Publications by authors named "Jason Lang"

136 Publications

Durability of Changes in Biomarkers of Cardiometabolic Disease: 1-Year Family-Based Intervention in Children with Obesity.

Metab Syndr Relat Disord 2021 Mar 1. Epub 2021 Mar 1.

Nemours Biomedical Research, Nemours Children's Specialty Care, Jacksonville, Florida, USA.

The sustainability of health benefits in response to lifestyle-based interventions remains unclear in children with overweight and obesity, and cardiometabolic disease (CMD). We determined the changes in novel biomarkers of CMD in a 1-year family-based intervention (FBI) program, during 6-month active monitoring phase and at 12-month follow-up. Children with an age-adjusted body mass index (BMI) percentile ≥85 ( = 130; age 8-11 years) were recruited for a 1-year (6-month monitored and 6-month unmonitored) randomized controlled FBI program. Anthropometry and selected biomarkers of CMD were measured in 87 participants, randomly allocated to intervention (INT) and education-only (EDU) groups, at baseline, immediately after a 6-month active intervention or control period, and at 12-month unmonitored follow-up. Samples from 87 participants (age 10.00 ± 0.11 years and Tanner stage ≤3) with obesity (BMI%ile = 97.45 ± 0.15) were available. Overall intervention effect (between groups), was observed for total (T) and high molecular weight (HMW) adiponectin, ratio of total to HMW adiponectin, fibrinogen, and interleukin (IL)-6 ( < 0.05 for all). However, between-group beneficial changes after adjusting for baseline levels were limited to BMI percentile, T and HMW adiponectin and their ratio, IL-6, and fibrinogen ( < 0.05 for all) mainly during the 6-month period of monitored intervention. Changes in traditional risk factors such as lipids and triglycerides were inconsistent. During the 6-month follow-up period, the changes in biomarkers leveled-off, except for T and HMW adiponectin, IL-6, and fibrinogen that continued to show benefits ( < 0.05) from the 6- to 12-month follow-up. The FBI program beneficially altered novel biomarkers of CMD during the monitored intervention phase in school-age children with obesity, but they mostly moved back toward baseline during the unmonitored follow-up phase. The changes in novel biomarkers of CMD appear to be more sensitive compared to the traditional risk factors. The study implies the need for refinements in lifestyle-based approaches in the preservation of cardiovascular health and calls for robust biomarkers to monitor the changes. The study was registered at ClinicalTrials.gov (NCT01146314).
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http://dx.doi.org/10.1089/met.2020.0097DOI Listing
March 2021

Clinician training, then what? Randomized clinical trial of child STEPs psychotherapy using lower-cost implementation supports with versus without expert consultation.

J Consult Clin Psychol 2020 Dec;88(12):1065-1078

Department of Psychology, Harvard University.

Objective: Implementation of evidence-based treatments in funded trials is often supported by expert case consultation for clinicians; this may be financially and logistically difficult in clinical practice. Might less costly implementation support produce acceptable treatment fidelity and clinical outcomes?

Method: To find out, we trained 42 community clinicians from four community clinics in Modular Approach to Therapy for Children (MATCH), then randomly assigned them to receive multiple lower-cost implementation supports (LC) or expert MATCH consultation plus lower-cost supports (CLC). Clinically referred youths (N = 200; ages 7-15 years, M = 10.73; 53.5% male; 32.5% White, 27.5% Black, 24.0% Latinx, 1.0% Asian, 13.5% multiracial, 1.5% other) were randomly assigned to LC (n = 101) or CLC (n = 99) clinicians, and groups were compared on MATCH adherence and competence, as well as on multiple clinical outcomes using standardized measures (e.g., Child Behavior Checklist, Youth Self-Report) and idiographic problem ratings (Top Problems Assessment).

Results: Coding of therapy sessions revealed substantial therapist adherence to MATCH in both conditions, with significantly stronger adherence in CLC; however, LC and CLC did not differ significantly in MATCH competence. Trajectories of change on all outcome measures were steep, positive, and highly similar for LC and CLC youths, with no significant differences; a supplemental analysis of posttreatment outcomes also showed similar LC and CLC posttreatment scores, with most LC-CLC differences nonsignificant.

Conclusions: The findings suggest that effective implementation of a complex intervention in clinical practice may be supported by procedures that are less costly and logistically challenging than expert consultation. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
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http://dx.doi.org/10.1037/ccp0000536DOI Listing
December 2020

The hallmarks of childhood abuse and neglect: A systematic review.

PLoS One 2020 8;15(12):e0243639. Epub 2020 Dec 8.

University of Glasgow, Glasgow, United Kingdom.

Background: Studies on the impacts of child maltreatment (CM) have been conducted in diverse areas. Mechanistic understanding of the complex interplay between factors is lacking. Hallmarking is an approach which identifies common factors across studies and highlights the most robust findings.

Objectives: In a review of systematic reviews and meta-analyses, we addressed the following questions: 1) What are the hallmarks associated with exposure to CM across the bio-ecological spectrum? 2) What is the strength of evidence to support each hallmark? 3) What are the gaps that future research should address?

Methods: A comprehensive literature search was carried out to find relevant systematic reviews or meta-analyses. 269 articles were read in full and 178 articles, encompassing more than 6000 original papers, were included in the final synthesis. All reviews were independently rated for quality by at least 2 reviewers using AMSTAR-2.

Results: Of 178 review articles, 6 were rated as high quality (all meta-analyses) and 46 were rated as medium quality. Most were from high income countries.

