PURPOSE:To evaluate the clinical efficacy, safety, and immunogenicity of biosimilar SSGJ-601 compared with ranibizumab in patients with macular edema secondary to branch retinal vein occlusion (BRVO). DESIGN:A multicenter, randomized, double-masked, active-controlled phase 3 clinical study. PARTICIPANTS:A total of 351 patients with macular edema secondary to BRVO were enrolled. METHODS:Evaluable patients (N=351) were randomized to receive intravitreal SSGJ-601(1.25mg per eye, Q4W) or intravitreal ranibizumab (0.5mg per eye, Q4W) from day 1 through week 20 (6 injections in total), and treatment transitioned to a pro re nata (PRN) schedule based on investigator-assessed retreatment criteria from week 24 to week 48. All patients completed their end-of-study visit at week 52. MAIN OUTCOME MEASURES:The primary efficacy endpoint was the Least Squares (LS) mean difference in change in best-corrected visual acuity (BCVA), measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, from baseline to week 24. Secondary efficacy endpoints, safety, pharmacokinetics, immunogenicity and change in VEGF concentration of SSGJ-601 were also analyzed. RESULTS:Demographic and baseline characteristics and exposure to treatment were similar between groups. In the study eye, SSGJ-601 was non-inferior to ranibizumab in improving the LS mean in BCVA letter count from baseline to week 24 (17.6 (0.66) vs. 18.2 (0.65) letters, -0.6 with 95%CI: (-2.4,1.3), P for non-inferior<0.0001), thus, the primary clinical efficacy end point was met. At each time point, the proportions of patients achieving BCVA gains of ≥5, ≥10, and ≥15 letters in the SSGJ-601 group were non-inferior to those in the ranibizumab group. Drug-related TEAEs (11.4% vs. 12.5%) and SAEs (6.9% vs. 9.1%) were comparable in the two treatment groups. A low incidence of binding antidrug antibodies was observed in SSGJ-611 group. CONCLUSIONS:This study supports the conclusion of no clinical meaningful differences in efficacy, safety, and immunogenicity between SSGJ-601 and ranibizumab in patients with macular edema secondary to BRVO. Additionally, treatment transitioned to a pro re nata (PRN) schedule based on investigator-assessed retreatment criteria resulted in sustained benefits in visual and anatomical outcomes.
IntroductionTo evaluate the feasibility of using diffusion-weighted magnetic resonance imaging (DWI) to differentiate connective tissue disease-associated optic neuritis(CTD-ON) from idiopathic optic neuritis (IDON). Materials and MethodsA retrospective observational study was conducted on 66 acute optic neuritis(ON) patients. Twenty-five patients (36 eyes) were comorbid with CTD, and 41 patients (49 eyes) had idiopathic ON and served as controls. All patients underwent routine magnetic resonance imaging (MRI) of the orbit and DWI.Affected optic nerves were evaluated for laterality, visual acuity, papilledema, visual outcome, and signal characteristics on DWI and conventional MRI. Clinical characteristics were compared using two-sample t-tests and chi-square tests. Spearman’s rank correlation, logistic regression, and receiver operating characteristic (ROC) curve analyses were performed to evaluate the diagnostic value of DWI for CTD-ON. ResultsCompared with the IDON group, patients with CTD-ON showed significantly more severe visual impairment and worse prognosis (P < 0.05). Optic nerve hyperintensity on DWI (DWI-H) was a significant risk factor for visual acuity at onset and final visual outcome in ON patients [ORs = 1.893 (95% CI: 1.322-2.711, P < 0.001), 1.716 (95% CI: 1.094-2.691, P = 0.019), respectively]. Acute CTD-ON patients were at higher risk of poor visual outcomes [OR = 2.593 (95% CI: 1.384-4.857, P = 0.003)]. ROC analysis showed that the combination of DWI-H and poor visual outcome yielded an AUC of 0.889 (95% CI: 0.820-0.959, P < 0.001), with a sensitivity of 88.9% and specificity of 77.6%. DiscussionThe pathogenesis of CTD-ON may involve the following mechanisms. First, CTD-related small-vessel vasculopathy, necrosis, and hypercoagulability-induced thrombosis may lead to vasculitic infarction and ischemic injury of the optic nerve, which manifests as hyperintensity on DWI. Second, autoantibodies induced by CTD may cross-react with neuronal cells. ConclusionPatients with CTD-ON demonstrate more severe visual impairment than those with IDON. The presence of DWI hyperintensity and poor prognosis in patients with ON should raise suspicion for CTD-ON in the appropriate clinical setting.
