USDA INITIATIVES

Agricultural and Food Policy,

Biological projectiles (phage, yeast, bacteria) for genetic transformation of plants

Summary: Bacteriophage lambda particles, yeast cells, and bacterial cells were tested as projectiles to deliver marker/reporter genes into plant cells via the biolistic process. When phage particles were complexed to tungsten or gold particles and used to bombard tobacco cells, fewer than 15 cell clusters per plate transiently expressed β-glucuronidase (GUS). Cells of wildtype Saccharomyces cerevisiae were too large to be effective projectiles, but use of a reduced-size mutant resulted in a small number of transformants. Escherichia coli cells complexed with tungsten were the most effective projectile for plant transformation. Various methods to prepare E. coli were tested to reduce particle size, improve binding of bacteria to metal particles, and/or minimize particle clumping. In maize, the number of transformants was highest when bacteria/tungsten particles were air-dried onto macrocarriers from an aqueous solution. When maize cells were bombarded with bacteria/tungsten projectiles, rates of transient gene expression (2000 per plate) and stable transformation (50 per plate) were only two- to threefold lower than when purified DNA was used. Transformation of tobacco with E. coli projectiles was improved when the bacteria were treated with a series of ethanol and ether washes, then dried into a powder. Nevertheless, tobacco transformation was still 24- (transient) and 200-fold (stable) less than when purified DNA was used. Biological projectiles can be effective for plant transformation and are advantageous because once a DNA construct is made and put into the appropriate microorganism, the need to isolate and purify DNA for the biolistic process is eliminated, which saves time and lessens DNA shear. Such projectiles may be especially well suited where high molecular weight DNA constructs are neede

Cost effectiveness analysis of Year 2 of an elementary school-located influenza vaccination program-Results from a randomized controlled trial.

BackgroundSchool-located vaccination against influenza (SLV-I) has the potential to improve current suboptimal influenza immunization coverage for U.S. school-aged children. However, little is known about SLV-I's cost-effectiveness. The objective of this study is to establish the cost-effectiveness of SLV-I based on a two-year community-based randomized controlled trial (Year 1: 2009-2010 vaccination season, an unusual H1N1 pandemic influenza season, and Year 2: 2010-2011, a more typical influenza season).MethodsWe performed a cost-effectiveness analysis on a two-year randomized controlled trial of a Western New York SLV-I program. SLV-I clinics were offered in 21 intervention elementary schools (Year 1 n = 9,027; Year 2 n = 9,145 children) with standard-of-care (no SLV-I) in control schools (Year 1 n = 4,534 (10 schools); Year 2 n = 4,796 children (11 schools)). We estimated the cost-per-vaccinated child, by dividing the incremental cost of the intervention by the incremental effectiveness (i.e., the number of additionally vaccinated students in intervention schools compared to control schools).ResultsIn Years 1 and 2, respectively, the effectiveness measure (proportion of children vaccinated) was 11.2 and 12.0 percentage points higher in intervention (40.7 % and 40.4 %) than control schools. In year 2, the cost-per-vaccinated child excluding vaccine purchase ($59.88 in 2010 US$) consisted of three component costs: (A) the school costs ($8.25); (B) the project coordination costs ($32.33); and (C) the vendor costs excluding vaccine purchase ($16.68), summed through Monte Carlo simulation. Compared to Year 1, the two component costs (A) and (C) decreased, while the component cost (B) increased in Year 2. The cost-per-vaccinated child, excluding vaccine purchase, was$59.73 (Year 1) and $59.88 (Year 2, statistically indistinguishable from Year 1), higher than the published cost of providing influenza vaccination in medical practices ($39.54). However, taking indirect costs (e.g., averted parental costs to visit medical practices) into account, vaccination was less costly in SLV-I ($23.96 in Year 1,$24.07 in Year 2) than in medical practices.ConclusionsOur two-year trial's findings reinforced the evidence to support SLV-I as a potentially favorable system to increase childhood influenza vaccination rates in a cost-efficient way. Increased efficiencies in SLV-I are needed for a sustainable and scalable SLV-I program

Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children.

