Quality of Life for SCI Clinical Trials: Development of the SCI-QOL

Kessler Foundation, Inc., West Orange NJ

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): The NIH Roadmap has recognized the importance of valid outcomes assessment in clinical research, stating: "There is a pressing need to better quantify clinically important symptoms and outcomes, including pain, fatigue, and quality of life. Through this effort, new technologies will be developed and tested to measure these self-reported health states and outcomes across a wide range of illnesses and disease severities." Despite this call for action, there is a paucity of health-related quality of life (HRQOL) measures that have been developed specifically for use with SCI populations. HRQOL measures used in SCI clinical trials tend to be generic instruments, containing irrelevant and sometimes offensive items which lack clinical utility. Traumatic SCI results in a sudden and devastating constellation of physiological changes, secondary complications, and impaired social and psychological function, all of which significantly impact HRQOL. A valid SCI-specific measure of QOL is needed to accurately measure both clinical and research outcomes. The current study aims to: 1) Construct a clinically relevant helath-related quality of life (HRQOL) measurement scale targeted towards individuals with SCI, 2) Ensure that the resulting scale is compatible with the "Neuro-QOL" measurement system to ensure acceptance by the field and utility in clinical trials, 3) Field Test the SCI-targeted and generic Neuro-QOL item banks with a sample of SCI patients, 4) Utilize Item Response Theory (IRT) methodology to refine and calibrate item banks for use with an SCI population in clinical trials, and 5) Develop a computerized adaptive testing (CAT) program for administration of the item banks and field test the CAT program in a new sample of SCI patients. The SCI-QOL scale will be developed using a state-of-the-art approach, employing both classical and contemporary methods of test construction and validation. Five different rehabilitation facilities from across the nation, including four Model SCI Systems, will participate in the development of this new HRQOL measure to ensure adequate sensitivity and specificity. The instrument will be developed as a CAT that will be practical and flexible for administration in many settings. Finally, the proposed study will fill a significant void by developing a meaningful, valid, and concise measure of HRQOL for use in outcome measurement of SCI clinical trials and will be integrated with the NINDS Neuro-QOL measure. [unreadable] [unreadable] [unreadable]