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

扩大退伍军人参与 SCI-QOL/CAT 验证的范围

• 批准号: 8088415
• 负责人: Ann Michele Spungen
• 金额: --
• 依托单位: JAMES J PETERS VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8088415
• 关键词: Address; Amyotrophic Lateral Sclerosis; Award; Biological Models; Boston; Characteristics; Computers; Contracts; Disadvantaged; Disease; Epilepsy; Foundations; Funding; General Population; Goals; Health; Hospitals; Individual; Information Systems; Institutes; Institution; Intervention; Measurement; Measures; Medical; Medical Research; Medical center; Medicine; Michigan; Multiple Sclerosis; Myasthenia Gravis; National Institute of Neurological Disorders and Stroke; Neuromuscular Diseases; Outcome; Outcome Measure; Parkinson Disease; Patient Outcomes Assessments; Patient Self-Report; Patients; Persons; Phase; Population; Psychometrics; Quality of life; Rehabilitation Research; Rehabilitation therapy; Reporting; Research Personnel; Sampling; Services; Site; Spinal cord injury; Stroke; Surveys; Testing; United States National Institutes of Health; Universities; Validation; Validity and Reliability; Veterans; disability; health related quality of life; improved functioning; innovation; instrument; nervous system disorder; sound; tool

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.

描述（由申请人提供）： 美国国立卫生研究院（NIH）开发了路线图计划项目，标题为“患者报告的结果测量信息系统（Promis）”，这是对普通人群的生活质量健康成果调查。在2004年，因为确定神经系统疾病的人与普通人群有不同的需求和医学问题，所以国家神经系统疾病和中风研究所（NINDS）向西北大学的David Cella博士授予了单独的合同，以开发患者报告的与Neurological Disordersersersersersersorsersersersersorsersecors的患者相关的患者（与Neurological disordersersersersorsersorsersersorsersementers-sqol）相关的质量。这些疾病包括：中风，帕金森氏病（PD），神经肌肉疾病[肌腱肌疗法和肌萎缩性侧面硬化症（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，具有SCI的人故意不包括在神经QOL中。 有效且有用的特异性测量工具的稀缺性阻碍了研究人员的努力，这些研究人员正在研究SCI人的改善功能和生活质量的干预措施。正在进行一项多站点协作研究，以开发和现场测试一种有意义的，相关和心理的与健康相关的生活质量量表，以在SCI人群中使用。这项对SCI-QOL的合作研究最初是作为后来联手的两个独立项目资助的。美国国家神经疾病与中风研究所（NINDS）授予波士顿大学，波士顿，马萨诸塞州波士顿大学和国家残疾人恢复研究所（NIDRR）的艾伦·杰特（Alan Jette）博士（NIDRR），在密歇根州安阿尔伯（Ann Arbor）的密歇根大学的戴维·塔尔斯基（David Tulsky）博士中，密歇根州安阿尔伯（Ann Arbor）授予了SCI特定的患者报告，以开发出了一项针对健康的竞争量，均为健康型号，良好的良好效果良好，良好的效果良好。 Promis，Neuro-QOL和SCI-QOL的三个项目都没有专门针对的退伍军人。该项目的目标是包括具有SCI的退伍军人（代表美国SCI的所有患者中的四分之一）在与脊髓损伤健康相关的生活质量（SCI-QOL）的验证阶段中。 [该乐器是由David Tulsky博士（以前是凯斯勒医学研究基金会/凯斯勒研究所开发通过将其添加到现有的，正在进行的介入研究中来进行。由于在这两个机构的SCI退伍军人中进行了大量持续的介入研究，因此，布朗克斯和坦帕VAMC唯一地提出了Sci-QoL的敏感性和后灵敏度成分。 我们的具体目的是：1）检查SCI-QOL的心理测量特征（可靠性和有效性）在具有SCI的退伍军人中； 2）确定在SCI-QOL（使用差异项目功能）上的测量差异和SCI的非退伍军人之间是否存在； 3）通过将其与使用的遗产工具进行比较，以在现有介入研究的背景下测试SCI-QOL度量的敏感性。我们建议研究400名具有SCI的退伍军人；纽约州布朗克斯市的詹姆斯·J·彼得斯医学中心（James J. Peters VA）在佛罗里达州坦帕市的詹姆斯·A·海利·VA医院（James A. 公共卫生相关性： SCI康复医学领域缺乏经过验证且可靠的患者报告，与健康相关的生活质量测量工具。介入的研究因没有这种工具而处于不利地位。 NIH已资助研究人员，以使用SCI称为SCI-QOL的非退伍军人开发科学特异性，生活质量调查工具。该项目的前两个阶段已经完成。验证阶段是在今年夏天开始的，我们建议将带有SCI的退伍军人添加到该计划中。此外，我们将测试退伍军人与具有SCI的非退伍军人之间的SCI-QOL，以确定其自我报告的生活质量是否存在差异。最后，我们将在现有的介入研究之前和之后测试SCI-QOL在布朗克斯和坦帕VAMC的SCI服务中的敏感性。