Piyasena Mapa Mudiyanselage Prabhath Nishantha, Gudlavalleti Venkata S Murthy, Gilbert Clare, Yip Jennifer Ly, Peto Tunde, MacLeod David, Fonseka Charith, Kulatunga Aruna, Bandutilake Bgwmkcb, Dhanapala Mangala, Pathirana Lalani, Dissanayake Heshani
Clinical Research Department, International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
School of Medicine, Dentistry and Bio-medical Science, Queen's University, Belfast, Ireland.
JMIR Res Protoc. 2018 Dec 10;7(12):e10900. doi: 10.2196/10900.
Visual impairment and blindness from diabetic retinopathy (DR), which can be reduced by early screening and treatment, is an emerging public health concern in low-income and middle-income countries (LMICs) owing to the increasing prevalence of diabetes mellitus (DM). However, no systematic screening exists in most LMIC settings. The Western province of Sri Lanka has the highest prevalence of DM (18.6%) in the country. A situational analysis identified a marked gap in DR screening (DRS) and treatment services uptake in this region; only opportunistic screening is practiced currently.
The aim of this protocol is to describe the methods of development and validation of a DRS intervention using a hand-held nonmydriatic digital camera by physician graders in a non-ophthalmological setting at a tertiary-level medical clinic to propose a valid and feasible modality to improve uptake.
DRS modality was developed after assessing barriers and identifying the most appropriate personnel, methods, and location for screening services, following formative research work. The validation will be conducted in a public sector tertiary care center in the Western province of Sri Lanka. The selected physicians will be trained on capturing and grading images according to a valid locally adopted protocol. Two physicians rated high on training will screen a sample of 506 people with DM at a medical clinic. They will use nonmydriatic and mydriatic 2-field imaging strategy. The validity of the proposed screening procedure will be assessed and compared with the mydriatic indirect biomicroscopic examination by a senior retinologist.
The validity of screening by physician graders will be analyzed and the sensitivity, specificity, and predictive values (with 95% CIs) calculated by the dilation status and for each grader. The diagnostic accuracy at each level of severity of DR will be assessed to define the most appropriate referable criteria. Data is currently being collected.
The outcome of this study will be useful for the detection of a defined level of DR at non-ophthalmological setting to filter the people with DM before referral to an eye clinic. This will be helpful to improve the uptake and identify risk groups in advance to prevent sight-threatening DR. Furthermore, evidence from this study will be useful for the implementation of a DRS program in this region and in similar communities.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10900.
糖尿病视网膜病变（DR）导致的视力损害和失明可通过早期筛查和治疗得以减轻。由于糖尿病（DM）患病率不断上升，在低收入和中等收入国家（LMICs），这已成为一个新出现的公共卫生问题。然而，在大多数LMICs环境中不存在系统的筛查。斯里兰卡西部省份是该国DM患病率最高的地区（18.6%）。一项情况分析发现该地区在DR筛查（DRS）和治疗服务利用方面存在明显差距；目前仅开展机会性筛查。
本方案的目的是描述在三级医疗诊所的非眼科环境中，由医生分级人员使用手持式非散瞳数码相机开展DRS干预措施的开发和验证方法，以提出一种有效且可行的方式来提高筛查参与率。
在进行形成性研究工作、评估障碍并确定筛查服务最合适的人员、方法和地点之后，开发DRS模式。验证将在斯里兰卡西部省份的一家公共部门三级护理中心进行。选定的医生将接受培训，按照有效的本地采用方案采集图像并进行分级。两名在培训中评分较高的医生将在一家诊所对506名DM患者样本进行筛查。他们将采用非散瞳和散瞳双视野成像策略。将评估所提议筛查程序的有效性，并与资深视网膜病专家的散瞳间接检眼镜检查结果进行比较。
将分析医生分级人员筛查的有效性，并按散瞳状态和每位分级人员计算敏感性、特异性和预测值（95%置信区间）。将评估DR各严重程度水平的诊断准确性，以确定最合适的转诊标准。目前正在收集数据。
本研究结果将有助于在非眼科环境中检测出特定水平的DR，以便在将DM患者转诊至眼科诊所之前对其进行筛选。这将有助于提高筛查参与率并提前识别风险群体，以预防威胁视力的DR。此外，本研究的证据将有助于在该地区和类似社区实施DRS项目。
国际注册报告识别码（IRRID）：PRR1-10.2196/10900。
