Over a 21-month period, a cluster of 13 safety events was observed in a perioperative service area that met criteria as either serious safety events per the health care performance improvement safety event classification system or Joint Commission sentinel events. This cluster of events served as the impetus to deploy high reliability organization (HRO) interventions to reduce potential future harm. To increase safety awareness and improve clinical safety across perioperative services, 3 interventions were iteratively implemented over a 6-month period: (1) surgical safety stand-downs; (2) error prevention training; and (3) establishment of a safety coach program. Simultaneously, analyses were conducted to address systemic causes leading to and preventing additional safety events from occurring. The impacts of these interventions were then monitored for over 2 years post-implementation to assess the outcome. Following the deployment of 3 interventions, we observed an increase in cases between events from a baseline mean of 2977 cases to a period of 39 654 cases (over 585 days) without a safety event triggering analysis. This occurred with a concurrent increased trend in safety reports. As a balancing metric, we did not observe decreased case volumes; in fact, cases increased throughout the observed period. Department-wide HRO-based interventions contributed to a significant decrease in serious safety and sentinel events and should be considered to improve patient care. Attention to departmental safety trends can drive systemic improvements leading to higher-quality perioperative care.
Background/Objectives: Inborn errors of immunity (IEI) are rare and complex pediatric disorders that create significant information gaps for families and non-specialist healthcare professionals. Large language models (LLMs) such as ChatGPT are increasingly used as on-demand health information resources; however, evidence on their performance in rare pediatric diseases remains limited. This study aimed to evaluate the reliability, quality, readability, understandability, reproducibility, and safety-related concerns of ChatGPT-4o responses to frequently searched questions about pediatric IEI posed by healthcare professionals and patients/caregivers. Methods: This cross-sectional evaluation used the publicly accessible ChatGPT-4o interface to generate responses to 20 frequently searched questions about pediatric IEI, equally distributed between healthcare professional (n = 10) and patient/caregiver queries (n = 10). Three pediatric allergy-immunology specialists independently evaluated response quality using the modified DISCERN (mDISCERN) and Global Quality Scale (GQS) tools, supplemented by a structured expert-based assessment of misinformation, safety-related concerns, suspected factual issues, missing disclaimers, and clinically meaningful inter-iteration inconsistency. Text readability was assessed using four validated indices (ARI, FRES, FKGL, GFR), comprehensibility using the Patient Education Materials Assessment Tool (PEMAT), and reproducibility using natural language processing methods. Results: ChatGPT-4o demonstrated strong overall performance, with median mDISCERN and GQS scores of 4 (IQR: 3-5) for both query types. Readability scores substantially exceeded recommended thresholds, with FKGL scores of 12.96 ± 0.69 and 10.83 ± 0.67 for professional and patient/caregiver queries, respectively. Mean PEMAT understandability scores were 71.80 ± 5.75% for professional queries and 80.80 ± 4.73% for patient/caregiver queries (p = 0.001). Reproducibility was high, with semantic similarity rates of 86.10 ± 3.84% and 87.30 ± 3.68%, respectively. Suspected factual issues were identified in 4 of 20 responses (20%), safety-related concerns in 3 (15%), clinically meaningful inter-iteration inconsistencies in 3 (15%), and missing medical disclaimers in all 20 responses (100%). Conclusions: ChatGPT-4o showed strong performance across validated quality metrics for pediatric IEI information support; however, its high reading level, universal absence of medical disclaimers, and occasional clinically meaningful inconsistencies limit its suitability as a standalone source for clinically sensitive guidance. These findings underscore the need for AI-driven patient education tools with improved readability, adaptive complexity adjustment, and safety-oriented communication.
