Diabetic Retinopathy Screening

Transcription

1 Diabetic Retinopathy Screening Consultation Feedback Report on the Draft Standards June 2016

2 Healthcare Improvement Scotland 2016 First published June 2016 The publication is copyright to Healthcare Improvement Scotland. All or part of this publication may be reproduced, free of charge in any format or medium provided it is not for commercial gain. The text may not be changed and must be acknowledged as Healthcare Improvement Scotland copyright with the document s date and title specified. 2

3 Contents Consultation on the Draft Standards for Diabetic Retinopathy Screening... 4 Standard 1: Governance and leadership... 5 Standard 2: Call-recall Standard 3: Uptake (now Attendance and uptake in final standards) Standard 4: The screening process Standard 5: Referral Standard 6: Treatment Other comments

4 Consultation on the Draft Standards for Diabetic Retinopathy Screening An 8-week consultation period took place immediately after the Draft Standards for Diabetic Retinopathy Screening were published in January During the consultation, a range of different methods to capture comments were used. During consultation, 446 comments were received from a variety of stakeholders. Duplicate comments, comments that do not relate to the standards and comments that state the respondent agrees with the proposed content, have been removed. In total, 355 comments were presented to the project group and each comment was considered and a response was provided. All comments and responses are detailed below and please note all comments have been anonymised. Stakeholder comments received from: Diabetes Scotland Diabetic Retinopathy Screening Collaborative Groups East Dunbartonshire Health and Social Care Partnership National Specialist and Screening Services Directorate NHS Ayrshire & Arran NHS Borders NHS Dumfries & Galloway NHS Fife NHS Forth Valley NHS Forth Valley Learning Disability Group NHS Greater Glasgow and Clyde NHS Grampian NHS Highland NHS Lanarkshire NHS Lothian NHS Shetland NHS Western Isles Optometry Scotland Royal College of Ophthalmologists Royal College of Physicians of Edinburgh Specsavers 4

5 Standard 1: Governance and leadership Standard 1 Statement comments Scotland has an effective national diabetic retinopathy screening service. 1 It should be modified to Cost-effective rather than just effective 2 Limited because there is no joined up approach with patients visiting their community Optometrist, there is no way of knowing whether patient s retinal images have changed since the last DRS. Allowing Optometrists to access DRS would create better quality and effective care for the patients (Optometrists have a VPN connection which could be modified to allow access to SCI DC), Optometrists could then compare retinal images taken in the practice with DRS images, with patient consent, thus negating over referral and patient stress. 3 The "What does the standard mean for people participating in DRS?" box says "you can expect the services to be committed to improving the screening and management of diabetic retinopathy". I recognise constant quality in the rationale and criteria but the commitment to improving is harder to discern. 4 The Royal College of Ophthalmologists has not taken sounding from members but no expressions of dissatisfaction have been voiced in Council meetings. 5 My retinopathy occurred between screenings and therefore was not picked up by the screening process before it affected my sight. 6 It could be better if optometry were allowed access to the Drs data base. We would benefit greatly by seeing the pxs last photograph as we would be able to determine whether or not there had been any This will remain as effective as it s not only referring to cost. scope of the standards. scope of the standards. 5

6 deterioration in their eye condition. In order to help increase the number of screenings, optoms should be able to upload any current photographs that they have taken in order that they can be screened. This would greatly increase the effectiveness of the screening program and avoid duplication of work. This would not be instead of screening but in addition. This would aid in capturing the nonattenders. 335 We recognise that Scotland has an effective national diabetic retinopathy screening service and welcome the opportunity to review its standards. Standard 1 Rationale comments Draft rationale - Population-based screening for eligible people can reduce blindness and visual impairment caused by diabetic retinopathy. Final rationale - Population-based screening for eligible people can reduce the risk of visual impairment and blindness caused by diabetic retinopathy. 7 Should be modified to significantly reduce... Your suggestion has informed the rewording of this sentence. 8 Agree with the above but needs rewording. Suggest Population-based screening for eligible people can reduce the risk of blindness and... 9 Suggest: Population-based screening for eligible people can reduce the risk of blindness. Explanation: Strictly speaking it is the risk of blindness that is reduced blindness itself is not reduced. 10 This rationale is proven by the far worse retinopathy seen in countries with no retinopathy screening service, and the early disease usually seen at referral from DRS in Scotland. 11 I am answering as a person participating in diabetic retinopathy screening. I have been told by my The document has been amended. The document has been amended. 6

7 Health Care professionals that the rationale is true and I believe them. 12 Well accepted concept provided hard to reach groups are targeted and treatment can be accessed in a timely fashion. 13 change of wording to "can reduce the risk of blindness" 14 As above, it did not stop me from having proliferative retinopathy between screenings which were annually. 15 It would work better If done in conjunction with optometry The document has been amended. Standard 1 Criterion 1.1 comments NHS boards have systems and processes in place to demonstrate the implementation of: (a) diabetic retinopathy screening national guidance 4 (b) multidisciplinary input to diabetic retinopathy screening (c) collection, monitoring, review and action on data relating to diabetic retinopathy screening, and (d) ongoing quality improvement in diabetic retinopathy screening. 16 The transfer of information between GP practice/sci Diabetes/Screening service/hospital eye service should be automated 17 Optometry Scotland have always considered that diabetic retinal screening should be done in primary care by optometry. The inconvenience for people with diabetes travelling for their screening when a photograph has already been taken at their local optometrist is doubling the work and removing, in a lot of cases, care from the community. 18 If Optometrists were allowed access to DRS images, it would be helpful if they could access on-going quality improvement also scope of the standards. scope of the standards. 7

