Adverse events among persons with TB using in-person vs. electronic directly observed therapy.

We evaluated patient safety within a randomized crossover trial comparing electronic directly observed therapy (eDOT) to in-person DOT (ipDOT) in persons undergoing TB treatment in New York City, NY, USA. Participant symptoms, symptom severity, and clinical management were documented. We assessed adverse event reports (AERs) by DOT method during the two-period crossover.

Challenges associated with electronic and in-person directly observed therapy during a randomized trial.

Electronic directly observed therapy (eDOT) has been proposed as an alternative to traditional in-person DOT (ipDOT) for monitoring TB treatment adherence. Information about the comparative performance and implementation of eDOT is limited. The frequency of challenges during DOT, challenge type, and effect on medication observation were documented by DOT method during a crossover, noninferiority randomized controlled trial.

In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence: A Randomized Noninferiority Trial.

Importance: Electronic 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.

Pre-exposure Prophylaxis (PrEP) Awareness and Prescribing Behaviors Among Primary Care Providers: DocStyles Survey, 2016-2020, United States.

Few studies have assessed providers' intent of prescribing PrEP in the future. We analyzed cross-sectional web-based surveys to estimate trends from 2016 to 2020 in PrEP awareness and prescribing behaviors in the United States among primary care providers. Multivariable logistic regression was used to estimate prevalence of PrEP awareness, prescribing behaviors, and likelihood of prescribing PrEP in the next 12 months.

Chemical analysis of snus products from the United States and northern Europe.

Introduction: Snus is an oral tobacco product that originated in Sweden. Snus products are available as fine-cut loose tobacco or in pre-portioned porous "pouches." Some snus products undergo tobacco pasteurization during manufacturing, a process that removes or reduces nitrite-forming microbes, resulting in less tobacco-specific nitrosamine content in the product.

Evaluation of Tobacco Smoke and Diet as Sources of Exposure to Two Heterocyclic Aromatic Amines for the U.S. Population: NHANES 2013-2014.

Background: Heterocyclic aromatic amines (HAA) are a group of hazardous substances produced during combustion of tobacco or high-temperature cooking of meats. 2-Amino-9H-pyrido[2,3-b]indole (AαC) is a major carcinogenic HAA in tobacco smoke.

Methods: Urinary AαC, used as a marker of AαC exposure, was analyzed on spot urine samples from adult participants of the 2013-2014 cycle of the National Health and Nutrition Examination Survey ( = 1,792).

Cumulative ROC curves for discriminating three or more ordinal outcomes with cutpoints on a shared continuous measurement scale.

Cumulative receiver operator characteristic (ROC) curve analysis extends classic ROC curve analysis to discriminate three or more ordinal outcome levels on a shared continuous scale. The procedure combines cumulative logit regression with a cumulative extension to the ROC curve and performs as expected with ternary (three-level) ordinal outcomes under a variety of simulated conditions (unbalanced data, proportional and non-proportional odds, areas under the ROC curve [AUCs] from 0.70 to 0.

Transparency and credibility of industry-sponsored clinical trial publications: a survey of journal editors.

To examine how medical journal editors perceive changes in transparency and credibility of industry-sponsored clinical trial publications over a 5 year period (2010 to 2015). From July to September 2015, a survey link was emailed to journal editors identified from the Thomson Reuters registry. Editors ranked their perception of: a) change in transparency and credibility of industry-sponsored clinical trial publications; b) 8 "Publication Best Practices" and the impact of each on transparency; and c) the importance and adoption of the previously published "10 Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research".

Systemic absorption of nicotine following acute secondhand exposure to electronic cigarette aerosol in a realistic social setting.

Evidence suggests exposure of nicotine-containing e-cigarette aerosol to nonusers leads to systemic absorption of nicotine. However, no studies have examined acute secondhand exposures that occur in public settings. Here, we measured the serum, saliva and urine of nonusers pre- and post-exposure to nicotine via e-cigarette aerosol.

Crotonaldehyde exposure in U.S. tobacco smokers and nonsmokers: NHANES 2005-2006 and 2011-2012.

Introduction: Crotonaldehyde is an α,β-unsaturated carbonyl compound that is a potent eye, respiratory, and skin irritant. Crotonaldehyde is a major constituent of tobacco smoke and its exposure can be quantified using its urinary metabolite N-acetyl-S-(3-hydroxypropyl-1-methyl)-L-cysteine (HPMM). A large-scale biomonitoring study is needed to determine HPMM levels, as a measure of crotonaldehyde exposure, in the general U.

Surveillance of Nicotine and pH in Cigarette and Cigar Filler.

