How is patients’ annualized risk determined? Was the algorithm clinically validated?
The annualized risk is calculated by a proprietary algorithm based upon major, well-established risk factors for the development of sight-threatening diabetic retinopathy. The algorithm has been validated for high predictive accuracy in Icelandic, Danish and Dutch diabetes cohorts.
Is the algorithm applicable to a variety of patient races and ethnicities?
The algorithm has been clinically validated in Northern European diabetes cohorts, which include a variety of races and ethnicities. Our team plans future validation for other populations in the near future. The processes implicated in sight-threatening diabetic retinopathy within all populations are predominantly dependent upon metrics employed by our algorithm, including blood glucose control, blood pressure status, disease duration, gender, diabetes sub-type, and presence or absence of non-proliferative retinopathy.
A number of emerging risk factors for sight-threatening diabetic retinopathy are not part of the clinical data entered into the calculator, including obstructive sleep apnea, obesity, and history of other diabetes complications like non-healing limb ulceration. Why not?
The algorithm accounts for 80% of established risk in patients with diabetes based upon a preponderance of research data, and has been validated for accuracy in large populations of patients with diabetes by accounting for the significant majority of total risk. These emerging factors probably account for 20% of total risk and may very well be important for refinement of predictive power, but require further validation. The personalized report form generated for each patient does, however, allow health care providers to communicate the presence of at least some of these emerging risk factors and recommend additional preventative strategies for patients based upon clinical judgment and new research findings.