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by Naoya Nakagawa, Ami Igarashi, Hideaki Yokogawa, Akira Kobayashi, Tomomi Higashide, Satoru Yamagami, Takahiko Hayashi
The aim of this study was to identify the clinical factors associated with postoperative visual acuity following Descemet’s membrane endothelial keratoplasty (DMEK), with emphasis on the impact of macular diseases. This retrospective multicenter study included consecutive eyes that underwent DMEK between March 1, 2011, and June 30, 2022, and had available optical coherence tomography findings. Eyes with other ocular diseases causing visual loss were excluded. Overall, 77 eyes of 66 patients were included in the study. Univariable and multivariable regression analyses were performed to identify the predictors of best-corrected visual acuity (BCVA) at the final follow-up. Worse preoperative visual acuity and macular comorbidity were identified as independent predictors of poorer postoperative BCVA. Among macular pathologies, cystoid macular edema was most strongly correlated with reduced vision in the univariable analysis (β = 0.195; p = 0.016). In the subgroup analysis, worse preoperative visual acuity and macular comorbidity remained significant predictors (p
by Jingwen Gao, Yasushige Shingu, Ryota Azuma, Satoru Wakasa
BackgroundInflammatory response plays a pivotal role in myocardial injury and post-infarction remodeling after acute myocardial infarction (AMI). Mechanical unloading (UL) of the left ventricle (LV) has been proposed as a potential therapeutic strategy to preserve cardiac function; however, its effects on myocardial inflammation remain incompletely understood.
MethodsWe employed a rat model of partial UL using heterotopic heart-lung transplantation following AMI. RNA sequencing (RNA-seq) was performed to evaluate transcriptomic changes, with a specific focus on inflammatory pathways in the non-infarcted remote area. Immune cell abundance was estimated using deconvolution analysis (QUANTISEQ). Quantitative PCR was performed to analyze some inflammatory cytokines, and macrophage polarization was evaluated by immunohistochemistry.
ResultsAMI significantly impaired cardiac function, which was mitigated by UL. RNA-seq analysis revealed marked activation of inflammatory pathways and identified several hub genes involved in cytokine signaling following AMI, while these transcriptional changes were not significantly altered in UL groups after AMI. Immune cell profiling demonstrated an increase in M2 macrophages after AMI, while UL preserved M2 macrophage levels. Histological analysis further supported UL’s modulatory effect on macrophage polarization. Pro-inflammatory cytokines TNFα and IL1β were upregulated after AMI but showed attenuation with UL.
ConclusionPartial UL potentially attenuates cardiac functional deterioration after AMI while exerting substantial effects on inflammatory gene expression and macrophage polarization. These findings suggest that the cardioprotective effects of UL may be correlated with the modulation of inflammatory pathways in the remote area after AMI.
Rising patient numbers and limited resources are creating a challenging environment for healthcare providers recently. Anaesthesiologists are also increasingly faced with complex situations, requiring high adaptability in the operating room. To enhance team adaptability during emergencies, effective communication methods are essential. This study aimed to compare the impact of mobile phones and intercoms on the response time and effectiveness of anaesthesiologist teams in emergency situations.
Prospective, observational and simulation study.
Anaesthesiology and Critical Care, Yokohama City University Medical Center, Yokohama, Japan.
This study, conducted at Yokohama City University Medical Center (Yokohama, Japan), evaluated how communication methods (intercoms vs mobile phones) impact the efficiency of anaesthesiologists in the simulation setting. Two scenarios were tested: (1) retrieving a video laryngoscope during a difficult intubation and (2) gathering support during cardiac arrest.
Outcomes measured included time to secure equipment, time for assistance to arrive and staff numbers gathered. The Wilcoxon signed-rank test was used to compare the outcomes between the intercom and mobile phone groups.
In scenario 1, the time to secure the video laryngoscope was significantly shorter with intercom use compared with mobile phones (intercom vs mobile phone, median (IQR): 29 (25–33) s vs 50 (39–62) s; p=0.013, effect size 20 (95% CI 7 to 31)). In scenario 2, the time from the request for assistance until the first supporting staff member reached the operating room was significantly shorter in using the intercoms (intercom vs mobile phone, median (IQR): 16 (14–18) s vs 35 (31–38) s; p=0.04, effect size 17 (95% CI 6 to 24)), and more personnel were available in the intercom group (intercom vs mobile phone, median (IQR): 3 (3–3.5) persons vs 2 (1–2) persons; p=0.04, effect size 1.5 (95% CI 1 to 3)).
