Last data update: Apr 22, 2024. (Total: 46599 publications since 2009)
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Hospitalization with cardiovascular conditions in the postpartum year among commercially insured women in the U.S
Ford ND , DeSisto CL , Womack LS , Galang RR , Hollier LM , Sperling LS , Wright JS , Ko JY . J Am Coll Cardiol 2024 83 (2) 382-384 Cardiovascular conditions are significant contributors to morbidity and mortality among pregnant and postpartum women.1 | | We used data from the MarketScan Commercial Claims and Encounters database to identify women 12 to 55 years of age who delivered from 2017 to 2019. Delivery hospitalizations and cardiovascular diagnoses and procedures (ie, conditions) were identified using International Classification of Diseases-10th Revision-Clinical Modification codes. Cardiovascular conditions included acute heart failure or pulmonary edema; acute myocardial infarction; arrhythmia; conduction disorders; cardiac arrest, ventricular fibrillation, or ventricular flutter; cardiomyopathy; congenital heart and great artery defects; conversion of cardiac rhythm; endocarditis, myocarditis, or pericarditis; hypertensive heart disease; ischemic heart disease; nonrheumatic valve disorders; pulmonary heart disease; rheumatic heart disease; and other heart diseases and complications. We calculated the prevalence of hospitalizations with any cardiovascular condition in the year postpartum. Among these patients, we calculated the prevalence of cardiovascular conditions at delivery hospitalization and the frequency of postpartum hospitalizations. For postpartum hospitalizations with cardiovascular conditions, we calculated timing relative to delivery hospitalization and the prevalence (95% CI) of specific cardiovascular conditions by timing since delivery hospitalization (early postpartum [1–42 days] vs late postpartum [43–365 days]), accounting for clustering at the patient level. The data were collected and statistically deidentified. The data are also compliant with the conditions set forth in sections 164.514(a) and 164.51(b)(1)(ii) of the Health Insurance Portability and Accountability Act of 1996 Privacy Rule; therefore, approval from an Institutional Review Board was not sought. |
A survey on mosquito control knowledge and insecticide use in New Orleans, La, 2020-2021
Cloherty ER , McAllister JC , Ottea JA , Healy K , Riegel C . J Am Mosq Control Assoc 2023 39 (4) 243-250 Mosquitoes are a known public nuisance and can vector various diseases. Historically, New Orleans, LA, has long been acquainted with the burden of mosquito-borne diseases, such as malaria and yellow fever in the 20th century and West Nile virus in the 21st century. Government mosquito control awareness campaigns have been around for decades as has the use of organophosphate and pyrethroid insecticides by mosquito abatement districts. However, few data are available on public perception of mosquito control and public usage of insecticides to kill mosquitoes in New Orleans. We conducted a survey from August 2020 to July 2021 to evaluate New Orleans residents' 1) general knowledge regarding mosquito control and 2) what measures and products they use to control mosquitoes. The aim of this survey was to determine how residents contribute to backyard mosquito control by do-it-yourself or professional applications of insecticides. The survey was disseminated both online and via mail. Of the 396 survey participants, nearly all (99.48%) agreed that mosquito control is important in New Orleans because it prevents mosquito bites (30.85%), prevents mosquito borne-diseases (38.51%), and prevents nuisance mosquitoes (29.17%). More than one-third (35%) of survey participants indicated that they empty containers to reduce adult mosquitoes on their own property. More than two-thirds of the participants (69.95%) would not hire a pest management professional to spray their yard for adult mosquitoes, and only 20% of survey participants do apply a pesticide to kill adult mosquitoes on their own property. None of our findings were associated with the level of education, gender, or age of participants. This study suggests that the City of New Orleans Mosquito, Termite and Rodent Control Board educational and outreach campaigns may be an effective tool in spreading mosquito control awareness and contribute to residents' knowledge of mosquito control. The data we collected indicate that residents understand what mosquito control is and why it is important in New Orleans. |
Examining the effects of gateway width on motorist yielding to pedestrians
Hochmuth J , Newton E , Van Houten R . Transp Res Rec 2023 The gateway in-street sign configuration has been demonstrated to be a low-cost method for increasing motorist yielding the right of way to pedestrians at crosswalks. It has previously been hypothesized that the gateway is effective because it visually narrows a travel lane. In the present study, gateway widths (i.e., distance between signs) were compared to determine whether there was a differential effect on motorist yielding. Experiment 1 was a parametric analysis of distance between the signs, varying in 2-ft intervals from 12 to 18 ft. The results showed that the percentage of motorists yielding increased as the distance between the signs decreased. Experiment 2 examined curb-top and gutter-pan placements of the edge signs at three different sites. Both placements produced substantial increases in yielding compared with baseline, though the difference between gutter-pan and curb-top placement was not significant at two of the three sites. Based on the distance between signs in these two configurations, the results at two of the sites aligned with those in Experiment 1, and one site demonstrated much higher yielding than would have been predicted. This suggests that small increases in the distance between signs may result in a minor decrease in yielding but may improve the survivability of the signs and reduce maintenance costs over time. The potential to combine this sign effect with other engineering treatments (e.g., curb extensions and bicycle lanes) was additionally explored. The results are discussed in relation to a perceived narrowing hypothesis, sign survival, cost effectiveness, and equity. © National Academy of Sciences: Transportation Research Board 2023. |
Another Year of Successes for PCD: Impact Factor, Collections, New Student Committee, Dr Lynne Wilcox Paper of the Year, and 2024 Calls for Papers
Jack L Jr . Prev Chronic Dis 2023 20 E106 Preventing Chronic Disease (PCD) brings 2023 to a close having achieved impressive accomplishments. This final Editor in Chief’s Column of the year provides updates on the journal’s increased impact factor; commitment to student development; publication of collections; formation of the Student Scientific Writing and Review Training Committee; upcoming 20th anniversary; and 2024 calls for papers. PCD has been positioned for success because of tremendous support from its editorial board, associate editors, Statistics Review Committee, and its pool of peer reviewers. PCD celebrates the hundreds of authors who submit articles annually to the journal for consideration. In addition, a major source of support to the journal has come from senior leadership in the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP). |
Clinical Policy: Critical Issues in the Management of Adult Patients Presenting to the Emergency Department With Mild Traumatic Brain Injury: Approved by ACEP Board of Directors, February 1, 2023 Clinical Policy Endorsed by the Emergency Nurses Association (April 5, 2023)
Valente JH , Anderson JD , Paolo WF , Sarmiento K , Tomaszewski CA , Haukoos JS , Diercks DB , Diercks DB , Anderson JD , Byyny R , Carpenter CR , Friedman B , Gemme SR , Gerardo CJ , Godwin SA , Hahn SA , Hatten BW , Haukoos JS , Kaji A , Kwok H , Lo BM , Mace SE , Moran M , Promes SB , Shah KH , Shih RD , Silvers SM , Slivinski A , Smith MD , Thiessen MEW , Tomaszewski CA , Trent S , Valente JH , Wall SP , Westafer LM , Yu Y , Cantrill SV , Finnell JT , Schulz T , Vandertulip K . Ann Emerg Med 2023 81 (5) e63-e105 This 2023 Clinical Policy from the American College of Emergency Physicians is an update of the 2008 “Clinical Policy: Neuroimaging and Decisionmaking in Adult Mild Traumatic Brain Injury in the Acute Setting.” A writing subcommittee conducted a systematic review of the literature to derive evidence-based recommendations to answer the following questions: 1) In the adult emergency department patient presenting with minor head injury, are there clinical decision tools to identify patients who do not require a head computed tomography? 2) In the adult emergency department patient presenting with minor head injury, a normal baseline neurologic examination, and taking an anticoagulant or antiplatelet medication, is discharge safe after a single head computed tomography? and 3) In the adult emergency department patient diagnosed with mild traumatic brain injury or concussion, are there clinical decision tools or factors to identify patients requiring follow-up care for postconcussive syndrome or to identify patients with delayed sequelae after emergency department discharge? Evidence was graded and recommendations were made based on the strength of the available data. Widespread and consistent implementation of evidence-based clinical recommendations is warranted to improve patient care. |
Reducing cancer risk through primary prevention activities among children: A demonstration project