Conclusions: Based on the most commonly reported high-quality research findings we propose that the hallmarks of exposure to child maltreatment are: Increased risk of psychopathology; Increased risk of obesity; Increased risk of high- risk sexual behaviours, Increased risk of smoking; and Increased risk of child maltreatment in children with disabilities. Research gaps include a lack of focus on complexity and resilience. Little can be concluded about directions of causality or mechanisms. Adequately powered prospective studies are required to move the field forward.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0243639PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723263PMC
February 2021

Leptin as a Predictor of Incident Asthma in Offspring of Obese Mothers.

Ann Am Thorac Soc 2020 12;17(12):1530-1532

Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1513/AnnalsATS.202008-1000EDDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7706607PMC
December 2020

Well-Child Care Attendance and Risk of Asthma Exacerbations.

Pediatrics 2020 12;146(6)

Children's Health & Discovery Initiative, Departments of Pediatrics and.

Background: Asthma remains a leading cause of hospitalization in US children. Well-child care (WCC) visits are routinely recommended, but how WCC adherence relates to asthma outcomes is poorly described.

Methods: We conducted a retrospective longitudinal cohort study using electronic health records among 5 to 17 year old children residing in Durham County with confirmed asthma and receiving primary care within a single health system, to compare the association between asthma exacerbations and previous WCC exposure. Exacerbations included any , or , coded asthma exacerbation encounter with an accompanying systemic glucocorticoid prescription. Exacerbations were grouped by severity: ambulatory encounter only, urgent care, emergency department, hospital encounters <24 hours, and hospital admissions ≥24 hours. In the primary analysis, we assessed time to asthma exacerbation based on the presence or absence of a WCC visit in the preceding year using a time-varying covariate Cox model.

Results: A total of 5656 children met eligibility criteria and were included in the primary analysis. Patients with the highest WCC visit attendance tended to be younger, had a higher prevalence of private insurance, had greater asthma medication usage, and were less likely to be obese. The presence of a WCC visit in the previous 12 months was associated with a reduced risk of all-cause exacerbations (hazard ratio: 0.90; 95% confidence interval: 0.83-0.98) and severe exacerbations requiring hospital admission (hazard ratio: 0.53; 95% confidence interval: 0.39-0.71).

Conclusions: WCC visits were associated with a lower risk of subsequent severe exacerbations, including asthma-related emergency department visits and hospitalizations. Poor WCC visit adherence predicts pediatric asthma morbidity, especially exacerbations requiring hospitalization.
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http://dx.doi.org/10.1542/peds.2020-1023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7706112PMC
December 2020

Evaluation of associations between asthma exacerbations and distance to roadways using geocoded electronic health records data.

BMC Public Health 2020 Oct 29;20(1):1626. Epub 2020 Oct 29.

Department of Biostatistics & Bioinformatics, Duke University, 2424 Erwin Road, Durham, NC, 27705, USA.

Background: Asthma exacerbations in children often require medications, urgent care, and hospitalization. Multiple environmental triggers have been associated with asthma exacerbations, including particulate matter 2.5 (PM2.5) and ozone, which are primarily generated by motor vehicle exhaust. There is mixed evidence as to whether proximity to highways increases risk of asthma exacerbations.

Methods: To evaluate the impact of highway proximity, we assessed the association between asthma exacerbations and the distance of child's primary residence to two types of roadways in Durham County, North Carolina, accounting for other patient-level factors. We abstracted data from the Duke University Health System electronic health record (EHR), identifying 6208 children with asthma between 2014 and 2019. We geocoded each child's distance to roadways (both 35 MPH+ and 55 MPH+). We classified asthma exacerbation severity into four tiers and fitted a recurrent event survival model to account for multiple exacerbations.

Results: There was a no observed effect of residential distance from 55+ MPH highway (Hazard Ratio: 0.98 (95% confidence interval: 0.94, 1.01)) and distance to 35+ MPH roadway (Hazard Ratio: 0.98 (95% confidence interval: 0.83, 1.15)) and any asthma exacerbation. Even those children living closest to highways (less 0.25 miles) had no increased risk of exacerbation. These results were consistent across different demographic strata.

Conclusions: While the results were non-significant, the characteristics of the study sample - namely farther distance to roadways and generally good ambient environmental pollution may contribute to the lack of effect. Compared to previous studies, which often relied on self-reported measures, we were able to obtain a more objective assessment of outcomes. Overall, this work highlights the opportunity to use EHR data to study environmental impacts on disease.
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http://dx.doi.org/10.1186/s12889-020-09731-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7599107PMC
October 2020

Caregiver satisfaction with their child's trauma-focused cognitive behavioral therapy.

Psychol Trauma 2020 Oct 1. Epub 2020 Oct 1.

Child Health and Development Institute of Connecticut, Inc.

Despite the value trauma-focused cognitive-behavioral therapy (TF-CBT) places on caregivers being included in treatment, limited qualitative research has examined their experience with treatment. Thus, this research aimed to assess (a) overall caregiver satisfaction; (b) aspects of TF-CBT caregivers found most and least useful or thought could be improved; and (c) if satisfaction differed between caregivers of completers and noncompleters. In total, 1,778 caregiver/child dyads were included. Caregivers of children receiving TF-CBT completed the Caregiver Satisfaction Questionnaire. To assess overall satisfaction, descriptive statistics were compiled. To assess what aspects of TF-CBT were most/least helpful or could be improved, thematic analysis was conducted. Finally, a t test was conducted to determine whether overall satisfaction with TF-CBT differed between caregivers who had children who did and did not complete treatment. Overall satisfaction with TF-CBT was high. Qualitatively, caregivers reported PRACTICE components, communication between parties in treatment, the child learning coping skills, and the child experiencing positive outcomes as most helpful. Least helpful aspects included scheduling, not seeing positive outcomes, and the child and outside factors impeding treatment. When making suggestions for improvement, caregivers suggested changes in scheduling and session length/frequency, and an increase in their involvement. Quantitatively, caregivers of children who completed treatment experienced significantly higher total mean satisfaction scores than caregivers of noncompleters. Caregiver satisfaction should be assessed during TF-CBT, with efforts made to identify and address key areas of concern caregivers may be experiencing. Focusing on caregiver satisfaction may prevent treatment attrition, allowing children to increasingly receive evidence-based care. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
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http://dx.doi.org/10.1037/tra0000834DOI Listing
October 2020

Obesity-related asthma in children: A role for vitamin D.

