A portable optical pulsatile flowmetry demonstrates strong clinical relevance for diabetic foot perfusion assessment.

We present a robust, cost-effective (<2000 USD), and portable optical diffuse speckle pulsatile flowmetry (DSPF) device with a flexible handheld probe for deep tissue blood flow measurement in the human foot as well as a first-in-man observational clinical study using the proposed optical device for tissue ischemia assessment and peripheral artery disease (PAD) diagnosis. Blood flow in tissue is inherently pulsatile in nature. However, most conventional methods cannot measure deep tissue-level pulsatile blood flow noninvasively. The proposed optical device can measure tissue-level pulsatile blood flow ∼6 mm underneath the skin surface. A new quantitative tissue perfusion index (TPIDSPF) based on frequency domain analysis of the pulsatile blood flow waveform is defined to assess tissue ischemia status. Through a clinical study involving 66 subjects, including healthy individuals and diabetes patients with and without PAD, TPIDSPF demonstrated strong correlations of 0.720 with transcutaneous tissue partial oxygen pressure (TcPO2) and 0.652 with toe-brachial index (TBI). Moreover, among the three methods, TPIDSPF demonstrated the highest area under the curve for PAD diagnosis among diabetes patients, with a notable value of 0.941. The promising clinical results suggest that the proposed optical method has the potential to be an effective clinical tool for identifying PAD among the diabetic cohort.

Tuberculosis Diagnostic Delays and Treatment Outcomes among Patients with COVID-19, California, USA, 2020.

We assessed tuberculosis (TB) diagnostic delays among patients with TB and COVID-19 in California, USA. Among 58 persons, 43% experienced TB diagnostic delays, and a high proportion (83%) required hospitalization for TB. Even when viral respiratory pathogens circulate widely, timely TB diagnostic workup for at-risk persons remains critical for reducing TB-related illness.

Latent Tuberculosis Infection Testing and Treatment at a Federally Qualified Health Center in Southern California: A Quality Improvement Project.

BACKGROUND: A key strategy to eliminate tuberculosis (TB) in the United States is to increase latent tuberculosis infection (LTBI) screening, testing, and treatment among non-US-born Asian populations. PURPOSE: The purpose was to increase LTBI screening, testing, and treatment at a community clinic. METHODS: Retrospective baseline LTBI data were retrieved through electronic medical record review. Interventions included adoption of standardized TB risk assessment, training providers to use shorter LTBI treatment regimens, and use of a care coordinator. Chart abstraction to examine outcomes was conducted postintervention at 4 months. RESULTS: In 2017, only 3 patients (7%) with LTBI were started on treatment. At 4 months postintervention, 28 (72%) patients with LTBI were started on treatment, of which 27 (96%) were placed on 3- to 4-month regimens. CONCLUSIONS: Training for providers and changes to clinic workflow, including use of a care coordinator, can help increase LTBI screening, testing, and treatment in community clinics.

Sociodemographic Characteristics, Comorbidities, and Mortality Among Persons Diagnosed With Tuberculosis and COVID-19 in Close Succession in California, 2020.