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.

Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies.

 To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals. A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor's policy) to peer reviewed journals within 18 months of study completion-that is, 31 December 2015. In addition, manuscripts from studies completing after 30 June 2014 were included irrespective of outcome if they were submitted before 31 December 2015.

Evaluation of Multiple Blood Matrices for Assessment of Human Exposure to Nerve Agents.

Biomedical samples may be used to determine human exposure to nerve agents through the analysis of specific biomarkers. Samples received may include serum, plasma, whole blood, lysed blood and, due to the toxicity of these compounds, postmortem blood. To quantitate metabolites resulting from exposure to sarin (GB), soman (GD), cyclosarin (GF), VX and VR, these blood matrices were evaluated individually for precision, accuracy, sensitivity and specificity.

Acrolein Exposure in U.S. Tobacco Smokers and Non-Tobacco Users: NHANES 2005-2006.

Background: Acrolein is a highly reactive α,β unsaturated aldehyde and respiratory irritant. Acrolein is formed during combustion (e.g.

Dietary sources of methylated arsenic species in urine of the United States population, NHANES 2003-2010.

Background: Arsenic is an ubiquitous element linked to carcinogenicity, neurotoxicity, as well as adverse respiratory, gastrointestinal, hepatic, and dermal health effects.

Objective: Identify dietary sources of speciated arsenic: monomethylarsonic acid (MMA), and dimethylarsinic acid (DMA).

Methods: Age-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.

Acrolein and asthma attack prevalence in a representative sample of the United States adult population 2000-2009.

Background: Acrolein is an air toxic and highly potent respiratory irritant. There is little epidemiology available, but US EPA estimates that outdoor acrolein is responsible for about 75 percent of non-cancer respiratory health effects attributable to air toxics in the United States, based on the Agency's 2005 NATA (National-Scale Air Toxics Assessment) and acrolein's comparatively potent inhalation reference concentration of 0.02 µg/m3.

Profiling cholinesterase adduction: a high-throughput prioritization method for organophosphate exposure samples.

A high-throughput prioritization method was developed for use with a validated confirmatory method detecting organophosphorus nerve agent exposure by immunomagnetic separation high-performance liquid chromatography tandem mass spectrometry. A ballistic gradient was incorporated into this analytical method to profile unadducted butyrylcholinesterase (BChE) in clinical samples. With Zhang et al.

Urinary perchlorate as a measure of dietary and drinking water exposure in a representative sample of the United States population 2001-2008.

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.

Adult template circumcision: a prospective, randomized, patient-blinded, comparative study evaluating the safety and efficacy of a novel circumcision device.

Objectives: In 2001, we reported a novel technique for pediatric circumcision that has proved to be fast, reliable, and safe during the past 4 years, with good cosmetic results. Inspired by our success with this technique, we have created a similar device to be used for adults.

Methods: We conducted a prospective, randomized, patient-blinded study to compare this device with that of the standard sleeve circumcision.

Effect of flexible cystoscopy on serum prostate-specific antigen values.

Objectives: To determine the effect of flexible cystoscopy on the total, free, and percent-free prostate-specific antigen (PSA) values in male volunteers. Flexible cystoscopy is the standard method of evaluation of the bladder and urethra. PSA measurement is currently used in conjunction with the digital rectal examination to detect and guide management of prostate cancer.

The longitudinal dependence of black carbon concentration on traffic volume in an urban environment.

The purpose of this study was to evaluate the effect of traffic volume on ambient black carbon (BC) concentration in an inner-city neighborhood "hot spot" while accounting for modifying effects of weather and time. Continuous monitoring was conducted for 12 months at the Baltimore Traffic Study site surrounded by major urban streets that together carry over 150,000 vehicles per day. Outdoor BC concentration was measured with an Aethalometer; vehicles were counted pneumatically on two nearby streets.

Oral ketoconazole for prevention of postoperative penile erection: a placebo controlled, randomized, double-blind trial.

Purpose: Patients undergoing penile surgery often have postoperative erections that can be painful and may interfere with wound healing. In retrospective studies ketoconazole has been shown to decrease the number and pain of postoperative erections. We conducted a prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of ketoconazole in the prevention of postoperative erections.

A 5-year followup study of asymptomatic men with testicular microlithiasis.

Purpose: Testicular microlithiasis is an imaging entity of the testicle with questionable significance as a marker for testicular cancer. In 2001 we reported on a large prospective screening study establishing the prevalence of testicular microlithiasis to be 5.6% in a healthy asymptomatic population of Army volunteers 18 to 35 years old.