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1.  A Capacity Building Program to Promote CBPR Partnerships Between Academic Researchers and Community Members 
Community-based participatory research (CBPR) adds community perspectives to research and aids translational research aims. There is a need for increased capacity in CBPR but few models exist for how to support the development of community/university partnerships
Evaluate an approach to promote nascent CBPR partnerships.
Design was a mixed-methods evaluation utilizing interviews, process notes, and open and closed ended survey questions. We trained ten community scholars, matched them with prepared researchers to form seven partnerships, and supported their developing partnerships. Sequential mixed-methods analysis assessed research and partnership processes and identified integrated themes.
Four of seven partnerships were funded within 15 months; all self-reported their partnerships as successful. Themes were: 1) Motivators contributed to partnership development and resiliency; 2) Partners took on responsibilities that utilized individuals' strengths; 3) Partners grappled with communication, decision-making, and power-dynamics; and 4) Community-university infrastructure was essential to partnership development.
This program for developing nascent partnerships between academicians and community members may guide others in increasing capacity for CBPR.
PMCID: PMC4313536  PMID: 22212224
community-based participatory research; translational research
2.  Facilitating Research Faculty Participation in CBPR: Development of a Model Based on Key Informant Interviews 
Community based participatory research (CBPR) may enhance the translational research process; however this would require increased institutional capacity for community engaged research. In this paper we first describe results of key informant interviews with academic health center faculty regarding facilitators to faculty participation in CBPR partnerships and then propose a model arising from these results for how increased capacity may be achieved.
Participants were 13 key informant faculty of varying levels of expertise in CBPR at a large university academic health center. Interviews were recorded and transcribed. A thematic content analysis of each interview was conducted by research team members.
Facilitators reported by faculty representing five health science schools were grouped into five thematic areas: 1) researcher personal attributes including an innate orientation towards working with community, 2) positive attitudes towards collaboration, 3) a partnership-building skill set, 4) community partners who are ready and eager to collaborate, and 5) supportive institutional policies and procedures.
We propose a model describing the relationship between personal attributes, learned/environmental factors and community facilitators that may be utilized to promote increased institutional capacity for CBPR and thus increase the likelihood of the successful translation of research findings into community settings.
PMCID: PMC4313885  PMID: 21500397
3.  [No title available] 
PMCID: PMC3929226  PMID: 24528900
4.  [No title available] 
PMCID: PMC3929228  PMID: 24528899
5.  [No title available] 
PMCID: PMC3929233  PMID: 24528897
6.  [No title available] 
PMCID: PMC3944911  PMID: 24118964
7.  [No title available] 
PMCID: PMC3945059  PMID: 24119049
8.  [No title available] 
PMCID: PMC4042394  PMID: 24528901
9.  [No title available] 
PMCID: PMC4074027  PMID: 24405608
10.  Value of Impedance Cardiography during Six-Minute Walk Test in Pulmonary Hypertension 
Methods that predict prognosis and response to therapy in pulmonary hypertension (PH) are lacking. We tested whether the noninvasive estimation of hemodynamic parameters during 6MWT in PH patients provides information that can improve the value of the test.
We estimated hemodynamic parameters during the 6MWT using a portable, signal-morphology based, impedance cardiograph (PhysioFlow Enduro, Paris, France) with real time wireless monitoring via a bluetooth USB adapter.
We recruited 48 subjects in the study (30 with PH and 18 healthy controls). PH patients had significantly lower maximum SV and CI and slower CO acceleration and decelerations slopes during the test when compared with healthy controls. In PH patients, CI change was associated with total distance walked (R=0.62, p<0.001) and percentage of predicted (R=0.4, p=0.03), HR recovery at 1 min (0.57, p<0.001), 2 min (0.65, p<0.001) and 3 min (0.66, p<0.001). Interestingly, in PH patients CO change during the test was predominantly related to an increase in SV instead of HR.
