Development of the Blood Pressure Symptom Subdomain for the SCI-QOL

SCI-QOL 的血压症状子域的开发

• 批准号: 8088632
• 负责人: Jill M. Wecht
• 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: 2011-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8088632
• 关键词: Accounting; Address; Area; Autonomic Dysreflexia; Blood Pressure; Calibration; Caring; Chronic; Clinical; Clinical Medicine; Clinical Research; Clinical Trials; Clinical Trials Design; Cognitive; Community Participation; Data; Development; Discipline; Emotional; Ensure; Evaluation; Fatigue; Focus Groups; Foundations; Funding; Future; General Population; Generic Drugs; Glare; Goals; Health; Healthcare; Hospitals; Hypertension; Hypotension; Impairment; Individual; Information Systems; Institutes; Interview; Investigation; Life; Literature; Location; Long-Term Care; Measurement; Measures; Medical; Medical center; Mental Depression; Methodology; Methods; Michigan; Motivation; Oranges; Orthostatic Hypotension; Outcome; Outcome Measure; Pathology; Patient Outcomes Assessments; Patients; Persons; Population; Probability; Process; Property; Psychometrics; Quality of life; Quality-of-Life Assessment; Rehabilitation Research; Rehabilitation therapy; Relative Risks; Research; Research Personnel; Research Proposals; Research Support; Risk; Role; Sampling; Science; Social Functioning; Social isolation; Social support; Spinal cord injury; Symptoms; Techniques; Technology; Testing; Translating; Translations; United States; United States National Institutes of Health; Universities; Validation; Veterans; Well in self; Writing; base; clinical practice; clinically relevant; cost; disability; economic impact; functional restoration; health related quality of life; improved; medical complication; model development; nervous system disorder; physical conditioning; prevent; psychologic; response; satisfaction; social; sound; stem; theories; tool; trait

DESCRIPTION (provided by applicant): Investigators at the National Institute of Health (NIH) recognize that health related quality of life (HRQOL) outcomes measures, including physical health, psychological and emotional well being, level of social support, community participation, and level of everyday functioning, predict overall long term satisfaction of an individual. As such, the NIH has funded and continues to support research initiatives aimed at the development of validated clinical tools to assess HRQOL for use in the general population (e.g. Patient-Reported Outcomes Measurement Information System [PROMIS]), as well as in persons with neurological disorders (Neuro-QOL) and individuals with spinal cord injury (SCI-QOL). Due to the unique constellation of physical limitations and secondary medical complications, individuals with SCI represent a challenging model for the development of HRQOL tools. That said, because of multiple co-morbid medical conditions, small changes in physical, psychological or social function may be magnified and translate into significant improvement in HRQOL in persons with SCI. An area of clinical medicine that has been overlooked in the SCI population is blood pressure dysregulation (BPD), which frequently manifests in persistent hypotension, orthostatic hypotension and/or sustained hypertension, as well as episodic uncontrolled hypotension and/or severe hypertension. The impact of BPD on HRQOL in the SCI population is presently unknown, however there is substantial evidence that conditions of blood pressure pathology, specifically chronic hypotension and hypertension, contribute to poor quality of life, low motivation, fatigue, social isolation and depression in the general population. It is likely that the same risk is present in the SCI population although clinical medicine lacks a sensitive and specific measurement tool for the accurate assessment of the impact of BPD on HRQOL in these individuals. Improving our understanding of the impact of BPD on HRQOL in persons with SCI will help target patients at greater relative risk for diminished QOL stemming from these multifaceted conditions. The goal of this project is to develop a unique, clinically relevant and powerful tool to determine the impact of BPD on HRQOL in individuals with SCI. We anticipate that this HRQOL tool will be an integral part of all future SCI clinical trials and clinical practice; a glaring omission to our current evaluation processes. The proposal will utilize contemporary, state of the art techniques which combine technology with the science of measurement to collect reliable, valid and useful data from a large sample of individuals with SCI in a manner which will minimize the burden, yet will maximize the yield. Furthermore the investigative team is unique in their individual expertise and is well poised and exceedingly competent at each of the individual areas of investigation; the union of scientific intellect on the project is unparalleled. PUBLIC HEALTH RELEVANCE: Spinal cord injury (SCI) is a lifelong condition, requiring care from multiple disciplines to diminish impairments, limit secondary complications, improve social functioning and quality of life (QOL). There are approximately 200,000 persons with SCI in the United States and 22% are veterans; the estimated annual cost to the VA for SCI health care is 2.14 billion. In recognition of the enormous expense associated with the long-term care of these individuals the VA supports and continues to fund research initiatives aimed at identifying optimal clinical practices for the care and management of SCI, by determining if clinical practices translate to improved outcomes and QOL (Quality Enhancement Research Initiative). The goal of this study is to develop a meaningful, relevant, and psychometrically sound tool to determine the impact of blood pressure dysregulation on QOL in persons with SCI.

