Quality of Life for SCI Clinical Trials: Development of the SCI-QOL

描述（由申请人提供）：NIH路线图已经认识到有效结果评估在临床研究中的重要性，指出：“迫切需要更好地量化临床重要症状和结果，包括疼痛，疲劳和生活质量。通过这一努力，将开发和测试新技术，以衡量这些自我报告的健康状况和各种疾病和疾病严重程度的结果。“尽管呼吁采取行动，但缺乏专门为SCI人群开发的健康相关生活质量（HRQOL）指标。在SCI临床试验中使用的HRQOL指标往往是通用的工具，包含不相关的，有时是冒犯性的项目，缺乏临床实用性。创伤性脊髓损伤导致一系列突发性和破坏性的生理变化、继发性并发症以及社会和心理功能受损，所有这些都显著影响HRQOL。需要一个有效的SCI特异性QOL指标来准确测量临床和研究结果。本研究旨在：1）构建针对SCI个体的临床相关的健康相关生活质量（HRQOL）测量量表，2）确保所得量表与“神经QOL”测量系统兼容，以确保在临床试验中被现场接受和实用，3）用SCI患者样本现场测试SCI目标和通用神经QOL项目库，4）利用项目反应理论（IRT）方法来改进和校准用于临床试验中的SCI人群的项目库，以及5）开发用于项目库管理的计算机化自适应测试（CAT）程序，并在SCI患者的新样本中实地测试CAT程序。SCI-QOL量表将采用最先进的方法开发，采用经典和现代的测试构建和验证方法。来自全国各地的五个不同的康复设施，包括四个SCI模型系统，将参与这项新的HRQOL措施的开发，以确保足够的敏感性和特异性。该工具将作为一个CAT开发，在许多情况下都将是实用和灵活的管理。最后，拟议的研究将填补一个显着的空白，开发一个有意义的，有效的，简明的衡量HRQOL用于SCI临床试验的结果测量，并将与NINDS神经QOL措施。

DESCRIPTION (provided by applicant): The NIH Roadmap has recognized the importance of valid outcomes assessment in clinical research, stating: "There is a pressing need to better quantify clinically important symptoms and outcomes, including pain, fatigue, and quality of life. Through this effort, new technologies will be developed and tested to measure these self-reported health states and outcomes across a wide range of illnesses and disease severities." Despite this call for action, there is a paucity of health-related quality of life (HRQOL) measures that have been developed specifically for use with SCI populations. HRQOL measures used in SCI clinical trials tend to be generic instruments, containing irrelevant and sometimes offensive items which lack clinical utility. Traumatic SCI results in a sudden and devastating constellation of physiological changes, secondary complications, and impaired social and psychological function, all of which significantly impact HRQOL. A valid SCI-specific measure of QOL is needed to accurately measure both clinical and research outcomes. The current study aims to: 1) Construct a clinically relevant helath-related quality of life (HRQOL) measurement scale targeted towards individuals with SCI, 2) Ensure that the resulting scale is compatible with the "Neuro-QOL" measurement system to ensure acceptance by the field and utility in clinical trials, 3) Field Test the SCI-targeted and generic Neuro-QOL item banks with a sample of SCI patients, 4) Utilize Item Response Theory (IRT) methodology to refine and calibrate item banks for use with an SCI population in clinical trials, and 5) Develop a computerized adaptive testing (CAT) program for administration of the item banks and field test the CAT program in a new sample of SCI patients. The SCI-QOL scale will be developed using a state-of-the-art approach, employing both classical and contemporary methods of test construction and validation. Five different rehabilitation facilities from across the nation, including four Model SCI Systems, will participate in the development of this new HRQOL measure to ensure adequate sensitivity and specificity. The instrument will be developed as a CAT that will be practical and flexible for administration in many settings. Finally, the proposed study will fill a significant void by developing a meaningful, valid, and concise measure of HRQOL for use in outcome measurement of SCI clinical trials and will be integrated with the NINDS Neuro-QOL measure.