Government statistical offices worldwide are under pressure to produce statistics rapidly and for more detailed geographies, to compete with unofficial estimates available from web-based big data sources or from private companies. Commonly suggested sources of improved health information are electronic health records and medical claims data. These data sources are collectively known as real-world data (RWD) because they are generated from routine health care processes, and they are available for millions of patients. It is clear that RWD can provide estimates that are more timely and less expensive to produce—but a key question is whether or not they are very accurate. To test this, we took advantage of a unique health data source that includes a full range of sociodemographic variables and compared estimates using all of those potential weighting variables versus estimates derived when only age and sex are available for weighting (as is common with most RWD sources). We show that not accounting for other variables can produce misleading and quite inaccurate health estimates. © 2024 American Association for Public Opinion Research. All rights reserved.

The 2014 chikungunya outbreak in the Dominican Republic resulted in intense local transmission, with high postoutbreak seroprevalence. The resulting population immunity will likely minimize risk for another large outbreak through 2035, but changes in population behavior or environmental conditions or emergence of different virus strains could lead to increased transmission.

INTRODUCTION: Exposure to unfavorable environmental conditions during pregnancy, such as extreme heat and air pollution, has been linked to increased risk of stillbirth, defined as fetal mortality at or after 20 weeks' gestation, however no studies have examined its association with social vulnerability. We examined associations between county-level stillbirth rates, environmental risk factors for stillbirth, and social vulnerability in the United States. METHODS: This ecologic study linked county-level data from three nationwide datasets on stillbirths (National Vital Statistics System), environmental conditions (North American Land Data Assimilation System and Environmental Protection Agency), and social vulnerability (Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry Social Vulnerability Index). Poisson and negative binomial models were fit to the variables and produced rate ratios to estimate associations among stillbirth rates, environmental risk factors, and social vulnerability. RESULTS: Social vulnerability was positively associated withn stillbirth rates, annual average number of extreme heat days, and ambient concentration of particulate matter ≤ 2.5 μm in diameter (PM2.5). The average number of days that ozone and PM2.5 each exceeded regulatory standards were not associated with stillbirth rates or social vulnerability. A positive association between average annual PM2.5 concentration and stillbirth rates was detected; no other significant associations between environmental risk factors and stillbirth rates were observed. DISCUSSION: We found evidence of associations between social vulnerability and stillbirth rates, and between social vulnerability and environmental risk factors for stillbirth at the county level. Further research could inform understanding of how social vulnerability impacts the relationship between environmental exposures and stillbirth risk.

BACKGROUND: Individual immune responses to SARS-CoV-2 are well-studied, while the combined effect of these responses on population-level immune dynamics remains poorly understood. Given the key role of population immunity on pathogen transmission, delineation of the factors that drive population immune evolution has critical public health implications. METHODS: We enrolled individuals 5 years and older selected using a multistage cluster survey approach in the Northwest and Southeast of the Dominican Republic. Paired blood samples were collected mid-pandemic (Aug 2021) and late pandemic (Nov 2022). We measured serum pan-immunoglobulin antibodies against the SARS-CoV-2 spike protein. Generalized Additive Models (GAMs) and random forest models were used to analyze the relationship between changes in antibody levels and various predictor variables. Principal component analysis and partial dependence plots further explored the relationships between predictors and antibody changes. FINDINGS: We found a transformation in the distribution of antibody levels from an irregular to a normalized single peak Gaussian distribution that was driven by titre-dependent boosting. This led to the convergence of antibody levels around a common immune setpoint, irrespective of baseline titres and vaccination profile. INTERPRETATION: Our results suggest that titre-dependent kinetics driven by widespread transmission direct the evolution of population immunity in a consistent manner. These findings have implications for targeted vaccination strategies and improved modeling of future transmission, providing a preliminary blueprint for understanding population immune dynamics that could guide public health and vaccine policy for SARS-CoV-2 and potentially other pathogens. FUNDING: The study was primarily funded by the Centers for Disease Control and Prevention grant U01GH002238 (EN). Salary support was provided by Wellcome Trust grant 206250/Z/17/Z (AK) and the Australian National Health and Medical Research Council Investigator grant APP1158469 (CLL).

Hand hygiene (HH) can reduce transmission of healthcare-associated infections (HAIs) in healthcare facilities and is especially important in low- and middle-income countries where HH infrastructure may be insufficient and the burden of HAIs is highest. At baseline, we assessed HH infrastructure and practices among healthcare workers (HCWs) at two large hospitals in the Dominican Republic during the COVID-19 pandemic. HCWs were observed for HH adherence (HHA) (defined as the use of alcohol-based hand rub (ABHR) or handwashing with soap and water) before and after patient contact and donning new gloves before patient contact. The baseline assessment was repeated following implementation of local production and distribution of ABHR and a HH promotion campaign. Descriptive analyses and regression models evaluated predictors of HHA and glove use. Cumulative HHA was 18.9%. While patient-care areas with a functional HH resource increased from 47% at baseline to 92% after the intervention, HHA declined from 23.0% to 16.7%. HHA was higher after patient contact (aOR = 5.88; 95% CI = 4.17–8.33), during a period of increased COVID-19 risk (aOR = 1.69; 95% CI = 1.05–2.77), during invasive patient contacts (aOR = 1.64; 95% CI = 1.23–2.17) and when gloves were not used (aOR = 1.25; 95% CI = 1.01–1.56). The negative association between glove use and HHA diminished when access to HH resources increased. New gloves were donned before 39.6% of patient contacts. Glove use was higher among nurses (aOR = 7.12; 95% CI = 3.02–16.79) and during invasive contacts (aOR = 4.76; 95% CI = 2.27–10.0). While access to HH resources increased after the interventions, HHA did not increase. HHA was lower when COVID-19 risk was lower. Findings from this study may guide future efforts to increase HHA among HCWs. Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.

