Telemedicine Approaches to Evaluating Acute-phase ROP - eROP

我们建议进行多中心临床研究，以评价其有效性、可靠性、可行性、安全性和相对安全性。 ROP远程医疗评估系统的成本效益，以检测符合RW的高危婴儿的眼睛- ROP标准和需要由有ROP经验的眼科医生进行诊断评价。我们将： 1.使用灵敏度和特异性计算系统的准确性，以提供远程评估 当与“金标准”间接检眼镜检查的结果相比时， 研究认证的眼科医生，在ROP诊断检查（有效性）方面接受严格培训; 2.确定阅片人内部和阅片人之间的一致性，以决定数字图像是否表明 眼睛需要由具有ROP经验的眼科医生进行诊断性间接检眼镜检查（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相关（安全性）; 5.比较采用远程医疗视网膜成像系统与 间接检眼镜检查的当前成本（成本效益）。 在美国和加拿大的大型临床中心，出生体重<1251 g的婴儿将接受数字化和数字化的检查。 在同一天进行视网膜成像和有临床指征的间接检眼镜检查。宽视场 双眼的数字图像将由非医师成像器使用标准化成像协议捕获。 RetCam Shuttle（R）（Clarity Medical Systems，普莱森顿，CA）是一种角膜接触式摄像机， 将使用宽视场（130度视场）视网膜图像。所有研究数据，包括人口统计学， 诊断检查、成像和安全性信息将安全传输至研究服务器。 视网膜图像将由经过培训的阅片人使用标准化方案进行分级，以识别RW- ROP。评分结果将与同一阶段的诊断检查结果进行比较。 相关性（参见说明）： 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 在美国和加拿大服务不足的地区，这一问题日益严重， 快速发展的国家。我们认为，一个系统的方法，使用数字视网膜成像结合 标准化分级提供了提高ROP护理质量、可及性和效率的机会。

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.