Pediatr Pulmonol 2021 Feb 8;56(2):354-361. Epub 2020 Dec 8.

Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.

Excess adipose tissue predisposes to an enhanced inflammatory state and can contribute to the pathogenesis and severity of asthma. Vitamin D has anti-inflammatory properties and low-serum levels are seen in children with asthma and in children with obesity. Here we review the intersection of asthma, obesity, and hypovitaminosis D in children. Supplementation with vitamin D has been proposed as a simple, safe, and inexpensive adjunctive therapy in a number of disease states. However, little research has examined the pharmacokinetics of vitamin D and its therapeutic potential in children who suffer from obesity-related asthma.
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http://dx.doi.org/10.1002/ppul.25053DOI Listing
February 2021

Performance of a computable phenotype for pediatric asthma using the problem list.

Ann Allergy Asthma Immunol 2020 11 17;125(5):611-613.e1. Epub 2020 Jul 17.

Children's Health and Discovery Initiative, Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina; Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina; Division of Allergy, Immunology, and Pulmonary Medicine, Duke Children's Hospital and Health Center, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1016/j.anai.2020.07.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7606382PMC
November 2020

Prevalence of Workplace Health Practices and Policies in Hospitals: Results From the Workplace Health in America Study.

Am J Health Promot 2020 11 20;34(8):867-875. Epub 2020 Feb 20.

Division of Nutrition, Physical Activity and Obesity, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, GA, USA.

Purpose: To provide a nationally representative description on the prevalences of policies, practices, programs, and supports relating to worksite wellness in US hospitals.

Design: Cross-sectional, self-report of hospitals participating in Workplace Health in America (WHA) survey from November 2016 through September 2017.

Setting: Hospitals across the United States.

Participants: Random sample of 338 eligible hospitals participating in the WHA survey.

Measures: We used previous items from the 2004 National Worksite Health Promotion survey. Key measures included presence of Worksite Health Promotion programs, evidence-based strategies, health screenings, disease management programs, incentives, work-life policies, barriers to health promotion program implementation, and occupational safety and health.

Analysis: Independent variables included hospital characteristics (eg, size). Dependent characteristics included worksite health promotion components. Descriptive statistics and χ analyses were used.

Results: Eighty-two percent of hospitals offered a wellness programs during the previous year with larger hospitals more likely than smaller hospitals to offer programs ( < .01). Among hospitals with wellness programs, 69% offered nutrition programs, 74% offered physical activity (PA) programs, and 84% had a policy to restrict all tobacco use. Among those with cafeterias or vending machines, 40% had a policy for healthier foods. Only 47% and 25% of hospitals offered lactation support or healthy sleep programs, respectively.

Conclusion: Most hospitals offer wellness programs. However, there remain hospitals that do not offer wellness programs. Among those that have wellness programs, most offer supports for nutrition, PA, and tobacco control. Few hospitals offered programs on healthy sleep or lactation support.
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http://dx.doi.org/10.1177/0890117120905232DOI Listing
November 2020

Gait and Functional Outcomes Between Cruciate-Retaining and Cruciate-Substituting Implants in Total Knee Arthroplasty: A Prospective, Randomized Study.

J Surg Orthop Adv 2019 ;28(3):215-223

EmergeOrtho/Blue Ridge Bone and Joint, Arden, North Carolina.

Significant debate persists about posterior cruciate-retaining (CR) versus posterior cruciate-substituting (PS) implant design for total knee arthroplasty (TKA). This study sought to test the hypothesis that CR TKA will facilitate improved early functional outcomes in gait compared with PS TKA. Patients were randomized to either the CR or PS implant. Various patient-reported and surgeon-reported outcomes as well as gait analyses were obtained pre- and postoperatively. Patients undergoing PS TKA had higher University of California, Los Angeles activity scores at 12 months. No significant difference in spatiotemporal, kinematic, or kinetic parameters between groups was detected, but there was a trend toward quadriceps overuse gait pattern in the CR group. Patients undergoing TKA with a PS implant were more willing to engage in regular higher level physical activity. The CR implant may be a risk factor for quadriceps overuse gait pattern, while the PS implant may be protective against quadriceps overuse. (Journal of Surgical Orthopaedic Advances 28(3):215-223, 2019).
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November 2019

Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma.

