How does eligibility for GusNIP produce prescriptions relate to fruit and vegetable purchases and what factors shape the relationship? A protocol for a secondary analysis of nationally representative data in the USA.

INTRODUCTION: US Department of Agriculture (USDA) Gus Schumacher Nutrition Incentive Programme (GusNIP) produce prescription programme (PPR) 'prescriptions' provide eligible participants with low income, risk for diet-related chronic disease and food insecurity a healthcare issued incentive to purchase lower to no cost fruits and vegetables (FVs). However, GusNIP requirements specify that PPR prescriptions can only be redeemed for fresh (not frozen, canned or dried) FVs. This requirement may prevent participants from fully engaging in or benefiting from GusNIP PPR, given communities with lower healthy food access may have reduced fresh FV accessibility. METHODS AND ANALYSIS: We will use the nationally representative 2012-2013 National Household Food Acquisition and Purchase Survey (FoodAPS) and complementary FoodAPS Geography Component data in a secondary data analysis to examine how household GusNIP PPR eligibility relates to the quantity and variety of fresh, frozen, canned and dried FV purchases and to what extent individual, household and food environment factors shape the relationship. FoodAPS data include household food purchasing and acquisition information across a 7 day period from 14 317 individuals among 4826 households and was collected between April 2012 and January 2013. The FoodAPS Geography Component provides information about the local community/environment relative to FoodAPS households. This study will examine the correlation or association of selected variables between different quantities and varieties of fresh, frozen, canned and dried FVs, as well as correlations among multilevel predictors. ETHICS AND DISSEMINATION: We are following data integrity standards as outlined by agreements with the USDA Economic Research Service. All results of analyses will undergo a thorough disclosure review to ensure no identifiable data are shared. Results will be disseminated to research, practice and policy communities using an Open Access peer-reviewed manuscript(s), scientific and practice presentations, and a public facing report and infographic.

Cognitive Functions and Subjective Hearing in Cochlear Implant Users.

Background and Objectives: : A cochlear implant (CI) is an effective prosthetic device used to treat severe-to-profound hearing loss. The present study examined cognitive function in CI users by employing a web-based cognitive testing platform, i.e., BrainCheck, and explored the correlation between cognitive function and subjective evaluation of hearing. Subjects and Methods: : Forty-two CI users (mean age: 58.90 years) were surveyed in the subjective evaluation of hearing, and 20/42 participated in the BrainCheck cognitive tests (immediate recognition, Trail Making A, Trail Making B, Stroop, digit symbol substitution, and delayed recognition). As controls for cognitive function, young normal-hearing (YNH, mean age=23.83 years) and older normal-hearing (ONH, mean age=52.67 years) listener groups were subjected to Brain- Check testing. Results: : CI users exhibited poorer cognitive function than the normal hearing groups in all tasks except for immediate and delayed recognition. The highest percentage of CI users who had "possible" and "likely" cognitive impairment, based on BrainCheck scores (ranging from 0-200), was observed in tests assessing executive function. The composite cognitive score across domains tended to be related to subjective hearing (p=0.07). Conclusions: : The findings of the current study suggest that CI users had a higher likelihood of cognitive impairment in the executive function domain than in lower-level domains. BrianCheck online cognitive testing affords a convenient and effective tool to self-evaluate cognitive function in CI users.

FirstStep2Health: A cluster randomised trial to promote healthy behaviours and prevent obesity amongst low-income preschoolers.

