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.
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