NIH PROMIS Statistical Coordinating Center(RMI)

描述(由申请人提供)：为患者报告的结果测量信息系统(PROIS)拟议的统计协调中心(SCC)将提供和管理一个安全的、可定制的数据收集、管理和报告系统，在心理测量和统计分析方面提供领导和专门知识；为与各种慢性病相关的健康状况领域创建题库；开发一个动态系统来管理计算机适应性测试(CAT)；为将使用题库和CAT系统的临床研究人员开发培训材料；与PROIS网络合作，发展持续的公私伙伴关系。我们的SCC调查人员在开发和评估PRO工具和题库方面处于国际领先地位，包括用于题库、CAT、固定评估、评分和多语言报告的相关软件；临床和调查研究研究的设计、实施和协调；以及用于分析自我报告数据的心理测量和统计方法的开发和应用。我们已经使用项目反应理论(IRT)为几个与健康相关的生活质量(HRQL)领域开发了可操作的题库。我们已经在众多患者群体中使用多种平台(例如，基于网络的、触摸屏、集成语音应答(IVR))测试了该系统。因此，从资助期间开始，我们将为主要研究站点(PR)和基于网络的数据收集提供初始PROIS软件。我们的软件包括一个模拟模式，该模式将有助于评估IRT模型、校准和其他CAT条件变化的影响。我们建议的项目团队在使用IRT和其他心理测量学和统计方法进行汇集数据分析方面拥有广泛的专业知识。我们的定位是为PROMIS活动提供领导，并推动建立和应用有效和临床有用的题库背后的科学。我们心理测量学和统计研究人员的科学实力、我们在数据管理和软件开发方面久经考验的能力以及我们跨学科和跨机构合作的记录独特地装备了我们拟议的SCC，使我们的贡献超越了启用和协调大规模数据收集和分析的范围。我们将利用由经验丰富的研究人员和专家组成的五个职能团队，协调、裁决和启动指导委员会和方案调查人员的意见，并将包括学术临床试验人员、政府、行业和患者等“利益相关者”的咨询意见。这一合作努力将确保PROMIS倡议的成功。

DESCRIPTION (provided by applicant): This proposed Statistical Coordinating Center (SCC) for the Patient Reported Outcomes Measurement Information System (PROMIS) will provide and manage a secure, customizable data collection, management and reporting system, provide leadership and expertise in psychometric and statistical analyses; create item banks for health status domains that have relevance across a variety of chronic diseases; develop a dynamic system to administer computer adaptive tests (CAT); develop training materials for clinical researchers who will use the item banks and CAT system; and work collaboratively with the PROMIS network to develop a sustained public-private partnership. Our SCC investigators are international leaders in the development and evaluation of PRO instruments and item banks including related software for item-banking, CAT, fixed assessments, scoring and reporting in multiple languages; the design, implementation and coordination of clinical and survey research studies; and the development and application of psychometric and statistical methods for analysis of self-report data. We have already developed operational item banks for several health-related quality of life (HRQL) domains using item response theory (IRT). We have tested this system in numerous patient populations and using multiple platforms (e.g., web-based, touch screens, Integrated Voice Response (IVR)). Thus, we will provide initial PROMIS software for primary research sites (PRS) and network-based data collection from the start of the funded period. Our software includes a simulation mode that will be useful in evaluating the impact of changing IRT models, calibrations and other CAT conditions. Our proposed project team has extensive expertise in conducting pooled data analysis using IRT and other psychometric and statistical methods. We are positioned to provide leadership of PROMIS activities and advance the science behind building and applying valid and clinically useful item banks. The scientific strength of our psychometric and statistical investigators, our proven capabilities in data management and software development, and our track record of interdisciplinary and inter-institutional collaboration uniquely equip our proposed SCC to accomplish and extend our contribution beyond enabling and coordinating large-scale data collection and analysis. Using five functional teams comprised of experienced investigators and specialists, we will coordinate, adjudicate and activate input from the Steering Committee and the PRS investigators, and will include advisory input from "stakeholders" including academic clinical trialists, government, industry and patients. This collaborative effort will ensure the success of the PROMIS initiative.