• A Real-World Prospective Observational Study to Describe the Safety Profile and Clinical Outcomes of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) In Chinese Patients with Chronic Obstructive Pulmonary Disease (COPD).
    4 days ago
    This observational, multicenter, prospective, single-arm study (NCT04536402) aimed to describe the safety profile and clinical outcomes of Budesonide/Glycopyrrolate/Formoterol Fumarate metered dose inhaler (BGF MDI) for Chinese patients with COPD in clinical practice.

    COPD patients who had been prescribed and had planned to take at least one inhalation of BGF MDI were followed-up for 12 weeks at 4-week intervals. The primary endpoints were incidences of adverse events (AEs) and serious adverse events (SAEs). Secondary endpoints included changes from baseline in COPD Assessment Test (CAT) score and St George's Respiratory Questionnaire (SGRQ) score and patient global impression of change (PGIC) scale at week 4. Patients were also stratified into subgroups according to the asthma history, exacerbation history, and baseline treatment and assessed.

    Of the enrolled 3,317 patients, 2,137 completed and 1,180 discontinued the study. No unexpected safety signals were observed; most AEs were mild (13.2%) or moderate (7.2%). SAEs occurred in 4.9% of patients. BGF MDI was associated with decreased CAT and SGRQ total scores (mean [SD] changes from baseline: -6.7 [7.27], -14.5 [18.19]) and increased FEV1 (189 mL, n = 241) at week 12. Similar trend of improvement was also observed in the subgroups. At week 4, 84.8% rated overall PGIC status as "improved," and 87.6% were satisfied with the MDI device.

    In real-world practice, BGF MDI demonstrated good tolerability consistent with previous RCTs, and associated with a trend toward improvement in patients' symptoms, quality of life, and lung function, regardless of asthma history, exacerbation history, or baseline treatment.

    NCT04536402 (ClinicalTrials.gov), registered on 28 August 2020.
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  • [Neurocognitive functioning after cognitive treatment in post-COVID].
    4 days ago
    Post-COVID is a post-infectious condition resulting from COVID-19 (SARS-CoV-2) that can cause a wide range of neurocognitive and psychological symptoms. As no curative treatment currently exists, it is important to help patients learn how to manage their symptoms.

    To examine whether adults with post-COVID benefit from a treatment program focused on cognitive resilience, in terms of cognitive functioning and psychological symptoms.

    A pre-post design without a control group was used within a mental health care setting. Twenty-three participants with post-COVID completed a 24-week group-based program consisting of two modules: balancing limited energy and cognitive rehabilitation. Neuropsychological tests, the SCL-90, and the RAND-36 were administered before and after treatment. Differences between pre- and post-treatment scores were analyzed using Wilcoxon signed-rank tests.

    Of the 23 participants, 15 completed the program. Verbal learning improved significantly (p = 0.01). No significant changes were found in other neurocognitive domains. Psychological symptoms decreased significantly (p = 0.03).

    Despite the small sample size, several significant improvements were observed. Participants reported feeling supported by peer contact within the group. Further research is needed to clarify a causal relationship between the treatment program and improvements in cognitive functioning.
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  • Five-year follow-up of phase II trial of autologous cord blood mononuclear cells for bronchopulmonary dysplasia prevention in very preterm infants.
    4 days ago
    We previously performed a phase II clinical trial involving the intravenous infusion of autologous cord blood mononuclear cells (ACBMNCs) to prevent bronchopulmonary dysplasia in premature infants. We reported the outcomes before discharge and at 2-year follow-up of the enrolled infants. We have reported the developmental outcomes at the 5-year follow-up visit.

    We evaluated the 5-year long-term outcomes of ACBMNCs infusion, including growth, respiratory, and neurodevelopmental outcomes, by interviewing the parents. Children's development was assessed using scores on the Chinese version of the Ages & Stages Questionnaires (ASQ), third edition (ASQ-3), completed by the parents or guardians. The primary outcome was the neurodevelopmental outcome. The secondary outcomes were growth and respiratory outcomes.

