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.

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.

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.

Prospective Observational Cohort Study of Tenecteplase Versus Alteplase in Routine Clinical Practice.

BACKGROUND: A 10-hospital regional network transitioned to tenecteplase as the standard of care stroke thrombolytic in September 2019 because of potential workflow advantages and reported noninferior clinical outcomes relative to alteplase in meta-analyses of randomized trials. We assessed whether tenecteplase use in routine clinical practice reduced thrombolytic workflow times with noninferior clinical outcomes. METHODS: We designed a prospective registry-based observational, sequential cohort comparison of tenecteplase- (n=234) to alteplase-treated (n=354) stroke patients. We hypothesized: (1) an increase in the proportion of patients meeting target times for target door-to-needle time and transfer door-in-door-out time, and (2) noninferior favorable (discharge to home with independent ambulation) and unfavorable (symptomatic intracranial hemorrhage, in-hospital mortality or discharge to hospice) in the tenecteplase group. Total hospital cost associated with each treatment was also compared. RESULTS: Target door-to-needle time within 45 minutes for all patients was superior for tenecteplase, 41% versus 29%; adjusted odds ratio, 1.85 (95% CI, 1.27-2.71); P=0.001; 58% versus 41% by Get With The Guidelines criteria. Target door-in-door-out time within 90 minutes was superior for tenecteplase 37% (15/43) versus 14% (9/65); adjusted odds ratio, 3.62 (95% CI, 1.30-10.74); P=0.02. Favorable outcome for tenecteplase fell within the 6.5% noninferiority margin; adjusted odds ratio, 1.26 (95% CI, 0.89-1.80). Unfavorable outcome was less for tenecteplase, 7.3% versus 11.9%, adjusted odds ratio, 0.77 (95% CI, 0.42-1.37) but did not fall within the prespecified 1% noninferior boundary. Net benefit (%favorable-%unfavorable) was greater for the tenecteplase sample: 37% versus 27%. P=0.02. Median cost per hospital encounter was less for tenecteplase cases ($13 382 versus $15 841; P<0.001). CONCLUSIONS: Switching to tenecteplase in routine clinical practice in a 10-hospital network was associated with shorter door-to-needle time and door-in-door-out times, noninferior favorable clinical outcomes at discharge, and reduced hospital costs. Evaluation in larger, multicenter cohorts is recommended to determine if these observations generalize.

Comparing enhancements to well-child visits in the prevention of obesity: ENCIRCLE cluster-randomized controlled trial.

BACKGROUND: Obesity disproportionally impacts rural, lower-income children in the United States. Primary care providers are well-positioned to engage parents in early obesity prevention, yet there is a lack of evidence regarding the most effective care delivery models. The ENCIRCLE study, a pragmatic cluster-randomized controlled trial, will respond to this gap by testing the comparative effectiveness of standard care well-child visits (WCV) versus two enhancements: adding a patient-reported outcome (PRO) measure (PRO WCV) and PRO WCV plus Food Care (telehealth coaching and a grocery store tour). METHODS: A total of 2,025 parents and their preschool-aged children (20-60 months of age) will be recruited from 24 Geisinger primary care clinics, where providers are randomized to the standard WCV, PRO WCV, or PRO WCV plus Food Care intervention arms. The PRO WCV includes the standard WCV plus collection of the PRO-the Family Nutrition and Physical Activity (FNPA) risk assessment-from parents. Parents complete the PRO in the patient-portal or in the clinic (own device, tablet, or kiosk), receive real-time feedback, and select priority topics to discuss with the provider. These results are integrated into the child's electronic health record to inform personalized preventive counseling by providers. PRO WCV plus Food Care includes referrals to community health professionals who deliver evidence-based obesity prevention and food resource management interventions via telehealth following the WCV. The primary study outcome is change in child body mass index z-score (BMIz), based on the World Health Organization growth standards, 12 months post-baseline WCV. Additional outcomes include percent of children with overweight and obesity, raw BMI, BMI50, BMIz extended, parent involvement in counseling, health behaviors, food resource management, and implementation process measures. DISCUSSION: Study findings will inform health care systems' choices about effective care delivery models to prevent childhood obesity among a high-risk population. Additionally, dissemination will be informed by an evaluation of mediating, moderating, and implementation factors. TRIAL REGISTRATION: ClinicalTrials.gov identifier (NCT04406441); Registered May 28, 2020.

