Clinical and Translational Science

Publications in this journal

• Article: The Sharing Partnership for Innovative Research in Translation (SPIRiT) Consortium: A Model for Collaboration across CTSA Sites.

  Steven E Reis, P Daniel Patterson, Garret A Fitzgerald, Daniel Ford, Robert S Sherwin, Julian Solway, Bradley A Evanoff
  Clinical and Translational Science 04/2013; 6(2):85-7.
• Article: Developing a Competency-Based Educational Structure within Clinical and Translational Science.

  Terri Collin Dilmore, Debra W Moore, Zuleikha Bjork
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  ABSTRACT: In the emerging field of clinical and translational science (CTS), where researchers use both basic and clinical science research methodologies to move discoveries to clinical practice, establishing standards of competence is essential for preparing physician-scientists for the profession and for defining the field. The diversity of skills needed to execute quality research within the field of CTS has heightened the importance of an educational process that requires learners to demonstrate competence. Particularly within the more applied clinical science disciplines where there is a multi- or interdisciplinary approach to conducting research, defining and articulating the unique role and associated competencies of a physician-scientist is necessary. This paper describes a systematic process for developing a competency-based educational framework within a CTS graduate program at one institution.
  Clinical and Translational Science 04/2013; 6(2):98-102.
• Article: Public Participation in, and Awareness about, Medical Research Opportunities in the Era of Clinical and Translational Research.

  Matthew M Davis, Sarah J Clark, Amy T Butchart, Dianne C Singer, Thomas P Shanley, Debbie S Gipson
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  ABSTRACT: In the United States, levels of public participation in medical research in the era of Clinical and Translational Science Awards (CTSAs) are unknown. In 2011, a household survey was administered to a sample of U.S. adults, asking whether they (and children <18 years old) had participated, or were aware of opportunities to participate, in medical research. Respondents living within 100 miles of CTSA sites were identified. Regression analyses of participation and awareness (PA) were performed, applying sampling weights to permit nationally representative inferences. Overall, 2,150 individuals responded (completion rate = 60%); 65% of adults and 63% of families with children resided within 100 miles of ≥1 CTSA location. Research participation rates were 11% among adults and 5% among children. Among nonparticipants, awareness rates were 64% among adults and 12% among parents of children. PA among adults was associated with higher income and education, older age, presence of chronic conditions, and living within 100 miles of four specific CTSA locations. For children, PA was associated with higher household income and parents' chronic health conditions. PA of medical research opportunities is substantially higher for adults than children. Higher PA levels near specific CTSAs merit investigation to identify their successful approaches.
  Clinical and Translational Science 04/2013; 6(2):88-93.
• Article: Developing Future Clinician Scientists while Supporting a Research Infrastructure.

  Maija Holsti, Kathleen M Adelgais, Leah Willis, Kammy Jacobsen, Edward B Clark, Carrie L Byington
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  ABSTRACT: Supporting clinical research is a national priority. Clinician scientists are rare and clinical trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested in biomedical careers often lack opportunities to perform clinical research. Describe an innovative undergraduate course that supports clinical research in an AMC. The course, Clinical Research Methods and Practice, offers undergraduate students the opportunity to learn clinical research through didactic and practical experiences. The students in turn support clinician scientists' conduct of clinical studies in an AMC. Clinician scientists receive research support and participate in mentoring sessions for students. Over seven semesters, 128 students have assisted in 21 clinical studies located in outpatient and inpatient units of two hospitals. Students identified and screened eligible patients, collected clinical data, assisted in obtaining informed consent, and transported specimens. Many of the clinician scientists have met their enrollment goals and several have been top-enrollers in multicenter clinical trials as a result of student support. The Clinical Research Methods and Practice class addresses barriers to clinical research in AMC. This may be a model for institutions committed to mentoring students early in their career and to developing infrastructures for clinical research. Clin Trans Sci 2013; Volume 6: 94-97.
  Clinical and Translational Science 04/2013; 6(2):94-7.
• Article: The CTSA as an Exemplar Framework for Developing Multidisciplinary Translational Teams.

