by Yuzhen Sun, Ziguang Zhou, Yu Mao, Niu Liu, Yanfeng Li, Weiyuan Fang
BackgroundPsoriasis, a chronic inflammatory skin disease affecting 2–3% of the global population, is driven by dysregulated immune responses. Despite advancements in biologic therapies, treatment challenges persist due to high recurrence rates. This study aimed to identify immune-related hub genes and elucidate their clinical implications in psoriasis pathogenesis and therapy.
MethodsMultiple microarray datasets from psoriasis patients (GSE30999, GSE106992, GSE14905, GSE78097, and GSE117468) were obtained to identify immune-key genes by differential gene analysis and Weighted Gene Co-expression Network Analysis (WGCNA). Subsequently, immune-related hub genes were identified using the Least Absolute Shrinkage and Selection Operator (LASSO) algorithm and Protein-Protein Interaction (PPI) networks, with further validation through Gene Set Enrichment Analysis (GSEA) and Receiver Operating Characteristic (ROC) curves to assess exploratory within-sample discrimination. Pearson correlation analysis evaluated the relationship between hub genes, skin lesion severity, and treatment outcomes. The study also conducted immune infiltration by using the Cell-type Identification by Estimating Relative Subsets Of RNA Transcripts (CIBERSORT) algorithm and identified potential therapeutic targets by the Drug-Gene Interaction Database (DGIdb).
ResultsThirty-one immune-related key genes were identified, and six hub genes (CLEC7A, CXCL1, IRF1, S100A12, S100A8, S100A9) were validated as central players in immune signaling pathways. These genes exhibited within-sample discrimination (AUC > 0.9) and correlated with disease severity and biological therapy efficacy. Immune infiltration analysis revealed increased activated memory CD4+ T cells and M1 macrophages in lesional skin, which was strongly associated with hub gene expression. Additionally, drug-gene interaction analysis identified potential therapeutic agents targeting these genes.
ConclusionThis study identified six immune-related hub genes that were closely linked to the severity of psoriasis, the effectiveness of biological treatments, and infiltrated activated memory CD4+ T cells and M1 macrophages. Our findings elucidate a novel immune-related hub gene network in psoriasis and provide potential targets for the development and application of biologics.
by Yuting Wang, Jun Li, Zhongsu Yu, Shuyuan Li, Yuxia Chen, Yun Pan, Liangping Cheng, Guangyuan Yu
Acute pancreatitis (AP) is a severe inflammatory disorder in which pyroptosis—a pro-inflammatory form of programmed cell death—may contribute to pathogenesis. However, the complete transcriptional profile of pyroptosis-related genes (PRGs) in AP and their potential as diagnostic biomarkers remain underexplored. This study aimed to systematically characterize pyroptosis-associated transcriptional signatures and identify the reliable biomarkers for diagnostic purposes. Three transcriptomic datasets from murine AP models were integrated to identify pyroptosis-related differentially expressed genes (PRDEGs). Functional enrichment and immune cell infiltration analyses were conducted to elucidate the biological pathways and immune microenvironment alterations associated with these genes. mRNA-transcription factor (TF) and mRNA-microRNA (miRNA) regulatory networks were constructed to investigate underlying molecular interactions. Machine learning techniques, including support vector machine (SVM) and least absolute shrinkage and selection operator (LASSO), were applied for feature selection, leading to the identification of key diagnostic markers and the development of a logistic regression model. The regression model were then assessed using an independent cohort of human peripheral blood samples. Eleven PRDEGs were identified, with enrichment observed in processes such as cytoskeletal organization, cell-substrate adhesion, and critical inflammatory signaling pathways, including MAPK and NF-κB. Immune infiltration analysis revealed significant correlations between these PRDEGs and various immune cell subsets, particularly M1 macrophages, Treg cells, and monocytes. A four-gene diagnostic signature, comprising ANXA3, IQGAP1, RELA, and VTN, was established through SVM and LASSO analysis. In the independent human cohort, the fixed-coefficient four-gene model demonstrated reduced discrimination, which likely reflects interspecies and tissue-specific variations. However, after optimizing the model to exclude non-significant predictors, a refined two-gene signature (ANXA3 and IQGAP1) exhibited improved accuracy, with excellent calibration and clinical net benefit. This study offers a comprehensive transcriptomic analysis of the pyroptosis-mediated landscape and immune microenvironment in AP. An optimized two-gene signature, comprising ANXA3 and IQGAP1, was validated in a human cohort with superior accuracy, reflecting critical disruptions in inflammatory pathways and cytoskeletal organization. Notably, ANXA3 demonstrated potential for stratifying disease severity. Although these markers hold potential for molecular diagnosis, further prospective studies are essential to establish their clinical specificity and generalizability across diverse populations.To explore the illness coping experiences of patients with moderate-to-severe burns and provide a reference for healthcare professionals to formulate coping strategies.
