ICAR Research Data Repository for Knowledge Management

This study is designed to evaluate the validity (including responsiveness) of selected PROMIS domains for patients with severe heart failure who receive a heart transplant. Heart transplantation tends to create large changes in cardiac functioning over a relatively short time period (i.e., 8-12 weeks). This study assessed patients at two time points: at baseline when patients were put on the heart transplant registry, and 8-12 weeks following the transplant procedure. The earliest time for which most patients were expected to show a benefit of the transplant procedure is 8-12 weeks post-transplant.

Clinical and patient-reported assessments were performed at baseline and 8-12 weeks (end of study). Clinical indicators of functioning include the New York Heart Association (NYHA) classification and the six-minute walk test. The Kansas City Cardiomyopathy Questionnaire (KCCQ), a disease-specific measure of health-related quality of life (HRQOL), were used as a point of reference for understanding the relative validity (including responsiveness) of the PROMIS item banks. Instruments include PROMIS computerized adaptive tests (CATS).