Patient navigator's role in latent tuberculosis infection at a New York City Health Department Chest Clinic.

Background: Philippines is one of the top ten countries of birth among individuals with tuberculosis in New York City (NYC). The NYC Health Department (HD) screened Filipino-born New Yorkers for latent TB infection (LTBI), but few of those tested positive completed evaluation and treatment. Objective: To increase the proportion of Filipinos with a positive QuantiFeron-TB Gold Plus (QFT-Plus) complete LTBI evaluation and treatment. Methods: Nine community-based LTBI screening events were conducted during September-December 2021. Patients with positive QFT-Plus results were offered no-cost LTBI evaluation and treatment at HD Chest Clinic. The HD engaged culturally- and linguistically-competent Filipino patient navigators (PN) to facilitate LTBI evaluation and treatment. Results: Of 77 Filipinos screened, 17 (22%) tested positive. Fourteen (82%) were evaluated for LTBI; eight of the 14 (57%) completed LTBI treatment. Conclusions: Pairing patients with culturally- and linguistically- competent Filipino PNs contributed to an increase in the proportion of Filipinos with a positive QFT-Plus who completed LTBI evaluation and treatment. TB prevention programs may wish to consider PNs in LTBI patient care.

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

BACKGROUND: 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.METHODS: Participant symptoms, symptom severity, and clinical management were documented. We assessed adverse event reports (AERs) by DOT method during the two-period crossover. Using Cox proportional-hazards mixed-effects models, we estimated the adjusted hazard ratio (aHR) of participants reporting an adverse event (AE) vs. not reporting an AE.RESULTS: Of 211 participants, 57 (27.0%) reported AEs during the two-period crossover; of these, 54.4% (31/57) were reported while using eDOT vs. 45.6% (26/57) while using ipDOT. Controlling for study group and period, the aHR for eDOT vs. ipDOT was 0.98 (95% CI 0.49-1.93). Although statistically not significant, the wide confidence intervals suggest that a significant association cannot be entirely ruled out. Gastrointestinal symptoms were most frequently reported (42.1%, 24/57). AER types and severity did not differ significantly by DOT method. Days from symptom onset to medical attention was similar across DOT methods (median: 1.0 day, IQR 0.0-2.0). No participants switched DOT methods due to AERs or monitoring concerns.CONCLUSION: Further evaluation to ascertain whether AERs differ when patients use eDOT vs. ipDOT is warranted.

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

BACKGROUND: 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.METHODS: 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. A logistic mixed-effects model that adjusted for the study design was used to estimate the percentage of successfully observed doses when challenges occurred.RESULTS: A total of 20,097 medication doses were scheduled for observation with either eDOT (15,405/20,097; 76.7%) or ipDOT (4,692/20,097; 23.3%) for 213 study participants. In total, one or more challenges occurred during 17.3% (2,672/15,405) of eDOT sessions and 15.6% (730/4,692) of ipDOT sessions. Among 4,374 documented challenges, 27.3% (n = 1,192) were characterized as technical, 65.9% (n = 2,881) were patient-related, and 6.9% (n = 301) were program-related. Estimated from the logistic model (n = 6,782 doses, 173 participants), the adjusted percentage of doses successfully observed during problematic sessions was 21.7% (95% CI 11.2-37.8) for eDOT and 4.2% (95% CI 1.1-14.7) for ipDOT.CONCLUSION: Compared to ipDOT, challenges were encountered in a slightly higher percentage of eDOT sessions but were more often resolved to enable successful dose observation during problematic sessions.

Cost savings associated with video directly observed therapy for treatment of tuberculosis.

OBJECTIVE: To calculate the per-session and annual direct program costs to implement directly observed therapy (DOT) for tuberculosis treatment and to conduct a cost attribution analysis under varying proportions of DOT utilization for four DOT types.DESIGN: Program data covering the study period from September 2014 to August 2015 in New York City (NYC) were used to conduct a retrospective bottom-up micro-costing economic evaluation. For each DOT type, potential per-session and annual program savings were estimated as the cost averted by adopting a uniform distribution of DOT alternatives. Sensitivity analyses explored aggregate cost impacts of unequal distributions.RESULTS: There was a total of 38 035 unique DOT visits, of which 12 002 (32%) were clinic-based (CDOT); 15 483 (41%) were field-based (FDOT); 7185 (19%) were live-video (LVDOT); and 3365 (9%) were recorded-video (RVDOT). The per-session direct costs (in 2016 $US) for DOT services delivered during the study period were $8.46 for CDOT; $19.83 for FDOT; $6.54 for LVDOT; and $5.35 for RVDOT. Sensitivity analyses supported the main findings.CONCLUSIONS: Significant cost savings were estimated with increased utilization of VDOT. Assuming equivalent treatment adherence, duration, completion, and adverse events across DOT types, RVDOT was the modality that most minimized cost.

Improved treatment completion with shorter treatment regimens for latent tuberculous infection.