Real-time information sharing through intercoms improved the ability of the anaesthesiologist team to respond more rapidly and effectively in emergency situations, enhancing overall team adaptability. This approach may improve patients’ outcomes by shortening response times and increasing team coordination.
The Novara Cohort Study (NCS) was established to investigate the biological, psychological and social factors that influence ageing in the general population. The study aims to identify early risk factors for frailty, allostatic load and cognitive decline, and to uncover molecular and functional markers of accelerated biological ageing. NCS addresses the need for detailed life-course data from Southern Europe to support personalised prevention and early diagnosis, and to promote healthy longevity.
NCS is a population-based, longitudinal cohort in the Novara province (Northern Italy), originally enrolling adults aged 35 and older. The inclusion criteria were later expanded to encompass all residents aged 18 and over, facilitating the study of ageing trajectories from early adulthood onward. As of mid-2025, about 1000 participants have been enrolled, and recruitment is ongoing. The cohort’s diversity in age, employment status and health conditions enhances its value for life-course analysis.
Following a pilot phase in 2022–2023, the whole study protocol now includes detailed demographic, clinical, behavioural, cognitive and psychosocial data, along with biological samples stored in the UPO Biobank. The protocol incorporates validated tools, comprehensive physical and cognitive assessments, and over 90 laboratory biomarkers covering inflammation, metabolism, hormonal function and coagulation. Additionally, a subset of participants underwent advanced inflammatory profiling by simultaneous measurement of 92 immune-related proteins and comprehensive genomic profiling using Illumina Single Nucleotide Polymorphism (SNP) arrays, capturing common genetic variation across multiple biological domains. Preliminary results demonstrate the feasibility of integrating deep phenotyping, reveal the roles of frailty in ageing and show initial evidence of age-related changes in inflammatory proteins.
NCS plans to enrol at least 10 000 participants and will conduct long-term follow-up using both passive methods, such as linking with clinical records and administrative health databases, and active in-person reassessments. Future phases will integrate clinical, behavioural and cognitive data with large-scale omics analyses, including genomics, proteomics, metabolomics and transcriptomics. Machine learning techniques will be employed to model biological age, identify early signs of age-related decline and develop personalised prevention strategies. By combining high-resolution phenotyping with multidimensional data, NCS aims to find modifiable risk factors and molecular signatures of ageing, supporting national and European research efforts and encouraging collaborative studies through open data-sharing frameworks.
by Aditya Sri Listyoko, Ryota Okazaki, Tomoya Harada, Genki Inui, Hiroki Kohno, Miyu Nishigami, Miki Takata, Masato Morita, Akira Yamasaki
BackgroundThe interaction between viral components and type 1 or type 2 cytokines during asthma exacerbations in the airway epithelium may contribute to worsening inflammation. However, these interactions in the small airway epithelium—particularly those involving alarmins (TSLP, IL-25, and IL-33) and IL-8—remain unclear. Dupilumab, a biologic agent used in severe asthma, blocks IL-4 receptor alpha (IL-4Rα) and may offer therapeutic benefits in virus-induced asthma exacerbations. In this study, we evaluate the effects of double-stranded RNA (dsRNA), in combination with various cytokines and dupilumab, on the Human Small Airway Epithelial Cells (HSAECs) line.
MethodsPrimary HSAECs were preincubated with dsRNA to induce the gene and protein expression of alarmins and IL-8. To evaluate the effects of cytokines on dsRNA-induced alarmin and IL-8 expression, various type 1 and type 2 cytokines were co-stimulated with dsRNA. Dupilumab was used as a pretreatment prior to co-stimulation with dsRNA and IL-4 or IL-13. Gene expression of TSLP, IL-25, IL-33, and IL-8 was assessed by quantitative PCR, and protein expression was evaluated by Western Blotting.