Estimation of hemodynamic parameters such as cardiac index during six-minute walk test is feasible and may provide useful information in patients with pulmonary hypertension.
PMCID: PMC4286797  PMID: 24330692
Cardiac output; Six-minute walk test; Pulmonary Hypertension
11.  Rituximab for Non-Hodgkin’s Lymphoma: A Story of Rapid Success in Translation 
Translational stories range from straightforward to complex. In this commentary, the story of the rapid and successful translation of rituximab therapy for the treatment of non-Hodgkin’s lymphoma (NHL) is examined. Development of this monoclonal antibody therapy began in the late 1980s. In 1994, rituximab received its first approval for the treatment of NHL by the United States Food and Drug Administration (FDA). Rituximab has since been approved for additional indications and has transformed medical practice. However, the social and political implications of these rapid successes are only beginning to become clear. In this commentary, key events in the rapid translation of rituximab from the bench to bedside are highlighted and placed into this historical framework. To accomplish this, the story of rituximab is divided into the following six topics, which we believe to be widely applicable to case studies of translation: (1) underlying disease, (2) key basic science, (3) key clinical studies in translation, (4) FDA approval process, (5) changes to medical practice, and (6) the social and political influences on translation.
PMCID: PMC4264563  PMID: 24528902
oncology; hematology; hematopathology; lymphoma; leukemia; immunotherapy
12.  The University of Chicago Institute for Translational Medicine 
PMCID: PMC4263030  PMID: 20443930
Clinical and translational science  2013;6(6):10.1111/cts.12116.
In dilated cardiomyopathy (DCM), the clinical and prognostic implications of rare variants in sarcomeric genes remain poorly understood. To address this question, we analyzed the outcome of rare sarcomeric gene variants in patients enrolled in our Familial Cardiomyopathy Registry.
DCM families harboring rare sarcomeric variants in MYH6, MYH7, MYBPC3, TNNT2 and TTN were identified. Genotype-phenotype association analysis was performed, and long-term survival-free from death or heart transplant was compared between carriers and non-carriers.
We found 24 rare variants (3 in MYH6, 3 in MYH7, 3 in MYBPC3, 2 in TNNT2 and 13 in TTN) affecting 52 subjects in 25 families. The phenotypes of variant carriers were severe (3 sudden deaths, 6 heart failure deaths, 8 heart transplants, 2 ventricular fibrillations). There was no difference in the overall long-term survival between carriers and the 33 non-carriers (p=0.322). However after 50 years of age, the combined endpoint of death or transplant was decreased in carriers as compared to non-carriers (p=0.026).
Patients with DCM carrying rare variants in sarcomeric genes manifest a poorer prognosis as compared to non-carriers after the age of 50 years. These data further support the role genetic testing in DCM for risk stratification.
PMCID: PMC3865161  PMID: 24119082
Cardiomyopathy; genes; prognosis; molecular genetics; genetics; phenotyping
14.  Do Clinical and Translational Science Graduate Students Understand Linear Regression? Development and Early Validation of the REGRESS Quiz 
Clinical and translational science  2013;6(6):10.1111/cts.12088.
Although regression is widely used for reading and publishing in the medical literature, no instruments were previously available to assess students' understanding. The goal of this study was to design and assess such an instrument for graduate students in Clinical and Translational Science and Public Health.
A 27-item REsearch on Global Regression Expectations in StatisticS (REGRESS) quiz was developed through an iterative process. Consenting students taking a course on linear regression in a Clinical and Translational Science program completed the quiz pre- and post-course. Student results were compared to practicing statisticians with a master's or doctoral degree in statistics or a closely related field.
52 students responded pre-course, 59 post-course, and 22 practicing statisticians completed the quiz. The mean (SD) score was 9.3 (4.3) for students pre-course and 19.0 (3.5) post-course (p<0.001). Post-course students had similar results to practicing statisticians (mean (SD) of 20.1(3.5); p=0.21). Students also showed significant improvement pre/post course in each of six domain areas (p<0.001). The REGRESS quiz was internally reliable (Cronbach's alpha 0.89).