8 scope of the standards. 19 This criterion is very important to ensure every NHS Board provides a diabetic retinopathy screening service which is fit for purpose and maintains the necessary standards of care. 20 Laudable aims but implementation and independent oversight is essential. 21 As above, optometry urgently need input to drs scope of the standards. Standard 1 Criterion 1.2 comments NHS boards have a designated public health lead acting as the diabetic retinopathy screening coordinator. 22 If Optometrists were allowed access to DRS images, it would be helpful if they could also participate in the diabetic retinopathy screening external quality assurance scheme. 23 The public health lead is an essential part of the screening management team. 24 An appropriate measure provided the post holder has adequate time and facilities available to carry out the role effectively. 25 The competencies of this role should be more precisely stated. A senior public health clinician provides vital perspective and experience to the DRS Collaborative. 26 Structural changes in smaller boards cannot always guarantee that it a public health lead but may be a senior member of the board 336 We support this criterion if the information on who the designated person in each health board is in the public domain and readily available to patients and the wider public. scope of the standards. scope of the standards. 8

9 Standard 1 Criterion 1.3 comments NHS boards have a designated lead clinician for diabetic retinopathy screening. 27 It is difficult to negotiate SPA for time spent on screening work 28 The clinical lead is essential to guide and advise on clinical issues and standards within the screening service and ensure graders receive sufficient training to perform their job safely. 29 Essential to ensure buy in from the hospital eye service and delivery of treatment and fail-safe. 30 An essential component of the standards 31 How would you find out who this is? The NHS board will provide this information. 337 We support this criterion if the information on the designated lead clinician in each health board is in the public domain and readily available to patients and the wider public. Standard 1 Criterion 1.4 comments Staff, involved in the ongoing management of diabetic retinopathy, participate in regular audit, which could include the diabetic retinopathy screening external quality assurance scheme Not everyone is assessed for quality. Some clinicians are carrying out screening in clinics but are not currently willing to undergo external quality assurance 33 This implies all the staff in secondary care and not just the ones involved in the screening service. Whilst that may be desirable, it does not happen at the moment, and the doctors in secondary care are not using the screening grading tool and so will not be familiar with the process in the way all the graders are. Is this what is intended by this standard? Thank you. The new wording for the criterion now addresses your comment. Thank you. The new wording for the criterion now addresses your comment. 9

10 34 Once per year would be adequate rather than six monthly 35 Ophthalmologists may think this criterion will apply to them. Suggest adding DRS so it reads DRS staff, involved in the clinical assessment of diabetic retinopathy, participate in the diabetic retinopathy screening external quality assurance scheme. 36 Require clarification Clinical Assessment is this ophthalmology? If so, not all ophthalmology staff to see diabetics participate in EQA. 37 Needs clarification, what is the definition of clinical assessment? Suggests all clinicians within Ophthalmology would need to participate in EQA Thank you. The new wording for the criterion now addresses your comment. Thank you. The new wording for the criterion now addresses your comment. Thank you. The new wording for the criterion now addresses your comment. Suggested change - Staff, involved in the grading assessment of diabetic retinopathy as part of the DRS Programme 38 We agree with this criterion if it is taken to mean DRS staff, ie staff who are part of the DRS service. If it is meant to include clinicians working in secondary care who deal with (and necessarily assess) referrals from DRS, then we feel this will be very difficult to achieve and enforce, (and will also have resource implications for secondary care). Thank you. The new wording for the criterion now addresses your comment. Can this please be clarified? 39 It is an excellent system and has enabled improvement in consistency of grading year on year. 40 EQA is an integral part of ensuring safety and effectiveness of the screening programme throughout Scotland. 41 Essential to maintain standards of service in a group of non medical staff tasked with a diagnostic role. 42 This could be a bit more specific -?clinical Thank you. The new wording for the criterion now 10

11 assessment or clinical grading 338 We would like to see evidence that supports the assertion that healthcare professionals are adequately supported to carry out their duties. Results of the quality assurance scheme should be made public on a quarterly basis. addresses your comment. Standard 1 Criterion 1.5 comments Staff meet the requirements of the DRS Collaborative 4 approved training programmes, relevant to their role. 43 Not everyone is assessed for quality. Some clinicians are carrying out screening in clinics but are not currently willing to undergo external quality assurance 44 Optometric staff need immediate training/drs approval when a practice has an approved screener leaving. 45 It is essential that all graders have attained a suitable level of knowledge to allow them to do their job safely. Approved training programmes are an effective way of ensuring this is the case. 46 Essential to maintain standards of service in a group of non medical staff tasked with a diagnostic role. 47 Think it's ridiculous that optoms require a city and guilds qualification in order to take fundus photos. Where is the evidence to say that this is necessary? This is a core part of our Gos eye exam. We do not need a city and guilds 339 We would like to see evidence that every health board in Scotland is compliant with this so as to avoid a disparity of care. We would also like to see each Health Board produce a timetable whereby plans to ensure each staff member receives the training is set out. Thank you. The new wording of criterion 1.4 now addresses your comment. scope of the standards. Standard 1 Criterion 1.6 comments NHS boards have access to a national IT system which enables data collection and supports 11