SETTING: Four New York City (NYC) Health Department tuberculosis (TB) clinics. OBJECTIVE: To assess the effectiveness of preferentially offering two shorter treatment regimens-4 months of daily rifampin (4R) and 3 months of once-weekly isoniazid and rifapentine (3HP)-as an alternative to 9 months of daily isoniazid (9H) for the treatment of latent tuberculous infection (LTBI). DESIGN: Retrospective analysis of patients treated for LTBI from January to June 2015. Poisson regression with robust standard error was used to examine the factors associated with treatment completion. RESULTS: Of the patients on 9H, 49% (27/55) completed treatment compared with 70% (187/269) of patients on 4R (P = 0.003) and 79% (99/125) of patients on 3HP (P < 0.001). When adjusting for age, sex, and TB risk factors, patients on 4R (adjusted risk ratio [aRR] 1.39, 95%CI 1.07-1.81) and 3HP (aRR 1.67, 95%CI 1.27-2.19) were more likely to complete treatment than patients on 9H. Treatment was discontinued due to side effects in 1% (3/269) of patients on 4R, 2% (2/125) of patients on 3HP, and 4% (2/55) of patients on 9H. CONCLUSIONS: Most patients were placed on shorter regimens for LTBI treatment, and higher treatment completion was observed. Encouraging community providers to use shorter regimens for LTBI treatment would reduce the TB disease burden in NYC.

Long-term functional outcomes and knee alignment of computer-assisted navigated total knee arthroplasty.

INTRODUCTION: This retrospective study examined the relationship between the mechanical axis throughout a functional arc of motion and functional outcome scores in patients undergoing computer-assisted navigation-based total knee arthroplasty (CAN-TKA) at 6-year follow-up. MATERIALS AND METHODS: The Stryker eNact Precision Knee Navigation System was utilized to obtain pre- and postoperative alignment measurements throughout the functional arc of motion. Patients were contacted via telephone and asked to complete the Short Form-12 and Western Ontario and McMaster Universities, which have been demonstrated to be reliable, valid, and sensitive assessment tools in this patient population. Statistical analysis was performed to determine the correlation between arc alignment and patient-reported functional outcome measures. RESULTS: A total of 47 patients at a mean of 76.1 (±6.3)-month follow-up and mean age of 65.9 (±7.9) years were surveyed. No correlation was found between the postoperative alignment or degree of intraoperative correction and the functional outcome scores. In a planned subgroup analysis of patients with a mean functional arc alignment greater than 3° from neutral, mean intraoperative degree of correction correlated with decreasing physical function (Spearman's ρ = 0.772, p = 0.04) and mean postoperative arc alignment positively correlated with increasing stiffness (ρ = 0.798, p = 0.03). CONCLUSION: This study suggests that patients undergoing CAN-TKA with mean functional arc range of motion greater than 3° may be at increased risk for suboptimal patient-reported functional outcomes. This study also illustrates the ability of CAN-TKA to measure the varus or valgus alignment of the knee throughout the entire range of motion.

Enhancing management of tuberculosis treatment with video directly observed therapy in New York City.

SETTING: Directly observed therapy (DOT), the standard of care for monitoring patients on treatment for tuberculosis (TB), requires substantial health department resources, and can be inconvenient and disruptive for patients. OBJECTIVE: To determine whether video technology for remote observation of patients on anti-tuberculosis treatment (VDOT) is as effective as in-person DOT. DESIGN: Eligible TB patients in New York City were prospectively enrolled in VDOT from September 2013 to September 2014. We compared treatment outcomes and worker output for VDOT and in-person DOT. RESULTS: Among 390 patients on DOT for the treatment of TB, 61 (16%) were on VDOT and 329 (84%) on in-person DOT. Adherence to scheduled VDOT sessions was 95% (3292/3455) compared to 91% (32 204/35 442) with in-person DOT (>P < 0.01). VDOT enabled a DOT worker to observe a maximum of 25 patients per day, similar to DOT workers who observed patients in clinic (n = 25), but twice that of DOT workers who observed patients in the community (n = 12). Treatment completion with VDOT was similar to that with in-person DOT (96% vs. 97%, P = 0.63). The primary problems encountered during VDOT sessions were interruption of video and audio connectivity. CONCLUSION: Implementation of VDOT resulted in successful anti-tuberculosis treatment outcomes while maximizing health department resources.

Transmission trends for human immunodeficiency virus associated tuberculosis in New York City.

SETTING: Since 1992, tuberculosis (TB) control measures have reduced incidence rates in New York City and elsewhere. Nevertheless, trends have not been uniform in all demographic groups. OBJECTIVE: To characterize the epidemiology of human immunodeficiency virus (HIV) associated TB in New York during the 1990s, we analyzed social, demographic and clinical characteristics and genetic data on Mycobacterium tuberculosis isolates among persons with known HIV-status. DESIGN: A retrospective case-control study to compare patients with HIV-associated TB and patients with TB alone. RESULTS: Of 546 patients (70.5%) in the Department of Health Tuberculosis Control Registry treated for TB, 385 also had documented HIV status; 198 were HIV-infected (51%) and 187 (49%) were not. Genotype analysis of the 385 M. tuberculosis isolates identified 200 (52%) clustered strains, representing recent transmission. Although the overall percentage of TB cases associated with restriction fragment length polymorphism (RFLP) clustering fell over the period studied, HIV-associated cases were still much more likely to be associated with clustering than non-HIV-associated cases. CONCLUSIONS: Continued attention is required to contain the spread of TB in this vulnerable population.