The initial validation is quite promising with statistically significant and meaningful differences across time and study populations. Further work is needed to validate the quiz across multiple institutions.
PMCID: PMC3868997  PMID: 24330688
Regression; Assessment; Validation
15.  Publication Track Records as a Metric of Clinical Research Training Effectiveness 
Clinical and translational science  2013;6(6):10.1111/cts.12089.
Clinical research training programs exist across the country, but no quantitative studies have been performed to evaluate the effectiveness of these programs. The goal of this study was to evaluate the success of the clinical research training program at the University of Cincinnati by comparing the publication histories of pediatric fellows who graduated from the clinical and translational research master of science (MS) degree programs between 1995 and 2011 with fellows who did not pursue an MS degree. Among 296 pediatric fellows, 44 of 54 graduates (81%) published at least 1 first-authored paper, as compared with 149 of 242 (62%) fellows who did not obtain an MS degree (p<0.01). In multivariable analysis, 3-4 years after program completion, MS graduates published more papers overall (R2=0.10) and more first-authored papers than did non-MS graduates (R2=0.04). These findings suggest that graduate training in clinical and translational research is related to an increase in research productivity as assessed by publication rates.
PMCID: PMC3869033  PMID: 24330690
16.  Guidelines for community based partners for reviewing research grant applications: Lessons from the Michigan Institute for Clinical and Health Research (MICHR) Community Engagement Research Core (CERC) 
One of most important mandates of the National Institutes of Health’s (NIH) Clinical and Translational Science Award’s (CTSA) awards is to accelerate the dissemination of scientific discoveries so that the public benefits from health related research. Carrying out that mandate requires equitable and bi-directional research partnerships with those who will use these discoveries to benefit health. The mission of the Michigan Institute for Clinical & Health Research’s (MICHR) Community Engagement & Research Core is to increase community decision-making and action for health promotion, disease prevention, and treatment by involving the community in all phases of clinical research. Some of the community partners serving on MICHR’s Community Engagement Coordinating Council (CECC) have expressed concern about reviewing university/community partner research projects. They found the scientific nature of proposals somewhat challenging. These guidelines are intended to help community partners bring to bear their unique expertise and experience in the evaluation of proposed research studies that include community partners as co-principle investigators. This paper provides an approach for ensuring the community’s voice plays an important role in reviewing pilot project proposals for community-engaged research.
PMCID: PMC3925334  PMID: 24330687
17.  Pathways of Translation: Deep Brain Stimulation 
Electrical stimulation of the brain has a 2000 year history. Deep brain stimulation (DBS), one form of neurostimulation, is a functional neurosurgical approach in which a high frequency electric current stimulates targeted brain structures for therapeutic benefit. It is an effective treatment for certain neuropathologic movement disorders and an emerging therapy for psychiatric conditions and epilepsy. Its translational journey did not follow the typical bench-to-bedside path, but rather reversed the process. The shift from ancient and medieval folkloric remedy to accepted medical practice began with independent discoveries about electricity during the 17th century and was fostered by technological advances of the 20th. In this article we review that journey and discuss how the quest to expand its applications and continue to improve outcomes is taking DBS from the bedside back to the bench.
PMCID: PMC4057890  PMID: 24330698
18.  Sildenafil increases muscle protein synthesis and reduces muscle fatigue 
Reductions in skeletal muscle function occur during the course of healthy aging as well as with bedrest or diverse diseases such as cancer, muscular dystrophy, and heart failure. However, there are no accepted pharmacologic therapies to improve impaired skeletal muscle function. Nitric oxide may influence skeletal muscle function through effects on excitation-contraction coupling, myofibrillar function, perfusion, and metabolism. Here we show that augmentation of nitric oxide-cyclic guanosine monophosphate signaling by short-term daily administration of the phosphodiesterase 5 inhibitor sildenafil increases protein synthesis, alters protein expression and nitrosylation, and reduces fatigue in human skeletal muscle. These findings suggest that phosphodiesterase 5 inhibitors represent viable pharmacologic interventions to improve muscle function.