OBJECTIVE: To evaluate the preliminary effects of a theory-based, multi-component intervention on improving healthy lifestyle behaviours and preventing obesity amongst low-income preschoolers. METHODS: A cluster randomised controlled trial was conducted at 10 daycare centres. The 16-week FirstStep2Health intervention, grounded in the Actor-Partner Interdependence Model and the Social Cognitive Theory, included five components: a Facebook-based parent programme, three virtual parent meetings, three weekly motivational text messages, parent-child learning via weekly child letters and daycare centre-based child programme. RESULTS: A total of 95 preschoolers (53 intervention and 42 control) participated. Preschoolers' mean age was 49.27 months, with 57.9% being female, 12.6% being Hispanic and 40% being African American. The intervention significantly decreased intervention preschoolers' fat intake (B = -33.76, p = 0.047) and % body fat (B = -1.18, p = 0.036) compared to the control. During year 2, there were significant intervention effects on increasing skin carotenoids (B = 87.06, p = 0.035). Although not statistically significant, the intervention showed positive effects on increasing preschoolers' fruit/vegetable intake; and decreasing screen time, body mass index z-score and proportion of overweight/obesity. CONCLUSIONS: Even with some potential limitations (small sample size, measurement concerns and confounding with Coronavirus Disease 2019 pandemic), the study's results support the preliminary efficacy of the FirstStep2Health intervention in preventing obesity amongst low-income racially diverse preschoolers.

Baseline higher hair cortisol moderated some effects in a healthy lifestyle intervention.

Children and families from socioeconomically marginalized background experience high levels of stress, especially persistent chronic stress, due to unstable housing, employment, and food insecurity. Although consistent evidence supports a stress-obesity connection, little research has examined the potential moderation role of stress in childhood obesity interventions. Therefore, this study aimed to explore how chronic stress (hair cortisol) moderated the effects of a healthy lifestyle intervention on improving behavioral and anthropometric outcomes among 95 socioeconomically marginalized parent-child dyads. Data were collected in a cluster randomized controlled trial with 10 Head Start childcare centers being randomized into intervention and control. The child sample (3-5 years old) included 57.9 % female, 12.6 % Hispanic, and 40.0 % Black. For the parents, 91.6 % were female, 8.4 % were Hispanic, 36.8 % were Black, and 56.8 % were single. Parent baseline hair cortisol significantly moderated the intervention effects on child fruit intake (B = -1.56, p = .030) and parent nutrition self-efficacy (B = 1.49, p = .027). Specifically, higher parent hair cortisol lowered the increases in child fruit intake but improved the increases in parent nutrition self-efficacy in the intervention group compared to control group. Child higher baseline hair cortisol was significantly associated with the decreases in child fruit intake (B = -0.60, p = .025). Child baseline hair cortisol significantly moderated the intervention effects on parent physical activity (PA) self-efficacy (B = -1.04, p = .033) and PA parental support (B = -0.50, p = .016), with higher child hair cortisol decreasing the improvement on these two outcomes in the intervention group compared to control group. Results from this study shed lights on the moderation role of chronic stress on impacting healthy lifestyle intervention effects. Although needing further investigation, the adverse effects of chronic stress on intervention outcomes should be considered when developing healthy lifestyle interventions for preschoolers and their families.

Which adolescents are more likely to complete home-based sleep manipulation trials?

OBJECTIVES: Attrition and nonadherence are common concerns that can distort findings in clinical trials. This study examines the potential for systematic attrition in the largest sample to date of adolescents undergoing sleep manipulation. METHODS: Using pooled data across two trials involving 242 adolescents, a cumulative logistic regression tested whether demographics and baseline sleep predicted study completion/adherence. RESULTS: Race, a composite measure of socioeconomic status, and its elements (e.g., income, education) individually predicted completion/adherence. When entered concurrently into a multivariate predictive model, only socioeconomic status and study (trial A vs. B) were significant. Adolescents from households with higher socioeconomic status were more likely to complete or adhere to the protocol than those from households with lower socioeconomic status, p < .001. CONCLUSIONS: Systematic attrition in sleep manipulation research could distort conclusions about under-resourced groups. Future sleep trials should intentionally measure systemic/structural factors and adopt strategies to recruit and retain participants from various backgrounds.

Precise infliximab exposure and pharmacodynamic control to achieve deep remission in paediatric Crohn's disease (REMODEL-CD): study protocol for a multicentre, open-label, pragmatic clinical trial in the USA.