Background Accurate and complete clinical documentation is essential for ensuring patient safety, continuity of care, and effective clinical decision-making. In many resource-limited settings, documentation practices remain inconsistent due to the absence of standardized tools, leading to gaps in care delivery. Objective This study aimed to evaluate and improve the completeness of pediatric follow-up documentation through the implementation of a structured follow-up card. Methods This was a closed-loop quality improvement project conducted at the pediatric outpatient department of Almanagil Teaching Hospital, Sudan. Two audit cycles were performed. The first cycle involved a retrospective review of 50 pediatric follow-up records over a two-week period in August 2025 to assess baseline documentation practices. Following this, a one-month intervention was implemented, introducing a structured pediatric follow-up card alongside brief staff orientation. The second cycle was conducted prospectively over two months (October-November 2025), including 50 follow-up records. Documentation completeness was assessed using predefined criteria, and comparisons between cycles were performed using the chi-square test, with a p-value <0.05 considered statistically significant. Results At baseline, documentation across all assessed variables was absent (0%). Following the intervention, significant improvements were observed across nearly all variables. Core documentation elements, including patient identification details, diagnosis, and treatment plan, reached 100% compliance (n = 50). Clinical variables such as chronic disease status and medication-related documentation improved to 74.0% (n = 37) and 68.0% (n = 34), respectively, while medication frequency and nutritional documentation exceeded 98.0% (n = 49). All improvements were statistically significant (p < 0.001), except for medical file number documentation, which remained unchanged. Conclusion The introduction of a structured pediatric follow-up card significantly improved documentation completeness. This study highlights the effectiveness of simple, low-cost interventions in addressing system-level documentation gaps and improving the quality of care in resource-limited settings.
Tranexamic acid (TXA) is a widely used antifibrinolytic agent in surgical and trauma settings in adults. This study aimed to evaluate the efficacy and safety of TXA in pediatric trauma patients across various clinical outcomes. A comprehensive literature search was conducted across 4 databases. We included clinical trials and observational studies that reported the use of TXA in pediatric trauma patients (aged ≤18 years). Data extraction and risk-of-bias assessment were performed by independent reviewers. Meta-analyses were conducted with RStudio software. A total of 12 studies (2 randomized controlled trials [RCTs] and 10 observational) involving 66,398 pediatric trauma patients were included. Tranexamic acid was not significantly associated with reduction in hospital mortality (OR = 1.06; 95% CI, 0.32-3.45) but was associated with significantly shorter hospital stays (mean difference [MD] = -1.49; 95% CI, -2.43 to -0.56). The need for emergency mechanical ventilation was higher among the TXA group (OR = 4.29; 95% CI, 2.52-7.31), whereas the need for mechanical ventilation at discharge was lower (OR = 0.23; 95% CI, 0.08-0.64). Tranexamic acid use did not significantly alter the risk of thromboembolic events (OR = 0.72; 95% CI, 0.19-2.79) or poor neurological outcomes (OR = 2.51; 95% CI, 0.86-7.35). Tranexamic acid may reduce hospital length of stay in pediatric trauma patients, with inconsistent effects on mortality and adverse events. Its use should be individualized based on injury severity and resource availability. Further high-quality research is needed to confirm these findings and clarify the role of TXA in pediatric trauma care.
Chest tube management is a high-risk, low-frequency clinical skill requiring prompt nursing assessment, troubleshooting, and escalation to prevent complications. Limited exposure may contribute to variability in nursing confidence. Simulation-based education reinforces pediatric nurses' readiness for chest tube management. This quality improvement initiative aimed to implement and evaluate a simulation-based educational intervention to improve pediatric nurses' confidence, anxiety, and knowledge related to chest tube management. This quality improvement initiative used a single-group pretest-post-test design with delayed follow-up, incorporating 3 assessment time points: preintervention, immediately postintervention, and 2-month follow-up. The study was conducted between July and December 2025 at a Level I pediatric Midwestern US trauma center. Registered nurses participated in a 1-hour simulation with 3 stations focused on chest tube assessment, troubleshooting, and escalation. Pediatric surgery faculty and residents served as facilitators. Surveys assessing confidence, anxiety, and knowledge were administered at all time points. Mean differences, 95% confidence intervals, and effect sizes were calculated. Sixty-five nurses completed preintervention and postintervention surveys; 22 completed follow-up. Mean confidence increased from 3.9 to 4.8 (mean difference 0.9; 95% CI, 0.7-1.1; Cohen d = 1.12), anxiety decreased from 2.9 to 1.9 (mean difference -1.0; 95% CI, -1.3 to -0.7; Cohen d = -0.83), and knowledge increased from 5.60/7 to 6.65/7 (mean difference 1.05; 95% CI, 0.84-1.26; Cohen d = 1.99). Improvements were observed at follow-up. Simulation-based education was associated with improved nurse confidence, reduced anxiety, and increased knowledge related to pediatric chest tube management.
