Unit 301 (Peter Dartnell) Q1a) Medical screening is a strategy to detect disease in a population of Individuals without signs and

symptoms of that disease. If the disease is detected early, it is with the hope that there can be a reduction to the mortality/morbidity that the disease can provoke. The screening procedure should be accurate enough to detect a true positive (an individual with the condition that is identified by the screening procedure as having the condition) as well as a true negative ( a healthy person who is identified by the screening procedure as not having the condition). However with all screening procedures a number of False Positives (healthy individuals who fail the screen) and False Negatives (individuals with the disease who pass the screen) will get through. It should be stated that the screening process is not a definitive diagnosis of either having or not having the disease, but it identifies individuals who might benefit from further testing to establish the diagnosis Screening is a risk reducing exercise to try and identify individuals that may benefit from further treatment to either alleviate or reduce further problems with a disease process. Q1b) Wilson and Jungner in 1968 laid down a principle for screening which screening procedures must adhere to be effective:a) The condition should be an important health problem b) There should be a treatment for the condition. c) Facilities for diagnosis and treatment should be available. d) There should be a latent period for the disease. e) There should be a test or examination for the disease. f) The test should be acceptable to the population. g) There should be an agreed policy of who to treat. h) The natural history of the condition should be adequately known. i) The total cost of finding a case should be economically balanced in relation to medical expenditure as a whole. j) Case finding should be an on going process, not a once and for all project.

Q2) Diabetic retinopathy is one of the most common causes of visual loss in the Western working population. Many patients with visual loss present to health care professional once the have a significant impairment. Diabetic Retinopathy screening allows individuals to be detected at a much early stage so vision loss can be stabilized or stopped. A secondary benefit is identifying individuals who may not have visually significant amounts of retinopathy, but a small amount may indicate there could be concerns re the efficacy of their current control and then and steps can be taken to address this and prevent further systemic diabetic damage. It can also aid a physician in ensuring the patients blood pressure and cholesterol levels are within normal limits. Other causes of visual loss in diabetics include trauma and injury, amblyopia, ARMD, retinal vein and or artery occlusion, ischaemic optic neuropathy, cataract, glaucoma, retinal detachment, hypertension, optic atrophy retinal dystrophies and myopic degeneration. These and any other non-diabetic sight threatening conditions are not being actively screened for on a diabetic retinopathy screening scheme. If they are identified there needs to be a protocol to refer these opportunistic discoveries. In Staffordshire as it is an optometrist driven scheme, these opportunist discoveries can be reported to both G.P and Ophthalmologist via the GOS18 referral procedure. Q3) Studies have shown that about 10% of diabetics will have diabetic retinopathy that will require treatment. Without treatment 6-9% of those with proliferative retinopathy will become blind and 10% with maculopathy will develop moderate visual loss annually. Studies in East Birmingham have shown there has been a noticeable reduction in severe visual impairment when a screening scheme was instigated. Blindness was reduced from 3.5% to 0.5% in Type 1 diabetics and a reduction from 1.1% to 0,6% in Type 2 diabetics as well as a significant reduction in visual loss in both groups. A second study showed a reduction in the rate visual loss by more than 33% over a twelve-year period. This was verified by a third study. A diabetic retinopathy screening scheme meets the Wilson-Jugner criteria for a successful programme as the disease process has important adverse effects, it can be treated by laser therapy, it can be detected by digital photography, it is an acceptable test and is very cost effective. The screening procedure is there to identify clinically significant signs in patients at an early stage before symptoms start. This then ensures the patient is referred to ophthalmology for potential laser treatment to stabilise and stop any further loss of vision due to retinopathy and or

maculopathy. With the different grading outcomes there are set time limits to ensure the patient is seen by an ophthalmologist to ensure treatment will be effective at preserving vision. Primary gradings must be assessed and transmitted to the central administration office within three working days of initial photography. This ensures that the secondary and possible referrals to ophthalmology managed in a timely and efficient way and the patient can get the appropriate treatment quickly to preserve vision.; Q4) The limitations of any screening process are the amount of true positives, false positives, true negatives and false negatives that are produced. All current UK DR screening projects should adhere to The Exeter Standards. These state there should be 80% sensitivity and 95% specificity. These values were set to minimise the false positives, Sensitivity is the number of true positives divided by the number added together of true positives and false negatives. Specificity is the number of true negatives divided by the number added together of true negatives and false positives. The gold standard for DR detection is accepted as an ophthalmologist using slit lamp bio fundoscopy. The nearest other method is analysis of two position digital photography (macula and disc centred). Two studies were undertaken to check sensitivity and specificity of digital photography compared with ophthalmological led slit lamp screening The Gloucester DR study showed an 87.8% sensitivity and 86.1% specificity The Liverpool study showed 84% sensitivity and 89% specificity. As can be seen digital photography does not quite reach full Exeter standards criteria, but is very close. No screening procedure will ever be 100% specific or sensitive. No matter how well constructed and performed there will always be a number of subjects mis-diagnosed or missed 5a) Most diabetics will realise the ultimate problem with retinopathy is blindness. This might be a remote chance, but is always a possibility that person has to live with. The mere fact they are being screened could show some problem within their eyes that could speed up this prognosis. A true positive shows the problem, which could cause anxiety, but the patient can be counselled that the problem has been identified at an early stage and can be treated to prevent future problems. False

