Home environment factors associated with child BMI changes during COVID-19 pandemic.

BACKGROUND: The influence of home obesogenic environments, as assessed by the validated Family Nutrition and Physical Activity (FNPA) tool, and child obesity during the COVID pandemic were evaluated using electronic health records in this retrospective cohort study. METHODS: Historical data on BMI and the FNPA screening tool were obtained from annual well-child visits within the Geisinger Health System. The study examined youth ages 2-17 that had a BMI record and an FNPA assessment prior to the pandemic (BMI 3/1/19-2/29/20), 1 BMI record 3 months into the pandemic (6/1/20-12/31/20) and 1 BMI in the second year of the pandemic (1/1/21-12/31/21). Tertiles of obesity risk by FNPA score were examined. Mixed-effects linear regression was used to examine change in BMI slope (kg/m2 per month) pre-pandemic to pandemic using FNPA summary and subscales scores as predictors and adjusting for confounding factors. RESULTS: The analyses included 6,746 children (males: 51.7%, non-Hispanic white: 86.6%, overweight:14.8%, obesity:10.3%, severe obesity: 3.9%; mean(SD) age: 5.7(2.8) years). The rate of BMI change in BMI was greatest from early pandemic compared to pre-pandemic for children in lowest versus highest tertiles of FNPA summary score (0.079 vs. 0.044 kg/m2), FNPA-Eating (0.068 vs. 0.049 kg/m2), and FNPA-Activity (0.078 vs. 0.052 kg/m2). FNPA summary score was significantly associated with change in BMI from the pre-pandemic to early pandemic period (p = 0.014), but not associated with change in BMI during the later pandemic period. CONCLUSIONS: This study provides additional insight into the changes in the rate of BMI change observed among children and adolescents in the United States during the COVID-19 pandemic. The FNPA provides ample opportunity to continue our exploration of the negative impact of the COVID-19 pandemic on the longitudinal growth patterns among children and adolescents.

Δ9-tetrahydrocannabinol and 11-hydroxy-Δ9-tetrahydrocannabinol as markers of cannabis use in urinary drug testing.

With some exceptions, California Assembly Bill 2188 will preclude the use of ∆9-tetrahydrocannabinol-9-carboxylic acid (Δ9-THC-COOH) as a marker of cannabis use in urinary workplace drug testing. The bill allows for the use of psychoactive cannabis markers, which include Δ9-tetrahydrocannabinol (Δ9-THC) and the metabolite 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-Δ9-THC). Both analytes are present in urine mainly as conjugated metabolites and will require hydrolysis prior to analysis, but very little is known about expected concentrations in urine. The aim of this study was to report concentrations from two large data sets comprising 1,411 workplace drug testing urine specimens positive by immunoassay (50 ng/mL cutoff) and discuss strategies for using 11-OH-Δ9-THC and/or Δ9-THC to detect cannabis use. Median 11-OH-Δ9-THC and Δ9-THC concentrations were 28-35% and 1.1-1.6% of those of Δ9-THC-COOH and correlations between analytes were observed. To avoid the risk of positives from passive exposure, laboratories could use a cutoff with equivalent sensitivity to cannabis exposure. A 5 ng/mL cutoff for 11-OH-Δ9-THC showed 92% agreement with a 15 ng/mL cutoff for Δ9-THC-COOH, with only 0.9% of specimens being positive only for 11-OH-Δ9-THC. It was not possible to propose an estimated cutoff for Δ9-THC, due to the constraints of the limit of detection used in this study.

Comparable efficacy of oral bendamustine versus intravenous administration in treating hematologic malignancies.

