NIH PROMIS Statistical Coordinating Center(RMI)

NIH PROMIS 统计协调中心（RMI）

基本信息

批准号：
7289881
负责人：
DAVID CELLA
金额：
$ 167.78万
依托单位：
NORTHSHORE UNIVERSITY HEALTHSYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-28 至 2009-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7289881
关键词：
Academy Address Administrator Adolescent Medicine Algorithms Amendment American American Psychological Association Appendix Archives Area Arthritis Attention Authorization documentation Back Bass Budgets Calibration Cardiovascular Diseases Case Report Form Cells Certification Characteristics Childhood Chronic Chronic Disease Chronic Fatigue Syndrome Classification Clinical Clinical Research Clinical Trials Code Cognitive Collaborations Collection Communication Communities Comprehension Computer Simulation Computer Systems Development Computer software Computers Computing Methodologies Concept Review Condition Confidentiality Confidentiality of Patient Information Congresses Consensus Consensus Development Consult Data Data Analyses Data Collection Data Coordinating Center Data Files Data Quality Data Reporting Data Security Data Set Databases Decision Making Depth Development Device or Instrument Development Diabetes Mellitus Dimensions Disabled Persons Disease Doctor of Philosophy Drug Industry Education Electronics Eligibility Determination Endocrinology English Language Ensure Equation Equilibrium Evaluation Exclusion Exercise Expert Opinion Facility Construction Funding Category Fatigue Feasibility Studies Feedback Floor Focus Groups Frequencies Funding GDF15 gene Gastrointestinal Diseases Generations Goals Gold Government Grant Guidelines HIV Hand Health Health Status Heart Diseases Hepatitis C Housing Human Human Resources Individual Industry Information Systems Institution International Internet Intervention Interview Java Knowledge acquisition Language Leadership Length Letters Licensing Licensure Location Maintenance Malignant Neoplasms Manuals Manufacturer Name Maps Measurement Measures Medicine Mental Health Meta-Analysis Methods Modeling Modification Monitor Monitoring Clinical Trials Names Network-based Neurology Numbers Online Systems Operating System Operative Surgical Procedures Outcome Outcome Assessment Outcome Measure Output PLAB Protein Pain Pain Measurement Paper Participant Patient Outcomes Assessments Patient Recruitments Patient Self-Report Patients Pediatrics Performance Persons Pharmacologic Substance Phase Physical Function Pilot Projects Population Positioning Attribute Principal Investigator Printing Procedures Process Production Programming Languages Property Protocol Compliance Protocols documentation Psychometrics Publishing Purpose Qualitative Methods Questionnaires Range Rate Reading Recommendation Rehabilitation therapy Reporting Research Research Design Research Ethics Committees Research Infrastructure Research Personnel Resources Respondent Review Committee Rheumatology Role Sampling Schedule Science Scientist Score Secure Security Self-Administered Shipping Ships Simulate Site Source Specialist Specific qualifier value Standards of Weights and Measures Statistical Methods Statistical Models Summary Reports Surveys Symptoms System System for Public Use TAF8 gene TNF gene Techniques Technology Technology Assessment Teleconferences Telephone Test Result Testing Text Time TimeLine Touch sensation Training Translating Translations United States National Institutes of Health Universities Update Variant Vision Voice Work Writing adjudicate adjudication base clinically significant computerized concept data acquisition data integrity data management data modeling day design disability expectation experience file format health related quality of life improved instrument laptop literacy medical specialties member novel oncology performance site programs protocol development quality assurance repository research study respiratory response simulation size skills software development software systems sound statistical center statistics success symposium technical report theories tool touchscreen trait treatment planning user-friendly virtual web interface

项目摘要

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.

描述（由申请人提供）：拟议的患者报告结果测量信息系统 (PROMIS) 统计协调中心 (SCC) 将提供和管理安全、可定制的数据收集、管理和报告系统，提供心理测量和统计方面的领导力和专业知识分析；为与各种慢性病相关的健康状况领域创建项目库；开发动态系统来管理计算机自适应测试（CAT）；为将使用项目库和 CAT 系统的临床研究人员开发培训材料；并与 PROMIS 网络合作，发展持续的公私伙伴关系。我们的 SCC 调查员是 PRO 工具和题库开发和评估方面的国际领先者，包括题库、CAT、固定评估、评分和多种语言报告的相关软件；临床和调查研究的设计、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) 为多个与健康相关的生活质量 (HRQL) 领域开发了可操作的项目库。我们已在众多患者群体中使用多个平台（例如基于网络、触摸屏、集成语音应答 (IVR)）对该系统进行了测试。因此，我们将从资助期开始为主要研究站点（PRS）和基于网络的数据收集提供初始 PROMIS 软件。我们的软件包括一个模拟模式，可用于评估更改 IRT 模型、校准和其他 CAT 条件的影响。我们提议的项目团队在使用 IRT 和其他心理测量和统计方法进行汇总数据分析方面拥有丰富的专业知识。我们的定位是领导 PROMIS 活动，并推进构建和应用有效且临床有用的项目库背后的科学。我们的心理测量和统计调查人员的科学实力、我们在数据管理和软件开发方面经过验证的能力，以及我们跨学科和机构间合作的记录，使我们拟议的 SCC 能够独特地完成和扩展我们的贡献，超越支持和协调大规模数据收集和分析。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、裁决和激活指导委员会和 PRS 研究人员的意见，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。这种协作努力将确保 PROMIS 计划的成功。