This cluster-randomised trial aims to evaluate the effectiveness of the WHO Integrated Care for Older People (ICOPE) intervention for community-dwelling older adults with declining intrinsic capacity in China, incorporating a cost-effectiveness analysis from a healthcare system perspective. This study will employ a community-based, cluster randomised controlled trial design. A total of 1,400 participants with declining intrinsic capacity aged ≥ 60 years will be recruited from 37 health service stations affiliated with seven community health service centres (CHCs) in Beijing. Within each CHC, clusters will be randomised to either the ICOPE intervention group or the standard health management care group. The ICOPE intervention will comprise a 4-month program featuring structured group health education sessions, group practice activities and online health education delivered via WeChat. Educational content will target six domains of intrinsic capacity: cognitive function, vitality/nutrition, sensory ability, psychological well-being, mobility and traditional Chinese medicine-based approaches. The primary outcomes will include health status and economic evaluations assessed at 12 and 24 months post-intervention. Health outcomes will encompass physical function, cognitive capacity, vitality, mobility, vision capacity, hearing capacity and psychological health. The economic evaluation will assess incremental cost-effectiveness based on quality-adjusted life-years gained, as measured by the EuroQol five-dimensional questionnaire (EQ-5D), using a 12-month time horizon. This trial will generate critical evidence on the effectiveness and cost implications of the WHO ICOPE integrated care model when implemented in a Chinese community setting.This study will provide research evidence on effectiveness and cost-effectiveness of the ICOPE intervention among community-dwelling older adults with declining intrinsic capacity in China. Findings will inform policy and practice development. The trial has been registered in the Chinese Clinical Trial Registry (ID: ChiCTR 2400090521). Date of registration: 08/10/2024.
Background Ocular ischemic syndrome (OIS) and subsequent neovascular glaucoma (NVG) lead to irreversible visual impairment. This study aimed to investigate the association of carotid artery revascularization and the collateral circulation types via the circle of Willis (CoW) with NVG and visual prognosis in patients with OIS. Methods This retrospective cohort study included 22 patients with OIS, with a median follow-up of 12 months. The collateral circulation patterns via the CoW were classified into five types. The association of the carotid artery revascularization, collateral circulation types via the CoW, and morphological characteristics of the CoW with the presence of NVG and visual outcomes was assessed. Results The median time interval from baseline to visual decline during follow-ups in patients with carotid artery revascularization was longer than that in patients without carotid artery revascularization (13 months vs 9.5 months, P=0.041). Lacking collateral inflow via the CoW to the hemisphere ipsilateral to OIS was associated with NVG (odds ratio (OR), 11.000; P=0.022). The diameters of the C6 and C7 segments of the internal carotid artery, the A1 segment of the anterior cerebral artery, and the ophthalmic artery in OIS eyes were smaller than those in the contralateral eyes. Conclusion Early carotid artery revascularization should be considered in patients with OIS, with or without NVG, as it may contribute to an improved visual prognosis. Patients without collateral inflow via the CoW to the hemisphere ipsilateral to OIS may have a higher risk of NVG.