INTRODUCTION: The only biologic therapy currently approved to treat moderate to severe Crohn's disease in children (<18 years old) are those that antagonise tumour necrosis factor-alpha (anti-TNF). Therefore, it is critically important to develop novel strategies that maximise treatment effectiveness in this population. There is growing evidence that rates of sustained corticosteroid-free clinical remission, endoscopic healing and drug durability considerably improve when patients receive early anti-TNF dose optimisations guided by reactive or proactive therapeutic drug monitoring and pharmacodynamic monitoring. In response, our team has developed a personalised and scalable infliximab dosing intervention that starts with dose selection and continues throughout maintenance to optimise drug exposure. We hypothesise that a precision dosing strategy starting from induction and targeting dose-specific pharmacokinetic and pharmacodynamic endpoints throughout therapy will significantly improve outcomes compared with a conventional dosing strategy. METHODS AND ANALYSIS: Conduct a clinical trial to assess rates of deep remission between Crohn's disease patients receiving infliximab with precision dosing (n=90) versus conventional care (n=90). Patients (age 6-22 years) will be recruited from 10 medical centres in the USA. Each centre has been selected to provide either precision dosing or conventional care dosing. Precision dosing includes the use of a clinical decision support tool (RoadMAB) from the start of infliximab to achieve specific (personalised) trough concentrations and specific pharmacodynamic targets (at doses 3, 4 and 6). Conventional care includes the use of a modified infliximab starting dose (5 or 7.5 mg/kg based on the pretreatment serum albumin) with a goal to achieve maintenance trough concentrations of 5-10 µg/mL. The primary endpoint is year 1 deep remission defined as a combination of clinical remission (paediatric Crohn's disease activity index<10 (child) or a Crohn's disease activity index<150 (adults)), off prednisone>8 weeks and endoscopic remission (simple endoscopic severity-Crohn's disease≤2). ETHICS AND DISSEMINATION: ). The study protocol has been approved by the Cincinnati Children's Hospital Medical Centre Institutional Review Board. Study results will be disseminated in peer-reviewed journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER: NCT05660746.

Differences between parent- and teacher-reported executive functioning behaviors after traumatic injuries.

Deficits in executive functioning (EF) behaviors are very common following pediatric traumatic brain injury (TBI) and can linger well after acute injury recovery. Raters from multiple settings provide information that may not be appreciated otherwise. We examined differences between parent and teacher ratings of EF using data examining longitudinal outcomes following pediatric TBI in comparison to orthopedic injury (OI). We used linear mixed models to determine the association of rater type and injury type with scores on the Behavior Rating Inventory of Executive Functioning (BRIEF). After controlling for demographic variables, rater type and injury type accounted for a small but significant proportion of the variance in EF. Teachers' ratings on the BRIEF were significantly higher than parent ratings for global EF and metacognition, but not for behavior regulation, regardless of injury type, indicating greater EF concerns. All BRIEF ratings, whether from teachers or parents, were higher for children with TBI than for those with OI. Results suggest that parents and teachers provide unique information regarding EF following traumatic injuries and that obtaining ratings from persons who observe children at school as well as at home can result in a better understanding of situation-specific variability in outcomes.

Association between parental education level & outcomes for children with long-term ventilator dependence: Communication behaviors as moderating variables.