Tuberculosis and HIV infection: epidemiology, immunology, and treatment.

Tuberculosis and HIV have combined to present a major threat to global public health. Each disease has a negative effect on the other, and mortality in patients with both tuberculosis and HIV is higher than that caused by either condition alone. In regions such as sub-Saharan Africa, as many as a third or more of all patients with tuberculosis have concomitant HIV infection. In urban centers in developed nations, HIV co-infection may also be quite common. Treatment of latent tuberculosis infection in persons with HIV is successful in preventing many cases of active disease, and newer ultra-short course regimens, such as those consisting of 2 months of rifampin and pyrazinamide, should aid in this effort. Diagnosis and treatment of active tuberculosis in HIV-infected patients may be difficult. Although treatment of active tuberculosis is generally successful in patients with HIV, drug interactions between anti-tuberculosis medications and antiretrovirals often complicate the matter, and expert guidance should be sought for proper management.

Comprehensive medical care among HIV-positive incarcerated women: the Rhode Island experience.

Our objective was to characterize the clinical presentation of human immunodeficiency virus (HIV) infection among incarcerated women in a program that provides HIV testing and primary care to all state prisoners in Rhode Island. A retrospective medical chart review on all HIV-seropositive women who were incarcerated between 1989 and 1994 and had at least two medical visits with an HIV medical care provider was used. At the Rhode Island Adult Correctional Institution (ACI), under mandatory testing laws between 1989 and 1994, 28% (172 of 623) of all women were identified with HIV infection. Of the 172 women who tested seropositive in prison, 110 were included in the study. Of the 110 women followed, 84% reported injection drug use (IDU) as their primary risk factor, and 30% reported both IDU and sex work. The median CD4 count was 596/mm3, with 60% having a CD4 count >500 cells/mm3. The most common medical conditions were vaginal candidiasis, oral candidiasis, and bronchitis. Antiretroviral therapy was well accepted and followed community standards. Continuity of medical care after release was facilitated by the same physician caring for the patient in the community setting, with 83% of women following up for HIV care after release. The medical conditions noted reflect that these women are early in the course of their HIV disease when they are initially diagnosed. This comprehensive program in Rhode Island's state prison plays a central role in the diagnosis of HIV-seropositive women and provides counseling, primary medical and gynecological care, and linkage to community resources after release.

HPLC purification of synthetic oligodeoxyribonucleotides containing base- and backbone-modified sequences.

Applications for a new polymer resin, PolyFlo, are described for both the small-scale and large-scale purification of synthetic oligodeoxyribonucleotides varying in length from 18-41 bases. The unique properties of this innovative resin provide > 95% purified full-length oligodeoxyribonucleotides with greater than 90% yield starting from either crude trityl-on or trityl-off unmodified as well as base (biotin)- or backbone (e.g., phosphorothioate)-modified products. Full biological activity of recovered nucleic acid is retained, and the resin is capable of removing contaminating endotoxins during purification. The resin performance is predictable and reliable. The resin can be regenerated easily and is particularly economic when employed directly in ammonia or with the trityl-off option. PolyFlo meets the requirements of current Good Manufacturing Practices.

Modified technique for balloon valvuloplasty of critical pulmonary stenosis in the newborn.

OBJECTIVES: We report our experience in eight consecutive neonates who underwent attempted balloon dilation as an initial therapy for critical valvular pulmonary stenosis, and we review in detail technical modifications that improved the success rate. BACKGROUND: Balloon dilation of the pulmonary valve has become the treatment of choice for valvular pulmonary stenosis in children and adults. There are few reports of its effectiveness in critical pulmonary stenosis in the newborn. In this setting, application of the technique of balloon dilation has been limited by the ability to advance the necessary guide wires and catheters across the stenotic, often near-atretic, pulmonary valve. METHODS: The pulmonary valve was crossed in all patients. When this could not be accomplished with an end-hole catheter, a soft guide wire was advanced directly across the pulmonary valve through the end-hole catheter positioned in the right ventricular outflow tract below the valve. Initial predilation was achieved in all patients by using a coronary dilation catheter in an effort to facilitate introduction of the definitive balloon dilation catheter. Definitive dilation with a balloon diameter of > or = 110% of the diameter of the pulmonary valve annulus was possible in six patients. RESULTS: Right ventricular pressure declined from a mean value of 108 +/- 32 mm Hg to a mean value of 49 +/- 11 mm Hg after balloon dilation, with no change in heart rate or aortic pressure in these six patients after definitive balloon dilation. CONCLUSIONS: The results of this small series suggest that critical valvular pulmonary stenosis in the newborn can be successfully treated by transluminal balloon valvuloplasty.