PURPOSE: The purpose of this study was to analyze potential differences in antitumor efficacy and pharmacokinetics between intravenous (IV) bendamustine and a novel orally administered (PO) bendamustine agent that is utilizing the beneficial properties of superstaturated solid dispersions formulated in nanoparticles. METHODS: Pharmacokinetics of IV versus PO bendamustine were determined by analysis of plasma samples collected from NSG mice treated with either IV or PO bendamustine. Plasma samples were analyzed using liquid chromatography-mass spectrometry following a liquid-liquid extraction to determine peak bendamustine concentration, area under the concentration-time curve, and the half-life in-vivo. In-vitro cytotoxicity of bendamustine against human non-Hodgkin Burkitt's Lymphoma (Raji), multiple myeloma (MM.1s), and B-cell acute lymphoblastic leukemia (RS4;11) cell lines was determined over time using MTS assays. Luciferase-tagged versions of the aforementioned cell lines were used to determine in-vivo bendamustine cytotoxicity of IV versus PO bendamustine at two different doses. RESULTS: Bendamustine at a high dose in-vitro causes cell death. There was no significant difference in antitumor activity between IV and novel PO bendamustine at a physiologically relevant concentration in all three xenograft models. In-vivo pharmacokinetics showed the oral bioavailability of bendamustine in mice to be 51.4%. CONCLUSIONS: The novel oral bendamustine agent tested exhibits good oral bioavailability and systemic exposure for in-vivo antitumor efficacy comparable to IV bendamustine. An oral bendamustine formulation offers exciting clinical potential as an additional method of administration for bendamustine and warrants further evaluation in clinical studies.

Stability of Nano-Emulsified Cannabidiol in Acidic Foods and Beverages.

Introduction: Food and beverage products containing cannabidiol (CBD) is a growing industry, but some CBD products contain Δ9-tetrahydrocannabinol (Δ9-THC), despite being labeled as "THC-free". As CBD can convert to Δ9-THC under acidic conditions, a potential cause is the formation of Δ9-THC during storage of acidic CBD products. In this study, we investigated if acidic products (pH ≤ 4) fortified with CBD would facilitate conversion to THC over a 2-15-month time period. Materials and Methods: Six products, three beverages (lemonade, cola, and sports drink) and three condiments (ketchup, mustard, and hot sauce), were purchased from a local grocery store and fortified with a nano-emulsified CBD isolate (verified as THC-free by testing). The concentrations of CBD and Δ9-THC were measured by Gas Chromatography Flame Ionization Detector (GC-FID) and Liquid Chromatography with tandem mass spectrometry (LC-MS/MS), respectively, for up to 15 months at room temperature. Results: Coefficients of variation (CVs) of initial CBD concentrations by GC-FID were <10% for all products except ketchup (18%), showing homogeneity in the fortification. Formation of THC was variable, with the largest amount observed after 15 months in fortified lemonade #2 (3.09 mg Δ9-THC/serving) and sports drink #2 (1.18 mg Δ9-THC/serving). Both beverages contain citric acid, while cola containing phosphoric acid produced 0.10 mg Δ9-THC/serving after 4 months. The importance of the acid type was verified using acid solutions in water. No more than 0.01 mg Δ9-THC/serving was observed with the condiments after 4 months. Discussion: Conversion of CBD to THC can occur in some acidic food products when those products are stored at room temperature. Therefore, despite purchasing beverages manufactured with a THC-free nano-emulsified form of CBD, consumers might be at some risk of unknowingly ingesting small amounts of THC. The results indicate that up to 3 mg Δ9-THC from conversion can be present in a serving of CBD-lemonade. Based on the previous studies, 3 mg Δ9-THC might produce a positive urine sample (≥15 ng/mL THC carboxylic acid) in some individuals. Conclusion: Consumers must exert caution when consuming products with an acidic pH (≤4) that suggests that they are "THC-Free," because consumption might lead to positive drug tests or, in the case of multiple doses, intoxication.

Examination of eating competence in a geo-diverse sample with metabolic syndrome.