The present study aimed to elucidate the neuroprotective mechanism of montelukast sodium (MS) in ischemic stroke, with particular emphasis on astrocyte-microglia interactions. In vivo, adult male mice (n = 10/group) were subjected to distal middle cerebral artery occlusion (dMCAO) and then intraperitoneally injected with MS (4 mg/kg) or an equivalent volume of saline for 7 consecutive days. In vitro, primary mouse astrocytes and microglia were isolated and co-cultured, then exposed to oxygen-glucose deprivation and reoxygenation (OGD/R) to mimic ischemic-reperfusion injury. Prior to MS intervention, astrocytes were transfected with HMGB1 overexpression plasmid (oeHMGB1) or short hairpin RNA against HMGB1 (shHMGB1) to overexpress or knock down HMGB1, or treated with an anti-HMGB1 antibody in the co-culture system. Primary outcomes included infarct volume (TTC staining), microglia activation (immunofluorescence), M1/M2-associated markers in microglia (RT-qPCR, immunofluorescence), S100 calcium-binding protein beta (S100β) levels, inflammatory mediators, and HMGB1/TLR4/NF-κB pathway activity (immunohistochemistry, RT-qPCR, Western Blot). MS administration reduced the cerebral infarction size in dMCAO mice, attenuated the upregulation of S100β and ROS levels, and suppressed HMGB1/TLR4/NF-κB signaling cascade in vivo. In the co-culture system, conditioned medium from MS-treated astrocytes promoted microglial polarization toward an M2-associated phenotype, as evidenced by increased Arg-1/CD206/IL-10 and decreased iNOS/TNF-α/CD16. The protective effects of MS were reversed by HMGB1 overexpression, but potentiated by HMGB1 neutralization. Crucially, pharmacological inhibition of TLR4 with TAK-242 mimicked the effects of MS, while the combination of MS and TAK-242 produced no additional benefits. Collectively, MS confers neuroprotection against cerebral ischemic injury by inhibiting HMGB1/TLR4/NF-κB signaling pathway and promoting microglial polarization.
Purpose:The purpose of this study was to investigate the morphological and hemodynamic characteristics of the ophthalmic artery (OA) in ocular ischemic syndrome (OIS) and identify features potentially associated with disease pathogenesis. Methods:This retrospective case-control study included 33 patients with OIS, 22 patients with internal carotid artery stenosis (ICAS), and 29 healthy controls. Clinical data and ophthalmic examinations were collected. The morphology and hemodynamics of the OA were quantified using three-dimensional (3D) reconstruction and computational fluid dynamics (CFD). Particle image velocimetry provided a qualitative consistency check for the CFD results. Results:The OA diameter in the OIS group was significantly smaller than that in the control and ICAS groups. Compared with the control group, the OIS group showed lower blood flow velocity and wall shear stress (8.25 ± 5.34 Pa vs. 13.50 ± 6.24 Pa; P = 0.004) at the OA origin. A smaller OA diameter and lower wall shear stress at the OA origin were significantly associated with the presence of OIS. A low wall shear stress was observed at the OA origin regardless of the flow direction in the OIS. Patients with high-velocity retrograde OA flow present severe ocular ischemic manifestations. Conclusions:Low wall shear stress may be a consistent hemodynamic characteristic of eyes with OIS. This hemodynamic feature may induce inward remodeling of the OA, leading to further luminal narrowing and exacerbation of ocular ischemia. The presence of high-velocity retrograde OA flow may indicate a severe degree of ocular ischemia, highlighting the potential of OA hemodynamics for improving risk stratification and guiding management.
Background:Sleep disturbances are common non-motor symptoms in Parkinson's disease (PD), significantly diminishing patients' quality of life. Management typically involves sleep hygiene education, psychotherapy, pharmacological and non-pharmacological interventions. This study aims to explore the safety and effectiveness of repeated lower extremity hot water bathing (REHAB) as a potential treatment for sleep disorders in this patient population. Methods:This is a randomized, controlled, open-label with trial outcome assessment. A total of 40 elderly patients with advanced PD will be enrolled and randomly assigned (1:1) to either a REHAB group or a control group. The control group will receive guideline-based usual care. While the REHAB group will receive the same usual care plus 30-min REHAB sessions, conducted daily for 5-7 days per week over 4 weeks, followed by a 2-week observation period. The primary objective of this study is to evaluate the safety of REHAB in elderly patients with advanced PD. These safety concerns include orthostatic hypotension associated with autonomic dysfunction, scalds or intolerance to hot water bathing due to sensory disorders (both common in PD patients), and signs of tissue damage. Secondary objectives include evaluating the impact of REHAB on sleep quality using the Parkinson's Disease Sleep Scale (PDSS) and polysomnography (PSG) at weeks 0, 4, and 6. Discussion:This novel randomized controlled trial will assess the safety and potential therapeutic benefits of REHAB for sleep disorders in elderly patients with advanced PD. The findings will inform design considerations for future phase III studies and may introduce a new rehabilitation strategy for managing sleep disturbances in this population. Trial registration:http://www.chictr.org.cn/, identifier: ChiCTR2400092087.
