Diagnostic Innovations in Glaucoma Study (DIGS): Functional Impairment

青光眼研究 (DIGS) 的诊断创新：功能障碍

• 批准号: 8161130
• 负责人: Felipe Medeiros
• 金额: $ 75.41万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8161130
• 关键词: Activities of Daily Living; Address; Automobile Driving; Blindness; Clinical; Clinical Trials; Collection; Data; Decision Making; Deterioration; Development; Diagnostic; Disease; Economic Factors; Evaluation; Eye; Glaucoma; Goals; Healthcare; Impairment; Investigation; Lead; Link; Longitudinal Studies; Measures; Methodology; Methods; Modeling; Motor Vehicles; National Eye Institute; Optic Disk; Optic Nerve; Outcome; Patient Outcomes Assessments; Patient Self-Report; Patients; Perception; Performance; Perimetry; Quality of life; Questionnaires; Recording of previous events; Records; Reporting; Research; Resources; Risk; Risk Factors; Role; Science; Severity of illness; Surrogate Endpoint; Testing; Time; United States; United States Food and Drug Administration; Validation; Vehicle crash; Vision; Vision research; Visual impairment; base; clinical care; clinically relevant; cohort; disability; functional disability; glaucoma test; health related quality of life; high risk; imaging modality; improved; innovation; predictive modeling; prevent; retinal nerve fiber layer; simulation; socioeconomics

DESCRIPTION (provided by applicant): The fundamental goal of glaucoma management is to prevent patients from developing visual impairment that is sufficient to produce disability in their daily lives and impair their health-related quality of life (HRQOL). The overall goal of the Diagnostic Innovations in Glaucoma Study (DIGS): Functional Impairment is to improve understanding of functional disability in glaucoma and how it relates to commonly performed clinical tests. This proposal will obtain measures of functional impairment in a well-defined cohort of glaucoma patients that has been followed for over 15 years with a very large variety of clinical functional and structural tests. Cross-sectional and longitudinal investigations will address the following 3 specific aims: 1) to objectively evaluate functional impairment in glaucoma using performance-based tests: driving simulation and the Assessment of Disability Related to Vision (ADREV) scale, 2) to improve understanding of HRQOL deterioration in glaucoma using patient-reported outcomes and 3) to predict which patients are at risk for functional impairment and decrease in HRQOL from glaucoma. In Specific Aim 1, we will study the relationships between performance-based measures of functional impairment and standard clinical tests for assessment of glaucomatous optic disc and retinal nerve fiber layer damage. The investigation of these relationships will help link the results obtained by conventional testing to information related to disability from the disease and, therefore, may have significant impact on how results from different clinical tests are used for decision making and as surrogate endpoints in clinical trials of glaucoma. In Specific Aim 2, we will investigate factors that determine patients' perceptions of impairment from glaucoma by studying the longitudinal associations between subjective (HRQOL questionnaires) and objective (performance-based) measures of functional impairment and how they are related to results of clinical tests, demographic and socio-economic factors. This will identify the reasons why some aspects of impairment are more perceptible or bothersome to patients than others and may assist in the development of strategies to compensate or minimize the impact of disability in the daily lives of glaucoma patients. In Specific Aim 3, we will evaluate the ability of baseline and longitudinal structural and functional measures in predicting which patients are at highest risk for development of functional disability. The goal is to develop predictive models that can be used for identification of patients at higher risk for functional impairment, leading to a more efficient management of glaucoma and ultimately to a reduction of disability from the disease. By evaluating measures of functional impairment and developing predictive models to identify patients at risk for disability, this proposal directly addresses the current National Eye Institute National Plan for Eye and Vision Research goal of developing diagnostic methodologies to prevent vision loss from glaucoma. PUBLIC HEALTH RELEVANCE: Glaucoma is a leading cause of vision loss in the United States and worldwide, frequently resulting in significant disability and decrease in health-related quality of life. The overall goal of this proposal entitled "Diagnostic Innovations in Glaucoma Study: Functional Impairment" is to improve understanding and develop methods to identify patients at risk for disability from the disease. Specifically, we will obtain measures of functional impairment in a well-defined cohort of glaucoma patients that have been followed for several years in order to 1) study the relationship between results on standard clinical tests and the ability of patients to perform activities of daily living, including driving simulation, 2) evaluate the relationship between subjective (patient-reported) and objective measures of impairment and how the association is influenced by disease severity and socio-economic variables and 3) use results of standard tests to predict which patients are at risk for functional impairment and decrease in quality of life from glaucoma.

描述（由申请人提供）：青光眼治疗的基本目标是防止患者出现足以导致其日常生活残疾和损害其健康相关生活质量（HRQOL）的视力损害。青光眼诊断创新研究（DIGS）：功能损伤的总体目标是提高对青光眼功能障碍的理解，以及它与常用临床试验的关系。本研究将对一组明确的青光眼患者进行超过15年的临床功能和结构测试，以获得功能损害的测量结果。横断面和纵向调查将解决以下3个具体目标：1)使用基于性能的测试客观评估青光眼的功能损害：驾驶模拟和视力相关残疾评估（ADREV）量表；2)使用患者报告的结果提高对青光眼HRQOL恶化的理解；3)预测哪些患者有青光眼功能损害和HRQOL下降的风险。在具体目标1中，我们将研究基于性能的功能损害测量与评估青光眼视盘和视网膜神经纤维层损伤的标准临床试验之间的关系。对这些关系的调查将有助于将传统测试获得的结果与该病致残的相关信息联系起来，因此可能对如何将不同临床测试的结果用于决策和作为青光眼临床试验的替代终点产生重大影响。在具体目标2中，我们将通过研究功能损害的主观（HRQOL问卷）和客观（基于表现的）测量之间的纵向关联，以及它们与临床试验结果、人口统计学和社会经济因素的关系，来调查决定患者对青光眼损害感知的因素。这将确定为什么某些方面的损害对患者来说比其他方面更容易察觉或更麻烦，并可能有助于制定补偿或最小化残疾对青光眼患者日常生活影响的策略。在具体目标3中，我们将评估基线和纵向结构和功能测量在预测哪些患者发生功能障碍的风险最高方面的能力。目标是开发预测模型，用于识别功能损害风险较高的患者，从而更有效地管理青光眼，并最终减少该病造成的残疾。通过评估功能损害的措施和开发预测模型来识别有残疾风险的患者，该提案直接解决了目前国家眼科研究所国家眼与视力研究计划的目标，即开发诊断方法来预防青光眼导致的视力丧失。