Last data update: May 06, 2024. (Total: 46732 publications since 2009)
Records 1-20 (of 20 Records) |
Query Trace: Sparks C[original query] |
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Racial and ethnic disparities in phthalate exposure and preterm birth: A pooled study of sixteen U.S. Cohorts
Welch BM , Keil AP , Buckley JP , Engel SM , James-Todd T , Zota AR , Alshawabkeh AN , Barrett ES , Bloom MS , Bush NR , Cordero JF , Dabelea D , Eskenazi B , Lanphear BP , Padmanabhan V , Sathyanarayana S , Swan SH , Aalborg J , Baird DD , Binder AM , Bradman A , Braun JM , Calafat AM , Cantonwine DE , Christenbury KE , Factor-Litvak P , Harley KG , Hauser R , Herbstman JB , Hertz-Picciotto I , Holland N , Jukic AMZ , McElrath TF , Meeker JD , Messerlian C , Michels KB , Newman RB , Nguyen RHN , O'Brien KM , Rauh VA , Redmon B , Rich DQ , Rosen EM , Schmidt RJ , Sparks AE , Starling AP , Wang C , Watkins DJ , Weinberg CR , Weinberger B , Wenzel AG , Wilcox AJ , Yolton K , Zhang Y , Ferguson KK . Environ Health Perspect 2023 131 (12) 127015 BACKGROUND: Phthalate exposures are ubiquitous during pregnancy and may contribute to racial and ethnic disparities in preterm birth. OBJECTIVES: We investigated race and ethnicity in the relationship between biomarkers of phthalate exposure and preterm birth by examining: a) how hypothetical reductions in racial and ethnic disparities in phthalate metabolites might reduce the probability of preterm birth; and b) exposure-response models stratified by race and ethnicity. METHODS: We pooled individual-level data on 6,045 pregnancies from 16 U.S. cohorts. We investigated covariate-adjusted differences in nine urinary phthalate metabolite concentrations by race and ethnicity [non-Hispanic White (White, 43%), non-Hispanic Black (Black, 13%), Hispanic/Latina (38%), and Asian/Pacific Islander (3%)]. Using g-computation, we estimated changes in the probability of preterm birth under hypothetical interventions to eliminate disparities in levels of urinary phthalate metabolites by proportionally lowering average concentrations in Black and Hispanic/Latina participants to be approximately equal to the averages in White participants. We also used race and ethnicity-stratified logistic regression to characterize associations between phthalate metabolites and preterm birth. RESULTS: In comparison with concentrations among White participants, adjusted mean phthalate metabolite concentrations were consistently higher among Black and Hispanic/Latina participants by 23%-148% and 4%-94%, respectively. Asian/Pacific Islander participants had metabolite levels that were similar to those of White participants. Hypothetical interventions to reduce disparities in metabolite mixtures were associated with lower probabilities of preterm birth for Black [13% relative reduction; 95% confidence interval (CI): - 34%, 8.6%] and Hispanic/Latina (9% relative reduction; 95% CI: - 19%, 0.8%) participants. Odds ratios for preterm birth in association with phthalate metabolites demonstrated heterogeneity by race and ethnicity for two individual metabolites (mono-n-butyl and monoisobutyl phthalate), with positive associations that were larger in magnitude observed among Black or Hispanic/Latina participants. CONCLUSIONS: Phthalate metabolite concentrations differed substantially by race and ethnicity. Our results show hypothetical interventions to reduce population-level racial and ethnic disparities in biomarkers of phthalate exposure could potentially reduce the probability of preterm birth. https://doi.org/10.1289/EHP12831. |
Development and validation of a risk model for hospital-acquired venous thrombosis: The Medical Inpatients Thrombosis and Hemostasis (MITH) Study
Zakai NA , Wilkinson K , Sparks AD , Packer RT , Koh I , Roetker NS , Repp AB , Thomas R , Holmes CE , Cushman M , Plante TB , Al-Samkari H , Pishko AM , Wood WA , Masias C , Gangaraju R , Li A , Garcia D , Wiggins KL , Schaefer JK , Hooper C , Smith NL , McClure LA . J Thromb Haemost 2023 BACKGROUND: Regulatory organizations recommend assessing hospital-acquired (HA) venous thromboembolism (VTE) risk for medical inpatients. OBJECTIVES: To develop and validate a risk assessment model (RAM) for HA-VTE in medical inpatients using objective and assessable risk factors knowable at admission. PATIENTS/METHODS: The development cohort included people admitted to medical services at the University of Vermont Medical Center (Burlington, VT, USA) between 2010-19 and the validation cohorts people admitted to Hennepin County Medical Center (Minneapolis, MN, USA), University of Michigan Medical Center (Ann Arbor, MI, USA), and Harris Health Systems (Houston, TX, USA). Individuals with VTE at admission, <18-years old, and admitted for <1 midnight were excluded. We used a Bayesian penalized regression technique to selected candidate HA-VTE risk factors for final inclusion in the RAM. RESULTS: The development cohort included 60,633 admissions and 227 HA-VTE and the validation cohorts 111,269 admissions and 651 HA-VTE. Seven HA-VTE risk factors with t-statistics ≥1.5 were included in the RAM: prior history of VTE, low hemoglobin, elevated creatinine, active cancer, hyponatremia, elevated red cell distribution width, and malnutrition. The AUC and calibration slope were 0.72 and 1.10. The AUC and calibration slopes were 0.70 and 0.93 at Hennepin County Medical Center, 0.70 and 0.87 at the University of Michigan Medical Center, and 0.71 and 1.00 at Harris Health Systems. The RAM performed well stratified by age, sex, and race. CONCLUSIONS: We developed and validated a RAM for HA-VTE in medical inpatients. By quantifying risk, clinicians can determine the potential benefits of measures to reduce HA-VTE. |