Effects of Dietary App-Supported Tele-Counseling on Sodium Intake, Diet Quality, and Blood Pressure in Patients With Diabetes and Kidney Disease.

OBJECTIVES: The aim of this study is to examine the effect of a telehealth intervention that used a dietary app, educational website, and weekly dietitian tele-counseling on sodium intake, diet quality, blood pressure, and albuminuria among individuals with diabetes and early-stage chronic kidney disease. DESIGN AND METHODS: We examined the effects of a dietary app-supported tele-counseling intervention in a single center, single arm study of 44 participants with type 2 diabetes and stage 1-3a chronic kidney disease. Participants recorded and shared dietary data via MyFitnessPal with registered dietitians, who used motivational interviewing to provide telephone counseling weekly for 8 weeks. After the 8-week intensive intervention, participants were followed at 6 and 12 months. Outcomes included 24-hour urine sodium (2 collections per timepoint), Healthy Eating Index 2015 score (three 24-hour dietary recalls per timepoint), 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP), and 24-hour urine albumin excretion. RESULTS: Out of 44 consented participants (mean age 60.3 ± 11.9 years, 43% female, 89% white, median estimated glomerular filtration rate was 78.5 mL/min/1.73 m2, median urine albumin excretion 52.9 mg/day, 84% hypertension), 32 (73%) completed 8-week follow-up, 27 (61%) completed 6-month follow-up, and 25 (57%) completed 12-month follow-up. Among participants who completed 12-month follow-up, reported sodium intake decreased by 638 mg/day from baseline of 2,919 mg/day (P < .001). The 24-hour mean urine sodium and albumin excretion did not decline over the study period. Healthy Eating Index 2015 score improved by 7.76 points at 12 months from a mean baseline of 54.6 (P < .001). Both 24-hour SBP and DBP declined at 12 months from baseline (SBP -5.7 mm Hg, 95% confidence interval -10.5 to -1.0, P = .02; DBP -4.1 mm Hg, 95% confidence interval -7.2 to -1.1, P = .01). CONCLUSIONS: Overall, this study demonstrates that a short, intensive, remotely delivered dietary intervention for adults with type 2 diabetes and early chronic kidney disease at high risk for disease progression and cardiovascular complications led to improvement in blood pressure and self-reported sodium intake and diet quality, but no improvement in albuminuria. Future research studies are needed to examine whether remotely delivered dietary interventions can ultimately improve kidney health over time.

Changes in Depressive Symptoms, Perceived Stress, and Food Security Among Study Participants With Metabolic Syndrome During a COVID-19-Mandated Research Pause.

INTRODUCTION: We explored how depressive symptoms, perceived stress, and food security of people with metabolic syndrome (MetS) changed during the COVID-19 pandemic. METHODS: An online survey was administered from October 2019 through March 2020, to participants in a 2-year lifestyle intervention trial to reverse MetS; the survey was repeated during the COVID-19 pandemic. Outcomes were a change in depressive symptoms, perceived stress, and food security as measured by the Patient Health Questionnaire-8 (PHQ-8), Perceived Stress Scale, and US Department of Agriculture's 10-item Adult Food Security Module. We analyzed changes in outcomes with measures of association, paired t tests, repeated measures, and independent t tests. RESULTS: Survey respondents (N = 132) were mostly female (67%), White (70%), and middle-aged, with a median income of $86,000. Frequency of depressive symptoms increased from baseline to follow-up and the increase was related to lower mean (SD) baseline vitality (44.4 [20.7] vs 60.3 [18.9]; P = .01) and mental health decline (71.0 [14.3] vs 82.0 [10.4]; P = .002). Mean (SD) perceived stress was significantly higher at baseline than follow-up (18.5 [6.4] vs 14.9 [7.2]; P < .001). Food security increased from 83% at baseline to 90% at follow-up (P < .001). Movement to or continued food insecurity (n = 13) tended to be associated with a racial or ethnic minority group (P = .05). CONCLUSION: A sample at high risk for COVID-19 did not experience increased stress or food insecurity, but demonstrated increased depressive symptoms after the onset of the COVID-19 pandemic, with some baseline susceptibility.

The Pennsylvania Rural Health Model: Hospitals' Early Experiences With Global Payment for Rural Communities.