Tai E , Chovnick G , Momin B , Townsend JS , Holman DM , Siegel D , House M . J Public Health Manag Pract 2023 CONTEXT: Opportunities to reduce the risk of cancer, including cervical, liver, and skin cancer, start early in life. To encourage adoption of primary prevention activities in childhood to reduce cancer risk later in life, Centers for Disease Control and Prevention conducted a demonstration project with 3 National Comprehensive Cancer Control Program (NCCCP) recipients. PROGRAM: Iowa, Northwest Portland Area Indian Health Board (NPAIHB), and Pennsylvania NCCCP recipients implemented evidence-based primary prevention activities for cervical, liver, and skin cancer among children using health care provider education, patient education, and policy development. IMPLEMENTATION: Iowa implemented an announcement approach to improve provider education on human papillomavirus (HPV) vaccination. Pennsylvania focused on patient education for reducing skin cancer risk and both provider and patient education for liver cancer prevention. NPAIHB created a sun safety intervention for tribal organizations, including a policy guide, media materials, and patient education. RESULTS: In Iowa, health care providers taking the announcement approach reported significantly higher mean scores on a posttest compared with a pretest regarding perceptions about HPV vaccination, self-efficacy, and behavioral intentions related to vaccination. Pennsylvania integrated sun safety education and sunscreen dispenser programs as a health and wellness initiative in 8 state parks and the Pennsylvania Department of Conservation and Natural Resources incorporated the program in its Pennsylvania Outdoor Recreation Plan. Pennsylvania also implemented health care provider education on the primary prevention of liver cancer through hepatitis B and hepatitis C screening and hepatitis B vaccination. The NPAIHB skin cancer policy guide was created and distributed for use to all 43 federally recognized tribes of Oregon, Washington, and Idaho served by NPAIHB. DISCUSSION: The identification, dissemination, and implementation of these efforts can serve as best practices for future childhood primary prevention programs. NCCCP recipients and public health professionals can use health care provider education, patient education, and policy development to reduce future risk for cervical, liver, and skin cancer among children. |
Prevalence of pharmacologic and nonpharmacologic pain management therapies among adults with chronic pain-United States, 2020
Rikard SM , Strahan AE , Schmit KM , Guy GP Jr . Ann Intern Med 2023 176 (11) 1571-1575 Background: In 2021, approximately 1 in 5 adults in the United States experienced chronic pain (1). The Centers for Disease Control and Prevention’s “CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022” (2) recommends maximizing nonpharmacologic and nonopioid therapies for pain as appropriate for the specific condition and patient. Whereas previous research reported the prevalence of use of nonpharmacologic and opioid therapies for pain (3), this study adds information about prescription nonopioids, over-the-counter pain relievers, and exercise. | | Objective: To estimate the prevalence of use of pharmacologic and nonpharmacologic therapies among adults with chronic pain in the United States. | | Methods and Findings: We used the 2020 National Health Interview Survey (NHIS) (31 568 total respondents) to identify adults who self-reported pain on most days or every day in the past 3 months (unweighted n = 7422) (4). Respondents reported use of pharmacologic (prescription opioids, prescription nonopioids, over-the-counter pain relievers) and nonpharmacologic (physical or occupational therapy [PT/OT], cognitive behavioral therapy [CBT], exercise, complementary therapies) pain management therapies in the past 3 months. We report therapy prevalence overall and by demographic characteristics. Adjusted prevalence was estimated using predictive margins from multivariable logistic regression models. All analyses account for the complex NHIS survey design. This study was exempt from institutional review board review. | | In 2020, approximately 54 million adults self-reported chronic pain. Among pharmacologic therapies, use of over-the-counter pain relievers in the past 3 months was most prevalent (75.5%), followed by prescription nonopioids (31.3%) and prescription opioids (13.5%) (Table 1). Among nonpharmacologic therapies, exercise was most prevalent (55.0%), followed by complementary therapies (36.7%), PT/OT (17.2%), and CBT (2.6%). Pharmacologic therapy use alone was reported by 26.6% of adults, with most (22.4%) reporting nonopioid use only and 1.0% reporting opioid use only. Most adults (60.2%) reported using both pharmacologic and nonpharmacologic therapies, with 50.9% reporting nonopioid and nonpharmacologic therapy use and 7.7% reporting combined use of opioids, nonopioids, and nonpharmacologic therapy. |
Building diversity, equity, inclusion, and accessibility capacity: Resources to promote best practices among professionals in scholarly publishing
Jack L Jr , Olson PJ , Baskin PK , Iwuchukwu OF . Prev Chronic Dis 2023 20 E105 The Council of Science Editors (CSE) is an international organization of more than 500 editorial professionals in the scientific, scientific publishing, and information science communities. The organization’s goal is to serve as an authoritative resource on current and emerging issues in the communication of scientific information (1). Similar to other scholarly publishing organizations, CSE continues to facilitate important conversations and training regarding why, how, and where principles of diversity, equity, inclusion, and accessibility (DEIA) should be integrated into scholarly publishing. With guidance from CSE members with expertise in DEIA in scholarly publishing, and the approval of CSE’s Board of Directors, the organization established the DEI Committee in 2021 (which was expanded to the DEIA Committee in 2023). The purpose of the DEIA Committee is “to support the organization in building capacity among its leadership, members, and the profession at large to deliver programmatic activities and training that integrate [DEIA] best practices in science editing, publication management, scholarly publishing and communication, member recruitment, participation, and engagement” (2). | | Since the committee’s inception, CSE has implemented and/or participated in 8 broad-ranging DEIA-related activities: 1) adding new content to CSE’s Recommendations for Promoting Integrity in Scientific Journal Publications (3) related to DEIA best practices in scholarly publishing; 2) completing a DEIA sensitivity review of Scientific Style and Format (4), the CSE style manual, for its upcoming 9th edition, scheduled for publication in 2024; 3) a DEIA-related symposium to update members on CSE’s progress in achieving DEIA-related objectives and activities identified in CSE’s Strategic Plan (2); 4) establishing a DEIA column in Science Editor (5), CSE’s quarterly magazine; 5) implementing an inaugural 1-day DEIA short course to a range of professionals in scholarly publishing; 6) implementing its Ethics Clinic on Diversity, Equity, and Inclusion (6); 7) actively serving as a member organization for the Coalition for Diversity & Inclusion in Scholarly Communications (C4DISC) (3); and 8) establishing CSE’s DEIA Scholarly Resources web page (7). |
Notes from the field: Surveillance of silicosis using electronic case reporting - California, December 2022-July 2023
Flattery J , Woolsey C , Epstein-Corbin M , Blackley DJ , Harrison RJ , Cummings KJ . MMWR Morb Mortal Wkly Rep 2023 72 (46) 1275-1276 Electronic case reporting (eCR) (1) is a promising rapid reporting mechanism, whereby electronic health records (EHRs) automatically generate and transmit a disease report to jurisdictional public health agencies in real time using previously established criteria. All 50 U.S. states and other jurisdictions are connected to the eCR infrastructure. The Reportable Conditions Knowledge Management System (RCKMS),* a component of the eCR infrastructure, is a real-time decision support service that processes reports according to jurisdictional reporting requirements with criteria defined by Council of State and Territorial Epidemiologists’ position statements (1). Health care organizations automatically generate and send an initial case report to the eCR infrastructure when trigger criteria, such as diagnosis codes or laboratory results, are met within their EHRs. Therefore, for all participating California health care organizations, if a health care encounter involves COVID-19 or mpox, an initial case report is generated and sent to the eCR infrastructure for processing. When there is a match between the initial case report triggered by an EHR, and a reportable condition rule is entered into RCKMS by a jurisdictional public health agency, the initial case report is routed by the eCR infrastructure to the public health agency. Other conditions can be added to public health agency reporting rules. | | Silicosis is a progressive, incurable, fibrotic lung disease caused by inhalation of respirable crystalline silica dust produced in industries such as construction, quarrying, and coal mining (2). A resurgence of silicosis among young workers fabricating engineered stone (quartz) countertops in California and in countries including Australia, Israel, and Spain has focused attention on the need for timely case identification for primary and secondary prevention (2–5). In December 2022, the California Department of Public Health (CDPH) added reporting rules for silicosis to RCKMS, so that any initial case report received by the eCR infrastructure from health care provider EHRs that includes a silicosis diagnosis in the patient’s problem list is sent to CDPH for silicosis surveillance. The purpose of this study was to evaluate the utility of eCR for identifying cases of silicosis in California. This study was reviewed and approved by the California Committee for the Protection of Human Subjects institutional review board.† |
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. |
2023 Updated ACVIM consensus statement on leptospirosis in dogs
