1. Lessons from the UK National DR Screening Program for Areas with Limited Resources Prof. Peter Scanlon MD FRCOphth FRCP DCH Programme Director English National Programme

2. UK Population Northern Ireland - population 1.8 million England - population 51.9 million 2.6 million with diabetes Scotland -population 5.2 million Wales- population 3.0 million

3. 2011-12 81 centres 2.6 million with diabetes 2.4 million offered 1.9 million actually screened Increase 121,000 in 12 months English National DR Screening Programme Large Telemedicine Programme Cost approx 80 million US dollars

4. Screening What are the risks? Are the risks changing?

5. Basis of the ENSPDR Grading Criteria Fundus photographic risk factors for progression of diabetic retinopathy. ETDRS report number 12. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology 1991; 98:823-33. ETDRS final Retinopathy Severity Scale ETDRS (Final) Grade LesionsRisk of progression to PDR in 1 year (ETDRS Interim) ETDRS follow up intervalsEnglish Screening Programme levels 3 No apparent retinopathy 10 14, 15 DR absent DR questionable R0 Currently screen Annually Mild NPDR20Micro aneurysms only1 yearR1 Screen annually Background microaneurysm(s) Retinal haemorrhage(s) any exudate venous loop 35 a b c d e One or more of the following: Venous loops > definite in 1 field SE, IRMA, or VB questionable Retinal haemorrhages present HE > definite in 1 field SE > definite in 1 field Level 30 = 6.2% 4-6 months Moderate NPDR43a b H/Ma moderate in 4-5 fields or severe in 1 field or IRMA definite in 1-3 fields Level 41 = 11.3% 3-6 months R2 Refer to ophthalmologist Pre-proliferative venous beading or reduplication intraretinal microvascular abnormality (IRMA) multiple blot haemorrhages Moderately severe NPDR 47 a b c d Both level 43 characteristics – H/Ma moderate in 4-5 fields or severe in 1 field and IRMA definite in 1-3 fields or any one of the following: IRMA in 4-5 fields HMA severe in 2-3 fields VB definite in 1 field Level 45 = 20.7% 4 months Severe NPDR53 a b c d One or more of the following: > 2 of the 3 level 47 characteristics H/Ma severe in 4-5 fields IRMA > moderate in 1 field VB > definite in 2-3 fields Level 51 = 44.2% Level 55 = 54.8%3 months Mild PDR61a b FPD or FPE present with NVD absent or NVE = definite R3 Proliferative Urgent referral to ophthalmologist Key points – refer at 11.3% risk of developing proliferative in 12 months R1 = background = mild NPDR = do not refer R2 = pre-proliferative = moderate to severe NPDR = refer R3 = proliferative = refer

6. Year of diagnosis of diabetes 1922–59 1960–69 1970–74 1975–80 WESDR: Twenty-Five Year Progression Of Retinopathy In Patients With T1DM Better glycaemic control and to a lesser extent BP control may be beneficial in reducing incidence of PDR and increasing odds of improvement of DR Reduction in prevalence of PDR in more recently diagnosed cohorts possible benefit of recent changes in management of diabetes Klein, R et al. Ophthalmol. 2008; 115:1859–1868 WESDR; Wisconsin Epidemiologic Study of Diabetic Retinopathy 70 60 50 40 30 20 10 0 PDR Prevalence (%) Duration of Diabetes (years) 0–45–910–1415–1920–2425–2930–3435+

7. Maculopathy M0No maculopathy M1Maculopathyexudate within 1 disc diameter (DD) of the centre of the fovea 29% thickening (Birmingham P Dodson personal communication) group of exudates within the macula Did not find CSMO if <1DD Mr N Dhingra, Wakefield UK any microaneurysm or haemorrhage within 1DD of the centre of the fovea only if associated with a best VA of  6/12 (if no stereo) 14% thickening (Birmingham P Dodson personal communication) What are the risks of developing Clinically Significant Macular Oedema from 2D photographic markers? Key points – M0 = No maculopathy M1 = Maculopathy

8. OCT photographic clinics for screen test positive maculopathy

9. Standardising the grading of retinopathy In 2009/10, English DESP introduced: Monthly QA test sets for all (1500+) graders in 86 local screening sites Sets of 30 (Yr 1) or 20 (Yr 2) cases / month, weighted to DR+ cases Year 1: Up to 12 blocks in numerical order Year 2: Up to 12 ‘monthly’ sets Accessed via the internet

10. Accessed via the internet at their own place of work or from home Not referred: 11/157 (7.0%) Exact: 235/300 (79%)

11. Exact agreement with R + M grade: Yr 1 Mean proportion (%) agreement with system grade Block number Yr 1 (2009-10) 1301 1278 1235 1112 1003 948 901 827 731 664 564 461 Number of Users completing all cumulative blocks - Trend: p<0.001

12. Exact agreement with R + M grade: Yr 2 Mean proportion (%) agreement with system grade Monthly sets Yr 2 (2011-12) 780 886 957 865 940 882 (0) 1016 896 1011 931 952 Number of Users completing set in month - Trend: p<0.01 N.B. No test was presented in October 2011 Mean (SD)

