The goal of this application is to empower anxiety disorders researchers to manage, share, and repurpose their research data more effectively throughout the research lifecycle by delivering an open--source, integrated data management platform that meets their needs. Mental health research has become more complex, collaborative, and interdisciplinary and sharing and repurposing data for replication and secondary analyses have become increasingly important to the advancement of science. These trends require a data management system that enables researchers to continuously integrate heterogeneous data across studies and sites throughout the data management lifecycle, allowing the data to be a renewable, rather than a disposable, resource. Although appropriate technology does not yet exist for anxiety disorders research, the open--source Research Exchange Database (RexDB) for autism comes close. RexDB for autism is the first robust, open--source system to meet the integrated lifecycle data management needs of autism researchers. We propose to make critical enhancements to RexDB that support three major types of anxiety research: (1) interventional research (such as clinical trials); (2) ancillary stuies conducted alongside clinical trials; and (3) longitudinal studies that follow up on participants in one or more clinical trials (e.g., integrated patient registries). To achieve our overarching aim, we will: (a) identify the features users need by engaging with stakeholders at four evaluation sites to clearly define software requirements;(b) deliver a preliminary version of the software tha empowers users to configure a robust data management system for anxiety research;; (c) implement and evaluate new features by soliciting regular stakeholder feedback and usability testing from each of the evaluation sites, addressing major gaps via an agile, iterative software development process; and (d) build an active community of users among anxiety disorders researchers. A data management system that meets the needs of anxiety disorders researchers will likely generalize across a broad spectrum of behavioral and mental health research. Success will accelerate research and increase the value of every research dollar spent by the NIH on mental health by transforming research data into a shared, renewable resource.
Public Health Relevance Statement: Public Health Relevance: This project will empower anxiety disorders researchers to make more effective use of the interdisciplinary research data they collect and to more efficiently exchange data with the scientific community. We will achieve this goal by delivering free (open-source) software that can easily integrate various kinds of data from different studies to meet the needs of anxiety researchers. This software will allow researchers to optimize their use of scarce research dollars, and will help accelerate progress in understanding anxiety and other mental disorders.
Project Terms: Address; Adverse event; Ancillary Study; Anxiety; Anxiety Disorders; Area; Autistic Disorder; base; Behavioral; behavioral health; Behavioral Research; Businesses; Clinical Research; Clinical Trials; Code; Collaborations; Communities; Complex; Computer software; Consent; Control Groups; cost; Data; Data Collection; data exchange; data management; Databases; Development; Electronic Health Record; Eligibility Determination; empowered; Enrollment; Evaluation; Feedback; follow-up; Funding; Goals; Good Clinical Practice; Grant; Guidelines; Health; Interdisciplinary Study; International; Intervention Studies; Licensing; Longitudinal Studies; meetings; Mental disorders; Mental Health; Modeling; open source; Parents; Participant; patient registry; Phase; Process; programs; Regulation; Reporting; Research; Research Methodology; Research Personnel; Resource Sharing; Resources; Safety Management; Sampling; Science; Selection Criteria; Services; Site; software development; Solutions; success; Support System; System; systems research; Technology; Testing; tool; trend; United States National Institutes of Health; usability; Work
