|
|
|
|
|
|
|
|
| 1U01AR052177-01 |
| Cella, David |
| d-cella@northwestern.edu |
| Professor of Psychiatry and Behavioral Sciences |
| NIH PROMIS Statistical Coordinating Center |
|
The Principal Investigator of the SCC is Dr. David Cella, Center on Outcomes, Research, and Education (CORE) at Evanston Northwestern Healthcare. In addition to investigators and research staff at CORE, the SCC team comprises key personnel from the Rehabilitation Institute of Chicago (RIC), UCLA Center for Health Sciences, United Biosource Corporation (MEDTAP), and Westat. |
|
|
|
|
| Allen Heinemann, PhD, Co-Investigator | | | | | Allen Heinemann, PhD, Physical Function/Disability (Rehabilitation Institute of Chicago) | | | | | Barbara Piper, RN, Fatigue/Nursing Expert (Scottsdale Healthcare/University of Arizona) | | | | | Beth Hahn, MA, Co-Investigator | | | | | Brice Hart, Senior Systems Analyst | | | | | Darrel Regier, MD, MPH, Mental Illness (American Psychiatric Association) | | | | | David Cella, PhD, Principal Investigator | | | | | Dennis Revicki, PhD, Co-Investigator | | | | | Dennis Turk, PhD, Pain Expert (University of Washington) | | | | | Donald Patrick, PhD, Multidisciplinary Health Outcomes (University of Washington) | | | | | Honghu Liu, PhD, Co-Investigator | | | | | Jacob Fox, MD, Neurology Expert (Rush Presbyterian-St. Luke's Medical Center)) | | | | | Jane Scott, PhD, on behalf of the Food and Drug Administration (CDER/FDA) | | | | | Jane Weeks, MD, Cancer Expert (National Comprehensive Cancer Network) | | | | | Jeanne Teresi, EdD, PhD, Psychometric and DIF Expert | | | | | Jennifer Huang, PhD, Senior Clinical Research Associate | | | | | Jerry Wernimont, Senior Systems Analyst | | | | | Jin-Shei Lai, OTR/PhD, Co-Investigator | | | | | Joyce West, PhD, MPP, Mental Illness Expert (Am. Psych. Int. for Research and Education) | | | | | Karen Gold, PhD, Co-Investigator | | | | | Karen Spritzer, Programmer and Analyst | | | | | Karin Coyne, PhD, MPH, Co-Investigator | | | | | Kevan Herold, MD, Diabetes Expert (Columbia University Medical Center) | | | | | Kevin Weiss, MD, MPH, Adult/Peds Respiratory Illness (Northwestern University) University) | | | | | Kimberly Webster, MA, Communications Director and Co-Investigator | | | | | Leo Morales, PhD, Co-Investigator | | | | | Leonard Jason, PhD, Fatigue Expert (DePaul University) | | | | | Liz Jansky, MA, Senior Clinical Research Associate | | | | | Margaret Rothman, PhD, on behalf of Pharmaceutical Research and Manufacturers Association-Health Outcomes Committee (Johnson & Johnson) | | | | | Michael Bass, MS, Programmer | | | | | Nan Rothrock, PhD, Project | | | | | Patricia Ganz, MD, Cancer Expert (University of California-Los Angeles) | | | | | Peter Tugwell, MD, Rheumatology Expert (Outcome Measures for Rheum. Arthritis Clin. Trls) | | | | | Randy Williams, MD, Cardiovascular Expert (Pharos Innovations) | | | | | Rene Gonin, PhD, Co-Investigator | | | | | Richard Gershon, PhD, Co-Investigator | | | | | Richard Harvey MD, Neurology Expert (Rehabilitation Insitute of Chicago) | | | | | Rita Bode, PhD, Co-Investigator | | | | | Robert Dworkin, PhD, Pain Expert (University of Rochester) | | | | | Ron Hambleton, PhD, Psychometric Expert | | | | | Ron Hays, PhD, Co-Investigator | | | | | Seung Choi PhD, Psychometrician | | | | | Stephen Duck, MD, Pediatric Expert (Evanston Northwestern Healthcare) | | | | | Steve Durako, Co-Investigator | | | | | Steven Reise, PhD, Co-Investigator | | | | | Susan Yount, PhD, Scientific Project Director and Co Investigator | | | | | Terry Svaglic, MAcc, Administrative Project Director | | | | | Wen-Hung Chen, PhD, Psychometrician | | | |
|
|
|
|
|
|
|

Abstract: This Statistical Coordinating Center (SCC) for 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 testing (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 patient-reported outcomes instruments and item banks, including related software for item-banking, CAT, fixed assessments, and 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 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). Thus, we will provide initial PROMIS software for primary research sites (PRSs) 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 interinstitutional 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 of experienced investigators and specialists, we will coordinate, adjudicate, and activate input from the Steering Committee and the PRS investigators, and we 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. |
|
|
|
|
|
 |
 |
 |
 |
|