N Engl J Med 2019 09;381(13):1227-1239

From National Jewish Health (M.E.W., R.C., J.T.O.), Denver, and University of Colorado School of Medicine (M.E.W., S.J.S., R.C., F.H., J.T.O.) and Children's Hospital Colorado (S.J.S.), Aurora - all in Colorado; Wake Forest School of Medicine (V.E.O., W.C.M., S.P.P.), Winston-Salem, North Carolina Clinical Research (C.F.L.), Raleigh, and Duke University Medical Center (N.L., L.Q.), Durham - all in North Carolina; Ann and Robert H. Lurie Children's Hospital of Chicago (J.A.P., R.G.R.), University of Illinois at Chicago (J.A.K., H.K.), Rush University Medical Center (J.M.), University of Chicago (E.N., J.S., S. White), and Northwestern University Feinberg School of Medicine (L.J.S.) - all in Chicago; Penn State University (V.C., S.J.K., D.M.), Hershey, and Allegheny General Hospital (D.G.) and University of Pittsburgh Medical Center (S. Wenzel), Pittsburgh - all in Pennsylvania; Nemours Children's Health System, Jacksonville (J.J.L., K.V.B., J.L.), and University of South Florida Morsani College of Medicine, Tampa (J.-C.C.) - both in Florida; University of Arizona Health Sciences, Tucson (E.R.B., M.K., F.M., D.A.M.); Washington University School of Medicine, St. Louis (L.B.B., A.B., M.C.); University of California, San Francisco (UCSF), San Francisco (M.B., M.D.C., S.C.L., D.L.) and UCSF Benioff Children's Hospital, Oakland (M.B., D.L.) - both in California; Brigham and Women's Hospital and Harvard Medical School (J.-C.C., N.G., E.I.) and Boston Children's Hospital (W.P., W.S.) - all in Boston; University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland (J.F.C., K.R.); University of Wisconsin-Madison, Madison (L.D., D.J.J., R.F.L., C.A.S.) and Aurora Sinai Medical Center, Milwaukee (L.S.-V.) - both in Wisconsin; Columbia University Irving Medical Center, New York, (E.D.); Emory University, Atlanta (A.M.F.); and University of New Mexico, Albuquerque (H.R.).

Background: Morbidity from asthma is disproportionately higher among black patients than among white patients, and black patients constitute the minority of participants in trials informing treatment. Data indicate that patients with inadequately controlled asthma benefit more from addition of a long-acting beta-agonist (LABA) than from increased glucocorticoids; however, these data may not be informative for treatment in black patients.

Methods: We conducted two prospective, randomized, double-blind trials: one involving children and the other involving adolescents and adults. In both trials, the patients had at least one grandparent who identified as black and had asthma that was inadequately controlled with low-dose inhaled glucocorticoids. We compared combinations of therapy, which included the addition of a LABA (salmeterol) to an inhaled glucocorticoid (fluticasone propionate), a step-up to double to quintuple the dose of fluticasone, or both. The treatments were compared with the use of a composite measure that evaluated asthma exacerbations, asthma-control days, and lung function; data were stratified according to genotypic African ancestry.

Results: When quintupling the dose of fluticasone (to 250 μg twice a day) was compared with adding salmeterol (50 μg twice a day) and doubling the fluticasone (to 100 μg twice a day), a superior response occurred in 46% of the children with quintupling the fluticasone and in 46% of the children with doubling the fluticasone and adding salmeterol (P = 0.99). In contrast, more adolescents and adults had a superior response to added salmeterol than to an increase in fluticasone (salmeterol-low-dose fluticasone vs. medium-dose fluticasone, 49% vs. 28% [P = 0.003]; salmeterol-medium-dose fluticasone vs. high-dose fluticasone, 49% vs. 31% [P = 0.02]). Neither the degree of African ancestry nor baseline biomarkers predicted a superior response to specific treatments. The increased dose of inhaled glucocorticoids was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years of age.

Conclusions: In contrast to black adolescents and adults, almost half the black children with poorly controlled asthma had a superior response to an increase in the dose of an inhaled glucocorticoid and almost half had a superior response to the addition of a LABA. (Funded by the National Heart, Lung, and Blood Institute; BARD ClinicalTrials.gov number, NCT01967173.).
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http://dx.doi.org/10.1056/NEJMoa1905560DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7026584PMC
September 2019

Enhancing Capacity for Trauma-informed Care in Child Welfare: Impact of a Statewide Systems Change Initiative.

Am J Community Psychol 2019 12 9;64(3-4):467-480. Epub 2019 Sep 9.

Connecticut Department of Children and Families, Hartford, CT, USA.

Youth involved in the child welfare system (CWS) are disproportionally impacted by the negative effects of exposure to trauma. While efforts to develop trauma-informed CWSs are accelerating, little research is available about the effects of these efforts on system capacity to respond to the needs of youth exposed to trauma. No studies evaluate longer-term effects of these efforts. In 2011, Connecticut implemented CONCEPT, a multi-year initiative to enhance capacity of the state's CWS to provide trauma-informed care. CONCEPT used a multi-component approach including workforce development, deployment of trauma screening procedures, policy change, improved access to evidence-based trauma-focused treatments, and focused evaluation of program effects. Changes in system capacity to deliver trauma-informed care were assessed using statewide stratified random samples of child welfare staff at three time points (Year 1: N = 223, Year 3: N = 231, Year 5: N = 188). Significant improvements across nearly all child welfare domains were observed during the first 3 years of implementation, demonstrating system-wide improvements in capacity to provide trauma-informed care. These gains were maintained through the final year of implementation, with continued improvements in ratings of collaboration between child welfare and behavioral health settings on trauma-related issues observed. Responses documented familiarity with and involvement in many of the CONCEPT activities and initiatives. Staff reported greater familiarity with efforts to increase access to specific evidence-based services (e.g., TF-CBT) or to enhance trauma-related policy and practice guidelines, but less familiarity with efforts to implement new practices (e.g., trauma screening) in various sectors. Staff also reflected on the contribution of these components to enhance system capacity for trauma-informed care.
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http://dx.doi.org/10.1002/ajcp.12375DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7894977PMC
December 2019

Systems Measures of a Trauma-Informed Approach: A Systematic Review.

Am J Community Psychol 2019 12 30;64(3-4):418-437. Epub 2019 Aug 30.

Division of Prevention and Community Research, Yale School of Medicine, New Haven, CT, USA.