ResultsdsRNA significantly increased the expression of TSLP and IL-8. IL-4 and IL-13 further enhanced dsRNA-induced TSLP and IL-8 gene and protein expression. In contrast, TNF-α reduced dsRNA-induced TSLP expression but enhanced IL-8 gene and protein expression. Dupilumab attenuated the expression of TSLP and IL-8 induced by co-stimulation with dsRNA and IL-4 or IL-13 in HSAECs.
ConclusionIn the microenvironment of small airway epithelial cells, particularly during viral infections, the presence of IL-4 or IL-13 may enhance the expression of TSLP and IL-8. Dupilumab attenuates this expression, potentially offering additional benefits in the treatment of asthma, especially during virus-induced asthma exacerbations.
by Suksan Kanoksin, Suphakarn Techapongsatorn
BackgroundSurgical smoke generated during energy-based operations is a known hazard containing particulate matter (PM), volatile organic compounds (VOCs), and biological debris, with insufficient adoption of commercial smoke evacuators due to cost and complexity.
ObjectiveThis study aimed to develop a cost-effective, modular and passive smoke evacuator and evaluate its efficacy in reducing PM and VOC levels during simulated laparoscopic procedures.
MethodsA prototype smoke evacuator incorporating a distilled water bubbling trap, activated carbon filter, and ULPA filter was tested in a sealed chamber simulating laparoscopic surgery using porcine liver tissue. The system was connected to a laparoscopic port through a three-way valve, allowing manual, on-demand smoke evacuation without continuous suction. Air quality metrics, including PM1.0, PM2.5, PM10, VOC, and CO₂, were measured continuously. Results were compared to baseline and performance benchmarks from commercial smoke evacuation systems. Statistical analysis was performed using paired t-tests.
ResultsThe prototype evacuator reduced PM2.5 levels by >99.5% and VOC concentrations by >95% compared to no-evacuation control trials (p 2.5 and VOC levels were restored to near-baseline values.
ConclusionThe developed modular passive smoke evacuator offers a promising and cost-effective solution to improve air quality and enhance occupational safety in operating rooms. The model represents an idealized simulation of laparoscopic smoke evacuation; further clinical validation in live surgical environments is warranted.
Treatment failure remains a major challenge in tuberculosis (TB) management. Rapid and objective assessment of treatment response is essential, as existing tools have limited accuracy and slow turnaround times. The PATHFAST TB LAM Ag assay (PATHFAST-LAM), an automated chemiluminescent enzyme immunoassay, was developed to quantify lipoarabinomannan (LAM) in sputum within 1 hour. Previous studies have shown a strong correlation between sputum LAM concentration and culture-based bacterial load. However, its clinical utility for predicting poor outcomes during treatment has not been prospectively evaluated.
We will conduct a prospective longitudinal study enrolling newly diagnosed, bacteriologically confirmed patients with pulmonary TB at Rhodes Chest Clinic and Mbagathi County Referral Hospital in Nairobi, Kenya. We will follow participants throughout the 6-month treatment course, attempting to collect sputum weekly during weeks 1–4, biweekly during weeks 5–12 and monthly during months 3–6. We will measure LAM concentrations at these time points using the PATHFAST-LAM assay. The primary outcome is to assess whether changes in sputum LAM concentration during the intensive phase (baseline to week 4 and/or week 8) predict a composite poor outcome, defined as positive sputum culture at month 6, treatment failure, death during treatment or relapse within 3 months after treatment completion. The primary endpoint is the area under the curve from the receiver operating characteristic analysis, representing the predictive performance of changes in sputum LAM concentration for the composite poor outcome. We will identify the optimal cut-off value for LAM change and estimate sensitivity and specificity with 95% CIs using 2x2 tables. We will apply an adaptive design that allows sample-size re-estimation after interim analysis.
The study was approved by the Kenya Medical Research Institute (KEMRI/SERU/CRDR/124/5241) and Nagasaki University (250619327). Findings will be disseminated through peer-reviewed publications and scientific meetings.
Siblings of children with disabilities or chronic illnesses often face significant challenges during their upbringing. Despite these difficulties, many develop a positive outlook and adapt successfully. To help individuals navigate developmental challenges in a healthy and manageable way, this study focuses on the concept of resilience. Although previous studies have primarily focused on the challenges and difficulties faced by siblings of children with disabilities and chronic illnesses, the factors influencing resilience in these siblings remain unclear. This review aims to inform the development of effective support systems for siblings of children with disabilities and chronic illnesses.