12 governance procedures. 48 It would be useful if this information was available to optometry as comparison could be made between the picture taken by the optometrist and the DRS picture. This would help reduce referrals. 49 This needs to include community optometry and to be bidirectional. It should also link to SCIDC and My Diabetes to support self management 50 The use of a national IT system allows the whole screening service throughout Scotland to deliver the same high standard of care and ensures equity of care. It is an integral part of the Scottish screening programme. 51 Does the data here mean photographs of eyes? or patient details to enable the identification of eligible patients? or both? 52 Essential to ensure rapid referral and fail-safe functions. 340 We would like to see quarterly key performance indicators reported to all MCN s across the country. These reports should fit with the Diabetes Improvement Plan and its commitment to public recording. scope of the standards. The data is referring to both. 12

13 Standard 2: Call-recall Standard 2 General comment 53 How do boards prioritise their patients? This is for local determination. Standard 2 Statement comments All eligible people are invited for diabetic retinopathy screening. 54 IT improvements would be welcomed to link National, local and G.P databases directly without a long chain of interfaces leading to the diabetic retinopathy screening (DRS) system. E.g. if patients do not consent to being included on one database then the break in chain will lead to no invitation being sent for DRS and a manual work around being implemented. scope of the standards. If a patient is deceased then the DRS system would get immediate action from their G.P. s input, rather than G.P. (EMIS) CHI SCI-Diabetes Soarian (DRS) chain. 55 Requires eligibility to be clearly stated. Eligibility (eligible people) is defined in the introduction, that is people who are over 12 years of age. 56 The link with SCI-Diabetes allows all people registered with diabetes to be offered retinopathy screening in a timely way. 57 It reads as if it only covers who. I wonder whether it should be amended to cover both who and when? eg by adding the words "in timely fashion" at the end. The rationale below covers both whereas the definition of 'eligible' elsewhere only covers who. 58 The means of identifying the target population is not clearly stated. Specific times are mentioned throughout the criteria. 13

14 scope of the standards. 59 Who are 'eligible'? Why would a diabetic not be eligible? Clarification please. 60 Non eligible people are also invited for this. I have been along the retinopathy path to the point of having vitrectomy surgery on my left eye. I should therefore no longer be called for this screening as I am seen in OP Ophthalmology at least 2-3 time a year for check ups. I still get called for retinopathy screening even after communicating with the department. Eligible people are defined in the introduction, that is people who are over 12 years of age scope of the standards. 61 Optoms could mop up the non attenders 62 I was invited for screening, unfortunately, NHS Grampian staff sent the invite BEFORE I was given the diagnosis for Type 2. Standard 2 Rationale comments Draft rationale - An effective and systematic call-recall service increases the number of eligible people participating in diabetic retinopathy screening. 2 The call-recall service is based on the DRS Collaborative national follow-up protocol 4, appropriate to the outcome of the screening. Notes: Eligible people: who did not attend their appointment can, at any time, contact the DRS Collaborative 4 for another appointment. who choose not to participate in diabetic retinopathy screening, inform their GP of their decision every 3 years. Final rationale - An effective and systematic call-recall service increases the number of eligible people participating in diabetic retinopathy screening. 2 The call-recall service is based on the DRS Collaborative national follow-up protocol 4, appropriate to the outcome of the screening. 14

15 63 The informed consent for op-out should be gained from GP and patient intention to opt-out should be conveyed to GP by screening service 64 If a person decides not to attend DRS they should be advised to attend an optometrist annually 65 While I agree with the rationale I don t think this has ever been the procedure generally. Patients are automatically re included as suspension is lifted after 3 years. DRS contacts GP when suspension end date is imminent. To my knowledge patients do not contact GP every three years. 66 Need to reword suggest who did not attend their appointment or take up invitation can, Those patients who opted out of the DRS Programme need to be prompted for their decision every 3 years. I.E. The suspension is lifted automatically and the patient is brought back into screening and invited to attend for DRS, he/she can then choose again to not participate by informing their GP and completing the necessary paperwork. 67 Our service model in NHS Ayrshire and Arran means that we do not invite people for an appointment, we invite them to make an appointment with an accredited optometrist. The wording in the preamble is therefore not appropriate to the Ayrshire and Arran setting. scope of the standards. scope of the standards. scope of the standards. The document has been amended. The document has been amended. In NHS Ayrshire and Arran, patients who have informed their GP of their decision not to participate in screening have their suspension automatically lifted after three years. The DRS office will then invite the patient back for DRS, should they decide to opt out again the patient is advised to contact their GP, where they will discuss screening and make an informed decision on whether to participate in future. It would be unlikely that the 15

16 patient would initiate this process. 68 The call-recall service greatly improves the number of patients screened effectively, and on an ongoing basis. 69 The detail of identification of patients under the care of the HES who may default is not detailed. 70 This misses out people who no longer have to be called for this screening. They are told they no longer should attend for this but when you try to cancel an appointment and any further appointments that might be sent, there is no system to stop these from being resent. 71 Why would someone choose not to attend retinopathy screening? I would leave out the second bullet. If they don t attend then a letter should go to their General Practice and then to the practice nurse to follow up. 72 As above. Optoms could massively improve uptake numbers 341 The sign guidelines say that eligible people who choose not to participate in diabetic retinopathy screening should inform their GP of their decision every 2 years. We believe it is important to explain that this is not a risk free option for individuals and that should people choose not to participate in the national screening program it is essential they have the adequate information to make their own choice. Ultimately people should be responsible for their own decisions, however all decisions should be made with all necessary information available. Even if someone drops out of the screening process, it is vital that individuals are audited so that they are offered the opportunity to re-join the service should they wish. We would like recognition of the clinical responsibility that healthcare professionals have to engage with individuals who have dropped out of scope of the standards. This is covered by the failsafe mechanism regulated by the DRS Collaborative. scope of the standards. 16

