: This is a revised application for the applicant's project evaluating the psychometric properties of generic and specific instruments to measure health-related quality of life (HRQOL) in transplant patients. The assessment of HRQOL in solid organ (liver, heart, kidney, lung) transplant candidates and recipients presents several challenges relating to psychometrics and score interpretation. These include: 1) establishing normative data or benchmarks for transplant recipients; 2) determining the validity and relative utility of instruments and scoring strategies for the measurement of generic HRQOL, depression, and anxiety in patients undergoing chronic immuno-suppression; and 3) establishing the sensitivity to change over time, and mapping the trajectory of recovery due to transplantation and the side effects of immuno-suppressive drugs. The proposed research entails an innovative evaluation and comparison of the psychometric properties of a battery of widely used generic and specific self-report instruments vis-a-vis their application in the discrete and longitudinal assessment of HRQOL using methods based on classical test theory (CTT) and on item response theory (IRT). Additionally, an investigator-developed inventory of patient satisfaction with the transplantation healthcare delivery system will be validated. Criterion measures include clinicians' assessments of functional performance, rejection episodes, anti-rejection medication regimens, other clinically relevant indices, and pre-specified definitions of change. Previous research, which employed longitudinal assessment of functional performance coupled with cross-sectional data relating to generic HRQOL, demonstrated that the greatest change in HRQOL and functional performance occurs within the first post-transplant year. Data acquisition will therefore occur at the time of evaluation for transplantation, every six months until transplantation, and at one, three, six, and twelve months post-transplantation. CTT- and IRT-based structures will be established and confirmed in two randomly assigned sub-samples, and the criterion-related validity of various scoring strategies will be evaluated and compared at each time point. Absolute and relative responsiveness to change will be evaluated across time. This research lays a foundation for enhanced validity and precision in the future evaluation of generic and specific HRQOL outcomes in organ transplant patients, and of the effects of new therapeutics and transplantation management programs. Additional research implications include potential impact on: 1) choice of instruments for future clinical trials; 2) health care policy and resource allocation decisions; and 3) individual decision making concerning organ transplantation and donation.
| Russell, Robert T; Feurer, Irene D; Wisawatapnimit, Panarut et al. (2008) The effects of physical quality of life, time, and gender on change in symptoms of anxiety and depression after liver transplantation. J Gastrointest Surg 12:138-44 |