  William J Calhoun, Kevin Wooten, Suresh Bhavnani, Karl E Anderson, Jean Freeman, Allan R Brasier
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  ABSTRACT: Translational science requires that scientists from multiple disciplines work together to improve the prevention, diagnosis, and treatment of human disease. Although a literature exists on the design and management of multidisciplinary teams, little has been written on multidisciplinary translational teams (MTTs). MTTs are distinct hybrid entities, with goals taken from both industry and academic models. We identified 30 design factors in 10 domains from a literature survey relevant to our MTT model: specific goals, structures, and processes. These dimensions were adapted to our own institutional environment in the selection and management of 11 MTTs that exploited resources of University of Texas Medical Branch (UTMB) Clinical and Translational Sciences Awards (CTSA). Case illustrations of two specific MTTs illustrate some of the challenges encountered and opportunities realized in terms of education and scientific advances. Network depiction of disciplinarity indicated that CTSA KRs and CTSA leadership contributed to discipline diversity especially in small (or nascent) MTTs. A separate depiction of MTT-KR utilization indicated that data analysis, translational technologies, and novel methods were heavily utilized by MTTs, whereas other KRs contributed significant effort to infrastructure development. We conclude that the CTSA can provide a rich infrastructural framework and scientific environment for the development of successful MTTs. Clin Trans Sci 2013; Volume 6: 60-71.
  Clinical and Translational Science 02/2013; 6(1):60-71.
• Article: Translational research applications for the study of adolescent sexual decision making.

  Coreen Farris, Aletha Y Akers, Julie S Downs, Erika E Forbes
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  ABSTRACT: Although the initiation of sexual behaviors in adolescence is normative, adverse sexual health outcomes disproportionately affect adolescents relative to adults. Efforts to improve sexual health and increase health promotion behaviors in adolescent populations have not been fully successful. In this paper, we propose that translational research that integrates insights from neuroscience, ecological systems theory, and decision science with adolescent sexual behavior research can lead to advances in our understanding of the etiology and prevention of sexual risk behaviors among adolescents. Moreover, these insights can be further translated to the design and implementation of clinical interventions that improve sexual health. Clin Trans Sci 2013; Volume 6: 78-81.
  Clinical and Translational Science 02/2013; 6(1):78-81.
• Article: Novel infrastructure for sepsis biomarker research in critically ill neonates and children.

  Justin E Juskewitch, Felicity T Enders, Roshini S Abraham, W Charles Huskins
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  ABSTRACT: Sepsis biomarker research requires an infrastructure to identify septic patients efficiently and to collect and store specimens properly. We developed a novel infrastructure to study biomarkers of sepsis in children. Patients in pediatric and neonatal intensive care units were enrolled prospectively; enrollment information was stored in a secure, remotely accessible database. Researchers were notified of electronic medical record (EMR) orders for blood cultures (a surrogate for a diagnostic evaluation of suspected sepsis) by a page triggered by the order. Staff confirmed patient enrollment and remotely submitted an EMR order for collection of study specimens simultaneous with the blood culture. Specimens were processed and stored by a mobile clinical research unit. Over 2 years, 2029 patients were admitted; 138 were enrolled. Staff received pages for 95% of blood cultures collected from enrolled patients. The median time between the blood culture order and collection was 34 minutes (range 9-241). Study specimens were collected simultaneously with 41 blood cultures. The median times between specimen collection and storage for flow cytometry and cytokine analysis were 33 minutes (range 0-82) and 52 minutes (range 28-98), respectively. This novel infrastructure facilitated prompt, proper collection and storage of specimens for sepsis biomarker analysis. Clin Trans Sci 2012; Volume #: 1-5.
  Clinical and Translational Science 02/2013; 6(1):21-5.
• Article: The Establishment of Research Ethics Consultation Services (RECS): An Emerging Research Resource.

