The Predictive Value of Pre-plus Disease in ROP

预加疾病对 ROP 的预测价值

• 批准号: 6930585
• 负责人: DAVID K WALLACE
• 金额: $ 26.78万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6930585
• 关键词: clinical research; disease /disorder etiology; disease /disorder proneness /risk; eye disorder diagnosis; human subject; infant human (0-1 year); ophthalmoscopy; pathologic process; patient oriented research; premature infant human; prognosis; retina circulation disorder; retinopathy of prematurity

DESCRIPTION (provided by applicant): This K23 Award will allow the candidate to obtain the training and skills necessary to develop and lead patient-oriented research projects in pediatric ophthalmology, including multi-center clinical trials. The candidate will learn study design, protocol development, grant application, project management, data analysis, statistical methods, communication of results, and medical ethics. To achieve these objectives, the candidate will (1) work under the direct supervision of Dr. Roy Beck on several clinical trials conducted by the Pediatric Eye Disease Investigator Group, (2) obtain a masters degree in public health with a concentration in epidemiology and a minor in biostatistics, and (3) complete a research project with the guidance of Dr. Graham Quinn in retinopathy of prematurity (ROP), one of the leading causes of childhood blindness in the United States. The proposed research project will utilize digital retinal images to test our hypothesis that eyes with pre-plus disease (mild to moderately abnormal vascular dilation and tortuosity of central, posterior retinal blood vessels) are more likely to develop sight-threatening ROP. The specific aims are (1) to investigate whether pre-plus predicts progression to severe ROP (threshold disease), (2) to determine if pre-plus adds predictive value beyond that already provided by established ROP descriptors of location (zone) and severity (stage), and (3) to study the natural history of pre-plus disease. To address these aims, 2 masked experts in ROP will grade the degree of vascular dilation and tortuosity in digital retinal images generated from video indirect ophthalmoscopy in a cohort of 150 infants. Eyes with pre-plus will be compared to normal eyes in regard to the proportion that progress to threshold. There are important clinical implications if pre-plus accurately predicts progression to threshold. These include improved ability to identify high-risk infants who may benefit from earlier than usual laser treatment, more effective screening protocols for some infants, and more accurate counseling of parents regarding the risk of disease progression.

描述（由申请人提供）：该 K23 奖项将使候选人获得开发和领导以患者为导向的儿科眼科研究项目（包括多中心临床试验）所需的培训和技能。候选人将学习研究设计、方案制定、拨款申请、项目管理、数据分析、统计方法、结果沟通和医学伦理。为了实现这些目标，候选人将 (1) 在 Roy Beck 博士的直接监督下，参与儿科眼病研究小组进行的多项临床试验，(2) 获得公共卫生硕士学位，主修流行病学，辅修生物统计学，(3) 在 Graham Quinn 博士的指导下完成早产儿视网膜病变 (ROP) 的研究项目，ROP 是儿童眼病的主要原因之一。 美国儿童失明。拟议的研究项目将利用数字视网膜图像来检验我们的假设，即患有前附加疾病（轻度至中度异常血管扩张和中央、后部视网膜血管扭曲）的眼睛更有可能出现威胁视力的 ROP。具体目标是 (1) 研究 pre-plus 是否可以预测进展为严重 ROP（阈值疾病），(2) 确定 pre-plus 是否可以增加预测价值，超出已建立的 ROP 位置（区域）和严重程度（阶段）描述符所提供的预测价值，以及 (3) 研究 pre-plus 疾病的自然史。为了实现这些目标，ROP 的 2 名蒙面专家将对 150 名婴儿的视频间接检眼镜生成的数字视网膜图像中的血管扩张和扭曲程度进行分级。将将具有预加的眼睛与正常眼睛进行比较，以了解进展到阈值的比例。如果 pre-plus 能够准确预测进展至阈值，则具有重要的临床意义。这些措施包括提高识别高危婴儿的能力，这些婴儿可能会受益于比通常更早的激光治疗，对某些婴儿进行更有效的筛查方案，以及为父母提供有关疾病进展风险的更准确的咨询。