Purpose To evaluate the efficacy and safety of intravitreal injection of conbercept for the treatment of macular edema secondary to central retinal vein occlusion (CRVO-ME). Methods Patients with CRVO were randomly divided into the treatment (conbercept injection) and control groups (sham injection) at a ratio of 2:1. The primary endpoint was the mean changes in best-corrected visual acuity (BCVA) from baseline to month 6. Results From baseline to month 6, the mean change in BCVA letters were 13.6 ± 12.1 (P < 0.0001) and − 2.2 ± 16.5 (P = 0.2188) in the treatment and control groups. From baseline to month 12, the mean change in BCVA letters were 14.4 ± 13.8 (P < 0.0001) and 3.0 ± 17.6 (P < 0.0001). The mean reduction of CRT from baseline to month 6 were 138.4 ± 99.4 µm (P < 0.0001) and 35.1 ± 98.8 µm (P = 0.0018). From baseline to month 12, the mean reduction values of CRT were 145.1 ± 105.1 µm (P < 0.0001) and 81.7 ± 107.9 µm (P < 0.0001). No new safety events were identified. Conclusions Intravitreal injection of conbercept has definite efficacy and expected controllable safety in patients with CRVO-ME, providing a more flexible strategy for conbercept in the clinical treatment of CRVO-ME. Trial Registration: ClinicalTrials.gov Identifier: NCT03223714, Date: July 21, 2017.
Objective:Hemophagocytic lymphohistiocytosis (HLH) associated retinopathy remains poorly characterized in terms of clinical phenotypes and pathogenesis. This retrospective study aimed to systematically define the multimodal imaging features of retinal lesions in patients with HLH and investigate its underlying pathological mechanisms to inform clinical practice. Methods:A retrospective case series analysis was conducted on 15 HLH patients with retinal lesions. Comprehensive ophthalmic evaluations, including fundoscopy and optical coherence tomography (OCT), were integrated with systemic multimodal imaging data. Results:Imaging analysis revealed characteristic retinal structural alterations, including retinal hemorrhage (26 eyes, 86.67%), outer retinal atrophy (20 eyes, 66.67%), outer retinal hyperreflective foci (7 eyes, 23.33%), ellipsoid zone disruption (17 eyes, 56.67%) and ellipsoid zone thinning (10 eyes, 33.33%). Multimodal imaging findings suggest a potential association between HLH related retinopathy and a hypoperfused ischemic state of the retina, though this requires further validation through larger scale statistical analysis. Notably, characteristic damage to the outer retinal structures was observed across HLH patients of different etiological subtypes and could manifest at any stage of the disease, including before and after interventions such as chemotherapy and hematopoietic stem cell transplantation. Discussion:The study data indicate potential involvement of HLH induced systemic cytokine storms, secondary hemoglobin reduction, and hematologic abnormalities such as thrombocytopenia in the observed retinal changes. These interpretations should be understood as hypothesis generating observations within the constraints of descriptive research methodology. Therefore, while cytokine cascade control remains a cornerstone of management, future studies should explore the potential benefit of blood component supplementation as an adjunctive therapy in HLH related retinopathy. Conclusion:These findings highlight the necessity of establishing early warning indicators for HLH associated retinopathy and conducting multicenter prospective studies to optimize evidence based diagnostic and therapeutic strategies.