Qualitative study using a descriptive phenomenological approach.
From 1 June to 30 September 2024, semi-structured interviews were conducted with 19 patients with moderate-to-severe burns. Colaizzi's seven-step method was used for data analysis.
Seven subthemes and three higher order themes were identified: (1) perception of illness experience; (2) coping with disease threats; and (3) benefits of coping with illness. Most of the participants faced multiple difficulties in their disease experiences, such as increased financial pressure, higher pressure on family caregiving, deformed physical conditions and negative emotions. Positive psychological qualities, family and social support played significant roles in coping with these challenges.
Patients with moderate-to-severe burns experience multiple difficulties during their recovery. Effective coping resources can help them overcome these challenges.
Healthcare professionals should work with patients with moderate-to-severe burns and their families to establish an effective support system that enhances patients' coping abilities and promotes their overall recovery.
Patients with moderate-to-severe burns face diverse challenges. However, their experiences and coping processes during recovery remain unclear. This study provided valuable insights into their illness experiences and coping strategies. The findings highlighted multiple difficulties, such as a significant increase in financial pressure and dependence on family caregiving, painful and deforming physical conditions and various negative emotions. Positive psychological qualities, family and social support play an important role in coping with these challenges. Healthcare professionals should work with patients and their families to establish effective support systems to promote overall recovery.
No patient or public involvement.
Preoperative anxiety is prevalent among neurosurgical patients and is associated with adverse clinical outcomes. Virtual reality (VR) technology offers an innovative approach to delivering immersive preoperative education, particularly in familiarising patients with the intensive care unit (ICU) environment. This study aims to evaluate whether a VR-based ICU orientation can reduce perioperative anxiety and improve psychological preparedness in adult neurosurgical patients.
This single-centre randomised controlled trial plans to enrol 108 patients at Xuanwu Hospital. Using a computer-generated random sequence, participants will be randomly assigned in a 1:1 ratio to two groups: a control group receiving standard preoperative guidance, and an experimental group receiving standard guidance plus a VR-based ICU experience tour conducted 1 day before surgery. The primary outcome measure is the incidence of anxiety within 24 hours before discharge from the ICU. Secondary outcome measures include the incidence of depression, cognitive impairment and delirium, duration of delirium, safety events and other clinical outcomes. Data collection points include baseline (T0), 24 hours before surgery (T1), during ICU stay (T2) and 30 days after discharge (T3). All data analyses will be performed using SPSS V.26.0 software and will follow the intention-to-treat principle. This study seeks to determine the effectiveness of a VR-based ICU experience tour in reducing perioperative psychological stress and improving postoperative clinical outcomes.
This study was approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University (Approval ID: (2024) NO.152-002). The initial approval was obtained on 4 July 2024, and remains valid through 4 July 2026. All participants will provide written informed consent before any data collection takes place. The research findings are intended to be disseminated through publication in peer-reviewed scientific journals.
ChiCTR2400093170.
The resilience education of intern nursing students has significant implications for the development and improvement of the nursing workforce. The clinical internship period is a critical time for enhancing resilience.
To evaluate the resilience level of Chinese nursing interns and explore the effects of factors affecting resilience early in their careers, focusing on the mediating roles of career adaptability between clinical learning environment and resilience.
The cross-sectional study design was adopted. From March 2022 to May 2023, 512 nursing interns in tertiary care hospitals were surveyed online with the Connor-Davidson Resilience Scale, the Clinical Learning Environment Scale for Nurse and the Career Adapt-Abilities Scale. Structural equation modelling was used to clarify the relationships among these factors. Indirect effects were tested using bootstrapped confidence intervals.