positive results would also cause anxiety, the may be relieved to find it was a false alarm, but may have less confidence in the scheme and may not attend in the future. A false negative on discovery could cause a lot of anger and loss of confidence in the scheme and could result in legal action if caused by negligence. Q5b) DR screening is targeted towards a population of established diabetics. The screening is not to identify the primary disease, but to identify ocular manifestations of the disease process. Conventional screening is to identify disease in an apparently healthy population with no obvious signs or symptoms.

Q6) Successful screening relies on cooperation and understanding from the patient and the scheme. It is important that the patient believes it is in their best interest to be actively involved in all aspects of screening and possible future treatment and implications if not being screened. However as adults they can make a decision not to be involved in screening. All patients should be supplied with information of the advantages of the screening procedure so they can make an informed decision if they wish to be screened or not. Once they have decided any result should be noted on their permanent record. If a patient is deemed not to be competent to make that decision a suitable third party can do it. It is vital that if this person is not a health professional that they are given the relevant information both verbally and written and their decision noted. Q7a) The National Screening Programme for Diabetic Retinopathy controls diabetic screening in the UK. Its aim is to reduce the risk of sight loss amongst diabetics by the prompt identification and effective treatment of sight threatening retinopathy at the appropriate stage during the disease process. The NSPDR set in place all key components for all UK based schemes. The components are as follows: A) Administration has to be in place to manage appointments and referrals.

B) Digital cameras must be available. C) Trained and accredited screening staff must be available D) There has to be internal and external quality assurance E) There must be a grading pathway to include quality assurance. F) Appropriate referrals to ophthalmology G) Laser treatment and referrals seen in a timely manner H) Information system to manage and report all of the above. I) Comprehensive annual reporting. The above list allows for the following requirements in a local scheme. The scheme requires that it is 1) Accurate. This ensues it identifies its target group of all diabetics over 12 years of age. 2) It is robust. (there is a central call/recall system. 3) There is adequate patient access both physical and the ability to communicate and understand. 4) There is an effective screening test. Two position digital imaging of the fundus meets the Exeter standards. 5) There should be a standardised test procedure. With the Staffordshire scheme there is both an imaging and grading protocol. 6) There should be an adequate referral pathway for both gradable and un-gradable images. 7) There should be adequate administration in place that ensure both internal and external quality assurance can take place. 8) There should be competent and trained staff available at all levels in the scheme.

Q7b) The Staffordshire scheme follows the above list. 1) Accurate. The central office receives data from GPs surgeries of all diabetics over 12 in its area and invitations are sent for screening. This list is then updated and amended appropriately. 2) Robust. There is a central co-ordinator to over see the list and make sure the list is as accurate as possible. There is a fail safe procedure to ensure this. 3) Adequate patient access. All patients are given a list of accredited optometrist practices in Staffordshire with contact details and opening

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times. These should be relatively local to most patients. There is a facility for domicllary photography if necessary. Effective screening test. All accredited practices use approved retinal cameras and use 2 position digital imaging as laid down in the Exeter Standards. Standardised test procedure. All accredited practices follow these guidelines for both imaging and grading Adequate referral pathway. All screen positives are sent to a secondary grader and then the appropriate decision is made. Both primary and secondary need to agree. In disputes the images are sent to arbitration for a final check. Ungradeable results are referred through to a specialist slit lamp grader for grading. Adequate administration in place. The central office has a dedicated i.t. support and admin team to answer queries from the public, graders and photographers. There is a system of internal Q.A where both primary and secondary graders have to agree. There is also now an external QA scheme where every grader has to grade 30 test photos each month to remain active on the scheme. Trained competent staff. All members of the scheme have to undertake a qualification relevant to their position in the scheme and attend training when required.

Q7c) The main advantages of a community based scheme is there is easy access for the patients, times can be booked 6-7 days per week, transportation can be easy to arrange, familiarity of the practice, job satisfaction for the grading team, continual professional development for the team along with professional support from colleagues. Q8) Poor performance from the screen could ultimately cause visual loss, lack of confidence in the scheme, increase in cost to the scheme for unnecessary re screens, unnecessary stress for the patient and a possibility of the scheme being cancelled due to not meeting its performance indicators.