17 the screening system. Standard 2 Criterion 2.1 comments NHS boards have a system in place to identify all eligible people for diabetic retinopathy screening. 73 If diabetes codes and suspensions are correctly entered and maintained by G.P. practices. 74 SciDiabetes is a very good system for identifying eligible people 75 Identification of eligible people is mandatory for screening to be offered appropriately. 76 Essential but reliant on GP input. 77 Is this not the national system that pulls from Sci DC? Yes, this is the system used at the moment. Standard 2 Criterion 2.2 comments NHS boards invite all eligible people for diabetic retinopathy screening. 78 With the first invite letter could you include a brochure that has: images to show the process from start to finish. include some patient stories to highlight why it s important to be screened. 79 Add to the first invite letter that you can bring someone with you to your test. 80 If the person needs to come either every 6 months, yearly or every two years you should explain why on the letter. scope of the standards but this comment has been raised with the DRS Collaborative. scope of the standards but this comment has been raised with the DRS Collaborative. scope of the standards but this comment has been raised with the DRS Collaborative. 17

18 81 Every letter should have contact details on it for someone that can answers questions you may have ie not just the receptionist. 82 Use the word important in the first letter to emphasis why people should come to their appointment. scope of the standards but this comment has been raised with the DRS Collaborative. scope of the standards but this comment has been raised with the DRS Collaborative. 83 This is essential in all regions. 84 Identification of the eligible population is criticalespecially hard to reach groups. 85 Non eligible people are also invited for this. I have been along the retinopathy path to the point of having vitrectomy surgery on my left eye. I should therefore no longer be called for this screening as I am seen in OP Ophthalmology at least 2-3 times a year for check ups. I still get called for retinopathy screening even after communicating with the department. scope of the standards. 86 Answer as above. Would prefer the diagnosis first. Standard 2 Criterion 2.3 comments The invitation to attend diabetic retinopathy screening is offered to all newly diagnosed patients within 30 calendar days of the DRS Collaborative 4 receiving notification. 87 Explanation of why it s 30 days is needed. Data from the DRS Collaborative suggests that currently 98% of newly diagnosed patients are invited to attend screening within 30 days, therefore, the project group felt this was a reasonable timescale to set. 18

19 88 Yes but this first invite might not be to their preferred screening location but their second invitation will. 89 This DRS service (GG&C) does not use invitations so we do not think that this standard applies to us can this be clarified. If it does apply to us, it appears to conflict with standard 2.4 which we currently aim to comply with. 90 Early assessment for retinopathy is important to detect any pathology at diagnosis of diabetes. The standards apply across all of NHSScotland. The project group felt that criteria 2.3 and 2.4 align. 2.3 relates to the person being contacted within 30 days (for some NHS boards this is by invitation, others will use different mechanisms). 2.4 relates to the appointment offer (which is within 90 days). 91 Laudable but what is the rationale for the timescale. Data from the DRS Collaborative suggests that currently 98% of newly diagnosed patients are invited to attend screening within 30 days therefore the project group felt this was a reasonable timescale to set. 342 We support this criterion. It is vital that timeframes are sensitive to ensure that people are aware of their diagnosis and have had time to come to terms with it before hearing from the DRS Collaborative. Standard 2 Criterion 2.4 comments The date of the appointment offered to all newly diagnosed patients is within 90 calendar days of the DRS Collaborative 4 receiving notification. 92 Explanation of why it s 90 days is needed. The project group reviewed the current data, considered the time-frame from the 19

20 perspective of both the service user and service provider, and felt 90 days was an appropriate time-frame. 93 What happens if the patient has had diabetes for a long time but never knew? Surely they should be fast tracked as 90 days is too long. 94 On occasion, this may be more difficult to achieve, if the patient s closest clinic is a mobile clinic which only runs 2-3 times per year. This can be overcome by offering an appointment at a static site. 95 Reword to The date of the appointment for newly diagnosed patients is within 90 calendar days of the DRS Collaborative receiving notification. 96 Does not reflect Health Boards where patients arrange their own appointments with optometrists. 97 Do not agree. Not all DRS screening programmes offer appointments some offer invitations for the patient to make their own appointment therefore cannot ensure the patient will make an appointment within the time limit specified above. This statement needs to reflect those Boards inviting patients but not appointing. This is for local determination. This is for local determination. The project group felt the current wording was appropriate. as long as the invitation is within 30 calendar days and that the date of appointment is within 90 calendar days then it is for local determination how this is achieved. Suggest, Newly diagnosed patients are contacted (either offered an appointment or asked to make their own appointment) within 90 calendar days of the DRS Collaborative receiving notification. 98 We currently operate to this standard, however there appears to be a possible conflict with standard 2.3 above. The project group felt the current wording was appropriate. The project group felt there is no conflict with 2.3 as this is regarding invitation whereas 2.4 is regarding appointment. 20