PURPOSE: The purpose of this study was to examine the correlation between parental education level and outcomes for children with long-term ventilator dependence (LTVD) and their families and whether parent communication behaviors with hospital nurses moderated the relationship. Advances in medical technology and policy changes allow children with LTVD to be cared for at home. The child's diagnosis and disease severity affect their health outcomes, as do their family's social determinants of health (SDoH) such as parent education. DESIGN AND METHODS: This secondary data analysis used chi-square tests to evaluate the correlation between parental education level and outcomes. Generalized linear mixed effect models were used to examine the moderation effect of parent communication behaviors. RESULTS: Lower parental education level was associated with more child respiratory infections and more parental uncertainty within one month following hospital discharge. Lower parent education level was also associated with fewer unplanned contacts with providers within one week post-discharge. Additionally, parent use of Verifying Understanding communication behaviors moderated the relationship between parental education level and number of respiratory infections and amount of parental uncertainty. Finally, parent use of Negotiating Roles moderated the association between education level and number of unplanned visits. CONCLUSIONS: Contradicting previous research, lower parental education level does not consistently correspond to adverse outcomes and may be explained by parents' determination to ensure optimal outcomes for their children with LTVD. PRACTICE IMPLICATIONS: Overall, healthcare providers should not be concerned that children with LTVD will have different outcomes based on their parents' education level.

Happy Family, Healthy Kids: A Healthy Eating and Stress Management Program in Low-Income Parent-Preschooler Dyads.

BACKGROUND: Substantial effort has been invested to combat childhood obesity, but overall effects are disappointing, especially in low-income racial minority children. One possible reason is a lack of focus on the important stress-eating connection. Stress can negatively influence eating behaviors, leading to an increased appetite for high-fat and energy-dense foods. OBJECTIVE: This study aimed to evaluate the preliminary effects of a healthy eating and stress management program targeting multiple theoretical variables on improving eating behavior (dyads' fruit/vegetable intake, emotional eating), food insecurity, anthropometric characteristics (dyads' body mass index, % body fat), cardiovascular health (dyads' blood pressure), and mental well-being (parental stress). METHODS: A one-group, quasi-experimental pilot study was conducted among 107 low-income parent-preschooler dyads. The 14-week program included a parent component, a parent-preschooler learning component, and a day care-based preschooler component. RESULTS: The program had positive effects on improving dyads' fruit/vegetable intake, food insecurity, body mass index, and blood pressure and parents' nutrition knowledge, self-efficacy, support, food resource management behavior, problem-focused coping, and home eating environment. The overall satisfaction rate was 95.2%, and 88.1% stated that the program assisted their families with having a healthy lifestyle. DISCUSSION: Results support the preliminary effects of the program on improving health outcomes in rural and urban low-income families. Although warranting further investigation with a more rigorous randomized controlled trial, the healthy eating and stress management program provides a potential solution to the current coexistence of an obesity epidemic and mental health crisis.

Which Program Implementation Factors Lead to more Fruit and Vegetable Purchases? An Exploratory Analysis of Nutrition Incentive Programs across the United States.

Background: Nutrition incentive (NI) programs help low-income households better afford fruits and vegetables (FVs) by providing incentives to spend on FVs (e.g., spend $10 to receive an additional $10 for FVs). NI programs are heterogeneous in programmatic implementation and operate in food retail outlets, including brick-and-mortar and farm-direct sites. Objective: This study aimed to explore NI program implementation factors and the amount of incentives redeemed. Methods: A total of 28 NI projects across the United States including 487 brick-and-mortar and 1078 farm-direct sites reported data between 2020 and 2021. Descriptive statistics and linear regression analyses (outcome: incentives redeemed) were applied. Results: Traditional brick-and-mortar stores had 0.48 times the incentives redeemed compared with small brick-and-mortar stores. At brick-and-mortar sites, automatic discounts had 3.47 times the incentives redeemed compared with physical discounts; and auxiliary services and marketing led to greater redemption. Farm-direct sites using multilingual and direct promotional marketing had greater incentives redeemed. Conclusions: To our knowledge, this is the first national study to focus on NI program implementation across sites nationwide. Factors identified can help inform future programming and research.

Heterogeneity in Neutrophil Extracellular Traps from Healthy Human Subjects.