The nursing interns showed a moderately high level of resilience [M (SD) = 70.15 (19.90)]. Gender, scholastic attainment, scholarship, career adaptability and clinical learning environment were influencing factors of nursing interns' resilience. Male interns with good academic performance showed higher levels of resilience. Career adaptability and clinical learning environment positively and directly affected their resilience level (β = 0.62, 0.18, respectively, p < .01). Career adaptability was also positively affected by the clinical learning environment (β = 0.36, p < .01), and mediated the effect of clinical learning environment on resilience (β = 0.22, p < .01).
Clinical learning environment can positively affect the resilience level of nursing interns. Career adaptability can affect resilience directly and also play a mediating role between clinical learning environment and resilience. Thus, promotion of career adaptability and clinical teaching environment should be the potential strategies for nursing interns to improve their resilience, especially for female nursing interns with low academic performance.
Lower extremity lymphedema (LEL) is a debilitating complication for patients with gynecologic cancer. A series of strategies have been recommended to mitigate the risk of LEL and improve patient outcomes; however, investigation into LEL risk management behaviours in this population is limited, and the absence of reliable and valid tools is an important reason.
To develop and evaluate the psychometric properties of the lower extremity lymphedema risk management behaviours questionnaire (LELRMBQ) for Chinese patients with gynaecologic cancer.
This was a methodological study.
Initial items were generated using a literature review. The initial LELRMBQ was refined, and its content validity was evaluated by conducting two rounds of expert consultation and a pilot study. Psychometric testing of 389 participants recruited by convenience sampling was conducted from December 2022 to June 2023. Exploratory factor analysis (EFA; subsample 1, N = 158) and confirmatory factor analysis (CFA; subsample 2, N = 231) were performed separately to determine the multi-dimensional structure of the questionnaire. Known-group validity, internal consistency reliability, and test–retest reliability were also evaluated.
A total of 25 items with satisfactory content validity were included in psychometric testing. The EFA identified a four-factor structure, comprising 18 items, which explained 74.49% of the total variance. The CFA supported this structure with acceptable fit indices. Known-group validity was partially supported by significant differences in total LELRMBQ scores among groups with different education levels, residence, cancer type, and LEL awareness. Internal consistency and temporal stability were acceptable.
The 18-item LELRMBQ demonstrated sufficient reliability and validity as a tool for measuring LEL risk management behaviours in patients with gynaecologic cancer.
The LELRMBQ has potential applicability in assessing LEL risk management behaviours, identifying gaps in educational practices, tailoring effective interventions, and evaluating intervention effectiveness.
This manuscript followed the STROBE guidelines.
Patients with gynecologic cancer participated in this study and provided the data through the survey.
Keloids are chronic fibroproliferative skin disorders with high recurrence rates and limited treatment options, yet reliable diagnostic biomarkers are lacking. Current classification systems rely heavily on clinical observation, underscoring the need for objective, noninvasive tools. In this exploratory study, serum-based 1H nuclear magnetic resonance (NMR) measurement combined with short-time Fourier transform (STFT) for time-frequency analysis was performed, followed by principal component analysis (PCA), to investigate potential patient subgroups. Serum samples from 29 patients were analysed and PC1 scores suggested two potential patient subgroups. Retrospective analysis showed that these subgroups differed primarily in keloid aetiology: one group predominantly included cases arising from unclear or minimal causes (e.g., acne, folliculitis), whereas the other comprised cases following clear traumatic events (e.g., surgery). Although most clinical variables showed no significant differences, significant differences in aetiology and Japan Scar Workshop Scar Scale (JSS) scores support the biological relevance of this separation of subgroups. These findings suggest that the time-frequency features of NMR signals from serum samples capture systemic characteristics associated with keloid pathophysiology. If validated in larger cohorts, this approach may serve as a noninvasive adjunct to clinical assessment and lay the foundation for objective patient stratification and precision-guided treatment strategies.
To identify the latent frailty trajectory and explore corresponding predictors among older adults living with frailty who experience hip fracture surgery within 3 months after discharge.
From December 2022 to November 2024, 178 individuals were consecutively enrolled in a longitudinal observational study conducted at a tertiary hospital in Zhejiang Province, China.
The Reported Edmonton Frail Scale measured the frailty level at 5 points, which included baseline (pre-fracture), at discharge, 2 weeks, 1 and 3 months after discharge. Latent class growth models were set up for the frailty trajectory. Multinomial logistic regression was performed to explore the predictors of frailty trajectory classes.
