Prospective Telemedicine Screening for Diabetics at High Risk for Retinopathy. PI- Jayne S Weiss, MD LSUHSC-NO.

Project Motivation Americans with diabetes project to double or triple by 2050 – CDC report Americans with diabetes project to double or triple by 2050 – CDC report Louisiana has the highest diabetes mortality rate (35.5 per 100,000 population) and the sixth highest prevalence of the disease in the nation. Louisiana has the highest diabetes mortality rate (35.5 per 100,000 population) and the sixth highest prevalence of the disease in the nation. Louisiana ranks second in the nation in obesity — a major risk factor for diabetes. Louisiana ranks second in the nation in obesity — a major risk factor for diabetes. In ten years, the prevalence of adult diabetes nearly doubled, increasing from 5.2 percent in 1997 to 10.1 percent in In ten years, the prevalence of adult diabetes nearly doubled, increasing from 5.2 percent in 1997 to 10.1 percent in Source CDC and

Project Motivation Many more diabetic patients are seen in LSU Healthcare services clinics than can be seen by our retina service, even for a yearly retinal photo and exam Many more diabetic patients are seen in LSU Healthcare services clinics than can be seen by our retina service, even for a yearly retinal photo and exam Without regular screening considerable numbers of Louisiana’s diabetics are at risk for Diabetic Retinopathy (DR) Without regular screening considerable numbers of Louisiana’s diabetics are at risk for Diabetic Retinopathy (DR) – Due to race, obesity, poorly controlled blood sugar

Diabetic Retinopathy Type I Type I – After 20 years, 99% had some degree of retinopathy – 3.6 % found to be legally blind and 86% of these attributed to DR Type II Type II – After 20 years, 60% had some degree of retinopathy – 1.6 % found to be legally blind, and 33% of these attributed to DR – BUT IF DR DETECTED EARLY, VISION LOSS CAN BE PREVENTED WITH LASER TREATMENT ** Higher in AA, Mexican Americans, Native Americans Source: Wisconsin Epidemiologic Study… Ophthalmology 115(11): Source: Wisconsin Epidemiologic Study… Ophthalmology 115(11):

Increased Rates of DR with Higher Hb A 1C levels Source: DCCT Group NEJM :

Telemedicine

Telemedicine Problems

Goals of Study To examine the sensitivity and specificity of the current method of screening in a retrospective study To examine the sensitivity and specificity of the current method of screening in a retrospective study To evaluate possible improvements in the screening method including: To evaluate possible improvements in the screening method including: – Dilated photography – Quality control at initial photo session – Expert, rather than less experienced readers

Initial Retrospective Study (Assess efficacy of current protocol) Retrospective study reviewing telemedicine photos from previous 6 month period that were already reviewed, diagnosed with some patients referred to ophthalmology Retrospective study reviewing telemedicine photos from previous 6 month period that were already reviewed, diagnosed with some patients referred to ophthalmology Expert “blinded” reader re-reads photos Expert “blinded” reader re-reads photos Compare the results of new read to previous (initial) diagnosis and disposition Compare the results of new read to previous (initial) diagnosis and disposition Compare the numbers of these patients who were diagnosed as having DR or not after initial read,with the numbers diagnosed as DR (yes, no) by the expert examiner. Compare the numbers of these patients who were diagnosed as having DR or not after initial read,with the numbers diagnosed as DR (yes, no) by the expert examiner.

Initial Retrospective Study Group 1 Those that had no retinopathy by either reader – and were not referred Group 2 Those that had retinopathy by both readers and were referred and seen. (clinical exam notes will be obtained and compared to photo readers conclusions) Group 3 Those that had disagreement between initial examiner and present examiner on presence of retinopathy Group 3a Group 3a Referred to clinic - clinical exam notes will be obtained Group 3b Group 3b Some not referred – to be referred and examined

Improve Screening (2 nd Prospective Study) Goal: Improve sensitivity and specificity of retinal photo screening for DR Goal: Improve sensitivity and specificity of retinal photo screening for DR Prospective study on patients who have already been examined by direct ophthalmic exam by the retina service. Prospective study on patients who have already been examined by direct ophthalmic exam by the retina service. The patients recruited will be those who have not yet received PRP if diagnosed with DR The patients recruited will be those who have not yet received PRP if diagnosed with DR Patients who have been examined but not diagnosed with DR – as control group. Patients who have been examined but not diagnosed with DR – as control group. These two groups will be recruited to have dilated retina photos taken These two groups will be recruited to have dilated retina photos taken These photos will be read by expert readers in a masked fashion These photos will be read by expert readers in a masked fashion Observer agreement statistics between readers of images and conclusions of direct exam Observer agreement statistics between readers of images and conclusions of direct exam Additional leg if first phase of study indicates non-mydriatic photos had adequate sensitivity. Compare non-mydriatic photos with dilated images for observer agreement with direct exam Additional leg if first phase of study indicates non-mydriatic photos had adequate sensitivity. Compare non-mydriatic photos with dilated images for observer agreement with direct exam

Participants Ophthalmology JSWeiss, S O’Sullivan, M Reinoso P Azar, B Fuller LSU H Thompson

Core Services Medical Informatics Design and Analysis Network Evaluation and Support

Timeline IRB submission Retrospective Review and Patient Exams 6 month Prospective Patient Exams and Photo 1 year Statistical Analysis 3 month

Prospectus for Study/ Conclusions Address serious problem in care delivery for Louisiana’s diabetic population Address serious problem in care delivery for Louisiana’s diabetic population Enhance methods for DR screening Enhance methods for DR screening Provide background studies for eventual automation of some parts of the process Provide background studies for eventual automation of some parts of the process......

Acknowledgements: Horswell, Ronald; Cerise, Frederick P; Kaiser, Michael MD; Besse, Jay A.; Yi, Yong; Fontham, Elizabeth; Thompson Hilary