The RIC Recruitment & Retention Materials Toolkit - a resource for developing community-informed study materials.

Clinical trials face many challenges with meeting projected enrollment and retention goals. A study's recruitment materials and messaging convey necessary key information and therefore serve as a critical first impression with potential participants. Yet study teams often lack the resources and skills needed to develop engaging, culturally tailored, and professional-looking recruitment materials. To address this gap, the Recruitment Innovation Center recently developed a Recruitment & Retention Materials Content and Design Toolkit, which offers research teams guidance, actionable tips, resources, and customizable templates for creating trial-specific study materials. This paper seeks to describe the creation and contents of this new toolkit.

Patient Perceptions of Receiving COVID-19 Test Results via an Online Patient Portal: An Open Results Survey.

BACKGROUND: In the United States, attention has been focused on "open notes" and "open results" since the Office of the National Coordinator for Health Information Technology implemented the 21st Century Cures Act Final Rule on information blocking. Open notes is an established best practice, but open results remains controversial, especially for diseases associated with stigma, morbidity, and mortality. Coronavirus disease 2019 (COVID-19) is associated with all three of these effects and represents an ideal disease for the study of open results for sensitive test results. OBJECTIVES: This study evaluates patient perspectives related to receiving COVID-19 test results via an online patient portal prior to discussion with a clinician. METHODS: We surveyed adults who underwent COVID-19 testing between March 1, 2020 and October 21, 2020 who agreed to be directly contacted about COVID-19-related research about their perspectives on receiving test results via a patient portal. We evaluated user roles (i.e., patient vs. care partner), demographic information, ease of use, impact of immediate release, notification of results, impact of viewing results on health management, and importance of sharing results with others. RESULTS: Users were mostly patients themselves. Users found the portal easy to use but expressed mixed preferences about the means of notification of result availability (e.g., email, text, or phone call). Users found immediate access to results useful for managing their health, employment, and family/childcare. Many users shared their results and encouraged others to get tested. Our cohort consisted mostly of non-Hispanic white, highly educated, English-speaking patients. CONCLUSION: Overall, patients found open results useful for COVID-19 testing and few expressed increased worries from receiving their results via the patient portal. The demographics of our cohort highlight the need for further research in patient portal equity in the age of open results.

Creating and implementing a COVID-19 recruitment Data Mart.

The COVID-19 pandemic has resulted in an unprecedented strain on every aspect of the healthcare system, and clinical research is no exception. Researchers are working against the clock to ramp up research studies addressing every angle of COVID-19 - gaining a better understanding of person-to-person transmission, improving methods for diagnosis, and developing therapies to treat infection and vaccines to prevent it. The impact of the virus on research efforts is not limited to investigators and their teams. Potential participants also face unparalleled opportunities and requests to participate in research, which can result in a significant amount of participant fatigue. The Vanderbilt Institute for Clinical and Translational Research recognized early in the pandemic that a solution to assist researchers in the rapid identification of potential participants was critical, and thus developed the COVID-19 Recruitment Data Mart. This solution does not rest solely on technology; the addition of experienced project managers to support researchers and facilitate collaboration was essential. Since the platform and study support tools were launched on July 20, 2020, four studies have been onboarded and a total of 1693 potential participant matches have been shared. Each of these patients had agreed in advance to direct contact for COVID-19 research and had been matched to study-specific inclusion/exclusion criteria. Our innovative Data Mart system is scalable and looks promising as a generalizable solution for simultaneously recommending individuals from a pool of patients against a pool of time-sensitive trial opportunities.

Tackling the "so what" problem in scientific research: a systems-based approach to resource and publication tracking.

Peer-reviewed publications are one measure of scientific productivity. From a project, program, or institutional perspective, publication tracking provides the quantitative data necessary to guide the prudent stewardship of federal, foundation, and institutional investments by identifying the scientific return for the types of support provided. In this article, the authors describe the Vanderbilt Institute for Clinical and Translational Research's (VICTR's) development and implementation of a semiautomated process through which publications are automatically detected in PubMed and adjudicated using a "just-in-time" workflow by a known pool of researchers (from Vanderbilt University School of Medicine and Meharry Medical College) who receive support from Vanderbilt's Clinical and Translational Science Award. Since implementation, the authors have (1) seen a marked increase in the number of publications citing VICTR support, (2) captured at a more granular level the relationship between specific resources/services and scientific output, (3) increased awareness of VICTR's scientific portfolio, and (4) increased efficiency in complying with annual National Institutes of Health progress reports. They present the methodological framework and workflow, measures of impact for the first 30 months, and a set of practical lessons learned to inform others considering a systems-based approach for resource and publication tracking. They learned that contacting multiple authors from a single publication can increase the accuracy of the resource attribution process in the case of multidisciplinary scientific projects. They also found that combining positive (e.g., congratulatory e-mails) and negative (e.g., not allowing future resource requests until adjudication is complete) triggers can increase compliance with publication attribution requests.