    In terms of the primary endpoint, intravenously infused ACBMNCs significantly improved the scores of the fine motor and personal-social domains in the ASQ (P = .044 and P = .048, respectively). This study also showed high consistency between the motor index in the Bayley score at a 2-year follow-up with both gross and fine motor domain scores, as well as the language index with communication, problem-solving, and personal-social domain scores. Although pneumonia-related hospitalizations were similar between the two groups, the intervention group showed a lower possibility of nocturnal cough.

    Infants who received intravenous ACBMNC infusion had better fine motor and personal-social abilities at 5 years than those in the control group. In addition to providing reassuring safety data, the study suggested longer-term neurodevelopmental benefits of ACBMNC intervention early in the NICU course. Further randomized placebo-controlled trials are essential to confirm these findings.

    The trial was prospectively registered at ClinicalTrials.gov (NCT02999373), registered on December 21, 2016.
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  • Impact of a Staged Enteral Nutrition Nursing Pathway Based on Dynamic Assessment of Tolerance and Aspiration Risk vs Usual Care on Feeding Intolerance in Older Adult Patients With Acute Ischemic Stroke and Dysphagia: A Single-Center Randomized Controlled Trial.
    4 days ago
    BACKGROUND Older adult patients with acute ischemic stroke have dysphagia and require early post-pyloric enteral nutrition, yet feeding intolerance and unstable energy delivery remain common, and practical pathways that integrate tolerance and aspiration risk are lacking. This trial evaluated whether a dual-axis staged nursing pathway, compared with usual care, was associated with lower feeding intolerance and better nutritional delivery. MATERIAL AND METHODS This single-center, parallel, 1: 1 randomized controlled trial enrolled older adult patients with acute ischemic stroke and dysphagia with post-pyloric nasoenteric tubes placed. The intervention group received a staged nursing pathway, and the control group received usual care. The primary outcome was 7-day feeding intolerance; secondary outcomes were time to ≥80% of target, target-achieving days, aspiration-related pneumonia, and safety. Analyses were intention-to-treat. RESULTS Compared with control, the intervention group had a lower 7-day risk of feeding intolerance (adjusted RR 0.61, 95% CI, 0.47-0.81; P=0.003); faster attainment of at least 80% of energy target (adjusted HR 1.65, log-rank P<0.001); target-achieving-day proportion was higher (difference 0.16, Holm-adjusted P=0.001); risk of aspiration-related pneumonia was lower (adjusted RR 0.54, Holm-adjusted P=0.041); and difference in feeding-related hypoxemia was not significant (P=0.189). No between-group differences were observed in tube displacement, upper gastrointestinal bleeding, or electrolyte disturbances (all P>0.05). Subgroup/sensitivity analyses were consistent. CONCLUSIONS A staged nursing pathway driven by dynamic dual-axis assessment was associated with lower feeding intolerance and earlier, more stable nutritional delivery in the context of post-pyloric feeding, without increasing short-term safety events.
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  • Catheter-Directed Thrombolysis and Direct Oral Anticoagulant Class Switch to Prevent Pulmonary Embolism From Large Inferior Vena Cava Thrombus.
    4 days ago
    BACKGROUND Inferior vena cava (IVC) thrombosis is an uncommon complication of deep vein thrombosis and may be associated with a high risk of severe pulmonary embolism, particularly in the presence of free-floating thrombi. Although IVC filter placement may be considered to prevent embolization, prolonged filter dwell increases the risk of recurrent venous thrombosis and reduces retrieval success, highlighting the importance of early thrombus clearance. However, evidence regarding optimal interventional and anticoagulation strategies for IVC thrombosis remains limited. CASE REPORT A 46-year-old woman with Down syndrome and adjustment disorder presented with sudden-onset chest pain and syncope. On admission, she was hypotensive and hypoxemic. Contrast-enhanced computed tomography revealed bilateral pulmonary emboli and a large floating IVC thrombus extending from below the renal vein to the right common iliac vein. A retrievable IVC filter was placed, and anticoagulation was initiated. No underlying thrombophilia was identified. After 2 weeks, regression of the IVC thrombus was insufficient, and catheter-directed thrombolysis with alteplase and heparin was performed, resulting in marked clinical improvement. The patient was discharged on apixaban. After 2.5 months, the pulmonary arterial thrombi had resolved; however, the IVC thrombus persisted. Switching anticoagulation from apixaban to dabigatran led to complete thrombus resolution 4 months after symptom onset, allowing successful retrieval of the IVC filter. CONCLUSIONS This case highlights the potential role of alteplase-based catheter-directed thrombolysis for early thrombus reduction and suggests that switching from a factor Xa inhibitor to a direct thrombin inhibitor may be effective in select patients with refractory IVC thrombosis.
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  • Responding to the COVID-19 pandemic through global partnerships: the case of the HRP Alliance for research capacity strengthening.
    4 days ago
    The UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) has a mandate to lead in sexual and reproductive health and rights research and to support research capacity strengthening. Starting in 2016, it did so through supporting the latter through a large network of research institutions called the HRP Alliance. This commentary highlights the work of the HRP Alliance in response to the coronavirus disease (COVID-19) pandemic.