Q9a) Internal QA is maintained by all primary failures and 10% of passes are secondarily graded. This is done on a day-to-day basis. If consensus is not met they then go to arbitration grading. If there are consistent problems with any grader further remedial may take be needed. External QA is provided by an independent third party and consists of all graders being asked to grade 30 test images once a month. If this is not undertaken the grader is removed from the scheme until that months test images are assessed. Q9b) QA monitors errors, helps improvement, protects patients, reduces risks and increases accurate diagnosis.

Q10)

a) To reduce new blindness due to diabetic retinopathy. Early detection leads to timely treatment on a better prognosis. b) To invite all eligible persons with known diabetes to attend for DR screening. This is to implement the first standard. c) To ensure the database is accurate. This so all known diabetics can be screened. d) To maximise the number of invited persons accepting the test .By answering queries or concerns reluctant patients may have and allowing them to make an informed decision about screening e) To ensure all photographs are of adequate quality. This allows accurate grading and unnecessary re screening. f) To ensure grading is accurate. This ensures less unnecessary referrals.

g) To ensure optimum workload for graders and to maintain expertise. All optometrist graders have to grade more than a set number of photographs to maintain expertise. h) To ensure timely referral of abnormal screening results. This is vital to allow timely ophthalmological intervention if appropriate. i) To ensure GP and patient are informed of all test results. This make sure everyone in the care of diabetes is aware of the current state of vision and control . j) To ensure timely consultation for all screen positive patients. This allows the appropriate expert to advise the patient about the treatment plan. k) To ensure timely treatment of those listed by ophthalmologist. Prompt treatment decreases the speed of visual loss. l) To minimize overall delay between screening event and first laser. Prompt treatment preserves vision longer. m) To follow up screen-positive patients. This ensures patients are not lost to screening if discharged from ophthalmology or fail to attend followup appointments. n) To minimize the anxiety associated with screening. Try to reduce false positive by training and review. o) To ensure timely re screening. This ensures patients are screened appropriately. p) To ensure that the public and health care professionals are informed at regular intervals. This allows everyone involved in the screening procedure to be informed of all relevant information. q) To ensure the scheme participates in QA. This ensures that there are a number of fail-safes to minimize errors and maintain high standards for the screening team. r) To optimise programme efficiency and ensure ability to assure quality of service. This ensures there are enough patients to make the scheme economically viable.

s) To ensure that all screening and grading of retinal images are provided by a trained and accredited workforce. This maintains high standards to ensure that the patients get the best possible care. t) To ensure timely biomicroscopy assements are undertaken for patients whos photos are unobtainable or u gradable. The scheme refers these patients to a specialist grader who can undertake a slit lamp assessment.

Q11) It is important to have a fail-safe procedure to minimize patient lost to screening. This is especially important in a large scheme with many thousands of patients There can be potential problems with patients who have been referred to ophthalmology and then discharged by the hospital. There has to be a protocol to re assign the patient back to screening. Another example is when a patient chooses to be seen privately. There is a system where they scheme invitation can be deferred for a period of time and monitored if the patient chooses to leave their private scheme. A designated fail-safe officer can monitor this. Q12) This ensures all diabetics over 12 years of age are screened appropriately. It is vital that the database is checked and rechecked as often as possible (data cleansing) to ensure it is as accurate as possible if new patients come to the area, existing patients leave or die, change GPs or are referred into or out of ophthalmology

Q13) The reasons leading to non-compliance are many and varied. These include fear, denial, external pressure, transport, age, other chronic medical conditions and ignorance. Many diabetics feel very well so they can be apathetic to routine monitoring. Other more elderly patients may have other more acute health problems and concentrate on those to the exclusion of DRscreening.

Q14) It is important to ascertain screen positives have been referred appropriately. Screening administration then can arrange an ophthalmology appointment and then ascertain the patient has attended and is treated. If they are then to be followed up in the HES their screening appointments can be deferred until they are subsequently discharged back to the community. Information from ophthalmology can be passed back through the system as part of training, QA and to boost job satisfaction for all team members.

Unit 301 B Q1) It is vital that the central database is checked and update regularly. In the Staffordshire scheme an administrator checks the PCT patient database monthly to delete any deceased patients. Some schemes have an electronic checking facility that updates the system automatically every 24 hours. When the patients wife phoned an apology should be made for any distress caused and she could be reassured that there will be checks made to ensure this does not happen again. The main problem is getting the information on the system from the PCT. Q2) It could be explained that whilst the patients optometrist is a fully capable and knowledgeable professional, but is not an accredited photographer and grader. Diabetic retinopathy is more consistently picked up using accredited graders and digital photography. Screening can be seen as a complementary procedure to a normal eye examination but needs to be conducted separately. The screening procedure can be explained to them. Information can be posted to the patient and then they can be followed up verbally to ensure they understand the information. If they still refuse screening they should be encouraged to be deferred for a period of time and then get an invitation to re-join the scheme in the future. The information should be recorded manually and the screening office informed.

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