Last data update: Apr 22, 2024. (Total: 46599 publications since 2009)
Records 1-30 (of 75 Records) |
Query Trace: Roth G [original query] |
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Population-based data linkage describing patterns of cancer clinical trial enrollment among children and adolescents
Siegel DA , Durbin EB , Pollock BH , Grimes A , Ji L , Alonzo TA , Vargas SL , Huang B , McDowell JR , Lycan E , Ransdell P , Tai E , Roth ME , Freyer DR . JCO Oncol Pract 2024 Op2300325 PURPOSE: Database linkage between cancer registries and clinical trial consortia has the potential to elucidate referral patterns of children and adolescents with newly diagnosed cancer, including enrollment into cancer clinical trials. This study's primary objective was to assess the feasibility of this linkage approach. METHODS: Patients younger than 20 years diagnosed with incident cancer during 2012-2017 in the Kentucky Cancer Registry (KCR) were linked with patients enrolled in a Children's Oncology Group (COG) study. Matched patients between databases were described by sex, age, race and ethnicity, geographical location when diagnosed, and cancer type. Logistic regression modeling identified factors associated with COG study enrollment. Timeliness of patient identification by KCR was reported through the Centers for Disease Control and Prevention's Early Case Capture (ECC) program. RESULTS: Of 1,357 patients reported to KCR, 47% were determined by matching to be enrolled in a COG study. Patients had greater odds of enrollment if they were age 0-4 years (v 15-19 years), reported from a COG-affiliated institution, and had renal cancer, neuroblastoma, or leukemia. Patients had lower odds of enrollment if Hispanic (v non-Hispanic White) or had epithelial (eg, thyroid, melanoma) cancer. Most (59%) patients were reported to KCR within 10 days of pathologic diagnosis. CONCLUSION: Linkage of clinical trial data with cancer registries is a feasible approach for tracking patient referral and clinical trial enrollment patterns. Adolescents had lower enrollment compared with younger age groups, independent of cancer type. Population-based early case capture could guide interventions designed to increase cancer clinical trial enrollment. |
Leveraging automated approaches to categorize birth defects from abstracted birth hospitalization data
Newton SM , Distler S , Woodworth KR , Chang D , Roth NM , Board A , Hutcherson H , Cragan JD , Gilboa SM , Tong VT . Birth Defects Res 2023 BACKGROUND: The Surveillance for Emerging Threats to Pregnant People and Infants Network (SET-NET) collects data abstracted from medical records and birth defects registries on pregnant people and their infants to understand outcomes associated with prenatal exposures. We developed an automated process to categorize possible birth defects for prenatal COVID-19, hepatitis C, and syphilis surveillance. By employing keyword searches, fuzzy matching, natural language processing (NLP), and machine learning (ML), we aimed to decrease the number of cases needing manual clinician review. METHODS: SET-NET captures International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes and free text describing birth defects. For unstructured data, we used keyword searches, and then conducted fuzzy matching with a cut-off match score of ≥90%. Finally, we employed NLP and ML by testing three predictive models to categorize birth defect data. RESULTS: As of June 2023, 8326 observations containing data on possible birth defects were submitted to SET-NET. The majority (n = 6758 [81%]) were matched to an ICD-10-CM code and 1568 (19%) were unable to be matched. Through keyword searches and fuzzy matching, we categorized 1387/1568 possible birth defects. Of the remaining 181 unmatched observations, we correctly categorized 144 (80%) using a predictive model. CONCLUSIONS: Using automated approaches allowed for categorization of 99.6% of reported possible birth defects, which helps detect possible patterns requiring further investigation. Without employing these analytic approaches, manual review would have been needed for 1568 observations. These methods can be employed to quickly and accurately sift through data to inform public health responses. |
Outcomes up to age 36 months after congenital Zika virus infection-U.S. states
Neelam V , Woodworth KR , Chang DJ , Roth NM , Reynolds MR , Akosa A , Carr CP , Anderson KN , Mulkey SB , DeBiasi RL , Biddle C , Lee EH , Elmore AL , Scotland SJ , Sowunmi S , Longcore ND , Ahmed M , Langlois PH , Khuwaja S , Browne SE , Lind L , Shim K , Gosciminski M , Blumenfeld R , Khuntia S , Halai UA , Locklear A , Chan M , Willabus T , Tonzel J , Marzec NS , Barreto NA , Sanchez C , Fornoff J , Hale S , Nance A , Iguchi L , Adibhatla SN , Potts E , Schiffman E , Raman D , McDonald MF , Stricklin B , Ludwig E , Denson L , Contreras D , Romitti PA , Ferrell E , Marx M , Signs K , Cook A , Leedom VO , Beauregard S , Orantes LC , Cronquist L , Roush L , Godfred-Cato S , Gilboa SM , Meaney-Delman D , Honein MA , Moore CA , Tong VT . Pediatr Res 2023 BACKGROUND: To characterize neurodevelopmental abnormalities in children up to 36 months of age with congenital Zika virus exposure. METHODS: From the U.S. Zika Pregnancy and Infant Registry, a national surveillance system to monitor pregnancies with laboratory evidence of Zika virus infection, pregnancy outcomes and presence of Zika associated birth defects (ZBD) were reported among infants with available information. Neurologic sequelae and developmental delay were reported among children with ≥1 follow-up exam after 14 days of age or with ≥1 visit with development reported, respectively. RESULTS: Among 2248 infants, 10.1% were born preterm, and 10.5% were small-for-gestational age. Overall, 122 (5.4%) had any ZBD; 91.8% of infants had brain abnormalities or microcephaly, 23.0% had eye abnormalities, and 14.8% had both. Of 1881 children ≥1 follow-up exam reported, neurologic sequelae were more common among children with ZBD (44.6%) vs. without ZBD (1.5%). Of children with ≥1 visit with development reported, 46.8% (51/109) of children with ZBD and 7.4% (129/1739) of children without ZBD had confirmed or possible developmental delay. CONCLUSION: Understanding the prevalence of developmental delays and healthcare needs of children with congenital Zika virus exposure can inform health systems and planning to ensure services are available for affected families. IMPACT: We characterize pregnancy and infant outcomes and describe neurodevelopmental abnormalities up to 36 months of age by presence of Zika associated birth defects (ZBD). Neurologic sequelae and developmental delays were common among children with ZBD. Children with ZBD had increased frequency of neurologic sequelae and developmental delay compared to children without ZBD. Longitudinal follow-up of infants with Zika virus exposure in utero is important to characterize neurodevelopmental delay not apparent in early infancy, but logistically challenging in surveillance models. |
Notes from the field: Autism spectrum disorder among children with laboratory evidence of prenatal Zika virus exposure - Puerto Rico, 2023
