Faculty Bibliography

Background/UNASSIGNED:Study coordinators play an essential role on study teams; however, there remains a paucity of research on the supports and services they need to effectively recruit and retain study participants. Methods/UNASSIGNED:A cross-sectional survey was conducted with 147 study coordinators from a large academic medical center. Survey items assessed barriers and facilitators to recruitment and retention, anxiety about reaching enrollment numbers, confidence for talking to potential study participants about research involvement, awareness and use of CTSA resources, and PI involvement with recruitment planning. Results/UNASSIGNED:Significant associations were found between anxiety about reaching target enrollment numbers and whether the study coordinator was the primary person responsible for developing a recruitment strategy. Three years or more serving as a study coordinator and levels of anxiety for reaching enrollment numbers was also significant. Conclusion/UNASSIGNED:More institutional level supports and formal training opportunities are needed to enhance study coordinators' effectiveness to recruit participants.

Partnership and engagement are mediators of change in the efficient uptake of evidence-based patient-centered health interventions. We reflect on our process of engagement and preparation of peer mentors in the development of peer-led psychotherapy intervention for HIV infected adolescents in active care at the Comprehensive Care Centre (CCC) at Kenyatta National Hospital. The program was implemented in two phases, using a Consultation, Involve, Collaboration and Empowerment approach as stepping stones to guide our partnership and engagement process with stakeholders and ten peer mentors embedded in the CCC. Our partnership process promoted equity, power-and-resource sharing including making the peer mentors in-charge of the process and being led by them in manual development. This process of partnership and engagement demonstrated that engaging key stakeholders in projects lead to successful development, implementation, dissemination and sustainment of evidence-based interventions. Feedback and insights bridged the academic and clinical worlds of our research by helping us understand clinical, family, and real-life experiences of persons living with HIV that are often not visible in a research process. Our findings can be used to understand and design mentorship programs targeting lay health workers and peer mentors at community health care levels.

This paper describes a mental health capacity-building partnership between the University of Nairobi (UON) and the University of Washington (UW) that was built upon a foundational 30-year HIV/AIDS research training collaboration between the two institutions. With funding from the US National Institute of Mental Health Medical Education Program Initiative (MEPI), UW and UON faculty collaborated to develop and offer a series of workshops in research methods, grant writing, and manuscript publication for UON faculty and post-graduate students committed to mental health research. UON and UW scientists provided ongoing mentorship to UON trainees through Skype and email. Three active thematic research groups emerged that focused on maternal and child mental health, gender-based violence, and HIV-related substance abuse. Challenges to conducting mental health research in Kenya included limited resources to support research activities, heavy teaching responsibilities, clinical duties, and administrative demands on senior faculty, and stigmatization of mental health conditions, treatment, and research within Kenyan society. The partnership yielded a number of accomplishments: a body of published papers and presentations at national and international meetings on Kenyan mental health topics, the institution of systematic mental health data collection in rural clinics, funded research proposals, and a mental health research resource centre. We highlight lessons learned for future mental health research capacity-building initiatives.

BACKGROUND:Randomized trials of CKD treatments traditionally use clinical events late in CKD progression as end points. This requires costly studies with large sample sizes and long follow-up. Surrogate end points like GFR slope may speed up the evaluation of new therapies by enabling smaller studies with shorter follow-up. METHODS:We used statistical simulations to identify trial situations where GFR slope provides increased statistical power compared with the clinical end point of doubling of serum creatinine or kidney failure. We simulated GFR trajectories based on data from 47 randomized treatment comparisons. We evaluated the sample size required for adequate statistical power based on GFR slopes calculated from baseline and from 3 months follow-up. RESULTS:In most scenarios where the treatment has no acute effect, analyses of GFR slope provided similar or improved statistical power compared with the clinical end point, often allowing investigators to shorten follow-up by at least half while simultaneously reducing sample size. When patients' GFRs are higher, the power advantages of GFR slope increase. However, acute treatment effects within several months of randomization can increase the risk of false conclusions about therapies based on GFR slope. Care is needed in study design and analysis to avoid such false conclusions. CONCLUSIONS:Use of GFR slope can substantially increase statistical power compared with the clinical end point, particularly when baseline GFR is high and there is no acute effect. The optimum GFR-based end point depends on multiple factors including the rate of GFR decline, type of treatment effect and study design.

