To save content items to your account,
please confirm that you agree to abide by our usage policies.
If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account.
Find out more about saving content to .
To save content items to your Kindle, first ensure firstname.lastname@example.org
is added to your Approved Personal Document E-mail List under your Personal Document Settings
on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part
of your Kindle email address below.
Find out more about saving to your Kindle.
Note you can select to save to either the @free.kindle.com or @kindle.com variations.
‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi.
‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
OBJECTIVES/GOALS: There is a critical need to provide quality training for study teams. Materials need to be flexible and available at the learner’s preferred time and format. DIAMOND was developed to provide nimble education offerings that respond to the changing landscape of clinical and translational research. METHODS/STUDY POPULATION: In 2018 four CTSA institutions (the University of Michigan, the Ohio State University, Rochester University, and Tufts University) collaborated to launch the DIAMOND portal. Developed as a CTSA-wide web-based platform, DIAMOND allows members of clinical and translational research teams to widely share and access training and education resources. In 2022 a MICHR-led update of DIAMOND used principles of user centered design to improve the platform. New features include updated search functions to quickly find and sort training materials, tagging training materials to the characteristics of a translational scientist, and development of user controlled customized playlists. RESULTS/ANTICIPATED RESULTS: DIAMOND currently includes 217 training resources developed by 30 CTSA hubs and private industry. The platform has over 600 page views per day from users across the U.S. and internationally. DIAMOND includes an easy-to-use form to upload new materials to the platform. Contributors are asked to include key words and select competency domains and characteristics of a translational scientist that apply to their materials. Other new features include tagging materials to streamline and improve search results, the ability to sort materials by competency domain or characteristics of a translational scientist, and the ability for users to create and share customized, personalized playlists. DISCUSSION/SIGNIFICANCE: DIAMOND is an important tool to support workforce development for study teams. Updates to the flexible digital platform meet the needs and preferences of adult learners and busy health professionals. Lessons learned from the design process and future plans for the platform will be explored.
OBJECTIVES/GOALS: Pharmacogenomic testing for major depressive disorder is an expanding area of precision medicine with multiple direct-to-provider tests available. While clinical evidence supporting testing is expanding, there has been little research on the views and experiences of patients and clinicians utilizing this novel intervention. METHODS/STUDY POPULATION: This ongoing study is conducting semi-structured interviews with clinicians and patients exploring their views of the benefits and limitations of pharmacogenomic testing. Qualitative interviews have been conducted with 10 patients and 10 clinicians who have experience with ordering or receiving results within the past 12 months. Interviews are being thematically coded following a modified grounded theory approach using the Dedoose software. Following the principles of exploratory sequential mixed methods design, findings will be used to develop a survey to be administered to prescribing clinicians in both primary care and psychiatry. The survey will examine clinician's knowledge, interest, and concerns about utilizing testing. RESULTS/ANTICIPATED RESULTS: Preliminary analysis of qualitative interviews indicates that both patients and clinicians find that the broader testing process has benefits beyond the test results themselves. Benefits identified by patients include an increased trust in the process of selecting medications, validation of their negative experiences with medications, and improved communication with their provider. Limitations identified by patients include difficulty in accessing test results, and gatekeeping for testing by providers. Benefits identified by clinicians include increased empathy with patients, medication adherence, and improved communication with patients about medication. Limitations identified by clinicians include difficulty with ordering and interpreting test results. DISCUSSION/SIGNIFICANCE: Medication selection is a difficult process for both patients and clinicians. Improvements to clinician-patient communication and medication adherence are important benefits to consider in the adoption of testing. Future research should include these dimensions in assessment of the benefits and limitations of testing.
Well-designed, accessible short-term research training programs are needed to recruit and retain underrepresented persons into clinical and translational research training programs and diversify the workforce. The Michigan Institute for Clinical and Health Research developed a summer research program, training over 270 students in 15 years. In response to the 2020 COVID-19 pandemic, we pivoted swiftly from an in-person format to a fully remote format. We describe this process, focusing on factors of diversity, equity, and inclusion including enabling student participation in remote research activities. We collected data about students’ learning experiences since the program’s inception; therefore, we could evaluate the impact of remote vs. in-person formats. We examined data from five cohorts: three in-person (2017–2019; n = 57) and two remote (2020–2021; n = 45). While there was some concern about the value of participating in a remote format, overall students in both formats viewed the program favorably, with students in the remote cohorts rating some aspects of the program significantly more favorably. In addition, more students who identified as Black or African American participated in the remote format than in the in-person format. We describe lessons learned from this unprecedented challenge and future program directions.