Roth NM , Delgado-López C , Wiggins LD , Muñoz NN , Mulkey SB , Nieves-Ferrer L , Woodworth KR , Rosario GM , Huertas MM , Moore CA , Tong VT , Gilboa SM , Valencia-Prado M . MMWR Morb Mortal Wkly Rep 2023 72 (29) 802-804 Infection during pregnancy with Zika virus, a mosquitoborne flavivirus, can cause birth defects and neurodevelopmental abnormalities (1). Autism spectrum disorder (ASD) is a neurodevelopmental disability characterized by social and communication impairment and restricted or repetitive patterns of behavior or interests (2); possible associations between antenatal exposure to a limited number of viruses and ASD have been observed (2). The U.S. Zika Pregnancy and Infant Registry (USZPIR)* monitors children born during January 1, 2016–March 31, 2018, to women with laboratory evidence of Zika virus infection during pregnancy. This report used data from USZPIR and the Puerto Rico Autism Registry† to estimate the prevalence of ASD diagnoses among children with possible prenatal Zika virus exposure and to describe prenatal characteristics and other outcomes by ASD diagnosis status. This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy.§ |
The 2017 Hurricane Public Health Responses: Case Studies Illustrating the Role of Centers for Disease Control and Prevention's Public Health Emergency Preparedness Program - Erratum
Martinez D , Landon KA , McDermott W , Roth J , Schnall AH , Talbert TP , Mainzer HM . Disaster Med Public Health Prep 2020 17 e8 In the original publication of this article, the title | was incorrect, and the key words were left out. The | article has since been corrected. | The publisher apologizes for the error. |
The American Heart Association 2030 Impact Goal: A Presidential Advisory From the American Heart Association
Angell SY , McConnell MV , Anderson CAM , Bibbins-Domingo K , Boyle DS , Capewell S , Ezzati M , de Ferranti S , Gaskin DJ , Goetzel RZ , Huffman MD , Jones M , Khan YM , Kim S , Kumanyika SK , McCray AT , Merritt RK , Milstein B , Mozaffarian D , Norris T , Roth GA , Sacco RL , Saucedo JF , Shay CM , Siedzik D , Saha S , Warner JJ . Circulation 2020 141 (9) e120-e138 Each decade, the American Heart Association (AHA) develops an Impact Goal to guide its overall strategic direction and investments in its research, quality improvement, advocacy, and public health programs. Guided by the AHA's new Mission Statement, to be a relentless force for a world of longer, healthier lives, the 2030 Impact Goal is anchored in an understanding that to achieve cardiovascular health for all, the AHA must include a broader vision of health and well-being and emphasize health equity. In the next decade, by 2030, the AHA will strive to equitably increase healthy life expectancy beyond current projections, with global and local collaborators, from 66 years of age to at least 68 years of age across the United States and from 64 years of age to at least 67 years of age worldwide. The AHA commits to developing additional targets for equity and well-being to accompany this overarching Impact Goal. To attain the 2030 Impact Goal, we recommend a thoughtful evaluation of interventions available to the public, patients, providers, healthcare delivery systems, communities, policy makers, and legislators. This presidential advisory summarizes the task force's main considerations in determining the 2030 Impact Goal and the metrics to monitor progress. It describes the aspiration that these goals will be achieved by working with a diverse community of volunteers, patients, scientists, healthcare professionals, and partner organizations needed to ensure success. |
Notes from the field: Prevalence of previous dengue virus infection among children and adolescents - U.S. Virgin Islands, 2022
Mac VV , Wong JM , Volkman HR , Perez-Padilla J , Wakeman B , Delorey M , Biggerstaff BJ , Fagre A , Gumbs A , Drummond A , Zimmerman B , Lettsome B , Medina FA , Paz-Bailey G , Lawrence M , Ellis B , Rosenblum HG , Carroll J , Roth J , Rossington J , Meeker JR , Joseph J , Janssen J , Ekpo LL , Carrillo M , Hernandez N , Charles P , Tosado R , Soto R , Battle S , Bart SM , Wanga V , Valentin W , Powell W , Battiste Z , Ellis EM , Adams LE . MMWR Morb Mortal Wkly Rep 2023 72 (11) 288-289 In May 2019, the Food and Drug Administration issued approval for Dengvaxia (Sanofi Pasteur), a live-attenuated, chimeric tetravalent dengue vaccine (1). In June 2021, the Advisory Committee on Immunization Practices (ACIP) recommended vaccination with Dengvaxia for children and adolescents aged 9–16 years with laboratory confirmation of previous dengue virus infection and who live in areas with endemic dengue transmission, such as the U.S. Virgin Islands (USVI)† (2). Confirming previous dengue virus infection before vaccine administration (prevaccination screening) is important because 1) although Dengvaxia decreases hospitalization and severe disease from dengue among persons with a previous infection, it increases the risk for these outcomes among persons without a previous infection; 2) many dengue virus infections are asymptomatic; and 3) many patients with symptomatic infections do not seek medical attention or receive appropriate testing (3). Sufficient laboratory evidence of previous dengue virus infection includes a history of laboratory-confirmed dengue§ or a positive serologic test result that meets ACIP-recommended performance standards for prevaccination screening, defined as high specificity (≥98%) and sensitivity (≥75%). A seroprevalence of 20% in the vaccine-eligible population (corresponding to a positive predictive value of ≥90% for a test with minimum sensitivity of 75% and minimum specificity of 98%) is recommended to maximize vaccine safety and minimize the risk for vaccinating persons without a previous dengue virus infection (2). |
Translating an economic analysis into a tool for public health resource allocation in cancer survivorship
Rivers Z , Roth JA , Wright W , Rim SH , Richardson LC , Thomas CC , Townsend JS , Ramsey SD . MDM Policy Pract 2023 8 (1) 23814683231153378 Background. The complexity of decision science models may prevent their use to assist in decision making. User-centered design (UCD) principles provide an opportunity to engage end users in model development and refinement, potentially reducing complexity and increasing model utilization in a practical setting. We report our experiences with UCD to develop a modeling tool for cancer control planners evaluating cancer survivorship interventions. Design. Using UCD principles (described in the article), we developed a dynamic cohort model of cancer survivorship for individuals with female breast, colorectal, lung, and prostate cancer over 10 y. Parameters were obtained from the National Program of Cancer Registries and peer-reviewed literature, with model outcomes captured in quality-adjusted life-years and net monetary benefit. Prototyping and iteration were conducted with structured focus groups involving state cancer control planners and staff from the Centers for Disease Control and Prevention and the American Public Health Association. Results. Initial feedback highlighted model complexity and unclear purpose as barriers to end user uptake. Revisions addressed complexity by simplifying model input requirements, providing clear examples of input types, and reducing complex language. Wording was added to the results page to explain the interpretation of results. After these updates, feedback demonstrated that end users more clearly understood how to use and apply the model for cancer survivorship resource allocation tasks. Conclusions. A UCD approach identified challenges faced by end users in integrating a decision aid into their workflow. This approach created collaboration between modelers and end users, tailoring revisions to meet the needs of the users. Future models developed for individuals without a decision science background could leverage UCD to ensure the model meets the needs of the intended audience. HIGHLIGHTS: Model complexity and unclear purpose are 2 barriers that prevent lay users from integrating decision science tools into their workflow.Modelers could integrate the user-centered design framework when developing a model for lay users to reduce complexity and ensure the model meets the needs of the users. |