Clinical and translational research studios: a multidisciplinary internal support program.

The Vanderbilt Institute for Clinical and Translational Research implemented the "Studio" Program in 2007 to bring together experts to provide free, structured, project-specific feedback for medical researchers. Studios are a series of integrated, dynamic, and interactive roundtable discussions that bring relevant research experts from diverse academic disciplines together to focus on a specific research project at a specific stage. Vanderbilt's Clinical and Translational Science Award supports the program, which is designed to improve the quality and impact of biomedical research. In this article, the authors describe the program's design, and they provide an evaluation of its first four years.After an investigator completes a brief online Studio application, a Studio "manager" reviews the request, assembles a panel of three to six experts (research faculty from multiple disciplines), and circulates the pre-review materials electronically. Investigators can request one of seven Studio formats: hypothesis generation, study design, grant review, implementation, analysis and interpretation, manuscript review, or translation. A Studio moderator leads each Studio session, managing the time (90 minutes) and discussion to optimize the usefulness of the session for the investigator.Feedback from the 157 Studio sessions in the first four years has been overwhelmingly positive. Investigators have indicated that their Studios have improved the quality of their science (99%; 121/122 responses), and experts have reported that the Studios have been a valuable use of their time (98%; 398/406 responses).

Development and reliability testing of the frequency, etiology, direction, and severity (FEDS) system for classifying glenohumeral instability.

HYPOTHESIS: Classification systems for glenohumeral instability (GHI) are opinion based, not validated, and poorly defined. The hypothesis driving this investigation is that a classification system with content validity will have high inter-observer and intra-observer agreement. MATERIALS AND METHODS: The classification system was developed by first conducting systematic literature review that identified 18 systems for classifying GHI. The frequency of characteristics used was recorded. Additionally, 31 members of the American Shoulder and Elbow Surgeons responded to a survey to identify features important to characterize GHI. Frequency, etiology, direction, and severity (FEDS) were most important. Frequency was defined as solitary (1 episode), occasional (2 to 5 times/y), or frequent (>5 times/year). Etiology was defined as traumatic or atraumatic. Direction referred to the primary direction of instability (anterior, posterior, or inferior). Severity was subluxation or dislocation. For reliability testing, 50 GHI patients completed a questionnaire at their initial visit. One of 6 sports medicine fellowship-trained physicians completed a similar questionnaire after examining the patient. Patients returned after 2 weeks and were examined by the original physician and 2 other physicians. Interrater and intrarater agreement for the FEDS classification system was calculated. RESULTS: Agreement between patients and physicians was lowest for frequency (39%; κ = 0.130) and highest for direction (82%; κ = 0.636). Physician intrarater agreement was 84% to 97% for the individual FEDS characteristics (κ = 0.69-0.87), and interrater agreement was 82% to 90% (κ = 0.44-0.76). CONCLUSIONS: The FEDS system has content validity and is highly reliable for classifying GHI. Physical examination using provocative testing to determine the primary direction of instability produces very high levels of interrater and intrarater agreement.

StarBRITE: the Vanderbilt University Biomedical Research Integration, Translation and Education portal.

StarBRITE is a one-stop, web-based research portal designed to meet the day-to-day needs of the Vanderbilt University and Meharry Medical College research community during the planning and conduct of research studies. StarBRITE serves as the main online location for research support addressing issues such as identification and location of resources, identification of experts, guidance for regulatory applications and approvals, regulatory assistance, funding requests, research data planning and collection, and serves as a central repository for educational offerings. To date, there have been more than 590,038 StarBRITE hits by more than 6582 cumulative users. We present here StarBRITE design objectives, details about technical infrastructure and system components, status report and activity metrics for the first 2.75-years of operation, and a report of lessons learned during organizing, launching and refining the portal.