We will search PubMed (MEDLINE), CINAHL (EBSCOhost), Web of Science and Ichushi-Web (a Japanese Medical Literature Database). Two independent reviewers will apply the inclusion and exclusion criteria to screen the titles and abstracts of the retrieved articles. Full texts of relevant studies will be reviewed. This scoping review focuses on studies addressing resilience in siblings of children with disabilities and chronic illnesses during childhood, with particular focus on the perspectives of siblings. The review will exclude conference proceedings, abstracts, posters, editorials, commentaries, opinion papers and review papers. However, important documents found during the search will be added if relevant. Using a custom data extraction method developed for this review, the researchers will extract relevant data, inductively and comprehensively organise similar codes, and identify key components of resilience.
This study does not involve human subjects and therefore does not require approval from an ethics committee for human subjects research. The results of this exploratory review will be disclosed through conference presentations and publication in peer-reviewed academic journals.
To explore patients' experiences of participation in surgical wound care and provide an in-depth understanding of their experiences with post-operative wound care during and post-hospitalisation.
A descriptive qualitative study.
Adult participants who had undergone surgery within 30 days were purposively selected from two surgical wards at Gold Coast University Hospital. Seventeen semi-structured phone interviews were conducted using a specifically developed and piloted interview guide. Textual data were analysed using inductive content analysis.
Three main categories were identified. The first category, ‘I didn't expect how distressing post-operative wound care would be; it's tougher than I thought,’ highlights the significant and unexpected physical and emotional challenges participants faced, which initially hindered their engagement. The second category highlights the impact of healthcare professional interactions on patient participation, ‘I want to be involved, but conflicting advice and dismissive behaviour discourage me.’ The third category, ‘With my family's help, wound care got easier as I tried, learned, and recovered,’ illustrates how family support facilitated participants' independence and engagement over time.
The spectrum of patient participation in surgical wound care is dynamic and impacted by environmental, physical and psychological factors. This research deepens understanding of patient participation by highlighting the importance of family support and a temporal perspective in patients' wound care journeys.
Findings showed participants were unprepared for surgical wound care, greatly influenced by healthcare provider communication and family support, and evolved in participation as time passed and their wounds healed. Additionally, participants valued intent just as significantly as their behaviours and regarded even minor involvement as totally participative. These insights can inform strategies to improve patient participation in surgical settings.
SRQR (Standards for Reporting Qualitative Research).
No patient was involved in this study.
Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.
This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.
Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.
jRCTs031240007.
by Azusa Kubota, Kentaro Kojima, Shinnosuke Koketsu, Takayuki Kannon, Takehiro Sato, Kazuyoshi Hosomichi, Yoshiaki Shinohara, Atsushi Tajima
Brain asymmetry is a fundamental feature of neural organization. However, the molecular basis of hippocampal lateralization in response to environmental stimuli remains poorly understood. Here, we examined the transcriptomic profiles of the left and right hippocampal CA1 regions in rats reared under isolated or enriched housing conditions to elucidate hemisphere-specific responses and shared molecular adaptations. RNA-sequencing analysis revealed lateralized differences in the number and identity of differentially expressed genes, accompanied by distinct biological themes, as indicated by overrepresentation and gene set enrichment analysis. The left CA1 region was prominently engaged in pathways related to synaptic organization and mitochondrial function, whereas the right CA1 region exhibited enrichment in transcriptional regulation and RNA metabolic processes. Despite these asymmetries, co-expression and protein–protein interaction network analyses revealed shared molecular architectures. Immediate early genes formed consistent central hubs across both hemispheres, and a common Mecp2–Grin2b–Cdkl5–Tet3 protein interaction cluster was identified as a potential integrative regulatory module. Additional enrichment analysis of differentially expressed genes shared between hemispheres further highlighted conserved responses, particularly in synaptic plasticity and cell–cell communication. Together, these findings demonstrate that the left and right CA1 regions employ distinct yet partially convergent transcriptional programs to adapt to environmental stimuli. This coordinated molecular asymmetry provides novel insights into hippocampal lateralization and its role in experience-dependent brain plasticity.