Assessment of vitamin D status and association with inflammation: Biomarkers reflecting inflammation and nutritional determinants of anemia (BRINDA) project
Young MF , Ou J , Duong C , Luo H , Beyh YS , Meng J , Gernand AD , Roth DE , Suchdev PS . Am J Clin Nutr 2023 117 (1) 175-181 BACKGROUND: It is unclear whether 25(OH)D concentrations in children and female adults may be influenced by inflammation and thus require adjustment when estimating the population prevalence of vitamin D deficiency. OBJECTIVES: We examined correlations between inflammation biomarkers, CRP or alpha-1-acid glycoprotein (AGP), and serum 25(OH)D concentrations among preschool children (PSC; 6-59 mo) and nonpregnant females of reproductive age (FRA; 15-49 y). METHODS: We analyzed cross-sectional data from 6 nationally representative nutrition surveys (Afghanistan, Cambodia, Pakistan, UK, USA, and Vietnam) conducted among PSC (n = 9880) and FRA (n = 14,749) from the Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia project. Rank correlations between CRP or AGP and 25(OH)D concentrations were examined while taking into account complex survey design effects. RESULTS: Among both PSC and FRA, correlations between inflammation and vitamin D biomarkers were weak and inconsistent across surveys. For PSC, correlation coefficients between CRP and 25(OH)D concentrations ranged from -0.04 to 0.08, and correlations between AGP and 25(OH)D ranged from 0.01 to 0.05. Correlation coefficients between CRP and 25(OH)D for FRA ranged from -0.11 to 0.14, and correlations between AGP and 25(OH)D concentrations ranged from -0.05 to 0.01. CONCLUSIONS: Based on the weak and inconsistent correlations between CRP or AGP and 25(OH)D, there is no rationale to adjust for these inflammation biomarkers when estimating population prevalence of vitamin D deficiency in PSC or FRA. |
Early and increased influenza activity among children - Tennessee, 2022-23 influenza season
Thomas CM , White EB , Kojima N , Fill MA , Hanna S , Jones TF , Newhouse CN , Orejuela K , Roth E , Winders S , Chandler DR , Grijalva CG , Schaffner W , Schmitz JE , DaSilva J , Kirby MK , Mellis AM , Rolfes MA , Sumner KM , Flannery B , Talbot HK , Dunn JR . MMWR Morb Mortal Wkly Rep 2023 72 (3) 49-54 Influenza seasons typically begin in October and peak between December and February (1); however, the 2022-23 influenza season in Tennessee began in late September and was characterized by high pediatric hospitalization rates during November. This report describes a field investigation conducted in Tennessee during November 2022, following reports of increasing influenza hospitalizations. Data from surveillance networks, patient surveys, and whole genome sequencing of influenza virus specimens were analyzed to assess influenza activity and secondary illness risk. Influenza activity increased earlier than usual among all age groups, and rates of influenza-associated hospitalization among children were high in November, reaching 12.6 per 100,000 in children aged <5 years, comparable to peak levels typically seen in high-severity seasons. Circulating influenza viruses were genetically similar to vaccine components. Among persons who received testing for influenza at outpatient clinics, children were twice as likely to receive a positive influenza test result as were adults. Among household contacts exposed to someone with influenza, children were more than twice as likely to become ill compared with adults. As the influenza season continues, it is important for all persons, especially those at higher risk for severe disease, to protect themselves from influenza. To prevent influenza and severe influenza complications, all persons aged ≥6 months should get vaccinated, avoid contact with ill persons, and take influenza antivirals if recommended and prescribed. |
Mpox cases among cisgender women and pregnant persons - United States, May 11-November 7, 2022
Oakley LP , Hufstetler K , O'Shea J , Sharpe JD , McArdle C , Neelam V , Roth NM , Olsen EO , Wolf M , Pao LZ , Gold JAW , Davis KM , Perella D , Epstein S , Lash MK , Samson O , Pavlick J , Feldpausch A , Wallace J , Nambiar A , Ngo V , Halai UA , Richardson CW , Fowler T , Taylor BP , Chou J , Brandon L , Devasia R , Ricketts EK , Stockdale C , Roskosky M , Ostadkar R , Vang Y , Galang RR , Perkins K , Taylor M , Choi MJ , Weidle PJ , Dawson P , Ellington S . MMWR Morb Mortal Wkly Rep 2023 72 (1) 9-14 Monkeypox (mpox) cases in the 2022 outbreak have primarily occurred among adult gay, bisexual, and other men who have sex with men (MSM); however, other populations have also been affected (1). To date, data on mpox in cisgender women and pregnant persons have been limited. Understanding transmission in these populations is critical for mpox prevention. In addition, among pregnant persons, Monkeypox virus can be transmitted to the fetus during pregnancy or to the neonate through close contact during or after birth (2-5). Adverse pregnancy outcomes, including spontaneous abortion and stillbirth, have been reported in previous mpox outbreaks (3). During May 11-November 7, 2022, CDC and U.S. jurisdictional health departments identified mpox in 769 cisgender women aged ≥15 years, representing 2.7% of all reported mpox cases.(†) Among cases with available data, 44% occurred in cisgender women who were non-Hispanic Black or African American (Black), 25% who were non-Hispanic White (White), and 23% who were Hispanic or Latino (Hispanic). Among cisgender women with available data, 73% reported sexual activity or close intimate contact as the likely route of exposure, with mpox lesions most frequently reported on the legs, arms, and genitals. Twenty-three mpox cases were reported in persons who were pregnant or recently pregnant(§); all identified as cisgender women based on the mpox case report form.(¶) Four pregnant persons required hospitalization for mpox. Eleven pregnant persons received tecovirimat, and no adverse reactions were reported. Continued studies on mpox transmission risks in populations less commonly affected during the outbreak, including cisgender women and pregnant persons, are important to assess and understand the impact of mpox on sexual, reproductive, and overall health. |
Epidemiologic and clinical features of mpox in transgender and gender-diverse adults - United States, May-November 2022