    The onset of the COVID-19 pandemic prompted the HRP Alliance to adapt the way they had been working. HRP Alliance research capacity strengthening hubs actively contributed to developing a research agenda based on WHO's research and development blueprint and country-specific needs. They also took on leading roles in developing, adapting to each country/setting, and implementing research projects aimed at understanding how the COVID-19 pandemic was affecting SRHR in different contexts and income settings. These studies provided opportunities for early career researchers and students to lead in project management, study implementation, training, and data analysis. Through a network of nimble research institutions, the HRP Alliance collaborated to generate evidence on the impact of COVID-19 on pregnancy, pregnancy outcomes, access to SRHR services, gender-based violence, and abortion care. The success of implementing these research response mechanisms and developing global networks of research and healthcare institutions, provided solid ground upon which to build SRHR research responses to future pandemics and other emerging diseases.

    Adequate readiness and response to global health emergencies require high quality and timely evidence generation. Global networks of research partner institutions, brought together through research capacity strengthening initiatives, can provide a fruitful platform ready and able to swiftly respond. However, inherent power imbalances and challenges to equitable partnerships need to be considered to ensure sustainable ways of working together.
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  • HLA-B class I allele associations with neurological complications in pediatric SARS-CoV-2 infection: a retrospective observational study.
    4 days ago
    Most severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in children are mild, yet neurological complications can occur. Host immune variability is partly determined by human leukocyte antigen (HLA) polymorphisms and may influence susceptibility. This study investigates whether specific HLA-B alleles are associated with neurological involvement in pediatric coronavirus disease 2019 (COVID-19).

    This retrospective study spanned over one year, including children with confirmed SARS-CoV-2 infection. Patients were classified into two groups: patients with COVID-19 with neurological disease (neuro-COVID-19), and those with COVID-19 without neurological disease (non-neuro COVID-19). A control group of 120 healthy children was included to represent baseline allele distribution. HLA-B class I allele typing was performed using polymerase chain reaction with sequence-specific oligonucleotide probes (PCR-SSOP).

    HLA-B49 represented the most common allele among children suffering from neurological COVID-19 (10.4%). None of the alleles reached statistical significance when compared in patients with and without neurological disease. A possible, but not statistically significant, lower frequency of the HLA-B52 allele was observed in cases with neurological manifestations (p = 0.088). However, in exploratory unadjusted analyses, HLA-B53 showed higher odds of neurological involvement when compared with children without neurological disease and healthy controls (OR = 6.29; 95% CI: 1.23-32.13; nominal p = 0.027), while HLA-B45 demonstrated a positive trend (OR = 3.75; 95% CI: 0.87-16.22; nominal p = 0.077). These allele-level findings were not corrected for multiple comparisons and should therefore be interpreted as exploratory and hypothesis-generating.