Interest in trauma-informed approaches has grown substantially. These approaches are characterized by integrating understanding of trauma throughout a program, organization, or system to enhance the quality, effectiveness, and delivery of services provided to individuals and groups. However, variation in definitions of trauma-informed approaches, coupled with underdeveloped research on measurement, poses challenges for evaluating the effectiveness of models designed to support a trauma-informed approach. This systematic review of peer-reviewed and gray literature identified 49 systems-based measures that were created to assess the extent to which relational, organizational, and community/system practices were trauma-informed. Measures were included if they assessed at least one component of a trauma-informed approach, were not screening or diagnostic instruments, were standardized, were relevant to practices addressing the psychological impacts of trauma, were printed in English, and were published between 1988 and 2018. Most (77.6%) measures assessed organizational-level staff and climate characteristics. There remain several challenges to this emerging field, including inconsistently reported psychometric data, redundancy across measures, insufficient evidence of a link to stakeholder outcomes, and limited information about measurement development processes. We discuss these opportunities and challenges and their implications for future research and practice.
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http://dx.doi.org/10.1002/ajcp.12388DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7003149PMC
December 2019

Effects of age, sex, race/ethnicity, and allergy status in obesity-related pediatric asthma.

Pediatr Pulmonol 2019 11 30;54(11):1684-1693. Epub 2019 Aug 30.

Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

Rationale: Obesity in children increases the risk for new asthma. How age, sex, race/ethnicity, and allergy status affect the relationship between obesity and asthma is unclear. This study describes the relationship between high body mass index (BMI) and incident asthma.

Methods: We conducted a retrospective cohort study to compare asthma incidence among normal weight, overweight, and obese 2 to 6, 7 to 11, and 12 to 17 year olds to define the effects of sex, race/ethnicity, and allergy status. Weight status was determined at baseline and asthma incidence was defined as ≥2 asthma encounters and ≥1 asthma prescriptions. We used multivariable Poisson regression to estimate adjusted incident asthma rates and risk ratios.

Results: Data from 192 843 2 to 6 year olds, 157 284 7 to 11 year olds, and 157 369 12 to 17 year olds were included. The relative risks (95% confidence interval [CI]) of new asthma among obese children in 2 to 6 year olds, 7 to 11 year olds, and 12 to 17 year olds were 1.25 (1.15, 1.37), 1.49 (1.32, 1.69) and 1.40 (1.21, 1.63), respectively. Among children with underlying allergic rhinitis, obesity did not increase the risk of new asthma. In children without allergic rhinitis, the risk for obesity-related asthma was highest in 7 to 11 year olds (risk ratio = 1.50 95% CI, 1.33, 1.60). Before age 12, females had a higher risk for obesity-related asthma; but after age 12, obese males had a higher asthma risk (interaction P-value < .05).

Conclusion: Obesity is a major preventable risk factor for pediatric asthma that appears to vary along the pediatric age continuum and depends on sex, race/ethnicity and atopy status.
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http://dx.doi.org/10.1002/ppul.24470DOI Listing
November 2019

A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.

Ther Drug Monit 2019 12;41(6):761-765

Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Background: Solithromycin is a fourth-generation macrolide antibiotic with potential efficacy in pediatric community-acquired bacterial pneumonia. Pharmacokinetic (PK) studies of solithromycin in pediatric subjects are limited, therefore application of minimally invasive drug sampling techniques, such as dried blood spots (DBS), may enhance the enrollment of children in PK studies. The objectives of this study were to compare solithromycin concentrations in DBS with those in liquid plasma samples (LPS) and to quantify the effects of modeling DBS concentrations on the results of a population PK model.

Methods: Comparability analysis was performed on matched DBS and LPS solithromycin concentrations collected from two different phase 1 clinical trials of solithromycin treatment in children (clinicaltrials.gov #NCT01966055 and #NCT02268279). Comparability of solithromycin concentrations was evaluated based on DBS:LPS ratio, median percentage prediction error, and median absolute percentage prediction error. The effect of correcting DBS concentrations for both hematocrit and protein binding was investigated. In addition, a previously published population PK model (NONMEM) was leveraged to compare parameter estimates resulting from either DBS or LPS concentrations.

Results: A total of 672 paired DBS-LPS concentrations were available from 95 subjects (age: 0-17 years of age). The median (range) LPS and DBS solithromycin concentrations were 0.3 (0.01-12) mcg/mL and 0.32 (0.01-14) mcg/mL, respectively. Median percentage prediction error and median absolute percentage prediction error of raw DBS to LPS solithromycin concentrations were 5.26% and 22.95%, respectively. In addition, the majority of population PK parameter estimates resulting from modeling DBS concentrations were within 15% of those obtained from modeling LPS concentrations.

Conclusions: Solithromycin concentrations in DBS were similar to those measured in LPS and did not require correction for hematocrit or protein binding.
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http://dx.doi.org/10.1097/FTD.0000000000000670DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6856424PMC
December 2019

Validity and Reliability of the Updated CDC Worksite Health ScoreCard.

J Occup Environ Med 2019 09;61(9):767-777

Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (Dr Roemer, Kent, McCleary, Dr Goetzel); IBM Watson Health, Bethesda, Maryland (Dr Mummert, Palmer, Dr Goetzel); Centers for Disease Control and Prevention/National Center for Chronic Disease Prevention and Health Promotion/Division of Population Health, Atlanta, Georgia (Dr Lang); Centers for Disease Control and Prevention/Office of Science/Office of Science Quality, Atlanta, Georgia (Dr Matson Koffman).

Objective: The aim of this study was to evaluate the reliability and validity of the updated 2019 CDC Worksite Health ScoreCard (CDC ScoreCard), which includes four new modules.

Methods: We pilot tested the updated instrument at 93 worksites, examining question response concurrence between two representatives from each worksite. We conducted cognitive interviews and site visits to evaluate face validity, and refined the instrument for public distribution.