Importance: Tuberculosis (TB) and COVID-19 are respiratory diseases that disproportionately occur among medically underserved populations; little is known about their epidemiologic intersection. Objective: To characterize persons diagnosed with TB and COVID-19 in California. Design, Setting, and Participants: This cross-sectional analysis of population-based public health surveillance data assessed the sociodemographic, clinical, and epidemiologic characteristics of California residents who were diagnosed with TB (including cases diagnosed and reported between September 3, 2019, and December 31, 2020) and COVID-19 (including confirmed cases based on positive results on polymerase chain reaction tests and probable cases based on positive results on antigen assays reported through February 2, 2021) in close succession compared with those who were diagnosed with TB before the COVID-19 pandemic (between January 1, 2017, and December 31, 2019) or diagnosed with COVID-19 alone (through February 2, 2021). This analysis included 3 402 713 California residents with COVID-19 alone, 6280 with TB before the pandemic, and 91 with confirmed or probable COVID-19 diagnosed within 120 days of a TB diagnosis (ie, TB/COVID-19). Exposures: Sociodemographic characteristics, medical risk factors, factors associated with TB severity, and health equity index. Main Outcomes and Measures: Frequency of reported successive TB and COVID-19 (TB/COVID-19) diagnoses within 120 days, frequency of deaths, and age-adjusted mortality rates. Results: Among the 91 persons with TB/COVID-19, the median age was 58.0 years (range, 3.0-95.0 years; IQR, 41.0-73.0 years); 52 persons (57.1%) were male; 81 (89.0%) were born outside the US; and 28 (30.8%) were Asian or Pacific Islander, 4 (4.4%) were Black, 55 (60.4%) were Hispanic or Latino, 4 (4.4%) were White. The frequency of reported COVID-19 among those who received a TB diagnosis between September 3, 2019, and December 31, 2020, was 225 of 2210 persons (10.2%), which was similar to that of the general population (3 402 804 of 39 538 223 persons [8.6%]). Compared with persons with TB before the pandemic, those with TB/COVID-19 were more likely to be Hispanic or Latino (2285 of 6279 persons [36.4%; 95% CI, 35.2%-37.6%] vs 55 of 91 persons [60.4%; 95% CI, 49.6%-70.5%], respectively; P < .001), reside in low health equity census tracts (1984 of 6027 persons [32.9%; 95% CI, 31.7%-34.1%] vs 40 of 89 persons [44.9%; 95% CI, 34.4%-55.9%]; P = .003), live in the US longer before receiving a TB diagnosis (median, 19.7 years [IQR, 7.2-32.3 years] vs 23.1 years [IQR, 15.2-31.5 years]; P = .03), and have diabetes (1734 of 6280 persons [27.6%; 95% CI, 26.5%-28.7%] vs 42 of 91 persons [46.2%; 95% CI, 35.6%-56.9%]; P < .001). The frequency of deaths among those with TB/COVID-19 successively diagnosed within 30 days (8 of 34 persons [23.5%; 95% CI, 10.8%-41.2%]) was more than twice that of persons with TB before the pandemic (631 of 5545 persons [11.4%; 95% CI, 10.6%-12.2%]; P = .05) and 20 times that of persons with COVID-19 alone (42 171 of 3 402 713 persons [1.2%; 95% CI, 1.2%-1.3%]; P < .001). Persons with TB/COVID-19 who died were older (median, 81.0 years; IQR, 75.0-85.0 years) than those who survived (median, 54.0 years; IQR, 37.5-68.5 years; P < .001). The age-adjusted mortality rate remained higher among persons with TB/COVID-19 (74.2 deaths per 1000 persons; 95% CI, 26.2-122.1 deaths per 1000 persons) compared with either disease alone (TB before the pandemic: 56.3 deaths per 1000 persons [95% CI, 51.2-61.4 deaths per 1000 persons]; COVID-19 only: 17.1 deaths per 1000 persons [95% CI, 16.9-17.2 deaths per 1000 persons]). Conclusions and Relevance: In this cross-sectional analysis, TB/COVID-19 was disproportionately diagnosed among California residents who were Hispanic or Latino, had diabetes, or were living in low health equity census tracts. These results suggest that tuberculosis and COVID-19 occurring together may be associated with increases in mortality compared with either disease alone, especially among older adults. Addressing health inequities and integrating prevention efforts could avert the occurrence of concurrent COVID-19 and TB and potentially reduce deaths.

Non-completion of latent tuberculosis infection treatment among Vietnamese immigrants in Southern California: A retrospective study.

OBJECTIVES: To examine socio-demographic and health-related factors associated with latent tuberculosis infection (LTBI) treatment refusal, non-initiation, and non-completion among a cohort of Vietnamese immigrants. DESIGN: This is a retrospective cohort study in which LTBI charts were reviewed at a public health clinic in Orange County, California between January 2010 and August 2011. SAMPLE: Altogether, 474 patient charts with documented LTBI treatment were reviewed for patients who met the inclusion criteria. MEASUREMENTS: Univariate and multivariate analyses were used to identify socio-demographic and health-related factors associated with LTBI treatment refusal, non-initiation, and non-completion. RESULTS: Of the 474 charts reviewed, 171(36.1%) patients refused LTBI treatment and 21(6.9%) accepted but did not initiate. Of the 282 that started treatment, 62 (22.0%) did not complete the regimen prescribed. The primary barrier documented for treatment refusal and non-completion was concern about medication side effects. Other barriers to treatment non-completion include transportation issues and conflicts with travel plans or work schedules. CONCLUSIONS: Community and public health nurses working with the Vietnamese immigrant population can play a vital role in improving patients' LTBI treatment acceptance, initiation, and completion. A proactive approach to addressing barriers and potential medication side effects can improve overall treatment success.

Wirelessly observed therapy compared to directly observed therapy to confirm and support tuberculosis treatment adherence: A randomized controlled trial.