Associations between prenatal urinary biomarkers of phthalate exposure and preterm birth: A pooled study of 16 US cohorts
Welch BM , Keil AP , Buckley JP , Calafat AM , Christenbury KE , Engel SM , O'Brien KM , Rosen EM , James-Todd T , Zota AR , Ferguson KK , Alshawabkeh AN , Cordero JF , Meeker JD , Barrett ES , Bush NR , Nguyen RHN , Sathyanarayana S , Swan SH , Cantonwine DE , McElrath TF , Aalborg J , Dabelea D , Starling AP , Hauser R , Messerlian C , Zhang Y , Bradman A , Eskenazi B , Harley KG , Holland N , Bloom MS , Newman RB , Wenzel AG , Braun JM , Lanphear BP , Yolton K , Factor-Litvak P , Herbstman JB , Rauh VA , Drobnis EZ , Sparks AE , Redmon JB , Wang C , Binder AM , Michels KB , Baird DD , Jukic AMZ , Weinberg CR , Wilcox AJ , Rich DQ , Weinberger B , Padmanabhan V , Watkins DJ , Hertz-Picciotto I , Schmidt RJ . JAMA Pediatr 2022 176 (9) 895-905 IMPORTANCE: Phthalate exposure is widespread among pregnant women and may be a risk factor for preterm birth. OBJECTIVE: To investigate the prospective association between urinary biomarkers of phthalates in pregnancy and preterm birth among individuals living in the US. DESIGN, SETTING, AND PARTICIPANTS: Individual-level data were pooled from 16 preconception and pregnancy studies conducted in the US. Pregnant individuals who delivered between 1983 and 2018 and provided 1 or more urine samples during pregnancy were included. EXPOSURES: Urinary phthalate metabolites were quantified as biomarkers of phthalate exposure. Concentrations of 11 phthalate metabolites were standardized for urine dilution and mean repeated measurements across pregnancy were calculated. MAIN OUTCOMES AND MEASURES: Logistic regression models were used to examine the association between each phthalate metabolite with the odds of preterm birth, defined as less than 37 weeks of gestation at delivery (n=539). Models pooled data using fixed effects and adjusted for maternal age, race and ethnicity, education, and prepregnancy body mass index. The association between the overall mixture of phthalate metabolites and preterm birth was also examined with logistic regression. G-computation, which requires certain assumptions to be considered causal, was used to estimate the association with hypothetical interventions to reduce the mixture concentrations on preterm birth. RESULTS: The final analytic sample included 6045 participants (mean [SD] age, 29.1 [6.1] years). Overall, 802 individuals (13.3%) were Black, 2323 (38.4%) were Hispanic/Latina, 2576 (42.6%) were White, and 328 (5.4%) had other race and ethnicity (including American Indian/Alaskan Native, Native Hawaiian, >1 racial identity, or reported as other). Most phthalate metabolites were detected in more than 96% of participants. Higher odds of preterm birth, ranging from 12% to 16%, were observed in association with an interquartile range increase in urinary concentrations of mono-n-butyl phthalate (odds ratio [OR], 1.12 [95% CI, 0.98-1.27]), mono-isobutyl phthalate (OR, 1.16 [95% CI, 1.00-1.34]), mono(2-ethyl-5-carboxypentyl) phthalate (OR, 1.16 [95% CI, 1.00-1.34]), and mono(3-carboxypropyl) phthalate (OR, 1.14 [95% CI, 1.01-1.29]). Among approximately 90 preterm births per 1000 live births in this study population, hypothetical interventions to reduce the mixture of phthalate metabolite levels by 10%, 30%, and 50% were estimated to prevent 1.8 (95% CI, 0.5-3.1), 5.9 (95% CI, 1.7-9.9), and 11.1 (95% CI, 3.6-18.3) preterm births, respectively. CONCLUSIONS AND RELEVANCE: Results from this large US study population suggest that phthalate exposure during pregnancy may be a preventable risk factor for preterm delivery. |
2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis
Fraenkel L , Bathon JM , England BR , St Clair EW , Arayssi T , Carandang K , Deane KD , Genovese M , Huston KK , Kerr G , Kremer J , Nakamura MC , Russell LA , Singh JA , Smith BJ , Sparks JA , Venkatachalam S , Weinblatt ME , Al-Gibbawi M , Baker JF , Barbour KE , Barton JL , Cappelli L , Chamseddine F , George M , Johnson SR , Kahale L , Karam BS , Khamis AM , Navarro-Millán I , Mirza R , Schwab P , Singh N , Turgunbaev M , Turner AS , Yaacoub S , Akl EA . Arthritis Care Res (Hoboken) 2021 73 (7) 924-939 OBJECTIVE: To develop updated guidelines for the pharmacologic management of rheumatoid arthritis. METHODS: We developed clinically relevant population, intervention, comparator, and outcomes (PICO) questions. After conducting a systematic literature review, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A voting panel comprising clinicians and patients achieved consensus on the direction (for or against) and strength (strong or conditional) of recommendations. RESULTS: The guideline addresses treatment with disease-modifying antirheumatic drugs (DMARDs), including conventional synthetic DMARDs, biologic DMARDs, and targeted synthetic DMARDs, use of glucocorticoids, and use of DMARDs in certain high-risk populations (i.e., those with liver disease, heart failure, lymphoproliferative disorders, previous serious infections, and nontuberculous mycobacterial lung disease). The guideline includes 44 recommendations (7 strong and 37 conditional). CONCLUSION: This clinical practice guideline is intended to serve as a tool to support clinician and patient decision-making. Recommendations are not prescriptive, and individual treatment decisions should be made through a shared decision-making process based on patients' values, goals, preferences, and comorbidities. |