BACKGROUND:Surrogate end points are needed to assess whether treatments are effective in the early stages of CKD. GFR decline leads to kidney failure, but regulators have not approved using differences in the change in GFR from the beginning to the end of a randomized, controlled trial as an end point in CKD because it is not clear whether small changes in the GFR slope will translate to clinical benefits. METHODS:, or ESKD) for each study. We used Bayesian mixed-effects analyses to describe the association of treatment effects on GFR slope with the clinical end point and to test how well the GFR slope predicts a treatment's effect on the clinical end point. RESULTS: CONCLUSIONS:With large enough sample sizes, GFR slope may be a viable surrogate for clinical end points in CKD RCTs.

BACKGROUND:Patients with active cancer account for a growing percentage of all emergency department (ED) visits and have a unique set of risks related to their disease and its treatments. Effective triage for this population is fundamental to facilitating their emergency care. OBJECTIVES/OBJECTIVE:We evaluated the validity of the Emergency Severity Index (ESI; version 4) triage tool to predict ED-relevant outcomes among adult patients with active cancer. METHODS:tests for independence to relate ESI scores with 1) disposition, 2) ED resource use, 3) hospital length of stay, and 4) 30-day mortality. RESULTS:Among the 1008 subjects included in this analysis, the ESI distribution skewed heavily toward high acuity (>95% of subjects had an ESI level of 1, 2, or 3). ESI was significantly associated with patient disposition and ED resource use (p values < 0.05). No significant associations were observed between ESI and the non-ED based outcomes of hospital length of stay or 30-day mortality. CONCLUSION/CONCLUSIONS:ESI scores among ED patients with active cancer indicate higher acuity than the general ED population and are predictive of disposition and ED resource use. These findings show that the ESI is a valid triage tool for use in this population for outcomes directly relevant to ED care.

Prenatal exposure to phenolic compounds, widely used in many consumer products, can alter lung development and increase the risk of respiratory disorders in the offspring. However, evidence is scarce and mostly focused on bisphenol-A (BPA), although there are other substitutes that could also interfere with the developing respiratory system. We aim to estimate the association between exposure to 5 phenols during pregnancy (BPA, BPAF, BPB, BPF, and BPS) and lung function, wheeze, and asthma in school-age children. We included 2685 mother-child pairs from 8 European birth cohorts. Phenols concentrations were determined in urinary maternal samples collected during pregnancy (1999-2010). Between 6 and 10 years of age, spirometry was performed, and wheeze and asthma were assessed from questionnaires. Adjusted multivariable linear regression and logistic regression models were used to assess the associations. We performed meta-analyses of cohort-specific estimates. We observed widespread prenatal BPA exposure with 79% of the samples above detectable limits; the other phenols were detected in fewer samples. Median BPA concentrations ranged from 1.04 to 9.54 ng/g of creatinine. Increasing BPA concentrations during pregnancy tended to be associated with lower FVC and FEV1 and were associated with increased odds of wheezing between ages 6 and 10 years (adjusted odds ratio=1.09; 95% CI=0.96, 1.24), but notwith asthma. Final results including associations of the other phenols with respiratory outcomes including wheezing patterns from birth will be presented. Preliminary results showed that prenatal exposure to BPA might increase the odds of wheezing in school-age children

PURPOSE/OBJECTIVE:Most surveillance efforts in childhood diabetes have focused on incidence, whereas prevalence is rarely reported. This study aimed to assess whether a mathematical illness-death model accurately estimated future prevalence from baseline prevalence and incidence rates in children. METHODS:SEARCH for Diabetes in Youth is an ongoing population-based surveillance study of prevalence and incidence of diabetes and its complications among youth in the United States. We used age-, sex-, and race/ethnicity-specific SEARCH estimates of the prevalence of type I and type II diabetes in 2001 and incidence from 2002 to 2008. These data were used in a partial differential equation to estimate prevalence in 2009 with 95% bootstrap confidence intervals. Model-based prevalence was compared with the observed prevalence in 2009. RESULTS:Most confidence intervals for the difference between estimated and observed prevalence included zero, indicating no evidence for a difference between the two methods. The width of confidence intervals indicated high precision for the estimated prevalence when considering all races/ethnicities. In strata with few cases, precision was reduced. CONCLUSIONS:Future prevalence of type I and type II diabetes in youth may be accurately estimated from baseline prevalence and incidence. Diabetes surveillance could benefit from potential cost savings of this method.