OBJECTIVE: This study investigates the role of trust in shaping COVID-19 vaccine acceptance in the Dominican Republic (DR) during the COVID-19 pandemic. DESIGN: Cross-sectional household survey. SETTING: Randomly selected households across 134 clusters in the DR, from 30 June 2021 to 12 October 2021. PARTICIPANTS: 5999 participants ≥16 years of age were enrolled. OUTCOME MEASURES: COVID-19 vaccine hesitancy (CVH) data were collected from participants ≥16 years of age and analysed as both an ordinal and binary variable. RESULTS: Overall, CVH was low (5.2% (95% CI 4.6% to 5.8%)), but more common among younger individuals, women and individuals of Mestizo ethnicity. Higher trust in local government, national government, scientists and local doctors (considered official sources) was associated with lower odds of CVH (OR 0.89 (95% CI 0.72 to 0.88), 0.89 (95% CI 0.81 to 0.98), 0.87 (95% CI 0.80 to 0.94) and 0.70 (95% CI 0.62 to 0.80), respectively). Higher trust in religious leaders, social media and traditional media (considered unofficial sources) was associated with higher odds of CVH, with respective ORs of 1.32 (95% CI 1.18 to 1.47), 1.30 (95% CI 1.19 to 1.41) and 1.08 (95% CI 0.97 to 1.22). CONCLUSION: We report findings on CVH from a national household survey in the DR and identify overall low rates of CVH but marked heterogeneity by age, gender and ethnicity. Trust in unofficial versus official sources of information is associated with increased CVH. These findings highlight and quantify the importance of trust as a key parameter when considering public health communication strategies.

Background: Proper hand hygiene (HH), which includes sanitizing with alcohol-based hand rub (ABHR) (or handwashing with soap and water if ABHR is unavailable), is key for preventing healthcare-associated infections (HCAI), including COVID-19. Understanding drivers of HH is key to improving adherence. Aim: This study aims to explore drivers and barriers to HH practice at two hospitals in the Dominican Republic in the context of the COVID-19 pandemic to inform development of HH behaviour change interventions. Methods: We conducted in-depth interviews with 20 hospital staff during September 2021. We used the COM-B (capability, opportunity, motivation, behaviour) model to explore HH experiences and preferences. Interviews were recorded, transcribed, coded, and analysed using a thematic approach. Results: A total of 11 parent codes and 27 sub-codes were identified, and 1145 coded segments were analysed. Use of handwashing with soap and water and/or sanitizing with ABHR was reported by all participants; handwashing was generally preferred. Participants expressed knowledge of proper HH methods (capability), but inconsistent supplies and lack of time presented HH challenges (opportunity). Interviewees described practicing HH to protect themselves and their families from COVID-19 and other infections (reflective motivation) or out of habit (automatic motivation). Discussion: By understanding and addressing underlying factors affecting HH, hospitals can decrease the risk of HCAIs. Our findings suggest that interventions implemented to improve HH in these hospitals should target motivation and opportunity. These findings informed a multimodal intervention to increase ABHR access and implement message-tested communications campaigns; end-point assessments will provide insights into the intervention's impact. © 2024

IMPORTANCE: Despite modest reductions in the incidence of hospital-onset Clostridioides difficile infection (HO-CDI), CDI remains a leading cause of health care-associated infection. As no single intervention has proven highly effective on its own, a multifaceted approach to controlling HO-CDI is needed. OBJECTIVE: To assess the effectiveness of the Centers for Disease Control and Prevention's Strategies to Prevent Clostridioides difficile Infection in Acute Care Facilities Framework (hereafter, the Framework) in reducing HO-CDI incidence. DESIGN, SETTING, AND PARTICIPANTS: This quality improvement study was performed within the Duke Infection Control Outreach Network from July 1, 2019, through March 31, 2022. In all, 20 hospitals in the network participated in an implementation study of the Framework recommendations, and 26 hospitals did not participate and served as controls. The Framework has 39 discrete intervention categories organized into 5 focal areas for CDI prevention: (1) isolation and contact precautions, (2) CDI confirmation, (3) environmental cleaning, (4) infrastructure development, and (5) antimicrobial stewardship engagement. EXPOSURES: Monthly teleconferences supporting Framework implementation for the participating hospitals. MAIN OUTCOMES AND MEASURES: Primary outcomes were HO-CDI incidence trends at participating hospitals compared with controls and postintervention HO-CDI incidence at intervention sites compared with rates during the 24 months before the intervention. RESULTS: The study sample included a total of 2184 HO-CDI cases and 7 269 429 patient-days. In the intervention cohort of 20 participating hospitals, there were 1403 HO-CDI cases and 3 513 755 patient-days, with a median (IQR) HO-CDI incidence of 2.8 (2.0-4.3) cases per 10 000 patient-days. The first analysis included an additional 3 755 674 patient-days and 781 HO-CDI cases among the 26 controls, with a median (IQR) HO-CDI incidence of 1.1 (0.7-2.7) case per 10 000 patient-days. The second analysis included an additional 2 538 874 patient-days and 1751 HO-CDI cases, with a median (IQR) HO-CDI incidence of 5.9 (2.7-8.9) cases per 10 000 patient-days, from participating hospitals 24 months before the intervention. In the first analysis, intervention sites had a steeper decline in HO-CDI incidence over time relative to controls (yearly incidence rate ratio [IRR], 0.79 [95% CI, 0.67-0.94]; P = .01), but the decline was not temporally associated with study participation. In the second analysis, HO-CDI incidence was declining in participating hospitals before the intervention, and the rate of decline did not change during the intervention. The degree to which hospitals implemented the Framework was associated with steeper declines in HO-CDI incidence (yearly IRR, 0.95 [95% CI, 0.90-0.99]; P = .03). CONCLUSIONS AND RELEVANCE: In this quality improvement study of a regional hospital network, implementation of the Framework was not temporally associated with declining HO-CDI incidence. Further study of the effectiveness of multimodal prevention measures for controlling HO-CDI is warranted.