BackgroundStudies have noted variations in the cost-effectiveness of school-located influenza vaccination (SLIV), but little is known about how SLIV's cost-effectiveness may vary by targeted age group (e.g., elementary or secondary school students), or vaccine consent process (paper-based or web-based). Further, SLIV's cost-effectiveness may be impacted by its spillover effect on practice-based vaccination; prior studies have not addressed this issue.MethodsWe performed a cost-effectiveness analysis on two SLIV programs in upstate New York in 2015-2016: (a) elementary school SLIV using a stepped wedge design with schools as clusters (24 suburban and 18 urban schools) and (b) secondary school SLIV using a cluster randomized trial (16 suburban and 4 urban schools). The cost-per-additionally-vaccinated child (i.e., incremental cost-effectiveness ratio (ICER)) was estimated by dividing the incremental SLIV intervention cost by the incremental effectiveness (i.e., the additional number of vaccinated students in intervention schools compared to control schools). We performed deterministic analyses, one-way sensitivity analyses, and probabilistic analyses.ResultsThe overall effectiveness measure (proportion of children vaccinated) was 5.7 and 5.5 percentage points higher, respectively, in intervention elementary (52.8%) and secondary schools (48.2%) than grade-matched control schools. SLIV programs vaccinated a small proportion of children in intervention elementary (5.2%) and secondary schools (2.5%). In elementary and secondary schools, the ICER excluding vaccine purchase was $85.71 and$86.51 per-additionally-vaccinated-child, respectively. When additionally accounting for observed spillover impact on practice-based vaccination, the ICER decreased to $80.53 in elementary schools -- decreasing substantially in secondary schools. (to$53.40). These estimates were higher than the published practice-based vaccination cost (median = $25.50, mean =$45.48). Also, these estimates were higher than our 2009-2011 urban SLIV program mean costs ($65) due to additional costs for use of a new web-based consent system ($12.97 per-additionally-vaccinated-child) and higher project coordination costs in 2015-2016. One-way sensitivity analyses showed that ICER estimates were most sensitive to the SLIV effectiveness.ConclusionsSLIV raises vaccination rates and may increase practice-based vaccination in primary care practices. While these SLIV programs are effective, to be as cost-effective as practice-based vaccination our SLIV programs would need to vaccinate more students and/or lower the costs for consent systems and project coordination.Trial registrationClinicalTrials.gov NCT02227186 (August 25, 2014), updated NCT03137667 (May 2, 2017)

Study Protocol: A Randomized Controlled Trial of Patient Navigation-Activation to Reduce Cancer Health Disparities

Abstract Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP) is a National Cancer Institute-sponsored, patient-level randomized trial (RCT) of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews) or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT00496678http://deepblue.lib.umich.edu/bitstream/2027.42/78254/1/1471-2407-10-551.xmlhttp://deepblue.lib.umich.edu/bitstream/2027.42/78254/2/1471-2407-10-551.pdfPeer Reviewe

Offender Reentry: A Mixed Model Study of Interorganizational Commitment to Partnership