The daily safety brief (DSB) is a structured approach to enhancing patient safety and readiness, widely used in free-standing children's hospitals. This observational study examines the implementation and feasibility of a DSB within a children's hospital embedded in an adult healthcare system-a unique challenge requiring adaptation to an infrastructure primarily designed for adult care. Using a descriptive, observational design, we tracked safety concerns reported during DSBs over a 12-month period across inpatient units and the pediatric emergency department. Safety concerns were categorized using a predefined taxonomy and reviewed by the implementation team. The implementation process confirmed the feasibility of integrating pediatric safety efforts within an adult system. While qualitative feedback suggested improved communication and situational awareness, this study did not measure direct improvements in patient safety outcomes, and the single-center design limits generalizability. The reduction in reported safety concerns over time should be interpreted cautiously, as changes in reporting may reflect cultural or behavioral factors rather than true safety improvements. This initiative highlights the potential for embedding pediatric safety practices within broader hospital operations, warranting further investigation using controlled designs with objective patient safety outcome measures.
The management of facial fractures in the pediatric population represents a unique challenge in facial fracture care, where fixation must strike a balance between stability and interference with growth and the need for secondary implant removal procedures. Bioresorbable fixation systems have been increasingly applied in this population; however, their pooled safety and performance data and clinical advantages over titanium fixation in the pediatric population are not well described. This systematic review and meta-analysis aimed to comprehensively assess the clinical outcomes and complication rates associated with the use of resorbable fixation systems in the management of pediatric facial fractures. The PubMed, Cochrane Library, Scopus, Web of Science, and ScienceDirect databases were searched for articles published until March 2025. The selection criteria were as follows: randomized controlled trials (RCTs), cohort studies, and comparative clinical studies of patients aged ≤18 years who received resorbable fixation systems for any facial fracture. The primary outcomes were infection, malocclusion, implant palpability, and plate removals. Study quality was assessed using the ROBINS-I risk of bias tool. A meta-analysis was conducted using a random-effects model and reported as log OR and logit event rate with 95% CI. Twenty-six studies reporting on nearly 620 patients were included in this review. The pooled infection rate was 3.2% (95% CI: 0.63-7.5%; I2 = 0%), malocclusion rate was 8.7% (95% CI: 1.88-15.7%; I2 = 0%), and implant palpability was observed in 11.8% of patients (95% CI: 6.42-17.2%; I2 = 0%). Compared with titanium fixation, resorbable systems were associated with a 96% reduction in the odds of plate removal (log OR: -3.287; 95% CI: -4.968 to -1.607; p = 0.00013). Statistical heterogeneity was low for all outcomes (I2 < 20%). No evidence of a significant publication bias was found. Resorbable fixation systems are safe, functionally effective, and growth-accommodating alternatives to titanium plates for managing facial fractures in children and adolescents. The greatly reduced risk of requiring secondary implant removal and low complication rates support their use as a first-line fixation strategy for facial fractures in the pediatric population.
IgA vasculitis nephritis (IgAVN) is an important cause of secondary glomerulonephritis and long-term renal morbidity in children. Traditional Chinese medicine (TCM) interventions are widely used for pediatric IgAVN, either alone or combined with Western medicine, but their efficacy and safety remain uncertain. This study evaluated the efficacy and safety of TCM interventions in children with IgAVN. Eight databases were searched from inception to March 7, 2025, for randomized controlled trials comparing TCM interventions with Western medicine alone in children with IgAVN. The primary outcome was the overall clinical effective rate. Secondary outcomes included 24-hour urinary protein excretion, urinary red blood cell count, β2-microglobulin, D-dimer, and adverse events. Meta-analyses were performed using RevMan 5.4. Risk of bias was assessed using the Cochrane risk-of-bias tool, and certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach. Nineteen randomized controlled trials involving 1764 children were included. Compared with Western medicine alone, TCM interventions improved the overall clinical effective rate (risk ratio = 1.20, 95% confidence interval [CI] = [1.15-1.25], P < .00001) and reduced 24-hour urinary protein excretion (standardized mean difference = -0.83, 95% CI = [-1.12 to -0.54], P < .00001) and β2-microglobulin levels (standardized mean difference = -0.54, 95% CI = [-0.70 to -0.38], P < .00001). Sensitivity analyses suggested possible reductions in urinary red blood cell count and D-dimer levels after excluding heterogeneous trials. The incidence of adverse events did not differ significantly between groups (risk ratio = 0.92, 95% CI = [0.60-1.40], P = .70). The certainty of evidence ranged from moderate to very low. The TCM interventions included in this review may provide short-term benefits in clinical response and selected renal-related laboratory outcomes in children with IgAVN, without increasing the observed incidence of adverse events. High-quality randomized trials with standardized outcomes, structured safety monitoring, and longer follow-up are needed.