Results: The mean question concurrence rate was 73.4%. Respondents reported the tool to be useful for assessing current workplace programs and planning future initiatives. On average, 43% of possible interventions included in the CDC ScoreCard were in place at the pilot sites.

Conclusion: The updated CDC ScoreCard is a valid and reliable tool for assessing worksite health promotion policies, educational and lifestyle counseling programs, environmental supports, and health benefits.
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http://dx.doi.org/10.1097/JOM.0000000000001660DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6743722PMC
September 2019

Barriers and consultation needs regarding implementation of evidence-based treatment in community agencies.

Child Youth Serv Rev 2018 Nov 4;94:368-377. Epub 2018 Oct 4.

Vice President for Mental Health Initiatives, Child Health and Development Institute of Connecticut, Inc.

There is growing recognition of the gap between research and practice in mental health settings, and community agencies now face significant pressure from multiple stakeholders to engage in evidence-based practices. Unfortunately, little is known about the barriers that exist among agencies involved in formal implementation efforts or their perceptions about how implementation experts can best support change. This study reports the results of a survey of 263 individuals across 32 agencies involved in a state-wide effort to increase access to an evidence-based trauma-focused treatment for children. Quantitative and qualitative results identified lack of time and secondary trauma as significant barriers to implementation and areas in which agencies desired consultation and support. Qualitative responses further suggested the importance of addressing client/structural barriers, staff turnover, and continued intervention training. Findings inform the development of a structured consultation process for community agencies focused on addressing the multiple barriers that can interfere with implementation of evidence-based treatment.
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http://dx.doi.org/10.1016/j.childyouth.2018.10.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6615900PMC
November 2018

Mometasone or Tiotropium in Mild Asthma with a Low Sputum Eosinophil Level.

N Engl J Med 2019 05 19;380(21):2009-2019. Epub 2019 May 19.

From the Division of Pulmonary and Critical Care Medicine and the Cardiovascular Research Institute (S.C.L., H.A.B., J.V.F., P.G.W.) and the Department of Pediatrics, Epidemiology, and Biostatistics (M.D.C.), University of California, San Francisco, San Francisco; the University of Illinois at Chicago (J.A.K.), the Department of Pediatrics, Rush University Medical Center (J.N.M.), Ann and Robert Lurie Children's Hospital of Chicago (J.A.P.), and Northwestern University, Feinberg School of Medicine (L.S.) - all in Chicago; the Department of Public Health Sciences, Penn State University, Hershey (T.S.K., V.M.C., D.T.M., A.-M.D.), and the University of Pittsburgh Asthma Institute (S.W., F.H.) and Allegheny General Hospital (D.G.), Pittsburgh - all in Pennsylvania; Nemours Children's Hospital, University of Central Florida College of Medicine, Orlando (J.E.L., K.V.B.), and Nemours Children's Health System, Jacksonville (J.E.L., K.V.B.) - both in Florida; the Department of Pediatrics and Medicine, National Jewish Health, Denver (R.C., S.J.S., M.E.W.), and Children's Hospital Colorado, Aurora (R.C., S.J.S., M.E.W.) - both in Colorado; Duke Allergy, Asthma, and Airway Center, Duke University School of Medicine, Durham (N.L., M.K., L.Q.), Wake Forest University School of Medicine, Winston-Salem (A.H., W.M., S.P.P.), and North Carolina Clinical Research, Raleigh (C.L.) - all in North Carolina; the Departments of Pediatrics and Medicine, Washington University in St. Louis School of Medicine, St. Louis (L.B.B., M.C.); Brigham and Women's Hospital and Harvard Medical School (J.C.C., E.I.) and Boston Children's Hospital (W.P.) - all in Boston; Rainbow Babies and Children's Hospital, Cleveland (J.C., R.M., K.R.); the University of Wisconsin, Madison (L.D., D.J., R.F.L., C.A.S.); Columbia University, New York (E.D.); the Department of Pediatrics, Emory University, Atlanta (A.M.F.); and the Arizona Respiratory Center, University of Arizona, Tucson (F.D.M., W.J.M.).

Background: In many patients with mild, persistent asthma, the percentage of eosinophils in sputum is less than 2% (low eosinophil level). The appropriate treatment for these patients is unknown.

Methods: In this 42-week, double-blind, crossover trial, we assigned 295 patients who were at least 12 years of age and who had mild, persistent asthma to receive mometasone (an inhaled glucocorticoid), tiotropium (a long-acting muscarinic antagonist), or placebo. The patients were categorized according to the sputum eosinophil level (<2% or ≥2%). The primary outcome was the response to mometasone as compared with placebo and to tiotropium as compared with placebo among patients with a low sputum eosinophil level who had a prespecified differential response to one of the trial agents. The response was determined according to a hierarchical composite outcome that incorporated treatment failure, asthma control days, and the forced expiratory volume in 1 second; a two-sided P value of less than 0.025 denoted statistical significance. A secondary outcome was a comparison of results in patients with a high sputum eosinophil level and those with a low level.

Results: A total of 73% of the patients had a low eosinophil level; of these patients, 59% had a differential response to a trial agent. However, there was no significant difference in the response to mometasone or tiotropium, as compared with placebo. Among the patients with a low eosinophil level who had a differential treatment response, 57% (95% confidence interval [CI], 48 to 66) had a better response to mometasone, and 43% (95% CI, 34 to 52) had a better response to placebo (P = 0.14). In contrast 60% (95% CI, 51 to 68) had a better response to tiotropium, whereas 40% (95% CI, 32 to 49) had a better response to placebo (P = 0.029). Among patients with a high eosinophil level, the response to mometasone was significantly better than the response to placebo (74% vs. 26%) but the response to tiotropium was not (57% vs. 43%).