Background: The burden of antimicrobial resistance (AMR) in Latin America is high. Little is known about healthcare workers’ (HCWs) perceptions of antimicrobial stewardship (AS) and antibiotic use (AU) in the region. Methods: HCWs from 42 hospitals in Panama, Guatemala, Colombia, Ecuador, and Argentina were invited to participate in an electronic, voluntary, anonymous survey regarding perceptions of AS and AU from March-April 2023. All participants were asked 21 questions; prescribers were asked additional questions about antibiotic prescribing. Answers with 5-point Likert scale were categorized into two groups, strongly agree/agree and neutral/disagree/strongly disagree. Results: Of 475 HCWs that completed the survey, 52% were physicians (29% in training), 28% nurses, 13% pharmacists, 3% microbiologists, and 3% “other.” Median years of experience was 12 (interquartile range 6, 20). Although 93% indicated optimizing AU was a priority at their healthcare facility (HCF), only 69% said the importance of AS was communicated at their HCF. Nurses and those in “other” roles were more likely to report lack of familiarity with the term AS than physicians (32% and 27% respectively vs. 21%, P< 0.01).Most (99%) respondents acknowledged that appropriate AU can reduce AMR and that inappropriate AU could harm patients. However, fewer thought antibiotics were overused (30%) or AMR was a problem (52%) in their HCF. Thirty-eight percent of HCWs did not have access to guidelines and 24% did not value recommendations by the AS team (Figure 1). Of prescribers, 99% reported to modify antibiotics based on culture results, 55% do not consult non-physician staff (e.g., pharmacists, nurses) to make antibiotic decisions, 20% do not use local guidelines or do not receive training on how to interpret culture results to make antibiotic decisions (Figure 2). Prescribers felt pressure from colleagues (38%) and patients or their families (63%) to make antibiotic decisions. Conclusion: Although most HCWs perceived improving AU as a priority, they did not perceive AU or AMR to be a problem in their HCF. Opportunities to optimize AU include improved access and adherence to guidelines, access to AMR data, teamwork, and education on AS for HCW. Disclosures: Sara E. Cosgrove, MD, MS, Debiopharm: Advisor/Consultant|Duke Clinical Research Institute: Advisor/Consultant Payal K. Patel, MD MPH, qiagen: Honoraria

Incidence of COVID-19 has been associated with sociodemographic factors. We investigated variations in SARS-CoV-2 seroprevalence at sub-national levels in the Dominican Republic and assessed potential factors influencing variation in regional-level seroprevalence. Data were collected in a three-stage cross-sectional national serosurvey from June to October 2021. Seroprevalence of antibodies against the SARS-CoV-2 spike protein (anti-S) was estimated and adjusted for selection probability, age, and sex. Multilevel logistic regression was used to estimate the effect of covariates on seropositivity for anti-S and correlates of 80% protection (PT(80)) against symptomatic infection for the ancestral and Delta strains. A total of 6683 participants from 134 clusters in all 10 regions were enrolled. Anti-S, PT80 for the ancestral and Delta strains odds ratio varied across regions, Enriquillo presented significant higher odds for all outcomes compared with Yuma. Compared to being unvaccinated, receiving ≥2 doses of COVID-19 vaccine was associated with a significantly higher odds of anti-S positivity (OR 85.94, [10.95-674.33]) and PT(80) for the ancestral (OR 4.78, [2.15-10.62]) and Delta strains (OR 3.08, [1.57-9.65]) nationally and also for each region. Our results can help inform regional-level public health response, such as strategies to increase vaccination coverage in areas with low population immunity against currently circulating strains.

Background E-cigarettes are the most commonly used tobacco product among US youth and are regularly used on school grounds. We assessed school staff’s awareness of students’ e-cigarette use, response by schools, and resources needed to address use, and examined e-cigarettes confiscated by school staff in North Carolina to guide prevention and identify needed resources. methods In May 2019, staff from a random sample of 25 of 451 North Carolina public and charter high schools were invited to complete an online survey and semistructured interview; 12 schools consented to ≥ 1 component (survey, N = 514; interviews, N = 35). Staff knowledge and perceptions of students’ e-cigarette use and school tobacco policies were assessed, including school efforts to address e-cigarette use. E-cigarette products confiscated by nine schools from students during the 2018-2019 school year were collected. limitations Only 12 public high schools participated, and these schools might not be representative of all North Carolina high schools. Quantitative surveys were not collected from all staff at participating schools; however, the response rate was 62% and included different staff positions and both urban and rural schools. Finally, e-cigarette products collected by schools might not be representative of all devices used by students. Results Among surveyed staff, 33% observed students using e-cigarettes on school grounds; 86% believed e-cigarette use somewhat or largely contributes to learning disruptions. Overall, 94% of respondents knew their school’s policy prohibits student e-cigarette use on school grounds, and 57% were not confident their school has resources to help students quit. From 35 interviews, themes included concern that schools’ tobacco-free policies do not deter use and additional resources are needed to address e-cigarette use in schools. Of 336 collected devices, there were different e-cigarette types and most (65%) e-liquid bottles were flavored. conclusion Efforts are warranted to incorporate evidence-based curricula; educate staff, parents, and youth regarding health risks of ecigarette use; and help youth quit e-cigarettes. © 2023 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.