GOAL: In January 2019, the first cohort of rural hospitals began to operate under the Pennsylvania Rural Health Model for all-payer prospective global budget reimbursement as part of a demonstration funded by the Center for Medicare and Medicaid Innovation. Using information from primary source documents and interviews with key stakeholders, we sought to identify challenges and lessons learned throughout the design, development, and early implementation stages of the model. METHODS: We relied on two qualitative research approaches: (1) review of primary source documents such as peer-reviewed publications and news accounts related to the model and (2) semistructured interviews with key staff and stakeholders, including current and former members of the Pennsylvania Department of Health, first-year applicant hospitals, technical assistance providers, and members of state and federal organizations and agencies familiar with the Pennsylvania and Maryland payment reform efforts for rural health and rural hospitals (N = 20). PRINCIPAL FINDINGS: We identified four primary attributes that innovative projects such as the model need: (1) a champion at the state and hospital level, significant cooperation across state agencies and between federal and state agencies, and support from nongovernment stakeholders; (2) ongoing engagement and education of all stakeholders, particularly related to rural health disparities, the challenges faced by rural hospitals (especially resource limitations), and the differences between rural and urban health and health service delivery; (3) realistic time lines, noting that stakeholder relationships with hospital leadership develop over many months; and (4) multistakeholder collaboration, because participating hospitals must have ongoing engagement with community members (i.e., consumers of healthcare), nonacute community partners, and other rural hospitals to foster a "rural health movement." APPLICATIONS TO PRACTICE: A successful Pennsylvania model holds promise for other states seeking to address the needs of rural populations and the hospitals that are vital to those communities. The lessons in this article can assist others in making the transition from volume to value in rural healthcare.

Development, Applications, and Refinement of the Family Nutrition and Physical Activity (FNPA) Child Obesity Prevention Screening.

Concerns regarding the continued high prevalence of childhood overweight and obesity have created a need for proactive approaches to behavior change. The Family Nutrition and Physical Activity (FNPA) screening tool was developed for research and clinical use to identify home environments and behaviors that could predispose youth to increased weight. FNPA scores have been shown to correlate with body mass index (BMI) percentiles in first-grade students and to predict unique variance in change in BMI percentiles from first to second grade. The FNPA has been used for family behavior counseling and is now a standard component of well-child visits throughout the Geisinger Health System in Pennsylvania. Parents complete the FNPA prior to annual visits, and providers can discuss areas of concern based on screening results. Children of parents who complete the FNPA have shown smaller increases in BMI z-scores over the following year than children of parents who did not complete the FNPA. The FNPA is also used to inform the arrangement of family-centered obesity treatment for children. Recently, the FNPA has undergone a systematic update to ensure its continued relevance and utility. The updated tool is provided, and current and future users can access more information about the tool at myfnpa.org.

A School Nurse Application of the ECHO Model.

Type I diabetes (T1D) is one of the most common childhood diseases and Type 2 diabetes (T2D) is increasing at alarming rates. Given that children spend a great percentage of their time in school, this setting is a critical environment for models of care that lead to better management of this and other health conditions. The School Nurses Managing Diabetes Care ECHO was offered to Colorado school nurses to build their capacity in providing evidence-based management of T1D. The purpose of this effort was to (1) determine whether or not the model could be used as a tool of collaboration and dissemination for school nurses across Colorado and (2) assess the effectiveness of the "School Nurses Managing Diabetes Care" ECHO learning series. Post-series survey results demonstrated a 25% increase in self-efficacy ratings, moving learners from "average among my peers" toward "competent." Additionally, all respondents planned to make one or more practice changes to improve care for students with T1D. Expanding the use of the ECHO model to implement intensive management of children and youth with T1D is critically important as rates of this and other chronic conditions continue to increase.

Remote Dietary Counseling Using Smartphone Applications in Patients With Stages 1-3a Chronic Kidney Disease: A Mixed Methods Feasibility Study.