Blackburn D , Roth NM , Gold JAW , Pao LZ , Olansky E , Torrone EA , McClung RP , Ellington SR , Delaney KP , Carnes N , Dawson P . MMWR Morb Mortal Wkly Rep 2022 71 (5152) 1605-1609 As of November 9, 2022, a total of 28,730 cases of monkeypox (mpox) had been reported in the United States,* primarily among adult cisgender men reporting recent male-to-male sexual contact (1). Transgender and gender-diverse persons, who constitute an estimated 0.5% of the U.S. adult population,(†) face unique health disparities and barriers to care (2-4). However, data on the epidemiologic and clinical features of Monkeypox virus infections in this population are limited (5). CDC analyzed U.S. case surveillance data on mpox cases in transgender and gender-diverse adults reported during May 17-November 4, 2022. During this period, 466 mpox cases in transgender and gender-diverse adults were reported, accounting for 1.7% of reported cases among adults. Most were in transgender women (43.1%) or gender-diverse persons (42.1%); 14.8% were in transgender men. Among 374 (80.3%) mpox cases in transgender and gender-diverse adults with information available on sexual or close intimate contact, 276 (73.8%) reported sexual or close intimate contact with a cisgender male partner during the 3 weeks preceding symptom onset. During the ongoing outbreak, transgender and gender-diverse persons have been disproportionately affected by mpox. Members of this population frequently reported recent sexual or close intimate contact with cisgender men, who might be in sexual networks experiencing the highest incidence of mpox. These findings highlight the importance of tailoring public health prevention and outreach efforts to transgender and gender-diverse communities and could guide strategies to reduce mpox transmission. |
Spatial, sociodemographic, and weather analysis of the Zika virus outbreak: U.S. Virgin Islands, January 2016-January 2018
Browne AS , Rickless D , Hranac CR , Beron A , Hillman B , de Wilde L , Short H , Harrison C , Prosper A , Joseph EJ , Guendel I , Ekpo LL , Roth J , Grossman M , Ellis BR , Ellis EM . Vector Borne Zoonotic Dis 2022 22 (12) 600-605 Background: The first Zika virus outbreak in U.S. Virgin Islands identified 1031 confirmed noncongenital Zika disease (n = 967) and infection (n = 64) cases during January 2016-January 2018; most cases (89%) occurred during July-December 2016. Methods and Results: The epidemic followed a continued point-source outbreak pattern. Evaluation of sociodemographic risk factors revealed that estates with higher unemployment, more houses connected to the public water system, and more newly built houses were significantly less likely to have Zika virus disease and infection cases. Increased temperature was associated with higher case counts, which suggests a seasonal association of this outbreak. Conclusion: Vector surveillance and control measures are needed to prevent future outbreaks. |
Seroprevalence, distribution, and risk factors for human leptospirosis in the United States Virgin Islands
Artus A , Schafer IJ , Cossaboom CM , Haberling DL , Galloway R , Sutherland G , Browne AS , Roth JJr , France V , Cranford HM , Kines KJ , Pompey J , Ellis BR , Walke H , Ellis EM . PLoS Negl Trop Dis 2022 16 (11) e0010880 BACKGROUND: The first documented human leptospirosis cases in the U.S. Virgin Islands (USVI) occurred following 2017 Hurricanes Irma and Maria. We conducted a representative serosurvey in USVI to estimate the seroprevalence and distribution of human leptospirosis and evaluate local risk factors associated with seropositivity. METHODOLOGY/PRINCIPAL FINDINGS: A stratified, two-stage cluster sampling design was used and consisted of three island strata and random selection of census blocks and then households. All eligible members of selected households were invited to participate (≥5 years old, resided in USVI ≥6 months and ≥6 months/year). Household and individual-level questionnaires were completed, and serum collected from each enrolled individual. Microscopic agglutination test serology was conducted, and bivariate and logistic regression analyses completed to identify risk factors for seropositivity. In March 2019, 1,161 individuals were enrolled from 918 households in St. Croix, St. Thomas, and St. John. The territory-wide weighted seroprevalence was 4.0% (95% CI:2.3-5.7). Characteristics/exposures independently associated with seropositivity using logistic regression included contact with cows (OR: 39.5; 95% CI: 9.0-172.7), seeing rodents/rodent evidence or contact with rodents (OR: 2.6; 95% CI: 1.1-5.9), and increasing age (OR: 1.02; 95% CI: 1.002-1.04); full or partial Caucasian/White race was negatively correlated with seropositivity (OR: 0.02, 95% CI: 0.04-0.7). Bivariate analysis showed self-reported jaundice since the 2017 hurricanes (pRR: 5.7; 95% CI: 1.0-33.4) was associated with seropositivity and using a cover/lid on cisterns/rainwater collection containers (pRR: 0.3; 95% CI: 0.08-0.8) was protective against seropositivity. CONCLUSIONS/SIGNIFICANCE: Leptospirosis seropositivity of 4% across USVI demonstrates an important human disease that was previously unrecognized and emphasizes the importance of continued leptospirosis surveillance and investigation. Local risk factors identified may help guide future human and animal leptospirosis studies in USVI, strengthen leptospirosis public health surveillance and treatment timeliness, and inform targeted education, prevention, and control efforts. |
Epidemiologic features of the monkeypox outbreak and the public health response - United States, May 17-October 6, 2022
Kava CM , Rohraff DM , Wallace B , Mendoza-Alonzo JL , Currie DW , Munsey AE , Roth NM , Bryant-Genevier J , Kennedy JL , Weller DL , Christie A , McQuiston JH , Hicks P , Strid P , Sims E , Negron ME , Iqbal K , Ellington S , Smith DK . MMWR Morb Mortal Wkly Rep 2022 71 (45) 1449-1456 On May 17, 2022, the Massachusetts Department of Health announced the first suspected case of monkeypox associated with the global outbreak in a U.S. resident. On May 23, 2022, CDC launched an emergency response (1,2). CDC's emergency response focused on surveillance, laboratory testing, medical countermeasures, and education. Medical countermeasures included rollout of a national JYNNEOS vaccination strategy, Food and Drug Administration (FDA) issuance of an emergency use authorization to allow for intradermal administration of JYNNEOS, and use of tecovirimat for patients with, or at risk for, severe monkeypox. During May 17-October 6, 2022, a total of 26,384 probable and confirmed* U.S. monkeypox cases were reported to CDC. Daily case counts peaked during mid-to-late August. Among 25,001 of 25,569 (98%) cases in adults with information on gender identity,(†) 23,683 (95%) occurred in cisgender men. Among 13,997 cisgender men with information on recent sexual or close intimate contact,(§) 10,440 (75%) reported male-to-male sexual contact (MMSC) ≤21 days preceding symptom onset. Among 21,211 (80%) cases in persons with information on race and ethnicity,(¶) 6,879 (32%), 6,628 (31%), and 6,330 (30%) occurred in non-Hispanic Black or African American (Black), Hispanic or Latino (Hispanic), and non-Hispanic White (White) persons, respectively. Among 5,017 (20%) cases in adults with information on HIV infection status, 2,876 (57%) had HIV infection. Prevention efforts, including vaccination, should be prioritized among persons at highest risk within groups most affected by the monkeypox outbreak, including gay, bisexual, and other men who have sex with men (MSM); transgender, nonbinary, and gender-diverse persons; racial and ethnic minority groups; and persons who are immunocompromised, including persons with advanced HIV infection or newly diagnosed HIV infection. |
Breast Milk Feeding of Infants at Birth Among People With Confirmed SARS-CoV-2 Infection in Pregnancy: SET-NET, 5 States, March 29, 2020-December 31, 2020.