Malaria diagnostic testing in Africa is threatened by Plasmodium falciparum parasites lacking histidine-rich protein 2 (pfhrp2) and 3 (pfhrp3) genes. Among 12,572 subjects enrolled along Ethiopia’s borders with Eritrea, Sudan, and South Sudan and using multiple assays, we estimate HRP2-based rapid diagnostic tests would miss 9.7% (95% CI 8.5-11.1) of falciparum malaria cases due to pfhrp2 deletion. Established and novel genomic tools reveal distinct subtelomeric deletion patterns, well-established pfhrp3 deletions, and recent expansion of pfhrp2 deletion. Current diagnostic strategies need to be urgently reconsidered in Ethiopia, and expanded surveillance is needed throughout the Horn of Africa.Competing Interest StatementJBP reports research support from Gilead Sciences, honoraria from Virology Education for medical education teaching, and non-financial support from Abbott Diagnostics, all outside the scope of the current work. SMF reports research support from AccessBio, outside of the current work.Funding StatementThis work was funded by the Global Fund to Fight AIDS, Tuberculosis, and Malaria through the Ministry of Health-Ethiopia (EPHI5405 to SMF) and the World Health Organization (JAC, JBP). It was also partially supported by MSF Holland, which supported field work in Gambella Region, the Doris Duke Charitable Foundation (JBP), and the US National Institutes of Health (R01AI132547 to JJJ, JAB, OA, and JBP; K24AI134990 to JJJ).Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:Ethical approval was obtained from the Ethiopia Public Health Institute (EPHI) Institutional Review Board (IRB; protocol EPHI-IRB-033-2017) and WHO Research Ethics Review Committee (protocol: ERC.0003174 001). Processing of de-identified samples and data at UNC was determined to constitute non-human subjects research by the UNC IRB (study 17-0155). The study was determined to be non-research by the Centers for Disease Control and Prevention Human Subjects office (0900f3eb81bb60b9).All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesGenomic sequencing data will be available through the Sequence Read Archive (BioSample accession numbers pending). De-identified datasets generated during the current study will be available as supplementary files. Code used during data analysis will be made available on GitHub.

The global SARS-CoV-2 immune landscape and population protection against emerging variants is largely unknown. We assessed SARS-CoV-2 antibody changes in the Dominican Republic and implications for immunological protection against variants of concern. Between March 2021 and August 2022, 2,300 patients with undifferentiated febrile illnesses were prospectively enrolled. Sera was tested for total anti-spike antibodies and simultaneously collected nasopharyngeal samples for acute SARSCoV-2 infection with RT-PCR. Geometric mean anti-spike titers increased from 6.6 BAU/ml (95% CI 5.1-8.7) to 1,332 BAU/ml (1055-1,682). Multivariable binomial odds ratios for acute SARS-CoV-2 infection were 0.55 (0.40-0.74), 0.38 (0.27-0.55), and 0.27 (0.18-0.40) for the second, third, and fourth versus the first anti-S quartile, with similar findings by viral strain. Integrated serological and virological screening can leverage existing acute fever surveillance platforms to monitor population-level immunological markers and concurrently characterize implications for emergent variant transmission in near real-time. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv 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.

BACKGROUND: Population-level SARS-CoV-2 immunological protection is poorly understood but can guide vaccination and non-pharmaceutical intervention priorities. Our objective was to characterise cumulative infections and immunological protection in the Dominican Republic. METHODS: Household members ≥5 years were enrolled in a three-stage national household cluster serosurvey in the Dominican Republic. We measured pan-immunoglobulin antibodies against the SARS-CoV-2 spike (anti-S) and nucleocapsid glycoproteins, and pseudovirus neutralising activity against the ancestral and B.1.617.2 (Delta) strains. Seroprevalence and cumulative prior infections were weighted and adjusted for assay performance and seroreversion. Binary classification machine learning methods and pseudovirus neutralising correlates of protection were used to estimate 50% and 80% protection against symptomatic infection. FINDINGS: Between 30 Jun and 12 Oct 2021 we enrolled 6683 individuals from 3832 households. We estimate that 85.0% (CI 82.1-88.0) of the ≥5 years population had been immunologically exposed and 77.5% (CI 71.3-83) had been previously infected. Protective immunity sufficient to provide at least 50% protection against symptomatic SARS-CoV-2 infection was estimated in 78.1% (CI 74.3-82) and 66.3% (CI 62.8-70) of the population for the ancestral and Delta strains respectively. Younger (5-14 years, OR 0.47 [CI 0.36-0.61]) and older (≥75-years, 0.40 [CI 0.28-0.56]) age, working outdoors (0.53 [0.39-0.73]), smoking (0.66 [0.52-0.84]), urban setting (1.30 [1.14-1.49]), and three vs no vaccine doses (18.41 [10.69-35.04]) were associated with 50% protection against the ancestral strain. INTERPRETATION: Cumulative infections substantially exceeded prior estimates and overall immunological exposure was high. After controlling for confounders, markedly lower immunological protection was observed to the ancestral and Delta strains across certain subgroups, findings that can guide public health interventions and may be generalisable to other settings and viral strains. FUNDING: This study was funded by the US CDC.

To assess changes in SARS-CoV-2 spike binding antibody prevalence in the Dominican Republic and implications for immunologic protection against variants of concern, we prospectively enrolled 2,300 patients with undifferentiated febrile illnesses in a study during March 2021-August 2022. We tested serum samples for spike antibodies and tested nasopharyngeal samples for acute SARS-CoV-2 infection using a reverse transcription PCR nucleic acid amplification test. Geometric mean spike antibody titers increased from 6.6 (95% CI 5.1-8.7) binding antibody units (BAU)/mL during March-June 2021 to 1,332 (95% CI 1,055-1,682) BAU/mL during May-August 2022. Multivariable binomial odds ratios for acute infection were 0.55 (95% CI 0.40-0.74), 0.38 (95% CI 0.27-0.55), and 0.27 (95% CI 0.18-0.40) for the second, third, and fourth versus the first anti-spike quartile; findings were similar by viral strain. Combining serologic and virologic screening might enable monitoring of discrete population immunologic markers and their implications for emergent variant transmission.