Sykes JE , Francey T , Schuller S , Stoddard RA , Cowgill LD , Moore GE . J Vet Intern Med 2023 37 (6) 1966-1982 Since publication of the last consensus statement on leptospirosis in dogs, there has been revision of leptospiral taxonomy and advancements in typing methods, widespread use of new diagnostic tests and vaccines, and improved understanding of the epidemiology and pathophysiology of the disease. Leptospirosis continues to be prevalent in dogs, including in small breed dogs from urban areas, puppies as young as 11 weeks of age, geriatric dogs, dogs in rural areas, and dogs that have been inadequately vaccinated for leptospirosis (including dogs vaccinated with 2-serovar Leptospira vaccines in some regions). In 2021, the American College of Veterinary Internal Medicine (ACVIM) Board of Regents voted to approve the topic for a revised Consensus Statement. After identification of core panelists, a multidisciplinary group of 6 experts from the fields of veterinary medicine, human medicine, and public health was assembled to vote on the recommendations using the Delphi method. A draft was presented at the 2023 ACVIM Forum, and a written draft posted on the ACVIM website for comment by the membership before submission to the editors of the Journal of Veterinary Internal Medicine. This revised document provides guidance for veterinary practitioners on disease in dogs as well as cats. The level of agreement among the 12 voting members (including core panelists) is provided in association with each recommendation. A denominator lower than 12 reflects abstention of ≥1 panelists either because they considered the recommendation to be outside their scope of expertise or because there was a perceived conflict of interest. |
Use of cancer survivorship care guidelines by primary care providers in the United States
Townsend JS , Rohan EA , Sabatino SA , Puckett M . J Am Board Fam Med 2023 36 (5) 789-802 BACKGROUND: National organizations have issued comprehensive cancer survivorship care guidelines to improve care of cancer survivors, many of whom receive care from primary care providers (PCPs). METHODS: We analyzed Porter Novelli's 2019 fall DocStyles survey to assess use of cancer survivorship care guidelines, receipt of survivorship training, types of survivorship services provided, and confidence providing care among PCPs in the United States. We grouped PCPs by use of any guideline ("users") versus no guideline use ("nonusers"). We calculated descriptive statistics and conducted multivariable logistic regression analyses to examine guideline use, having received training on providing survivorship care services, and confidence in providing care. Within the panel, sampling quotas were set so that 1000 primary care physicians, 250 OB/GYNs, 250 pediatricians, and 250 nurse practitioners/physician assistants were recruited. RESULTS: To reach selected quotas, 2696 health professionals were initially contacted to participate, resulting in a response rate of 64.9%. Sixty-two percent of PCPs reported using guidelines and 17% reported receiving survivorship care training. Use of any guidelines or receiving training was associated with reporting providing a range of survivorship services and confidence in providing care. After adjusting for demographic characteristics, guideline users were more likely than nonusers to report assessing genetic cancer risk (OR = 2.65 95% confidence interval (CI) (1.68, 4.17)), screening for cancer recurrence (OR = 2.32 95% CI (1.70, 3.18)) or a new cancer (OR = 1.63, 95% CI (1.20, 2.22)), and treating depression (OR = 1.64, 95% CI (1.20, 2.25)). Receipt of training was also positively associated with providing genetic risk assessment, surveillance for recurrence, as well as assessing late/long-term effects, and treating pain, fatigue, and sexual side effects. CONCLUSION: Survivorship care guidelines and training support PCPs in providing a range of survivorship care services. |
The elimination of hepatitis D as a public health problem: Needs and challenges
Vanwolleghem T , Armstrong PA , Buti M , FitzSimons D , Valckx S , Hendrickx G , Van Damme P . J Viral Hepat 2023 31 (1) 47-50 Infection with hepatitis D virus leads to liver disease and cancer most rapidly of all hepatitis viruses. However, knowledge about hepatitis D remains poor and the burden and impact are underestimated, even though some 12-15 million people mainly in low- and middle-income countries may be affected. Its epidemiology is changing, with increasing migration leading to increased risks of infection and disease. A recent Viral Hepatitis Prevention Board meeting reviewed the current epidemiological status, improvements in diagnostic testing, advances in the development of novel antiviral agents in phase III trials and the need for a greater public health response, such as new guidelines and recommended testing of all people newly identified as infected with hepatitis B virus for hepatitis D virus infection. It identified issues and needs for attention with regard to prevention, diagnosis and treatment. |
Incidence of TB disease among persons who use drugs in California
Frazier C , Nabity SA , Flood J . Int J Tuberc Lung Dis 2023 27 (10) 781-783 TB may disproportionately affect persons who use drugs (PWUD),1–3 but the TB incidence rate among PWUD has not been estimated in the United States (U.S). California has the highest TB case burden and the highest frequency of current drug use: in 2019, 23.5% of incident TB cases in the U.S. occurred in California (5.3/100,000), and the state has an estimated 4.7 million PWUD.4,5 A better understanding of the intersection between drug use and TB will promote equity-informed interventions that account for social aspects of TB risk.6 In the study presented here, we estimate the incidence of TB disease among PWUD in California, describe the characteristics of TB patients who use drugs, and evaluate drug use as a risk factor for adverse treatment outcomes. | | We analyzed surveillance data of incident TB disease reported to the California Department of Public Health (CDPH; Richmond, CA, USA) TB registry in persons ≥12 years of age from 2015–2019. The denominator population of PWUD (who reported drug use in the past year) was derived from the National Survey of Drug Use and Mental Health (NSDUH) of noninstitutionalized civilians who were aged ≥12 years and resided in fixed-address households. We accessed prevalence estimates derived from the NSDUH through the Restricted Online Data Access System.7 NSDUH prevalence estimates are based on 2 years of pooled sample data and, because each year had two estimates (e.g., for 2018 data for 2017–2018 and 2018–2019), we used the average for the annual denominator value. We considered persons with TB who use drugs (PWUD-TB) as patients who reported any injecting or noninjecting drug use in the year preceding TB diagnosis. We used the NSDUH past-year variable ‘Any illicit drug use’ as the PWUD population denominator. We determined whether cases were attributable to recent transmission using a plausible source-case algorithm that associates genetic isolates with likely TB source cases.8 We defined TB treatment noncompletion as premature treatment cessation due to loss to follow-up, refusal, or nonadherence. We defined treatment extension as the completion of an appropriate regimen in more than 12 months, excluding patients with multidrug-resistant TB. We calculated the annual incidence of TB disease among PWUD aged ≥12 years from 2015 to 2019 by dividing the annual frequency of PWUD-TB by the corresponding NSDUH prevalence estimate of past-year drug use for California, stratified by place of birth. We used the χ2 test for comparison of categorical variables and the Wilcoxon rank-sum test for continuous variables (α = 0.05). Finally, we constructed multivariable log-binomial models to determine the independent association of drug use with treatment extension and treatment noncompletion (α = 0.05). This activity was determined to meet the requirements of public health surveillance by the Centers for Disease Control and Prevention (CDC) as defined in 45 CFR 46.102(l)(2), and thus did not require institutional board review. CDPH also determined this work to be non-research. Informed consent was not required. |
Exposure risks and potential control measures for a fire behavior lab training structure: part b-chemical gas concentrations
Horn GP , Stakes K , Neumann D , Madrzykowski D , Fent KW . Fire Technol 2023 [Epub ahead of print] Firefighters' or instructors' exposure to airborne chemicals during live-fire training may depend on fuels being burned, fuel orientation and participants' location within the structure. This study was designed to evaluate the impact of different control measures on exposure risk to combustion byproducts during fire dynamics training where fuel packages are mounted at or near the ceiling. These measures included substitution of training fuels (low density wood fiberboard, oriented strand board (OSB), pallets, particle board, plywood) and adoption of engineering controls such as changing the location of the instructor and students using the structure. Experiments were conducted for two different training durations: the typical six ventilation cycle (six-cycle) and a shorter three ventilation cycle (three-cycle) with a subset of training fuels. In Part A of this series, we characterized the fire dynamics within the structure, including the ability of each fuel to provide an environment that achieves the training objectives. Here, in Part B, airborne chemical concentrations are reported at the location where fire instructors would typically be operating. We hypothesized that utilizing a training fuel package with solid wood pallets would result in lower concentrations of airborne contaminants at the rear instructor location than wood-based sheet products containing additional resins and/or waxes. In the six-cycle experiments (at the rear instructor location), OSB-fueled fires produced the highest median concentrations of benzene and 1,3 butadiene, plywood-fueled fires produced the highest total polycyclic aromatic hydrocarbon (PAH) concentrations, particle board-fueled fires produced the highest methyl isocyanate concentrations, and pallet-fueled fires produced the highest hydrogen chloride concentrations. All fuels other than particle board produced similarly high levels of formaldehyde at the rear instructor location. The OSB fuel package created the most consistent fire dynamics over six-cycles, while fiberboard resulted in consistent fire dynamics only for the first three cycles. In the follow-on three-cycle experiment, PAH, benzene, and aldehyde concentrations were similar for the OSB and fiberboard-fueled fires. Air sampling did not identify any clear differences between training fires from burning solid wood pallets and those that incorporate wood-based sheet products for this commonly employed fuel arrangement with fuels mounted high in the compartment. However, it was found that exposure can be reduced by moving firefighters and instructors lower in the compartment and/or by moving the instructor in charge of ventilation from the rear of the structure (where highest concentrations were consistently measured) to an outside position. |