Eating competence (EatC) is an intra-individual approach to eating attitudes and behaviors associated with greater well-being. EatC research has not included persons with confirmed metabolic syndrome (MetS). Therefore, EatC of persons with MetS was explored to identify unique associations and inform implementation of MetS lifestyle interventions using baseline data from a multisite, randomized trial of a 2-year lifestyle intervention with MetS. EatC, measured with the Satter Eating Competence Inventory 2.0 (ecSI 2.0™), was examined for relationships with bioclinical measures (e.g., blood pressure, lipids), medication use, BMI, waist circumference, fruit/vegetable intake, and psychosocial factors, (e.g., stress, mindfulness). Data were collected in person and video call by trained research personnel. EatC was examined as a continuous score and as a categorical variable with ecSI 2.0™ scores ≥ 32 considered eating competent. Participants (n = 618) were predominantly female (76%), White (74%), college educated (60%). Mean age was 55.5 ± 11 y. Mean ecSI 2.0™ was 29.9 ± 7.4 and 42% were eating competent. EatC was greater for males, persons who were older and food secure. Competent eaters (vs. non-eating competent) had lower waist circumference (112.7 ± 12.5 cm vs.116.8 ± 16.0 cm; P < 0.001) and BMI (35.0 ± 6.1 vs. 37.5 ± 7.3; P < 0.001). Serum triglycerides, HDL-cholesterol, fasting blood glucose, HbA1c, and blood pressure did not differ by EatC status. Compared to non-eating competent persons, competent eaters perceived less stress, were more mindful, indicated better physical function, and more habitual vegetable intake (all P < 0.001) and sensory awareness (P < 0.05). EatC in MetS paralleled the non-MetS profile. EatC was associated with a healthier psychosocial profile, waist circumference and BMI. Findings support further research to examine the mediational or moderating influence of EatC in the treatment of MetS.

Agreement between parent-report and EMR height, weight, and BMI among rural children.

Introduction: Remote anthropometric surveillance has emerged as a strategy to accommodate lapses in growth monitoring for pediatricians during coronavirus disease 2019 (COVID-19). The purpose of this investigation was to validate parent-reported anthropometry and inform acceptable remote measurement practices among rural, preschool-aged children. Methods: Parent-reported height, weight, body mass index (BMI), BMI z-score, and BMI percentile for their child were collected through surveys with the assessment of their source of home measure. Objective measures were collected by clinic staff at the child's well-child visit (WCV). Agreement was assessed using correlations, alongside an exploration of the time gap (TG) between parent-report and WCV to moderate agreement. Using parent- and objectively reported BMI z-scores, weight classification agreement was evaluated. Correction equations were applied to parent-reported anthropometrics. Results: A total of 55 subjects were included in this study. Significant differences were observed between parent- and objectively reported weight in the overall group (-0.24 kg; p = 0.05), as well as height (-1.8 cm; p = 0.01) and BMI (0.4 kg/m2; p = 0.02) in the ≤7d TG + Direct group. Parental reporting of child anthropometry ≤7d from their WCV with direct measurements yielded the strongest correlations [r = 0.99 (weight), r = 0.95 (height), r = 0.82 (BMI), r = 0.71 (BMIz), and r = 0.68 (BMI percentile)] and greatest classification agreement among all metrics [91.67% (weight), 54.17% (height), 83.33% (BMI), 91.67% (BMIz), and 33.33% (BMI percentile)]. Corrections did not remarkably improve correlations. Discussion: Remote pediatric anthropometry is a valid supplement for clinical assessment, conditional on direct measurement within 7 days. In rural populations where socioenvironmental barriers exist to care and surveillance, we highlight the utility of telemedicine for providers and researchers.

Systematic web monitoring of drug test subversion strategies in the United States.

As negative drug tests are frequently a condition for employment, some people who use drugs will try to subvert the testing. In this study, systematic web monitoring was used to investigate how drug test subversion is discussed online. Posts pertaining to drug test subversion were obtained from public websites and the dark web (n = 634, July-December 2021). Most information from public websites came from Twitter (65%), and 94% of dark web posts were from Reddit. The posts were manually coded to extract quantitative and qualitative information about drug test subversion tactics. Most posts discussed urine drug tests (85%), followed by hair (11%) and oral fluid (2%), and the most discussed drugs were marijuana (72%) and cocaine (7.3%). Urine drug test subversion mainly pertained to specimen substitution, with synthetic urine or urine from another person. Another strategy was to mask diluted urine by ingesting creatine. Urine adulteration was rarely discussed. Hair test subversion involved harsh treatments with products such as bleach, baking soda, and/or detergent. Hair removal was also discussed. Oral fluid test subversion focused on removing drugs from the oral cavity through vigorous brushing of teeth and tongue as well as the use of mouthwash, hydrogen peroxide, gum, and commercial detox products. This study highlights subversion strategies used by donors. Although little evidence was provided as to the effectiveness of these strategies, this information may help guide future studies and development of specimen validity testing to minimize the impact of drug test subversion attempts.