Reliable SARS-CoV-2 correlates of protection (COP) are crucial for predicting individual-level risk of infection, estimating population susceptibility, and assessing future epidemic risks.1 However, COP studies are challenging given that blood samples ideally need to be collected close to the time of exposure, which is hard to predict. Thus, most existing SARS-CoV-2 COP estimates are based on vaccine efficacy trial data,2, 3 which include frequent blood sampling and strict infection monitoring and are therefore well suited for this purpose. Yet these trials were conducted before the circulation of highly immune-evasive variants of concern (VOC), and in populations with little previous exposure to SARS-CoV-2, limiting their current relevance. We previously reported how existing acute fever surveillance platforms could be used to monitor population-level temporal changes in SARS-CoV-2 immune markers, and documented that higher antibody levels were associated with lower risk of SARS-CoV-2 infection.4 Here, we build off that previous work to show that routinely collected fever surveillance data analysed using a prospective test-negative design5 can generate rapid and VOC-specific immune COP for symptomatic infection.

OBJECTIVE: Fetal death certificates (FDCs) are the main source of stillbirth surveillance data in the United States, yet previous studies suggest FDCs have incomplete ascertainment. The objectives of this analysis were (1) to evaluate whether the use of an existing birth defects surveillance program (the Metropolitan Atlanta Congenital Defects Program [MACDP]) to conduct surveillance on stillbirths enhances case ascertainment, and (2) to compare stillbirth prevalence estimates in metropolitan Atlanta using data from MACDP and FDCs, independently and combined, from 2009-2015. METHODS: Stillbirths were ascertained by MACDP and FDCs from 2009-2015. Capture-recapture methods were used to estimate the relative contributions of each data source. Prevalence estimates generated from each data source independently and combined were compared. RESULTS: There were 3,031 stillbirths ascertained by FDCs and MACDP in metropolitan Atlanta from 2009-2015. It was assumed that 35% of FDCs unlinked to MACDP were misclassified as stillbirth. Under this assumption, an estimated 2,610 total stillbirths occurred. Accounting for potential misclassification in the FDC, the prevalence rate for stillbirth was 6.9 per 1,000 live births plus stillbirths for stillbirths captured only in FDC, and 6.2 per 1,000 live births plus stillbirths for stillbirths caught only in MACDP. Using both sources combined for casefinding, the prevalence rate was 10.0 per 1,000 live births plus stillbirths for all years combined. CONCLUSIONS: Expanding certain birth defects surveillance programs to conduct surveillance on stillbirths could potentially enhance existing surveillance data on stillbirths when linked to FDCs.

BACKGROUND: Venous thromboembolism (VTE) is a preventable, common vascular disease that has been estimated to affect up to 900,000 people per year. It has been associated with risk factors such as recent surgery, cancer, and hospitalization. VTE surveillance for patient management and safety can be improved via natural language processing (NLP). NLP tools have the ability to access electronic medical records, identify patients that meet the VTE case definition, and subsequently enter the relevant information into a database for hospital review. OBJECTIVE: We aimed to evaluate the performance of a VTE identification model of IDEAL-X (Information and Data Extraction Using Adaptive Learning; Emory University)-an NLP tool-in automatically classifying cases of VTE by "reading" unstructured text from diagnostic imaging records collected from 2012 to 2014. METHODS: After accessing imaging records from pilot surveillance systems for VTE from Duke University and the University of Oklahoma Health Sciences Center (OUHSC), we used a VTE identification model of IDEAL-X to classify cases of VTE that had previously been manually classified. Experts reviewed the technicians' comments in each record to determine if a VTE event occurred. The performance measures calculated (with 95% CIs) were accuracy, sensitivity, specificity, and positive and negative predictive values. Chi-square tests of homogeneity were conducted to evaluate differences in performance measures by site, using a significance level of .05. RESULTS: The VTE model of IDEAL-X "read" 1591 records from Duke University and 1487 records from the OUHSC, for a total of 3078 records. The combined performance measures were 93.7% accuracy (95% CI 93.7%-93.8%), 96.3% sensitivity (95% CI 96.2%-96.4%), 92% specificity (95% CI 91.9%-92%), an 89.1% positive predictive value (95% CI 89%-89.2%), and a 97.3% negative predictive value (95% CI 97.3%-97.4%). The sensitivity was higher at Duke University (97.9%, 95% CI 97.8%-98%) than at the OUHSC (93.3%, 95% CI 93.1%-93.4%; P<.001), but the specificity was higher at the OUHSC (95.9%, 95% CI 95.8%-96%) than at Duke University (86.5%, 95% CI 86.4%-86.7%; P<.001). CONCLUSIONS: The VTE model of IDEAL-X accurately classified cases of VTE from the pilot surveillance systems of two separate health systems in Durham, North Carolina, and Oklahoma City, Oklahoma. NLP is a promising tool for the design and implementation of an automated, cost-effective national surveillance system for VTE. Conducting public health surveillance at a national scale is important for measuring disease burden and the impact of prevention measures. We recommend additional studies to identify how integrating IDEAL-X in a medical record system could further automate the surveillance process.