Over 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.
We will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.
Ethical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.
This study aims to estimate the prevalence and dual use of cigarettes, heated tobacco products (HTPs) and electronic cigarettes (e-cigarettes) among individuals aged 18–24 in Japan.
This cross-sectional study involved a door-to-door survey administered by trained interviewers using a structured questionnaire.
Individuals aged 18–24 residing in 220 areas within 10 ordinance-designated cities (Sapporo, Sendai, Saitama, Chiba, Yokohama, Kawasaki, Sagamihara, Nagoya, Osaka and Fukuoka) as well as Tokyo’s 23 wards in Japan in 2019 were included.
A total of 1738/5500 individuals were included in the analysis, with participants evenly distributed by sex, age and residential area.
Cigarette, HTP and e-cigarette use was assessed.
The weighted prevalence of the current use of cigarettes, HTPs and e-cigarettes accounted for 10.1% (95% CI 8.7, 11.5), 5.1% (95% CI 4.1, 6.1) and 1.8% (95% CI 1.2, 2.4), respectively. Approximately 68.2% of the people who used HTPs at the time were dual users of both HTPs and cigarettes. There was a significant gap in tobacco product use between individuals aged 20–24 and those aged 18–19, with this difference remaining after adjusting for covariates.
In 2019, cigarettes were the most used tobacco-related product among young adults in Japan. Smoking initiation appears to notably increase at age 20 when smoking becomes legal in Japan. The prevalence of HTP use among young adults in Japan is notably higher than in other countries.
This research paper presents a study protocol for an exploratory clinical trial evaluating the safety and potential efficacy of autologous peripheral blood mononuclear cell (PBMNC)-loaded injectable cell scaffold (ICS-001) for angiogenic therapy in chronic limb-threatening ischaemia (CLTI). CLTI, the advanced stage of peripheral artery disease, presents significant therapeutic challenges.
Angiogenic therapy using ICS-001 with PBMNCs—a novel approach designed to enhance local cell retention and promote neovascularisation—will be explored. The study will address the pathophysiology of CLTI, the limitations of current treatments and the rationale for cell-based therapies, alongside the clinical trial design for evaluating the safety and efficacy of ICS-001. We hypothesise that ICS-001 will improve ulcer healing and reduce ischaemic rest pain in patients with CLTI. This paper outlines the methodology, including patient selection, CD34+ cell mobilisation, scaffold preparation, injection protocols, clinical assessments, data collection and safety monitoring. The anticipated results, discussion and conclusion will offer insight into the clinical significance and potential impact of ICS-001 as a pioneering angiogenic therapy for CLTI.
The institutional review boards of all participating hospitals approved this study protocol (latest version V.6.0, 5 June 2025). Final data will be made publicly available. A report detailing the study results will be submitted for publication in an appropriate peer-reviewed journal.
Data are available on reasonable request. Technical appendix, statistical code is available by contacting the corresponding author. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) licence, which permits others to distribute, remix, adapt, build on this work non-commercially, and licence their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
jRCT2052230115, Japan Registry of Clinical Trials.
To clarify how public health nurses allocate their time across various tasks and compare time-use patterns between prefectural and municipal public health nurses in Japan, where distinct administrative mandates define their roles.
A self-reported, prospective time study.
Public health nurses from two municipalities and one prefecture recorded their daily practices and time allocations using Kintone. Time allocation differences by administrative level and job position were analysed using linear mixed-effects models.
Overall, 121 participants contributed 9502 person-days of data. Participants spent an average of 463.6 min/workday on work-related activities. Municipal public health nurses dedicated more time to application paperwork (64.0 min), health examinations (57.6 min), and individual coordination (48.3 min). Prefectural public health nurses allocated more time to business management and organisational operations (69.0 min) and traveliing, particularly in rural contexts. Managers spent less time on direct care and more on administrative tasks.
This study provides the first quantitative, self-reported evidence of task distribution among public health nurses across administrative levels and positions. The findings reflect structural differences in role expectations and underscore the need to reallocate workloads to better align with each level's mandate.
