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.

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.

Molecular epidemiology of tuberculosis after declining incidence, New York City, 2001-2003.

Tuberculosis incidence in New York City (NYC) declined between 1992 and 2000 from 51.1 to 16.6 cases per 100,000 population. In January 2001, universal real-time genotyping of TB cases was implemented in NYC. Isolates from culture-confirmed tuberculosis cases from 2001 to 2003 were genotyped using IS6110 and spoligotype to describe the extent and factors associated with genotype clustering after declining TB incidence. Of 2408 (91.8%) genotyped case isolates, 873 (36.2%) had a pattern indistinguishable from that of another study period case, forming 212 clusters; 248 (28.4%) of the clustered cases had strains believed to have been widely transmitted during the epidemic years in the early 1990s in NYC. An estimated 27.4% (873 minus 212) of the 2408 cases were due to recent infection that progressed to active disease during the study period. Younger age, birth in the United States, homelessness, substance abuse and presence of TB symptoms were independently associated with greater odds of clustering.