Notes from the field: Hantavirus pulmonary syndrome - Denver, Colorado, 2018
Tobolowsky F , Burakoff A , House J , Marzec N , Neumeier A , Sparks P , McLees M . MMWR Morb Mortal Wkly Rep 2019 68 (35) 771-772 On February 16, 2018, a previously healthy woman aged 47 years sought treatment at the emergency department of a hospital in Denver, Colorado, for acute onset of chest pain, shortness of breath, tachypnea, fever (103.9°F [40.0°C]), and hypoxemia. Five days earlier, she had developed fever, nausea, vomiting, muscle pains, and diarrhea, associated with progressive dyspnea. A chest radiograph at admission revealed interstitial markings bilaterally. Twelve hours after arrival she was intubated and mechanically ventilated and transferred to the intensive care unit for management of hypoxic respiratory failure, disseminated intravascular coagulation, and shock. The patient had thrombocytopenia, hemoconcentration, and elevated liver enzymes. She was initially treated with broad-spectrum antimicrobials and supportive care. Because the patient had clinically compatible symptoms and suggestive laboratory findings for hantavirus infection, on hospital day 3, specimens were collected and sent for testing. On hospital day 11, results of a hantavirus enzyme-linked immunosorbent assay by a commercial laboratory were positive for antihantavirus immunoglobulin G (IgG) and IgM. Serologic testing for Sin Nombre virus, performed by the Colorado Department of Public Health and Environment Laboratory, was positive for IgM and negative for IgG, consistent with acute Sin Nombre virus infection. Hantavirus pulmonary syndrome was confirmed, and antibiotics were stopped; the patient recovered after a 13-day hospitalization. |
Nano-metal oxides: Exposure and engineering control assessment
Garcia A , Eastlake A , Topmiller JL , Sparks C , Martinez K , Geraci CL . J Occup Environ Hyg 2017 14 (9) 0 In January 2007, the National Institute for Occupational Safety and Health (NIOSH) conducted a field study to evaluate process specific emissions during the production of ENMs. This study was performed using the nanoparticle emission assessment technique (NEAT). During this study, it was determined that ENMs were released during production and cleaning of the process reactor. Airborne concentrations of silver, nickel, and iron were found both in the employee's personal breathing zone and area samples during reactor cleaning. At the completion of this initial survey, it was suggested that a flanged attachment be added to the local exhaust ventilation system. NIOSH re-evaluated the facility in December 2011 to assess worker exposures following an increase in production rates. This study included a fully comprehensive emissions, exposure, and engineering control evaluation of the entire process. This study made use of the nanoparticle exposure assessment technique (NEAT 2.0). Data obtained from filter-based samples and direct reading instruments indicate that reactor cleanout increased the overall particle concentration in the immediate area. However, it does not appear that these concentrations affect areas outside of the production floor. As the distance between the reactor and the sample location increased, the observed particle number concentration decreased, creating a concentration gradient with respect to the reactor. The results of this study confirm that the flanged attachment on the local exhaust ventilation system served to decrease exposure potential. Given the available toxicological data of the metals evaluated, caution is warranted. One should always keep in mind that occupational exposure levels were not developed specifically for nanoscale particles. With data suggesting that certain nanoparticles may be more toxic than the larger counterparts of the same material; employers should attempt to control emissions of these particles at the source, to limit the potential for exposure. |
Refinement of the nanoparticle emission assessment technique into the Nanomaterial Exposure Assessment Technique (NEAT 2.0)