21 99 Would it be possible to do this earlier, as some type 2 patients have significant disease on diagnosis? Also, many are anxious when diagnosed and 3 months can seem a long time. 100 NHS Ayrshire and Arran do not offer appointments; they send a letter asking the patient to make an appointment with an accredited optometrist. Community optometrists hold their own data on bookings and appointments, which is not shared with the DRS office. The DRS office is only aware of whether a result appears in SOARIAN, i.e. if the patient booked an appointment, attended that appointment, and the images were uploaded to SOARIAN. Absence of results in SOARIAN could mean that the patient booked an appointment but did not turn up. It is therefore not possible for the DRS office to know if patients have made an appointment within 90 days or not, and as a result it is not possible to monitor or report on this standard in NHS Ayrshire and Arran. It is suggested that this standard is removed, or that a waiver for this standard is in place for NHS Ayrshire and Arran. 101 No, on the basis that this time period has been clinically evaluated as a reasonable time period with a shorter time period would posing no real reduction in any risk of having a condition that is treatable days to appointment is a reasonable target for new patient referrals. This is for local determination. as long as the invitation is within 30 calendar days and that the date of appointment is within 90 calendar days then it is for local determination how this is achieved. 103 Consider removing the word offered. The project group felt the current wording was appropriate. 104 Seems reasonable but is it supported by data? The project group felt the current wording was appropriate and is supported by DRS Collaborative data. 21

22 105 Don t agree. In our area we letter patients to make their own appointment at a time and place that suits them. Would suggest changing wording to newly diagnosed patients are contacted within 90 calendar days either with an appointment or an invitation to make an appointment 343 The 18 Weeks Referral To Treatment (RTT) standard has been set out to by the Scottish Government. We would appreciate assurances that 90 this criterion meets this standard. The project group supports a person-centred approach within the specified timeframes. The project group felt the current wording was appropriate. This criterion is addressing referral for assessment and not referral for treatment. Standard 2 Criterion 2.5 comments NHS boards recall all eligible people for diabetic retinopathy screening at a frequency appropriate to the: (a) DRS Collaborative national follow-up protocol 4, and (b) outcome of the diabetic retinopathy screening. 106 Frequency should be every two years for those who had no retinopathy for two consecutive yearly screening 107 Many low risk patients could safely be screened at 2 yearly intervals 108 Recall for repeat examination at an appropriate length of time for the individual patient is important for safety and for flexibility within the system to enhance efficiency of service delivery. 109 Should 2.5a have a little reference 4 attached to it? And indeed everywhere there is a reference to these protocols? 110 I was always called once a year no matter the outcome of the screening. It may have changed since then but I don t think so as I am still being called every year even though I should no longer receive appointments for this service. The document has been amended. 22

23 344 We are concerned that some people may believe that they are no longer at risk of retinopathy and therefore cease to attend retinal screening appointments. Information sheets will be updated to reflect changes. We have a strong concern that people who are moved to biennial screening may misunderstand this and believe that they are no longer at risk of retinopathy and cease to attend retinal screening appointments. It is essential that any changes are communicated in an effective and accessible manner to all people living with diabetes. We are already concerned that many people with diabetes do not understand the difference between retinal screening and their annual eye health check with their high street optician. The early stages of retinopathy are often symptomless, it is vital that people with diabetes understand the risks of developing this complication and the actions they can take. Primary healthcare professionals and screening providers have important roles to play in ensuring people are encouraged and enabled to attend their eye screening appointment. Accurate and consistent grading is essential to ensure patient safety and to prevent unnecessary sight loss. This must be demonstrably in place before any changes to the screening intervals are implemented, with the data publically available. Standard 2 Criterion 2.6 comments NHS boards recall all eligible people who have not responded to the diabetic retinopathy screening invitation in line with DRS Collaborative protocols. 111 This criterion is important as a small but significant group exists of those who fail to attend the screening, often for many years. 112 No, on the basis that the protocols are regularly 23

24 reviewed. 113 It is important to continue to offer screening to all eligible people. 345 We would appreciate the opportunity to gain insight into the checks and balances that are employed to ensure that people do not fall through the net. This comment has been discussed with the DRS collaborative who have explained that as you are already part of their executive committee, you will have the chance to gain insight. Standard 2 Criterion 2.7 comments NHS boards have a system in place to identify all eligible people who choose not to participate in diabetic retinopathy screening, and who have notified their GP of their decision. 114 As above they should be advised to attend their optometrist annually 115 Currently the system will show all temporary suspensions and a manual search is required to select those who have opted out as a reason for suspension. 116 GPs are often slow to take action. Greater powers to DRS administration in this regard would be helpful 117 This maybe something Optometrists could access as patients sometime tell them of this decision. 118 Patients who do not wish to be screened should be identified, but allowed the option of being screened at any future date they may wish to engage with this service. 119 Some pxs are annoyed at having to have dilation again over and above their Gos eye exam. Despite encouraging them to attend they see it as unnecessary 346 We would appreciate the opportunity to gain insight into the checks and balances that are employed to This comment has been discussed with the DRS 24

25 ensure that people do not fall through the net. collaborative who have explained that as you are already part of their executive committee, you will have the chance to gain insight. 25