Neutrophil Extracellular Traps (NETs), a key component of early defense against microbial infection, are also associated with tissue injury. NET composition has been reported to vary with some disease states, but the composition and variability of NETs across many healthy subjects provides a critical comparison that has not been well investigated. We evaluated NETs from twelve healthy subjects of varying ages isolated from multiple blood draws over a three and one half-year period to delineate the variability in extracellular DNA, protein, enzymatic activities, and susceptibility to protease inhibitors. We calculated correlations for NET constituents and loss of human bronchial epithelial barrier integrity, measured by transepithelial electrical resistance, after NET exposure. We found that although there was some variability within the same subject over time, the mean numbers of neutrophils, protein, LDH, serine protease activities, and cytokines IL-8, IL-1RA, and G-CSF in isolated NETs were consistent across subjects. Total DNA and double stranded DNA content in NETs were different across donors. NETs had little or no TNFα, IL-17A, or GM-CSF. NET DNA concentration correlated with increased NET neutrophil elastase activity and higher NET IL-1RA concentrations. NET serine protease activity varied considerably within the same donor from day-to-day. Mean response to protease inhibitors was significantly different across donors. NET DNA concentration correlated best with reductions in barrier integrity of human bronchial epithelia. Defining NET concentration by DNA content correlates with other NET components and reductions in NET-driven epithelial barrier dysfunction, suggesting DNA is a reasonable surrogate measurement for these complex structures in healthy subjects.

Elevated parent and child hair cortisol moderated the efficacy of a mindful eating intervention.

To explore whether elevated baseline hair cortisol moderated effects of a mindful eating intervention on anthropometrics, blood pressure (BP), household food insecurity, eating behaviour, and various psychosocial outcomes. The 14-week intervention included a parent Facebook-based programme, 3 parent meetings, preschooler letters connecting school learning to home practices, and a preschool-based mindful eating programme. Among 107 parent-preschooler dyads, mean age was 47.32 months for preschoolers and 30.12 years for parents. Among preschoolers, 54.2% were female, 8.4% were Hispanic, and 19.6% were Black. Among parents, 95.3% were female, 6.5% were Hispanic, 15.0% were Black, 39.4% were single, and 43.4% were unemployed. Preschoolers' elevated hair cortisol was related to a smaller reduction in preschoolers' % body fat (r =.31) and smaller increases in parents' perceived responsibility for child feeding (r = -.37). Parents' elevated hair cortisol was associated with smaller decreases in preschoolers' emotional eating (r = .39) and household food insecurity (r = .44). Relationships between baseline hair cortisol and post-intervention outcomes (BP, emotional eating, fruit/vegetable intake, food insecurity, and coping) varied by baseline values of outcome variables. Given that stress may attenuate intervention effects, a stress management component may be necessary to foster positive behavioural changes. Moreover, interventions should be tailored according to participants' characteristics to achieve optimal effects.

Comparing the Driving Skills of Adolescents with Obstructive Sleep Apnea to Healthy Controls: The Results of a Case-Controlled Observational Study.

Auto crashes are a leading cause of death and injury among adolescents. Untreated obstructive sleep apnea (OSA) can cause sleepiness and inattention, which could negatively impact novice drivers, but OSA-related studies have focused on older drivers. This study used a driving simulator to examine whether licensed 16-19-year-old adolescents with OSA have diminished driving skills. Twenty-one adolescents with OSA and twenty-eight without OSA (both confirmed using polysomnography) completed two randomly ordered driving trials in a simulator (with induced distractions versus without). A mixed ANOVA examined the between-subjects effect of the OSA group, the within-subjects effect of the distraction condition, and the group-by-condition interaction effect on the ability to maintain lane position and the frequency of extended eye glances away from the roadway. T-tests were also used to examine group differences in reported sleepiness and inattention during daily life. The distraction task increased extended off-road glances and difficulties maintaining lane position (p < 0.001). However, adolescents with OSA did not display worse eye glance or lane position than controls and there were no significant group-by-condition interactions. Although the groups differed on polysomonographic features, there were also no significant differences in reported sleepiness or inattention. The distraction task negatively impacted both groups of adolescent drivers, but those with OSA did not fare differentially worse. Most adolescents in our study had mild OSA (median obstructive apnea-hypopnea index = 4.4), the most common form in the community. It remains possible that youth with more severe OSA would show increased driving impairment.

