Background: Efgartigimod is a human IgG1 antibody Fc-fragment that reduces IgG levels through FcRn blockade. A key efficacy indicator in the treatment of IgG autoantibody-mediated generalized myasthenia gravis (gMG) is improvement in MG-ADL score. Methods: The ADAPT phase 3 trial evaluated safety and efficacy of efgartigimod in patients with gMG, including reaching and maintaining of minimal symptom expression (MSE; defined as an MG-ADL total score of 0 or 1). Results: 167 patients (AChR-Ab+, n=129; AChR-Ab-, n=38) were randomized to receive treatment cycles of 4 weekly infusions of efgartigimod or placebo. Significantly more AChR-Ab+ efgartigimod-treated patients achieved MSE during cycle 1 compared to placebo-treated patients (40.0% [n=26/65] vs 11.1% [n=7/63; P<0.0001]). In cycle 2, 31.4% (n=16/51) of AChR-Ab+ patients in the efgartigimod cohort achieved MSE compared to none in the placebo cohort. MG-ADL score improved by ≥6 points in 56.9% of AChR-Ab+ efgartigimod-treated patients compared to 20.6% of placebo-treated patients in cycle 1. Most patients achieved MSE by week 4 of a cycle, paralleling early reduction in IgG levels, and MSE duration ranged from 1 to ≥10 weeks. Adverse events were predominantly mild to moderate. Conclusions: Efgartigimod treatment resulted in more patients with AChR-Ab+ gMG achieving both MSE and clinically meaningful MG-ADL improvements.

Background: Efgartigimod, a human IgG1 antibody Fc-fragment, reduces IgG levels through neonatal Fc receptor blockade. Patients with anti-acetylcholine receptor antibody–negative (AChR-Ab–) generalized myasthenia gravis (gMG) comprise 15%-20% of the gMG population and have limited approved treatment options. We evaluated long-term safety and efficacy of efgartigimod in AChR-Ab– patients from ADAPT/ADAPT+ (open-label extension). Methods: ADAPT evaluated safety and efficacy of efgartigimod versus placebo in AChR-Ab+ (n=129) and Ab– (n=38) patients with gMG. This integrated analysis includes 37 AChR-Ab– patients who received ≥1 dose of efgartigimod in ADAPT/ADAPT+ through October 2020 (median[range] follow-up: 453[85-721] days). Responder status was defined as ≥2-point (MG-ADL) and ≥3-point (QMG) improvement for ≥4 consecutive weeks (with first improvement 1 week after last infusion). Results: Among AChR-Ab– patients in ADAPT (cycle 1), 68.4% (13/19) efgartigimod-treated were MG-ADL responders (placebo, 63.2% [12/19]), and 52.6% (10/19) were QMG responders (placebo, 36.8% [7/19]). In the integrated ADAPT/ADAPT+ analysis (cycle 1), AChR-Ab– patients improved from baseline in MG-ADL/QMG scores, with consistent improvements across multiple subsequent cycles. No clinically meaningful differences in safety or efficacy outcomes between AChR-Ab+ and Ab– patients occurred. Conclusions: Long-term treatment (median >1 year) with efgartigimod was well tolerated and associated with clinically meaningful improvements in MG-ADL/QMG scores in AChR-Ab– patients.

Background: The 26-week double-blind, randomized, placebo-controlled period (RCP) of the CHAMPION MG study (NCT03920293) demonstrated ravulizumab’s efficacy and tolerability in anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG). Methods: In the ongoing open-label extension (OLE), patients receive intravenous ravulizumab (blind loading dose in placebo-treated patients or bridging dose in ravulizumab-treated patients, then 3000–3600 mg according to body weight every 8 weeks) for ≤4 years. Data from RCP baseline up to Week 60 were analyzed. Results: Ravulizumab’s long-term efficacy (n=161) and safety (n=169) were assessed. Patients who switched from placebo in the RCP to ravulizumab in the OLE (n=83) showed rapid improvement (least squares mean, 95%CI) in Myasthenia Gravis-Activity of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) total scores, which were maintained through 34 weeks (MG-ADL: −1.7, −2.7 to −0.8; QMG: −3.1, −4.2 to −1.9). Improvements achieved by ravulizumab-treated patients (n=78) in the RCP were sustained through 60 weeks (MG-ADL: −4.0, −4.8 to −3.1; QMG: −4.1, −5.4 to −2.9). Ravulizumab was well tolerated; no meningococcal infections were reported. Four deaths unrelated to study treatment occurred. Conclusions: Ravulizumab demonstrated sustained improvements in MG symptoms and was well tolerated for up to 60 weeks in adults with AChR Ab+ gMG.