Preventable harm in pediatric care requires coordinated, cross-institutional learning. The Child Health Patient Safety Organization established weekly safety huddles to enhance situational awareness and strengthen a protected learning network under the Patient Safety and Quality Improvement Act. This iterative time-series quality improvement study examined weekly huddle content, assessed targeted interventions to increase participation, and evaluated engagement trends over time. The primary outcome was composite engagement, defined as ≥80% annual attendance and ≥5 submitted reports. Secondary measures included attendance, quarterly reporting, and categorization of reported safety events. Frequently reported events involved medication issues, diagnostic errors, and device malfunctions. Targeted interventions increased composite engagement from 21% to 71.4%, alongside improvements in weekly attendance and quarterly reporting. Organizations also reported using huddle insights to guide internal risk assessments and escalate concerns. Child Health Patient Safety Organization safety huddles improved participation, supported shared learning, and strengthened safety culture consistent with learning-organization and high-reliability principles.
Quantify post-traumatic stress disorder (PTSD) prevalence rates in pediatric nurses; identify the strength, direction, and predictive relationship between PTSD and psychological capital (PsyCap), psychological safety, coworker support, and supervisor support; and explore nurses' perceptions and coping strategies for dealing with work-related trauma. A convergent mixed-methods cross-sectional, correlational-predictive online research study design utilizing the Conservation of Resources theoretical framework. Convenience sample of pediatric nurses working in direct patient care in the United States. Post-Traumatic Checklist for DSM-5 (PCL-5), Psychological Capital Questionnaire (PCQ), Psychological Safety tool, Coworker Support Scale (CSS), and Supervisor Support Scale (SSS). Qualitative questions were content analyzed. Descriptive and inferential statistics, including hierarchical regression models, were used. One-hundred and seventy-one participants were included in the analysis; 56.7% met the cut-point for full PTSD criteria. PTSD symptoms were inversely related to nurses' Psychological Capital and PsyCap scores. Additionally, Psychological Safety and PsyCap were independent predictors of PTSD when entered in the hierarchical regression analysis model. A joint display table was developed to integrate qualitative and quantitative findings. PTSD is a concern for direct-care pediatric nurses. Results from the hierarchical regression analysis lend important insight into workforce factors (Psychological Safety) and intrapersonal qualities (PsyCap) affecting PTSD symptomology in pediatric nurses. Qualitative comments support the importance of coworker, leader, and organizational support for individuals. Implication to Practice This study highlights potential predictive and protective intrapersonal, interpersonal, and organizational factors on pediatric nurses' PTSD symptomology.
Parents of children with pediatric orthopaedic conditions frequently have questions after their clinic visit, and a reliable postconsultation resource to address these enquiries is lacking. Online resources are variable in quality, and general purpose artificial intelligence (AI) models have demonstrated safety limitations, including unprompted treatment recommendations and citation inaccuracies. A purpose-built, supervised generative AI solution may offer a safer and more reliable alternative. A generative AI chatbot was developed using retrieval-augmented generation and trained on OrthoKids educational materials covering 5 common pediatric orthopaedic conditions: in-toeing, flatfoot, scoliosis, bow legs, and knock knees. After iterative refinement by 2 fellowship-trained pediatric orthopaedic surgeons, the chatbot was evaluated by 18 multidisciplinary clinicians using a structured 12-item 5-point Likert scale survey assessing accuracy, safety, usability, and clinical acceptability. Mean scores exceeded 4.0 of 5.0 on 11 of 12 domains. Clarity of explanation achieved unanimous positive endorsement (100%), while protocol alignment received the highest mean score (4.50 ± 0.62). Citation accuracy was the lowest-rated domain (4.00 ± 0.77). No hallucinations were identified, and 88.9% of evaluators confirmed the absence of unprompted treatment recommendations. The reverse-scored safety item (Q8) demonstrated the greatest inter-rater variability (mean 3.11 ± 1.57), with orthopaedic specialists rating perceived harm substantially lower (mean 1.33) than nurses (mean 4.40). A purpose-built gen AI chatbot demonstrated high clinical accuracy and acceptability among multidisciplinary evaluators, with effective avoidance of unprompted treatment recommendations. These pilot findings support feasibility for use as a parental education adjunct in pediatric orthopaedic practice. Level III. See Instructions for Authors for a complete description of levels of evidence.