Background: Premature acute coronary syndrome (ACS) has attracted attention due to high rates of recurrent ischemic events and mortality. We aimed to explore the characteristic changes of the ocular hemodynamics in patients with premature ACS. Methods: 116 participants (30 healthy controls, 30 with premature ACS, 56 with non-premature ACS) undergoing computed tomographic angiography (CTA) were enrolled. Head and neck CTA images were used to construct three-dimensional models of participants' ophthalmic arteries (OAs). Morphological parameters were measured, and numerical simulations based on computational fluid dynamics were used to acquire hemodynamic parameters of OAs. Retinal and choroidal vascular parameters were obtained by color fundus images and optical coherence tomography. Results: No significant differences in morphology of the OAs among the three groups. Hemodynamic simulation showed a significantly slower OA blood velocity in patients with premature ACS than in the control (P < 0.001) and non-premature groups (P = 0.038). Lower wall shear stress was found in patients with premature ACS than that in control (P = 0.015) and non-premature groups (P = 0.049). Patients with non-premature ACS had a higher wall pressure than healthy controls (P = 0.035). Mass flow ratios were decreased in all ACS groups (P < 0.001). Patients with premature ACS had smaller central retinal artery equivalent and choroidal vascularity index. The hemodynamic parameters of OA were correlated with several clinical indicators. Conclusions: Hemodynamics changes of OA and microcirculation of the retina and choroid in patients with premature ACS appeared before OA morphological changes. Premature ACS may aggravate ocular ischemic lesions more than non-premature ACS. Our findings could potentially guide future studies into a better understanding of the association of ocular lesions with systemic conditions in patients with premature ACS.
OBJECTIVE:This study aims to investigate the effect of β2-microgolobulin (β2-MG) on the occurrence of cardiovascular events (CVE) in hemodialysis patients and its relationship with prognosis. METHODS:In this retrospective study, we included 102 hemodialysis patients treated at Jinan People's Hospital Affiliated with Shandong First Medical University from September 2020 to January 2023. Clinical and follow-up data were collected. Logistic regression was used to evaluate the relationship between β2-MG and CVEs, while Cox proportional hazards regression analysis was used to assess the possible correlation between β2-MG and prognosis. RESULTS:CVEs occurred in 41 of the 102 patients (40.20%). Of the patients, 72 patients survived, and 30 patients died, with an average survival time of 22.47±7.41 months (range: 7-38 months). Univariate analysis revealed no significant differences in age, albumin, serum soluble growth stimulating expression gene 2 protein (ST2), β2-MG, or urea clearance index (Kt/V) between the CVE group and the non-CVE group, nor between the death and survival groups (P>0.05). However, logistic regression analysis showed that elevated serum ST2 and β2-MG levels >30.1 mg/L were independent risk factors for CVE in hemodialysis patients (P<0.05). Cox regression analysis revealed that an increase in β2-MG level was an independent risk factor for mortality in these patients (OR=3.385, P<0.05). Survival analysis demonstrated a significant difference in survival among patients with different β2-MG levels (Log-rank2=18.230, P<0.001). CONCLUSION:Elevated β2-MG level is an independent risk factor for CVEs and mortality in hemodialysis patients, serving as an effective indicator for predicting the occurrence and prognosis of these outcomes.