BACKGROUND: Public health reporting is the cornerstone of public health practices that inform prevention and control strategies. There is a need to leverage advances made in the past to implement an architecture that facilitates the timely and complete public health reporting of relevant case-related information that has previously not easily been available to the public health community. Electronic laboratory reporting (ELR) is a reliable method for reporting cases to public health authorities but contains very limited data. In an earlier pilot study, we designed the Public Health Automated Case Event Reporting (PACER) platform, which leverages existing ELR infrastructure as the trigger for creating an electronic case report. PACER is a FHIR (Fast Health Interoperability Resources)-based system that queries the electronic health record from where the laboratory test was requested to extract expanded additional information about a case. OBJECTIVE: This study aims to analyze the pilot implementation of a modified PACER system for electronic case reporting and describe how this FHIR-based, open-source, and interoperable system allows health systems to conduct public health reporting while maintaining the appropriate governance of the clinical data. METHODS: ELR to a simulated public health department was used as the trigger for a FHIR-based query. Predetermined queries were translated into Clinical Quality Language logics. Within the PACER environment, these Clinical Quality Language logical statements were managed and evaluated against the providers' FHIR servers. These predetermined logics were filtered, and only data relevant to that episode of the condition were extracted and sent to simulated public health agencies as an electronic case report. Design and testing were conducted at the Georgia Tech Research Institute, and the pilot was deployed at the Medical University of South Carolina. We evaluated this architecture by examining the completeness of additional information in the electronic case report, such as patient demographics, medications, symptoms, and diagnoses. This additional information is crucial for understanding disease epidemiology, but existing electronic case reporting and ELR architectures do not report them. Therefore, we used the completeness of these data fields as the metrics for enriching electronic case reports. RESULTS: During the 8-week study period, we identified 117 positive test results for chlamydia. PACER successfully created an electronic case report for all 117 patients. PACER extracted demographics, medications, symptoms, and diagnoses from 99.1% (116/117), 72.6% (85/117), 70.9% (83/117), and 65% (76/117) of the cases, respectively. CONCLUSIONS: PACER deployed in conjunction with electronic laboratory reports can enhance public health case reporting with additional relevant data. The architecture is modular in design, thereby allowing it to be used for any reportable condition, including evolving outbreaks. PACER allows for the creation of an enhanced and more complete case report that contains relevant case information that helps us to better understand the epidemiology of a disease.

Two reports in the current issue of JAMA Cardiology describe cases of acute myocarditis that occurred among persons who received the BNT162b2-mRNA (Pfizer-BioNTech) or mRNA-1273 (Moderna) messenger RNA (mRNA)–based COVID-19 vaccines authorized for use in the US.1,2 During the clinical evaluations of these patients, alternative etiologies for myocarditis were not detected. | | The first report describes 4 cases of myocarditis with symptom onset 1 to 5 days after receipt of a second dose of mRNA-based COVID-19 vaccine (2 receiving the BNT162b2-mRNA vaccine and 2 receiving the mRNA-1273 vaccine) who were evaluated in a single tertiary care medical center (Duke University Medical Center) that attempted to define its catchment population.1 Three cases occurred in men aged 23 to 36 years and the fourth in a 70-year-old woman; details about the medical history of the fourth patient were not provided, but she received coronary angiography during her evaluation and no atherosclerosis was found. All presented with severe acute chest pain, had abnormal electrocardiogram results, and had evidence of myocardial injury demonstrated by elevated troponin levels. Cardiac magnetic resonance imaging was performed in these 4 patients on days 3 through 5 after vaccine receipt, and the findings were consistent with acute myocarditis as defined by recent expert consensus guidelines.3

BACKGROUND: Epidemiologic studies demonstrated that overweight/obese girls (OW/OB) undergo thelarche and menarche earlier than normal weight girls (NW). There have been no longitudinal studies to specifically investigate how body weight/fat affects both clinical and biochemical pubertal markers in girls. METHODS: 90 girls (36 OW/OB, 54 NW), aged 8.2-14.7 years, completed 2.8 ± 1.7 study visits over the course of four years. Visits included dual-energy x-ray absorptiometry to calculate total body fat (TBF), Tanner staging, breast ultrasound for morphological staging (BMORPH; A-E), pelvic ultrasound, hormone tests, and assessment of menarchal status. The effect of TBF on pubertal markers was determined using a mixed, multi-state, or Cox proportional hazards model, controlling for baseline BMORPH. RESULTS: NW were older than OW/OB (11.3 vs. 10.2 yrs, p<0.01) at baseline and had more advanced BMORPH (p<0.01). LH, estradiol, and ovarian and uterine volumes increased with time with no effect of TBF. There was a time x TBF interaction for FSH, inhibin B, estrone, total and free testosterone, and androstenedione: levels were initially similar, but after 1 yr, levels increased in girls with higher TBF, plateaued in girls with mid-range TBF, and decreased in girls with lower TBF. Girls with higher TBF progressed through BMORPH stage D more slowly but achieved menarche earlier than girls with lower TBF. CONCLUSIONS: In late puberty, girls with higher TBF demonstrate differences in standard hormonal and clinical markers of puberty. Investigation of the underlying causes and clinical consequences of these differences in girls with higher TBF deserves further study.

Primary care providers play a vital role for HIV prevention and care in high burden areas of the Southeast United States. Studies reveal that only a third of these providers had previous HIV-related training. We evaluated the effects of targeted online continuing medical education training on HIV-related knowledge, attitudes and practices among providers in the Southeast. During April 2017-February 2018, we administered baseline and six-month follow-up surveys to assess changes attributed to online training among a representative sample of providers from six Southeast locations. Data were analyzed using logistic regression analysis (p < 0.05). Baseline and follow-up surveys were completed by 349 participants (61.2% female, 64.6% white, 69.6% physicians, and 27.5% aged 40 years or less); 18% (n = 63) of whom visited online training websites sent following the baseline survey. Comparing baseline versus follow-up responses, providers who completed online training were half as likely to identify "patients' age" (30% vs. 15%) and "patients' race" (3% vs. 1.4%) as barriers to discussing sex with clients; survey responses by participants who declined training remained unchanged. Based on baseline versus follow-up responses, providers who visited online training websites were more likely to become familiar with preexposure prophylaxis (PrEP) (38% vs. 58%); participants who declined training remained unchanged at 45%. No impact on clinical practices such as PrEP prescriptions was identified. Targeted online training can enhance HIV readiness and should be explored for providers in the Southeast, particularly for enhancing PrEP service delivery.