Impact of heat on emergency hospital admission in Texas: geographic and racial/ethnic disparities.

BACKGROUND: Studies exploring the racial/ethnicity disparity of the impact of heat on hospital admission are notably limited, especially in Texas, a state with a diverse population and consistently ranking among the top ten U.S. states for heat-related deaths per capita from 2018 to 2020. OBJECTIVE: Our objective is to determine the correlation between elevated temperatures and emergency hospital admissions for various causes and age groups across 12 Metropolitan Statistical Areas(MSAs) in Texas. Additionally, we aim to investigate health inequalities in the five largest MSAs in Texas between 2004 and 2013. METHODS: We used MSA-level hospital admission and weather data to estimate the relationship between heat and emergency hospital admissions. We applied a Generalized Additive Model and random effects meta-analysis to calculate MSA-specific associations and overall correlation, repeating the analysis for age groups and specific causes of admission. We also investigated health disparities across racial and ethnic groups and performed a sensitivity analysis. RESULTS: The results showed that a 1 °C increase in temperature was associated with a 0.50% (95% CI [0.38%, 0.63%]) increase in all-cause emergency hospital admissions. Heat's impact on hospital admissions varied among age groups and causes, with children under 6 years showing the highest effect estimate (0.64% (95% CI [0.32%,0.96%])). Statistically significant associations were found for Cardiovascular Diseases (0.27% (95% CI [0.07%,0.47%])), Ischemic Heart Diseases (0.53% (95% CI [0.15%,0.92%])), Pneumonia (0.70% (95% CI [0.25%,1.16%])), and Respiratory Diseases (0.67% (95% CI [0.18%,1.17%])). Health disparities were found among racial and ethnic groups in the five largest MSAs. IMPACT STATEMENT: Studies exploring the impact of heat on hospital admission in Texas are notably limited. Our research provided a comprehensive examination of the connection between heat and emergency hospital admissions throughout Texas. Furthermore, we are the first to examine racial/ethnic disparities, identifying African American and Hispanic groups as disproportionately affected. These insights provide valuable insights for policymakers to allocate resources and implement strategies to mitigate the negative consequences of rising temperatures.

Automated, machine learning-based alerts increase epilepsy surgery referrals: A randomized controlled trial.

OBJECTIVE: To determine whether automated, electronic alerts increased referrals for epilepsy surgery. METHODS: We conducted a prospective, randomized controlled trial of a natural language processing-based clinical decision support system embedded in the electronic health record (EHR) at 14 pediatric neurology outpatient clinic sites. Children with epilepsy and at least two prior neurology visits were screened by the system prior to their scheduled visit. Patients classified as a potential surgical candidate were randomized 2:1 for their provider to receive an alert or standard of care (no alert). The primary outcome was referral for a neurosurgical evaluation. The likelihood of referral was estimated using a Cox proportional hazards regression model. RESULTS: Between April 2017 and April 2019, at total of 4858 children were screened by the system, and 284 (5.8%) were identified as potential surgical candidates. Two hundred four patients received an alert, and 96 patients received standard care. Median follow-up time was 24 months (range: 12-36 months). Compared to the control group, patients whose provider received an alert were more likely to be referred for a presurgical evaluation (3.1% vs 9.8%; adjusted hazard ratio [HR] = 3.21, 95% confidence interval [CI]: 0.95-10.8; one-sided p = .03). Nine patients (4.4%) in the alert group underwent epilepsy surgery, compared to none (0%) in the control group (one-sided p = .03). SIGNIFICANCE: Machine learning-based automated alerts may improve the utilization of referrals for epilepsy surgery evaluations.