26 Standard 3: Uptake (now Attendance and uptake in final standards) Standard 3 General comments 120 What about using more tech to get young people to attend their appointments. The Florence text service. 121 Why not ask the person how they want to be communicated with , text, and letter. 122 Defo need to make more links to private optometrists. Someone who lives in a remote village shouldn't need to travel if they have a local optometrist. This is for local determination. This is for local determination. Standard 3 Statement comments Draft statement - The number of eligible people participating diabetic retinopathy screening is maximised within the principles of informed choice. Final statement - The number of people attending diabetic retinopathy screening is maximised within the principles of informed choice. 123 Whilst recognising the importance of the principles of informed choice, the percentage of patients who repeatedly Do Not Attend appointments, puts strain on the service in terms of meeting screening targets and also has financial implications in terms of postage, administration time, office consumables etc. Continuing work to target chronic DNA patients to encourage attendance is vital and the DRS Collaborative has a role to play in co-ordinating such efforts and disseminating good practice across Scotland. 124 Informed consent should emphasize the risk of blindness if patients opt out 125 We could provide better diabetic domiciliary care. 126 It is important to try to encourage as many eligible people to be screened as possible as this reduces the risk of blindness or loss of vision. Clearly patients have a choice about being screened, but need to be 26

27 aware of the risk of sight-threatening pathology developing undetected if no screening is performed. 127 There should be a requirement on the board to investigate groups who demonstrate a lower than expected uptake to ascertain the reasons for their lower attendance. Boards should make reasonable attempts to mitigate such barriers to attendance. 128 I d like a not sure option here. I don t know what the principles of informed choice are. I have found some usages of the phrase elsewhere (eg in NHS Choices) but it would be useful to know what it means in this context, in particular which choices it includes and which it does not. If Informed choice about to accept the screening or not it is clearly a very important criterion for maximising participation. E.g. are location, access to location, day / time also criteria, choice of appointment time also important? 129 Some pxs choose to attend an optom and trust us to screen and can t understand the need for Drs despite us explaining This is for local determination. Informed choice is when an individual receives the right information, at the right time, in the right format for them to inform their decisions regarding whether to attend screening, and any subsequent treatment and care. Standard 3 Rationale comments Draft rationale - Visual impairment and sight-loss rates can be reduced by diabetic retinopathy screening. 6 Maximising uptake for diabetic retinopathy screening ensures that NHS boards identify, refer and treat people appropriately and effectively. Providing accessible and responsive information supports people to make informed choices and helps to maximise uptake. Engaging with people, where uptake may be lower than expected is also important for maximising uptake. Final rationale The risk of visual impairment and blindness rates can be reduced by diabetic retinopathy screening. 6 Providing accessible and responsive information on diabetic retinopathy screening supports people to make informed choices and helps to maximise attendance Informed choice is when an individual receives the right information, at the right time, in the right format for them to decide whether or not to attend their screening appointment. 27

28 Engaging with people whose attendance is low is important for maximising attendance The terms attendance and uptake used here are defined as: attendance - the invited person attends their screening appointment, and uptake - the invited person completes the screening process, including slit lamp examination, when images are ungradable. 130 This is an area that requires more work in Fife as it has not been possible to divert staff from screening to fully develop such engagement processes, however, it is an area which has been identified as requiring more work and sharing good practice from other areas would assist with this. 131 Need to reword the Rationale suggest The risk of visual impairment and sight-loss rates can be reduced... The document has been amended. Don t like the wording seldom hear groups suggest Engaging with hard to reach communities, where uptake may be lower than expected is also important for maximising uptake/participation. Hard to reach groups is always going to be difficult to increase uptake especially for the travelling community who are not registered with a GP and therefore do not appear on the screening system to invite. Remove comma after expected in the last sentence. 132 Optometrists could help the NHS Boards identify, refer and treat people appropriately and effectively 133 Extra effort for seldom heard groups is important so they receive the same standard of care available to other groups. 134 The principle of attempting engage with hard to reach/seldom heard groups is vital not only in screening but also after identification of disease and 28

29 subsequent treatment. A strong body of evidence exists to demonstrate that these groups are more likely to present late and default from screening and treatment unless effectively engaged they will remain a source of SI and SSI outcomes. 135 Is there a definition of seldom heard groups? What does it mean in plain English? 136 Suggest change to the risk of visual impairment... Seldom heard groups are a strange term. Hard to reach groups seems more appropriate. 137 These pxs may find it easier to attend their community optom on the high st The rationale has been amended and no longer refers to seldom heard groups. The document has been amended. 138 Is Seldom heard the correct terminology? The rationale has been amended and no longer refers to seldom heard groups. 347 We are enthusiastic about helping to provide accessible and responsive information that supports people to make informed choices and helps to maximise uptake of the screening programme. We agree it is important to engage with seldom heard groups where uptake is lower than expected and believe that we can inform this process. Each health board needs to qualify who these are and indicate how they plan to reach out to these groups. Providers with relatively low take-up rates need to review how screening services are configured. Diabetes networks should be involved in the review and design of local services. Standard 3 Criterion 3.1 comments Draft criterion - NHS boards ensure that a minimum of 80% of eligible people who wish to participate in diabetic retinopathy screening are screened within the prescribed interval, in line with DRS Collaborative protocols. Final criterion - NHS boards ensure that a minimum of 80% of invited people attend a screening 29

