Extending Veteran Participation in the Validation of the SCI-QOL/CAT

描述（由申请人提供）： 美国国立卫生研究院（NIH）开发了名为“患者报告结果测量信息系统（PROMIS）"的路线图倡议项目，这是一项针对普通人群的生活质量健康结果调查。2004年，由于确定神经系统疾病患者与普通人群有不同的需求和医疗问题，国家神经系统疾病和中风研究所（NINDS）与西北大学的大卫切拉博士签订了一份单独合同，以开发一种患者报告的结果/健康相关的生活质量工具，专门用于神经系统疾病患者（Neuro-QOL）。这些疾病包括：中风、帕金森病（PD）、神经肌肉疾病[重症肌无力和肌萎缩侧索硬化（ALS）]、癫痫和多发性硬化（MS）。由于资金限制和潜在的其他更具体的需求，SCI患者故意不包括在神经生活质量中。 有效和有用的SCI专用测量工具的缺乏阻碍了研究人员的努力，他们正在调查改善SCI患者功能和生活质量的干预措施。正在进行一项多中心合作研究，以开发和现场测试一种有意义的、相关的和心理测量学上合理的健康相关生活质量量表，用于SCI人群。这项SCI-QOL的合作研究最初是作为两个独立的项目资助的，后来又联合起来。美国国家神经疾病和卒中研究所（NINDS）资助了马萨诸塞州波士顿市波士顿大学的Alan Jette博士，美国国家残疾康复研究所（NIDRR）资助了密歇根大学安阿伯的大卫·图尔斯基博士，以开发一种SCI特定的患者报告的健康相关生活质量结局指标，即SCI-QOL。PROMIS、NEURO-QOL和SCI-QOL这三个项目都没有专门针对退伍军人。该项目的目标是将SCI退伍军人（约占美国SCI患者的四分之一）纳入脊髓损伤健康相关生活质量（SCI-QOL）的验证阶段。[This该仪器由大卫·图尔斯基博士（以前在凯斯勒医学研究基金会/凯斯勒研究所工作，但最近搬到了密歇根大学）与来自几个SCI模型系统站点的研究人员和西北大学的心理测量学家一起开发。除了在验证样本中包括退伍军人外，我们的研究还建议确定退伍军人和非退伍军人SCI患者之间是否存在生活质量差异，并通过将其添加到现有的正在进行的干预性研究中来确定SCI- QOL的敏感性。布朗克斯和坦帕的VAMC是唯一能够执行SCI- QOL的前后敏感性部分的，因为在这两个机构的SCI退伍军人中正在进行许多正在进行的干预性研究。 我们的具体目标是：1）检查心理测量特征（信度和效度）的SCI-QOL在人群中的SCI; 2）以确定是否存在测量差异的SCI-QOL（使用差异项目功能）之间的退伍军人和非退伍军人与SCI;和3）通过将SCI-QOL测量与传统工具进行比较，在现有干预性研究的背景下测试SCI-QOL测量的灵敏度市.我们我们计划研究400名脊髓损伤的退伍军人，其中200名在纽约州布朗克斯的詹姆斯J彼得斯退伍军人医疗中心，200名在詹姆斯A。佛罗里达州坦帕的Haley VA医院超过3年。 公共卫生相关性： SCI康复医学领域缺乏一个经过验证的、可靠的、患者报告的、与健康相关的生活质量测量工具。干预性研究由于没有这样的工具而处于不利地位。美国国立卫生研究院资助研究人员开发一种SCI特异性的生活质量调查工具，称为SCI-QOL。该项目的前两个阶段已经完成。验证阶段将于今年夏天开始，我们建议将SCI退伍军人添加到该计划中。此外，我们将测试我们的退伍军人和非退伍军人SCI之间的SCI-QOL，以确定他们自我报告的生活质量是否存在差异。最后，我们将在布朗克斯和坦帕VAMC的SCI服务处正在进行的现有干预性研究之前和之后测试SCI-QOL的敏感性。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: 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.