One hundred fifty-three participants completed the full follow-up. Latent class growth models identified 3 frailty trajectories. Class 1: moderate frailty transformed to severe frailty (n = 27; 17.65%); Class 2: mild frailty transformed to moderate frailty (n = 86; 56.20%); Class 3: pre-frailty transformed to mild frailty (n = 40; 26.15%). A higher-level D-Dimer at admission and the five-item version of the Geriatric Depression Scale increased the incidence of Class 2 compared to Class 3. The higher scores of the Abbreviated Mental Test decreased the incidence of Class 2 compared to Class 3. Longer surgical waiting time, a higher-level five-item version of the Geriatric Depression Scale and the Age-Adjusted Charlson Comorbidity Index increased the incidence of Class 1 compared to Class 3. The higher scores of the Abbreviated Mental Test and Mini Nutritional Assessment Short Form decreased the incidence of Class 1 compared to Class 3.
Three frailty trajectory classes were identified among older adults living with frailty who experience hip fracture surgery after discharge within 3 months. D-Dimer at admission, surgical waiting time, depressive symptoms, cognitive status, comorbidity index and nutritional status are associated with these fluctuating frailty trajectories.
Modifiable factors such as improving nutrition and cognitive status and managing depression, comorbidities and preoperative evaluations provide methods for future interventions to prevent or mitigate frailty among this population.
What problem did the study address? Frailty is an inherent dynamic among older adults living with frailty who experience hip fracture surgery after discharge within 3 months. Some factors affect the mitigated frailty process in this population. What were the main findings? Three frailty trajectory classes were identified in this study. And the level of their frailty worsens 3 months after surgery compared to pre-fracture. D-Dimer at admission, surgical waiting time, depressive symptoms, cognitive status, comorbidity index and nutritional status are associated with these fluctuating frailty trajectories. Where and on whom will the research have an impact? The findings of this study provide screening, intervention and discharge plan evidence for healthcare workers in orthopaedics and geriatrics Departments. Helping community healthcare workers and primary caregivers set the theoretical basis for home-based intervention programs.
We have adhered to relevant EQUATOR guidelines using the STROBE reporting method.
No patient or public contribution.
We aimed to identify the barriers and facilitators to participation in interventions aimed at improving cognitive function among older adults with type 2 diabetes mellitus (T2DM) and mild cognitive impairment (MCI) in rural areas.
This study is the qualitative phase of a larger randomised controlled trial and employs a descriptive approach.
We conducted in-depth, semi-structured face-to-face interviews with older adults diagnosed with T2DM and MCI in rural areas of China in November 2023. The interviews were guided by the Capability, Opportunity, Motivation, and Behaviour (COM-B) model and the Theoretical Domains Framework (TDF). The interview recordings were transcribed and analysed using NVivo V.11 software. Two research assistants independently coded the transcriptions, and the identified barriers and facilitators were mapped to the corresponding domains within the COM-B model and TDF.
A total of 26 older adults, aged 60–87, participated in the interviews. Nine themes were identified, including disease awareness, disease attitude, social interaction, responsibility and health, emotion guidance, organisational management, expertise and benefits, self-perception and role identity crisis. These themes mapped onto the three core components of the COM-B model as well as the nine domains of the TDF, which include: knowledge, environmental context and resources, social influences, intentions, emotions, reinforcement, beliefs about consequences, beliefs about capabilities and social identity.
Addressing barriers and leveraging facilitators can effectively enhance the willingness of elderly patients in rural areas to participate in interventions aimed at improving cognitive function. A multi-layered approach should be adopted, focusing on disease knowledge and attitudes, social interactions, the impact of the disease burden on both family and individuals, emotional state, organisational management, team expertise and timely assessment, individual self-efficacy and role perception.
The study adheres to the COREQ reporting guidelines.
The participants in this study were older adults with T2DM and MCI from rural areas. Participants were involved in the development of the interview guide and were subsequently interviewed regarding the facilitators and barriers to their participation in cognitive function interventions.
Postoperative delirium (POD) is a common and serious complication after cardiac surgery, particularly in elderly patients, and is associated with adverse short- and long-term outcomes. Effective preventive strategies remain limited. Liraglutide, a glucagon-like peptide-1 receptor agonist, has demonstrated potential neuroprotective, anti-inflammatory and metabolic benefits, which may reduce the incidence of POD.
