naioti EA , Ginde AA , Douin DJ , Olson SM , Talbot HK , Casey JD , Mohr NM , Zepeski A , Gaglani M , McNeal T , Ghamande S , Shapiro NI , Gibbs KW , Files DC , Hager DN , Shehu A , Prekker ME , Erickson HL , Gong MN , Mohamed A , Henning DJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto 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 , Exline MC , Halasa N , Chappell JD , Lauring AS , Grijalva CG , Rice TW , Jones ID , Stubblefield WB , Baughman A , Womack KN , Lindsell CJ , Hart KW , Zhu Y , Stephenson M , Schrag SJ , Kobayashi M , Verani JR , Patel MM , IVY Network Investigators . MMWR Morb Mortal Wkly Rep 2021 70 (34) 1156-1162 Real-world evaluations have demonstrated high effectiveness of vaccines against COVID-19-associated hospitalizations (1-4) measured shortly after vaccination; longer follow-up is needed to assess durability of protection. In an evaluation at 21 hospitals in 18 states, the duration of mRNA vaccine (Pfizer-BioNTech or Moderna) effectiveness (VE) against COVID-19-associated hospitalizations was assessed among adults aged ≥18 years. Among 3,089 hospitalized adults (including 1,194 COVID-19 case-patients and 1,895 non-COVID-19 control-patients), the median age was 59 years, 48.7% were female, and 21.1% had an immunocompromising condition. Overall, 141 (11.8%) case-patients and 988 (52.1%) controls were fully vaccinated (defined as receipt of the second dose of Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines ≥14 days before illness onset), with a median interval of 65 days (range = 14-166 days) after receipt of second dose. VE against COVID-19-associated hospitalization during the full surveillance period was 86% (95% confidence interval [CI] = 82%-88%) overall and 90% (95% CI = 87%-92%) among adults without immunocompromising conditions. VE against COVID-19- associated hospitalization was 86% (95% CI = 82%-90%) 2-12 weeks and 84% (95% CI = 77%-90%) 13-24 weeks from receipt of the second vaccine dose, with no significant change between these periods (p = 0.854). Whole genome sequencing of 454 case-patient specimens found that 242 (53.3%) belonged to the B.1.1.7 (Alpha) lineage and 74 (16.3%) to the B.1.617.2 (Delta) lineage. Effectiveness of mRNA vaccines against COVID-19-associated hospitalization was sustained over a 24-week period, including among groups at higher risk for severe COVID-19; ongoing monitoring is needed as new SARS-CoV-2 variants emerge. To reduce their risk for hospitalization, all eligible persons should be offered COVID-19 vaccination. |
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. |
Evaluating the Use of LAST 2-Tiered Nomenclature and Its Impact on Reporting Cervical Lesions in a Population-Based Cancer Registry
Hsieh MC , Van Dyne E , Lefante C , Shapiro JA , Pordell P , Lynch MA , Gomez N , Mumphrey B , Maniscalco L , Jetly-Shridhar R , Saraiya M , Wu XC . J Registry Manag 2019 46 (4) 120-127 BACKGROUND: Since 2012, the Lower Anogenital Squamous Terminology (LAST) Project recommended a 2-tiered nomenclature, low-grade and high-grade squamous intraepithelial lesion (LSIL and HSIL), to replace the 3-tiered cervical intraepithelial neoplasia (CIN) system for HPV-associated lesions. Prior to 2019, preinvasive cervical lesions classified as CIN3, severe dysplasia, carcinoma in situ (CIS), and adenocarcinoma in situ (AIS) were considered reportable to the Louisiana Tumor Registry for a CIN3 project funded by the Centers for Disease Control and Prevention (CDC); but lesions classified exclusively as high-grade/HSIL based on the 2-tiered system were not considered reportable. Due to the terminology changes, we wanted to know whether pre-2019 reportable criteria need to be modified to capture all reportable precancerous cervical cases diagnosed in 2019 forward. OBJECTIVES: To evaluate the utilization of LAST 2-tiered classification, low-grade and high-grade squamous