Orthognathic surgery is a definitive treatment for dentofacial deformities, yet comprehensive synthesis of clinical outcomes, complications, and quality of life impacts remains limited. This systematic review critically evaluates contemporary evidence on orthognathic surgery effectiveness and safety. A systematic search of PubMed/MEDLINE, Embase, Cochrane CENTRAL, Web of Science, and Scopus was conducted through December 2024. Studies reporting clinical outcomes, complications, or quality of life following orthognathic surgery in patients with dentofacial deformities were included. Quality assessment employed the Cochrane Risk of Bias tool and Newcastle-Ottawa Scale. Meta-analysis with random-effects models was performed where appropriate. Sixty-five studies encompassing 6,482 patients were included. Mean ANB angle improvements were 6.8° (95% CI: 6.2-7.4°) for class III and 5.4° (95% CI: 4.9-5.9°) for class II corrections, with 87.3% maintaining skeletal stability at ≥1-year follow-up. Overall complication rate was 32.4% (95% CI: 28.7-36.1%), predominantly minor and self-limiting. Neurosensory disturbances occurred in 52.8% of cases, with 92.6% recovering by 12 months and permanent alterations in 3.4%. Relapse (>2mm) occurred in 18.7% of cases. Quality of life demonstrated substantial improvements with standardized mean difference of -1.84 (95% CI: -2.12 to -1.56, p < 0.001) for OQLQ total scores. Patient satisfaction reached 87.6% (95% CI: 84.2-91.0%), with higher ratings for aesthetic vs. functional outcomes.Conclusion: Orthognathic surgery effectively corrects dentofacial deformities with significant clinical and quality of life improvements. However, moderate complication rates and relapse risk necessitate careful patient selection, informed consent, and long-term follow-up.Keywords: orthognathic surgery; dentofacial deformities; systematic review; quality of life; complications; patient satisfaction; skeletal stability; neurosensory disturbances.
To evaluate the introduction of locally configured standard concentration (StdC) intravenous drug infusions in critically ill children. This two-year quality improvement retrospective cohort study (2018-20) examined post-implementation of 47 StdC drugs configured across three weight bands: <5 kg, 5-20 kg and >20 kg in a 26-bed, multispecialty paediatric intensive care unit. The main outcome measures were (1) adherence to StdC use (non-adherence defined as using a bespoke drug concentration), (2) attempts at dosing above the pre-set infusion rates, known as hard limit events (HLEs), (3) incidents related to infusions and (4) percentage of total fluid allowance available for nutrition. In total, 33 224 infusions were administered, with morphine, clonidine and milrinone representing 61%. Most of them (83.6%) were initiated in children in the lower weight bands. Adherence to StdCs was 96% and was similar across weight bands. A total of 204 498 pump programming events were examined, with 418 (0.2%) being HLEs. Only 21 HLEs (0.01%) were considered potentially clinically significant (defined as programming >2.5 times the maximum dose). Following investigation, 20/21 were found likely to be related to training episodes, rather than true errors. Twenty clinical incidents linked to StdC infusions were reported but none caused harm. The mean fluid allowance available for nutrition after accounting for StdC volumes was 38.8% in the <5 kg weight band, and 71% and 67.4% in the other two bands, respectively. Configured StdCs are effective and safe across all weight bands and allow for partial provision of nutritional needs in fluid-restricted patients. The high adherence rate facilitated pharmacy supplying infusions as Ready-To-Administer (RTA).
BackgroundI-131 metaiodobenzylguanidine (MIBG) therapy effectively treats high-risk neuroblastoma but exposes caregivers and healthcare providers to radiation risks. Managing patient anxiety and agitation is essential for safety. Dexmedetomidine has shown potential as an anxiolytic, but its feasibility and acceptability in this setting are underexplored. This quality improvement (QI) project aimed to evaluate the feasibility and nurse acceptability of dexmedetomidine anxiolysis in our patient population.MethodA retrospective chart review was conducted for pediatric patients who received dexmedetomidine during MIBG therapy between January and June 2023. Feasibility was assessed through adverse events, vital sign changes, and dose adjustments. Nurse acceptability was evaluated using a questionnaire adapted from the Theoretical Framework of Acceptability and a follow-up focus group.ResultsSeven patients received the full MIBG dose with dexmedetomidine and experienced no adverse events. Minor, transient vital sign changes were noted, and all patients adhered to radiation safety protocols. Ten nurses completed the acceptability questionnaire; 100% reported that dexmedetomidine was easy to administer, promoted patient safety, and supported safe MIBG administration. Ninety percent found dexmedetomidine to be an acceptable anxiolytic. Focus group participants (n = 3) identified themes surrounding intravenous access challenges and the need for improved interdisciplinary communication.DiscussionDexmedetomidine appeared to be a feasible and acceptable anxiolytic for pediatric patients receiving MIBG therapy in this small, single-unit QI project. Practice changes included a preadmission multidisciplinary huddle, interdisciplinary huddle requests for clinical concerns, and a dexmedetomidine administration standard operating procedure. This project underscores the importance of multidisciplinary collaboration and nurse feedback in refining clinical practice.