This is a single-centre, randomised, double-blind, placebo-controlled trial in elderly patients undergoing elective cardiac surgery. Participants will be randomised in a 1:1 ratio to receive liraglutide or placebo from the day before surgery until postoperative day 3. A total of 260 patients are planned to be enrolled in this study. The primary endpoint is the incidence of POD within 7 days, assessed using the Confusion Assessment Method (CAM) or CAM-intensive care unit. Secondary outcomes include delirium severity, neurocognitive and psychological function, cardiac function, clinical outcomes, major adverse cardiovascular events within 1 year and perioperative biomarker changes. Exploratory outcomes include functional MRI in selected subgroups and additional biomarker analyses.
The protocol has been approved by the Medical Ethics Committee of Nanjing Drum Tower Hospital. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.
ChiCTR2500106943.
Skin temperature, including absolute temperature (at bony prominence areas under long-term compression) and relative temperature (the difference between bony prominence and adjacent control area), may serve as early warning indicators for PI. However, the optimal indicator remains unclear. This meta-analysis therefore synthesises evidence on their association with PI risk to identify the best indicator and evaluate its early-warning accuracy.
Systematic review and meta-analysis.
We included prospective cohort studies of adult patients investigating longitudinal associations between skin temperature and subsequent PI development. We pooled standardised mean difference (SMD) and odds ratios, complemented by summary receiver operating characteristic (SROC) curve analysis. The overall quality of evidence was evaluated using the GRADE method.
We researched PubMed, Embase, CINAHL, Cochrane Library (CENTRAL), Wanfang and CNKI databases from inception to September 25, 2024.
After screening 1354 titles and abstracts, ten studies comprising 1742 participants were included in the final synthesis. No significant difference in absolute temperature (combined SMD) was found between the PI and non-PI groups (seven studies included). In addition, decreased relative temperature (< −0.1°C) was associated with a 16-fold increased likelihood of PI (95% CI 6.38–40.19, I 2 = 79.4%) (three studies included), with the SROC curve analysis showing an AUC of 0.776. According to GRADE, the evidentiary certainty was very low for AT and low for RT.
Relative temperature is significantly related to the risk of PI, supporting its role as a promising early warning indicator. Future studies should establish a standardised measurement protocol to facilitate its clinical application.
Monitoring skin temperature changes holds promise as a non-invasive tool for early warning of PI risk. However, the amount and quality of available evidence limit our confidence in these findings, underscoring the need for further research before a definitive conclusion can be drawn.
This study followed PRISMA guidelines.
No patient or public contribution.
PROSPERO CRD42024550099
The treatment of chronic wounds in the Aged is often difficult. Masquelet technique is used for the treatment of infected large segmental bone defects as it provides an adequate blood supply for bone and soft tissue reconstruction. In this study, a two-stage wound management strategy was used, consisting of covering the initial wound with bone cement and skin grafting under induced membranes. From September 2020 to September 2022, 20 Aged patients with chronic refractory wounds of the lower extremities with exposed bone or tendons were recruited in the Department of Wound Repair Surgery of the Second Affiliated Hospital of Wenzhou Medical University. Each patient was reconstructed according to a two-stage process. In the first stage, while treating the patient's underlying disease, several debridements were first performed on the wound; subsequently, the Masquelet technique was applied to seal the wound with antibiotic bone cement. Four to 6 weeks later, the second stage was initiated—after confirming the sufficient formation of wound induced membranes, the bone cement was removed, and free skin grafts were finally used to cover the chronic refractory wounds on the extremities. The area of the defects ranged from 4.5 × 3.0 cm to 15.0 × 6.0 cm, and all soft tissue defects were associated with tendon or bone exposure. After the surgery, patients attended regular outpatient visits and were followed up by telephone and video to observe the healing of the wounds and whether there were any complications in the donor site. The Lower Extremity Function Scale (LEFS) score was used to evaluate the functional recovery of the lower extremities. We found that all implants survived without necrosis or infection. All 20 cases were followed up regularly after surgery for 3 to 12 months, with a mean of 7.6 months. In the first stage, Induced Membranes induction was performed 1–4 times, with an average of (1.3 ± 0.7) times, and in the second stage, free skin grafting was performed on the induction membrane, and all 20 cases of skin grafting survived without necrosis or infection; the appearance and texture of the skin in the grafted area were satisfactory, and the postoperative LEFS score was (69.83 ± 10.82). Finally, our strategy for the management of chronic refractory wounds in the Aged can achieve satisfactory clinical results, reduce surgical risk, be simple and reliable, and be an effective addition to the repair modality.
by Jessica Liu, Sameer Pandya, Andreas Coppi, H. Patrick Young, Harlan M. Krumholz, Wade L. Schulz, Guannan Gong
BackgroundNear real-time electronic health record (EHR) data offers significant potential for secondary use in research, operations, and clinical care, yet challenges remain in ensuring data quality and stability. While prior studies have assessed retrospective EHR datasets, few have systematically examined the integrity of real-time data for research readiness.