intraepithelial lesion, and p16 immunohistochemistry (IHC) testing on cervical biopsy/surgical specimens, assess the search criteria needed to identify high-grade lesions for the CDC-funded CIN3 project, and assess the impact of underreporting cervical lesions caused by terminology changes. METHODS: An equal number of abnormal/precancerous and normal cervical findings from biopsy pathology reports received in 2015 were randomly selected by an artificial intelligence (AI) search engine developed by Artificial Intelligence in Medicine Inc (AIM) using pre2019 search criteria. Selected pathology reports were reflagged for the reportability by AIM audit software based on 2019 search criteria and manually reviewed for the use of reportable terms including CIN3, severe dysplasia, CIS, AIS, highgrade/HSIL terminology, and CIN2 or CIN2-3 with positive p16 IHC testing. Cohen's kappa statistic was used to assess the agreement between AIM auto-coding and manual review. Positive predictive values (PPV) and sensitivity tests were computed to evaluate the reportable terms. RESULTS: Six out of 9 surveyed laboratories used 2-tiered terminology on cervical biopsy pathology reports and 7 performed p16 IHC tests. Of 1,974 randomly selected reports from 5 laboratories, 987 were flagged as precancer by AI using pre-2019 search criteria. After adding the high-grade/HSIL term into pre-2019 search criteria, precancerous reports increased by 29%. After manual review, 41.6% of these cases were reportable precancerous cervical cases with a PPV of 0.65 (95% CI, 0.62-0.67) and 13.6% had p16 IHC performed. CONCLUSIONS: Both the 2-tiered and 3-tiered nomenclature are needed to ensure complete identification of all reportable high-grade cervical lesions. |
Sudden unexpected infant death rates differ by age at death
Shapiro-Mendoza CK . J Pediatr 2018 198 322-325 Bass et al show that SUID differs by age at death. Understanding factors related to age differences informs interventions. SUID rarely occurs in the neonatal period. Of the 4 million US births in 2015, SUID accounted for 108 deaths at 0–6 days and 314 deaths at 7–27 days. Fifty-one deaths were sudden unexpected postnatal collapse (SUPC), born >35 weeks’ gestation, 10-minute APGAR >7, died before 7 days(1). The higher SUID rates in infants 7–27 days compared to infants 0–7 days likely reflect different underlying etiologies. The Centers for Disease Control and Prevention’s SUID Case Registry (2) program works with child death review teams to better document the burden of SUID. Review teams are uniquely positioned to evaluate information about SUID, including SUPC in their jurisdictions. Teams review environmental and clinical factors from scene investigation, autopsy, and medical records for all SUID. Dissemination of review findings and recommendations assists jurisdictions in developing programs to improve infant health and well-being. Review teams collaborate with healthcare providers and parent education programs to encourage uptake of infant safe sleep recommendations (3). Ongoing surveillance of SUID rates by age at death is important to evaluate the impact of infant care interventions, identify new risk factors, and track progress towards reducing SUID mortality. |
Breast, cervical, and colorectal cancer screening test use in the US territories of Guam, Puerto Rico, and the US Virgin Islands