PMCID: PMC4076819  PMID: 24330691
20.  The Design and Conduct of a Community-Based Registry and Biorepository: A Focus on Cardiometabolic Health in Latinos 
Latinos are disproportionately impacted by obesity and type 2 diabetes but remain underrepresented in biomedical research. Therefore, the purpose of this project was to develop a research registry and biorepository to examine cardiometabolic disease risk in the Latino community of Phoenix, Arizona. The overarching goal was to establish the research infrastructure that would encourage transdisciplinary research regarding the biocultural mechanisms of obesity-related health disparities and facilitate access to this research for the Latino community.
Prior to recruitment, key stakeholders from the local Latino community were engaged to develop a broad rapport within the community and seek advice regarding recruitment, enrollment, and follow-up. Self-identified community-dwelling Latinos underwent a comprehensive cardiometabolic health assessment that included anthropometrics, a fasting laboratory panel, and a 2-hour oral glucose tolerance test with measures of insulin and glucose to estimate insulin action and secretion. Separate consent was requested for future contact and banking of serum, DNA, and RNA. Research collaborations were sought out based on the cultural and metabolic profile of participants, faculty research agendas, and the potential for generating hypotheses.
A total of 667 participants (20.4% children, and 79.6% adults) were enrolled with 97% consenting to the registry and 94% to banking of samples. The prevalence of overweight/obesity was 50% in children and 81% in adults. Nearly 20% of children and more than 45% of the adults exhibited some degree of hyperglycemia. To date, more than 15 research projects have been supported through this infrastructure and have included projects on the molecular biology of insulin resistance to the sociocultural determinants of health behaviors and outcomes.
The high prevalence of obesity and cardiometabolic disease risk factors coupled with the overwhelming majority of participants consenting to be re-contacted, highlights the importance of supporting research infrastructure to generate hypotheses about obesity-related health in Latinos. Future studies that stem from the initial project will likely advance the limited understanding regarding the biocultural determinants of health disparities in the Latino community.
PMCID: PMC4225082  PMID: 24119012
insulin resistance; obesity; registry; biobank; Latino
21.  Building Leadership among Laboratory-Based and Clinical and Translational Researchers: The University of California, San Francisco Experience 
In 2005 the University of California, San Francisco (UCSF) implemented the Scientific Leadership and Management (SLM) course, a 2-day leadership training program to assist laboratory-based postdoctoral scholars in their transition to independent researchers managing their own research programs. In 2011, the course was expanded to clinical and translational junior faculty and fellows. The course enrollment was increased from approximate 100 to 123 participants at the same time. Based on course evaluations, the number and percent of women participants appears to have increased over time from 40% (n = 33) in 2007 to 53% (n = 58) in 2011. Course evaluations also indicated that participants found the course to be relevant and valuable in their transition to academic leadership. This paper describes the background, structure, and content of the SLM and reports on participant evaluations of the course offerings from 2007 through 2011.
PMCID: PMC4224438  PMID: 24405661
ethics; outcomes research; translational research
22.  Construction of a US Fibromyalgia Registry Using the Fibromyalgia Research Survey Criteria 
Utilizing billing records we identified patients seen at Mayo Clinic with a diagnosis or history of fibromyalgia who were then contacted for enrollment in a fibromyalgia research registry. Fibromyalgia was confirmed through medical record review. Eligible patients were mailed an invitation that included a demographic questionnaire and the Fibromyalgia Research Survey. The Fibromyalgia Research Survey yields a widespread pain score (scale range 0–19) and a symptom severity score (scale range 0–12). 4,034 patients returned the completed survey; 92.8% were female, their mean age was 57.4 (±13.4), and 83.7% were from the Midwest region of the US. The mean widespread pain score for all participants was 11.3 (±4.5) and the mean symptom severity score was 8.2 (±2.4), indicating moderate to severe fibromyalgia symptoms which is not unusual for patients presenting to a tertiary care center. Using a systematic process we describe the creation of a fibromyalgia registry for future research.
