Distinguishing between translational science and translational research in CTSA pilot studies: A collaborative project across 12 CTSA hubs.

Introduction: The institutions (i.e., hubs) making up the National Institutes of Health (NIH)-funded network of Clinical and Translational Science Awards (CTSAs) share a mission to turn observations into interventions to improve public health. Recently, the focus of the CTSAs has turned increasingly from translational research (TR) to translational science (TS). The current NIH Funding Opportunity Announcement (PAR-21-293) for CTSAs stipulates that pilot studies funded through the CTSAs must be "focused on understanding a scientific or operational principle underlying a step of the translational process with the goal of developing generalizable solutions to accelerate translational research." This new directive places Pilot Program administrators in the position of arbiters with the task of distinguishing between TR and TS projects. The purpose of this study was to explore the utility of a set of TS principles set forth by NCATS for distinguishing between TR and TS. Methods: Twelve CTSA hubs collaborated to generate a list of Translational Science Principles questions. Twenty-nine Pilot Program administrators used these questions to evaluate 26 CTSA-funded pilot studies. Results: Factor analysis yielded three factors: Generalizability/Efficiency, Disruptive Innovation, and Team Science. The Generalizability/Efficiency factor explained the largest amount of variance in the questions and was significantly able to distinguish between projects that were verified as TS or TR (t = 6.92, p < .001) by an expert panel. Conclusions: The seven questions in this factor may be useful for informing deliberations regarding whether a study addresses a question that aligns with NCATS' vision of TS.

Licit Substance Use and Premenstrual Syndrome Symptom Severity in Female College Students.

Introduction: Premenstrual syndrome (PMS) affects the majority of women and is characterized by physical, behavioral, and mood symptoms, which can have a profound impact on quality of life. PMS symptoms have also been linked to licit substance use. This study examined the relationships between daily/problem use (DPU) of caffeine (Caf+), alcohol (Alc+), and tobacco (Cig+) and PMS symptomology in a sample of college women. Methods: Participants (N = 196) completed an anonymous one-time health survey. Demographic, PMS symptomatology, and DPU of licit substance variables were examined. Independent t-tests compared PMS symptom scores in women with and without Caf+, Cig+, and Alc+ use. One-way analysis of variances examined the associations between PMS symptom severity and number of DPU-positive substances. Results: PMS subscale severity (pain [F(2,190) = 4.47, p = 0.013], affective [F(2,192) = 8.21, p < 0.001], and water retention [F(2,191) = 13.37, p < 0.001]) and total PMS symptom severity [F(2,189) = 10.22, p < 0.001] showed a dose response effect, with the number of licit substances with DPU significantly associated with PMS symptom severity. Conclusions: This study findings provide important new information about the relationship between PMS symptoms and at-risk substance use. These are cross-sectional data, however, and affirm a need for longitudinal research to better understand the associations, with a focus on potential benefits of education and intervention.

The CTSA External Reviewer Exchange Consortium (CEREC): Engagement and efficacy.

INTRODUCTION: Many institutions evaluate applications for local seed funding by recruiting peer reviewers from their own institutional community. Smaller institutions, however, often face difficulty locating qualified local reviewers who are not in conflict with the proposal. As a larger pool of reviewers may be accessed through a cross-institutional collaborative process, nine Clinical and Translational Science Award (CTSA) hubs formed a consortium in 2016 to facilitate reviewer exchanges. Data were collected to evaluate the feasibility and preliminary efficacy of the consortium. METHODS: The CTSA External Reviewer Exchange Consortium (CEREC) has been supported by a custom-built web-based application that facilitates the process and tracks the efficiency and productivity of the exchange. RESULTS: All nine of the original CEREC members remain actively engaged in the exchange. Between January 2017 and May 2019, CEREC supported the review process for 23 individual calls for proposals. Out of the 412 reviews requested, 368 were received, for a fulfillment ratio of 89.3%. The yield on reviewer invitations has remained consistently high, with approximately one-third of invitations being accepted, and of the reviewers who agreed to provide a review, 88.3% submitted a complete review. Surveys of reviewers and pilot program administrators indicate high satisfaction with the process. CONCLUSIONS: These data indicate that a reviewer exchange consortium is feasible, adds value to participating partners, and is sustainable over time.