ORNATE-India is made up five work packages (WP) led by a multidisciplinary team of researchers in the UK and India. The Kerala Study (WP1) aims to develop a diabetic retinopathy care pathway in Kerala and the Smart India Study to initiate a systematic diabetic retinopathy screening programme and test the accuracy of non-laboratory tests to diagnose diabetes, pre-diabetes and complications compared to the standard laboratory tests and retinal imaging. WP2 and WP3 focuses on developing simple innovative tools to automate the grading of diabetic retinopathy images and a blood sensor to identify sight threatening diabetic retinopathy. The data generated in WP1 will be used to measure the cost effectiveness of various screening models and care pathways and establish feasibility for all low and middle income countries in WP4. Risk modelling of diabetes and its complications in ethnic groups globally will be developed and validated using big data analytics in WP5.
The Kerala Study
Kerala is the most advanced state in India in terms of literacy, economic progress, social uplift and demographic transition but is known as the diabetes capital of India. The prevalence of diabetes can be as high as 20% ─ double the national average of 8%. The prevalence of diabetic retinopathy among the diabetic population is ~ 18%. Currently, there is no systematic diabetic retinopathy screening programme in the public sector.
The overarching objective of the Kerala Study, planned in collaboration with the Government of Kerala, is to reduce the risk of visual impairment due to diabetes by developing a diabetic retinopathy care pathway.
We aim to evaluate the effectiveness of introducing screening and treatment pathways for diabetic retinopathy in the public system in Kerala by adapting care pathways in developed countries to local needs and resources. The researchers intend to introduce a complex intervention of screening for diabetic retinopathy at the primary care level, laser treatment at district hospitals and complex referrals to the tertiary centres by increasing research and service capacity and capability. The quality and delivery of the intervention is also assessed at each sector of the care pathway to evaluate whether the study is delivered as intended.
This pilot study will take place within the public health system in Thiruvananthapuram and will inform the roll-out of the diabetic retinopathy care pathway throughout the Kerala State.
Proposed Pathway for Diabetic Retinopathy
People with diabetes registered in the noncommunicable disease (NCD) register at 16 Family Health Centres (FHCs) in Thiruvananthapuram district will be invited to be screened for complications of diabetes.
Map showing the locations of the 16 FHCs in Thiruvananthapuram district of Kerala
Screening for diabetic retinopathy will be carried out using smartphone-based mydriatic retinal imaging (Remidio Innovative Solutions, Bengaluru, India).
Screening for diabetic retinopathy using a smartphone-based fundus camera
a) Healthy retina b) diabetic retinopathy- hemorrhages and cotton wool spots
The staff at the FHCs will collate the data at primary care level. The retinal images will be linked to the eHealth register and uploaded to the Regional Institute of Ophthalmology (RIO) where the image will be graded by optometrists and results reported back to FHCs. Annual recall of patients with non-referable retinopathy will be arranged.
If patients are diagnosed with diabetic retinopathy and require treatment they are referred to a District Hospital (DH) for laser surgery or to RIO if anti-VEGF treatment is necessary. Treatment outcomes at DH and RIO will be collected as below.
Health Economic Evaluation
The key outcome of the Kerala Study is the number of cases of severe visual impairment or blindness due to sight threatening diabetic retinopathy averted as a result of the new care pathway and quality-adjusted life-year (QALY) gains arising from cases averted. We will use EQ5D, an instrument to measure of health-related quality of life, with vision bolt-on data where data is available and detailed cost data. At the conclusion of this study, we hope to assess the effectiveness and implementation of a complex diabetic retinopathy care pathway integrating care at primary, secondary and tertiary care, covering a proportion of the diabetic population in Thiruvananthapuram. This pilot data will be useful for Kerala and will set the scene for a policy for State-wide Diabetes Complications Screening and Treatment Pathway with clinical impact on the patient, impact on the community, impact on staff and economic impact on family and public purse and integrating it to primary care practice.
Proposed Diabetic Retinopathy Care Pathway