The spontaneous death or loss of a fetus during pregnancy is termed a fetal death. In the United States, national data on fetal deaths are available for losses at ≥20 weeks' gestation.* Deaths occurring during this period of pregnancy are commonly known as stillbirths. In 2017, approximately 23,000 fetal deaths were reported in the United States (1). Racial/ethnic disparities exist in the fetal mortality rate; however, much of the known disparity in fetal deaths is unexplained (2). CDC analyzed 2015-2017 U.S. fetal death report data and found that non-Hispanic Black (Black) women had more than twice the fetal mortality rate compared with non-Hispanic White (White) women and Hispanic women. Fetal mortality rates also varied by maternal state of residence. Cause of death analyses were conducted for jurisdictions where >50% of reports had a cause of death specified. Still, even in these jurisdictions, approximately 31% of fetal deaths had no cause of death reported on a fetal death report. There were differences by race and Hispanic origin in causes of death, with Black women having three times the rate of fetal deaths because of maternal complications compared with White women. The disparities suggest opportunities for prevention to reduce the U.S. fetal mortality rate. Improved documentation of cause of death on fetal death reports might help identify preventable causes and guide prevention efforts.

Although non-Hispanic American Indian and Alaska Native (AI/AN) persons account for 0.7% of the U.S. population,* a recent analysis reported that 1.3% of coronavirus disease 2019 (COVID-19) cases reported to CDC with known race and ethnicity were among AI/AN persons (1). To assess the impact of COVID-19 among the AI/AN population, reports of laboratory-confirmed COVID-19 cases during January 22(†)-July 3, 2020 were analyzed. The analysis was limited to 23 states(§) with >70% complete race/ethnicity information and five or more laboratory-confirmed COVID-19 cases among both AI/AN persons (alone or in combination with other races and ethnicities) and non-Hispanic white (white) persons. Among 424,899 COVID-19 cases reported by these states, 340,059 (80%) had complete race/ethnicity information; among these 340,059 cases, 9,072 (2.7%) occurred among AI/AN persons, and 138,960 (40.9%) among white persons. Among 340,059 cases with complete patient race/ethnicity data, the cumulative incidence among AI/AN persons in these 23 states was 594 per 100,000 AI/AN population (95% confidence interval [CI] = 203-1,740), compared with 169 per 100,000 white population (95% CI = 137-209) (rate ratio [RR] = 3.5; 95% CI = 1.2-10.1). AI/AN persons with COVID-19 were younger (median age = 40 years; interquartile range [IQR] = 26-56 years) than were white persons (median age = 51 years; IQR = 32-67 years). More complete case report data and timely, culturally responsive, and evidence-based public health efforts that leverage the strengths of AI/AN communities are needed to decrease COVID-19 transmission and improve patient outcomes.

Public health needs up-to-date information for surveillance and response. As healthcare application programming interfaces become widely available, a novel data gathering mechanism could provide public health with critical information in a timely fashion to respond to a fast-moving epidemic. In this article, we extrapolate from our experiences using a Fast Healthcare Interoperability Resource-based architecture for infectious disease surveillance for sexually transmitted diseases to its application to gather case information for an outbreak. One of the challenges with a fast-moving outbreak is to accurately assess its demand on healthcare resources, since information specific to comorbidities is often not available. These comorbidities are often associated with poor prognosis and higher resource utilization. If the comorbidity data and other clinical information were readily available to public health workers, they could better address community disruption and manage healthcare resources. The use of FHIR resources available through application programming and filtered through tools such as described herein will give public health the flexibility needed to investigate rapidly emerging disease while protecting patient privacy.

Mental health (MH) disorders are associated with HIV-related risk and health outcomes. Primary care providers (PCPs) conducting MH screenings can link persons living with HIV (PWH) to appropriate services, particularly in HIV burden areas of Southeastern States (the South). Little data exist on PCPs' MH screening practices. Depression, MH history, and substance use screenings among PCPs were examined in the South. Rao-Scott chi-square (chi(2)[df]) statistics (p </= 0.05) analyzed MH screening between PCPs with and without PWH patients. Compared with PCPs without PWH patients, PCPs with PWH patients routinely screened for substance use more frequently (50.6% vs. 43.2%; chi(2)[1] = 20.3; p < 0.0001). Compared with PCPs without PWH patients, PCPs with PWH patients routinely screened for depression less frequently (36.2% vs. 50.9%; chi(2)[1] = 32.0; p < 0.0001). Providers increasing MH screenings will improve HIV-related outcomes in the South.

OBJECTIVE: To estimate the risk of stillbirth (fetal death at 20 weeks of gestation or more) associated with specific birth defects. METHODS: We identified a population-based retrospective cohort of neonates and fetuses with selected major birth defects and without known or strongly suspected chromosomal or single-gene disorders from active birth defects surveillance programs in nine states. Abstracted medical records were reviewed by clinical geneticists to confirm and classify all birth defects and birth defect patterns. We estimated risks of stillbirth specific to birth defects among pregnancies overall and among those with isolated birth defects; potential bias owing to elective termination was quantified. RESULTS: Of 19,170 eligible neonates and fetuses with birth defects, 17,224 were liveborn, 852 stillborn, and 672 electively terminated. Overall, stillbirth risks ranged from 11 per 1,000 fetuses with bladder exstrophy (95% CI 0-57) to 490 per 1,000 fetuses with limb-body-wall complex (95% CI 368-623). Among those with isolated birth defects not affecting major vital organs, elevated risks (per 1,000 fetuses) were observed for cleft lip with cleft palate (10; 95% CI 7-15), transverse limb deficiencies (26; 95% CI 16-39), longitudinal limb deficiencies (11; 95% CI 3-28), and limb defects due to amniotic bands (110; 95% CI 68-171). Quantified bias analysis suggests that failure to account for terminations may lead to up to fourfold underestimation of the observed risks of stillbirth for sacral agenesis (13/1,000; 95% CI 2-47), isolated spina bifida (24/1,000; 95% CI 17-34), and holoprosencephaly (30/1,000; 95% CI 10-68). CONCLUSION: Birth defect-specific stillbirth risk was high compared with the U.S. stillbirth risk (6/1,000 fetuses), even for isolated cases of oral clefts and limb defects; elective termination may appreciably bias some estimates. These data can inform clinical care and counseling after prenatal diagnosis.