Lewis EL , Smoots AN , Woodworth KR , Olsen EO , Roth NM , Yazdy M , Shephard H , Sizemore L , Wingate H , Dzimira P , Reynolds B , Lush M , Fuchs EL , Ojo K , Siebman S , Hall AJ , Azziz-Baumgartner E , Perrine C , Hsia J , Ellington S , Tong VT , Gilboa SM . Am J Public Health 2022 112 S787-s796 Objectives. To describe prevalence of breast milk feeding among people with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during pregnancy and examine associations between breast milk feeding, timing of maternal infection before delivery, and rooming-in status during delivery hospitalization. Methods. We performed a retrospective cohort study using data from Massachusetts, Minnesota, Nebraska, Pennsylvania, and Tennessee of whether people with confirmed SARS-CoV-2 infection during pregnancy in 2020 initiated breast milk feeding at birth. Results. Among 11114 (weighted number) people with SARS-CoV-2 infection in pregnancy, 86.5% (95% confidence interval [CI]=82.4%, 87.6%) initiated breast milk feeding during birth hospitalization. People with infection within 14 days before delivery had significantly lower prevalence of breast milk feeding (adjusted prevalence ratio [APR]=0.88; 95% CI=0.83, 0.94) than did those with infection at least 14 days before delivery. When stratified by rooming-in status, the association between timing of infection and breast milk feeding remained only among infants who did not room in with their mother (APR=0.77; 95% CI=0.68, 0.88). Conclusions. Pregnant and postpartum people with SARS-CoV-2 infection should have access to lactation support and be advised about the importance of breast milk feeding and how to safely feed their infants in the same room. (Am J Public Health. 2022;112(S8):S787-S796. https://doi.org/10.2105/AJPH.2022.307023). |
Infectious aetiologies of neonatal illness in South Asia classified using WHO definitions: a primary analysis of the ANISA study
Arvay ML , Shang N , Qazi SA , Darmstadt GL , Islam MS , Roth DE , Liu A , Connor NE , Hossain B , Sadeq-Ur Rahman Q , El Arifeen S , Mullany LC , Zaidi AKM , Bhutta ZA , Soofi SB , Shafiq Y , Baqui AH , Mitra DK , Panigrahi P , Panigrahi K , Bose A , Isaac R , Westreich D , Meshnick SR , Saha SK , Schrag SJ . Lancet Glob Health 2022 10 (9) e1289-e1297 BACKGROUND: Globally, neonatal mortality accounts for almost half of all deaths in children younger than 5 years. Aetiological agents of neonatal infection are difficult to identify because the clinical signs are non-specific. Using data from the Aetiology of Neonatal Infections in south Asia (ANISA) cohort, we aimed to describe the spectrum of infectious aetiologies of acute neonatal illness categorised post-hoc using the 2015 WHO case definitions of critical illness, clinical severe infection, and fast breathing only. METHODS: Eligible infants were aged 0-59 days with possible serious bacterial infection and healthy infants enrolled in the ANISA study in Bangladesh, India, and Pakistan. We applied a partial latent class Bayesian model to estimate the prevalence of 27 pathogens detectable on PCR, pathogens detected by blood culture only, and illness not attributed to any infectious aetiology. Infants with at least one clinical specimen available were included in the analysis. We assessed the prevalence of these aetiologies according to WHO's case definitions of critically ill, clinical severe infection, and infants with late onset, isolated fast breathing. For the clinical severe definition, we compared the prevalence of signs by bacterial versus viral aetiology. FINDINGS: There were 934 infants (992 episodes) in the critically ill category, 3769 (4000 episodes) in the clinical severe infection category, and 738 (771 episodes) in the late-onset isolated fast breathing category. We estimated the proportion of illness attributable to bacterial infection was 32·7% in infants in the critically ill group, 15·6% in the clinical severe infection group, and 8·8% among infants with late-onset isolated fast breathing group. An infectious aetiology was not identified in 58-82% of infants in these categories. Among 4000 episodes of clinical severe infection, those with bacterial versus viral attribution had higher proportions of hypothermia, movement only when stimulated, convulsions, and poor feeding. INTERPRETATION: Our modelled results generally support the revised WHO case definitions, although a revision of the most severe case definition could be considered. Clinical criteria do not clearly differentiate between young infants with and without infectious aetiologies. Our results highlight the need for improved point-of-care diagnostics, and further study into neonatal deaths and episodes with no identified aetiology, to ensure antibiotic stewardship and targeted interventions. FUNDING: The Bill and Melinda Gates Foundation. |
Prevalence of individual brain and eye defects potentially related to Zika virus in pregnancy in 22U.S. states and territories, January 2016 to June 2017
Delaney A , Olson SM , Roth NM , Cragan JD , Godfred-Cato S , Smoots AN , Fornoff J , Nestoridi E , Eckert V , Forkner A , Stolz A , Crawford K , Cho SJ , Elmore A , Langlois P , Nance A , Denson L , Forestieri N , Leedom VO , Tran T , Valencia-Prado M , Romitti P , Barton JE , St John K , Mann S , Orantes L , DeWilde L , Tong VT , Gilboa SM , Moore CA , Honein MA . Birth Defects Res 2022 114 (14) 805-811 During the Centers for Disease Control and Prevention's Zika Virus Response, birth defects surveillance programs adapted to monitor birth defects potentially related to Zika virus (ZIKV) infection during pregnancy. Pregnancy outcomes occurring during January 2016 to June 2017 in 22 U.S. states and territories were used to estimate the prevalence of those brain and eye defects potentially related to ZIKV. Jurisdictions were divided into three groups: areas with widespread ZIKV transmission, areas with limited local ZIKV transmission, and areas without local ZIKV transmission. Prevalence estimates for selected brain and eye defects and microcephaly per 10,000 live births were estimated. Prevalence ratios (PRs) and 95% confidence intervals (CIs) were estimated using Poisson regression for areas with widespread and limited ZIKV transmission compared with areas without local ZIKV transmission. Defects with significantly higher prevalence in areas of widespread transmission were pooled, and PRs were calculated by quarter, comparing subsequent quarters to the first quarter (January-March 2016). Nine defects had significantly higher prevalence in areas of widespread transmission. The highest PRs were seen in intracranial calcifications (PR = 12.6, 95% CI [7.4, 21.3]), chorioretinal abnormalities (12.5 [7.1, 22.3]), brainstem abnormalities (9.3 [4.7, 18.4]), and cerebral/cortical atrophy (6.7 [4.2, 10.8]). The PR of the nine pooled defects was significantly higher in three quarters in areas with widespread transmission. The largest difference in prevalence was observed for defects consistently reported in infants with congenital ZIKV infection. Birth defects surveillance programs could consider monitoring a subset of birth defects potentially related to ZIKV in pregnancy. |
SARS-CoV-2 infections among neonates born to pregnant people with SARS-CoV-2 infection: Maternal, pregnancy and birth characteristics.