Task prioritisation, information and communication technology tool integration, and administrative support are essential in optimising public health nurses' contributions to community health. These strategies can reduce non-clinical workload and enable public health nurses to focus on high-impact, value-added public health services that promote health equity.
This study closes a longstanding gap by quantifying PHNs' time allocation, revealing the hidden burden of administrative work, and providing critical insights for workforce planning and sustainable public health service delivery.
This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology guideline.
No Patient or Public Involvement.
UMIN Clinical Trials Registry; UMIN000051509 (https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000058761; August 1, 2023)
To analyse the incidence of physical restraint use during painful and stressful procedures in hospitalised children, as well as the factors associated with its use.
Observational, longitudinal and prospective study.
Children aged between 28 days and 10 years in a public hospital in Brazil were each observed undergoing clinical procedures over a 6-h period. Data were collected on demographics, observed pain using validated measures, stress behaviours, and the use of physical restraint. Descriptive and inferential analyses were performed. National ethical guidelines were strictly followed.
1210 procedures were observed on 75 children, including 351 painful and 859 stressful procedures. Physical restraint was used in 270 (22.3%) procedures; of these, 131 (48.5%) were painful procedures and 139 (51.5%) were stressful procedures. In stressful procedures, at least one stress-related behaviour was observed before the initiation of physical restraint. Factors associated with increased use of physical restraint during painful procedures were younger children, with higher levels of care dependency, higher pain scores during procedures, and those who underwent intravenous medication administration, airway suctioning, tube insertion, and fixation changes. In stressful procedures, the factors associated with higher use of physical restraint were younger children, hospitalisation due to respiratory conditions, those who underwent physical examinations, inhaled medication, and nasal lavage; and the child's expression of stress behaviour before the procedure starts. Predictors of physical restraint included morning period, younger age group, male or female sex, and transfer from the Intensive Care Unit.
A high incidence of physical restraints was observed across multiple painful and stressful procedures performed within a 6-h period, associated with variables related to both the child's characteristics and the procedures.
This study aims to encourage reconsideration of the frequent use of physical restraint in paediatric procedures, calling for a reframing of its application as an unquestioned practice toward an approach that prioritises protecting and respecting a child as a subject with needs, rights, and desires.
Strengthening the Reporting of Observational studies in Epidemiology (STROBE).
Atopic dermatitis (AD) is a chronic inflammatory skin condition that impairs the quality of life of affected paediatric patients and their families. Dupilumab, an antagonist of the shared alpha chain subunit of the cytokines interleukin-4 and interleukin-13, has revolutionised the management of moderate-to-severe AD by effectively targeting type 2 inflammation. However, live attenuated vaccines, including live attenuated influenza vaccines (LAIVs), are contraindicated during dupilumab therapy owing to limited safety data. This restriction poses challenges to immunisation strategies, particularly in paediatric populations. This study aims to evaluate the safety and efficacy of LAIV in paediatric patients with AD undergoing dupilumab therapy.
This multicentre, prospective, single-arm, open-label trial will enrol 50 paediatric patients aged 2–18 years with AD undergoing dupilumab treatment. The participants will receive intranasal LAIV, followed by a 25-week observation period after vaccination. The primary outcome is the proportion of participants with a four-fold or greater increase in haemagglutination inhibition titres against influenza strains A(H1N1), A(H3N2) and B at 4 weeks post vaccination. The secondary outcomes include the incidence of influenza and systemic or local adverse events, such as injection site reactions, fever and other influenza-like symptoms observed within 4 weeks of vaccination. Exploratory endpoints include the evaluation of immunosuppressive markers such as neutrophil counts, lymphocyte subsets and serum immunoglobulin G levels. Safety analyses will assess the frequency of each adverse event, whereas efficacy analyses will focus on immunogenicity and influenza incidence during the 25-week follow-up period. This study aims to provide critical safety and immunogenicity data to guide immunisation strategies in biologically treated paediatric patients with AD.
This study complies with the principles of the Declaration of Helsinki and received ethics approval from the Institutional Review Board of Chiba University Hospital as a specified clinical trial. Informed consent and assent will be obtained as appropriate based on the participants’ ages. These findings will be disseminated through peer-reviewed journals and scientific conferences to inform clinical vaccination strategies for biologically treated populations.
jRCTs031240442.
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