Eastlake AC , Beaucham C , Martinez KF , Dahm MM , Sparks C , Hodson LL , Geraci CL . J Occup Environ Hyg 2016 13 (9) 0 Engineered nanomaterial emission and exposure characterization studies have been completed at more than 60 different facilities by the National Institute for Occupational Safety and Health (NIOSH). These experiences have provided NIOSH the opportunity to refine an earlier published technique, the Nanoparticle Emission Assessment Technique (NEAT 1.0), into a more comprehensive technique for assessing worker and workplace exposures to engineered nanomaterials. This change is reflected in the new name Nanomaterial Exposure Assessment Technique (NEAT 2.0) which distinguishes it from NEAT 1.0. NEAT 2.0 places a stronger emphasis on time-integrated, filter-based sampling (i.e., elemental mass analysis and particle morphology) in the worker's breathing zone (full shift and task specific) and area samples to develop job exposure matrices. NEAT 2.0 includes a comprehensive assessment of emissions at processes and job tasks, using direct-reading instruments (i.e., particle counters) in data-logging mode to better understand peak emission periods. Evaluation of worker practices, ventilation efficacy, and other engineering exposure control systems and risk management strategies serve to allow for a comprehensive exposure assessment. |
Prothrombin G20210A mutation is associated with young-onset stroke: the genetics of early-onset stroke study and meta-analysis.
Jiang B , Ryan KA , Hamedani A , Cheng Y , Sparks MJ , Koontz D , Bean CJ , Gallagher M , Hooper WC , McArdle PF , O'Connell JR , Stine OC , Wozniak MA , Stern BJ , Mitchell BD , Kittner SJ , Cole JW . Stroke 2014 45 (4) 961-7 BACKGROUND AND PURPOSE: Although the prothrombin G20210A mutation has been implicated as a risk factor for venous thrombosis, its role in arterial ischemic stroke is unclear, particularly among young adults. To address this issue, we examined the association between prothrombin G20210A and ischemic stroke in a white case-control population and additionally performed a meta-analysis. METHODS: From the population-based Genetics of Early Onset Stroke (GEOS) study, we identified 397 individuals of European ancestry aged 15 to 49 years with first-ever ischemic stroke and 426 matched controls. Logistic regression was used to calculate odds ratios (ORs) in the entire population and for subgroups stratified by sex, age, oral contraceptive use, migraine, and smoking status. A meta-analysis of 17 case-control studies (n=2305 cases <55 years) was also performed with and without GEOS data. RESULTS: Within GEOS, the association of the prothrombin G20210A mutation with ischemic stroke did not achieve statistical significance (OR=2.5; 95% confidence interval [CI]=0.9-6.5; P=0.07). However, among adults aged 15 to 42 years (younger than median age), cases were significantly more likely than controls to have the mutation (OR=5.9; 95% CI=1.2-28.1; P=0.03), whereas adults aged 42 to 49 years were not (OR=1.4; 95% CI=0.4-5.1; P=0.94). In our meta-analysis, the mutation was associated with significantly increased stroke risk in adults ≤55 years (OR=1.4; 95% CI=1.1-1.9; P=0.02), with significance increasing with addition of the GEOS results (OR=1.5; 95% CI=1.1-2.0; P=0.005). CONCLUSIONS: The prothrombin G20210A mutation is associated with ischemic stroke in young adults and may have an even stronger association among those with earlier onset strokes. Our finding of a stronger association in the younger young adult population requires replication. |
Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccination
Pahud BA , Williams SE , Dekker CL , Halsey N , Larussa P , Baxter RP , Klein NP , Marchant CD , Sparks RC , Jakob K , Aukes L , Swope S , Barnett E , Lewis P , Berger M , Dreskin SC , Donofrio PD , Sejvar JJ , Slade BA , Gidudu J , Vellozzi C , Edwards KM . Pediatr Infect Dis J 2013 32 (2) 163-168 BACKGROUND: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between 2009 and 2013. METHODS: Vaccine Adverse Event Reporting System received reports of adverse events following immunization (AEFI) after H1N1 vaccination. Selected reports were referred to the Centers for Disease Control and Prevention's Clinical Immunization Safety Assessment network for additional review. We assessed causality using modified World Health Organization criteria. RESULTS: There were 3,928 reports of AEFI in children younger than age 18 years after 2009 H1N1 vaccination received by January 31, 2010. Of these, 214 (5.4%) were classified as serious nonfatal and 109 were referred to Clinical Immunization Safety Assessment for further evaluation. Ninety-nine (91%) had sufficient initial information to begin investigation and are described here. The mean age was 8 years (range, 6 months-17 years) and 38% were female. Median number of days between vaccination and symptom onset was 2 (range, -11 days to +41 days). Receipt of inactivated, live attenuated, or unknown type of 2009 H1N1 vaccines was reported by 68, 26 and 5 cases, respectively. Serious AEFI were categorized as neurologic events in 47 cases, as hypersensitivity in 15 cases and as respiratory events in 10 cases. At the time of evaluation, recovery was described as complete (61), partial (16), no improvement (1), or unknown (21). Causality assessment yielded the following likelihood of association with 2009 H1N1 vaccination: 8 definitely; 8 probably; 21 possibly; 43 unlikely; 17 unrelated; and 2 unclassifiable. CONCLUSIONS: Most AEFI in children evaluated were not causally related to vaccine and resolved without sequelae. Detailed clinical assessment of individual serious AEFI can provide reassurance of vaccine safety. |
Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)
Loughlin AM , Marchant CD , Adams W , Barnett E , Baxter R , Black S , Casey C , Dekker C , Edwards KM , Klein J , Klein NP , Larussa P , Sparks R , Jakob K . Vaccine 2012 30 (50) 7253-9 Adverse events following immunization (AEFI) reported to the national Vaccine Adverse Event Reporting System (VAERS) represent true causally related events, as well as events that are temporally, but not necessarily causally related to vaccine. OBJECTIVE: We sought to determine if the causal relationships between the vaccine and the AEFI reported to VAERS could be assessed through expert review. DESIGN: A stratified random sample of 100 VAERS reports received in 2004 contained 13 fatal cases, 19 cases with non-fatal disabilities, 39 other serious non-fatal cases and 29 non-serious cases. Experts knowledgeable about vaccines and clinical outcomes, reviewed each VAERS report and available medical records. MAIN OUTCOME MEASURES: Modified World Health Organization criteria were used to classify the causal relationship between vaccines and AEFI as definite, probable, possible, unlikely or unrelated. Five independent reviewers evaluated each report. If they did not reach a majority agreement on causality after initial review, the report was discussed on a telephone conference to achieve agreement. RESULTS: 108 AEFIs were identified in the selected 100 VAERS reports. After initial review majority agreement was achieved for 83% of the AEFI and 17% required further discussion. In the end, only 3 (3%) of the AEFI were classified as definitely causally related to vaccine received. Of the remaining AEFI 22 (20%) were classified as probably and 22 (20%) were classified as possibly related to vaccine received; a majority (53%) were classified as either unlikely or unrelated to a vaccine received. CONCLUSIONS: Using VAERS reports and additional documentation, causality could be assessed by expert review in the majority of VAERS reports. Assessment of VAERS reports identified that causality was thought to be probable or definite in less than one quarter of reports, and these were dominated by local reactions, allergic reactions, or symptoms known to be associated with the vaccine administered. |
Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination
Williams SE , Pahud BA , Vellozzi C , Donofrio PD , Dekker CL , Halsey N , Klein NP , Baxter RP , Marchant CD , Larussa PS , Barnett ED , Tokars JI , McGeeney BE , Sparks RC , Aukes LL , Jakob K , Coronel S , Sejvar JJ , Slade BA , Edwards KM . Vaccine 2011 29 (46) 8302-8 BACKGROUND: Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009-2010 influenza season. Investigators in the Clinical Immunization Safety Assessment (CISA) network sought to characterize these SAEs and to assess their possible causal relationship to vaccination. METHODS: Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) physicians reviewed all SAE reports (as defined by the Code of Federal Regulations, 21CFR section 314.80) after receipt of H1N1 vaccine reported to VAERS between October 1, 2009 and March 31, 2010. Non-fatal SAE reports with neurologic presentation were referred to CISA investigators, who requested and reviewed additional medical records and clinical information as available. CISA investigators assessed the causal relationship between vaccination and the event using modified WHO criteria as defined. RESULTS: 212 VAERS reports of non-fatal serious neurological events were referred for CISA review. Case reports were equally distributed by gender (50.9% female) with an age range of 6 months to 83 years (median 38 years). The most frequent diagnoses reviewed were: Guillain-Barre Syndrome (37.3%), seizures (10.8%), cranial neuropathy (5.7%), and acute disseminated encephalomyelitis (3.8%). Causality assessment resulted in classification of 72 events as "possibly" related (33%), 108 as "unlikely" related (51%), and 20 as "unrelated" (9%) to H1N1 vaccination; none were classified as "probable" or "definite" and 12 were unclassifiable (6%). CONCLUSION: The absence of a specific test to indicate whether a vaccine component contributes to the pathogenesis of an event occurring within a biologically plausible time period makes assessing causality difficult. The development of standardized protocols for providers to use in evaluation of adverse events following immunization, and rapid identification and follow-up of VAERS reports could improve causality assessment. |
Overview of the Clinical Consult Case Review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004-2009
Williams SE , Klein NP , Halsey N , Dekker CL , Baxter RP , Marchant CD , Larussa PS , Sparks RC , Tokars JI , Pahud BA , Aukes L , Jakob K , Coronel S , Choi H , Slade BA , Edwards KM . Vaccine 2011 29 (40) 6920-7 BACKGROUND: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). METHODS: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. RESULTS: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. CONCLUSIONS: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations. |
Novel multitarget real-time PCR assay for rapid detection of Bordetella species in clinical specimens.