Tic disorder (TD) affects 2.68% of children in China. It is classified as a movement disorder, with dysfunction in cortical-striatal-thalamic-cortical circuits implicated in its pathophysiology. Western medical treatments for TD may be associated with adverse reactions and suboptimal adherence in some patients. Pediatric Anshen Bunao Granules (PABG) is an in-house traditional Chinese medicine (TCM) preparation with over 20 years of clinical use for TD, approved by the Guangdong Provincial Drug Administration for use in medical institutions across Guangdong Province. Observational studies have reported effects of PABG; however, high-level evidence remains lacking. This study aims to evaluate the efficacy and safety of PABG in children with TD. This is a randomized, double-blind, active-controlled, parallel-group trial. A total of 150 children aged 4-16 years with TD (TCM syndrome: Spleen Deficiency with Phlegm Accumulation and Wind-Phlegm Disturbance Syndrome) will be recruited from Shenzhen Traditional Chinese Medicine Hospital, Guangdong Province, China. Eligible participants will be stratified by age group and baseline Yale Global Tic Severity Scale (YGTSS) total score, and randomly allocated at a ratio of 2:2:1 to the low-dose PABG group, high-dose PABG group, or active control group (receiving 5% of the active ingredients to maintain blinding) for 8 consecutive weeks of treatment. Primary outcomes will be the change in YGTSS Total Tic Score (YGTSS-TTS) from baseline to Week 8, and the proportion of participants with a ≥ 30% reduction in YGTSS-TTS at Week 8. Secondary outcomes will be assessed using the YGTSS, the TCM Syndrome Rating Scale (TCM-SRS), and the Gilles de la Tourette Syndrome-Quality of Life Scale for Children and Adolescents (C&A-GTS-QoL). Safety assessments will include vital signs, physical examination, laboratory tests, ECG, and adverse events. This trial will provide evidence on the efficacy and safety of PABG for children with TD. The findings may inform clinical application and potential registration of this in-house TCM preparation. https://itmctr.ccebtcm.org.cn/, ITMCTR2025001659.
Introduction: Advances in pediatric oncology have transformed cancer into a condition with chronic and long-term developmental consequences. While survival rates have improved significantly, the literature on psychosocial outcomes remains fragmented and inconsistent, with a notable lack of person-centered analyses that account for the heterogeneity of adaptive trajectories. Current evidence fails to explain why survivors with similar clinical profiles exhibit divergent psychological phenotypes, particularly regarding the late effects of multimodal treatments. The aim of this study was to identify heterogeneous psychosocial profiles among adolescent cancer survivors and to examine their associations with treatment complexity and quality of life. Materials and Methods: This cross-sectional study included 165 adolescents aged 12-18 years (mean age: 14.64 years) who were in clinical remission following oncological treatment. Standardized assessment tools were used: the Children's Depression Inventory 2 (CDI-2™) to measure depressive symptoms, the KIDSCREEN-10 index to assess health-related quality of life (HRQoL), and a scale evaluating satisfaction across 14 life domains. Adaptive profiles were identified using a Two-Stage Cluster Procedure, and risk factors were examined using multinomial logistic regression. Results: Four clusters were identified in the study population: a depressive-dysphoric profile, an anhedonic-withdrawn profile, a highly adaptive profile, and a mixed (struggling) profile. Treatment complexity was identified as a significant independent predictor of membership in the high-distress (depressive) cluster. While each additional therapeutic modality beyond standard chemotherapy was associated with a markedly increased risk (OR = 8.91; p < 0.001), the relatively wide confidence interval (95% CI: 3.27-24.31) suggests that the exact magnitude of this effect should be interpreted with caution. The high lower bound of the interval (3.27), however, strongly supports the directional association of cumulative iatrogenic burden with psychological adaptation. Subjective quality of life functioned as a protective factor against depressive symptoms (OR = 0.57); however, paradoxically, higher self-reported quality of life increased the likelihood of classification into the anhedonic group (OR = 1.81). This divergence between high self-reported HRQoL and social withdrawal potentially suggests a 'well-being paradox'. It is hypothesized that standard HRQoL instruments may primarily capture physical remission and relief from acute somatic symptoms, potentially masking underlying social-emotional deficits. This suggests that HRQoL scores in survivors should be interpreted with caution and complemented by specific affective screenings. Conclusions: The absence of a uniform pattern of psychological response to cancer among adolescent survivors supports the validity of a patient-centered approach. The burden associated with intensive multimodal treatment significantly increases the likelihood of full-syndrome depression during adolescence. Moreover, the identification of a cluster suggestive of anhedonic and socially withdrawn features highlights the limitations of standard screening tools focused solely on the detection of overt sadness. This heterogeneity underscores the need for personalized psycho-oncological care and the implementation of intensified monitoring for patients at high medical risk.