描述(由申请人提供)： 美国国立卫生研究院(NIH)的研究人员认识到，与健康相关的生活质量(HRQOL)结果测量，包括身体健康、心理和情感健康、社会支持水平、社区参与和日常功能水平，可以预测个人的总体长期满意度。因此，NIH资助并继续支持旨在开发有效的临床工具来评估HRQOL的研究倡议，以供普通人群使用(例如，患者报告的结果测量信息系统[PROIS])，以及用于神经疾病患者(Neuro-QOL)和脊髓损伤患者(SCI-QOL)。由于独特的生理限制和继发性医疗并发症，SCI患者代表了HRQOL工具开发的一个具有挑战性的模型。也就是说，由于多种并存的疾病，生理、心理或社会功能的微小变化可能会被放大，并转化为脊髓损伤患者的HRQOL的显著改善。被SCI人群忽视的一个临床领域是血压失调(BPD)，它经常表现为持续性低血压、直立性低血压和/或持续性高血压，以及发作性失控低血压和/或严重高血压。BPD对脊髓损伤人群HRQOL的影响目前尚不清楚，但有大量证据表明，血压病理状况，特别是慢性低血压和高血压，会导致普通人群生活质量差、动力不足、疲劳、社交孤立和抑郁。很可能在脊髓损伤人群中也存在同样的风险，尽管临床医学缺乏一种敏感和具体的测量工具来准确评估BPD对这些人的HRQOL的影响。提高我们对BPD对SCI患者HRQOL的影响的了解，将有助于针对因这些多方面情况而导致生活质量下降的相对风险更高的患者。该项目的目标是开发一种独特的、临床相关的和强大的工具来确定BPD对脊髓损伤患者的HRQOL的影响。我们预计，这种HRQOL工具将成为未来所有SCI临床试验和临床实践中不可或缺的一部分；这是我们目前评估过程中的一个明显遗漏。该提案将利用当代最先进的技术，将技术与测量科学相结合，以最大限度地减少负担，同时最大限度地提高收益的方式，从脊髓损伤患者的大样本中收集可靠、有效和有用的数据。此外，调查小组在其个人专业知识方面独一无二，在每个单独的调查领域都做得很好，能力非常强；该项目的科学智力的结合是无与伦比的。 公共卫生相关性： 脊髓损伤(SCI)是一种终生疾病，需要多学科的护理，以减少损伤，限制继发性并发症，改善社会功能和生活质量(QOL)。美国大约有20万SCI患者，其中22%是退伍军人；退伍军人管理局每年用于SCI医疗保健的费用估计为21.4亿美元。认识到与这些人的长期护理相关的巨额费用，退伍军人管理局支持并继续资助旨在确定SCI护理和管理的最佳临床实践的研究倡议，通过确定临床实践是否转化为改善结果和QOL(质量增强研究倡议)。这项研究的目的是开发一种有意义的、相关的和心理测量学上合理的工具来确定血压失调对脊髓损伤患者生活质量的影响。