Polysubstance use in pregnancy: Surveillance, interventions, and next steps
Park Y , Dang EP , Board A , Gilboa SM , Ondersma SJ , Smid MC , Shakib JH , Mitchell KT , England LJ , Broussard CS , Meaney-Delman D , Iskander J , Kim SY . J Womens Health (Larchmt) 2023 32 (9) 899-904 Substance use during pregnancy increases risk for a wide range of adverse maternal and neonatal health outcomes. Polysubstance use is common among people who use substances during pregnancy; however, the risks of combined substance exposures during pregnancy are poorly understood. In this report, we provide an overview of the activities of the Centers for Disease Control and Prevention (CDC) and partners and identified gaps related to (1) surveillance, (2) routine screening, and (3) prevention of polysubstance use during pregnancy. Efforts by CDC and other partners to reduce polysubstance use during pregnancy can improve the health of pregnant people and their infants and children. |
Notes from the field: Cruise ship norovirus outbreak associated with person-to-person transmission - United States Jurisdiction, January 2023
Crisp CA , Jenkins KA , Dunn I , Kupper A , Johnson J , White S , Moritz ED , Rodriguez LO . MMWR Morb Mortal Wkly Rep 2023 72 (30) 833-834 CDC’s Vessel Sanitation Program (VSP) monitors cases of acute gastroenteritis (AGE) on board cruise ships traveling to a U.S. port (1). Persons who have ≥3 loose stools (or more than normal for that person) within a 24-hour period or vomiting plus one other sign or symptom (e.g., fever, diarrhea, bloody stool, myalgia, abdominal cramps, or headache) meet the case definition for reportable AGE (2). When the percentage of passengers or crew members with AGE is ≥2% and the ship is due to arrive at a U.S. port within 15 days, the Maritime Illness Disease Reporting System alerts VSP and activates an investigation (1). During the first week of January 2023, VSP was notified of cases of AGE affecting >2% of passengers on board a ship that had completed three voyages in Europe and was within 15 days of arriving at a U.S. port (voyage 4)* (Figure). Ship medical crew members submitted stool samples from ill travelers for testing. All samples tested positive for norovirus genotype II. While the ship was sailing to a U.S. port, VSP monitored AGE cases on board and reviewed case data. By mid-January, passenger AGE prevalence reached 3.4%. |
Expected Rates of Select Adverse Events following Immunization for COVID-19 Vaccine Safety Monitoring (preprint)
Abara WE , Gee J , Delorey M , Ye T , Mu Y , Shay DK , Shimabukuro T . medRxiv 2021 2021.08.31.21262919 Background Knowledge of expected rates of potential adverse events of special interest (AESI) that may occur coincidentally following COVID-19 vaccination is essential for vaccine safety surveillance and assessment. We calculated the expected rates of 21 potential AESI following COVID-19 vaccination among vaccinated persons within 1 day, 7 days, and 42 days of vaccination.Methods We used meta-analytic methods to estimate background rates of 21 medical conditions considered potential AESI and calculated expected rates of each potential AESI within 1 day, 7 days, and 42 days of vaccination.Results Background rates of three commonly monitored AESI, Guillain-Barre syndrome (GBS), myopericarditis, and all-cause deaths were 2.0 GBS cases/100,000 person-years, 1.3 myopericarditis cases/100,000 person-years, and 863.8 all-cause deaths/100,000 person-years, respectively. Based on these background rates, if 10,000,000 persons are vaccinated, we would expect 0.5, 3.7, and 22.5 GBS cases; 0.3, 2.4, and 14.3 myopericarditis cases; and 236.5, 1655.5, and 9932.8 all-cause deaths to occur in coincident temporal association (i.e., as a result of background incidence) within 1 day, 7 days, and 42 days of vaccination, respectively.Conclusion Knowledge of expected rates of potential AESI can help contextualize adverse health events associated temporally with immunization, aid in safety signal detection, guide COVID-19 vaccine public health communication, and inform benefit-risk assessments of COVID-19 vaccines.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThere are no funding sources for this study.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This analysis was exempt from CDC Institutional Review Board review.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.YesWe conducted a meta-analysis using incidence rate data from eligible published studies cited in this paper. |
Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods (preprint)
Smith ER , Oakley E , He S , Zavala R , Ferguson K , Miller L , Grandner GW , Abejirinde IO , Afshar Y , Ahmadzia H , Aldrovandi G , Akelo V , Tippett Barr BA , Bevilacqua E , Brandt JS , Broutet N , Fernández Buhigas I , Carrillo J , Clifton R , Conry J , Cosmi E , Delgado-López C , Divakar H , Driscoll AJ , Favre G , Flaherman V , Gale C , Gil MM , Godwin C , Gottlieb S , Hernandez Bellolio O , Kara E , Khagayi S , Kim CR , Knight M , Kotloff K , Lanzone A , Le Doare K , Lees C , Litman E , Lokken EM , Laurita Longo V , Magee LA , Martinez-Portilla RJ , McClure E , Metz TD , Money D , Mullins E , Nachega JB , Panchaud A , Playle R , Poon LC , Raiten D , Regan L , Rukundo G , Sanin-Blair J , Temmerman M , Thorson A , Thwin S , Tolosa JE , Townson J , Valencia-Prado M , Visentin S , von Dadelszen P , Adams Waldorf K , Whitehead C , Yang H , Thorlund K , Tielsch JM . medRxiv 2022 2020.11.08.20228056 We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.Competing Interest StatementClare Whitehead declares a a relationship with the following entities, Ferring Pharmaceuticals COVID19 Investigational, Grant, NHMRC Fellowship (salary support). Alice Panchaud declares the following research grants to institution: H2020-Grant (Consortium member of Innovative medicine initiative call 13 topic 9) (ConcePTION), Efficacy and safety studies on Medicines EMA/2017/09/PE/11, Lot 4, WP 2 lead (CONSIGN: Study on impact of COVID-19 infection and medicines in pregnancy), Safety monitoring of COVID-19 vaccines in the EU Reopening of competition no. 20 under a framework contract following procurement procedure EMA/2017/09/PE (Lot 3) 4. Federal Office of Public Health (207000 CHF). (The COVI-Preg registry). Edward Mullins declares a relationship with the following entities National Institute for Health Research (Project grant for PAN COVID study) Deborah Money declares a relationship with the following entities, Canadian Institutes of Health Research (payments to my institution only), Public Health Agency of Canada (payments to my institution only), BC Womens Foundation (payments to my institution only) and is a Member of the COVID-19 Immunity Task Force sponsored by the Canadian government. Torri D. Metz declares a relationship with the following entities, Pfizer (site Principal Investigator for SARS-CoV-2 vaccination in pregnancy study, money paid to institution and member of Medical Advisory Board for SARS-CoV-2 vaccination in pregnancy study, money paid to me), NICHD (subcommittee Chair for the NICHD Maternal-Fetal Medicine Units Network Gestational Research Assessments of COVID-19 (GRAVID) study), and Society for Maternal-Fetal Medicine (board member). Erica Lokken declares a relationship with the following entity, US NIH (paid institution). Karen L. Kotloff declares a relationship with the following entity, Bill and Melinda Gates Foundation. Siran He declares a relationship with the following entity, Bill and Melinda Gates Foundtion (payments made to my institution). Valerie Flaherman declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments to my institution), Yellow Chair Foundati n (payments to my institution), Robert Woods Johnson Foundation (payments to my institution), CDC Foundation, California Health Care Foundation (payments to my institution), Tara Health Foundation (payments to my institution), UCSF Womens Health Center of Excellence (payments to my institution) and California Department of Health Care Services (payments made to my institution). Jose Sanin-Blair declares a relationship with the following entity, Ferring Pharmaceuticals which give a grant ($10,000) for the expenses of RECOGEST trial and is a part of the Columbian Federation of Perinatology Yalda Afshar declares a relationship with the following entities, Bill and Melinda Gates Foundation (payments made to my institution), CDC Foundation (payments made to my institution), Robert Woods Johnson Foundation (payments made to my institution), and UCLA Deans Office COVID-19 research (payments made to my institution). Rebecca Cliffton declares a relationship with the following entity, NIH HD36801 (MFMU Network DCC).Clinical TrialPROSPERO ID: 188955Funding StatementFunded by the Bill & Melinda Gates Foundation grant to Emily Smith (INV-022057) at George Washington University and a grant to Emily Smith via a grant from the Bill & Melinda Gates Foundation to Stephanie Gaw (INV-017035) at University of California San Francisco.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This is a protocol paper and thus exempt from ethical approval. Ultimately, the meta-analysis study is exempt from human research ethics approval as the study authors will be synthesizing de-identified or aggregate data.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThis is a protocol paper and there is no related data to share. |