Tatti KM , Sparks KN , Boney KO , Tondella ML . J Clin Microbiol 2011 49 (12) 4059-66 A novel multi-target real-time PCR (R-PCR) assay for the rapid identification and speciation of Bordetella pertussis, B. parapertussis, and B. holmesii was developed using multi-copy insertion sequences (IS) in combination with the pertussis toxin subunit S1 (ptxS1) singleplex assay. The R-PCR targets for the multiplex assay include IS481 commonly found in B. pertussis and B. holmesii, IS1001 of B. parapertussis, and the IS1001-like sequence of B. holmesii. Overall, 402 Bordetella spp. and 66 non-Bordetella spp. isolates were tested in the multi-target assay. Cross-reactivity was found only with 5 B. bronchiseptica isolates which were positive with IS1001 of B. parapertussis. The lower limit of detection (LLOD) of the multiplex assay was similar to the LLOD of each target in an individual assay format which was approximately 1 genomic equivalent per reaction for all targets. A total of 197 human clinical specimens obtained during cough-illness outbreak investigations were used to evaluate the multi-target R-PCR assay. The multiplex assay results from 87 clinical specimens were compared to the individual R-PCR assays and culture. The multi-target assay is useful as a diagnostic tool to confirm B. pertussis infections and to rapidly identify other Bordetella species. In conclusion, the use of this multi-target R-PCR approach increases specificity, while decreasing the amount of time, reagents, and specimen necessary for R-PCR reactions used for accurate diagnosis of pertussis-like illness. |
Sensitization and chronic beryllium disease at a primary manufacturing facility, part 3: exposure-response among short-term workers
Schuler CR , Virji MA , Deubner DC , Stanton ML , Stefaniak AB , Day GA , Park JY , Kent MS , Sparks R , Kreiss K . Scand J Work Environ Health 2011 38 (3) 270-81 OBJECTIVES: Exposure-response relations for beryllium sensitization (BeS) and chronic beryllium disease (CBD) using aerosol mass concentration have been inconsistent, although process-related risks found in most studies suggest that exposure-dependent risks exist. We examined exposure-response relations using personal exposure estimates in a beryllium worker cohort with limited work tenure to minimize exposure misclassification. METHODS: The population comprised workers employed in 1999 with six years or less tenure. Each completed a work history questionnaire and was evaluated for immunological sensitization and CBD. A job-exposure matrix was combined with work histories to create individual estimates of average, cumulative, and highest-job-worked exposure for total, respirable, and submicron beryllium mass concentrations. We obtained odds ratios from logistic regression models for exposure-response relations, and evaluated process-related risks. RESULTS: Participation was 90.7% (264/291 eligible). Sensitization prevalence was 9.8% (26/264), with 6 sensitized also diagnosed with CBD (2.3%, 6/264). A general pattern of increasing sensitization prevalence was observed as exposure quartile increased. Both total and respirable beryllium mass concentration estimates were positively associated with sensitization (average and highest job), and CBD (cumulative). Increased sensitization prevalence was identified in metal/oxide production, alloy melting and casting, and maintenance, and for CBD in melting and casting. Lower sensitization prevalence was observed in plant-area administrative work. CONCLUSIONS: Sensitization was associated with average and highest job exposures, and CBD was associated with cumulative exposure. Both total and respirable mass concentrations were relevant predictors of risk. New process-related risks were identified in melting and casting and maintenance. |
Associations between urinary metabolites of di(2-ethylhexyl) phthalate and reproductive hormones in fertile men
Mendiola J , Jorgensen N , Andersson AM , Calafat AM , Silva MJ , Redmon JB , Sparks A , Drobnis EZ , Wang C , Liu F , Swan SH . Int J Androl 2011 34 369-378 Widely used man-made chemicals, including phthalates, can induce hormonal alterations through a variety of cellular and molecular mechanisms. A number of rodent and observational studies have consistently demonstrated the anti-androgenic effect of several phthalates. However, there are only limited data on the relationship between exposure to these chemicals and reproductive hormone levels in men. All men (n = 425) were partners of pregnant women who participated in the Study for Future Families in five US cities and provided urine and serum samples on the same day. Eleven phthalate metabolites were measured in urine and serum samples were analysed for reproductive hormones, including follicle-stimulating hormone, luteinizing hormone, testosterone, inhibin B and oestradiol and sex hormone-binding globulin (SHBG). Pearson correlations and parametric tests were used for unadjusted analyses, and multiple linear regression analysis was performed controlling for appropriate covariates. We observed weak or no associations with urinary phthalates other than di(2-ethylhexyl) phthalate (DEHP). All measures of testosterone [total, calculated free testosterone and the free androgen index (FAI)] were inversely correlated with the urinary concentrations of four DEHP metabolites. After adjustment by appropriate covariates, there was no longer an association between urinary DEHP metabolite concentrations and total testosterone levels; however, FAI was significantly associated with the urinary concentrations of several DEHP metabolites. SHBG was positively related to the urinary concentrations of mono(2-ethylhexyl) phthalate, but not with other DEHP metabolites, an association that was attenuated after adjustment. Our results suggest that DEHP exposure of fertile men is associated with minor alterations of markers of free testosterone. |