Gopalani SV , Soman A , Shapiro JA , Miller JW , Ortiz-Ortiz KJ , Castañeda-Avila MA , Buenconsejo-Lum LE , Fredericks LE , Tortolero-Luna G , Saraiya M . Cancer Epidemiol 2023 84 102371 BACKGROUND: The United States Preventive Services Task Force (USPSTF) recommends breast, cervical, and colorectal cancer screening among eligible adults, but information on screening use in the US territories is limited. METHODS: To estimate the proportion of adults up-to-date with breast, cervical, and colorectal cancer screening based on USPSTF recommendations, we analyzed Behavioral Risk Factor Surveillance System data from 2016, 2018, and 2020 for the 50 US states and DC (US) and US territories of Guam and Puerto Rico and from 2016 for the US Virgin Islands. Age-standardized weighted proportions for up-to-date cancer screening were examined overall and by select characteristics for each jurisdiction. RESULTS: Overall, 67.2% (95% CI: 60.6-73.3) of women aged 50-74 years in the US Virgin Islands, 74.8% (70.9-78.3) in Guam, 83.4% (81.7-84.9) in Puerto Rico, and 78.3% (77.9-78.6) in the US were up-to-date with breast cancer screening. For cervical cancer screening, 71.1% (67.6-74.3) of women aged 21-65 years in Guam, 81.3% (74.6-86.5) in the US Virgin Islands, 83.0% (81.7-84.3) in Puerto Rico, and 84.5% (84.3-84.8) in the US were up-to-date. For colorectal cancer screening, 45.2% (40.0-50.5) of adults aged 50-75 years in the US Virgin Islands, 47.3% (43.6-51.0) in Guam, 61.2% (59.5-62.8) in Puerto Rico, and 69.0% (68.7-69.3) in the US were up-to-date. Adults without health care coverage reported low test use for all three cancers in all jurisdictions. In most jurisdictions, test use was lower among adults with less than a high school degree and an annual household income of < $25,000. CONCLUSION: Cancer screening test use varied between the US territories, highlighting the importance of understanding and addressing territory-specific barriers. Test use was lower among groups without health care coverage and with lower income and education levels, suggesting the need for targeted evidence-based interventions. |
Effectiveness of monovalent mRNA COVID-19 vaccination in preventing COVID-19-associated invasive mechanical ventilation and death among immunocompetent adults during the Omicron variant period - IVY Network, 19 U.S. States, February 1, 2022-January 31, 2023
DeCuir J , Surie D , Zhu Y , Gaglani M , Ginde AA , Douin DJ , Talbot HK , Casey JD , Mohr NM , McNeal T , Ghamande S , Gibbs KW , Files DC , Hager DN , Phan M , Prekker ME , Gong MN , Mohamed A , Johnson NJ , Steingrub JS , Peltan ID , Brown SM , Martin ET , Monto AS , Khan A , Bender WS , Duggal A , Wilson JG , Qadir N , Chang SY , Mallow C , Kwon JH , Exline MC , Lauring AS , Shapiro NI , Columbus C , Gottlieb R , Vaughn IA , Ramesh M , Lamerato LE , Safdar B , Halasa N , Chappell JD , Grijalva CG , Baughman A , Womack KN , Rhoads JP , Hart KW , Swan SA , Lewis N , McMorrow ML , Self WH . MMWR Morb Mortal Wkly Rep 2023 72 (17) 463-468 As of April 2023, the COVID-19 pandemic has resulted in 1.1 million deaths in the United States, with approximately 75% of deaths occurring among adults aged ≥65 years (1). Data on the durability of protection provided by monovalent mRNA COVID-19 vaccination against critical outcomes of COVID-19 are limited beyond the Omicron BA.1 lineage period (December 26, 2021-March 26, 2022). In this case-control analysis, the effectiveness of 2-4 monovalent mRNA COVID-19 vaccine doses was evaluated against COVID-19-associated invasive mechanical ventilation (IMV) and in-hospital death among immunocompetent adults aged ≥18 years during February 1, 2022-January 31, 2023. Vaccine effectiveness (VE) against IMV and in-hospital death was 62% among adults aged ≥18 years and 69% among those aged ≥65 years. When stratified by time since last dose, VE was 76% at 7-179 days, 54% at 180-364 days, and 56% at ≥365 days. Monovalent mRNA COVID-19 vaccination provided substantial, durable protection against IMV and in-hospital death among adults during the Omicron variant period. All adults should remain up to date with recommended COVID-19 vaccination to prevent critical COVID-19-associated outcomes. |
Medicaid expansion in Oregon and postpartum healthcare among people with and without prenatal substance use disorder