OBJECTIVE(S): Although healthy dietary patterns are associated with decreased mortality in patients with chronic kidney disease (CKD), few patients receive dietitian counseling due to concerns such as dietitian availability, travel distance, and cost. Our objective was to determine the feasibility of dietary smartphone application-supported telecounseling to reduce sodium intake and improve dietary quality in patients with early CKD. METHODS: This was a pre-post, mixed methods feasibility study of 16 patients with Stage 1-3a CKD in central/northeast Pennsylvania. Patients recorded and shared dietary data via smartphone applications with registered dietitians, who used motivational interviewing to provide telephone counseling weekly for 8 weeks. Seven patients were assigned to a customized study-specific application and nine patients to a commercially available, free application (MyFitnessPal). Participant satisfaction was assessed via survey, and participants were invited to complete a semistructured interview. Outcomes assessed included sodium intake, Healthy Eating Index 2015 score, weight, and 24-hour blood pressure (BP). RESULTS: Mean age was 64.7 years, 31% were female, 100% were white, 13% had income <$25,000. Adherence was excellent with 14 (88%) entering dietary data at least 75% of total days. Patients reported high satisfaction with the intervention and dietitian telecounseling. Use of dietary apps was viewed positively for allowing tracking of sodium and energy intake although some participants experienced functionality issues with the customized application that were not generally experienced by those using the commercially available free application. Sodium intake (-604 mg/day, 95% confidence interval [CI]: -1,104 to -104), Healthy Eating Index 2015 score (3.97, 95% CI: 0.03-7.91), weight (-3.4, 95% CI: -6.6 to -0.1), daytime systolic BP (-5.8, 95% CI: -12.1 to 0.6), and daytime diastolic BP (-4.1, 95% CI: -7.9 to -0.2) improved after the intervention. CONCLUSIONS: An application-supported telecounseling program with a registered dietitian appears to be a feasible and well-accepted strategy to improve dietary quality and improve cardiovascular risk factors in patients with early kidney disease.

A Quality Improvement Project to Improve the Use of Mother's Own Milk (MOM) With Precision Oropharyngeal Therapy.

BACKGROUND: Bioprotective properties of mother's own milk (MOM) support the use of targeted MOM administration methods, including oropharyngeal therapy (OPT) with MOM, which may mimic the protective effects of swallowed amniotic fluid, thereby improving infant health outcomes. PURPOSE: To increase the use of MOM-OPT in premature infants in the first week of life. METHODS: Quality improvement methods were used to implement precision dosing of OPT. RESULTS: After changing processes and replacing the colostrum immune therapy practice with longer-term precision OPT, the percentage of ordered doses administered to infants in the first week of life increased from 24% to 64%. There was also a 15% increase in very low birth-weight infants who received MOM (from 50% to 65%) at discharge. There were no reported adverse events related to OPT administration. IMPLICATIONS FOR PRACTICE: Replacing the unit's short-term colostrum immune therapy protocol with the longer-term precision OPT increased the number of doses given in the first week of life and increased the number of very low birth-weight infants discharged receiving MOM. IMPLICATIONS FOR RESEARCH: Researchers should consider studying the reported positive effects of OPT related to infant response (positive oral stimulation, reduction in oral aversion, and improved oral feeding skills), parent participation in care, and maternal milk expression behaviors (longer milk expression duration).

A patient-centered, coordinated care approach delivered by community and pediatric primary care providers to promote responsive parenting: pragmatic randomized clinical trial rationale and protocol.

BACKGROUND: Economically disadvantaged families receive care in both clinical and community settings, but this care is rarely coordinated and can result in conflicting educational messaging. WEE Baby Care is a pragmatic randomized clinical trial evaluating a patient-centered responsive parenting (RP) intervention that uses health information technology (HIT) strategies to coordinate care between pediatric primary care providers (PCPs) and the Special Supplemental Nutrition Program for Women, Infant and Children (WIC) community nutritionists to prevent rapid weight gain from birth to 6 months. It is hypothesized that data integration and coordination will improve consistency in RP messaging and parent self-efficacy, promoting shared decision making and infant self-regulation, to reduce infant rapid weight gain from birth to 6 months. METHODS/DESIGN: Two hundred and ninety mothers and their full-term newborns will be recruited and randomized to the "RP intervention" or "standard care control" groups. The RP intervention includes: 1) parenting and nutrition education developed using the American Academy of Pediatrics Healthy Active Living for Families curriculum in conjunction with portions of a previously tested RP curriculum delivered by trained pediatric PCPs and WIC nutritionists during regularly scheduled appointments; 2) parent-reported data using the Early Healthy Lifestyles (EHL) risk assessment tool; and 3) data integration into child's electronic health records with display and documentation features to inform counseling and coordinate care between pediatric PCPs and WIC nutritionists. The primary study outcome is rapid infant weight gain from birth to 6 months derived from sex-specific World Health Organization adjusted weight-for-age z-scores. Additional outcomes include care coordination, messaging consistency, parenting behaviors (e.g., food to soothe), self-efficacy, and infant sleep health. Infant temperament and parent depression will be explored as moderators of RP effects on infant outcomes. DISCUSSION: This pragmatic patient-centered RP intervention integrates and coordinates care across clinical and community sectors, potentially offering a fundamental change in the delivery of pediatric care for prevention and health promotion. Findings from this trial can inform large scale dissemination of obesity prevention programs. TRIAL REGISTRATION: Restrospective Clinical Trial Registration: NCT03482908 . Registered March 29, 2018.