Background: Efgartigimod is a human IgG1 antibody Fc-fragment that reduces total and pathogenic IgG autoantibody levels through FcRn blockade. ADAPT was a phase 3 trial evaluating efgartigimod in patients with generalized myasthenia gravis (gMG). Patients who completed ADAPT could enroll in ADAPT+ (open-label extension). Methods: Efgartigimod (10 mg/kg intravenous) was administered in cycles of 4 weekly infusions, with subsequent cycles initiated based on clinical evaluation. ADAPT+ evaluated long-term safety and tolerability of efgartigimod in patients with gMG. Efficacy was assessed utilizing MG-ADL and QMG scores. Results: Of 167 patients from ADAPT, 151 (90%) entered ADAPT+, and 145 received ≥1 cycle as of January 2022. Over 217.55 patient-years of follow-up (mean duration per patient, 548 days), incidence of adverse events did not increase with subsequent cycles. AChR-Ab+ patients with ≥1 year of follow-up across ADAPT/ADAPT+ (n=95) received a median (range) 5.0 (0.4–7.6) cycles per year. All AChR-Ab+ patients (n=111) demonstrated consistent improvements (mean change [SE], week 3 of cycle 1) in MG-ADL (-5.0 [0.33]; up to 14 cycles) and QMG (-4.7 [0.41]; up to 7 cycles) scores during each cycle. Conclusions: These ADAPT+ analyses suggest long-term efgartigimod treatment is well tolerated and efficacious. Additional final data cut analyses will be presented at CNSF 2023.

The paper is concerned with common shock models of claim triangles. These are usually constructed as linear combinations of shock components and idiosyncratic components. Previous literature has discussed the unbalanced property of such models, whereby the shocks may over- or under-contribute to some observations. The literature has also introduced corrections for this. The present paper discusses “auto-balanced” models, in which all shock and idiosyncratic components contribute to observations such that their proportionate contributions are constant from one observation to another. The conditions for auto-balance are found to be simple and applicable to a wide range of model structures. Numerical illustrations are given.

Objectives: Healthcare-associated infections (HAIs) are one of the greatest challenges and concerns in Vietnam and around the world. Many studies have shown that HAIs may result in an increase in hospital length of stay, antibiotic use, multidrug-resistant organism (MDROs) infections, treatment costs, and mortality. Therefore, in the past 5 years, the Department of Infection Control of Cho Ray Hospital has carried out many infection and prevention control (IPC) activities to reduce the rates of HAI and MDRO infection. We evaluated IPC activities and results achieved in these efforts at Cho Ray Hospital during 2017–2021. Methods: We described the implemented IPC activities and retrospectively collected data from HAIs surveillance reports during 2017–2021 for 3 intensive care units (ICUs): ICU-B, ICU-D, and the NICU. Results: In the past 5 years, we implemented synchronous IPC activities, including promoting hand hygiene training and surveillance, environmental cleaning surveillance, carrying out improvement projects such as a ventilator-associated pneumonia (VAP) prevention bundle, an MDRO prevention bundle, and an environmental cleaning quality improvement project. Many positive results were achieved, although a slight increase in the HAI incidence occurred in 2021 due to the COVID-19 pandemic. Overall, the hand hygiene compliance rate increased from 49.7% to 83.8%. The rate of HAIs per 1,000 patient days decreased steadily from 5.4 to 2.4. The VAP rate fell from 30.5 to 17.2 per 1,000 patient days, and the central-line–associated bloodstream infection (CLABSI) rate decreased gradually from 5.4 to 2.4 per 1,000 patient days. The catheter-associated urinary tract infection (CAUTI) rate decreased from 2.9 to 0.9 per 1,000 patient days, and the MDRO infection rate decreased significantly from 32.7 to 11.3 per 1,000 patient days. Conclusions: The synchronous implementation of HAI prevention bundles promoting hand hygiene and environmental cleaning achieved significant effects in the efforts to decrease HAIs and MDROs in the ICUs of Cho Ray Hospital.

Objectives: During the COVID-19 surge, our hospital was overloaded due to the increasingly high volume of patients and lack of resources, which resulted in difficulties in complying with infection control and prevention (IPC) practices. In this study, we estimated healthcare-associated infection (HAI) incidence and relevant factors among COVID-19 patients in Hung Vuong hospital. Methods: This study included all SARS-CoV-2–positive adult patients hospitalized between September 1 and October 31, 2021. The Centers for Disease Control and Prevention definition of HAI in the acute-care setting was used. Results: Among 773 patients, 21 (2.72%) developed 26 separate HAIs. The cumulative days of hospitalization were 5,607. The incidence of HAI among COVID-19 patients was 4.64 per 1,000 days of hospitalization. The most frequent HAI was clinically defined pneumonia (46.2%), for which the ventilator-associated pneumonia (VAP) rate was 41.9 per 1,000 ventilator days. Among 21 positive cultures, the most frequently isolated microorganisms were pseudomonas aeruginosa, Klebsiella pneumoniae, and escherichia coli. HAIs were significantly associated with the number of central-line days (OR, 1.74; 95% CI, 1.33–2.78), the number of indwelling urinary catheter days (OR, 1.46; 95% CI, 1.05–2.03), the length of administration days (OR, 1.25; 95% CI, 1.07–1.45), antibiotics use prior to HAIs (OR, 0.01; 95% CI, 0.01–0.21), and the number of nasal cannula days (OR, 0.62; 95% CI, 0.44–0.85). Conclusions: COVID-19 makes patients more vulnerable and may require more invasive procedures, increasing the infection risk by opportunistic pathogens like gram-negative Enterobacteriaceae. Hence, fundamental IPC recommendations should be strongly implemented.

