Dynamic Outcome Assessment in Multi Center Trials(RMI)

描述(由申请人提供)：测量技术的最新发展使研究人员和临床医生能够更有效、更精确和更方便地评估患者报告的结果(PRO)。患者报告结果测量信息系统(PROIS)网络的目标是开发一种使用计算机化自适应测试(CAT)评估PROIS的统一方法。该网络努力的成功将在一定程度上取决于将技术成果纳入多中心临床试验的能力。到目前为止，很少有工作涉及何时以及如何将这些新的评估技术纳入多中心试验。这些新方法带来了更高的精确度和更少的患者负担，但也带来了更大的后勤复杂性和成本。PROMIS网站应用的总体目标是确定和解决将CAT整合到多中心临床试验中的挑战。我们将通过追求四个具体目标来实现这一目标：(1)开发将计算机化自适应测试集成到多中心临床试验所使用的当前和未来数据捕获系统中的选项。(2)评估多中心临床试验站点使用计算机化自适应测试收集PRO数据的准备情况。(3)进行模拟，以探讨在多中心临床试验中实施不同PRO数据收集模式的成本和收益。(4)制定建议，将计算机化的适应性测试纳入多中心临床试验中使用的当前和未来的数据捕获系统。拟议的独立研究直接针对PROMIS网络的具体目标，使PROMIS工具在临床研究界得到最大程度的接受，并利用可行性研究结果来加强PROMIS。我们还为全网络研究提出了两个概念，涉及疼痛的评估和确定PRO中最小重要差异的标准过程。

DESCRIPTION (provided by applicant): Recent developments in measurement technology can allow researchers and clinicians to assess patientreported outcomes (PROs) with greater validity, precision, and convenience. The goal of the Patient-Reported Outcomes Measurement Information System (PROMIS) Network is to develop a unified approach for assessing PROs using computerized adaptive testing (CAT). The success of the Network's efforts will depend in part on the ability to incorporate the technological achievements into multicenter clinical trials. To date, little work has addressed when and how these new assessment technologies should be incorporated into multicenter trials. These new methods bring potential for greater precision and less patient burden, but also for greater logistic complexity and cost. The overall objective of this PROMIS site application is to identify and address challenges to integrating CAT into multicenter clinical trials. We will accomplish this by pursuing four Specific Aims: (1) To develop options for integrating computerized adaptive testing into current and future data capture systems used in multicenter clinical trials. (2) To assess the readiness of sites in multicenter clinical trials to collect PRO data using computerized adaptive testing. (3) To conduct simulations to explore the costs and benefits of implementing different PRO data collection models in multicenter clinical trials. (4) To develop recommendations for incorporating computerized adaptive testing into current and future data capture systems used in multicenter clinical trials. The proposed independent study directly addresses the specific objectives of the PROMIS Network by maximizing acceptance of the PROMIS tool in the clinical research community and using feasibility study results to enhance the PROMIS. We also propose two concepts for Network-wide study relating to the assessment of pain and the defining a standard process for determining minimally important differences in PROs.