RM-04-011

DYNAMIC ASSESSMENT OF PATIENT-REPORTED CHRONIC

DISEASE OUTCOMES

Pre-Application MeetingJanuary 26, 2004

Rockville, MD

Deborah N. Ader, Ph.D., NIAMSAderd@mail.nih.gov

Larry Fine, M.D., DrPH, OBSSRFinel@mail.nih.gov

Call-in: (888) 566-5788

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

SABPRS

SCC

NIH Science Officers

PRS

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 proposalMaximum Budget: $450,000 total

Network Projects Two Network Concept ProposalsEstimated 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?