Extending an Open-Source Integrated Data Management Platform to Anxiety Disorders

将开源集成数据管理平台扩展到焦虑症

• 批准号: 8789179
• 负责人: LEON ROZENBLIT
• 金额: $ 22.23万
• 依托单位: PROMETHEUS RESEARCH, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-03 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8789179
• 关键词: Address; Adverse event; Ancillary Study; Anxiety; Anxiety Disorders; Area; Autistic Disorder; Behavioral; Behavioral Research; Businesses; Clinical Research; Clinical Trials; Code; Collaborations; Communities; Complex; Computer software; Consent; Control Groups; Data; Data Collection; Databases; Development; Electronic Health Record; Eligibility Determination; Enrollment; Evaluation; Feedback; Funding; Goals; Good Clinical Practice; Grant; Guidelines; Health; Interdisciplinary Study; International; Intervention Studies; Licensing; Longitudinal Studies; Mental Health; Mental disorders; Modeling; Parents; Participant; Phase; Process; Regulation; Reporting; Research; Research Methodology; Research Personnel; Resource Sharing; Resources; Safety Management; Sampling; Science; Selection Criteria; Services; Site; Solutions; Support System; System; Technology; Testing; United States National Institutes of Health; Work; base; behavioral health; cost; data exchange; data management; empowered; follow-up; meetings; open source; patient registry; programs; software development; success; systems research; tool; trend; usability

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：本申请的目的是通过提供满足其需求的开放源，综合的数据管理平台，使研究人员能够在整个研究生命周期内更有效地管理，共享和重新利用他们的研究数据。心理健康研究变得更加复杂，协作和跨学科，共享和重新利用数据进行复制，次要分析对科学的发展变得越来越重要。这些趋势需要一个数据管理系统，使研究人员能够在整个数据管理生命周期中跨研究和站点之间不断整合异质数据，从而使数据成为可再生的，而不是可支配的资源。尽管焦虑症研究尚不存在适当的技术，但自闭症的开放源研究交换数据库（REXDB）即将接近。 REXDB的自闭症是第一个健壮的开放源系统，可满足自闭症研究人员的综合生命周期数据管理需求。我们建议对支持三种主要焦虑研究的REXDB进行关键增强：（1）介入研究（例如临床试验）； （2）与临床试验一起进行的辅助Stuies； （3）跟进参与者的纵向研究 一个或多个临床试验（例如，综合患者注册表）。为了实现我们的总体目标，我们将：（a）通过与四个评估网站上的利益相关者互动来明确定义软件要求来确定用户所需的功能；（b）提供该软件的初步版本，使用户能够配置强大的数据管理系统以进行焦虑研究； （c）通过从每个评估站点征求常规利益相关者的反馈和可用性测试来实现和评估新功能，从而通过敏捷的迭代软件开发过程来解决主要差距； （d）在焦虑症研究人员中建立一个积极的用户社区。满足焦虑症需求的数据管理系统研究人员可能会概括各种行为和心理健康研究。成功将加速研究，并通过将研究数据转换为共享的可再生资源，从而增加NIH对心理健康所花费的每笔研究美元的价值。