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)制定了名为“患者报告结果测量信息系统(PROIS)”的路线图倡议项目，这是一项面向普通人群的生活质量健康结果调查。2004年，由于确定神经疾病患者与普通人群有不同的需求和医疗问题，美国国家神经疾病和中风研究所(NINDS)向西北大学的David Cella博士授予了一份单独的合同，开发一种专门针对神经疾病患者的患者报告结果/与健康相关的生活质量工具(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症(ALS)]、癫痫和多发性硬化症(MS)。由于资金限制和潜在的其他更具体的需求，脊髓损伤患者故意不被包括在神经生活质量中。缺乏有效和有用的脊髓损伤专用测量工具阻碍了研究人员的努力，他们正在研究改善脊髓损伤患者功能和生活质量的干预措施。一项多地点合作研究正在进行中，以开发和实地测试有意义的、相关的和心理健康相关的生活质量量表，供脊髓损伤人群使用。这项关于SCI-QOL的合作研究最初是作为两个独立的项目资助的，后来这两个项目联合起来。美国国家神经疾病和中风研究所(NINDS)向来自马萨诸塞州波士顿大学的艾伦·杰特博士提供资金，国家残疾康复研究所(NIDRR)资助密歇根大学安娜堡分校的大卫·图尔斯基博士开发一种针对SCI患者报告的结果测量健康相关生活质量的指标，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。该项目的目标是将患有脊髓损伤的退伍军人(约占美国所有脊髓损伤患者的四分之一)纳入脊髓损伤健康相关生活质量(SCI-QOL)的验证阶段。[这一工具是由大卫·图尔斯基博士(前凯斯勒医学研究基金会/凯斯勒研究所，最近搬到密歇根大学)与几个SCI模型系统站点的研究人员和西北大学的心理测量学家共同开发的。]除了将退伍军人纳入验证样本外，我们的研究还建议确定患有脊髓损伤的退伍军人和非退伍军人之间是否存在生活质量差异，并通过将其添加到现有的、正在进行的干预研究中来确定SCI-QOL的敏感性。布朗克斯和坦帕的VAMC是独特的，可以执行SCI-QOL的前后敏感性部分，因为这两个机构正在对患有SCI的退伍军人进行大量的干预性研究。我们的具体目标是：1)检验SCI-QOL在退伍军人SCI人群中的心理测量学特征(信度和效度)；2)确定SCI-QOL在退伍军人和非退伍军人之间是否存在测量差异；3)通过与使用的遗留工具(S)进行比较，在现有干预研究的背景下测试SCI-QOL测量的敏感性。我们建议对400名患有脊髓损伤的退伍军人进行研究；200名在纽约布朗克斯的詹姆斯·J·彼得斯退伍军人医疗中心，200名在佛罗里达州坦帕市的詹姆斯·A·黑利退伍军人医院，为期3年。 公共卫生相关性： 脊髓损伤康复医学领域缺乏有效和可靠的、患者报告的、与健康相关的生活质量测量工具。由于没有这样的工具，干预性研究处于不利地位。美国国立卫生研究院资助研究人员开发了一种针对脊髓损伤的非退伍军人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，我们建议将患有脊髓损伤的退伍军人加入这一计划。此外，我们将测试我们的退伍军人和患有脊髓损伤的非退伍军人之间的SCI-QOL，以确定他们的自我报告的生活质量是否存在差异。最后，我们将在Bronx和Tampa VAMC的SCI服务正在进行的现有干预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.