ECHO PRO Research Resource: A Developmentally-based Measurement Science Framework for Assessing Environmental Exposure and Child Health

项目摘要：我们建议为ECHO财团提供资源，让最先进的患者参与其中 报告结果(PRO)评估和分析，由我们现有的临床、开发 心理测量、分析和技术专长。ECHO PRO CORE的责任范围将 包括：1)维持和提供成人和儿童的暴露和健康评估，包括自我 和代理报告，对儿童在多个环境中的功能的观察测量，以及性能 衡量儿童功能的多方面；2)协助协调中心(CC)和队列地点 在ECHO研究中纳入并适当使用PRO和观察性措施；3)发展和 验证新仪器(并根据需要修改现有仪器)；以及4)就数据分析提供咨询 这包括ECHO PRO工具，包括心理测量分析，以评估新的和现有的措施 在ECHO联盟中表演。为了实现这一目标，我们提出了四个具体目标：目标1是作为 ECHO PRO研究资源，提供选择、开发和验证方面的指导和专业知识 自我报告、观察性和基于绩效的成人和儿童PRO(CPRO)措施。我们将框定和 使ECHO联盟的纵向队列研究可以使用的策略来探索 环境暴露与儿童健康结果之间的关系。目标2是标准化、组织化、 管理和分析队列站点的PRO核心要素数据收集所产生的数据。劳作 我们将与现场队列工作人员以及CC和DAC密切合作，收集、集成和分析PRO数据 关于其信度、效度、发展敏感性和可变性，以及与其他关键因素的关系 环境和临床变量。这一目标包括对以下各项措施进行彻底的管理 Echo Pro Core。目标3是提供支持收集所需的软件和硬件， 传输和存储财团收集的PRO数据。我们将提供一个整合的平台， 自动使用调查引擎、数据捕获和安全数据传输。这个平台将是兼容的 利用各种信息收集模式(包括基于网络/移动的输入，非数字纸源数据， 和其他人)。最后，目标4是提供全面的管理、协调和沟通 ECHO PRO核心与NIH、CC和其他ECHO组件的工作。我们将集中ECHO PRO 围绕评估中心技术和我们的健康状况的资源衡量的内容包括所有 在RFA中指定的主要评估系统。这些系统将由我们的人员提供支持， 在结果研究、统计学、心理测量学、调查设计、信息技术和 定性/跨文化方法。我们还将参与和管理以下几个项目的投入和专业知识 以产前和产后为重点的环境暴露方面的联合点和专家合作调查员 风险、发展科学(婴儿和儿童早期发育)、母胎医学和儿科学。

PROJECT SUMMARY: We propose to resource the ECHO consortium with state-of-the-science patient reported outcome (PRO) assessment and analysis, enabled by our existing clinical, developmental, psychometric, analytic and technical expertise. The scope of responsibility for the ECHO PRO Core will include: 1) maintaining and providing adult and pediatric exposure and health assessments that include self- and proxy- reports, observational measures of child functioning within multiple contexts, and performance measures of multiple facets of child functioning; 2) assisting the Coordinating Center (CC) and cohort sites with inclusion and appropriate use of PROs and observational measures into the ECHO studies; 3) developing and validating new instruments (and modifying existing instruments as needed); and 4) advising on data analyses that include ECHO PRO tools, including psychometric analyses to evaluate new and existing measures as they perform in the ECHO Consortium. To achieve this, we propose four specific aims: Aim 1 is to serve as the ECHO PRO research resource, providing direction and expertise on the selection, development and validation of self-report, observational and performance-based adult and child PRO (cPRO) measures. We will frame and enable strategies that are available to the longitudinal cohort studies of the ECHO consortium to explore the relationship between environmental exposures and child health outcomes. Aim 2 is to standardize, organize, curate and analyze the data arising from the PRO core element data collection at the Cohort Sites. Working closely with cohort site staff as well as the CC and DAC, we will assemble, integrate, and analyze PRO data with regard to its reliability, validity, developmental sensitivity and variability, and relationship to other critical environmental and clinical variables. This aim includes thorough curation of the entire spectrum of measures in the ECHO PRO Core. Aim 3 is to provide the software and hardware necessary to support the collection, transfer and storage of the PRO data collected by the Consortium. We will provide an integrated platform for automated use of a survey engine, data capture, and secure data transfer. This platform will be compatible with various modes of information collection (including web/mobile based entry, non-digital paper source data, and others). Finally, Aim 4 is to provide overall management, coordination and communication regarding the work of the ECHO PRO Core with the NIH, CC and other ECHO constituents. We will centralize ECHO PRO resources around Assessment Center technology and our HealthMeasures content that includes all of the major assessment systems named in the RFA. These systems will be supported by our personnel with expertise in outcomes research, statistics, psychometrics, survey design, information technology, and qualitative / cross-cultural methods. We will also engage and manage input and expertise of several consortium sites and expert co-investigators in environmental exposures with emphasis on pre- and post-natal risk, developmental science (infant and early child development), maternal-fetal medicine, and pediatrics.