Background: Coronary microcirculatory dysfunction (CMD) after percutaneous coronary intervention (PCI) in patients suffering from acute myocardial infarction (AMI) may adversely affect prognosis. The objective of this study was to assess the postoperative microcirculatory status and to construct a predictive model for CMD. Methods: This study is a retrospective analysis of 187 AMI patients who underwent PCI at Xuanwu Hospital. Patients were divided into two cohorts based on postoperative angiography-derived microcirculatory resistance (AMR) values: a non-CMD group (AMR <250 mmHg*s/m, n = 93) and a CMD group (AMR ≥250 mmHg*s/m, n = 76). Clinical and laboratory data were extracted, predictive models were constructed and risk factors associated with CMD were identified through the implementation of LASSO regression analyses. Results: The non-CMD group (n = 93) had a significantly lower body mass index (BMI) (25.40 ± 2.84) and a higher proportion of males (91.4%) compared to the non-CMD group (n = 76) (BMI: 26.64 ± 3.74, p < 0.05; males: 78.9%, p < 0.05). The non-CMD group also exhibited lower Creatine Kinase (CK) levels, glucose levels (GLU), mean platelet volume (MPV), and platelet distribution width (PDW). LASSO regression identified significant predictors of CMD after PCI in AMI patients. A nomogram showed excellent predictive performance (area under curve (AUC): 0.737) and higher net benefit compared to individual models. Conclusion: The predictive model developed in this study effectively identifies the risk of microcirculatory dysfunction in AMI patients after PCI, providing important insights for clinical decision-making. Future research should further validate the external applicability of this model and explore its potential in clinical practice. Clinical Trial Registration: NCT06062316, https://clinicaltrials.gov/study/NCT06062316?term=NCT06062316&rank=1, registration time: December 21, 2023.
PURPOSE:Ischemic stroke is a cerebrovascular disease with high mortality and disability. Due to similar physiological characteristics, ocular vascular characteristics are important indicators for monitoring cerebrovascular diseases. This study aimed to develop a nomogram prediction model for ischemic stroke based on ocular hemodynamic characteristics. DESIGN:Retrospective clinical cohort study. METHODS:A total of 337 patients were included in this study and randomly divided into 235 training and 102 validation cohorts. The general data were collected, and the hemodynamic parameters of ophthalmic artery, central retinal artery and posterior ciliary artery were detected by ultrasound. The retinal vascular diameter was extracted from the color fundus image, and the relevant laboratory indexes of the patients were collected. Logistic regression analysis was used to determine the risk factors of ischemic stroke. A nomogram was constructed based on the identified risk factors, and the accuracy and clinical applicability of the model were analyzed using the receiver operating curve (ROC), Hosmer-Lemeshow test, and decision curve analysis (DCA). RESULTS:Independent risk factors for ischemic stroke including hypertension (OR 2.17, 95% confidence interval [CI] 1.16 to 4.08; P = .016), hyperlipidemia (OR 2.21, 95% CI 1.18 to 4.14; P = .013), and resistance index of ophthalmic artery (OR 5.98, 95% CI 3.27 to 10.93; P < .001) were identified by multivariate regression analysis. The area under the ROC curve of the training cohort was 0.790 (95% CI 0.733 to 0.847) and that of the validation cohort was 0.773 (95% CI 0.679 to 0.866), revealing the consistent ability of the nomogram to predict ischemic stroke. The mean absolute error of the training and validation cohorts were 0.020 and 0.013, respectively. In addition, the DCA curve showed good clinical benefit. CONCLUSIONS:The nomogram combining traditional factors and ophthalmic artery resistance index has a preferable predictive performance for ischemic stroke. This suggests that the model combined with ocular hemodynamics can effectively promote the early diagnosis and intervention of ischemic stroke.
Purpose: To evaluate the short- and long-term effect of pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling on visual acuity and macular morphology in myopic foveoschisis (MF) patients and to identify potential prognostic factors. Methods: We retrospectively analyzed the clinical data of patients with MF who underwent PPV with ILM peeling by the same senior fundus surgeon at Beijing Friendship Hospital from January 2016 to December 2022. The peeling was strategically centered on the macular fovea, extending to encompass the superotemporal and inferotemporal vascular arcades. Univariate analysis and multivariate logistic regression analysis were conducted to screen out the prognostic factors. Results: 36 eyes of 36 consecutive patients were analyzed in total. Best-corrected visual acuity (BCVA) improved significantly from 1.10 ± 0.61 logMAR to 0.78 ± 0.58 logMAR (p=0.031). 23 eyes (63.89%) had postoperative BCVA improved ≥ 2 Snellen lines. The mean central fovea thickness (CFT) decreased from 427.14 ± 255.91 μm to 155.85 ± 67.33 μm (p < 0.001). 18 and 16 eyes achieved partial and complete retinal reattachment, respectively, as follows. The twelfth month postoperatively was a threshold to influence the resolution of MF significantly, but it did not affect the visual outcome. Multiple logistic regression showed CFT (OR = 1.007, 95% CI = 1.001, 1.013, p value = 0.034) remained significant to predict the complete retina resolution. For visual acuity, integrated ellipsoid zone (EZ) band (OR = 0.239, 95% CI = 0.073, 0.783, p value = 0.018) might be a significant predictive factor. Subgroup analysis further indicated that in eyes with an intact EZ band, a poorer baseline BCVA was associated with an increase in postoperative BCVA (p=0.015). Conversely, in those with disrupted EZ band, all included factors showed no significant difference. Conclusion: The study observed trends in the recovery pattern of the retina following surgery and suggested potential factors that may be associated with improvements in both visual acuity and retinal reattachment. The findings may offer some guidance to ophthalmic surgeons in considering the timing of surgery, although further research is needed to confirm these trends as definitive predictors.