MethodsWe developed an automated benchmarking pipeline to evaluate the stability and completeness of real-time EHR data from the Yale New Haven Health clinical data warehouse, transformed into the OMOP common data model. Twenty-nine weekly snapshots of the EHR collected from July to November 2024 and twenty-two daily snapshots collected from April to May 2025 were analyzed. Benchmarks focused on (1) clinical actions such as patient additions, deletions, and merges; (2) changes in demographic variables (date of birth, gender, race, ethnicity); and (3) stability of discharge information (time and status). A synthetic dataset derived from MIMIC-III was used to validate the benchmarking code prior to large-scale analyses.
ResultsBenchmarking revealed frequent updates due to clinical actions and demographic corrections across consecutive snapshots. Demographic changes were most frequently related to race and ethnicity, highlighting potential workflow and data entry inconsistencies. Discharge time and status values demonstrated instability for several days post-encounter, typically reaching a stable state within 4–7 days. These findings indicate that while near real-time EHR data provide valuable insights, the timing of data stabilization is critical for accurate secondary use.
ConclusionsThis study demonstrates the feasibility of automated benchmarking to assess the integrity of real-time EHR data and identify when such data become analysis ready. Our findings highlight key challenges for secondary use of dynamic clinical data and provide an automated framework that can be applied across health systems to support high-quality research, surveillance, and clinical trial readiness.
Investigate the epidemiological characteristics of outpatients initially diagnosed with skin ulcers who were ultimately confirmed to have cutaneous malignant tumours, and provide a diagnostic and therapeutic basis for the occurrence of secondary diseases in chronic wounds. We conducted a retrospective study analysing clinical data from patients initially diagnosed with skin ulcers at our hospital between July 2021 and February 2025, and analysed the epidemiological characteristics of malignant transformation in these ulcer cases. Among 128 patients initially diagnosed with skin ulcers, 16 cases (12.5%) were confirmed with cutaneous malignancies. The malignant group had a significantly higher mean age (69.44 ± 11.30 years) compared to the non-malignant group (58.39 ± 17.88 years; t = 5.752, p = 0.01). The distribution of lesion sites differed significantly between the malignant and non-malignant groups (χ2 = 30.498, p < 0.01). In the malignant group, the head and neck (41.2%) and trunk & extremities (41.2%) were the predominant sites. The most common malignancy was squamous cell carcinoma (SCC). The trunk & extremities was the most frequent site (62.5%). The second was basal cell carcinoma, which mainly occurs in the head and neck (80.0%). The mean duration of ulceration was 4.5 years. The primary treatment modality was surgical excision (11 cases, 68.8%). Approximately one-seventh of skin ulcer cases were confirmed as cutaneous malignancies. This finding underscores the significance of skin ulcers as potential malignant lesions, highlighting the need for clinicians to maintain a high index of suspicion and promptly perform histopathological examinations to improve early detection rates of skin cancers.
by Yinli Shi, Shuang Guan, Sicun Wang, Muzhi Li, Yanan Yu, Jun Liu, Weibin Yang, Zhong Wang
BackgroundAlthough filgotinib, a selective Janus kinase 1 inhibitor, has been increasingly applied in the treatment of inflammatory diseases, its comprehensive safety profile remains insufficiently characterized. Using data from the FAERS database covering Q1 2014 to Q2 2024, this study attempts to analyze adverse event signals linked to filgotinib and provide guidance for the safe and sensible clinical usage of filgotinib.
MethodsFrom Q1 2014 to Q2 2024, information on adverse drug events (ADEs) associated with filgotinib was gathered. The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were among the signal detection methods that were employed for analysis following data normalization.
