Objective: To evaluate the effect of the FAST (Find cases Actively, Separate safely, Treat effectively) strategy on time to tuberculosis diagnosis and treatment for patients at a general hospital in a tuberculosis-endemic setting. Design: Prospective cohort study with historical controls. Participants: Patients diagnosed with pulmonary tuberculosis during hospitalization at Hospital Nacional Hipolito Unanue in Lima, Peru. Methods: The FAST strategy was implemented from July 24, 2016, to December 31, 2019. We compared the proportion of patients with drug susceptibility testing and tuberculosis treatment during FAST to the 6-month period prior to FAST. Times to diagnosis and tuberculosis treatment were also compared using Kaplan-Meier plots and Cox regressions. Results: We analyzed 75 patients diagnosed with pulmonary tuberculosis through FAST. The historical cohort comprised 76 patients. More FAST patients underwent drug susceptibility testing (98.7% vs 57.8%; OR, 53.8; P < .001), which led to the diagnosis of drug-resistant tuberculosis in 18 (24.3%) of 74 of the prospective cohort and 4 (9%) of 44 of the historical cohort (OR, 3.2; P = .03). Overall, 55 FAST patients (73.3%) started tuberculosis treatment during hospitalization compared to 39 (51.3%) controls (OR, 2.44; P = .012). FAST reduced the time from hospital admission to the start of TB treatment (HR, 2.11; 95% CI, 1.39–3.21; P < .001). Conclusions: Using the FAST strategy improved the diagnosis of drug-resistant tuberculosis and the likelihood and speed of starting treatment among patients with pulmonary tuberculosis at a general hospital in a tuberculosis-endemic setting. In these settings, the FAST strategy should be considered to reduce tuberculosis transmission while simultaneously improving the quality of care.
Background Acute otitis media (AOM) leads to considerable healthcare resource utilization in children. Streptococcus pneumoniae is an important cause of AOM. Merck is developing V114, an investigational 15-valent PCV that contains PCV13 serotypes as well as 22F and 33F. To demonstrate the potential value of V114, it is important to estimate the remaining clinical burden associated with AOM. This study estimated AOM incidence rates (IRs) before and after the introduction of 7-valent and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) in the US. Methods This was a retrospective observational study using IBM MarketScan® Commercial Claims and Encounters (CCAE) (1998-2018) and Multi-State Medicaid databases (2001-2018). AOM claims in children < 18 years old were identified using ICD9 codes 382.x and ICD10 codes H66.x and H67.x. An episode could comprise one or more AOM-related claims. A gap of at least 14 days between two AOM-related claims was required to define the start of a new episode. IRs were defined as the numbers of episodes per 1,000 person-years (PY). Annual IRs were stratified by age groups (< 2, 2-4, and 5-17), and reported separately for CCAE and Medicaid databases. Results AOM IRs declined over time among commercially and Medicaid-insured children in all age groups < 18 years old. In particular, among children < 2 years, AOM IRs declined from 1,111 in 1998 to 727/1,000 PY in 2018 in commercially plans and from 895 in 2001 to 656/1,000 PY in 2018 in Medicaid (Figure 1). In children 2-4 years, AOM IRs declined from 517 in 1998 to 400/1,000 PY in 2018 in commercial plans and from 385 in 2001 to 329/1,000 PY in 2018 in Medicaid (Figure 2). In children 5-17 years, AOM IRs declined from 112 in 1998 to 87/1,000 PY in 2018 in commercial plans and from 98 in 2001 to 87/1,000 in 2018 in Medicaid (Figure 3). Figure 1. AOM incidence in commercially and Medicaid-insured children ages 0 - 1 years, episodes per 100,000 patient-years (1998 - 2018) Figure 2. AOM incidence in commercially and Medicaid-insured children ages 2 - 4 years, episodes per 100,000 patient-years (1998 - 2018) Figure 3. AOM incidence in commercially and Medicaid-insured children ages 5 - 17 years, episodes per 100,000 patient-years (1998 - 2018) Conclusion AOM IRs declined following the introduction of PCV7 and PCV13; however, disease burden remains substantial in younger children. The impact of future PCVs on AOM will depend on the proportion of AOM caused by S. pneumoniae and vaccine-type serotypes. Disclosures Tianyan Hu, PhD, Merck (Employee, Shareholder) Yan Song, PhD, Merck (Consultant) Nicolae Done, PhD, Merck & Co., Inc. (Consultant) Eli Orvis, BA, Merck (Consultant) James Signorovitch, PhD, Merck & Co., Inc. (Consultant) Tanaz Petigara, PhD, Merck & Co., Inc. (Employee, Shareholder)
The economic burden of rheumatoid arthritis (RA) to both patients and society is high.Healthcare costs are not often collected as outcomes in clinical trials of RA treatments.Patient-reported outcomes, such as the Short Form 36 (SF-36) Health Survey, are frequently collected in clinical trials to assess health-related quality of life from the patient perspective and may provide a means to evaluate the economic benefit of various RA treatments.What was learned from the study?On the basis of improvements in healthrelated quality of life in the short and long term, combination therapy with upadacitinib 15 mg once daily was associated with significantly lower direct medical costs than combination therapy with tofacitinib 5 mg twice daily in patients with moderate to severe RA.In addition, upadacitinib 15 mg once daily monotherapy was associated with significantly lower direct medical costs than methotrexate monotherapy for patients with moderate to severe RA.Estimates of healthcare expenditures using the patient-reported outcome SF-36 may improve our understanding of the economic implications of different RA treatment strategies.
Background Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population. Methods and findings We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: −0.06; 95% CI [−0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. Conclusions In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes. Trial registration This study is registered with ClinicalTrials.gov NCT03154320.
Background: Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment would be superior to standard care in this population. Methods and Findings: We conducted an open-label randomized trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day treatment [TB medication if TB; ART if no TB]) vs. standard care. In both groups, ART was initiated two weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group). Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 229 (91.6%) were retained, and 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 218 (87.2%) were retained, and 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% vs. 67.2%; risk difference: -0.06; 95% CI: -0.15, 0.02; p=0.14). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. Conclusions: In patients with TB symptoms at HIV diagnosis, same-day treatment is not associated with superior retention and viral suppression. A short delay in ART initiation, which facilitates more feasible TB testing, does not compromise outcomes.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.