Objectives: Nurses’ clinical research activities have contributed to optimizing the care process and improving patient outcomes, and generative artificial intelligence (GAI) may help clinical nurses strengthen their research skills. To support research, this study aimed to explore the Chinese nurses’ perceptions and experiences of GAI training. Methods: This study used a descriptive qualitative design. The China Nurses Network conducted a three-day training session on “GAI for Nursing Research” theme, we selected 23 nurses by a convenience sampling method among participating in the training. The researchers conducted three focus group interviews at the end of each day. All focus groups were interviewed face-to-face to facilitate interaction, data collection, and observation. The data were analyzed using conventional content analysis and coded manually. Results: The results showed that nurses’ use of GAI to support scientific research was dynamic and characterized by evolving perceptions and practices. Four themes and 11 sub-themes emerged from the analysis: 1) utilization efficacy: cope with research ability, affected by many factors; 2) booster research: growth and challenges go hand in hand; 3) role reversal: from GAI-dominated to nurse-dominated; 4) beautiful dream: more features on research, more assistants on clinical care. Conclusions: The effectiveness of GAI in supporting clinical nurses in conducting research is mainly limited by differences in personal research literacy, lack of ethical regulation, and information accuracy. In the future, it is necessary to improve nurses’ relevant skills through specialized training and promote the standardization of technical regulations to ensure the appropriate application of GAI in nursing research.
BACKGROUND:Aspiration, the entry of food, fluids, saliva or gastric contents into the airway, is common in older adults and may lead to pneumonia or even death. Multidisciplinary management has the opportunity to help prevent aspiration in older patients. However, implementation in clinical practice remains problematic. By investigating the perspectives of stakeholders, comprehensive barriers and improvements measures can be identified to help manage aspiration risk. METHOD:Doctors, therapists, nurses, patients and their caregivers were recruited from wards in three tertiary hospitals. Semi-structured interviews were conducted to explore participants' views and experiences on the implementation of aspiration risk management. Data were analysed using content analysis. RESULTS:Data from 62 participants revealed barriers and improvements measures in aspiration risk management in older patients: Barriers: (i) Patient-related barriers, related to cognition, physical condition, compliance and caregiver burden; (ii) Healthcare-related barriers, including insufficient professional competence, lack of personalised guidance and education and limited communication; (iii) Support system and environmental barriers, including insufficient collaboration, limited processes, insufficient technical support and uneven hospital management attention. Improvements measures: (i) Hybrid management model of online and offline integration; (ii) Clear role definition across multiple roles; (iii) Visualization or quantification of aspiration display; (iv) Personalised and dynamic aspiration management strategies; (v) Strengthening communication and trust to improve adherence; (vi) Emotional support and supervision by caregivers. CONCLUSION:All major stakeholders faced some challenges, and it was necessary to strengthen teamwork, make good use of new technology support and enhance humanistic care to help stakeholders manage aspiration risk in older patients.
