IMPORTANCEElectronic directly observed therapy (DOT) is used increasingly as an alternative to in-person DOT for monitoring tuberculosis treatment. Evidence supporting its efficacy is limited. OBJECTIVE To determine whether electronic DOT can attain a level of treatment observation as favorable as in-person DOT. DESIGN, SETTING, AND PARTICIPANTS This was a 2-period crossover, noninferiority trial with initial randomization to electronic or in-person DOT at the time outpatient tuberculosis treatment began. The trial enrolled 216 participants with physician-suspected or bacteriologically confirmed tuberculosis from July 2017 to October 2019 in 4 clinics operated by the New York City Health Department. Data analysis was conducted between March 2020 and April 2021. INTERVENTIONS Participants were asked to complete 20 medication doses using 1 DOT method, then switched methods for another 20 doses. With in-person therapy, participants chose clinic or community-based DOT; with electronic DOT, participants chose live video-conferencing or recorded videos. MAIN OUTCOMES AND MEASURES Difference between the percentage of medication dosesparticipants were observed to completely ingest with in-person DOT and with electronic DOT.Noninferiority was demonstrated if the upper 95% confidence limit of the difference was 10% or less. We estimated the percentage of completed doses using a logistic mixed effects model, run in 4 modes: modified intention-to-treat, per-protocol, per-protocol with 85% or more of doses conforming to the randomization assignment, and empirical. Confidence intervals were estimated by bootstrapping (with 1000 replicates). RESULTSThere were 173 participants in each crossover period (median age, 40 years [range, 16-86 years]; 140 [66%] men; 80 [37%] Asian and Pacific Islander, 43 [20%] Black, and 71 [33%] Hispanic individuals) evaluated with the model in the modified intention-to-treat analytic mode. The percentage of completed doses with in-person DOT was 87.2% (95% CI, 84.6%-89.9%) vs 89.8%(95% CI, 87.5%-92.1%) with electronic DOT. The percentage difference was −2.6% (95% CI, −4.8% to −0.3%), consistent with a conclusion of noninferiority. The 3 other analytic modes yielded equivalent conclusions, with percentage differences ranging from −4.9% to −1.9%. CONCLUSIONS AND RELEVANCEIn this trial, the percentage of completed doses under electronic DOT was noninferior to that under in-person DOT. This trial provides evidence supporting the (continued) Key Points Question Is electronic directly observed therapy (DOT) noninferior to in-person DOT in supporting medication adherence for tuberculosis treatment? Findings In this randomized, 2-period crossover noninferiority trial of 216 patients with tuberculosis, the modified intention-to-treat analysis estimate of the percentage of medication doses staff observed patients ingest with in-person DOT was 87.2% vs 89.8% with electronic DOT. The percentage difference between DOT methods was −2.6%, which was less than the noninferiority margin of 10% at a statistically sign...

This study evaluated the estrogenicity of polychlorinated biphenyls (PCBs) present in environmental media and human tissue and assessed exposure pathways for PCB-derived estrogenic potency in air, soil, and dust from New Bedford, MA, an area with a PCB-contaminated Superfund site. Thirty-four PCB congeners were assayed for estrogenic potency using E-SCREEN, an assay based on the estrogen-dependent proliferation of MCF-7 cells in vitro. Childhood exposure to estradiol-equivalents via PCBs in environmental media was estimated byweighting previously reported New Bedford congener-specific concentrations by their relative estrogenic potency and published inhalation and soil ingestion rates. Thirteen congeners were weakly estrogenic in E-SCREEN: PCBs 17, 18, 30, 44, 49, 66, 74, 82, 99, 103, 110, 128, and 179. These PCBs were typically 6 orders of magnitude less potent than 17beta-estradiol, with proliferative potencies ranging from 0.0007% to 0.0040%. Of the environmental media assessed, air (inhalation) had the highest PCB-derived estradiol-equivalent exposure. PCB estrogenic potency information from this study provides an important resource both for preliminary estimation of routes of human exposure to xenoestrogens and for application to human health studies focused on estrogen-responsive health outcomes, such as reproductive development and related malignancies.

BackgroundArsenic is an ubiquitous element linked to carcinogenicity, neurotoxicity, as well as adverse respiratory, gastrointestinal, hepatic, and dermal health effects.ObjectiveIdentify dietary sources of speciated arsenic: monomethylarsonic acid (MMA), and dimethylarsinic acid (DMA).MethodsAge-stratified, sample-weighted regression of NHANES (National Health and Nutrition Examination Survey) 2003–2010 data (∼8,300 participants ≥6 years old) characterized the association between urinary arsenic species and the additional mass consumed of USDA-standardized food groups (24-hour dietary recall data), controlling for potential confounders.ResultsFor all arsenic species, the rank-order of age strata for median urinary molar concentration was children 6–11 years > adults 20–84 years > adolescents 12–19 years, and for all age strata, the rank-order was DMA > MMA. Median urinary molar concentrations of methylated arsenic species ranged from 0.56 to 3.52 µmol/mol creatinine. Statistically significant increases in urinary arsenic species were associated with increased consumption of: fish (DMA); fruits (DMA, MMA); grain products (DMA, MMA); legumes, nuts, seeds (DMA); meat, poultry (DMA); rice (DMA, MMA); rice cakes/crackers (DMA, MMA); and sugars, sweets, beverages (MMA). And, for adults, rice beverage/milk (DMA, MMA). In addition, based on US (United States) median and 90th percentile consumption rates of each food group, exposure from the following food groups was highlighted: fish; fruits; grain products; legumes, nuts, seeds; meat, poultry; and sugars, sweets, beverages.ConclusionsIn a nationally representative sample of the US civilian, noninstitutionalized population, fish (adults), rice (children), and rice cakes/crackers (adolescents) had the largest associations with urinary DMA. For MMA, rice beverage/milk (adults) and rice cakes/crackers (children, adolescents) had the largest associations.

