Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant

The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap
initiative to develop a computerized system measuring patient-reported outcomes in
respondents with a wide range of chronic diseases and demographic characteristics. In the
first four years of its existence, the PROMIS network developed item banks for measuring
patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical
function, and social functioning. During the item banking process, the PROMIS network
conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses
to refine the meaning, clarity, and literacy demands of all items. The item banks were
administered to over 20,000 respondents and calibrated using models based on item response
theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were
developed and implemented. The network has designed a series of studies using clinical
populations to evaluate the item attributes, examine their utility as CATs, and validate the
item banks. More information on the PROMIS network can be found at www.nihpromis.org.

The purpose of this research study is to learn about the experience and impact of having
congestive heart failure (CHF). In particular, we hope to develop better questionnaires that
can measure heart failure patients' quality-of-life.