  Jennifer B McCormick, Richard R Sharp, Abigale L Ottenberg, Carson R Reider, Holly A Taylor, Benjamin S Wilfond
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  ABSTRACT: Emphasis on translational research to facilitate progression from the laboratory into the community also creates a dynamic in which ethics and social policy questions and solutions are ever pressing. In response, academic institutions are creating Research Ethics Consultation Services (RECS). All Clinical Translational Science Award institutions were surveyed in early 2010 to determine which institutions have a RECS in operation and what is their composition and function. Of the 46 institutions surveyed, 33 (70%) have a RECS. Only 15 RECS have received any consult requests in the last year. Issues that are common among these relatively nascent services include relationships with institutional oversight committees, balancing requestor concerns about confidentiality with research integrity and human subjects protection priorities, tracking consult data and outcomes, and developing systems for internal evaluation. There is variability in how these issues are approached. It will be important to be attentive to the institutional context to develop an appropriate approach. Further data about the issues raised by requestors and the recommendations provided are necessary to build a community of scholars who can navigate and resolve ethical issues encountered along the translational research pathway. Clin Trans Sci 2013; Volume 6: 40-44.
  Clinical and Translational Science 02/2013; 6(1):40-4.
• Article: Visual voices: a participatory method for engaging adolescents in research and knowledge transfer.

  Michael A Yonas, Jessica G Burke, Elizabeth Miller
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  ABSTRACT: Integrating the expertise and perspectives of adolescents in the process of generating and translating research knowledge into practice is often missed, yet is essential for designing and implementing programs to promote adolescent health. This paper describes the use of the arts-based participatory Visual Voices method in translational research. Visual Voices involves systematic creative writing, drawing, and painting activities to yield culturally relevant information which is generated by and examined with adolescents. Qualitative data products include the created artistic products and transcripts from group discussions of the content developed and presented. Data are analyzed and compared across traditional (e.g., transcripts) and nontraditional (e.g., drawings and paintings) media. Findings are reviewed and interpreted with participants and shared publicly to stimulate community discussions and local policy and practice changes. Visual Voices is a novel method for involving adolescents in translational research though Integrated Knowledge Transfer (IKT), a process for bringing researchers and stakeholders together from the stage of idea generation to implementing evidence-based initiatives. Clin Trans Sci 2013; Volume 6: 72-77.
  Clinical and Translational Science 02/2013; 6(1):72-7.
• Article: Report on CTSA Consortium Use of the Community Engagement Consulting Service.

  Lori Carter-Edwards, Jennifer L Cook, Mary Anne McDonald, Sarah M Weaver, Kemi Chukwuka, Milton Mickey Eder
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  ABSTRACT: The CTSA Community Engagement Consultative Service (CECS) is a national partnership designed to improve community engaged research (CEnR) through expert consultation. This report assesses the feasibility of CECS and presents findings from 2008 to 2009. A coordinating center and five regional coordinating sites managed the service. CTSAs identified a primary previsit CE best practice for consultants to address and completed self-assessments, postvisit evaluations, and action plans. Feasibility was assessed as the percent of CTSAs participating and completing evaluations. Frequencies were calculated for evaluation responses. Of the 38 CTSAs, 36 (95%) completed a self-assessment. Of these 36 sites, 83%, 53%, and 44% completed a consultant visit, evaluation, and action plan, respectively, and 56% of the consultants completed an evaluation. The most common best practice identified previsit was improvement in CEnR (addressing outcomes that matter); however, relationship building with communities was most commonly addressed during consulting visits. Although 90% of the consultants were very confident sites could develop an action plan, only 35% were very confident in the CTSAs' abilities to implement one. Academic medical centers interested in collaborating with communities and translating research to improve health need to further develop their capacity for CE and CEnR within their institutions. Clin Trans Sci 2013; Volume 6: 34-39.
  Clinical and Translational Science 02/2013; 6(1):34-9.
• Article: Patient Recruitment into a Multicenter Randomized Clinical Trial for Kidney Disease: Report of the Focal Segmental Glomerulosclerosis Clinical Trial (FSGS CT).

  Maria Ferris, Victoria Norwood, Milena Radeva, Jennifer J Gassman, Amira Al-Uzri, David Askenazi, Tej Matoo, Maury Pinsk, Amita Sharma, William Smoyer, Jenna Stults, Shefali Vyas, Robert Weiss, Debbie Gipson, Frederick Kaskel, Aaron Friedman, Marva Moxey-Mims, Howard Trachtman
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  ABSTRACT: We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology. Clin Trans Sci 2013; Volume 6: 13-20.
  Clinical and Translational Science 02/2013; 6(1):13-20.
• Article: A roundup of news and information from our communit.

  Carrie Printz
  Clinical and Translational Science 02/2013; 6(1):1-2.
• Article: A research mentor training curriculum for clinical and translational researchers.