BackgroundAcrolein is a highly reactive α,β unsaturated aldehyde and respiratory irritant. Acrolein is formed during combustion (e.g., burning tobacco or biomass), during high-temperature cooking of foods, and in vivo as a product of oxidative stress and polyamine metabolism. No biomonitoring reference data have been reported to characterize acrolein exposure for the U.S. population.ObjectivesOur goals were to a) evaluate two acrolein metabolites in urine—N-acetyl-S-(3-hydroxypropyl)-l-cysteine (3HPMA) and N-acetyl-S-(2-carboxyethyl)-l-cysteine (CEMA)—as biomarkers of exposure to acrolein for the U.S. population by age, sex, race, and smoking status; and b) assess tobacco smoke as a predictor of acrolein exposure.MethodsWe analyzed urine from National Health and Nutrition Examination Survey (NHANES 2005–2006) participants ≥ 12 years old (n = 2,866) for 3HPMA and CEMA using ultra-high-performance liquid chromatography coupled with electrospray ionization tandem mass spectrometry (UPLC/ESI-MSMS). Sample-weighted linear regression models stratified for non-tobacco users versus tobacco smokers (as defined by serum cotinine and self-report) characterized the association of urinary 3HPMA and CEMA with tobacco smoke exposure, adjusting for urinary creatinine, sex, age, and race/ethnicity.Results3HPMA and CEMA levels were higher among tobacco smokers (cigarettes, cigars, and pipe users) than among non-tobacco users. The median 3HPMA levels for tobacco smokers and non-tobacco users were 1,089 and 219 μg/g creatinine, respectively. Similarly, median CEMA levels were 203 μg/g creatinine for tobacco smokers and 78.8 μg/g creatinine for non-tobacco users. Regression analysis showed that serum cotinine was a significant positive predictor (p < 0.0001) of both 3HPMA and CEMA among tobacco smokers.ConclusionsTobacco smoke was a significant predictor of acrolein exposure in the U.S. population.CitationAlwis KU, deCastro BR, Morrow JC, Blount BC. 2015. Acrolein exposure in U.S. tobacco smokers and non-tobacco users: NHANES 2005–2006. Environ Health Perspect 123:1302–1308; http://dx.doi.org/10.1289/ehp.1409251

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Perchlorate (ClO(4)(-)) is ubiquitous in the environment and inhibits the thyroid's uptake of iodide. Food and tap water are likely sources of environmental exposure to perchlorate. The aim of this study was to identify significant dietary sources of perchlorate using perchlorate measured in urine as an exposure indicator. Sample-weighted, age-stratified linear regression models of National Health and Nutrition Examination Survey (NHANES) 2001-2008 data (n=16,955 participants) characterized the association between urinary perchlorate and the mass consumed in USDA food groups, controlling for urinary creatinine and other potential confounders. Separate models of NHANES 2005-2006 data (n=2841) evaluated the association between urinary perchlorate and perchlorate consumed via residential tap water. Consumption of milk products was associated with statistically significant contributions to urinary perchlorate across all age strata: 2.93 ng ClO(4)(-)/ml per kg consumed for children (6-11 years-old (YO)); 1.54 ng ClO(4)(-)/ml per kg for adolescents (12-19 YO); and 0.69 ng ClO(4)(-)/ml per kg for adults (20-84 YO). Vegetables were a significant contributor for adolescents and adults, whereas fruits and eggs contributed significantly only for adults. Dark-green leafy vegetables contributed the most among all age strata: 30.83 ng ClO(4)(-)/ml per kg for adults. Fats, oils, and salad dressings were significant contributors only for children. Three food groups were negatively associated with urinary perchlorate: grain products for children; sugars, sweets, and beverages for adolescents; and home tap water for adults. In a separate model, however, perchlorate consumed via home tap water contributed significantly to adult urinary perchlorate: 2.11E-4 ng ClO(4)(-)/ml per ng perchlorate in tap water consumed. In a nationally representative sample of the United States 6-84 YO, diet and tap water contributed significantly to urinary perchlorate, with diet contributing substantially more than tap water.

This study characterizes U.S. population exposure to crotonaldehyde and confirms that tobacco smoke is a major exposure source. Urinary HPMM levels were significantly higher among exclusive combusted tobacco users compared to non-users, and serum cotinine and cigarettes per day were significant predictors of increased urinary HPMM. This study also found that sex, age, ethnicity, pre-exam fasting time, and fruit consumption are related to urinary HPMM levels.

Objective We examined differences between nicotine concentrations and pH in cigarette and cigar tobacco filler. Methods Nicotine and pH levels for 50 cigarette and 75 cigar brands were measured. Non-mentholated and mentholated cigarette products were included in the analysis along with several cigar types as identified by the manufacturer: large cigars, pipe tobacco cigars, cigarillos, mini cigarillos, and little cigars. Results There were significant differences found between pH and nicotine for cigarette and cigar tobacco products. Mean nicotine concentrations in cigarettes (19.2 mg/g) and large cigars (15.4 mg/g) were higher than the other cigars types, especially the pipe tobacco cigars (8.79 mg/g). The mean pH for cigarettes was pH 5.46. Large cigars had the highest mean pH value (pH 6.10) and pipe tobacco cigars had the lowest (pH 5.05). Conclusions Although cigarettes are the most common combustible tobacco product used worldwide, cigar use remains popular. Our research provides a means to investigate the possibility of distinguishing the 2 tobacco product types and offers information on nicotine and pH across a wide range of cigarette and cigar varieties that may be beneficial to help establish tobacco policies and regulations across product types.