PROMIS Statistical Center


Grant Number: 1U54AR057951-01
Project Title: NIH PROMIS Statistical Center
PI Name, Title and Contact Information: David Cella, Professor of Psychiatry and Behavioral Sciences; Chair, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University
Other Key Personnel: Susan Yount, PhD, Co-investigator and Scientific Executive Director
Ronald Hays, PhD, Co-Investigator and Head, Psychometric Methods and Applications Core
Beth Hahn, MA, Co-Investigator and Head, Biostatistics and Database Management Core
Jennifer Beaumont, MS, Co-Investigator
Wen-Hung Chen, PhD, Co-Investigator
Seung Choi, PhD, Co-Investigator
Peter Connor, Administrator
Helena Correia, MA (eq), Co-Investigator
Richard Gershon, PhD, Co-Investigator
Robert Gibbons, PhD, Consultant
Ron Hambleton, PhD, Consultant
Jennifer Huang, PhD, Co-Investigator
Liz Jansky, MA, Co-Investigator
Jin-Shei Lai, OTR/PhD, Co-Investigator
Hunghu Liu, PhD, Co-Investigator
Susan Magasi, PhD, OT, Co-Investigator
Steven Reise, PhD, Co-Investigator
Dennis Revicki, PhD, Co-Investigator
Matthias Rose, MD, PhD, Consultant
Nan Rothrock, PhD, Co-Investigator
Kathleen Swantek, MLS, Resource Librarian
Jeanne Teresi, EdD, PhD, Consultant
Vitali Ustsinovich, MA , Project Manager
Margaret Vernon, PhD, Co-Investigator
David Victorson, PhD, Co-Investigator
Katy Wortman, Database Manager
Web Site:  

Abstract:

The Patient-Reported Outcomes Measurement Information System (PROMIS) Statistical Center (PSC) advises and educates members of the network on a range of qualitative research methods; develops and implements processes to ensure data quality; provides leadership in the development of PROMIS-approved translations of new and extant domains; assists in the development and implementation of protocols, provides consultation on research design, sample size, sampling plans and power estimates for item bank testing; and provides psychometric and statistical support for the network. The PSC serves as the repository for all data collected across the PROMIS network, enabling central quality assurance of data and analysis integrity. PSC investigators provide leadership and expertise in mixed quantitative and qualitative methods approaches to develop, test and refine PROMIS items banks and assessment tools. The PSC also participates with the PROMIS Network Steering Committee (PNSC) to prioritize the science and other decisions to be made regarding PROMIS measurement science and tools to support its widespread use. Our PSC investigators are international leaders in the development and evaluation of PRO instruments and item banks; the design, implementation and coordination of clinical and survey research studies; and the development and application of psychometric, statistical and qualitative methods for analysis of self-report data, and cross-cultural PRO development and evaluation, including multi-lingual translations. Our own work in developing PROs and developing and using various forms of technology for their administration affords us valuable experience in collaborating with informatics experts, such as the PTC, to advance the use of these tools in research and practice. Investigators have 4-years of collaborative experience on PROMIS I and even more on related research. The PSC offers the combination of the scientific and collaborative experience of our psycho-metric, statistical and qualitative investigators; capabilities in data and project coordination and management; and a track record of network leadership and interdisciplinary and inter-institutional collaboration. Through 3 functional cores and an admin unit, we solicit, coordinate and activate input from the PNSC, PTC, PNC and the PRS investigators to ensure the success of the PROMIS initiative.

Goal:

The goals of the PSC are embedded in the overall goals of the PROMIS Network. The PSC provides expert input, education, and, in cases where needed, analysis of data collected at the network research sites. The PSC is the repository of all data collected across the PROMIS network, enabling central quality assurance of data and analysis integrity. The PSC serves as advisors and collaborators on the standard PROMIS qualitative and quantitative methods employed to develop, test and refine PROMIS item banks and assessment tools. The PSC participates with the PROMIS Network Steering Committee (PNSC) to prioritize the science and many decisions that must be made regarding PROMIS measurement science and measurement tools to support its widespread use. The PSC engages in a range activities of the PROMIS network, such as advising research sites on qualitative research methods, survey design, survey methods and sampling strategies; psychometric analysis of response data; statistical analysis of demographic, clinical and self-report data; and data management and reporting. The specific aims of the PSC are divided into four areas that also define our structure and organization: Psychometric Methods and their Applications, Biostatistics and Data Management, Survey Design and Qualitative Methods, and Administrative.

Psychometric Methods and their Applications

AIM 1: To advise, educate and participate in the psychometric, statistical and survey research methods associated with network validation studies

AIM 2: To further develop our fully functional CAT system by advancing multidimensional and bifactor CAT and improving item selection and score estimation

AIM 3: To support the science behind testing items banks in different diseases and ethnic groups

Biostatistics and Data Management

AIM 4: To advise and conduct statistical tests of equivalence or comparability of different modes of administration

AIM 5: To advise, educate and participate in incorporating existing but as-yet-unvalidated PROMIS item banks into testing of multiple disease populations and the US general population

AIM 6: To evaluate the validity, including meaningful differences and responsiveness to change, of PROMIS instruments in clinical populations tested in the PROMIS Network

Survey Design and Qualitative Methods

AIM 7: To improve usability of PROMIS domains and tools for clinical research settings by producing clear, easy-to-complete, PROMIS assessment short forms and health profiles

AIM 8: To enable and evaluate translations of new PROMIS item banks into Spanish and other languages, and calibrate translated item banks with sufficient data

AIM 9: To advise and educate network members regarding PROMIS qualitative methods and analytic frameworks for developing additional domains

Administrative

AIM 10: To participate in the process of building partnerships that facilitate use of PROMIS by the clinical research community, thereby securing long-term sustainability for the PROMIS domains and tools

For questions concerning the Statistical Center’s role in the PROMIS network, please contact David Cella by e-mail at d-cella@northwestern.edu. For more information about the PROMIS network, go to http://www.nihpromis.org.