Using multiple imputation of real-world data to estimate clinical remission in pediatric inflammatory bowel disease.

Aim: To evaluate the performance of the multiple imputation (MI) method for estimating clinical effectiveness in pediatric Crohn's disease in the ImproveCareNow registry; to address the analytical challenge of missing data. Materials & methods: Simulation studies were performed by creating missing datasets based on fully observed data from patients with moderate-to-severe Crohn's disease treated with non-ustekinumab biologics. MI was used to impute sPCDAI remission statuses in each simulated dataset. Results: The true remission rate (75.1% [95% CI: 72.6%, 77.5%]) was underestimated without imputation (72.6% [71.8%, 73.3%]). With MI, the estimate was 74.8% (74.4%, 75.2%). Conclusion: MI reduced nonresponse bias and improved the validity, reliability, and efficiency of real-world registry data to estimate remission rate in pediatric patients with Crohn's disease.

Outpatient hospital utilization after single event multi-level surgery in children with cerebral palsy.

PURPOSE: This study aimed to examine outpatient hospital utilization (number of specialties seen and number of visits to each specialty) in the year after single event multi-level surgery (SEMLS) in children with cerebral palsy (CP), and to determine if utilization differs across the medical center in the year after compared to the year before SEMLS. METHODS: This retrospective cross-sectional study used electronic medical record data of outpatient hospital utilization in children with CP who underwent SEMLS. RESULTS: Thirty children with CP (Gross Motor Function Classification System Levels I-V, mean age of 9.9 years) were included. In the year after surgery, a significant difference (p = 0.001) was found for the number of specialties seen, with non-ambulatory children seeing more specialties than ambulatory children. No statistically significant difference was found between the number of outpatient visits to each specialty in the year after SEMLS. Compared to the year before SEMLS, fewer therapy visits occurred in the year after SEMLS (p < 0.001) but significantly more visits to orthopaedics (p = 0.001) and radiology (p = 0.001). CONCLUSION: Children with CP had fewer therapy visits but more orthopaedic and radiology visits the year after SEMLS. Nearly half of the children were non-ambulatory. Examination of care needs in children with CP undergoing SEMLS is justified with consideration of ambulatory status, surgical burden, and post-operative immobilization.

Findings from a Randomized Controlled Trial of SMART: An EHealth Intervention for Mild Traumatic Brain Injury.

OBJECTIVE: The aim of this study was to examine the efficacy of the SMART (Self-Management After Recent Traumatic brain injury) program and potential moderators. METHODS: Parallel randomized controlled trial (ClinicalTrials.gov Identifier: NCT03498495) was conducted. Eligibility criteria included treatment for mild traumatic brain injury in the emergency department and age 11-18 years. Participants were assigned equally to SMART (n = 35) or usual care (UC; n = 36). SMART included symptom monitoring and online modules supporting the return to activities and symptom management. Coping and quality of life (QoL) (primary outcomes) and post-concussive symptoms (secondary outcome) were assessed at baseline and weekly for 4 weeks. RESULTS: Groups did not differ in coping, QoL, or return to pre-injury symptom levels at any time point. Problem-focused engagement (PFE) moderated group differences over time (p = .02). At high PFE, UC participants reported lower QoL at time 1 (effect size [ES] = 0.60); SMART participants did not report a decline at any point. At low PFE, SMART participants reported declining QoL from pre-injury to time 1 (ES = 0.68), whereas UC participants reported an increase from time 1 to 3 (ES = 0.56). PFE also moderated group differences on the Health and Behavior Inventory (HBI) cognitive (p = .02) and somatic symptom scales (p = .05). At high PFE, SMART participants reported a more rapid return to pre-injury levels than UC participants (p = .05). Resilience also moderated group differences in QoL and HBI cognitive recovery. CONCLUSION: Effectiveness of the SMART app varied based on preinjury coping styles and resilience, underscoring the potential need to tailor treatments to individual characteristics.

