Abstract
BackgroundVisual 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.ObjectiveThe 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.MethodsDRS 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.ResultsThe 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.ConclusionsThe 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
Highlights
The prevalence of diabetes mellitus (DM) and the number of people affected by DM is increasing rapidly in all regions
The outcome of this study will be useful for the detection of a defined level of diabetic retinopathy (DR) at non-ophthalmological setting to filter the people with DM before referral to an eye clinic
Evidence from this study will be useful for the implementation of a DR screening (DRS) program in this region and in similar communities
Summary
The prevalence of diabetes mellitus (DM) and the number of people affected by DM is increasing rapidly in all regions. The International Diabetes Federation estimated that 425 million people had diabetes in 2017, which will increase to 629 million in 2045 globally [1] This increase is expected to be the highest in low-income and middle-income countries (LMICs) compared with high-income countries (HIC) [2]. Diabetic retinopathy (DR) is a common microvascular complication of DM, which can lead to visual impairment and blindness if not detected early and treated [3]. Diabetic retinopathy screening (DRS) can be done in 2 ways, systematic screening similar to national-level programs in HIC versus opportunistic screening and case detection, which is common in low-income settings. 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). A situational analysis identified a marked gap in DR screening (DRS) and treatment services uptake in this region; only opportunistic screening is practiced currently
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