Estimating typhoid incidence from community-based serosurveys: A multicohort study in Bangladesh, Nepal, Pakistan and Ghana (preprint)
Aiemjoy K , Seidman JC , Saha S , Munira SJ , Islam Sajib MS , Sium SMA , Sarkar A , Alam N , Zahan FN , Kabir MS , Tamrakar D , Vaidya K , Shrestha R , Shakya J , Katuwal N , Shrestha S , Yousafzai MT , Iqbal J , Dehraj IF , Ladak Y , Maria N , Adnan M , Pervaiz S , Carter AS , Longley AT , Fraser C , Ryan ET , Nodoushani A , Fasano A , Leonard MM , Kenyon V , Bogoch II , Jeon HJ , Haselbeck A , Park SE , Zellweger RM , Marks F , Owusu-Dabo E , Adu-Sarkodie Y , Owusu M , Teunis P , Luby SP , Garrett DO , Qamar FN , Saha SK , Charles RC , Andrews JR . medRxiv 2022 2021.10.20.21265277 Background The incidence of enteric fever, an invasive bacterial infection caused by typhoidal Salmonellae, is largely unknown in regions lacking blood culture surveillance. New serologic markers have proven accurate in diagnosing enteric fever, but whether they could be used to reliably estimate population-level incidence is unknown.Methods We collected longitudinal blood samples from blood culture-confirmed enteric fever cases enrolled from surveillance studies in Bangladesh, Nepal, Pakistan, and Ghana and conducted cross-sectional serosurveys in the catchment areas of each surveillance site. We used ELISAs to measure quantitative IgA and IgG antibody responses to Hemolysin E (HlyE) and S. Typhi lipopolysaccharide (LPS). We used Bayesian hierarchical models to fit two-phase power-function decay models to the longitudinal antibody responses among enteric fever cases and used the joint distributions of the peak antibody titers and decay rate to estimate population-level incidence rates from cross-sectional serosurveys.Findings The longitudinal antibody kinetics for all antigen-isotypes were similar across countries and did not vary by clinical severity. The seroincidence of typhoidal Salmonella infection among children <5 years ranged between 58.5 per 100 person-years (95% CI: 42.1 - 81.4) in Dhaka, Bangladesh to 6.6 (95% CI: 4.3-9.9) in Kavrepalanchok, Nepal, and followed the same rank order as clinical incidence estimates.Interpretation The approach described here has the potential to expand the geographic scope of typhoidal Salmonella surveillance and generate incidence estimates that are comparable across geographic regions and time.Funding This work was supported by the Bill and Melinda Gates Foundation (INV-000572).Evidence before this study Previous studies have identified serologic responses to two antigens (Hemolysin E [HlyE] and Salmonella lipopolysaccharide [LPS]) as promising diagnostic markers of acute typhoidal Salmonella infection. We reviewed the evidence for seroepidemiology tools for enteric fever available as of November 01, 2021, by searching the National Library of Medicine article database and medRxiv for preprint publications, published in English, using the terms “enteric fever”, “typhoid fever”, “Salmonella Typhi”, “Salmonella Paratyphi”, “typhoidal Salmonella”, “Hemolysin E”, “Salmonella lipopolysaccharide”, “seroconversion”, “serosurveillance”, “seroepidemiology”, “seroprevalence” and “seropositivity.” We found no studies using HlyE or LPS as markers to measure the incidence or prevalence of enteric fever in a population. Anti-Vi IgG responses were used as a marker of population seroprevalence in cross-sectional studies conducted in South Africa, Fiji, and Nepal, but were not used to calculate population-based incidence estimates.Added value of this study We developed and validated a method to estimate typhoidal Salmonella incidence in cross-sectional population samples using antibody responses measured from dried blood spots. First, using longitudinal dried blood spots collected from over 1400 blood culture-confirmed cases in four countries, we modeled the longitudinal dynamics of antibody responses for up to two years following infection, accounting for heterogeneity in antibody responses and age-dependence. We found that longitudinal antibody responses were highly consistent across four countries on two continents and did not differ by clinical severity. We then used these antibody kinetic parameters to estimate incidence in population-based samples in six communities across the four countries, where concomitant population-based incidence was measured using blood cultures. Seroincidence estimates were much higher than blood-culture-based case estimates across all six sites, suggestive of a high incidence of asymptomatic or unrecognized infections. Still, the rank order of seroincidence and culture-based incidence rates were the same, with the highest rates in Bangladesh and lowest in Ghana.Implications of all the available evidence Many a -risk low- and middle-income countries lack data on typhoid incidence needed to inform and evaluate vaccine introduction. Even in countries where incidence estimates are available, data are typically geographically and temporally sparse due to the resources necessary to initiate and sustain blood culture surveillance. We found that typhoidal Salmonella infection incidence can be estimated from community-based serosurveys using dried blood spots, representing an efficient and scalable approach for generating the typhoid burden data needed to inform typhoid control programs in resource-constrained settings.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis study was funded by th eBill and Melinda Gates Foundation (grant INV-000572)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:Institutional Review Boards in the United States (Centers for Disease Control and Prevention; Stanford University Institutional Review Board), Bangladesh (Bangladesh Institute of Child Health Ethical Review Committee), Nepal (Nepal Health Research Council Ethical Review Board), Pakistan (AKU Ethic Review Committee and Pakistan National Bioethics Committee), Korea (International Vaccine Institute IRB), Belgium (Institute of Tropical Medicine Antwerp Institutional Review Board) and Ghana (Komfo Anokye Teaching Hospital, Committee on Human Research, Publication and Ethics) approved the study forms and protocols.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesAll data produced in the present study are available upon reasonable request to the authors |
A Remote Household-Based Approach to Influenza Self-Testing and Antiviral Treatment (preprint)
Heimonen J , McCulloch DJ , O'Hanlon J , Kim AE , Emanuels A , Wilcox N , Brandstetter E , Stewart M , McCune D , Fry S , Parsons S , Hughes JP , Jackson ML , Uyeki TM , Boeckh M , Starita LM , Bedford T , Englund JA , Chu HY . medRxiv 2021 2021.02.01.21250973 Background Households represent important settings for transmission of influenza and other respiratory viruses. Current influenza diagnosis and treatment relies upon patient visits to healthcare facilities, which may lead to under-diagnosis and treatment delays. This study aimed to assess the feasibility of an at-home approach to influenza diagnosis and treatment via home testing, telehealth care, and rapid antiviral home delivery.Methods We conducted a pilot interventional study of remote influenza diagnosis and treatment in Seattle-area households with children during the 2019-2020 influenza season using pre-positioned nasal swabs and home influenza tests. Home monitoring for respiratory symptoms occurred weekly; if symptoms were reported within 48 hours of onset, participants collected mid-nasal swabs and used a rapid home-based influenza immunoassay. An additional home-collected swab was returned to a laboratory for confirmatory influenza RT-PCR testing. Baloxavir antiviral treatment was prescribed and delivered to symptomatic and age-eligible participants, following a telehealth encounter.Results 124 households comprising 481 individuals self-monitored for respiratory symptoms, with 58 home tests administered. 12 home tests were positive for influenza, of which 8 were true positives confirmed by RT-PCR. The sensitivity and specificity of the home influenza test was 72.7% and 96.2%, respectively. There were 8 home deliveries of baloxavir, with 7 (87.5%) occurring within 3 hours of prescription, and all within 48 hours of symptom onset.Conclusions We demonstrate the feasibility of self-testing combined with rapid home delivery of influenza antiviral treatment. This approach may be an important control strategy for influenza epidemics and pandemics.Summary In this pilot study, 481 individuals self-monitored for respiratory symptoms. Of 58 home tests, 12 were influenza-positive. There were 8 baloxavir home deliveries within 48 hours of illness onset. A home-based approach to influenza diagnosis and treatment could be feasible.Competing Interest StatementH.Y.C. has received research support from GlaxoSmithKline, Novavax, and Sanofi Pasteur; J.A.E. has received research support from AstraZeneca, GlaxoSmithKine, Merck, and Pfizer and served as a consultant for Sanofi Pasteur and Meissa Vaccines. M.L.J. has received research support from Sanofi Pasteur. M.B. receives research support and serves as a consultant for Ansun Biopharma, Gilead Sciences, Janssen, and Vir Biotechnology; and serves as a consultant to GlaxoSmithKline, ReViral, ADMA, Pulmocdie and ModernaClinical TrialNCT04141930Funding StatementThe Seattle Flu Study is funded by Gates Ventures. The funder was not involved in the design of the study, does not have any ownership over the management and conduct of the study, the data, or the rights to publish.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:University of Washington Institutional Review Board (STUDY00008200)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).Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData and code used for analyses may be available upon request. |