Olsen EO , Roth NM , Aveni K , Santos P , Sizemore L , Halai UA , Nestoridi E , Barton JE , Mobley E , Siebman S , Fussman C , Mbotha D , Dzimira P , Silcox KM , Khuwaja S , Roscom D , Lush M , Chicchelly S , Delgado-López C , Schlosser L , Read J , Ellington SR , Hall AJ , Gilboa SM , Tong VT , Woodworth KR . Paediatr Perinat Epidemiol 2022 36 (4) 476-484 BACKGROUND: Multiple reports have described neonatal SARS-CoV-2 infection, including likely in utero transmission and early postnatal infection, but published estimates of neonatal infection range by geography and design type. OBJECTIVES: To describe maternal, pregnancy and neonatal characteristics among neonates born to people with SARS-CoV-2 infection during pregnancy by neonatal SARS-CoV-2 testing results. METHODS: Using aggregated data from the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET) describing infections from 20 January 2020 to 31 December 2020, we identified neonates who were (1) born to people who were SARS-CoV-2 positive by RT-PCR at any time during their pregnancy, and (2) tested for SARS-CoV-2 by RT-PCR during the birth hospitalisation. RESULTS: Among 28,771 neonates born to people with SARS-CoV-2 infection during pregnancy, 3816 (13%) underwent PCR testing and 138 neonates (3.6%) were PCR positive. Ninety-four per cent of neonates testing positive were born to people with infection identified ≤14 days of delivery. Neonatal SARS-CoV-2 infection was more frequent among neonates born preterm (5.7%) compared to term (3.4%). Neonates testing positive were born to both symptomatic and asymptomatic pregnant people. CONCLUSIONS: Jurisdictions reported SARS-CoV-2 RT-PCR results for only 13% of neonates known to be born to people with SARS-CoV-2 infection during pregnancy. These results provide evidence of neonatal infection identified through multi-state systematic surveillance data collection and describe characteristics of neonates with SARS-CoV-2 infection. While perinatal SARS-CoV-2 infection was uncommon among tested neonates born to people with SARS-CoV-2 infection during pregnancy, nearly all cases of tested neonatal infection occurred in pregnant people infected around the time of delivery and was more frequent among neonates born preterm. These findings support the recommendation for neonatal SARS-CoV-2 RT-PCR testing, especially for people with acute infection around the time of delivery. |
Appreciative inquiry and the co-creation of an evaluation framework for Extension for Community Healthcare Outcomes (ECHO) implementation: A two-country experience
Ghosh S , Struminger BB , Singla N , Roth BM , Kumar A , Anand S , Mtete E , Lusekelo J , Massawe I , Jarpe-Ratner E , Seweryn SM , Risley K , Moonan PK , Pinsker E . Eval Program Plann 2022 92 102067 Persistent gaps exist in healthcare workers' capacity to address HIV and tuberculosis in Asia and Africa due to constraints in resources and knowledge. Project ECHO (Extension for Community Healthcare Outcomes) leverages video-enabled technology to build workforce capacity and promote collaboration through mentorship and case-based learning. To understand current perceptions of ECHO participants and develop a comprehensive evaluation framework for ECHO implementation, we utilized modified appreciative inquiry guided focus group discussions (FGD) in India and Tanzania and called it SCORE (Strengths, Challenges, Opportunities, Results, and Evaluation). Content and thematic analysis of transcripts from FGDs and key-informant interviews triangulated perceptions of diverse stakeholders about ECHO implementation and identified key elements for development of the framework. The perceived strengths (S) were capacity building and establishing communities of practice. The perceived challenges (C) included securing resources, engaging leadership, and building systems for monitoring impact. Improved internet connectivity, addressing logistical challenges, encouraging session interactivity, and having strategic scale-up plans were perceived opportunities (O). Additionally, gathering measurable results (R) led to development of a comprehensive evaluation (E) framework. Contextualizing and facilitating SCORE with qualitative analysis of findings 6-12months post-ECHO implementation may serve as a best practice to assess mid-course corrections to improve ECHO implementation quality. |
Identifying possible inaccuracy in reported birth head circumference measurements among infants in the US Zika Pregnancy and Infant Registry
Roth NM , Woodworth KR , Godfred-Cato S , Delaney AM , Olson SM , Nahabedian JF3rd , Reynolds MR , Jones AM , Neelam V , Valencia-Prado M , Delgado-López C , Lee EH , Ellis EM , Lake-Burger H , Tonzel JL , Higgins CA , Chan RL , Tong VT , Gilboa SM , Cragan JD , Honein MA , Moore CA . Birth Defects Res 2022 114 (8) 314-318 BACKGROUND: The US Zika Pregnancy and Infant Registry (USZPIR) monitors infants born to mothers with confirmed or possible Zika virus infection during pregnancy. The surveillance case definition for Zika-associated birth defects includes microcephaly based on head circumference (HC). METHODS: We assessed birth and follow-up data from infants with birth HC measurements <3rd percentile and birthweight ≥10th percentile to determine possible misclassification of microcephaly. We developed a schema informed by literature review and expert opinion to identify possible HC measurement inaccuracy using HC growth velocity and longitudinal HC measurements between 2 and 12 months of age. Two or more HC measurements were required for assessment. Inaccuracy in birth HC measurement was suspected if growth velocity was >3 cm/month in the first 3 months or HC was consistently >25th percentile during follow-up. RESULTS: Of 6,799 liveborn infants in USZPIR, 351 (5.2%) had Zika-associated birth defects, of which 111 had birth HC measurements <3rd percentile and birthweight ≥10th percentile. Of 84/111 infants with sufficient follow-up, 38/84 (45%) were classified as having possible inaccuracy of birth HC measurement, 19/84 (23%) had HC ≥3rd percentile on follow-up without meeting criteria for possible inaccuracy, and 27/84 (32%) had continued HC <3rd percentile. After excluding possible inaccuracies, the proportion of infants with Zika-associated birth defects including microcephaly decreased from 5.2% to 4.6%. CONCLUSIONS: About one-third of infants in USZPIR with Zika-associated birth defects had only microcephaly, but indications of possible measurement inaccuracy were common. Implementation of this schema in longitudinal studies can reduce misclassification of microcephaly. |
Zika-associated birth defects reported in pregnancies with laboratory evidence of confirmed or possible Zika virus infection - U.S. Zika Pregnancy and Infant Registry, December 1, 2015-March 31, 2018
Roth NM , Reynolds MR , Lewis EL , Woodworth KR , Godfred-Cato S , Delaney A , Akosa A , Valencia-Prado M , Lash M , Elmore A , Langlois P , Khuwaja S , Tufa A , Ellis EM , Nestoridi E , Lyu C , Longcore ND , Piccardi M , Lind L , Starr S , Johnson L , Browne SE , Gosciminski M , Velasco PE , Johnson-Clarke F , Locklear A , Chan M , Fornoff J , Toews KE , Tonzel J , Marzec NS , Hale S , Nance AE , Willabus T , Contreras D , Adibhatla SN , Iguchi L , Potts E , Schiffman E , Lolley K , Stricklin B , Ludwig E , Garstang H , Marx M , Ferrell E , Moreno-Gorrin C , Signs K , Romitti P , Leedom V , Martin B , Castrodale L , Cook A , Fredette C , Denson L , Cronquist L , Nahabedian JF3rd , Shinde N , Polen K , Gilboa SM , Martin SW , Cragan JD , Meaney-Delman D , Honein MA , Tong VT , Moore CA . MMWR Morb Mortal Wkly Rep 2022 71 (3) 73-79 Zika virus infection during pregnancy can cause serious birth defects of the brain and eyes, including intracranial calcifications, cerebral or cortical atrophy, chorioretinal abnormalities, and optic nerve abnormalities (1,2). The frequency of these Zika-associated brain and eye defects, based on data from the U.S. Zika Pregnancy and Infant Registry (USZPIR), has been previously reported in aggregate (3,4). This report describes the frequency of individual Zika-associated brain and eye defects among infants from pregnancies with laboratory evidence of confirmed or possible Zika virus infection. Among 6,799 live-born infants in USZPIR born during December 1, 2015-March 31, 2018, 4.6% had any Zika-associated birth defect; in a subgroup of pregnancies with a positive nucleic acid amplification test (NAAT) for Zika virus infection, the percentage was 6.1% of live-born infants. The brain and eye defects most frequently reported included microcephaly, corpus callosum abnormalities, intracranial calcification, abnormal cortical gyral patterns, ventriculomegaly, cerebral or cortical atrophy, chorioretinal abnormalities, and optic nerve abnormalities. Among infants with any Zika-associated birth defect, one third had more than one defect reported. Certain brain and eye defects in an infant might prompt suspicion of prenatal Zika virus infection. These findings can help target surveillance efforts to the most common brain and eye defects associated with Zika virus infection during pregnancy should a Zika virus outbreak reemerge, and might provide a signal to the reemergence of Zika virus, particularly in geographic regions without ongoing comprehensive Zika virus surveillance. |
Assessing rodents as carriers of pathogenic Leptospira species in the U.S. Virgin Islands and their risk to animal and public health.