Attitudes and beliefs of parents concerned about vaccines: impact of timing of immunization information
Vannice KS , Salmon DA , Shui I , Omer SB , Kissner J , Edwards KM , Sparks R , Dekker CL , Klein NP , Gust DA . Pediatrics 2011 127 Suppl 1 S120-6 OBJECTIVES: To determine if giving vaccine-information materials before the 2-month vaccination visit to mothers with concerns about vaccine safety positively changed their attitudes and beliefs about vaccine safety. METHODS: Mothers who indicated concerns about infant vaccinations were recruited from 2 separate sites in Tennessee and California and were given vaccine information at 1 of 3 times: during a prenatal visit; a 1-week postpartum well-child visit; or a 2-month vaccination visit. A separate group of concerned mothers was assigned to be followed longitudinally at all 3 time points and was analyzed separately. The mothers reviewed a new vaccine-information pamphlet and Vaccine Information Statements (VIS) from the Centers for Disease Control and Prevention. Attitudes and beliefs about immunization were assessed both before and after the review of materials with written surveys. RESULTS: A total of 272 mothers with immunization concerns participated in the study. After review of the materials, mothers in all groups were significantly more likely to respond positively to questions and statements supporting the safety and importance of vaccines. Mothers who received this information at earlier visits were not significantly more likely to respond positively than mothers who received the information at the child's 2-month vaccination visit; however, participating mothers did indicate a preference for receiving vaccine information before the first vaccination visit. CONCLUSIONS: Distribution of the vaccine-information pamphlet and Vaccine Information Statements significantly improved attitudes about vaccination regardless of at what visit they were provided. Allowing adequate time to review vaccine information, even if done at the vaccination visit, may benefit concerned mothers. |
Are environmental levels of bisphenol A associated with reproductive function in fertile men?
Mendiola J , Jorgensen N , Andersson AM , Calafat AM , Ye X , Redmon JB , Drobnis EZ , Wang C , Sparks A , Thurston SW , Liu F , Swan SH . Environ Health Perspect 2010 118 (9) 1286-91 BACKGROUND: Rodent and in vitro studies have demonstrated the estrogenicity of bisphenol A (BPA). However, few studies have examined the relationship between human exposure to BPA and male reproductive function. OBJECTIVES: We investigated the relationships between environmental BPA exposure and reproductive parameters, including semen quality and male reproductive hormones, in prospectively recruited fertile men. METHODS: Participants (n = 375) were partners of pregnant women who participated in the Study for Future Families in four U.S. cities, and all of the men provided blood, semen, and urine samples. BPA was measured in urine. Serum samples were analyzed for reproductive hormones, including follicle-stimulating hormone, luteinizing hormone (LH), testosterone, inhibin B, estradiol, and sex hormone-binding globulin (SHBG), as well as the free androgen index (FAI). Semen analyses were performed according to World Health Organization criteria. Pearson correlations were used for unadjusted analyses, and multiple linear regression analyses were used to examine associations controlling for age, body mass index, smoking, ethnicity, urinary creatinine concentration, time of sample collection, and duration of abstinence. RESULTS: After multivariate adjustment, we observed no significant associations between any semen parameter and urinary BPA concentration. However, a significant inverse association was found between urinary BPA concentration and FAI levels and the FAI/LH ratio, as well as a significant positive association between BPA and SHBG. CONCLUSIONS: Our results suggest that, in fertile men, exposure to low environmental levels of BPA may be associated with a modest reduction in markers of free testosterone, but any effects on reproductive function are likely to be small, and of uncertain clinical significance. |
Guillain-Barre syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data