PMCID: PMC3801292  PMID: 24127929
23.  Assessing Research Interest and Capacity in Community Health Centers 
Community health centers (CHCs) have great potential to participate in the development of evidence-based primary care but face obstacles to engagement in clinical translational research.
To understand factors associated with CHC interest in building research infrastructure, Harvard Catalyst and the Massachusetts League of Community Health Centers conducted an online survey of medical directors in all 50 Massachusetts CHC networks.
Thirty-two (64%) medical directors completed the survey representing 126 clinical sites. Over 80% reported that their primary care providers (PCPs) were slightly to very interested in future clinical research and that they were interested in building research infrastructure at their CHC. Frequently cited barriers to participation in research included financial issues, lack of research skills and lack of research infrastructure. In bivariate analyses, PCP interest in future clinical research and a belief that involvement in research contributed to PCP retention were significantly associated with interest in building research infrastructure.
CHCs critical role in caring for vulnerable populations ideally positions them to raise relevant research questions and translate evidence into practice. Our findings suggest a high interest in engagement in research among CHC leadership. CTSAs have a unique opportunity to support local CHCs in this endeavor.
PMCID: PMC3801296  PMID: 24127928
24.  Researching Together: A CTSA Partnership of Academicians and Communities for Translation 
The Colorado Clinical & Translational Sciences Institute (CCTSI) aims to translate discovery into clinical practice. The Partnership of Academicians and Communities for Translation (PACT) represents a robust campus-community partnership.
The CCTSI collected data on all PACT activities including meeting notes, staff activity logs, stakeholder surveys and interviews, and several key component in-depth evaluations. Data analysis by Evaluation and Community Engagement Core and PACT Council members identified critical shifts that changed the trajectory of community engagement efforts.
Ten “critical shifts” in six broad rubrics created change in the PACT. Critical Shifts were decision points in the development of the PACT that represented quantitative and qualitative changes in the work and trajectory. Critical shifts occurred in PACT management and leadership, financial control and resource allocation, and membership and voice.
The development of a campus-community partnership is not a smooth linear path. Incremental changes lead to major decision points that represent an opportunity for critical shifts in developmental trajectory. We provide an enlightening, yet cautionary, tale to others considering a campus-community partnership so they may prepare for crucial decisions and critical shifts. The PACT serves as a genuine foundational platform for dynamic research efforts aimed at eliminating health disparities.
PMCID: PMC3801390  PMID: 24127922
Community Engagement; Community Based Participatory Research; Translational Research; Clinical and Translational Science Award
25.  Training the Translational Research Teams of the Future: UC Davis - HHMI Integrating Medicine into Basic Science Program 
There is a need for successful models of how to recruit, train, and retain bench scientists at the earliest stages of their careers into translational research. One recent, promising model is the University of California Davis Howard Hughes Medical Institute Integrating Medicine into Basic Science (HHMI-IMBS) program, part of the HHMI Med into Grad initiative. This article outlines the HHMI-IMBS program’s logic, design, and curriculum that guide the goal of research that moves from bedside to bench. That is, a curriculum that provides graduate students with guided translational training, clinical exposure, team science competencies and mentors from diverse disciplines that will advance the students careers in clinical translational research and re-focusing of research to answer clinical dilemmas. The data indicate that this training program provides an effective, adaptable model for training future translational researchers. HHMI-IMBS students showed improved confidence in conducting translational research, greater interest in a future translational career, and higher levels of research productivity and collaborations than a comparable group of pre-doctoral students.
PMCID: PMC3801412  PMID: 24127920
translational training; medical education; graduate students

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