BACKGROUND: Excellent adherence to tuberculosis (TB) treatment is critical to cure TB and avoid the emergence of resistance. Wirelessly observed therapy (WOT) is a novel patient self-management system consisting of an edible ingestion sensor (IS), external wearable patch, and paired mobile device that can detect and digitally record medication ingestions. Our study determined the accuracy of ingestion detection in clinical and home settings using WOT and subsequently compared, in a randomized control trial (RCT), confirmed daily adherence to medication in persons using WOT or directly observed therapy (DOT) during TB treatment. METHODS AND FINDINGS: We evaluated WOT in persons with active Mycobacterium tuberculosis complex disease using IS-enabled combination isoniazid 150 mg/rifampin 300 mg (IS-Rifamate). Seventy-seven participants with drug-susceptible TB in the continuation phase of treatment, prescribed daily isoniazid 300 mg and rifampin 600 mg, used IS-Rifamate. The primary endpoints of the trial were determination of the positive detection accuracy (PDA) of WOT, defined as the percentage of ingestions detected by WOT administered under direct observation, and subsequently the proportion of prescribed doses confirmed by WOT compared to DOT. Initially participants received DOT and WOT simultaneously for 2-3 weeks to allow calculation of WOT PDA, and the 95% confidence interval (CI) was estimated using the bootstrap method with 10,000 samples. Sixty-one participants subsequently participated in an RCT to compare the proportion of prescribed doses confirmed by WOT and DOT. Participants were randomized 2:1 to receive WOT or maximal in-person DOT. In the WOT arm, if ingestions were not remotely confirmed, the participant was contacted within 24 hours by text or cell phone to provide support. The number of doses confirmed was collected, and nonparametric methods were used for group and individual comparisons to estimate the proportions of confirmed doses in each randomized arm with 95% CIs. Sensitivity analyses, not prespecified in the trial registration, were also performed, removing all nonworking (weekend and public holiday) and held-dose days. Participants, recruited from San Diego (SD) and Orange County (OC) Divisions of TB Control and Refugee Health, were 43.1 (range 18-80) years old, 57% male, 42% Asian, and 39% white with 49% Hispanic ethnicity. The PDA of WOT was 99.3% (CI 98.1; 100). Intent-to-treat (ITT) analysis within the RCT showed WOT confirmed 93% versus 63% DOT (p < 0.001) of daily doses prescribed. Secondary analysis removing all nonworking days (weekends and public holidays) and held doses from each arm showed WOT confirmed 95.6% versus 92.7% (p = 0.31); WOT was non-inferior to DOT (difference 2.8% CI [-1.8%, 9.1%]). One hundred percent of participants preferred using WOT. WOT associated adverse events were <10%, consisting of minor skin rash and pruritus associated with the patch. WOT provided longitudinal digital reporting in near real time, supporting patient self-management and allowing rapid remote identification of those who needed more support to maintain adherence. This study was conducted during the continuation phase of TB treatment, limiting its generalizability to the entire TB treatment course. CONCLUSIONS: In terms of accuracy, WOT was equivalent to DOT. WOT was superior to DOT in supporting confirmed daily adherence to TB medications during the continuation phase of TB treatment and was overwhelmingly preferred by participants. WOT should be tested in high-burden TB settings, where it may substantially support low- and middle-income country (LMIC) TB programs. TRIAL REGISTRATION: ClinicalTrials.gov NCT01960257.

Time to Detection in Culture Supports Prediction of Low Transmissibility of Tuberculosis and Discontinuation of Isolation for Low-Risk Patients With A Single AFB-Negative and NAAT-Negative Respiratory Specimen.

For 94 patients with culture-positive pulmonary tuberculosis, time-to-detection (TTD), acid-fast bacilli (AFB) smear, and nucleic acid amplification test (NAAT) results were reviewed. All 12 patients whose first specimen was negative by AFB smear and NAAT had prolonged TTD, indicating low transmissibility and supporting discontinuing isolation for low-risk patients.Infect Control Hosp Epidemiol 2018;39:619-621.

Management of latent tuberculosis infection in child contacts of multidrug-resistant tuberculosis.

After exposure to a teacher with multidrug-resistant pulmonary tuberculosis, 31 children developed latent infection. Twenty-six were treated with levofloxacin and pyrazinamide. Twelve required a change in therapy secondary to adverse effects. The most common adverse effects included abdominal pain, arthralgias/myalgias and elevated transaminases. All children reported at least 1 adverse effect. Fifteen children completed treatment. All adverse effects were transient.