Conclusions: The majority of patients with mild, persistent asthma had a low sputum eosinophil level and had no significant difference in their response to either mometasone or tiotropium as compared with placebo. These data provide equipoise for a clinically directive trial to compare an inhaled glucocorticoid with other treatments in patients with a low eosinophil level. (Funded by the National Heart, Lung, and Blood Institute; SIENA ClinicalTrials.gov number, NCT02066298.).
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http://dx.doi.org/10.1056/NEJMoa1814917DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6711475PMC
May 2019

Interviews with caregivers during acute asthma hospitalisations.

J Asthma 2020 07 26;57(7):778-786. Epub 2019 Apr 26.

Department of Nursing, The University of Alabama in Huntsville, Huntsville, Alabama, USA.

Childhood asthma is complex and poor management of childhood asthma is the leading health reason for pediatric emergency department visits, hospitalizations and missed school days for school-aged children. The purpose of this study was to explore caregiver perceptions of home management of childhood asthma in school-aged children who have been hospitalized for asthma. Using qualitative descriptive design with in-depth interviews, we aimed to explore family caregiver perceptions of managing asthma in school-aged children between 5 and 12 years of age. Data were collected from 17 participants; however, two transcripts were incomplete due to interruption in interview from medical team. The sample consisted of 15 families with child age mean of 8 years, and diagnosed with asthma at 2 years and 8 months. Four experts with asthma and research design analyzed all transcripts and six clear themes emerged. These themes included family or caregiver burden, care coordination, certainty or uncertainty continuum, effort to control, sign or symptom recognition, and trigger recognition. In this article, we defined each theme and identify specific statements from families on daily life when affected by childhood asthma. The findings of this study confirm and extend results from other studies of caregivers who have school-aged children diagnosed with asthma. This study found that families play a vital role in management of asthma on a daily basis and families often assess the overall management of asthma by all child relations throughout the day. Clinical implications are highlighted within each theme.
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http://dx.doi.org/10.1080/02770903.2019.1602875DOI Listing
July 2020

Results of the Workplace Health in America Survey.

Am J Health Promot 2019 06 22;33(5):652-665. Epub 2019 Apr 22.

1 Department of Health Behavior, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.

Purpose: To provide a nationally representative snapshot of workplace health promotion (WHP) and protection practices among United States worksites.

Design: Cross-sectional, self-report Workplace Health in America (WHA) Survey between November 2016 and September 2017.

Setting: National.

Participants: Random sample of US worksites with ≥10 employees, stratified by region, size, and North American Industrial Classification System sector.

Measures: Workplace health promotion programs, program administration, evidence-based strategies, health screenings, disease management, incentives, work-life policies, implementation barriers, and occupational safety and health (OSH).

Analysis: Descriptive statistics, t tests, and logistic regression.

Results: Among eligible worksites, 10.1% (n = 3109) responded, 2843 retained in final sample, and 46.1% offered some type of WHP program. The proportion of comparable worksites with comprehensive programs (as defined in Healthy People 2010) rose from 6.9% in 2004 to 17.1% in 2017 ( P < .001). Occupational safety and health programs were more prevalent than WHP programs, and 83.5% of all worksites had an individual responsible for employee safety, while only 72.2% of those with a WHP program had an individual responsible for it. Smaller worksites were less likely than larger to offer most programs.

Conclusion: The prevalence of WHP programs has increased but remains low across most health programs; few worksites have comprehensive programs. Smaller worksites have persistent deficits and require targeted approaches; integrated OSH and WHP efforts may help. Ongoing monitoring using the WHA Survey benchmarks OSH and WHP in US worksites, updates estimates from previous surveys, and identifies gaps in research and practice.
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http://dx.doi.org/10.1177/0890117119842047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6643274PMC
June 2019

Adverse childhood experiences, epigenetics and telomere length variation in childhood and beyond: a systematic review of the literature.

Eur Child Adolesc Psychiatry 2020 Oct 9;29(10):1329-1338. Epub 2019 Apr 9.

Institute of Health and Wellbeing, MVLS, University of Glasgow, Glasgow, UK.

A systematic review following PRISMA guidelines was conducted to answer the question: What epigenetic, telomeric and associated biological changes are associated with exposure to adverse childhood experiences (ACEs) in the under 12s? Using PRISMA guidelines, appropriate databases were searched. 190 papers were returned with 38 articles fully reviewed. Articles were each independently quality rated by two authors using the Crowe Critical Appraisal Tool and data were extracted. Of the 38 articles, 23 were rated as very high quality. Most study participants were adults (n = 7769) with n = 727 child participants. Only seven of the very/high-quality studies were prospective and involved children. Methylation was the most studied method of epigenetic modification. There is some evidence supporting epigenetic modification of certain markers in participants exposed to ACEs measured in adulthood. Research is lacking on non-coding aspects of the epigenome and on coding aspects other than DNA methylation. There is some evidence of a more powerful effect on telomere length if physical neglect was involved. Much further work is required to model biological and psychological effects of epigenetic changes during childhood using prospective study designs. The effect of ACEs on the cellular ageing process during childhood is inadequately investigated and relies solely on measure of telomere length. Future research suggestions are proposed.
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http://dx.doi.org/10.1007/s00787-019-01329-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7501093PMC
October 2020

Severe childhood asthma exacerbations: Is treatment response variability in the genes?

Pediatr Pulmonol 2019 06 13;54(6):680-682. Epub 2019 Mar 13.

Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1002/ppul.24309DOI Listing
June 2019

Fish Oil Supplementation in Overweight/Obese Patients with Uncontrolled Asthma. A Randomized Trial.