Initiation of Disease-Modifying Therapies in Rheumatoid Arthritis Is Associated With Changes in Blood Pressure.

PURPOSE: This study reports the effect of disease-modifying therapies for rheumatoid arthritis (RA) on systolic and diastolic blood pressure (SBP, DBP) over 6 months and incident hypertension over 3 years in a large administrative database. METHODS: We used administrative Veterans Affairs databases to define unique dispensing episodes of methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, tumor necrosis factor inhibitors, and prednisone among patients with RA. Changes in SBP and DBP in the 6 months before disease-modifying antirheumatic drug initiation were compared with changes observed in the 6 months after initiation. The risk of incident hypertension within 3 years (new diagnosis code for hypertension and prescription for antihypertensive) was also assessed. Multivariable models and propensity analyses assessed the impact of confounding by indication. RESULTS: A total of 37,900 treatment courses in 21,216 unique patients contributed data. Overall, there were no changes in SBP or DBP in 6 months prior to disease-modifying antirheumatic drug initiation (all P > 0.62). In contrast, there was a decline in SBP (ß = -1.08 [-1.32 to -0.85]; P < 0.0001) and DBP (ß = -0.48 [-0.62 to -0.33]; P < 0.0001) over the 6 months following initiation. The greatest decline was observed among methotrexate and hydroxychloroquine users. Methotrexate users were 9% more likely to have optimal blood pressure (BP) after 6 months of treatment. Patients treated with leflunomide had increases in BP and a greater risk of incident hypertension compared with patients treated with methotrexate (hazard ratio, 1.53 [1.21-1.91]; P < 0.001). CONCLUSIONS: Blood pressure may improve with treatment of RA, particularly with methotrexate or hydroxychloroquine. Leflunomide use, in contrast, is associated with increases in BP and a greater risk of incident hypertension.

Loss Aversion of Time: Serving School Lunches Faster without Impacting Meal Experience.

Loss aversion has been extensively studied in economics, but there is less discussion of it in the context of time. Results from a field experiment conducted in a U.S. public school lunch cafeteria suggest that students could be loss averse to time and that interventions, such as a pre-plated service lane could increase the speed of service and guide students to make better food choices. Faster, pre-plated service lanes may leverage loss aversion bias, be beneficial for larger schools, reduce wait time for students, and thereby increase their satisfaction with the service process.

International Interlaboratory Digital PCR Study Demonstrating High Reproducibility for the Measurement of a Rare Sequence Variant.

This study tested the claim that digital PCR (dPCR) can offer highly reproducible quantitative measurements in disparate laboratories. Twenty-one laboratories measured four blinded samples containing different quantities of a KRAS fragment encoding G12D, an important genetic marker for guiding therapy of certain cancers. This marker is challenging to quantify reproducibly using quantitative PCR (qPCR) or next generation sequencing (NGS) due to the presence of competing wild type sequences and the need for calibration. Using dPCR, 18 laboratories were able to quantify the G12D marker within 12% of each other in all samples. Three laboratories appeared to measure consistently outlying results; however, proper application of a follow-up analysis recommendation rectified their data. Our findings show that dPCR has demonstrable reproducibility across a large number of laboratories without calibration. This could enable the reproducible application of molecular stratification to guide therapy and, potentially, for molecular diagnostics.

A Mechanistic Model for Cooperative Behavior of Co-transcribing RNA Polymerases.

