jointly sponsored this new practice guideline on the treatment of drug-resistant tuberculosis (DR-TB). The document includes recommendations on the treatment of multidrug-resistant TB (MDR-TB) as well as isoniazid-resistant but rifampin-susceptible TB. Methods: Published systematic reviews, meta-analyses, and a new individual patient data meta-analysis from 12,030 patients, in 50 studies, across 25 countries with confirmed pulmonary rifampinresistant TB were used for this guideline. Meta-analytic approaches included propensity score matching to reduce confounding. Each recommendation was discussed by an expert committee, screened for conflicts of interest, according to the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Results: Twenty-one Population, Intervention, Comparator, and Outcomes questions were addressed, generating 25 GRADE-based recommendations. Certainty in the evidence was judged to be very low, because the data came from observational studies with significant loss to follow-up and imbalance in background regimens between comparator groups. Good practices in the management of MDR-TB are described. On the basis of the evidence review, a clinical strategy tool for building a treatment regimen for MDR-TB is also provided. Conclusions: New recommendations are made for the choice and number of drugs in a regimen, the duration of intensive and continuation phases, and the role of injectable drugs for MDR-TB. On the basis of these recommendations, an effective all-oral regimen for MDR-TB can be assembled. Recommendations are also provided on the role of surgery in treatment of MDR-TB and for treatment of contacts exposed to MDR-TB and treatment of isoniazid-resistant TB.
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...
Objective-Few patients take inhaled corticosteroids as recommended. This study aimed to determine the effectiveness of school-based supervised asthma therapy in improving asthma control. The primary hypothesis was that the supervised asthma therapy group would have a lower proportion of children experiencing an episode of poor asthma control (EPAC) each month compared to the usual care group.Patients and Methods-Children were eligible if they had physician-diagnosed persistent asthma, the need for daily controller medication, and the ability to use a dry-powder inhaler and a PFM. The trial used a two-group randomized longitudinal design with 15 month follow-up. 290 children from 36 schools were randomly assigned to either: school-based supervised asthma therapy or usual care. Ninety-one percent of children were African American and 57% were male. Mean age was 11 years (SD = 2.1). An EPAC was defined as one or more of the following each month: 1) an absence from school due to respiratory illness/asthma; 2) average use of rescue medication more than two times per week (not including pre-exercise treatment); or 3) at least one red or yellow PFM reading.Results-240 children completed the study. There were no differences in the likelihood of an EPAC between the baseline and follow-up period in the usual care group (p=0.77); however, among those in the supervised therapy group, the odds of experiencing an EPAC during the baseline period were 1.57 times the odds of experiencing an EPAC during the follow-up period (90% CI: 1.20, 2.06, p=0.006). GEE modeling revealed a marginally significant interaction between the intervention and time period (p=0.065) indicating that children in the supervised therapy group showed greater improvement in asthma control.Conclusions-Supervised asthma therapy improves asthma control. Clinicians who have pediatric asthma patients with poor outcomes that may be due to non-adherence should consider supervised therapy.
Most commonly reported was medication side effects or fear of side effects.
On October 9, 2020, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). On May 13, 2020, the Wisconsin Supreme Court declared the state's Safer at Home Emergency Order (https://evers. wi.gov/Documents/COVID19/EMO28-SaferAtHome.pdf) "unlawful, invalid, and unenforceable,"* thereby increasing opportunities for social and business interactions. By mid-June, Winnebago County, † Wisconsin experienced an increase in the number of infections with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), with the largest increase among persons aged 18-23 years (young adults) (1). This age group § accounts for 12.5% of the population in the county. To identify factors that influence exposure to COVID-19 among young adults in Winnebago County, characteristics of COVID-19 cases and drivers of behaviors in this age group were examined. During March 1-July 18, 2020, 240 young adults received positive SARS-CoV-2 test results, accounting for 32% of all Winnebago County cases. In 30 key informant interviews, most interviewees reported exposure to misinformation, conflicting messages, or opposing views about the need for and effectiveness of masks. Thirteen young adults described social or peer pressure to not wear a mask and perceived severity of disease outcome for themselves as low but high for loved ones at risk. Having low perceived severity of disease outcome might partly explain why, when not in physical contact with loved ones at risk, young adults might attend social gatherings or not wear a mask (2). Exposure to misinformation and unclear messages has been identified as a driver of behavior during an outbreak (3,4), underscoring the importance of providing clear and consistent messages * h t t p s : / / w w w. w i c o u r t s. g o v / s c / o p i n i o n / D i s p l a y D o c u m e n t. pdf?content=pdf&seqNo=260868. † The COVID-19 data provided in this report are specific to the Winnebago County Health Department (WCHD) jurisdiction. Data for the portions of the City of Menasha or City of Appleton that fall within Winnebago County are not included. Data provided on the Wisconsin Department of Health Services website might be different than the information provided by WCHD because the state reports data for the entire county, which includes those portions of Menasha and Appleton. § Percentage of population includes persons aged 18-24 years in Winnebago County, Wisconsin, and were obtained using the U.S.
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