Haight SC , Yoon J , Luck J , Harvey M , Shapiro-Mendoza C , Li R , Ko JY . Drug Alcohol Depend Rep 2022 5 100096 BACKGROUND: People with a maternal substance use disorder (SUD) may experience a lack of access to necessary healthcare and more specifically, postpartum healthcare. It is not known whether increased insurance coverage introduced by Medicaid expansion has improved postpartum healthcare utilization among this population. METHODS: Oregon 2008-2016 birth certificates and Medicaid claims were used to examine whether continuous insurance enrollment and postpartum healthcare utilization increased post-Medicaid expansion in a population with and without SUD (n = 9,337). International Classification of Diseases codes were used to identify deliveries, SUD, and postpartum healthcare. Univariable and multivariable generalized linear regression with standard errors clustered by individual were used to estimate the association between Medicaid expansion and postpartum healthcare utilization, stratified by maternal SUD. RESULTS: Among the 10.3% with SUD, expansion was not associated with increased continuous enrollment or postpartum healthcare utilization. Among those without SUD, post-expansion deliveries were associated with increased continuous enrollment (+105.0 days; 95% CI=96.9-113.2), total (+4.4; 95% CI=2.9-6.0), postpartum (+0.3; 95% CI=0.2-0.4), inpatient (+0.9; 95% CI=0.7-1.1), outpatient (+2.3; 95% CI=1.4-3.3), office (+0.9; 95% CI=0.2-1.6), and emergency department (+0.3; 95% CI=0.1-0.5) visits. Among deliveries to postpartum people with SUD, 27.2% had opioid use disorder (OUD); expansion was associated with increased OUD medication use (12.0% vs 18.3%) and number of fills (6.7 vs 16.6). CONCLUSIONS: Medicaid expansion in Oregon was only associated with increased Medicaid-financed healthcare utilization for postpartum people without SUD, with the exception of those with OUD, demonstrating the need for assessing various strategies to improve postpartum healthcare utilization. |
Sudden unexpected infant deaths: 2015-2020
Shapiro-Mendoza CK , Woodworth KR , Cottengim CR , Erck Lambert AB , Harvey EM , Monsour M , Parks SE , Barfield WD . Pediatrics 2023 151 (4) OBJECTIVE: Although the US infant mortality rate reached a record low in 2020, the sudden infant death syndrome (SIDS) rate increased from 2019. To understand if the increase was related to changing death certification practices or the coronavirus disease 2019 (COVID-19) pandemic, we examined sudden unexpected infant death (SUID) rates as a group, by cause, and by race and ethnicity. METHODS: We estimated SUID rates during 2015 to 2020 using US period-linked birth and death data. SUID included SIDS, unknown cause, and accidental suffocation and strangulation in bed. We examined changes in rates from 2019 to 2020 and assessed linear trends during prepandemic (2015-2019) using weighted least squares regression. We also assessed race and ethnicity trends and quantified COVID-19-related SUID. RESULTS: Although the SIDS rate increased significantly from 2019 to 2020 (P < .001), the overall SUID rate did not (P = .24). The increased SIDS rate followed a declining linear trend in SIDS during 2015 to 2019 (P < .001). Other SUID causes did not change significantly. Our race and ethnicity analysis showed SUID rates increased significantly for non-Hispanic Black infants from 2019 to 2020, widening the disparities between these two groups during 2017 to 2019. In 2020, <10 of the 3328 SUID had a COVID-19 code. CONCLUSIONS: Diagnositic shifting likely explained the increased SIDS rate in 2020. Why the SUID rate increased for non-Hispanic Black infants is unknown, but warrants continued monitoring. Interventions are needed to address persistent racial and ethnic disparities in SUID. |
Counseling women of reproductive age about emergency preparedness - Provider attitudes and practices
