Telemedicine Approaches to Evaluating Acute-phase ROP - eROP

我们建议进行一项多中心临床研究，以评估其有效性、可靠性、可行性、安全性和相关性。 ROP远程医疗评估系统检测符合RW-R的高危婴儿眼睛的成本-效果 ROP标准和对ROP有经验的眼科医生进行诊断评估的必要性。我们将： 1.使用灵敏度和特异度计算系统的准确性，以提供远程评价 与由一家医疗机构进行的“黄金标准”间接眼底检查的结果进行比较 研究认证的眼科医生，在ROP诊断检查方面接受过严格的培训(有效性)； 2.确定阅读器内部和阅读器间的协议，以确定数字图像是否表明 需要有ROP经验的眼科医生进行间接眼底镜检查(可靠性)； 3.确定是否可以对每个婴儿进行成像评估(可行性)； 4.检查与数字成像相关的眼部和全身并发症，并与 与眼科医生进行的诊断检查有关(安全)； 5.比较采用远程医疗视网膜成像系统的成本和收益 间接检眼镜检查的当前费用(成本效益)。 在美国和加拿大的大型临床中心，出生体重为1251克的婴儿将同时接受数字化 视网膜成像和临床指征的间接眼底镜检查在同一天进行。宽视场 双眼的数字图像将由非医生成像器使用标准化的成像协议捕获。 Retcam Shuttle(R)(Clarity Medical Systems，加利福尼亚州普莱森顿)是一款角膜接触式相机，可以捕捉 将使用宽视场(130度视野)视网膜图像。所有的研究数据，包括人口统计学， 诊断检查、成像和安全信息将安全地传输到研究服务器。 视网膜图像将由训练有素的读者使用标准化的方案进行分级，以识别患有RW的眼睛- ROP。评分结果将与同一次会议上的诊断检查进行比较。 相关性(请参阅说明)： 早产儿视网膜病变(ROP)是可治疗的儿童失明的主要原因。ROP正在成为一种 美国和加拿大服务不足地区的问题日益严重，疫情在 快速发展的国家。我们认为一种系统的方法来使用数字视网膜成像结合 标准化分级为提高ROP护理的质量、途径和效率提供了机会。

We propose a multi-center clinical study will evaluate the validity, reliability, feasibility, safety and relative cost-effectiveness of an ROP telemedicine evaluation system to detect eyes of at-risk babies who meet RW- ROP criteria and need of a diagnostic evaluation by an ophthalmologist experienced in ROP. We shall: 1. Calculate the accuracy, using sensitivity and specificity, of the system to provide remote evaluations when compared with the findings of a "gold standard" indirect ophthalmoscopic examination performed by a Study-certified ophthalmologist, rigorously trained in ROP diagnostic examinations (validity); 2. Determine intra-reader and inter-reader agreement for deciding whether digital images indicate that the eye are in need of diagnostic indirect ophthalmoscopy by ophthalmologist experienced In ROP (reliability); 3. Determine whether imaging evaluation can be achieved for each baby (feasibility); 4. Examine ocular and systemic complications associated with digital imaging and compared with those associated with diagnostic examinations performed by an ophthalmologist (safety); 5. Compare the costs and benefits of adopting a telemedicine retinal imaging system compared to the current cost of indirect ophthalmoscopic examinations (cost-effectiveness). Babies with birth weights of <1251g at large clinical centers in the US and Canada will undergo both digital retinal imaging and clinically indicated indirect ophthalmoscopic examinations on the same day. Wide-field digital images of both eyes will be captured by non-physician imagers using standardized imaging protocols. The RetCam Shuttle(R) (Clarity Medical Systems, Pleasanton, CA) a corneal-contact camera that captures wide field (130 degree field of view) retinal images, will be used. All study data, including demographic, diagnostic examinations, imaging, and safety information, will be securely transmitted to a Study server. Retinal images will be graded by Trained Readers using a standardized protocol to identify eyes with RW- ROP. Results of the gradings will be compared to the diagnostic examinations at the same session. RELEVANCE (See instructions): Retinopathy of prematurity (ROP) is the leading cause of treatable childhood blindness. ROP is becoming an increasing problem in underserved areas of the US and Canada, and epidemic rates are being found in rapidly developing countries. We submit that a systematic approach to use digital retinal imaging combined with standardized grading offers the opportunity to improve quality, access and efficiency of ROP care.