The National Institutes of Health (NIH) has developed the roadmap initiative project entitled "Patient Reported Outcomes Measurement Information System (PROMIS)", a quality of life health outcomes survey for the general population. In 2004, because it was determined that persons with neurological disorders have different needs and medical issues than the general population, the National Institute of Neurological Disorders and Stroke (NINDS) awarded a separate contract to Dr. David Cella at Northwestern University, to develop a patient reported outcomes/health-related quality of life instrument specific for persons with the neurological disorders (Neuro-QOL). These disorders included: stroke, Parkinson's disease (PD), neuromuscular disorders [myasthenia gravis and amyotrophic lateral sclerosis (ALS)], epilepsy, and multiple sclerosis (MS). Persons with SCI were intentionally not included in the Neuro-QOL due to funding limitations and potential other more specific needs. The scarcity of valid and useful SCI-specific measurement tools hinders the efforts of researchers who are investigating interventions for improved function and quality of life in persons with SCI. A multisite collaborative study is ongoing to develop and field- test a meaningful, relevant and psychometrically sound health-related quality of life scale for use in an SCI population. This collaborative study of the SCI-QOL was originally funded as two separate projects that have subsequently joined forces. National Institute of Neurological Diseases and Stroke (NINDS) awarded funding to Dr. Alan Jette from Boston University, Boston, MA and the National Institute of Disability Rehabilitation Research (NIDRR) funded Dr. David Tulsky at the University of Michigan, Ann Arbor, MI to develop an SCI-specific patient reported outcomes measure of health-related quality of life, namely the SCI-QOL. None of the three projects PROMIS, NEURO-QOL, and SCI-QOL have specifically targeted veterans. The goals of this project are to include veterans with SCI (representing about one-fourth of all persons with SCI in the USA) in the validation phase of the spinal cord injury health-related quality of life (SCI-QOL). [This instrument is being developed by Dr. David Tulsky (formerly at the Kessler Medical Research Foundation/Kessler Institute but who has recently moved to the University of Michigan) in conjunction with investigators from several SCI model system sites and psychometricians at Northwestern University.] In addition to including veterans in the validation sample, our study proposes to determine if quality of life differences exist between veterans and nonveterans with SCI and to determine the sensitivity of the SCI- QOL by adding it to existing, ongoing interventional studies. The Bronx and Tampa VAMCs are uniquely posed to perform the pre and post sensitivity component of the SCI- QOL because of the numerous ongoing interventional studies being conducted in veterans with SCI at both institutions.
Our Specific Aims are: 1) To examine the psychometric characteristics (reliability and validity) of the SCI-QOL in a population of veterans with SCI;2) To determine whether measurement differences exist on the SCI-QOL (using differential item functioning) between veterans and nonveterans with SCI;and 3) To test the sensitivity of the SCI-QOL measures within the context of existing interventional studies by comparing it with the legacy tool(s) being used. We are proposing to study 400 veterans with SCI;200 at the James J. Peters VA Medical Center, Bronx, NY and 200 at the James A. Haley VA Hospital, Tampa, FL over 3 years.
The field of SCI rehabilitation medicine lacks a validated and reliable, patient reported, health-related quality of life measurement tool. Interventional studies are disadvantaged by not having such a tool. The NIH has funded investigators to develop a SCI-specific, quality of life survey tool in nonveterans with SCI called the SCI-QOL. The first two Phases of this project have been completed. The validation Phase is beginning this summer and we are proposing to add veterans with SCI to this initiative. Additionally, we will be testing the SCI-QOL between our veterans and the nonveterans with SCI to determine if there are differences in their self-reported quality of life. Lastly, we will be testing the sensitivity of the SCI-QOL before and after existing interventional studies that are ongoing at the SCI Services of the Bronx and Tampa VAMCs.