Meeker JR , Simeone R , Shapiro-Mendoza CK , Snead M , Hall R , Ellington S , Galang RR . Prev Med 2023 170 107473 We report healthcare provider attitudes and practices on emergency preparedness counseling for women of reproductive age (WRA), including pregnant, postpartum, and lactating women (PPLW), for disasters and weather emergencies. DocStyles is a web-based panel survey of primary healthcare providers in the United States. During March 17-May 17, 2021, obstetricians-gynecologists, family practitioners, internists, nurse practitioners, and physician assistants were asked about the importance of emergency preparedness counseling, level of confidence, frequency, barriers to providing counseling, and preferred resources to support counseling among WRA and PPLW. We calculated frequencies of provider attitudes and practices, and prevalence ratios with 95% CIs for questions with binary responses. Among 1503 respondents (family practitioners (33%), internists (34%), obstetrician-gynecologists (17%), nurse practitioners (8%), and physician assistants (8%)), 77% thought emergency preparedness was important, and 88% thought counseling was necessary for patient health and safety. However, 45% of respondents did not feel confident providing emergency preparedness counseling, and most (70%) had never talked to PPLW about this topic. Respondents cited not having time during clinical visits (48%) and lack of knowledge (34%) as barriers to providing counseling. Most respondents (79%) stated they would use emergency preparedness educational materials for WRA, and 60% said they were willing to take an emergency preparedness training. Healthcare providers have opportunities to provide emergency preparedness counseling; however, many have not, noting lack of time and knowledge as barriers. Emergency preparedness resources combined with training may improve healthcare provider confidence and increase delivery of emergency preparedness counseling. |
Total and subgenomic RNA viral load in patients infected with SARS-CoV-2 Alpha, Delta, and Omicron variants
Dimcheff DE , Blair CN , Zhu Y , Chappell JD , Gaglani M , McNeal T , Ghamande S , Steingrub JS , Shapiro NI , Duggal A , Busse LW , Frosch AEP , Peltan ID , Hager DN , Gong MN , Exline MC , Khan A , Wilson JG , Qadir N , Ginde AA , Douin DJ , Mohr NM , Mallow C , Martin ET , Johnson NJ , Casey JD , Stubblefield WB , Gibbs KW , Kwon JH , Talbot HK , Halasa N , Grijalva CG , Baughman A , Womack KN , Hart KW , Swan SA , Surie D , Thornburg NJ , McMorrow ML , Self WH , Lauring AS . J Infect Dis 2023 228 (3) 235-244 BACKGROUND: SARS-CoV-2 genomic and subgenomic RNA levels are frequently used as a correlate of infectiousness. The impact of host factors and SARS-CoV-2 lineage on RNA viral load is unclear. METHODS: Total nucleocapsid (N) and subgenomic N (sgN) RNA levels were measured by RT-qPCR in specimens from 3,204 individuals hospitalized with COVID-19 at 21 hospitals. RT-qPCR cycle threshold (Ct) values were used to estimate RNA viral load. The impact of time of sampling, SARS-CoV-2 variant, age, comorbidities, vaccination, and immune status on N and sgN Ct values were evaluated using multiple linear regression. RESULTS: Ct values at presentation for N (mean ±standard deviation) were 24.14±4.53 for non-variants of concern, 25.15±4.33 for Alpha, 25.31±4.50 for Delta, and 26.26±4.42 for Omicron. N and sgN RNA levels varied with time since symptom onset and infecting variant but not with age, comorbidity, immune status, or vaccination. When normalized to total N RNA, sgN levels were similar across all variants. CONCLUSIONS: RNA viral loads were similar among hospitalized adults, irrespective of infecting variant and known risk factors for severe COVID-19. Total N and subgenomic RNA N viral loads were highly correlated, suggesting that subgenomic RNA measurements adds little information for the purposes of estimating infectivity. |
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