30 appointment within 30 calendar days. 139 Explain why it s 80%. Patients will see this and expect it to be 100%. 140 Fife DRS finds it a challenge most years to meet the minimum of 80% of patients to be screened, due in the main to the level of patients who Do Not Attend. The service always meets its target of inviting 100% of the eligible population. Strong consideration should be given to removing the uptake target. 141 Ayrshire and Arran patients arrange their own appointments therefore although invited to screening, the onus is on the patient to make and attend their appointments. 142 Many patients will DNA no matter how hard we try to offer screening. Evening clinics are helpful but have limited uptake. 80% is realistic. 143 No, on the basis that the protocols are regularly reviewed. 144 It is important all Boards aim for the same high standard of screening and monitor to ensure this is happening. The project group would like to point out that 80% is a minimum. 80% is an appropriate target to quality assure the programme effectively. 145 What happens if they don t meet the minimum? scope of the standards and this is part of NHS board s clinical assurance. 146 In line with English national standards. The bald achievement of percentage uptake without reference to the high risk subgroups in the target population makes this a potentially flawed target. 147 The number could be higher if they stopped calling people who no longer need the screening as they are in the system for more regular check ups at the The project group disagrees and felt this area is outwith the scope of the standards. 30

31 OP clinics. 148 Optometry could increase this percentage scope of the standards. 149 Remove who wish. The document has been amended. 348 DRS Collaborative protocols state that a minimum of 80% of eligible people who wish to participate in diabetic retinopathy screening are screened within the prescribed interval. We would like to see formal recognition that every eligible person in Scotland should receive screening. 100% screening is of course aspirational but we must learn to work in partnership with one another so that the time and location of screening fits with the nature of peoples working lives, aspirational outcomes should be the objective of everyone working in healthcare. The project group would like to point out that 80% is a minimum. Standard 3 Criterion 3.2 comments (now criterion 3.3 in final standards) Draft criterion NHS boards maximise uptake by ensuring that eligible people, regardless of their personal circumstances or characteristics: (a) are offered an opportunity to participate, and (b) receive accessible and responsive information to support them make an informed choice. Final criterion NHS boards maximise attendance by ensuring that eligible people, regardless of their personal circumstances or characteristics: (a) are offered an opportunity to attend, and (b) receive accessible and responsive information to support them make an informed choice. 150 Reword to NHS boards maximise uptake by ensuring that all eligible people, regardless of their personal circumstances or characteristics: By putting all, this takes away the need to list all minority groups. The document has been amended to include a separate criterion to address uptake. 31

32 151 Need for better domiciliary diabetic care. 152 GP practices could do more to encourage participation 153 Screening information should be made available to all groups of people who are eligible, which will require extra effort to ensure minority groups are given the information in a format they can access and understand. 154 Would it be simpler to say NHS boards maximise uptake by ensuring that all eligible people:? 349 Diagnosis should be presented in an accessible manner that meets the individual needs of the person. It is absolutely vital that an individual understands what they are being offered, as well as they risks of not complying with the screening process. The document has been amended to include a separate criterion to address uptake. 32

33 Standard 4: The screening process Standard 4 General comment 155 Maybe mention newly diagnosed specifically somewhere here. Should be treated slightly differently to repeat invitations. Newly diagnosed is covered in Standard 2. Standard 4 Statement comments Diabetic retinopathy screening is safe, effective and person-centred. 156 Should be modified cost-effective The word effective comes from the Quality Ambitions. 157 Again it should be carried out at the optometrist. People then do not have to travel to the screening and it is done once no duplication 158 The screening is safe and effective and aims to be person-centred. Offering screening in many easy to access locations and a choice of appointment times should help to facilitate ease of use by the eligible people. Using variable screening intervals should help to make the service more person-centred. scope of the standards. Standard 4 Rationale comments To promote safe and effective care, images are obtained by competent staff using equipment and techniques which meet DRS Collaborative protocols. 4 To ensure accurate results from the images obtained, the images are graded by an approved automated system and/or competent staff. When people who have participated in the screening process receive accurate and timely results, this supports a person-centred approach to care and reduces unnecessary anxiety. 159 Accuracy and promptness of reporting of images is essential in reducing unnecessary anxiety for patients. 160 If this worked it would be great but my retinopathy problem appeared in between screening visits so anxiety will always be there if the gap in screening is 33

34 still so long. 350 We agree that diabetic retinopathy screening should be safe, effective and person-centred. The person has to be at the centre of how all our services across the NHS are delivered. People who have participated in the screening process must receive accurate and timely results. Supporting a person-centred approach to care reduces unnecessary anxiety. People need to be informed in a timely, sensitive manner and in a format that the person would prefer to receive, this could involve , text message, letter etc. Standard 4 Criterion 4.1 comments The diabetic retinopathy screening process is carried out in line with DRS Collaborative protocols. 161 Everyone should follow the criteria whether they are doing screening in NHS or privately 162 No, on the basis that the protocols are regularly reviewed. 163 National protocols provide reassurance for all service users. 164 Boards should have flexibility to amend the protocols locally to ensure the integrity, continuity and delivery of service where it can be shown that the measures differing from national protocols are proportionate, pragmatic and safe. scope of the standards. Standard 4 Criterion 4.2 comments All equipment is procured, maintained and used in line with DRS Collaborative protocols. 165 Approval of Cameras and automated grading systems should be made easier to remove barriers to entry of more cost-effective devices. Currently the system is too expensive and complex for new companies to apply for approval 166 No, on the basis that the protocols are regularly 34