This study aims to analyze the influence of neighborhood effects (NE) on tea farmers' intention to convert from traditional to organic farming in the mountainous areas of northern Vietnam. It differs from previous studies in two aspects. First, we combine the theory of planned behavior and the theory of herd behavior to explain farmers' intention to convert from traditional to organic farming, focusing on the impact of the NE. Secondly, to measure NE, we use a combination of questionnaires and methods of measuring herd behavior by McCartney and Shah. Using the generalized structural equation modeling and data collected from 263 tea farmers in Thai Nguyen, we found that NE has a positive and direct significant effect on farmers' intention to convert to organic tea production in the case where neighbors both live nearby and have a close relationship with the subject. In addition, it indirectly impacts farmers' conversion intention through attitude, subjective norms and perceived behavior control. To encourage tea farmers to convert to organic farming, policymakers and extension workers should take advantage of the NE to increase farmers' confidence about the benefits and the possibility of successful organic farming.

Many research topics in natural language processing (NLP), such as explanation generation, dialog modeling, or machine translation, require evaluation that goes beyond standard metrics like accuracy or F1 score toward a more human-centered approach. Therefore, understanding how to design user studies becomes increasingly important. However, few comprehensive resources exist on planning, conducting, and evaluating user studies for NLP, making it hard to get started for researchers without prior experience in the field of human evaluation. In this paper, we summarize the most important aspects of user studies and their design and evaluation, providing direct links to NLP tasks and NLP-specific challenges where appropriate. We (i) outline general study design, ethical considerations, and factors to consider for crowdsourcing, (ii) discuss the particularities of user studies in NLP, and provide starting points to select questionnaires, experimental designs, and evaluation methods that are tailored to the specific NLP tasks. Additionally, we offer examples with accompanying statistical evaluation code, to bridge the gap between theoretical guidelines and practical applications.

This paper examines the effect of frontier academic research on technological development and the way institutional quality influences this impact. Using a dataset that covers 18 OECD countries over the 2003–2017 period, we find that frontier academic research exerts an important influence on total factor productivity. First, frontier academic research induces technological change by directly enhancing production processes and management methods. Second, frontier academic research stimulates industrial innovations, which in turn improves productivity. Regarding the moderating effect of institutional variables on these relationships, we find that positive moderation only exists for some, not all, of the institutional variables. In that case, a higher level of these variables is found to strengthen the way countries reap benefits from frontier academic research and industrial innovation. However, the moderation of institutions is much less clear with the process that turns frontier academic research into industrial innovations.

As the third decade of the twenty-first century begins, Vietnam embarks on a more advanced phase of national development and international integration, with a greater emphasis on foreign policy as part of the country's overall national defence and development strategy. This informs greater expectations about shifts in Vietnam's foreign policy perception and discourse in pursuit of national interests and the regime's legitimacy amidst major domestic and international developments. This article analyses the making, in terms of processes and actors, and the evolution, in terms of themes and directions, of Vietnam's foreign policy under the Thirteenth National Congress of the Communist Party of Vietnam, which was held in early 2021. The article argues that while embedding continuity with what the country has been pursuing since its renovation process (known as Doi Moi) started in the mid-1980s, Vietnam's foreign policy under the Thirteenth Party Congress is crafted on a broader base of domestic consensus and features new dimensions, implying stronger domestic support for Hanoi's conduct of foreign affairs and a Vietnamese nation brand with greater visibility and contribution in the regional and global arenas in the coming years.

Acute myocarditis is one of the common complications of coronavirus disease 2019 (COVID-19) with a relatively high case fatality. Here reported is a fulminant case of a 42-year-old previously healthy woman with cardiogenic shock and refractory cardiac arrest due to COVID-19-induced myocarditis who received veno-arterial (VA) extracorporeal membrane oxygenation (ECMO) after 120 minutes of cardiopulmonary resuscitation (CPR). This is the first adult case of cardiac arrest due to COVID-19-induced myocarditis supported by ECMO that fully recovered with normal neurological functions. The success of the treatment course with full recovery emphasized the potential role of ECMO in treating these patients.