Safety Monitoring of mRNA Vaccines Administered During the Initial 6 Months of the U.S. COVID-19 Vaccination Program: Reports to Vaccine Adverse Events Reporting System (VAERS) and v-safe (preprint)
Rosenblum HG , Gee J , Liu R , Marquez PL , Zhang B , Strid P , Abara WE , McNeil MM , Myers TR , Hause AM , Su JR , Baer B , Menschik D , Markowitz LE , Shimabukuro TT , Shay DK . medRxiv 2021 2021.10.26.21265261 Background In December 2020, two mRNA-based COVID-19 vaccines were authorized for use in the United States. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, and v-safe, an active surveillance system.Methods VAERS and v-safe data during December 14, 2020—June 14, 2021 were analyzed. VAERS reports were categorized as non-serious, serious, or death; reporting rates were calculated. Rates of reported deaths were compared to expected mortality rates by age. Proportions of v-safe participants reporting local and systemic reactions or health impacts the week following doses 1 and 2 were determined.Findings During the analytic period, 298,792,852 doses of mRNA vaccines were administered in the United States. VAERS processed 340,522 reports; 92·1% were non-serious; 6·6%, serious, non-death; and 1·3%, death. Over half of 7,914,583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose 2. Injection-site pain, fatigue, and headache were commonly reported during days 0–7 following vaccination. Reactogenicity was reported most frequently one day after vaccination; most reactions were mild. More reports of being unable to work or do normal activities occurred after dose 2 (32·1%) than dose 1 (11·9%); <1% of participants reported seeking medical care after vaccination. Rates of deaths reported to VAERS were lower than expected background rates by age group.Interpretation Safety data from >298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the U.S. vaccination program show the majority of reported adverse events were mild and short in duration.Competing Interest StatementDisclosures: Ruiling Liu- Stock or stock options, Johnson &Johnson50 shares of stocks Moderna20 shares of stocks & Spouse works for Ethicon|Johnson & Johnson, on surgery robotics Funding StatementThis study did not receive any funding.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:Both VAERS and v-safe conduct surveillance as a public health function and are exempt from institutional review board review. This analysis was reviewed by the CDC and conducted in accordance with applicable federal law and CDC policy (See: 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C. 552a; 44 U.S.C. 3501 et seq.). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData produced in the present study are available upon reasonable request to the authors |
Seroprevalence of SARS-CoV-2 during pregnancy and associated outcomes: results from an ongoing prospective cohort study, New York City (preprint)
Molenaar NM , Rommel AS , de Witte L , Dolan SM , Lieb W , Ibroci E , Ohrn S , Lynch J , Capuano C , Stadlbauer D , Krammer F , Zapata LB , Brody RI , Rhoda SSperling , Omara Afzal , Mr Roy Missall , Amy Balbierz , Teresa Janevic , Joanne Stone , Elizabeth AHowell , Veerle Bergink . medRxiv 2021 2021.02.01.21250943 Background In May-July 2020 in the New York City area, up to 16% of pregnant women had reportedly been infected with SARS-CoV-2. Prior studies found associations between SARS-CoV-2 infection during pregnancy and certain adverse outcomes (e.g., preterm birth, cesarean delivery). These studies relied on reverse transcription polymerase chain reaction (RT-PCR) testing to establish SARS-CoV-2 infection. This led to overrepresentation of symptomatic or acutely ill cases in scientific studies.Objective To expand our understanding of the effects of SARS-CoV-2 infection during pregnancy on pregnancy outcomes, regardless of symptomatology and stage of infection, by using serological tests to measure IgG antibody levels.Study Design The Generation C Study is an ongoing prospective cohort study conducted at the Mount Sinai Health System. All pregnant women receiving obstetrical care at the Mount Sinai Hospital and Mount Sinai West Hospital from April 20, 2020 onwards are eligible for participation. For the current analysis, we included participants who had given birth to a liveborn singleton infant on or before August 15, 2020. Blood was drawn as part of routine clinical care; for each woman, we tested the latest sample available to establish seropositivity using a SARS-CoV-2 serologic enzyme-linked immunosorbent assay. Additionally, RT-PCR testing was performed on a nasopharyngeal swab taken during labor and delivery. Pregnancy outcomes of interest (i.e., gestational age at delivery, birth weight, mode of delivery, Apgar score, ICU/NICU admission, and neonatal hospital length of stay) and covariates were extracted from electronic medical records. Among all Generation C participants who had given birth by August 15, 2020 (n=708), we established the SARS-CoV-2 seroprevalence. Excluding women who tested RT-PCR positive at delivery, we conducted crude and adjusted linear and logistic regression models to compare antibody positive women without RT-PCR positivity at delivery with antibody negative women without RT-PCR positivity at delivery. We stratified analyses by race/ethnicity to examine potential effect modification.Results The SARS-CoV-2 seroprevalence based on IgG measurement was 16.4% (n=116, 95% CI 13.7-19.3). Twelve women (1.7%) were SARS-CoV-2 RT-PCR positive at delivery (11 of these women were seropositive). Seropositive women were generally younger, more often Black or Hispanic, and more often had public insurance and higher pre-pregnancy BMI compared with seronegative women. SARS-CoV-2 seropositivity without RT-PCR positivity at delivery was associated with decreased odds of caesarean delivery (aOR 0.48, 95%CI 0.27; 0.84) compared with seronegative women without RT-PCR positivity at delivery. Stratified by race/ethnicity, the association between seropositivity and decreased odds of caesarean delivery remained for non-Hispanic Black/African-American and Hispanic women, but not for non-Hispanic White women. No other pregnancy outcomes differed by seropositivity, overall or stratified by race/ethnicity.Conclusion Seropositivity for SARS-CoV-2 without RT-PCR positivity at delivery, suggesting that infection occurred earlier during pregnancy, was not associated with selected adverse maternal or neonatal outcomes among live births in a cohort sample of women from New York City. While non-Hispanic Black and Latina women in our cohort had a higher rate of SARS-CoV-2 seropositivity compared with non-Hispanic White women, we found no increase in adverse maternal or neonatal outcomes among these groups due to infection.Competing Interest StatementMount Sinai has licensed serological assays to commercial entities and has filed for patent protection for serological assays. D.S and F.K. are listed as inventors on the pending patent application. The other authors have nothing to report.Funding StatementThis study is partially funded (contract 75D30120C08186) by the US Centers for Disease Control and Prevention (CDC), who also provided technical assistance related to analysis and interpretation of data and writing the report. The find ngs and conclusions in this report are those of the authors and do not necessarily represent the official position of the CDC. Initial assay development work in the Krammer laboratory was partially supported by the NIAID Centers of Excellence for Influenza Research and Surveillance (CEIRS) contract HHSN272201400008C (FK, for reagent generation), Collaborative Influenza Vaccine Innovation Centers (CIVIC) contract 75N93019C00051 (FK, for reagent generation), and the generous support of the JPB foundation, the Open Philanthropy Project (#2020-215611) and other philanthropic donations. These funding sources were not involved in the current study.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:All participants provided informed consent per the institutional review board (IRB)-approved study protocol (IRB at the Icahn School of Medicine at Mount Sinai, protocol IRB-20-03352, April 15, 2020).All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData not publicly available. Please contact the corresponding author for data requests. |
Utilization of Whole Genome Sequencing to Understand SARS-CoV-2 Transmission Dynamics in Long-Term Care Facilities, Correctional Facilities and Meat Processing Plants in Minnesota, March – June 2020 (preprint)
Lehnertz NB , Wang X , Garfin J , Taylor J , Zipprich J , VonBank B , Martin K , Eikmeier D , Medus C , Wiedinmyer B , Bernu C , Plumb M , Pung K , Honein MA , Carter R , MacCannell D , Smith KE , Como-Sabetti K , Ehresmann K , Danila R , Lynfield R . medRxiv 2021 2020.12.30.20248277 Congregate settings and high-density workplaces have endured a disproportionate impact from COVID-19. In order to provide further understanding of the transmission patterns of SARS-CoV-2 in these settings, whole genome sequencing (WGS) was performed on samples obtained from 8 selected outbreaks in Minnesota from March – June, 2020. WGS and phylogenetic analysis was conducted on 319 samples, constituting 14.4% of the 2,222 total SARS-CoV-2-positive individuals associated with these outbreaks. Among the sequenced specimens, three LTCFs and both correctional facilities had spread associated with a single genetic sequence. A fourth LTCF had outbreak cases associated with two distinct sequences. In contrast, cases associated with outbreaks in the two meat processing plants represented multiple SARS-CoV-2 sequences. These results suggest that a single introduction of SARS-CoV-2 into a facility can result in a widespread outbreak, and early identification and cohorting of cases, along with continued vigilance with infection prevention and control measures is imperative.Competing Interest StatementThe authors have declared no competing interest.Funding StatementStudy was supported by the ELC Cares grant from CDC.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:The manuscript was reviewed in accordance with standard CDC protocol, in which the approved CDC chain of command in the COVID 19 response division reviewed the manuscript and determined that it was non-research, public health response. As such, it was determined by CDC review to be exempt from further institutional review board evaluation. In summary, this manuscript and activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy (see e.g., 45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C 552a; 44 U.S.C. 351 et seq.).All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThere is no referred data. |