    This study suggests a possible immunogenetic contribution to neurological complications in pediatric COVID-19, with a nominal unadjusted signal for HLA-B53. Given the small sample size, multiple-allele testing, and the absence of adjusted modelling, this finding should be considered exploratory and hypothesis-generating. Validation in larger multicenter cohorts with correction for multiple comparisons and adjustment for relevant confounders is required.
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  • Respiratory Syncytial Virus Suppression through Public Health and Social Measures, Hong Kong, China, 2020-2023.
    4 days ago
    Public health measures during COVID-19 were associated with reduced respiratory syncytial virus cases in Hong Kong, China. Mask wearing was associated with a 35% reduction; avoidance behaviors and hand hygiene were also associated with reductions. After the mask mandate was lifted in March 2023, we observed resurgence in RSV activity.
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  • Single-mother households and risk of poor dietary quality among schoolchildren: results from a nationwide survey.
    4 days ago
    The COVID-19 pandemic prompted lifestyle changes and increased parental stress and food insecurity, raising concern for single-parent households. This study investigates disparities in schoolchildren's diet quality in single-parent and two-parent households in Japan before, during and after the April 2020 state of emergency, considering financial status and parental meal preparation skills.

    Data from a nationwide cross-sectional study conducted in December 2020 were analysed. A stratified two-stage cluster sampling design was used to select households with fifth-grade and eighth-grade students. Parents reported their child's dietary intake before, during and after the state of emergency and their knowledge about food. 'Poor dietary quality' was defined as failing to consume any of the following food categories at least twice a day: 'milk and dairy products', 'meat, fish or eggs', 'vegetables' and 'fruits'. Multilevel modified Poisson models were used to estimate prevalence risk ratios and differences in dietary quality.

    Among 1534 parents, single-mother households exhibited higher risk of poor dietary quality during and after the state of emergency (univariate prevalence differences 13.4% (95% CI 3.5% to 23.2%) and 8.3% (95% CI 1.8% to 14.8%), respectively) compared with two-parent households. This difference persisted after adjusting for child sex and grade but substantially diminished after accounting for food literacy and financial status. No significant increase was observed in single-father households.

    Single-mother households, marked by lower food literacy and income, experience a higher prevalence of poor dietary quality. Targeted support is crucial to improve diet quality in single-mother households compared with their two-parent counterparts.
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  • Qualitative exploration assessing the acceptability of shared decision-making for prescribing airway clearance techniques in adults with bronchiectasis.
    4 days ago
    Determine patients' and physiotherapists' prospective acceptability of using a shared decision-making (SDM) intervention to support patient choice of airway clearance technique (ACT) prescription for adults with bronchiectasis.

    We conducted a qualitative study using focus groups and interviews.

    Participants were recruited throughout the UK. All interviews and focus groups were conducted from the researcher's private home or Research Team office at Newcastle University. Face-to-face focus groups or interviews were conducted in a university conference room.

    21 physiotherapists and 21 patients living with bronchiectasis participated.

    12 themes were identified covering all seven domains of the theoretical framework of acceptability. Themes included: adherence, cultural challenges, education, empowerment, engagement, flexibility, health literacy, overwhelming information, participant understanding, resources, supportive of preferences and time.

    A SDM intervention to support patient choice of ACT in bronchiectasis appears to be acceptable to both stakeholder groups. Additionally, we identified novel factors informing the design and implementation of a future SDM intervention. Future research should consider the systematic development of an SDM intervention to support patient choice of ACT in bronchiectasis.
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