Dynamic Outcome Assessment in Multi Center Trials(RMI)

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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.