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ASCO Educational Book; 2009
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New Tools for Measuring Patient-reported Outcomes in Cancer Research: The Patient-reported Outcomes Measurement Information System (PROMIS)

David Cella, PhD, Bryce B. Reeve, PhD, Nan Rothrock, PhD, Kimberly Webster, MA, Kevin P. Weinfurt, PhD for the PROMIS Cooperative Group

From the Center on Outcomes, Research and Education, NorthShore University Health System, and Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL; Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC

Supported by National Institutes of Health Grant U01AR052177 to the Center on Outcomes, Research and Education, Evanston Northwestern Healthcare, and National Institutes of Health Grant U01AR052186 to Duke University Medical Center.

Address reprint requests to Kevin P. Weinfurt, PhD, Box 17969, Duke University Medical Center, Durham, NC 27715; e-mail: kevin.weinfurt{at}duke.edu

Overview: Patient-reported outcomes (PROs) have played an integral role in the evaluation of new cancer treatments and in monitoring the health of cancer populations over time. Recent decades have witnessed both a growth in the number of measures and methodological improvements to the process of designing and evaluating measures. In late 2004, a group of outcomes scientists from seven institutions and the National Institutes of Health (NIH) formed a cooperative group funded under the NIH Roadmap for Medical Research Initiative to reengineer the clinical research enterprise (http://www.nihroadmap.nih.gov). This initiative — the Patient-Reported Outcomes Measurement Information System (PROMIS) — aims to revolutionize the way PRO tools are selected and used in clinical research and practice evaluation. It will also establish a national resource for accurate and efficient measurement of patient-reported symptoms and other health outcomes in clinical practice. (For more information about the NIH Roadmap, please visit the website at http://www.nihroadmap.nih.gov. For more information about PROMIS, visit http://www.nihpromis.org.) The purpose of this chapter is to provide a summary of the measure development process used in PROMIS. This review includes how measurement domains were identified and defined, how items were constructed and evaluated to measure the domains, and how pools of similar items were examined statistically to arrive at the PROMIS item banks. We conclude with a review of the PROMIS products that are currently available to researchers. The presentations during the educational session will review this material briefly but will focus more directly on the psychometric advances reflected by PROMIS and practical implications for cancer researchers.