  Christine Pfund, Stephanie House, Kimberly Spencer, Pamela Asquith, Paula Carney, Kristyn S Masters, Richard McGee, Janet Shanedling, Stephanie Vecchiarelli, Michael Fleming
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  ABSTRACT: To design and evaluate a research mentor training curriculum for clinical and translational researchers. The resulting 8-hour curriculum was implemented as part of a national mentor training trial. The mentor training curriculum was implemented with 144 mentors at 16 academic institutions. Facilitators of the curriculum participated in a train-the-trainer workshop to ensure uniform delivery. The data used for this report were collected from participants during the training sessions through reflective writing, and following the last training session via confidential survey with a 94% response rate. A total of 88% of respondents reported high levels of satisfaction with the training experience, and 90% noted they would recommend the training to a colleague. Participants also reported significant learning gains across six mentoring competencies as well as specific impacts of the training on their mentoring practice. The data suggest the described research mentor training curriculum is an effective means of engaging research mentors to reflect upon and improve their research mentoring practices. The training resulted in high satisfaction, self-reported skill gains as well as behavioral changes of clinical and translational research mentors. Given success across 16 diverse sites, this training may serve as a national model. Clin Trans Sci 2013; Volume 6: 26-33.
  Clinical and Translational Science 02/2013; 6(1):26-33.
• Article: Role for CTSAs in Leveraging a Distributed Research Infrastructure to Engage Diverse Stakeholders in Emergent Research Policy Development.

  Ann J Melvin, Kelly Edwards, Jason Malone, Laurie Hassell, Benjamin S Wilfond
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  ABSTRACT: This paper is a case study of our regional Clinical Translational Science Award's (CTSA) development of a coordinated response to the advanced notice of proposed rulemaking on Human Subjects Research Protections during the fall of 2011. Our CTSA was well positioned to quickly activate and coordinate a response to this important and time sensitive issue because we had established infrastructure and resources both within our CTSA and through our partnering institutions, existing relationships with key individuals in the institutions, and credibility as a trusted source of information. Three town hall meetings were organized and a Website was created to collect online comments. Ultimately, comments were collected, prioritized, and organized into a single, coordinated response. This case study demonstrates the value of a distributed research infrastructure and the role CTSAs like our Institute of Translational Health Sciences can play to engage the regional research community about important developments in the research landscape and to respond to requests for feedback to policy makers. Clin Trans Sci 2013; Volume 6: 57-59.
  Clinical and Translational Science 02/2013; 6(1):57-9.
• Article: A patient-centric goal in time to blood pressure control from drug therapy initiation.

  Song Hee Hong, Junling Wang, Sunghee Tak
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  ABSTRACT: A time frame in which newly diagnosed hypertensive patients attain blood pressure (BP) goal would guide patients through uncertainty associated with initiating drug therapy for hypertension control. This study estimates time to BP goal resulting from drug therapy initiation among real-world hypertensive patients and identifies factors associated with variations in time to BP goal. The study uses a historical cohort design. Hypertensive patients who had initiated antihypertensive drug therapy between July 1, 2002, and December 31, 2003, were followed up to 12 months until the end of 2004. Electronic medical records from a medical group were linked with pharmacy claims, as well as with medical claims. Survival analyses were used to compare lengths of time needed to reach BP goals. A total of 223 patients from a real world practice setting had initiated antihypertensive drug therapy. The patients took 3.25 months (95% CI: 2.49-4.82) to reach BP goal. The patient-centric time to BP goal was 7.1 weeks longer than those reported in controlled experimental settings. This finding highlights the gap between results of controlled clinical trials and their application to clinical practice, and informs healthcare practitioners of the importance of setting a patient-centric goal in pharmacological treatment of hypertension. Clin Trans Sci 2012; Volume #: 1-6.
  Clinical and Translational Science 02/2013; 6(1):7-12.
• Article: Development, implementation, and evaluation of an interprofessional course in translational research.