Treatment and biologic maintenance-dosing patterns among pediatric patients with ulcerative colitis or Crohn's disease.

OBJECTIVES: To assess treatment patterns and initial and maintenance dosing of biologics over 3 years in pediatric patients with ulcerative colitis (UC) or Crohn's disease (CD), utilizing data from the ImproveCareNow registry. METHODS: Pediatric patients diagnosed with UC or CD and aged 2-17 years were included in the study. Descriptive statistics were employed to summarize baseline demographics. The proportion of patients on medication for UC or CD were analyzed at the baseline visit, 1-year, and 3-year time points (Cohort 1). Biologic maintenance dosage was calculated only for patients who had data for dose and weight at all-time points (Cohort 2). RESULTS: In Cohort 1 (UC = 1784; CD = 4720), baseline treatment in UC included corticosteroid, 5-ASA, and 6-MP/AZA; at 1-year and 3-year time points, treatment with 5-ASA and corticosteroid decreased, whereas 6-MP/AZA and anti-TNFs increased. In CD, baseline treatment included corticosteroid, anti-TNF, 6-MP/AZA, and methotrexate; use of corticosteroids decreased, whereas the use of methotrexate and anti-TNFs increased over 3 years. In Cohort 2 (UC = 350; CD = 1537), at first maintenance dose, UC patients on infliximab received a mean dose of 10.5 mg/kg/8 wk, adalimumab (weight < 40 kg and ≥40 kg) 1.3 mg/kg/2 wk and 0.8 mg/kg/2 wk, and vedolizumab 6.9 mg/kg/8 wks. At the first maintenance dose, CD patients on infliximab received a mean dose of 8.1 mg/kg/8 wk, adalimumab (weight < 40 kg) 1.1 mg/kg/2 wk, adalimumab (weight ≥ 40 kg) 0.8 mg/kg/2 wk, and vedolizumab 10.5 mg/kg/8 wks. CONCLUSION: The use of corticosteroids was common at the initial visit in patients. Anti-TNFs remain the most used class of biologics, however, reported doses in our study were substantially higher than the standard dosing guidelines.

Heterogeneity in Neutrophil Extracellular Traps from Healthy Human Subjects.

Neutrophil extracellular traps (NETs), a key component of early defense against microbial infection, are also associated with tissue injury. NET composition has been reported to vary with some disease states, but the composition and variability of NETs across many healthy subjects provide a critical comparison that has not been well investigated. We evaluated NETs from twelve healthy subjects of varying ages isolated from multiple blood draws over a three-and-one-half-year period to delineate the variability in extracellular DNA, protein, enzymatic activities, and susceptibility to protease inhibitors. We calculated correlations for NET constituents and loss of human bronchial epithelial barrier integrity, measured by transepithelial electrical resistance, after NET exposure. We found that although there was some variability within the same subject over time, the mean NET total DNA, dsDNA, protein, LDH, neutrophil elastase (NE), and proteinase 3 (PR3) in isolated NETs were consistent across subjects. NET serine protease activity varied considerably within the same donor from day to day. The mean NET cathepsin G and MPO were significantly different across donors. IL-8 > IL-1RA > G-CSF were the most abundant cytokines in NETs. There was no significant difference in the mean concentration or variability of IL-8, IL-1RA, G-CSF, IL-1α, IL-1ß, or TNF-α in different subjects' NETs. NET DNA concentration was correlated with increased NET neutrophil elastase activity and higher NET IL-1RA concentrations. The mean reduction in protease activity by protease inhibitors was significantly different across donors. NET DNA concentration correlated best with reductions in the barrier integrity of human bronchial epithelia. Defining NET concentration by DNA content correlates with other NET components and reductions in NET-driven epithelial barrier dysfunction, suggesting DNA is a reasonable surrogate measurement for these complex structures in healthy subjects.