HIV disproportionately affects persons in Southeast United States. Primary care providers (PCPs) are vital for HIV prevention. Data are limited about their prescribing of antiretrovirals (ARVs) for prevention, including non-occupational post-exposure prophylaxis (nPEP), pre-exposure prophylaxis (PrEP), and antiretroviral therapy (ART). We examined these practices to assess gaps. During April-August 2017, we conducted an online survey of PCPs in Atlanta, Baltimore, Baton Rouge, Miami, New Orleans, and Washington, DC to assess HIV-related knowledge, attitudes and practices. Adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) were used to estimate correlates of nPEP, PrEP and ART prescribing practices. Adjusting for MSA and specialty, the weighted sample (n=820, 29.6% adjusted response rate) comprised 60.2% white and 59.4% females. PCPs reported ever prescribing nPEP (31.0%), PrEP (18.1%), and ART (27.2%). Prescribing nPEP was associated with nPEP familiarity (aPR=2.63, 95% CI 1.59, 4.35) and prescribing PrEP (aPR=3.57, 95% CI 2.78, 4.55). Prescribing PrEP was associated with PrEP familiarity (aPR=4.35, 95% CI 2.63, 7.14), prescribing nPEP (aPR=5.00, 95% CI 2.00, 12.50), and providing care for persons with HIV (aPR=1.56, 95% CI 1.06, 2.27). Prescribing ART was associated with nPEP familiarity (aPR=1.89, 95% CI 1.27, 2.78) and practicing in outpatient public practice versus hospital-based facilities (aPR=2.14 95% CI 1.51, 3.04), and inversely associated with collaborations involving specialists (aPR=0.60, 95% CI 0.42, 0.86). A minority of PCPs surveyed from the Southeast report ever prescribing ARVs for prevention. Future efforts should include enhancing HIV care coordination and developing strategies to increase use of biomedical tools.

BACKGROUND: Girls who are overweight/obese (OB) develop breast tissue but do not undergo menarche (the first menstrual period) significantly earlier than girls of normal weight (NW). It has been proposed that estrogen synthesized by adipose tissue may be contributory, yet OB do not have higher serum estrogen levels than NW matched on breast stage. We hypothesized that estrogen synthesized locally, in mammary fat, may contribute to breast development. This hypothesis would predict that breast development would be more advanced than other estrogen-sensitive tissues as a function of obesity and body fat. METHODS: Eighty premenarchal girls (26 OB, 54 NW), aged 8.2-14.7 years, underwent dual-energy x-ray absorptiometry to calculate percent body fat (%BF), Tanner staging of the breast, breast ultrasound for morphological staging, trans-abdominal pelvic ultrasound, hand x-ray (bone age, BA), a blood test for reproductive hormones, and urine collection to determine the vaginal maturation index (VMI), an index of estrogen exposure in urogenital epithelial cells. RESULTS: When controlling for breast morphological stage determined by ultrasound, %BF was not associated with serum estrogen or gonadotropin (LH and FSH) levels or with indices of systemic estrogen action (uterine volume, endometrial thickness, BA advancement, and VMI). Tanner breast stage did not correlate with breast morphological stage and led to misclassification of chest fatty tissue as breast tissue in some OB. CONCLUSIONS: These studies do not support the hypothesis that estrogen derived from total body fat or local (mammary) fat contributes to breast development in OB girls.

BACKGROUND: Systematic surveillance for venous thromboembolism (VTE) in the United States has been recommended by several organizations. Despite adoption of electronic medical records (EMRs) by most health care providers and facilities, however, systematic surveillance for VTE is not available. OBJECTIVES: This article develops a comprehensive, population-based surveillance strategy for VTE in a defined geographical region. METHODS: The primary surveillance strategy combined computerized searches of the EMR with a manual review of imaging data at the Duke University Health System in Durham County, North Carolina, United States. Different strategies of searching the EMR were explored. Consolidation of results with autopsy reports (nonsearchable in the EMR) and with results from the Durham Veterans' Administration Medical Center was performed to provide a comprehensive report of new VTE from the defined region over a 2-year timeframe. RESULTS: Monthly searches of the primary EMR missed a significant number of patients with new VTE who were identified by a separate manual search of radiology records, apparently related to delays in data entry and coding into the EMR. Comprehensive searches incorporating a location-restricted strategy were incomplete due to the assigned residence reflecting the current address and not the address at the time of event. The most comprehensive strategy omitted the geographic restriction step and identified all patients with VTE followed by manual review of individual records to remove incorrect entries (e.g., outside the surveillance time period or geographic location; no evidence for VTE). Consolidation of results from the EMR searches with results from autopsy reports and the separate facility identified additional patients not diagnosed within the Duke system. CONCLUSION: We identified several challenges with implementing a comprehensive VTE surveillance program that could limit accuracy of the results. Improved electronic strategies are needed to cross-reference patients across multiple health systems and to minimize the need for manual review and confirmation of results.