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.

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.