In fast-transcribing prokaryotic genes, such as an rrn gene in Escherichia coli, many RNA polymerases (RNAPs) transcribe the DNA simultaneously. Active elongation of RNAPs is often interrupted by pauses, which has been observed to cause RNAP traffic jams; yet some studies indicate that elongation seems to be faster in the presence of multiple RNAPs than elongation by a single RNAP. We propose that an interaction between RNAPs via the torque produced by RNAP motion on helically twisted DNA can explain this apparent paradox. We have incorporated the torque mechanism into a stochastic model and simulated transcription both with and without torque. Simulation results illustrate that the torque causes shorter pause durations and fewer collisions between polymerases. Our results suggest that the torsional interaction of RNAPs is an important mechanism in maintaining fast transcription times, and that transcription should be viewed as a cooperative group effort by multiple polymerases.

Predictors of Retention among African Americans in a Randomized Controlled Trial to Test the Healthy Eating and Active Living in the Spirit (HEALS) Intervention.

INTRODUCTION: Retention of racial/ethnic minority groups into research trials is necessary to fully understand and address health disparities. This study was conducted to identify participants' characteristics associated with retention of African Americans (AAs) in a randomized controlled trial (RCT) of a behavioral intervention. METHODS: Using data from an RCT conducted from 2009 to 2012 among AAs, participant-level factors were examined for associations with retention between three measurement points (ie, baseline, 3-month, and 12-month). Chi-square tests and logistic regression analyses were conducted to compare retained participants to those who were not retained in order to identify important predictors of retention. RESULTS: About 57% of participants (n=238) were retained at 12 months. Baseline characteristics that showed a statistically significant association with retention status were age, marital status, body mass index (BMI), intervention group, enrollment of a partner in the study, and perceived stress score (PSS). Multivariable logistic regression that adjusted for age, BMI, and PSS showed the odds of being retained among participants who enrolled with a partner was 2.95 (95% CI: 1.87-4.65) compared with participants who had no study partner enrolled. The odds of being retained among participants who were obese and morbidly obese were .32 and .27 (95% CI: .14-.74 and .11-.69), respectively, compared with participants who had normal weight. CONCLUSION: Having a partner enrolled in behavioral interventions may improve retention of study participants. Researchers also need to be cognizant of participants' obesity status and potentially target retention efforts toward these individuals.

Relationships between County Health Rankings and child overweight and obesity prevalence: a serial cross-sectional analysis.

BACKGROUND: The County Health Rankings (CHR) system provides health rankings for U.S. counties. These factors may have utility for evaluating and predicting health outcomes. This study examined the association between CHR factors and the prevalence of child overweight/obesity (OWOB) in the state of Pennsylvania over 3 years. METHODS: The prevalence of childhood OWOB was obtained for all Pennsylvania school districts for the 2009-10 through 2011-12 school years. Correlational and inferential statistical analyses were used to examine the associations between the prevalence of OWOB in grades K-6 (OWOB1) and 7-12 (OWOB2) and z-score for the overall CHR Health Factors rank, as well as for individual predictive factors (Health Behaviors, Clinical Care, Social and Economic Factors and Physical Environment). RESULTS: Low to moderate correlations (0.29-0.43) were found between OWOB1 and CHR factors. Weaker and less consistent correlations were found for adolescents. There was a significantly higher prevalence of OWOB in counties with poorer CHR scores. CONCLUSIONS: County-level adult indicators of health are significantly associated with levels of child obesity. Future studies should examine the relationship between CHR and other health outcomes.

Clinically Available Medicines Demonstrating Anti-Toxoplasma Activity.

Toxoplasma gondii is an apicomplexan parasite of humans and other mammals, including livestock and companion animals. While chemotherapeutic regimens, including pyrimethamine and sulfadiazine regimens, ameliorate acute or recrudescent disease such as toxoplasmic encephalitis or ocular toxoplasmosis, these drugs are often toxic to the host. Moreover, no approved options are available to treat infected women who are pregnant. Lastly, no drug regimen has shown the ability to eradicate the chronic stage of infection, which is characterized by chemoresistant intracellular cysts that persist for the life of the host. In an effort to promote additional chemotherapeutic options, we now evaluate clinically available drugs that have shown efficacy in disease models but which lack clinical case reports. Ideally, less-toxic treatments for the acute disease can be identified and developed, with an additional goal of cyst clearance from human and animal hosts.