Sejvar JJ , Kohl KS , Gidudu J , Amato A , Bakshi N , Baxter R , Burwen D , Cornblath DR , Cleerbout J , Edwards KM , Heininger U , Hughes R , Khuri-Bulos N , Korinthenberg R , Law BJ , Munro U , Maltezou HC , Nell P , Oleske J , Sparks R , Velentgas P , Vermeer P , Wiznitzer M . Vaccine 2010 29 (3) 599-612 Among the various events reported as adverse outcomes following immunizations, neurologic adverse events following immunization (AEFI) are among the most severe and the most difficult to assess. The multifaceted presentation of neurologic illness, the relative lack of familiarity of many clinicians with the approach to and diagnosis of neurologic disease, and the relative scarcity of trained neurologists in many parts of the world make neurologic AEFI some of the most challenging issues in clinical vaccinology. Further, the severity of central and peripheral nervous system events in individual patients often heightens the concern when such illnesses are associated with antecedent immunizations. The lack of a common definition of GBS and FS hinders comparability and uniform reporting of these adverse events. | Sections 2 Clinical case definitions: Guillain–Barré syndrome (GBS), 3 Guidelines for data collection, analysis, and presentation of GBS and FS as adverse events following immunization of this paper provide the case definitions and guidelines for data collection, analysis, and presentation that the Brighton Collaboration GBS Working Group (hereafter referred to as the Working Group) has developed for the standardized collection and assessment of information about GBS and FS. Widespread use of these definitions with their guidelines will improve data comparability and allow for a better understanding of these neurological events that are applicable in study settings with different availability of resources, in health care settings that differ by availability of and access to health care, and in different geographic regions. |
Differential maternal responses to a newly developed vaccine information pamphlet
Klein NP , Kissner J , Aguirre A , Sparks R , Campbell S , Edwards KM , Dekker CL , Shui I , Gust DA . Vaccine 2009 28 (2) 323-8 We compared the response to a new vaccine information pamphlet with the current CDC Vaccine Information Statements (VIS) among recently delivered mothers who were screened to identify those with concerns about immunization. Eligible mothers (n=226) were randomly assigned to one of three equal groups; those reviewing only the new pamphlet, those receiving only VIS, or those receiving both. Among those mothers reviewing both, 61% preferred the new pamphlet for its visual appeal (P<0.0001) and ease of understanding (P=0.005). Overall, mothers expressed increased confidence and fewer concerns regarding multiple injections after reviewing the pamphlet. However, older, more-highly educated mothers were less likely to report improved vaccine confidence after reviewing either the pamphlet or the VIS. Mothers in all three groups stated a preference for receiving the vaccine information during pregnancy or prior to the actual immunization visit. These data suggest that early provision of tailored immunization material along with the VIS to new mothers may enhance their overall confidence in vaccines and that additional strategies targeted toward certain mothers may be needed. |
Chlamydia prevalence among women and men entering the National Job Training Program: United States, 2003-2007
Satterwhite CL , Tian LH , Braxton J , Weinstock H . Sex Transm Dis 2009 37 (2) 63-7 OBJECTIVE: To analyze 5-year prevalence trends in Chlamydia trachomatis infections among high-risk young men and women aged 16 to 24 years entering the National Job Training Program, where universal screening is required. METHODS: Entrance exams conducted in over 100 National Job Training Program centers from 2003 to 2007 were considered. Women provided cervical specimens tested using either a DNA hybridization probe (PACE 2, Gen-Probe, San Diego, CA) or a strand displacement amplification test (SDA, BD ProbeTec ET, Becton-Dickinson, Sparks, MD). In the absence of a pelvic exam, urine specimens were tested using SDA. PACE 2 testing was performed predominately from 2002 to 2005; from 2005 to 2007, SDA was used. All male testing was conducted using SDA on urine specimens. Chlamydia prevalence trends were assessed for women and men, using logistic regression models. Adjusted odds ratios (AOR), 95% confidence intervals (CI), and P-values were calculated. RESULTS: Approximately 15,000 women and 30,000 men were screened annually for chlamydia. Among both sexes, adjusted prevalence declined significantly from 2003 to 2007. In 2003, crude prevalence among women was 9.9%; in 2007, prevalence was 13.7%. However, after controlling for covariates, including increasingly sensitive tests, the model indicated a significant declining prevalence trend (AOR: 0.95, CI: 0.93-0.97, 4.6% decrease in odds per year). Among men, crude prevalence in 2003 was 8.4%; in 2007, prevalence was 8.3%; after controlling for possible confounding, a significant decline in prevalence was also detected (AOR: 0.98, CI: 0.96-0.99, 1.9% decrease in odds per year). CONCLUSIONS: In a relatively stable, high-risk population of young women and men, adjusted chlamydia prevalence declined from 2003 to 2007. Test technology plays a critical role in interpreting rates and should be considered whenever chlamydia rates are examined. |
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