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

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，健康相关的生活质量（HRQOL）结果指标，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，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经验证的临床工具以评估HRQOL的研究计划，以用于普通人群（例如，患者报告结局测量信息系统[PROMIS]）以及神经系统疾病患者（Neuro-QOL）和脊髓损伤患者（SCI-QOL）。由于身体限制和继发性医疗并发症的独特星座，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，由于多种共病的医疗条件，身体，心理或社会功能的微小变化可能会被放大，并转化为SCI患者HRQOL的显着改善。在SCI人群中被忽视的一个临床医学领域是血压失调（BPD），其经常表现为持续性低血压、体位性低血压和/或持续性高血压，以及间歇性不受控制的低血压和/或重度高血压。BPD对SCI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，导致一般人群生活质量差、动力不足、疲劳、社会孤立和抑郁。尽管临床医学缺乏敏感和特异的测量工具来准确评估BPD对这些个体HRQOL的影响，但SCI人群中可能存在相同的风险。提高我们对BPD对SCI患者HRQOL影响的理解，将有助于针对因这些多方面条件而导致QOL降低的相对风险更大的患者。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SCI患者HRQOL的影响。我们预计，这一HRQOL工具将成为未来所有SCI临床试验和临床实践的一个组成部分，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，将联合收割机技术与测量科学相结合，以最小化负担但最大化产量的方式从SCI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长方面是独一无二的，在每个调查领域都有很好的准备和极强的能力;该项目的科学智慧的结合是无与伦比的。

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.