RM DYNAMIC ASSESSMENT OF PATIENT-REPORTED CHRONIC DISEASE OUTCOMES Pre-Application Meeting January 26, 2004 Rockville, MD

Deborah N. Ader, Ph.D., NIAMS Larry Fine, M.D., DrPH, OBSSR Call-in: (888)

Improve assessment of self-reported symptoms and other domains of health-related quality of life across a wide range of chronic diseases GOAL of RFA

STRUCTURE Collaborative agreement network - Patient Reported Outcomes Measurement Information System (PROMIS) consisting of: 3-6 Primary Research Sites A Statistical Coordinating Center Steering Committee Scientific Advisory Board

SAB PRS SCCSCC NIH Science Officers PRS SC

BROAD OBJECTIVES Develop and test a large bank of items measuring PRO Create a CAT for efficient assessment of PRO across a range of chronic diseases

BROAD OBJECTIVES Create a publicly available, adaptable and sustainable system that will:  Administer a CAT-based PRO questionnaire or allow researchers to download the CAT  Collect PRO data for research and to update  Provide instant reports

SPECIFIC RESEARCH OBJECTIVES Develop a core set of questions:  Primarily from existing items  Most common dimensions of PRO relevant to widest range of chronic diseases; special interest in pain and fatigue  Large diverse sample

SPECIFIC RESEARCH OBJECTIVES Develop common metrics Create item bank using modern measurement theory Develop CAT Create web-based, user-friendly repository Plan to maximize acceptance Conduct feasibility studies Plan for a public private partnership

Primary Research Sites Identify and define key PRO constructs Contribute expertise to design PROMIS Collect data from specified populations Conduct independent studies that will complement PROMIS

PRS APPLICATIONS Independent Project  25-Page research proposal  Maximum Budget: $450,000 total Network Projects  Two Network Concept Proposals  Estimated budget - Total budget for PRS and Network combined not to exceed $875,000

Statistical Coordinating Center Collect, manage, and analyze PRO data using psychometric, statistical, and survey research methods Design and create a use-friendly PROMIS that protects patient confidentiality

SCC APPLICATIONS Item Bank Development CAT Development PRO Assessment, Data Collection, Reporting System Data management, training, and QC Data analysis Data confidentiality and system security Communication Scientific leadership and dissemination

QUESTIONS?