  Georgeanna F W B Robinson, Judith A Erlen, Doris M Rubio, Wishwa N Kapoor, Samuel M Poloyac
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  ABSTRACT: The advancement of research from basic science discovery to clinical application requires the extensive collaboration of individuals from multiple disciplines, therefore the ability to work as an effective interprofessional team is essential for researchers in clinical and translational science (CTS). Courses that build interprofessional skills are a key component in CTS education, but the development of these courses poses numerous administrative and educational challenges. This paper describes the processes of designing, implementing, and evaluating an innovative graduate-level course that combines online lectures and in-class facilitated group discussions to promote interprofessional interactions. The course offers students the opportunity to interact with and learn from individuals in a variety of disciplines, and it requires students to engage in interprofessional group work to meet the course objectives. During the past 4 years, 96 students from the schools of medicine, pharmacy, nursing, public health, and health and rehabilitation sciences at a large urban university have completed the course. The course has been well-received, with 87% of students rating its overall quality as excellent, good, or satisfactory. The course offers educators a model to teach graduate students the skills that are essential for becoming effective CTS researchers. Clin Trans Sci 2012; Volume #: 1-7.
  Clinical and Translational Science 02/2013; 6(1):50-6.
• Article: From an Infrastructure to a Service-based Business Model: 5 Years of Mobile Clinical Research at the University of Michigan.

  Margaret G McCammon, Christina M Conrad, Zachary T Klug, C Daniel Myers, Marie L Watkins, John W Wiley, Cynthia L Bower
  Clinical and Translational Science 02/2013; 6(1):3-6.
• Article: Moderate oxidative stress and high antioxidative activity are associated with steatosis in Japanese males.

  Takuya Imatoh, Seiichirou Kamimura, Shinichi Tanihara
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  ABSTRACT: Steatosis is an increasingly common problem worldwide, accompanying increasing obesity. Recently, it has been suggested that oxidative stress plays an important role in development of fatty liver disease. We carried out an epidemiological study to clarify the role of oxidative stress and antioxidative activity in steatosis. This study was conducted with 184 male workers who had received their annual health checkup. Steatosis was confirmed using ultrasonography. Oxidative stress and antioxidative activity were assessed using the dROM test and the BAP test, respectively. Steatosis was confirmed in 59 subjects (29.7%) by ultrasonography. There was no significant difference between cases and controls in BAP levels (2229.0 μmol/L vs. 2194.3μmol/L, p = 0.83). The steatosis group showed significantly lower dROM levels than the control group (332.7 U. CARR vs. 316.8 U. CARR, p < 0.05). In addition, we carried out logistic regression analysis to assess the combination between dROM levels and BAP levels. Subjects with high dROM levels and high BAP levels had 74% lower risk for steatosis than subjects with low dROM levels and high BAP levels. Our results suggested that moderate oxidative stress and high antioxidative activity was associated with decreased steatosis risk in Japanese males. Clin Trans Sci 2013; Volume 6: 45-49.
  Clinical and Translational Science 02/2013; 6(1):45-9.
• Article: Preliminary Competencies for Comparative Effectiveness Research.

  Jodi B Segal, Wishwa Kapoor, Timothy Carey, Pamela H Mitchell, Michael D Murray, Kenneth G Saag, Glen Schumock, Daniel Jonas, Michael Steinman, Rosemarie Filart, Morris Weinberger, Harry Selker
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  ABSTRACT: The Clinical and Translational Science Award (CTSA) Workgroup for Comparative Effectiveness Research (CER) Education, Training, and Workforce Development identified a need to delineate the competencies that practitioners and users of CER for patient-centered outcomes research, should acquire. With input from CTSA representatives and collaborators, we began by describing the workforce. We recognize the workforce that conducts CER and the end users who use CER to improve the health of individuals and communities. We generated a preliminary set of competencies and solicited feedback from the CER representatives at each member site of the CTSA consortium. We distinguished applied competencies (i.e., skills needed by individuals who conduct CER) from foundational competencies that are needed by the entire CER workforce, including end users of CER. Key competency categories of relevance to both practitioners and users of CER were: (1) asking relevant research questions; (2) recognizing or designing ideal CER studies; (3) executing or using CER studies; (4) using appropriate statistical analyses for CER; and (5) communicating and disseminating CER study results to improve health. Although CER is particularly broad concept, we anticipate that these preliminary, relatively generic competencies will be used in tailoring curricula to individual learners from a variety of programmatic perspectives. Clin Trans Sci 2012; Volume 5: 476-479.
  Clinical and Translational Science 12/2012; 5(6):476-479.