Resident Burnout, Wellness, Professional Development, and Engagement Before and After New Training Schedule Implementation.

Importance: Burnout is a work-related syndrome of depersonalization (DP), emotional exhaustion (EE), and low personal achievement (PA) that is prevalent among internal medicine resident trainees. Prior interventions have had modest effects on resident burnout. The association of a new 4 + 4 block schedule (4 inpatient weeks plus 4 outpatient weeks) with resident burnout has not previously been evaluated. Objective: To evaluate the association of a 4 + 4 block schedule, compared with a 4 + 1 schedule, with burnout, wellness, and self-reported professional engagement and clinical preparedness among resident physicians. Design, Setting, and Participants: This nonrandomized preintervention and postintervention survey study was conducted in a single academic-based internal medicine residency program from June 2019 to June 2021. The study included residents in the categorical, hospitalist, and primary care tracks in postgraduate years 1 and 2 (PGY1 and PGY2). Data analysis was conducted from October to December 2022. Intervention: In the 4 + 4 structure, resident schedules alternated between 4-week inpatient call-based rotations and 4-week ambulatory non-call-based rotations. Main Outcomes and Measures: The primary outcome was burnout, assessed using the Maslach Burnout Inventory subcategories of EE (range, 0-54), DP (range, 0-30), and PA (range, 0-48), adjusted for sex and PGY. Secondary outcomes included In-Training Examination (ITE) scores and a questionnaire on professional, educational, and health outcomes. Multivariable logistic regression was used to assess the primary outcome, 1-way analysis of variance was used to compare ITE percentiles, and a Bonferroni-adjusted Kruskal Wallis test was used for the remaining secondary outcomes. The findings were reexamined with several sensitivity analyses, and Cohen's D was used to estimate standardized mean differences (SMDs). Results: Of the 313 eligible residents, 216 completed the surveys. A total of 107 respondents (49.5%) were women and 109 (50.5%) were men; 119 (55.1%) were PGY1 residents. The survey response rates were 78.0% (85 of 109) in the preintervention cohort and 60.6% (63 of 104) and 68.0% (68 of 100) in the 2 postintervention cohorts. The PGY1 residents had higher response rates than the PGY2 residents (119 of 152 [78.2%] vs 97 of 161 [60.2%]; P < .001). Adjusted EE scores (mean difference [MD], -6.78 [95% CI, -9.24 to -4.32]) and adjusted DP scores (MD, -3.81 [95% CI, -5.29 to -2.34]) were lower in the combined postintervention cohort. The change in PA scores was not statistically significant (MD, 1.4 [95% CI, -0.49 to 3.29]). Of the 15 items exploring professional, educational, and health outcomes, a large positive association was observed for 11 items (SMDs >1.0). No statistically significant change in ITE percentile ranks was noted. Conclusions and Relevance: In this survey study of internal medicine resident physicians, a positive association was observed between a 4 + 4 block training schedule and internal medicine resident burnout scores and improved self-reported professional, educational, and health outcomes. These results suggest that specific 4 + 4 block combinations may better improve resident burnout than a 4 + 1 combination used previously.

Fentanyl as a marker of illicit drug use in morphine-positive urine specimens from workplace drug testing.

Total morphine is an important urinary marker of heroin use but can also be present from prescriptions or poppy seed ingestion. In specimens with morphine concentrations consistent with poppy seed ingestion (<4,000 ng/mL), 6-acetylmorphine has served as an important marker of illicit drug use. However, as illicit fentanyl has become increasingly prevalent as a contaminant in the drug supply, fentanyl might be an alternative marker of illicit opioid use instead of or in combination with 6-acetylmorphine. The aim of this study was to quantify opiates, 6-acetylmorphine, fentanyl and fentanyl analogs in 504 morphine-positive (immunoassay 2,000 ng/mL cutoff) urine specimens from workplace drug testing. Almost half (43%) of morphine-positive specimens had morphine concentrations below 4,000 ng/mL, illustrating the need for markers to differentiate illicit drug use. In these specimens, fentanyl (22% co-positivity) was more prevalent than 6-acetylmorphine (12%). Co-positivity of 6-acetylmorphine and semi-synthetic opioids increased with morphine concentration, while fentanyl prevalence did not. In 110 fentanyl-positive specimens, the median norfentanyl concentration (1,520 ng/mL) was 9.6× higher than the median fentanyl concentration (159 ng/mL), illustrating the possibility of using norfentanyl as a urinary marker of fentanyl use. The only fentanyl analog identified was para-fluorofentanyl (n = 50), with results from most specimens consistent with para-fluorofentanyl contamination in illicit fentanyl. The results confirm the use of fentanyl by employees subject to workplace drug testing and highlight the potential of fentanyl and/or norfentanyl as important markers of illicit drug use.