This study explores the associations between the independent variables of organizational motivations and culture with the dependent variable of organizational commitment to local jail reentry partnerships. A cross-sectional, mixed methods design was used based primarily on a quantitative survey mailed to organizational informants involved in jail reentry activities within three central Florida counties. Qualitative data was also collected by observing conveniently sampled reentry meetings and analyzing the content of social artifacts, such as meeting handouts, minutes, e-mails, and other related documents. This study extends the literature by using the theoretical framework of Oliver (1990) to develop measures of organizations\u27 motivations (i.e., reciprocity, stability, efficiency, asymmetry, and legitimacy) to partner with jails in reentry. It also extends the literature of Fletcher, Lehman, Wexler, Melnick, Taxman, and Young (2009) by furthering the development of valid measures of interorganizational relationships. Fletcher and associates found two levels of relationships (i.e., structured and unstructured); whereas this study found that organizations are linked according to elements (i.e., linking clients, services, providers, data, program evaluation and grant funding, and management) within increasing levels of complexity. Bivariate and multivariate analyses indicated positive associations between the predictor and outcome variables, as hypothesized. However, the sample size was not large enough to determine the strength or significance between the variables. The directed content analysis of the qualitative data supported the presence of the theoretical constructs, but also indicated that they were not mutually exclusive or exhaustive. Two of the three counties ended formal reentry meetings, so a case study approach was used to analyze the three counties using the theory of loose coupling (Orton & Weick, 1990; Weick, 1976). Although all three counties experienced the same external pressures to begin formal meetings, there were differences in partnership structures, leadership goals, and events which serve to explain why only one county was able to sustain those formal meetings. Results of this study have both research and practical implications. The development of valid measures for moderating variables in reentry will allow researchers to relate those variables to reentry program outcomes. By exploring the associations between organizational motivations and cultures with varying levels of commitment to interorganizational relationships, correctional officials will better understand who will partner, why, and to what degree. As a result, we may better understand the extent to which reforms targeting offender reentry can be successfully planned, implemented, and sustained. There are limitations to this study. Methodological errors associated with surveys, the primary data collection method herein, include the following: measurement, coverage, sampling, and nonresponse (Dillman, Smyth, & Christian, 2009). Despite having a relatively large sample size for analysis at the organizational level, the correlation design and small sample size (N = 68) limit the ability to draw causal inferences

Healthcare Provider Communication in Teens with Type 1 Diabetes: Parental Overprotection and Interpersonal Effectiveness Skills

Type 1 diabetes (T1D) is a complex chronic illness requiring both complex daily treatments and ongoing healthcare provider interactions to support optimal glycemic levels necessary for long-term health and quality of life. Adolescents do not manage their T1D by themselves but rather in collaboration with parents who often help in health tasks and navigating healthcare provider interactions. Although parental support is critical for the adolescent’s development of disease-management skills, it requires parents maintain a delicate balance of allowing adolescent autonomy and providing parent support. When parental support shifts to parental overprotection, i.e., restricting and limiting an adolescent’s activity engagement, it may impair adolescent’s skill development and mastery necessary to complete diabetes-management tasks independently, including healthcare provider communication. In particular, parental overprotection may impact the adolescent’s interpersonal effectiveness skills, in that adolescents may not learn how to be mindful and attentive to relationships or build a repertoire of mindfulness and self-compassion that would support effective healthcare provider communication and more independent diabetes management. Thus, adolescent experiences of interpersonal effectiveness skills, parental overprotection, and healthcare provider communication may have long-term implications for diabetes outcomes as the adolescent transitions to adulthood. Adolescents with type 1 diabetes might then benefit from an intervention targeted at interpersonal effectiveness skills to both reduce parental overprotection and improve healthcare provider communication. Adolescent participants (n=25, mean age=16.25, 56% female) completed a baseline survey for a pilot intervention study aimed at increasing mindfulness and decreasing diabetes-related stress. Adolescents reported on mindfulness, self-compassion, parental overprotection, and health care provider communication. The present study found that increased adolescent perception of parental overprotection was associated with decreased interpersonal effectiveness skills (mindfulness and self-compassion) and all were associated with increased difficulty with communicating with healthcare providers about diabetes. In addition, the potential utility of a mindfulness intervention for improving interpersonal effectiveness skills, decreasing parental overprotection, and improving adolescent healthcare provider communication was examined. The results also indicate potentially meaningful change scores for the four variables of interests between treatment and waitlist groups with very small to large effect sizes that may accrue into meaningful changes across time. Further, among adolescents who were highly engaged in the intervention program (n=11), mindfulness, self-compassion, parental overprotection, and healthcare provider communication again showed potentially meaningful change scores with small to medium effect sizes that may have long-term impact across time. These findings indicate that a mindfulness-based intervention has potential utility, especially for participants who were highly engaged in the program. Parental overprotection and interpersonal effectiveness skills may be key factors to target in interventions to support the transition of diabetes-management behaviors from parent to adolescent as the adolescent ages into young adulthood, particularly with regard to adolescents learning to communicate with their healthcare providers