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...
Farmworkers are calling for stronger workplace protections to prevent pesticide exposure and reduce health risks for workers and their families. In 1992, the U.S. Environmental Protection Agency (EPA) promulgated the Worker Protection Standard (WPS) as the primary set of regulations protecting the nation's 1-2 million farmworkers from occupational pesticide exposure. After more than 20 years, the EPA proposed revisions to the WPS. The proposed revisions were posted in the Federal Register and made available for public comment on 19 March 2014. In response to these revisions, farmworker organizations conducted outreach in agricultural communities to document and submit farmworkers' first-hand accounts of pesticide exposure as public comments. Through this process, farmworkers--a typically underrepresented, poorly protected, and disenfranchised population--made their voices heard and advocated for changes to improve their health and safety. Their comments in this article articulate the need for stronger workplace protections and enforcement measures to reduce health risks for workers, families, and communities.
Both tuberculosis (TB) and COVID-19 can affect the respiratory system, and early findings suggest co-occurrence of these infectious diseases can result in elevated mortality. A retrospective cohort of patients who were diagnosed with TB and COVID-19 concurrently (within 120 days) between March 2020 and June 2022 in New York City (NYC) was identified. This cohort was compared with a cohort of patients diagnosed with TB-alone during the same period in terms of demographic information, clinical characteristics, and mortality. Cox proportional hazards regression was used to compare mortality between patient cohorts. One hundred and six patients with concurrent TB/COVID-19 were identified and compared with 902 patients with TB-alone. These two cohorts of patients were largely demographically and clinically similar. However, mortality was higher among patients with concurrent TB/COVID-19 in comparison to patients with TB-alone, even after controlling for age and sex (hazard ratio 2.62, 95% Confidence Interval 1.66–4.13). Nearly one in three (22/70, 31%) patients with concurrent TB/COVID-19 aged 45 and above died during the study period. These results suggest that TB patients with concurrent COVID-19 were at high risk for mortality. It is important that, as a high-risk group, patients with TB are prioritized for resources to quickly diagnose and treat COVID-19, and provided with tools and information to protect themselves from COVID-19.
Background There is substantial evidence that resecting adrenal metastases can be safely accomplished and extend overall survival in select patients. However, patient access to this operation has not been studied at the population level. The purpose of this study was to determine differences in utilization rates of adrenal metastasectomy (ADMX) across patient populations. Methods The Healthcare Utilization Project National Inpatient Sample was used to identify patients who had adrenal metastases (ADM) and who underwent ADMX from 2007 to 2011. Patients were identified by ICD-9-CM diagnosis and procedure codes. Predictor variables included sex, race, median household income, and primary insurance payer. Primary outcomes included receiving an ADMX and same hospitalization mortality. Secondary outcomes included length of stay, infection, cardiac, pulmonary, and renal complications. Univariable and multivariable logistic regression models were used to identify statistical associations. Results 32,331 ADM and 1070 ADMX patients identified in the database. Despite similar comorbidities, Black patients had 0.30 (95% CI 0.21-0.41) lower odds to receive an ADMX compared to White patients. Medicaid patients had 0.38 (0.28-0.52) less odds and Private Insurance patients 1.18 (1.00-1.39) more odds to receive an ADMX compared to Medicare patients. Women had a 1.39 (1.22-1.58) higher odds ratio of undergoing ADMX compared to men. Of the ADMX cohort, there was no difference in same hospitalization mortality or surgical complications. Conclusions Black and Medicaid patients underwent fewer adrenal metastasectomies despite similar comorbidities and postoperative outcomes. This suggests a potential disparity in access to this treatment that disproportionately affects Black and low-income patients, and prompts further study, outreach attempts, as well as, research into improving access.
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