Comparable Efficacy of Oral Bendamustine versus Intravenous Administration in Treating Hematologic Malignancies.

Purpose: The purpose of this study was to analyze potential differences in antitumor efficacy and pharmacokinetics between intravenous (IV) bendamustine (BEN) and a novel orally administered bendamustine agent (PO) that is utilizing the beneficial properties of superstaturated solid dispersions formulated in nanoparticles. Methods: Pharmacokinetics of IV versus PO BEN were determined by analysis of plasma samples collected from NSG mice treated with either IV or PO BEN. Plasma samples were analyzed using liquid chromatography-mass spectrometry (LC/MS/MS) following a liquid-liquid extraction to determine peak BEN concentration (Cmax), area under the concentration-time curve (AUC) and the half-life (t1/2) in-vivo. in-vitro cytotoxicity of BEN against human non-Hodgkin's Burkitt's Lymphoma (Raji), multiple myeloma (MM.1s), and B-cell acute lymphoblastic leukemia (RS4;11) cell lines was determined over time using MTS assays. Luciferase-tagged versions of the aforementioned cell lines were used to determine in-vivo BEN cytotoxicity of IV versus PO BEN at two different doses. Results: Bendamustine at a high dose in-vitro causes cell death. There was no significant difference in antitumor efficacy between IV and novel PO BEN at a physiologically relevant concentration in all three xenograft models. In-vivo pharmacokinetics showed the oral bioavailability of BEN in mice to be 51.4%. Conclusions: The novel oral BEN agent tested exhibits good oral bioavailability and systemic exposure for in-vivo antitumor efficacy comparable to IV BEN. An oral BEN formulation offers exciting clinical potential as an additional method of administration for bendamustine and warrants further evaluation in clinical studies.

Addressing Mental Health Disability in Unsheltered Homelessness: Outpatient Conservatorship in Los Angeles.

OBJECTIVE: The authors sought to describe a pilot program for gravely disabled individuals experiencing unsheltered homelessness in Los Angeles County that illustrates a promising public health framework to address mental health-related disability in homeless populations. METHODS: Homeless outreach teams implementing the outpatient conservatorship (OPC) pilot program adopted a population health approach, multisystem care coordination, and prioritization of the least restrictive environments. The program allowed initiation of a Lanterman-Petris-Short (LPS) conservatorship outside of a hospital, with the goal of serving highly vulnerable individuals in the least restrictive settings. Between August 2020 and July 2021, the OPC pilot program served 43 clients, corresponding to 2% of those served by the outreach teams during that period. Using observational program evaluation data, the authors examined the impact of the program on this sample of participants. RESULTS: At 12 months, 81% of OPC clients were no longer experiencing unsheltered homelessness; 65% accessed an LPS conservatorship. Although most OPC clients utilized a psychiatric hospital, 54% left locked settings earlier than would have been possible without the program. One-third of clients referred for LPS conservatorship used unlocked licensed residential facilities in the first year. Negative events, such as remaining in unsheltered homelessness, were more common among clients not referred for LPS conservatorship. CONCLUSIONS: Timely receipt of street-based services and coordination of care before, during, and after referral for LPS conservatorship reduced use of restrictive settings. The OPC program's components constitute a promising triadic framework for addressing mental health disability among unsheltered individuals that warrants further investigation.

Childhood Obesity and Early Body Mass Index Gains Associated with COVID-19 in a Large Rural Health System.