Mapping SARS-CoV-2 Antibody Epitopes in COVID-19 Patients with a Multi-Coronavirus Protein Microarray (preprint)
Camerini D , Randall AZ , Trappl-Kimmons K , Oberai A , Hung C , Edgar J , Shandling A , Huynh V , Teng AA , Hermanson G , Pablo JV , Stumpf MM , Lester SN , Harcourt J , Tamin A , Rasheed M , Thornburg NJ , Satheshkumar PS , Liang X , Kennedy RB , Yee A , Townsend M , Campo JJ . medRxiv 2021 2021.01.14.21249690 The emergence and rapid worldwide spread of SARS-CoV-2 has accelerated research and development for controlling the pandemic. A multi-coronavirus protein microarray was created containing full-length proteins, overlapping protein fragments of varying lengths and peptide libraries from SARS-CoV-2 and four other human coronaviruses. Sera from confirmed COVID-19 patients as well as unexposed individuals were applied to multi-coronavirus arrays to identify specific antibody reactivity. High level IgG, IgM and IgA reactivity to structural proteins S, M and N, as well as accessory proteins, of SARS-CoV-2 were observed that was specific to COVID-19 patients. Overlapping 100, 50 and 30 amino acid fragments of SARS-CoV-2 proteins identified antigenic regions. Numerous proteins of SARS-CoV, MERS-CoV and the endemic human coronaviruses, HCoV-NL63 and HCoV-OC43 were also more reactive with IgG, IgM and IgA in COVID-19 patient sera than in unexposed control sera, providing further evidence of immunologic cross-reactivity between these viruses. The multi-coronavirus protein microarray is a useful tool for mapping antibody reactivity in COVID-19 patients.Competing Interest StatementDavid Camerini, Arlo Z. Randall, Amit Oberai, Christopher Hung, Joshua Edgar, Adam Shandling, Vu Huynh, Andy A. Teng, Gary Hermanson, Jozelyn V. Pablo, Xiaowu Liang, Angela Yee and Joseph J. Campo are employees of Antigen Discovery Inc. In addition, Xiaowu Liang and Angela Yee have an equity interest in Antigen Discovery Inc. The other authors declare non competing interests.Funding StatementNo external funding was used in this study.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This study was approved by the Mayo Clinic Human Subjects Institutional Review Board and the Centers for Disease Control and Prevention Human Subjects Office.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.YesAll data are freely available. |
Neutralizing Antibody Response to Pseudotype SARS-CoV-2 Differs between mRNA-1273 and BNT162b2 COVID-19 Vaccines and by History of SARS-CoV-2 Infection (preprint)
Tyner HL , Burgess JL , Grant L , Gaglani M , Kuntz JL , Naleway AL , Thornburg NJ , Caban-Martinez AJ , Yoon SK , Herring MK , Beitel SC , Blanton L , Nikolich-Zugich J , Thiese MS , Pleasants JF , Fowlkes AL , Lutrick K , Dunnigan K , Yoo YM , Rose S , Groom H , Meece J , Wesley MG , Schaefer-Solle N , Louzado-Feliciano P , Edwards LJ , Olsho LEW , Thompson MG . medRxiv 2021 2021.10.20.21265171 Background Data on the development of neutralizing antibodies against SARS-CoV-2 after SARS-CoV-2 infection and after vaccination with messenger RNA (mRNA) COVID-19 vaccines are limited.Methods From a prospective cohort of 3,975 adult essential and frontline workers tested weekly from August, 2020 to March, 2021 for SARS-CoV-2 infection by Reverse Transcription- Polymerase Chain Reaction (RT-PCR) assay irrespective of symptoms, 497 participants had sera drawn after infection (170), vaccination (327), and after both infection and vaccination (50 from the infection population). Serum was collected after infection and each vaccine dose. Serum- neutralizing antibody titers against USA-WA1/2020-spike pseudotype virus were determined by the 50% inhibitory dilution. Geometric mean titers (GMTs) and corresponding fold increases were calculated using t-tests and linear mixed effects models.Results Among 170 unvaccinated participants with SARS-CoV-2 infection, 158 (93%) developed neutralizing antibodies (nAb) with a GMT of 1,003 (95% CI=766-1,315). Among 139 previously uninfected participants, 138 (99%) developed nAb after mRNA vaccine dose-2 with a GMT of 3,257 (95% CI = 2,596-4,052). GMT was higher among those receiving mRNA-1273 vaccine (GMT =4,698, 95%CI= 3,186-6,926) compared to BNT162b2 vaccine (GMT=2,309, 95%CI=1,825-2,919). Among 32 participants with prior SARS-CoV-2 infection, GMT was 21,655 (95%CI=14,766-31,756) after mRNA vaccine dose-1, without further increase after dose- 2.Conclusions A single dose of mRNA vaccine after SARS-CoV-2 infection resulted in the highest observed nAb response. Two doses of mRNA vaccine in previously uninfected participants resulted in higher nAb to SARS-CoV-2 than after one dose of vaccine or SARS- CoV-2 infection alone. Neutralizing antibody response also differed by mRNA vaccine product.Main Point Summary One dose of mRNA COVID-19 vaccine after previous SARS-CoV-2 infection produced the highest neutralizing antibody titers; among those without history of infection, two doses of mRNA vaccine produced the most robust response.Competing Interest StatementAllison Naleway receives research funding from Pfizer and Vir Biotechnology and Jennifer Kuntz receives research funding from Pfizer, Novartis, and Vir Biotechnology for unrelated studies. All other authors: No conflicts. Funding StatementThis work was supported by the Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases [contracts 75D30120R68013 to Marshfield Clinic Research Institute, 75D30120C08379 to the University of Arizona, and 75D30120C08150 to Abt Associates].Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This study is governed by Centers for Disease Control and Prevention IRB review board and gave ethical approval for this work.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesAll data produced in the pres nt work are contained in the manuscript |
Predicting future ocular Chlamydia trachomatis infection prevalence using serological, clinical, molecular, and geospatial data (preprint)
Tedijanto C , Aragie S , Tadesse Z , Haile M , Zeru T , Nash SD , Wittberg DM , Gwyn S , Martin DL , Sturrock HJW , Lietman TM , Keenan JD , Arnold BF . medRxiv 2021 2021.07.19.21260623 Trachoma is an infectious disease characterized by repeated exposures to Chlamydia trachomatis (Ct) that may ultimately lead to blindness. Certain areas, particularly in Africa, pose persistent challenges to elimination of trachoma as a public health problem. Efficiently identifying communities with high infection burden could help target more intensive control efforts. We hypothesized that IgG seroprevalence in combination with geospatial layers, machine learning, and model-based geostatistics would be able to accurately predict future community-level ocular Ct infections detected by PCR. We used measurements from 40 communities in the hyperendemic Amhara region of Ethiopia. Median Ct infection prevalence among children 0-5 years old increased from 6% at enrollment to 29% by month 36. At baseline, correlation between seroprevalence and Ct infection was stronger among children 0-5 years old (ρ = 0.77) than children 6-9 years old (ρ = 0.48), and stronger than the correlation between clinical trachoma and Ct infection (0-5y ρ = 0.56; 6-9y ρ = 0.40). Seroprevalence was the strongest concurrent predictor of infection prevalence at month 36 among children 0-5 years old (cross-validated R2 = 0.75, 95% CI: 0.58-0.85), though predictive performance declined substantially with increasing temporal lag between predictor and outcome measurements. Geospatial variables, a spatial Gaussian process, and stacked ensemble machine learning did not meaningfully improve predictions. Serological markers among children 0-5 years old may be an objective, programmatic tool for identifying communities with high levels of active ocular Ct infections, but accurate, future prediction in the context of changing transmission remains an open challenge.SIGNIFICANCE STATEMENT Trachoma is targeted for elimination as a public health problem by 2030. District-level estimates of clinical disease among children 1-9 years old are currently used to guide control programs and assess elimination. However, clinical trachoma is a subjective indicator. Serological markers present an objective, scalable alternative that could be measured in integrated platforms. In a hyperendemic region, community-level seroprevalence aligned more closely with concurrent infection prevalence than clinical trachoma. The correlation between seroprevalence and infection prevalence was stronger among 0–5-year-olds compared to 6–9-year-olds and was consistent over a three-year period of increasing transmission. Serosurveillance among children 0-5 years old may be a promising monitoring strategy to identify communities with the highest burdens of ocular chlamydial infection.Competing Interest StatementThe authors have declared no competing interest.Clinical TrialNCT02754583Funding StatementWe would like to thank the WUHA study participants and field team without whom this research would not be possible. This work was supported by the National Institute of Allergy and Infectious Diseases (R03 AI147128 to BFA) and the National Eye Institute (U10 EY023939 to JDK). This work was also made possible in part by an Unrestricted Grant from Research to Prevent Blindness. We would also like to thank Abbott for its donation of the m2000 RealTime molecular diagnostics system and consumables.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:Approval for the study was obtained from the University of California, San Francisco Institutional Review Board (14-14004).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.YesDe-identified data and code to replicate this work is available on Github. https://github.com/ctedijanto/swift-spatial-prediction |
