Vision-QOL-CAT: A Functional Health CAT for those with Visual Disorders

描述（由申请人提供）：随着人口老龄化，视力丧失是一个日益严重的公共卫生问题，影响着300多万美国人。眼科疾病对健康相关生活质量（HRQOL）的影响以及新治疗方法的益处尚未得到很好的理解，也没有与其他医疗条件进行比较。虽然用于测量视觉障碍影响的自我评估工具（例如，VF-14、ADVS、NEI-VFQ），但更有效地测量视觉障碍对广泛的功能健康水平和综合领域的影响的工具的开发没有跟上通用HRQOL工具的进步。 我们建议使用项目反应理论（IRT）和计算机化自适应测试（CAT）技术，在其他条件的研究证明，建立一个更有效的患者报告的结果（PRO）的工具（VISION-QOL-CAT）来衡量成人视觉障碍的影响。CAT针对每个领域对每个人提出的问题进行了调整，从而提高了测量的精度和范围，而不会增加受访者的负担。我们第一阶段的目标是：（1）构建和管理（N=300）新的视觉特异性HRQOL项目库，以测量视觉障碍的影响，并对其有用性进行初步的心理测量和临床评估;（2）开发一个全面的（视觉特定和通用HRQOL）和灵活的VISION-QOL-CAT原型解决方案;以及（3）在视力诊所环境中对原型工具进行试点测试（N=100），并与现有的“传统”全长静态问卷进行比较。我们将与马萨诸塞大学纪念眼科中心合作，对视力丧失严重程度不同的成年患者进行实地调查，包括“湿性”和“干性”类型的年龄相关性黄斑变性。第一阶段的产品将是一个原型综合VISION-QOL- CAT的可行性，可接受性和经验性能与静态通用和视觉特定的HRQOL工具相比，初步证据。 在第二阶段，该系统将得到扩展（内容）和改进（管理效率、可靠范围、心理测量和效用指数评分选项、患者和提供者报告、用户友好文档），并在不同平台（例如，iPod/iPhone/iPad，基于互联网，PC，电话IVR），并在普通人群和患有眼病的人群中正常。 通过降低数据收集成本，减少响应负担，消除“天花板”和“地板”的影响，并提高个人评分的精度，HRQOL结果在临床研究中观察到的可以监测和管理，以改善护理成人视力障碍。 公共卫生相关性：VISION-QOL-CAT是一种评估视觉障碍对生活质量（QOL）影响的新工具。原型研究将提供关于新工具在临床环境中的可行性和可接受性的初步证据。该工具的性能将与其他患者报告的QOL工具进行比较，以测量通用和视觉特定的健康结果。更实用和有用的工具将使人们有可能在做出治疗决定时考虑功能健康和福祉，并使患者能够在管理其眼病方面发挥更积极的作用。

DESCRIPTION (provided by applicant): With the aging of the population, vision loss is a growing public health problem affecting more than 3 million Americans. The impact of eye disease on health-related quality of life (HRQOL) and the benefits of new treatments are not well understood and have not been compared with those for other medical conditions. Although self-assessment tools for measuring the impact of visual disorders (e.g., VF-14, ADVS, NEI-VFQ) are available, the development of instruments that are more efficient in measuring the impact of visual disorders over a wide range of functional health levels and comprehensive domains has not kept pace with advancements achieved for generic HRQOL tools. We propose to use Item Response Theory (IRT) and Computerized Adaptive Testing (CAT) techniques, proven in studies of other conditions, to build a more efficient Patient-Reported Outcomes (PRO) instrument (VISION-QOL-CAT) to measure the impact of adult visual disorders. CATs tailor questions administered to each individual for each domain, thereby increasing precision and range of measurement without increasing respondent burden. Our Phase I aims are to: (1) construct and administer (N=300) new vision-specific HRQOL item banks to measure the impact of visual disorders and perform preliminary psychometric and clinical evaluations of their usefulness; (2) develop a comprehensive (vision-specific and generic HRQOL) and flexible VISION-QOL-CAT prototype solution; and (3) pilot test (N=100) the prototype tool in comparison with existing "legacy" full-length static questionnaires in a vision clinic setting. We will partner with the UMass Memorial Eye Center in fielding surveys of adult patients differing in severity of vision loss, including both "wet" and "dry" types of age- related macular degeneration. The product of Phase I will be a prototype comprehensive VISION-QOL- CAT with preliminary evidence regarding feasibility, acceptability, and empirical performance in comparison with static generic and vision-specific HRQOL tools. In Phase II, the system will be expanded (content) and improved (administration efficiency, reliable range, psychometric and utility index scoring options, patient and provider reports, user-friendly documentation) and further evaluated in both qualitative and quantitative terms (psychometrics, clinical responsiveness) across different platforms (e.g., iPod/iPhone/iPad, Internet-based, PC, telephone IVR), and normed in general populations and among those with eye disease. By lowering data collection costs, reducing response burden, eliminating "ceiling" and "floor" effects and increasing the precision of individual scores, the HRQOL outcomes observed in clinical research may be monitored and managed to improve care for adults with visual disorders. PUBLIC HEALTH RELEVANCE: The VISION-QOL-CAT is a new tool for assessing the impact of visual disorders on quality of life (QOL). The prototype study will provide preliminary evidence regarding feasibility and acceptability of the new tool in a clinical setting. The tool's performance will be compared to other patient-reported QOL tools for measuring generic and vision-specific health outcomes. More practical and useful tools will make it possible to consider functional health and well-being in making treatment decisions and in enabling patients to play a more active role in managing their eye disease.