The increasing clinical complexity of pediatric patients, combined with global nursing workforce shortages, requires reliable tools to measure nursing care complexity and support evidence-based staffing decisions. In highly specialized settings such as pediatric cardiovascular units, patient acuity and cognitive nursing workload are particularly demanding. However, data on validated tools for assessing care complexity in pediatric contexts remain limited. To measure nursing care complexity in pediatric cardiovascular patients and to identify clinical and organizational factors associated with higher complexity levels using validated pediatric acuity tools. A retrospective cross-sectional observational study was conducted on 313 patient records from the Pediatric and Congenital Cardiac Surgery and Cardiology Unit and the Pediatric Intensive Care Unit of a tertiary university hospital in Italy (January-December 2022). Nursing care complexity was assessed using the CAMEO II tool for intensive care and the Inpatient CAMEO tool for ward settings. Descriptive statistics were performed. Associations between complexity and categorical variables were analyzed using chi-square tests. Simple and multiple linear regression analyses were conducted to identify predictors of baseline complexity (T0). Statistical significance was set at p 0.05. All patients admitted to the intensive care unit showed medium nursing care complexity. In the inpatient cardiac unit, 27% of patients had low complexity and 73% had medium complexity; no high-complexity cases were observed. Younger age was significantly associated with higher complexity (B = -0.29, p 0.001). Urgent admission (B = 6.73, p 0.001) and longer hospital stay (B = 0.37, p 0.001) were also significant predictors. Organizational variables, including day of the week and work shift, were not significantly associated with complexity. The regression model explained 46% of the variance in baseline complexity scores (adjusted R² = 0.451). In pediatric cardiovascular settings, nursing care complexity is primarily driven by patient-related clinical factors rather than organizational variables. Younger and urgently admitted patients with longer hospital stays require higher cognitive nursing workload. The systematic implementation of validated acuity tools such as CAMEO II and Inpatient CAMEO may support evidence-based workforce planning, optimize nurse-to-patient ratios according to patient acuity, and enhance quality and safety of care. These findings are particularly relevant in the context of healthcare resource constraints and contribute to improving organizational decision-making in specialized pediatric settings.
Sialorrhea significantly impairs quality of life in children with neurodisabilities, including cerebral palsy, yet safe and effective pharmacologic treatment options remain limited. Although atropine is widely used for sialorrhea, it is most commonly used off-label as ophthalmic drops administered intraorally, an approach constrained by poor mucosal retention, frequent dosing, medication-error risk, and systemic anticholinergic adverse effects. To address these limitations, we developed a novel mucoadhesive atropine oral gel (0.01% weight/weight (w/w)) to enhance intraoral residence time and support controlled local and systemic exposure. The pharmacokinetics and safety of the atropine gel were evaluated in a Phase I clinical trial in healthy adults, which informed the development and validation of a physiologically based pharmacokinetic (PBPK) model incorporating a mechanistic oral cavity framework. The oral cavity PBPK model accounts for salivary flow, mucosal absorption, swallowing, and saliva-tissue exchange across six compartments, enabling predictions of local and systemic exposure and evaluation of formulation-relevant determinants of intraoral absorption. Pediatric PBPK simulations were scaled from the adult model using Population Estimates for Age-Related Physiology™ (PEAR Physiology™) to support model-informed dose selection. Simulations identified a minimum pediatric dose range of 0.25 mg/kg once or twice daily, with twice-daily dosing to maintain plasma concentrations within the established minimum effective and maximum tolerated concentration range. Collectively, this work demonstrates the utility of PBPK modeling as a translational tool to integrate formulation attributes, oral cavity physiology, and pediatric dose selection, and supports the clinical advancement of mucoadhesive atropine gel as a safer alternative to off-label intraoral atropine eye drops.