OBJECTIVE: To evaluate body mass index (BMI) change among a population of children with a high proportion residing in rural areas across two pandemic time periods. METHODS: Electronic health records were evaluated in a rural health system. INCLUSION CRITERIA: 2-17 years at initial BMI; >2 BMIs during pre-pandemic (January 1, 2018-February 29, 2020); >1 BMI in early pandemic (June 1, 2020-December 31, 2020); and >1 BMI in later pandemic (January 1, 2021-December 31, 2021). Mixed effects linear regression models were used to estimate average monthly rate of change in BMI slope (∆BMI) from pre-pandemic to pandemic and test for effect modification of sex, race/ethnicity, age, BMI, public insurance, and rural address. RESULTS: Among the 40,627 participants, 50.2% were female, 84.6% were non-Hispanic white, 34.9% used public insurance, and 42.5% resided in rural areas. The pre-pandemic proportion of children with overweight, obesity, and severe obesity was 15.6%, 12.8%, and 6.3%, respectively. The ∆BMI nearly doubled during the early pandemic period compared with the pre-pandemic period (0.102 vs 0.055 kg/m2), however, ∆BMI in the later pandemic was lower (0.040 vs 0.055 kg/m2). ∆BMI remained higher in the later pandemic for all race categories compared to Non-Hispanic white. Children with public insurance had higher ∆BMI compared to those with private insurance that remained higher in the later pandemic (0.051 vs 0.035 kg/m2). There was no significant difference between ∆BMI for rural and urban children during pandemic periods. CONCLUSIONS: Despite the decreased ∆BMI among children in the later pandemic, prevalence of obesity and severe obesity remain high. Efforts must continue to be made to limit excess weight gain during childhood and to assess the impact of forces like structural and social factors in both etiology and prevention.

Fixed Versus Body-Sized-Based Dosing of Monoclonal Antibodies.

Monoclonal antibody products are an increasing portion of novel drug approvals. The labeling of initial drug approvals frequently involves body-size-based rather than fixed-dose administration regimens for adults without clear rationale for doing so. This presents challenges when prescribing these products for patients with extremes of body habitus who constitute a small portion of enrollment in pre-approval investigations. Fixed-dose regimens allow for standardized preparation with the potential to reduce the risk of calculation errors, drug waste, and make home administration more practical. Fixed-dose rather than body-size-based monoclonal antibody regimens should serve as the initial approach in early phase 1 clinical trials.

Ribosome Abundance Control in Prokaryotes.

Cell growth is an essential phenotype of any unicellular organism and it crucially depends on precise control of protein synthesis. We construct a model of the feedback mechanisms that regulate abundance of ribosomes in E. coli, a prototypical prokaryotic organism. Since ribosomes are needed to produce more ribosomes, the model includes a positive feedback loop central to the control of cell growth. Our analysis of the model shows that there can be only two coexisting equilibrium states across all 23 parameters. This precludes the existence of hysteresis, suggesting that the ribosome abundance changes continuously with parameters. These states are related by a transcritical bifurcation, and we provide an analytic formula for parameters that admit either state.

Qualitative inquiry with persons with obesity about weight management in primary care and referrals.

Introduction: Referrals to evidence-based weight management in the community-commercial sector are aligned with clinical recommendations but underutilized. Methods: This qualitative study explored patients' perceptions and expectations about obesity treatment in primary care and referral to community-commercial sector programs. Individual semi-structured interviews were conducted with a sample of US persons with obesity via telephone. Audiotape transcripts, interviewer notes, and independent review of data by two investigators allowed for data and investigator triangulation. Transcripts were analyzed using thematic analysis. Results: Data saturation was reached with 30 participants who had a mean age of 41.6 years (SD 9.4), 37% male, 20% Black/African American and 17% Hispanic, 57% college educated, and 50% were employed full-time. Three primary themes emerged: (1) frustration with weight management in primary care; (2) patients expect providers to be better informed of and offer treatment options; and (3) opportunities and challenges with referrals to community-commercial programs. Discussion: Patients expect that providers offer personalized treatment options and referrals to effective community-commercial programs are an acceptable option. If patient-level data are shared between clinical and community entities to facilitate referrals, then privacy and security issues need attention. Future research is needed to determine feasibility of implementing clinical to community-commercial referrals for obesity treatment in the United States.

Advancing workforce diversity by leveraging the Clinical and Translational Science Awards (CTSA) program.