Although several initiatives have produced core competency domains for training the translational science workforce, training resources to help clinical research professionals advance these skills reside primarily within local departments or institutions. The Development, Implementation, and AssessMent of Novel Training in Domain (DIAMOND) project was designed to make this training more readily and publicly available. DIAMOND includes a digital portal to catalog publicly available educational resources and an ePortfolio to document professional development. DIAMOND is a nationally crowdsourced, federated, online catalog providing a platform for practitioners to find and share training and assessment materials. Contributors can share their own educational materials using a simple intake form that creates an electronic record; the portal enables users to browse or search this catalog of digital records and access the resources. Since September 2018, the portal has been visited more than 5,700 times and received over 280 contributions from professionals. The portal facilitates opportunities to connect and collaborate regarding future applications of these resources. Consequently, growing the collection and increasing numbers of both contributors and users remains a priority. Results from a small subset of users indicated over half accomplished their purpose for visiting the site, while qualitative results showed that users identified several benefits and helpful features of the ePortfolio.
There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual’s preparedness to function efficiently in the clinical research enterprise and tools to evaluate the quality and effectiveness of programs that are designed to educate and train clinical research professionals. Here we report the development and validation of a competency self-assessment entitled the Competency Index for Clinical Research Professionals, version II (CICRP-II).
CICRP-II was developed using data collected from clinical research coordinators (CRCs) participating in the “Development, Implementation and Assessment of Novel Training In Domain-Based Competencies” (DIAMOND) project at four clinical and translational science award (CTSA) hubs and partnering institutions.
An exploratory factor analysis (EFA) identified a two-factor structure: the first factor measures self-reported competence to perform Routine clinical research functions (e.g., good clinical practice regulations (GCPs)), while the second factor measures competence to perform Advanced clinical functions (e.g., global regulatory affairs). We demonstrate the between groups validity by comparing CRCs working in different research settings.
The excellent psychometric properties of CICRP-II and its ability to distinguish between experienced CRCs at research-intensive CTSA hubs and CRCs working in less-intensive community-based sites coupled with the simplicity of alternative methods for scoring respondents make it a valuable tool for gauging an individual’s perceived preparedness to function in the role of CRC as well as an equally valuable tool to evaluate the value and effectiveness of clinical research education and training programs.
OBJECTIVES/SPECIFIC AIMS: The DIAMOND project encourages study team workforce development through the creation of a digital learning space that brings together resources from across the CTSA consortium. This allows for widespread access to and dissemination of training and assessment materials. DIAMOND also includes access to an ePortfolio that encourages CRPs to define career goals and document professional skills and training. METHODS/STUDY POPULATION: Four CTSA institutions (the University of Michigan, the Ohio State University, University of Rochester, and Tufts CTSI) collaborated to develop and implement the DIAMOND portal. The platform is structured around eight competency domains, making it easy for users to search for research training and assessment materials. Contributors can upload links to (and meta-data about) training and assessment materials from their institutions, allowing resources to be widely disseminated through the DIAMOND platform. Detailed information about materials included in DIAMOND is collected through an easy to use submission form. DIAMOND also includes an ePortfolio designed for CRPs. This encourages workforce development by providing a tool for self-assessment of clinical research skills, allowing users to showcase evidence of experience, training and education, and fosters professional connections. RESULTS/ANTICIPATED RESULTS: To date, more than 100 items have been posted to DIAMOND from nine contributors. In the first 30 days there were 229 active users with more than 500 page views from across the U.S. as well as China and India. Training materials were viewed most often from four competency domains: 1) Scientific Concepts & Research Design, 2) Clinical Study Operations, 3) Ethical & Participant Safety, and 4) Leadership & Professionalism. Additionally, over 100 CRPs have created a DIAMOND ePortfolio account, using the platform to document skills, connect with each other, and search for internships and job opportunities. DISCUSSION/SIGNIFICANCE OF IMPACT: Lessons learned during development of the DIAMOND digital platform include defining relevant information to collect for the best user experience; selection of a standardized, user-friendly digital platform; and integration of the digital network and ePortfolio. Combined, the DIAMOND portal and ePortfolio provide a professional development platform for clinical research professionals to contribute, access, and benefit from training and assessment opportunities relevant to workforce development and their individual career development needs.
Research shows incentives can motivate faculty to increase their engagement in mentoring, despite a myriad of institutional barriers. One such incentive may be the implementation of a university-wide mentor award program to promote a culture of mentorship.
A new mentorship award was created at a research-intensive university and faculty recipients were surveyed to assess their perceptions of the award’s impact on their mentoring practices and career.
Sixty-two percent of awardees (n=21) completed the survey and felt the recognition incentivized them to engage in further mentoring and participate in formal mentorship training. Most awardees referenced the award in their CVs, performance evaluations, and grant proposals. Additionally, they felt the award effectively promoted mentoring among the broader faculty community.
Growth of clinical and translational research depends in part on the mentorship received by early career faculty. Therefore, other research universities may benefit from implementing such awards.
OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.
This study examined the demographic, medical, and psychiatric correlates of hallucinations and paranoid delusions reported by proxy informants for 822 elders aged 70 or older. This sample comprised people who were deemed unable to complete a direct interview in a large nationwide study of aging. Marital status, trouble with vision, and cognitive impairment were associated with report of both paranoid delusions and hallucinations. Depressive symptoms and stroke were associated with hallucinations only. These results suggest that inadequate external stimulation in the elderly leads to psychotic experiences.
Email your librarian or administrator to recommend adding this to your organisation's collection.