Background Malnutrition and weight instability are common but often under-recognized in patients receiving active cancer treatment. Treatment toxicities, altered metabolism, and psychological distress may reduce intake, promote muscle wasting, and cause unintentional weight loss, thereby worsening treatment tolerance, hospitalization risk, survival, and patient-reported outcomes. At the Armed Forces Hospital Southern Region (AFHSR) Oncology Center, improving nutritional care was identified as a patient safety and quality priority. Local problem A pre-intervention review of 50 patients receiving active oncologic therapy showed that nine (18.0%) experienced weight loss greater than 3%, three (6.0%) experienced weight gain greater than 3%, and 38 (76.0%) maintained stable body weight. These findings highlighted a significant care gap in systematic nutritional screening, timely referral, and proactive management of nutrition-related symptoms. Methods A structured quality improvement approach was used. Root cause analysis identified key contributors to unintentional weight loss, and Pareto analysis prioritized the most important and modifiable causes. A solution selection matrix was then applied to identify interventions that were feasible, cost-effective, and likely to yield meaningful clinical benefit. The selected strategies were implemented and refined through iterative FOCUS-PDSA cycles. Data analysis was conducted using the IBM SPSS Statistics for Windows, Version 27 (Released 2019; IBM Corp., Armonk, New York, United States). Interventions Three consecutive PDSA cycles were implemented in the Oncology and Radiation Departments at AFHSR. The first cycle focused on early nutritional screening and structured education for all eligible patients, with follow-up every two to three weeks. The second cycle targeted patients who did not maintain stable body weight despite education alone; these patients received individualized dietary counselling, oral nutritional supplementation, and practical guidance regarding meal size, content, and timing. The third cycle addressed refractory cases with persistent weight loss risk despite prior interventions and incorporated pharmacological management of chemotherapy-induced nausea and vomiting as well as psychological support to improve adherence and nutritional intake. Results A total of 141 patients were enrolled, of whom 117 (83%) received chemotherapy. Although all 141 patients received nutritional education, 82 (58%) required oral nutritional supplements, 106 (75%) maintained stable body weight, and 35 (25%) required pharmacologic intervention. Control charts showed improvement in weight stability from about 80% initially to a mean of 93.6%, within control limits and without rule violations. Moving range charts showed reduced variability over time. Process capability was high (Cp=2.809, Cpk=2.541). Analyses of >3% weight loss and gain also showed capable, well-centered processes. Patient satisfaction with nutritional education, oral supplementation, and the overall nutrition service was high. Conclusions A structured multidisciplinary nutritional support program significantly improved and sustained weight stability among patients receiving active cancer treatment. The intervention achieved statistical control, high process capability, and consistent adherence, supporting its value as a cost-effective and sustainable quality improvement strategy in oncology practice.
Periorificial dermatitis (POD) is a common inflammatory skin condition primarily affecting infants, children, and young women. Novel therapies such as phosphodiesterase 4 (PDE4) inhibitors provide promising non-steroidal anti-inflammatory treatment options. This study evaluated the efficacy and safety of topical crisaborole 2% ointment, a PDE4 inhibitor, for treating pediatric patients with POD. A randomized, double-blind, vehicle-controlled trial included 23 participants aged 3 months to 18 years. Patients were treated with crisaborole 2% ointment or placebo for 4 weeks, followed by a 4-week treatment-free observational period. Primary endpoints were a 50% reduction in the Perioral Dermatitis Severity Index (PODSI) and an Investigator's Global Assessment (IGA) score of 0 or 1 by day 14. Assessments were also conducted on days 29 and 58. Secondary measures included changes in Quality-of-Life Index scores over time and safety evaluations. Both groups demonstrated improvement in PODSI and IGA scores during treatment. Although a small, non-significant numerical trend favored the crisaborole group across primary and secondary endpoints, no statistically significant differences between crisaborole and placebo were observed at any time point. Mild burning or stinging were reported more frequently in the crisaborole group, but they were generally tolerable. While there was a modest numerical trend favoring crisaborole, its efficacy was not statistically superior to placebo in this small pilot study. Larger studies are needed to further validate the efficacy of crisaborole for the treatment for POD. Clinical Trial Registry of the Ministry of Health of Israel Identifier: MOH_2020-05-12_008827.