Ann Am Thorac Soc 2019 05;16(5):554-562

2 Center for Pharmacogenomics and Translational Research, Nemours Children's Health System, Jacksonville, Florida.

Omega-3 fatty acid (n3PUFA) supplementation has been proposed as a promising antiasthma strategy. The rs59439148 polymorphism affects leukotriene production and possibly inflammatory responses to n3PUFA. Assess the effects of n3PUFA supplementation and genotype on asthma control in patients with obesity and uncontrolled asthma. This multicenter trial among 12- to 25-year-olds with overweight/obesity and uncontrolled asthma randomized subjects in a 3:1 allotment to n3PUFA (4 g/d) or soy oil control for 24 weeks. Asthma Control Questionnaire was the primary outcome; secondary outcomes included blood leukocyte n3PUFA levels, urinary leukotriene-E4, spirometry, and asthma-related events. The number of SP1 tandem repeats in rs59439148 determined genotype status. Simple and multivariable generalized linear models assessed effects on outcomes. Ninety-eight participants were randomized (77 to PUFA, 21 to control), and more than 86% completed all visits. Asthma and demographic characteristics were similar among treatment groups. n3PUFA treatment increased the n3-to-n6 PUFA ratio in circulating granulocytes ( = 0.029) and monocytes ( = 0.004) but did not affect mean Asthma Control Questionnaire change at 6 months (n3PUFA: mean, -0.09; 95% confidence interval [CI], 0.09 to 0.10; vs. control: mean, -0.18; 95% CI, -0.42 to 0.06;  = 0.58). Changes in urinary leukotriene-E4 ( = 0.24), forced expiratory volume in 1 second % predicted ( = 0.88), and exacerbations (relative risk [RR], 0.92; 95% CI, 0.30-2.89) at 6 months were similar in both groups. n3PUFA treatment was associated with reduced asthma-related phone contacts (RR, 0.34; 95% CI, 0.13-0.86;  = 0.02). genotype did not affect n3PUFA treatment responses. We did not find evidence that n3PUFA use improves most asthma-related outcomes and cannot recommend it as a prevention strategy for overweight/obese patients with asthma. Clinical trial registered with www.clinicaltrials.gov (NCT01027143).
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http://dx.doi.org/10.1513/AnnalsATS.201807-446OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6491059PMC
May 2019

Genotype tailored treatment of mild symptomatic acid reflux in children with uncontrolled asthma (GenARA): Rationale and methods.

Contemp Clin Trials 2019 03 16;78:27-33. Epub 2019 Jan 16.

Division of Allergy/Immunology and Pulmonary Medicine, Duke University School of Medicine, Duke Children's Hospital and Health Center, Durham, NC, United States. Electronic address:

Asthma causes enormous suffering and cost for children in the US and around the world [1-3]. Co-morbid gastroesophageal reflux disease (GERD) makes asthma management more difficult due to increased symptoms. Proton pump inhibitor (PPI) drugs are effective at improving to GERD symptoms, however they have demonstrated only modest and variable effects on asthma control in the setting of co-morbid GERD. Importantly, PPI metabolism and efficacy depend on CYP2C19 genotype. The Genotype Tailored Treatment of Symptomatic Acid Reflux in Children with Uncontrolled Asthma (GenARA) study is a randomized, double-blind, placebo-controlled trial to determine if genotype-tailored PPI dosing improves asthma symptoms among children with inadequately controlled asthma and GERD symptoms. This study has an innovative design to both assess the efficacy of genotype-tailored PPI dosing and perform pharmacokinetic modeling of the oral PPI Lansoprazole. Children ages 6-17 years old with clinician-diagnosed asthma and mild GERD symptoms will submit a saliva sample for CYP2C19 genotyping. Participants will undergo a two-step randomization to: (1) genotype-tailored versus conventional dosing of open-label oral lansoprazole for pharmacokinetic modeling, and (2) genotype-tailored lansoprazole daily versus placebo for 24 weeks to determine the effect of genotype-tailored PPI dosing on asthma control. Measures of asthma control, spirometry, and nasal washes during acute illnesses will be collected at 8-week intervals throughout the study. GenARA will better define the effects of CYP2C19 genotype on the dose response of lansoprazole in children and adolescents and assess if a novel dosing regimen improves GERD and asthma control.
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http://dx.doi.org/10.1016/j.cct.2019.01.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7039713PMC
March 2019

The impact of exercise on asthma.

Authors:
Jason E Lang

Curr Opin Allergy Clin Immunol 2019 04;19(2):118-125

Division of Allergy/Immunology and Pulmonary Medicine, Duke Children's Hospital and Health Center, Durham, North Carolina, USA.

Purpose Of Review: Asthma is one of the most common chronic diseases in children and adults in developed countries around the world. Despite international treatment guidelines, poor asthma control remains a frequent problem leading to missed school and work, and emergency room visits and hospitalizations. Many patients with asthma report exercise as a trigger for their asthma, which likely leads to exercise avoidance as a means to control symptoms. Evolving research has suggested that routine exercise may actually help improve some aspects of asthma control. This review discusses the recent research addressing how routine exercise affects important asthma-related outcomes including symptoms, lung function and quality of life.

Recent Findings: Several systematic reviews and meta-analyses have been conducted in recent years, which strongly support the safety of routine exercise in children and adults with asthma. Exercise appears to favor improvements in aerobic fitness, asthma symptoms and quality of life, but results so far are less consistent in demonstrating improvements to lung function and airway hyperresponsiveness.

Summary: In addition to routine management guidelines, clinicians should recommend for their patients with asthma routine exercise for its general health benefits and likely improvement in asthma symptoms and quality of life.
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http://dx.doi.org/10.1097/ACI.0000000000000510DOI Listing
April 2019