RESUMEN
Introduction: A guiding principle behind the development and deployment of the REDCap data management platform has always included attention to workflow design that allows easy implementation of best practices for clinical and translational researchers. CDISC standards such as CDASH have helped the clinical research community improve the efficiency, actionability, and quality of their clinical trials data, but have had limited uptake among the academic institutions. Objective: To create a scalable methodology to convert CDISC CDASH eCRF instrument metadata into REDCap data dictionaries for the purpose of simplifying adoption and use of CDASH instruments by research teams across the REDCap Consortium. Implementation: We have used our replicable methods to translate metadata from 34 CDASH Foundational eCRFs and 20 CDASH Crohn's Disease eCRFs into REDCap eCRF metadata and have made these instruments available in the REDCap Shared Data Instrument Library for widespread sharing and uptake across the REDCap Consortium. Users can import the standardized eCRFs directly into their REDCap projects for immediate use in clinical trial data collection. Conclusion: Disseminating CDISC standards through the REDCap community will increase the accessibility of these standards for academic medical centers. Having academic clinical researchers using CDISC standards may lead to more research datasets that interoperate with pharmaceutical sponsored trials, and more discoveries from secondary use of clinical research data.
RESUMEN
BACKGROUND: Financial incentives may aid recruitment to clinical trials, but evidence regarding risk/burden-driven variability in participant preferences for incentives is limited. We developed and tested a framework to support real-world decisions on recruitment budget. METHODS: We included two phases: an Anchoring Survey, to ensure we could capture perceived unpleasantness on a range of life events, and a Vignette Experiment, to explore relationships between financial incentives and participants' perceived risk/burden and willingness to participate in high- and low-risk/burden versions of five vignettes drawn from common research activities. We compared vignette ratings to identify similarly rated life events from the Anchoring Survey to contextualize ratings of study risk. RESULTS: In our Anchoring Survey (n = 643), mean ratings (scale 1 = lowest risk/burden to 5 = highest risk/burden) indicated that the questions made sense to participants, with highest risk assigned to losing house in a fire (4.72), and lowest risk assigned to having blood pressure taken (1.13). In the Vignette Experiment (n = 534), logistic regression indicated that amount of offered financial incentive and perceived risk/burden level were the top two drivers of willingness to participate in four of the five vignettes. Comparison of event ratings in the Anchoring Survey with the Vignette Experiment ratings suggested reasonable concordance on severity of risk/burden. CONCLUSIONS: We demonstrated feasibility of a framework for assessing participant perceptions of risk for study activities and discerned directionality of relationship between financial incentives and willingness to participate. Future work will explore use of this framework as an evidence-gathering approach for gauging appropriate incentives in real-world study contexts.