Hamond C , Browne AS , deWilde LH , Hornsby RL , LeCount K , Anderson T , Stuber T , Cranford HM , Browne SK , Blanchard G , Horner D , Taylor ML , Evans M , Angeli NF , Roth J , Bisgard KM , Salzer JS , Schafer IJ , Ellis BR , Alt DP , Schlater L , Nally JE , Ellis EM . Sci Rep 2022 12 (1) 1132 Leptospirosis is a global zoonotic disease caused by pathogenic bacteria of the genus Leptospira. We sought to determine if rodents in U.S. Virgin Islands (USVI) are carriers of Leptospira. In total, 140 rodents were sampled, including 112 Mus musculus and 28 Rattus rattus. A positive carrier status was identified for 64/140 (45.7%); 49 (35.0%) were positive by dark-field microscopy, 60 (42.9%) by culture, 63 (45.0%) by fluorescent antibody testing, and 61 (43.6%) by real-time polymerase chain reaction (rtPCR). Molecular typing indicated that 48 isolates were L. borgpetersenii and 3 were L. kirschneri; the remaining nine comprised mixed species. In the single culture-negative sample that was rtPCR positive, genotyping directly from the kidney identified L. interrogans. Serotyping of L. borgpetersenii isolates identified serogroup Ballum and L. kirschneri isolates as serogroup Icterohaemorrhagiae. These results demonstrate that rodents are significant Leptospira carriers and adds to understanding the ecoepidemiology of leptospirosis in USVI. |
Mongooses (Urva auropunctata) as reservoir hosts of Leptospira species in the United States Virgin Islands, 2019-2020.
Cranford HM , Browne AS , LeCount K , Anderson T , Hamond C , Schlater L , Stuber T , Burke-France VJ , Taylor M , Harrison CJ , Matias KY , Medley A , Rossow J , Wiese N , Jankelunas L , de Wilde L , Mehalick M , Blanchard GL , Garcia KR , McKinley AS , Lombard CD , Angeli NF , Horner D , Kelley T , Worthington DJ , Valiulis J , Bradford B , Berentsen A , Salzer JS , Galloway R , Schafer IJ , Bisgard K , Roth J , Ellis BR , Ellis EM , Nally JE . PLoS Negl Trop Dis 2021 15 (11) e0009859 During 2019-2020, the Virgin Islands Department of Health investigated potential animal reservoirs of Leptospira spp., the bacteria that cause leptospirosis. In this cross-sectional study, we investigated Leptospira spp. exposure and carriage in the small Indian mongoose (Urva auropunctata, syn: Herpestes auropunctatus), an invasive animal species. This study was conducted across the three main islands of the U.S. Virgin Islands (USVI), which are St. Croix, St. Thomas, and St. John. We used the microscopic agglutination test (MAT), fluorescent antibody test (FAT), real-time polymerase chain reaction (lipl32 rt-PCR), and bacterial culture to evaluate serum and kidney specimens and compared the sensitivity, specificity, positive predictive value, and negative predictive value of these laboratory methods. Mongooses (n = 274) were live-trapped at 31 field sites in ten regions across USVI and humanely euthanized for Leptospira spp. testing. Bacterial isolates were sequenced and evaluated for species and phylogenetic analysis using the ppk gene. Anti-Leptospira spp. antibodies were detected in 34% (87/256) of mongooses. Reactions were observed with the following serogroups: Sejroe, Icterohaemorrhagiae, Pyrogenes, Mini, Cynopteri, Australis, Hebdomadis, Autumnalis, Mankarso, Pomona, and Ballum. Of the kidney specimens examined, 5.8% (16/270) were FAT-positive, 10% (27/274) were culture-positive, and 12.4% (34/274) were positive by rt-PCR. Of the Leptospira spp. isolated from mongooses, 25 were L. borgpetersenii, one was L. interrogans, and one was L. kirschneri. Positive predictive values of FAT and rt-PCR testing for predicting successful isolation of Leptospira by culture were 88% and 65%, respectively. The isolation and identification of Leptospira spp. in mongooses highlights the potential role of mongooses as a wildlife reservoir of leptospirosis; mongooses could be a source of Leptospira spp. infections for other wildlife, domestic animals, and humans. |
Public health branch incident management and support as part of the Federal Government response during the emergency phase of Hurricanes Irma and Maria in Puerto Rico and the US Virgin Islands
Cruz MA , Rivera-González LO , Irvin-Barnwell E , Cabrera-Marquez J , Ellis E , Ellis B , Qi B , Maniglier-Poulet C , Gerding JA , Shumate A , Andujar A , Yoder J , Laco J , Santana A , Bayleyegn T , Luna-Pinto C , Rodriguez LO , Roth J , Bermingham J , Funk RH , Raheem M . J Emerg Manag 2021 19 (8) 63-77 On September 6 and 20, 2017, Hurricanes Irma and Maria made landfall as major hurricanes in the US Caribbean Territories of the Virgin Islands and Puerto Rico with devastating effects. As part of the initial response, a public health team (PHT) was initially deployed as part of the US Department of Health and Human Services Incident Response Coordination Team. As a result of increased demands for additional expertise and resources, a public health branch (PHB) was established for coordinating a broad spectrum of public health response activities in support of the affected territories. This paper describes the conceptual framework for organizing these activities; summarizes some key public health activities and roles; outlines partner support and coordination with key agencies; and defines best practices and areas for improvement in disaster future operations. © 2021 Weston Medical Publishing. All rights reserved. |
A Protocol for a Comprehensive Monitoring and Evaluation Framework With a Compendium of Tools to Assess Quality of Project ECHO (Extension for Community Healthcare Outcomes) Implementation Using Mixed Methods, Developmental Evaluation Design
Ghosh S , Roth BM , Massawe I , Mtete E , Lusekelo J , Pinsker E , Seweryn S , Moonan PK , Struminger BB . Front Public Health 2021 9 714081 Introduction: The United States Centers for Disease Control and Prevention (CDC), through U.S. President's Emergency Plan for AIDS Relief (PEPFAR), supports a third of all people receiving HIV care globally. CDC works with local partners to improve methods to find, treat, and prevent HIV and tuberculosis. However, a shortage of trained medical professionals has impeded efforts to control the HIV epidemic in Sub-Saharan Africa and Asia. The Project Extension for Community Healthcare Outcomes (ECHO(TM)) model expands capacity to manage complex diseases, share knowledge, disseminate best practices, and build communities of practice. This manuscript describes a practical protocol for an evaluation framework and toolkit to assess ECHO implementation. Methods and Analysis: This mixed methods, developmental evaluation design uses an appreciative inquiry approach, and includes a survey, focus group discussion, semi-structured key informant interviews, and readiness assessments. In addition, ECHO session content will be objectively reviewed for accuracy, content validity, delivery, appropriateness, and consistency with current guidelines. Finally, we offer a mechanism to triangulate data sources to assess acceptability and feasibility of the evaluation framework and compendium of monitoring and evaluation tools. Expected impact of the study on public health: This protocol offers a unique approach to engage diverse group of stakeholders using an appreciative inquiry process to co-create a comprehensive evaluation framework and a compendium of assessment tools. This evaluation framework utilizes mixed methods (quantitative and qualitative data collection tools), was pilot tested in Tanzania, and has the potential for contextualized use in other countries who plan to evaluate their Project ECHO implementation. |
Clinical phenotype in infants with negative Zika virus immunoglobulin M testing born to mothers with confirmed Zika virus infection during pregnancy