Effectiveness of Influenza Vaccines in the HIVE household cohort over 8 years: is there evidence of indirect protection? (preprint)
Malosh RE , Petrie JG , Callear A , Truscon R , Johnson E , Evans R , Bazzi L , Cheng C , Thompson MS , Martin ET , Monto AS . medRxiv 2021 2021.02.16.21251827 Background The evidence that influenza vaccination programs regularly provide protection to unvaccinated individuals (i.e. indirect effects) of a community is lacking. We sought to determine the direct, indirect, and total effects of influenza vaccine in the Household Influenza Vaccine Evaluation (HIVE) cohort.Methods Using longitudinal data from the HIVE cohort from 2010-11 through 2017-18, we estimated direct, indirect, and total influenza vaccine effectiveness (VE) and the incidence rate ratio of influenza virus infection using adjusted mixed-effect Poisson regression models. Total effectiveness was determined through comparison of vaccinated members of full or partially vaccinated households to unvaccinated individuals in completely unvaccinated households.Results The pooled, direct VE against any influenza was 30.2% (14.0-43.4). Direct VE was higher for influenza A/H1N1 43.9% (3.9 to 63.5) and B 46.7% (17.2 to 57.5) than A/H3N2 31.7% (10.5 to 47.8); and was higher for young children 42.4% (10.1 to 63.0) than adults 18.6% (−6.3 to 37.7). Influenza incidence was highest in completely unvaccinated households (10.6 per 100 person-seasons) and lower at all other levels of household vaccine coverage. We found little evidence of indirect VE after adjusting for potential confounders. Total VET was 56.4% (30.1-72.9) in low coverage, 43.2% (19.5-59.9) in moderate coverage, and 33.0% (12.1 to 49.0) in fully vaccinated households.Conclusion Influenza vaccines may have a benefit above and beyond the direct effect but that effect in this study was small. While there may be exceptions, the goal of global vaccine recommendations should remain focused on provision of documented, direct protection to those vaccinated.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was funded by the National Institute of Allergy and Infectious Disease (R03AI137658). The HIVE Study was further supported by the Centers for Disease Control and Prevention (U01 IP000170, U01 IP000474) and the National Institute of Allergy and Infectious Diseases (R01 AI097150, R56 AI097150).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:The HIVE study is approved by the institutional review board at the University of Michigan Medical School.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.YesThe data included in this analysis are available from the corresponding author on reasonable request. |
Emergence and evolution of Plasmodium falciparum histidine-rich protein 2 and 3 deletion mutant parasites in Ethiopia (preprint)
Feleke SM , Reichert EN , Mohammed H , Brhane BG , Mekete K , Mamo H , Petros B , Solomon H , Abate E , Hennelly C , Denton M , Keeler C , Hathaway NJ , Juliano JJ , Bailey JA , Rogier E , Cunningham J , Aydemir O , Parr JB . medRxiv 2021 2021.01.26.21250503 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. |
Estimating the contribution of HIV-infected adults to household pneumococcal transmission in South Africa, 2016-2018: A hidden Markov modelling study (preprint)
Thindwa D , Wolter N , Pinsent A , Carrim M , Ojal J , Tempia S , Moyes J , McMorrow M , Kleynhans J , Gottberg AV , French N , Cohen C , Flasche S . medRxiv 2021 2021.05.21.21257622 Human immunodeficiency virus (HIV) infected adults are at a higher risk of pneumococcal colonisation and disease, even while receiving antiretroviral therapy (ART). To help evaluate potential indirect effects of vaccination of HIV-infected adults, we assessed whether HIV-infected adults disproportionately contribute to household transmission of pneumococci. We constructed a hidden Markov model to capture the dynamics of pneumococcal carriage acquisition and clearance observed during a longitudinal household-based nasopharyngeal swabbing study, while accounting for sample misclassifications. Households were followed-up twice weekly for 10 months for nasopharyngeal carriage detection via real-time PCR. We estimated the effect of participant’s age, HIV status, presence of a HIV-infected adult within the household and other covariates on pneumococcal acquisition and clearance probabilities. Of 1,684 individuals enrolled, 279 (16.6%) were younger children (<5 years-old) of whom 4 (1.5%) were HIV-infected and 726 (43.1%) were adults (≥18 years-old) of whom 214 (30.4%) were HIV-infected, most (173, 81.2%) with high CD4+ count. The observed range of pneumococcal carriage prevalence across visits was substantially higher in younger children (56.9-80.5%) than older children (5-17 years-old) (31.7-50.0%) or adults (11.5-23.5%). We estimate that 14.4% (95% Confidence Interval [CI]: 13.7-15.0) of pneumococcal-negative swabs were false negatives. Daily carriage acquisition probabilities among HIV-uninfected younger children were similar in households with and without HIV-infected adults (hazard ratio: 0.95, 95%CI: 0.91-1.01). Longer average carriage duration (11.4 days, 95%CI: 10.2-12.8 vs 6.0 days, 95%CI: 5.6 - 6.3) and higher median carriage density (622 genome equivalents per millilitre, 95%CI: 507-714 vs 389, 95%CI: 311.1-435.5) were estimated in HIV-infected vs HIV-uninfected adults. The use of ART and antibiotics substantially reduced carriage duration in all age groups, and acquisition rates increased with household size. Although South African HIV-infected adults on ART have longer carriage duration and density than their HIV-uninfected counterparts, they show similar patterns of pneumococcal acquisition and onward transmission.Author summary We assessed the contribution of HIV-infected adults to household pneumococcal transmission by applying a hidden Markov model to pneumococcal cohort data comprising 115,595 nasopharyngeal samples from 1,684 individuals in rural and urban settings in South Africa. We estimated 14.4% of sample misclassifications (false negatives), representing 85.6% sensitivity of a test that was used to detect pneumococcus. Pneumococcal carriage prevalence and acquisition rates, and average duration were usually higher in younger or older children than adults. The use of ART and antibiotics reduced the average carriage duration across all age and HIV groups, and carriage acquisition risks increased in larger household sizes. Despite the longer average carriage duration and higher median carriage density in HIV-infected than HIV-uninfected adults, we found similar carriage acquisition and onward transmission risks in the dual groups. These findings suggest that vaccinating HIV-infected adults on ART with PCV would reduce their risk for pneumococcal disease but may add little to the indirect protection against carriage of the rest of the population.Competing Interest StatementThe authors have declared no competing interest.Clinical TrialNCT02519803Clinical Protocols https://www.medrxiv.org/content/10.1101/2021.01.06.21249313v1.full.pdf Funding StatementThis research was commissioned by the National Institute for Health Research (NIHR) Global Health Research Unit on Mucosal Pathogens under the UK Government. PHIRST study was funded by a cooperative agreement with the United States Centers for Disease Control and Prevention (grant number 1U01IP001048) (https://www.cdc.gov) and the Bill and Melinda Gates Foundation (Grant number: OPP1164778) (https://www.gatesfoundation.org). DT, OJ are supported by th National Institute for Health Research (NIHR) Global Health Research Unit on Mucosal Pathogens (MPRU) using UK aid from the UK Government (16/136/46) (https://www.mpru.org). AP is supported by the Bill and Melinda Gates Foundation (https://www.gatesfoundation.org). SF is supported by a Sir Henry Dale Fellowship jointly funded by the Wellcome Trust and the Royal Society (Grant number 208812/Z/17/Z) (https://wellcome.org). CC and AvG receive grant support through their institution from Sanofi Pasteur (https://www.sanofi.com/en). The funders had no involvement in the study design; collection, analysis and interpretation of data; writing of the report; or decision to submit the article for publication.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:The longitudinal pneumococcal carriage data described in this study were obtained from consenting South African children and adults as part of the PHIRST study. The use of data was granted by the University of Witwatersrand, Human Research Ethics Committee (HREC) and the Protocol Review Committee (PRC) under approval 150808, the US CDC Institutional Review Board relied on the local review (6840), and the London School of Hygiene and Tropical Medicine Observational Research Ethics Committee under approval 17902.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData cannot be shared publicly because of confidentiality. Data are available from the National Institute of Communicable Disease (NICD) if authorised by Institutional Data Access / Ethics Committee (contact via Professor Cherly Cohen, cherylc@nicd.ac.za) for researchers who meet the criteria for access to confidential data. The code underlying the results presented in the study are available from GitHub through the following link (https://github.com/deusthindwa/hmm.pneumococcus.hiv.south-africa) or contact Deus Thindwa through email: deus.thindwa@gmail.com |
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