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可以使研究人员和临床医生以更高的有效性，准确性和便利性评估患者报告的结果（PROs）。患者报告结果测量信息系统（PROMIS）网络的目标是开发一种使用计算机化自适应测试（CAT）评估PROs的统一方法。该网络努力的成功将部分取决于将技术成果纳入多中心临床试验的能力。迄今为止，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。这些新方法可能带来更高的精度和更少的患者负担，但也会增加后勤复杂性和成本。这个PROMIS网站申请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)开发将计算机自适应测试集成到当前和未来多中心临床试验中使用的数据捕获系统的选择。(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，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)为将计算机化自适应测试纳入当前和未来多中心临床试验中使用的数据采集系统提出建议。拟议的独立研究通过最大化临床研究界对PROMIS工具的接受度，并使用可行性研究结果来增强PROMIS，直接解决了PROMIS网络的具体目标。我们还提出了与疼痛评估和确定pro最小重要差异的标准过程相关的网络范围研究的两个概念。

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.