Secondary Analysis of the Data from the Telemedicine Approaches to Evaluating Acute-phase ROP (e-ROP)

 描述(由申请人提供)：拟议的项目将利用远程医疗方法评估早产儿急性期视网膜病变(e-ROP)的综合数据集，这是一项由国家眼科研究所赞助的大型多中心研究，以评估远程医疗系统的有效性，以确定哪些婴儿的ROP足够严重，需要眼科医生进行评估。这项提案的具体目标不包括电子研究的主要目标，这些目标已经实现。相反，拟议项目的目标是对电子ROP数据进行更多的二次分析，以进一步评价远程医疗对ROP的有效性，并改进图像评估系统，以优化准确性和效率。实现这些目标的具体目标是：(1)描述图像评估结果的特征，包括婴儿双眼ROP特征(阶段、区域和疾病)的对称性，他们第一次检测的时间，以及ROP特征随时间的进展。(2)描述影像检查发现RW-ROP早于诊断性检查的特征。(3)结合成像时的图像评估和体重增加评估，评估是否可以根据风险分层减少ROP评估的次数。(4)评估单一阅读器系统是否与有两个阅读器的系统和由第三个阅读器判定差异的系统具有同等的灵敏度和特异度，并描述需要判定的图像的特征。(5)对临床诊断检查结果不完善的图像进行潜在类分析，计算图像评价的灵敏度和特异度。E-ROP数据集是实现这些目标的独特而宝贵的资源。对1257名婴儿的7749个图像集的图像分级结果的分析可能有助于制定更准确、更有效的分级方案，以识别高危婴儿，供眼科医生进行ROP评估。非常大的样本量、高质量的数据集、以及调查人员的丰富经验和高生产率，以及e-ROP合作小组的全力支持，都支持拟议项目取得高收益的可行性和可能性。

 DESCRIPTION (provided by applicant): The proposed project will utilize the comprehensive dataset from the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy of Prematurity (e-ROP), a large-scale multi-center study, sponsored by the National Eye Institute, to evaluate the validity of a telemedicine system to identify infants who have sufficiently severe ROP to require evaluation by an ophthalmologist. The specific aims of this proposal do not include the major goals of the e-ROP Study, which have been accomplished already. Instead, the goals of the proposed project involve additional secondary analyses of the e-ROP data to further evaluate the validity of telemedicine for ROP and to refine the system for image evaluation to optimize accuracy and efficiency. The Specific Aims to achieve these goals are: (1) To describe characteristics of image evaluation findings, including the symmetry of ROP features (stage, zone, and plus disease) between paired eyes of infants, the time of their first detection, and the progression of ROP features over time. (2) To describe the characteristics of eyes that were found to have RW-ROP by image evaluation earlier than by diagnostic exam. (3) To evaluate whether the number of ROP evaluations can be reduced based on the risk stratification using a combination of image evaluation and weight gain assessment at the time of imaging. (4) To evaluate whether a single reader system provides equivalent sensitivity and specificity as a system with two readers and adjudication of discrepancies by a third reader, and to describe the characteristics of images that require adjudication. (5) To calculate the sensitiviy and specificity of image evaluation using latent class analysis that considers the clinical diagnostic examination finding as imperfect. The e-ROP dataset is a unique and valuable resource for accomplishing these Aims. The analyses of the image grading results from 7749 image sets of 1257 infants may lead to the development of more accurate and efficient grading protocol for identifying high risk infants for ROP evaluation by an ophthalmologist. The very large sample size, high quality of the dataset, as well as the rich experience and high productivity of the investigators along with the full support of the e-ROP Collaborative Group, support the feasibility and likelihood of high yield of the proposed project.