Anti-vascular endothelial growth factor (VEGF) drugs are the first-line treatment option for DME management. However, part of DME was refractory to anti-VEGF medicine. With promotion of imaging technology, various retinal morphological characteristics are considered to be related to the prognosis of DME treatment. This study aimed to identify reliable predictive baseline morphological characteristics for refractory diabetic macular edema. This retrospective study was to investigate refractory diabetic macular edema and were followed up for 6 months post-treatment. According to the treatment results, the cohort was divided into refractory or improved group. Baseline morphological characteristics were evaluated and analyzed using optical coherence tomography. Serous retinal detachment (63
With Generation Z becoming the primary group of nursing learners and the increasing shortage of nursing education resources, augmented reality and mixed reality based on head-mounted displays are being used more and more in nursing education. However, the current application landscape and the proper usage of these concepts remain unclear. Therefore, this study aims to conduct a scoping review to explore the current applications of head-mounted display-based augmented reality and mixed reality in nursing education and to clarify the definitions and usage of the concepts of augmented reality and mixed reality, ultimately providing directions for future applications and research. Based on the five-stage framework and PRISMA-ScR guidelines, a comprehensive collection and summarization of evidence regarding the application of head-mounted display-based augmented reality and mixed reality in nursing education were conducted. The databases retrieved include CNKI, Wanfang Database, VIP, CBM, PubMed, Cochrane Library, Embase, CINAHL, Web of Science, Scopus, IEEE Xplore, ACM Digital Library, and Ei. The languages of the included literature are Chinese and English. The retrieval was up to October 2024. A total of 44 studies were included in this review, covering three types of head-mounted displays: immersive head-mounted displays, smart glasses, and smartphone-based head-mounted displays. The main application areas were skills training and knowledge acquisition. Most of the studies were feasibility studies, though they also included some efficacy studies and research on personal experiences. In addition, these studies often employed vague or inconsistent definitions of augmented reality and mixed reality. Despite various explorations in the application of head-mounted display-based augmented reality and mixed reality in nursing education, there is still room for improvement in the relevant theory and utilization of this technology. In the future, interventions should use the three dimensions (observation of reality, real - virtual interaction, and fidelity of virtuality) described in detail, rather than simply employing the concepts of augmented reality or mixed reality. Efforts should be concentrated on developing and implementing head-mounted displays combined with other technologies that boast enhanced performance and cost - effectiveness, and further validating their effectiveness.
Purpose: To evaluate the efficacy, durability and safety of intravitreal faricimab versus aflibercept over 48 weeks in patients with neovascular age-related macular degeneration (nAMD) from the LUCERNE China subpopulation. Design: LUCERNE (NCT03823300) was a phase 3 global, double-masked, active comparator-controlled trial. The China subpopulation comprised patients from mainland China, Taiwan and Hong Kong. Methods: Treatment-na & iuml;ve patients aged >= 50 years with nAMD were randomized 1:1 to receive faricimab 6.0 mg up to every 16 weeks (Q16W) based on prespecified disease criteria after four initial Q4W doses or aflibercept 2.0 mg Q8W after three initial Q4W doses. The primary endpoint was mean change from baseline in best- corrected visual acuity (BCVA) averaged over weeks 40 to 48. Anatomical, durability and safety outcomes were also evaluated. Results: The China subpopulation comprised 119 patients (faricimab: n = 59, aflibercept: n = 60). At weeks 40 to 48, adjusted mean (95% confidence interval [CI]) BCVA letter gains from baseline were +9.7 (7.4 to 12.0) and +9.8 (7.5 to 12.1) with faricimab and aflibercept, respectively. Central subfield thickness was reduced from baseline by weeks 40 to 48 in both arms, with an adjusted mean (95% CI) change of-145.4 mu m (-156.2 to-134.6) and-156.5 mu m (-167.3 to-145.7) for faricimab and aflibercept, respectively. By week 48, 87.3% of the patients were on extended >= Q12W faricimab dosing. Faricimab was well tolerated with no new safety signals. Conclusions: Faricimab up to Q16W showed durable efficacy in the LUCERNE China subpopulation, consistent with global findings. Faricimab may reduce treatment burden for patients with nAMD in China, without compromising efficacy.