Godfred-Cato S , Newton S , Adams L , Valencia-Prado M , Lake-Burger H , Morrison A , Jones AM , Olson SM , Roth NM , Tong VT , Gilboa SM , Meaney Delman D , Honein MA , Staples JE , Moore CA . Birth Defects Res 2021 113 (17) 1267-1274 BACKGROUND: Recommended testing for both infants with Zika-associated birth defects (i.e., microcephaly and selected brain or eye anomalies) and infants without birth defects whose mothers had laboratory evidence of possible Zika virus (ZIKV) infection during pregnancy includes nucleic acid amplification testing (NAAT) and immunoglobulin M (IgM) testing within days after birth. Brain and eye defects highly specific for congenital ZIKV infection have been described; sporadic reports have documented negative ZIKV testing in such infants. METHODS: Infants from the U.S. Zika Pregnancy and Infant Registry and Zika Birth Defects Surveillance with Zika-associated birth defects and maternal and infant laboratory testing for ZIKV and two congenital infections (i.e., cytomegalovirus [CMV] and toxoplasmosis) were reviewed for phenotype and laboratory results. Infants with at least one defect considered highly specific for congenital ZIKV infection were designated as having congenital Zika syndrome (CZS) clinical phenotype for this study. RESULTS: Of 325 liveborn infants with Zika-associated birth defects and laboratory evidence of maternal ZIKV infection, 33 (10%) had CZS clinical phenotype; 171 (53%) had ZIKV IgM testing with negative or no ZIKV NAAT. ZIKV IgM was negative in the remaining 120 infants, and for 90%, testing for CMV and toxoplasmosis was missing/incomplete. Among 11 infants testing negative for ZIKV IgM, CMV, and toxoplasmosis, 2 infants had CZS clinical phenotype. CONCLUSIONS: These data add support to previous reports of negative ZIKV IgM testing in infants with clear maternal and phenotypic evidence of congenital ZIKV infection. Follow-up care consistent with the diagnosis is recommended regardless of infant ZIKV test results. |
Determination of freedom-from-rabies for small Indian mongoose populations in the United States Virgin Islands, 2019-2020
Browne AS , Cranford HM , Morgan CN , Ellison JA , Berentsen A , Wiese N , Medley A , Rossow J , Jankelunas L , McKinley AS , Lombard CD , Angeli NF , Kelley T , Valiulus J , Bradford B , Burke-France VJ , Harrison CJ , Guendel I , Taylor M , Blanchard GL , Doty JB , Worthington DJ , Horner D , Garcia KR , Roth J , Ellis BR , Bisgard KM , Wallace R , Ellis EM . PLoS Negl Trop Dis 2021 15 (7) e0009536 Mongooses, a nonnative species, are a known reservoir of rabies virus in the Caribbean region. A cross-sectional study of mongooses at 41 field sites on the US Virgin Islands of St. Croix, St. John, and St. Thomas captured 312 mongooses (32% capture rate). We determined the absence of rabies virus by antigen testing and rabies virus exposure by antibody testing in mongoose populations on all three islands. USVI is the first Caribbean state to determine freedom-from-rabies for its mongoose populations with a scientifically-led robust cross-sectional study. Ongoing surveillance activities will determine if other domestic and wildlife populations in USVI are rabies-free. |
A Preparedness Model for Mother-Baby Linked Longitudinal Surveillance for Emerging Threats.
Woodworth KR , Reynolds MR , Burkel V , Gates C , Eckert V , McDermott C , Barton J , Wilburn A , Halai UA , Brown CM , Bocour A , Longcore N , Orkis L , Lopez CD , Sizemore L , Ellis EM , Schillie S , Gupta N , Bowen VB , Torrone E , Ellington SR , Delaney A , Olson SM , Roth NM , Whitehill F , Zambrano LD , Meaney-Delman D , Fehrenbach SN , Honein MA , Tong VT , Gilboa SM . Matern Child Health J 2021 25 (2) 1-9 INTRODUCTION: Public health responses often lack the infrastructure to capture the impact of public health emergencies on pregnant women and infants, with limited mechanisms for linking pregnant women with their infants nationally to monitor long-term effects. In 2019, the Centers for Disease Control and Prevention (CDC), in close collaboration with state, local, and territorial health departments, began a 5-year initiative to establish population-based mother-baby linked longitudinal surveillance, the Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET). OBJECTIVES: The objective of this report is to describe an expanded surveillance approach that leverages and modernizes existing surveillance systems to address the impact of emerging health threats during pregnancy on pregnant women and their infants. METHODS: Mother-baby pairs are identified through prospective identification during pregnancy and/or identification of an infant with retrospective linking to maternal information. All data are obtained from existing data sources (e.g., electronic medical records, vital statistics, laboratory reports, and health department investigations and case reporting). RESULTS: Variables were selected for inclusion to address key surveillance questions proposed by CDC and health department subject matter experts. General variables include maternal demographics and health history, pregnancy and infant outcomes, maternal and infant laboratory results, and child health outcomes up to the second birthday. Exposure-specific modular variables are included for hepatitis C, syphilis, and Coronavirus Disease 2019 (COVID-19). The system is structured into four relational datasets (maternal, pregnancy outcomes and birth, infant/child follow-up, and laboratory testing). DISCUSSION: SET-NET provides a population-based mother-baby linked longitudinal surveillance approach and has already demonstrated rapid adaptation to COVID-19. This innovative approach leverages existing data sources and rapidly collects data and informs clinical guidance and practice. These data can help to reduce exposure risk and adverse outcomes among pregnant women and their infants, direct public health action, and strengthen public health systems. |
Appendix Q: Recommendations for Developing Molecular Assays for Microbial Pathogen Detection Using Modern In Silico Approaches.
SantaLucia J , Sozhamannan S , Gans JD , Koehler JW , Soong R , Lin NJ , Xie G , Olson V , Roth K , Beck L . J AOAC Int 2020 103 (4) 882-899 We describe the use of in silico approaches to improve the process of molecular assay development and reduce time and cost by utilizing available databases of whole genome pathogen sequences combined with modern bioinformatics and physical modeling tools. Well-characterized assays are needed for accurately detecting pathogens in environmental and patient samples and also for evaluation of the efficacy of a medical countermeasure that may be administered to patients. The polymerase chain reaction (PCR) remains the gold standard for pathogen detection due to the simplicity of its instrumentation, low cost of reagents, and outstanding limit of detection (LOD), sensitivity, and specificity. However, creation of such PCR assays often involves iterations of design, preliminary testing, and thorough validation with clinical isolates and testing in relevant matrices, which can be time consuming, costly, and result in suboptimal assays. Since formal validation (e.g., for Emergency Use Authorization [EUA] or Food and Drug Administration [FDA] licensure) of an infectious disease assay can be very expensive and can require extensive time of development, having a well-designed assay up front is a critical first step. Yet, many assays described in the literature utilized limited design capabilities and many initially promising assays fail the validation process, resulting in increased costs and timelines for successful product development. While the computational approaches outlined in this document by no means obviate the need for wet lab testing, they can reduce the amount of effort wasted on empirical optimization and iterative redesigns and also guide validation studies. The proposed computational approaches also result in higher performing assays with better sensitivity, specificity, and lower LOD and reduce the possibility of assay failure due to signature erosion. To provide clarity, an extensive glossary of defined terms is provided. © AOAC INTERNATIONAL 2020. |
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