13. Agreement against system & peers April, Screen no.7 ‘System’ grade Grader 23 -

14. Agreement against system & peers April, Screen no.8 ‘System’ grade Grader 23 -

15. Screening Programme – why does it matter?

16. Generic QA Themes & Objectives ThemeObjective 1. Identify cohortTo maximise offer of screening to all eligible population 2. InformTo maximise informed choice throughout screening programme 3. InviteIn those who want screening, to facilitate uptake in eligible population 4. TestTo maximise accuracy of screening test 5. Minimising harmTo minimise potential harms from screening 6. DiagnoseTo ensure accurate diagnosis 7. Intervene/ TreatTo ensure high quality and timely intervention 8. OutcomeTo optimise public health and individual outcomes in target population 9. StaffTo ensure that whole screening programme is provided by a trained and competent workforce 10. Commissioning and governanceTo ensure effective commissioning and good governance of the screening programme 11. User experience/ patient journey To ensure a high quality journey throughout the screening process 12. EqualityTo ensure that screening programmes fulfil their requirements to reduce health inequalities

17. Diabetic Retinopathy Screening How to Start Buy a Fundus Camera?

18. Step 1. Manoeuvring around the politics of funding Many different levels Who is going to provided funding to support Is this going to be run by Public Health Physicians or by Specialists – Diabetologist? Or Ophthalmologist? A Champion is needed who has some skills in diplomacy Budgets need to be ring fenced Politics change from when a service is getting off the ground to when it is up and running

19. European Experience - barriers Public awareness Patient compliance Lack of funding for equipment, training, education Collaboration between ophthalmologists and diabetologists Lack of engagement of private providers of eye care Lack of systematic process, competency, registers, data Political instability Access to laser treatment remained poor in a few countries. Some perverse financial incentives were reported causing for example intravitreal bevacizumab or triamcinolone being given even when laser is available.

20. Step 2: Are Assessment and Treatment facilities available? Adequate number of lasers and ophthalmologists to treat If not - Contract with an organisation that can provide treatment

21. Step 3. Identify cohort for invitation and call - recall Diabetes Register How do you record patient details? If literacy levels are low the patient surname may be spelled differently at each visit Is there a National ID number? Are births and deaths recorded in the population?

22. Step 4. How are you going to invite them? Letter? Word of mouth? Etc……….. In those who want screening, to facilitate uptake in eligible population

23. Step 5. How are you going to inform the patients and maximise uptake? To maximise informed choice throughout the screening programme 1. Educating the population - this is not a diagnostic test – some patients with sight threatening diabetic retinopathy will be missed. 2. Patient education, engagement with patient organisations, 3. Appropriate exclusion criteria e.g. those already under ophthalmology, terminally ill etc..

24. Step 6. Establish an IT infrastructure Preferably as simple as possible Need reliable power supply An inexpensive joined up solution for administration of call recall, screening, grading and audit is an urgent requirement. Make sure images attached to patient details Who is going to support that IT iinfrastructure? How is it going to be backed up? How are you going to ensure confidentiality of patient data?

25. Step 7 - Purchase a Camera Minimum camera specification Most of the modern non-mydriatic digital cameras meet a good quality specification What relationship is there with the camera manufacturer for technical support in your area?

26. Image sizes of cameras and recommend compression at source Output resolution Output Resolution in millions of pixels Uncompressed File size in MB 12:1 Compression in KB 20:1 Compression in KB CameraBackHV Nidek NM-1000 integral 13601024 1.394.2MB348KB209KB Kowa Non-Myd alpha integral 16001216 1.955.8MB486KB292KB Topcon NW100 integral 17921184 2.12.6.4MB530KB318KB Topcon NW6 Nikon D1H 20001312 2.627.9MB656KB394KB Nikon D1x 30081960 5.9017.7MB1.47MB884KB Nikon D1x 20001312 2.627.9MB656KB394KB Canon CR6/DGi Canon EOS 10D 30722048 6.2918.9MB1.57MB944KB Canon EOS 10D 20481360 2.798.4MB696KB418KB D30 21601440 3.119.3MB778KB467KB

27. Step 8 - The test and grading images – Choices for programmes 1.Mydriasis or non-mydriasis? 2.The number of fields 3.The grading referral criteria 4.Viewing the images for grading

28. The test – mydriasis, selective mydriasis or not? Clear protocols need to be in place

29. The test – number of fields and positioning

30. The Grading Referral Criteria Recommend R0M0, R1M0, R1M1 etc…. So that every eye has at least an R and M grade This makes it much easier to compare between programmes Retinopathy progresses with increasing ischaemia R grade Leaks occur in the macular area M grade The treated patient is more difficult to grade

31. Recommendations on Viewing Images 1.Screen resolution 2.Display 60% of the image at once on the grading screen

32. Management of patients with ungradable images Clear protocols need to be in place

33. Step 9.Employ and train a competent workforce To ensure that whole screening programme is provided by a trained and competent workforce 1.Staff accreditation 2.Evidence of ongoing CPD and EQA test sets

34. Step 10. introduce some Quality Assurance 1.Reduce the probability of error and risk 2.Ensure that errors are dealt with competently and sensitively 3.Help professionals and organisations improve year on year 4.Set and keep under review national standards; 5.Manage these processes.

35. 1. What would I do with 150k USD recurring? Start with a pilot project Check that assessment and laser treatment facilities in place Liaise with local patient groups, ophthalmologists and diabetologists Write protocols and decide on patient pathways for screen positive and ungradable images Make sure adequate power supply to screening and grading locations Employ someone with IT skills Choose software, hardware and back up facilities

36. 2. What would I do with 150k USD recurring? Decide on grading form that refers at the agreed level of risk Train non medical graders Buy a camera Provide patients with appropriate education Invite cohort for screening Photograph eyes Send image to central grading where possible.

37. Thank you for listening It is worth doing despite all the obstacles and organisational difficulties!