ResultsFilgotinib was shown to be the main suspected medication in ADE reports, exposing 103 preferred terms (PTs) in 17 system organ classes (SOCs). Infections, gastrointestinal disorders, and musculoskeletal and connective tissue disorders were the most commonly reported adverse effects. Additionally, atrial fibrillation, alopecia, elevated serum creatinine, blood creatinine increased, pulmonary embolism, epididymitis, respiratory failure, and osteopenia were identified as potential disproportionate reporting signals for filgotinib, although these were not listed in the official drug label. Notable significant signals included large intestine erosion (ROR 2186.05, 95%CI(ROR): 1015.94–4703.86, PRR 2176.18, 95%CI(PRR): 1014.64–4667.42), mesenteric arterial occlusion (ROR 1832.17, 95%CI(ROR): 897.68–3739.48, PRR 1822.71, 95%CI(PRR): 896.17–3707.20), repetitive strain injury (ROR 1149.27, 95%CI(ROR): 363.16–3637.01, PRR 1147.05, 95%CI(PRR): 363.24–3622.15), oligoarthritis (ROR 755.02, 95%CI(ROR): 310.74–1834.54, PRR 752.59, 95%CI(PRR): 310.60–1823.51), and periostitis (ROR 676.03, 95%CI(ROR): 319.36–1431.06, PRR 672.98, 95%CI(PRR): 318.97–1419.87). The subgroup analysis identified obvious sex and age-specific trends in filgotinib-related adverse reactions, emphasizing a higher risk of renal disorders in females, a preponderance of gastrointestinal events in males, and age-dependent trends involving mesenteric occlusion, increased serum creatinine, and immunoglobulin reduction.
ConclusionWhile filgotinib demonstrates therapeutic efficacy, it is associated with a range of potential adverse events, underscoring the need for vigilant clinical monitoring. Particular attention should be given to gastrointestinal, cardiovascular, respiratory, and metabolic complications.
This study aimed to develop and preliminarily validate the KAP scale for pain management in older adults with dementia among nursing assistants.
A cross-sectional study.
An initial item pool was constructed through literature reviews, semi-structured interviews and team discussions. Items were screened and optimised through two rounds of Delphi expert consultations, a pilot survey and item analysis, yielding a draft version of the scale. Psychometric evaluation was conducted to refine the scale into its final form.
The final KAP scale developed in this study comprised 31 items. The scale exhibited good content validity, with item-level content validity index (I-CVI) values ranging from 0.83 to 1.00. Exploratory factor analysis revealed that the scale extracted five factors, which accounted for 65.732% of the cumulative variance, and all items demonstrated rotated factor loadings > 0.5, indicating good construct validity. The Cronbach's α coefficients for the knowledge, attitudes and practices dimensions were 0.877, 0.915 and 0.935, respectively, and the split-half reliability coefficients were 0.909, 0.886 and 0.864.
The KAP scale for pain care in older adults with dementia developed in this study possesses good reliability and validity and can be used to assess the knowledge, attitudes and behavioural levels of nursing assistants in pain care.
This study developed and psychometrically validated a KAP scale specifically designed to assess pain care for older adults with dementia among nursing assistants. Clinical managers can utilise this tool to systematically identify deficiencies in staff members' knowledge, attitudes or practices, thereby providing scientific evidence for the development of targeted pain care training programs and pain management strategies. This contributes to enhancing nursing assistants' pain care competence, ultimately alleviating the pain burden of older adults with dementia and improving their quality of life.
The STROBE checklist was used as a guideline.
No patient or public involvement.
Delayed antibiotic prescribing (DAP) has demonstrated efficacy in reducing inappropriate antibiotic use for uncomplicated respiratory tract infections (uRTIs) in primary care across high-income countries. However, evidence regarding its effectiveness in low-income and middle-income countries remains limited. This cluster-randomised controlled trial (cRCT) aims to evaluate the effectiveness of DAP for optimising antibiotic use in primary healthcare institutions (PHIs) in China.
We designed a pragmatic, multicentre, open-label, three-arm cRCT in adult patients with uRTIs. The study will involve 12 PHIs in Korla City of China. Participating institutions will be randomised at a 1:1:1 ratio to three parallel arms: (1) DAP-intervention arm, (2) Immediate antibiotic prescribing comparator arm and (3) Usual care (observational arm). The primary outcome is symptom duration. Secondary outcomes include symptom severity, antibiotic use, adverse events, patient satisfaction and patient belief regarding antibiotic efficacy.
Ethics committee approval of this study was obtained from Peking University Institution Review Board (IRB00001052-24169). The findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.
ChiCTR2500097330.