Clinical trials continue to disproportionately underrepresent people of color. Increasing representation of diverse backgrounds among clinical research personnel has the potential to yield greater representation in clinical trials and more efficacious medical interventions by addressing medical mistrust. In 2019, North Carolina Central University (NCCU), a Historically Black College and University with a more than 80% underrepresented student population, established the Clinical Research Sciences Program with support from the Clinical and Translational Science Awards (CTSA) program at neighboring Duke University. This program was designed to increase exposure of students from diverse educational, racial, and ethnic backgrounds to the field of clinical research, with a special focus on health equity education. In the first year, the program graduated 11 students from the two-semester certificate program, eight of whom now hold positions as clinical research professionals. This article describes how leveraging the CTSA program helped NCCU build a framework for producing a highly trained, competent, and diverse workforce in clinical research responsive to the call for increased diversity in clinical trial participation.

Australian Donation and Transplantation Biobank: A Research Biobank Integrated Within a Deceased Organ and Tissue Donation Program.

We aimed to facilitate the donation of tissue samples for research by establishing a centralized system integrated in the organ donation program for collection, storage, and distribution of samples (the Australian Donation and Transplantation Biobank [ADTB]). Methods: Feasibility of a research biobank integrated within the deceased organ and tissue donation program was assessed. DonateLife Victoria sought consent for ADTB donation after consent was received for organ donation for transplantation from the donor's senior available next of kin. ADTB samples were collected during donation surgery and distributed fresh to researchers or stored for future research. The main outcome measures were ADTB donation rates, ADTB sample collection, ADTB sample use, and to identify ethical considerations. Results: Over 2 y, samples were collected for the ADTB from 69 donors (28% of 249 donors). Samples were obtained from the spleen (n = 59, 86%), colon (n = 57, 83%), ileum (n = 56, 82%), duodenum (n = 55, 80%), blood (n = 55, 80%), bone marrow (n = 55, 80%), skin (n = 54, 78%), mesenteric lymph nodes (n = 56, 81%), liver (n = 21, 30%), lung (n = 29, 42%), and lung-draining lymph node (n = 29, 42%). Heart (n = 20), breast (n = 1), and lower urinary tract (n = 1) samples were obtained in the second year. Five hundred fifty-six samples were used in 19 ethics-approved research projects spanning the fields of immunology, microbiology, oncology, anatomy, physiology, and surgery. Conclusions: The integration of routine deceased donation and transplantation activities with a coordinated system for retrieval and allocation of donor samples for use in a range of research projects is feasible and valuable.

Coordination Between Primary Care and Women, Infants, and Children to Prevent Obesity for Infants from Low-Income Families: A Pragmatic Randomized Clinical Trial.

Background: Rapid weight gain during infancy is associated with risk for later obesity, yet little research to date has examined the effect of a responsive parenting (RP) intervention with care coordination between pediatric primary care providers and Women, Infants, and Children nutritionists on infant weight. Methods: The Women, Infants, and Children Enhancements to Early Healthy Lifestyles for Baby (WEE Baby) Care study is a pragmatic, randomized clinical trial for mothers and infants (n = 288) designed to examine the effect of a patient-centered RP intervention that used advanced health information technology strategies to coordinate care to reduce rapid infant weight gain compared with standard care. General linear models examined intervention effects on infant conditional weight gain scores, weight-for-age z scores, BMI, and overweight status (BMI-for-age ≥85th percentile) from birth to age 6 months, and mothers' use of food to soothe from age 2 to 6 months. Results: There were no intervention effects on infant conditional weight gain scores or overweight status at 6 months. Infants in the RP intervention had lower mean weight-for-age z scores [M = -0.04, standard error (SE) = 0.04 vs. M = 0.05, SE = 0.04; p = 0.008] and lower mean BMI (M = 16.05, SE = 0.09 vs. M = 16.24, SE = 0.09; p = 0.03) compared with standard care. Mothers' use of emotion-based food to soothe was lower in the RP intervention compared with standard care from age 2 to 6 months [M difference = -0.32, standard deviation (SD) = 0.81 vs. 0.00, SD = 0.90; p = 0.01]. Conclusions: This pragmatic, patient-centered RP intervention did not reduce rapid infant weight gain or overweight but was associated with modestly lower infant BMI and reduced mothers' use of emotion-based food to soothe. Trial Registration: clinicaltrials.gov identifier: NCT03482908.