35 reviewed. 167 This ensures standardisation of quality of images and screening. 168 In the case where a board uses independent contractors (i.e. Optometrists) to deliver aspects of DRS then equipment procurement lies with the individual contractors and not with the board. This criterion should only apply to equipment directly procured and operated by NHS Boards. 169 The technology available is advancing rapidly and can be adapted in the screening process eg use of OCT for cases of macula changes. This may reduce the need for referral into secondary services if virtual and remote reporting can be done. It is the NHS board s responsibility to ensure that external contractors meet all current relevant DRS standards. Standard 4 Criterion 4.3 comments DRS Collaborative protocols 4 are used to internally and externally quality assure the work of graders. A maximum rate of ungradable images is 2.5% for digital imaging and 2% for slit lamp examinations. 170 If a slit lamp examination is ungradable because of cataract that is what the examination will pick up (a common problem). This could easily lead to over 2.5% failure rate, because of the pathology, not a fault of the service, so is it meaningful to refer to a 2% failure rate for slit lamp exam? The failure rates are based on DRS Collaborative data. 171 Cataract waiting times may sway this figure 172 Where did the 2.5% and 2% figures come from? Will these figures set boards up to fail? 173 Surely this depends on the patients the graders see? Populations can differ slightly from one Board to another and can have an overall affect on these criteria. The national diabetic population is aging (living longer) but not necessarily living healthier, The figures are based on DRS Collaborative data which many NHS boards are already currently meeting. The project group felt these are important measures which will not only be beneficial to patients but will 35

36 surely this criterion needs to reflect this? also reflect quality of service. What is the actual benefit to the patient of this criterion? Doesn t reflect quality the standard doesn t improve the patients experience. Do not agree 174 Would recommend that NES should run courses to ensure Optometrists familiar with grading and be able to understand and use it. NHS England uses Optometrists in various parts of the country to be DRS graders. 175 Keeping ungradeable images to a minimum ensures care is taken when images are captured and reduces the rate of unnecessary referrals to ophthalmology, which is stressful for patients and puts pressure on the ophthalmology service. The same principle applies to slit lamp examinations. 176 Please could you clarify where the value of 2.5% and 2% were obtained from? 177 Graders who have areas of geographical responsibility may see differences in upgradable rate due to population differences between such areas. We also consider that in time the rate of upgradable images may rise due to the ageing population. 178 This is determined by the definition of gradability used and how closely this is adhered to. EQA processes need to test this element of grading. 179 Understand the rationale for quality control but unsure that this really captures it appropriately. scope of the standards. The failure rates are based on DRS Collaborative data. The project group felt these are important measures which will not only be beneficial to patients but will also reflect quality of service. The project group noted this is only one element of quality control. Standard 4 Criterion 4.4 comments A minimum of 95% of people screened are sent the result within 20 working days of being screened. 36

37 180 Maybe newly diagnosed patients should be sent their results a little quicker. 181 The letter doesn't current say who to contact should the patient want to discuss the results. 182 Yes I think this is currently achievable by most Health Boards 183 No. It is noted that this is the minimum requirement and the services should aim to exceed this. 184 This is a high standard, but is regularly attained and maintains a high quality of service for patients. 185 It can be worrying if you are in the 5% who do not receive the result within 20 working days especially if you have been in the other 95% in previous years. However, otherwise the criterion is OK. 186 Needs to include statement on how are those who need referral for proliferative disease are informed of their diagnosis. 187 I never received any result from any retinopathy screening I ever had. I was just told that everything was ok at each visit. everyone should receive their results as soon as possible so no need to be explicit. scope of the standards but this comment has been raised with the DRS Collaborative. scope of the standards but this comment has been raised with the DRS Collaborative. 37

38 Standard 5: Referral Standard 5 General comments 188 Informed choice is needed here akin to standard 3. scope of this standard but this comment has been raised with the DRS Collaborative. 189 Better explanation of this part of the process needed in the letter that is sent out. 190 Why does this not follow the 18 week referral to treatment time frame? For cancer it's 61 days. scope of the standards but this comment has been raised with the DRS Collaborative. This standard is referral for assessment and not referral for treatment. Standard 5 Statement comments Draft statement - Eligible people are referred to ophthalmology services for assessment in line with DRS Collaborative referral protocols. Final statement People who require referral and have been screened are referred to ophthalmology services for assessment in line with DRS Collaborative referral protocols There is a case of having a mid-level virtual assessment using OCT for M2 patients that are currently being referred to ophthalmology services as per DRS Collaborative referral protocol 192 If the time frames below are correct, I do not believe this to be the case 193 I agree with the standard, but have some reservations about the timing see comments to standard 6. OK for the most part, but such urgency not necessary e.g. if a patient has had previous Rx but This statement is referring to acute patients and will also follow the DRS Collaborative grading protocol. 38

39 has a remnant of new vessels, and it is thought safer to get him/her back into secondary care, but not necessarily urgently, i.e. this will leave no opportunity for discretion on the part of the recipient of the referral. The referral would still come as an R Referral of patients with potentially sightthreatening retinopathy is the main reason for performing screening, so appropriate treatments can be offered in a timely fashion. 195 Or they wait until they have to refer themselves when problems present themselves. 196 The Ayrshire and Arran model allows the optom on the spot to refer that px in either urgently or non urgently. The fact that they can do a slit lamp exam on the spot is invaluable 351 It is important that people are aware of the clinical protocols in place at each step of the patient journey. Easy read versions of referral protocols for patients and healthcare professionals should be readily available. We would be happy to contribute to this process. We have forwarded on your offer to help with the referral protocols to the DRS Collaborative. Standard 5 Rationale comments Draft rationale - Timely referral of eligible people with active asymptomatic proliferative retinopathy and symptomatic diabetic macular oedema reduces the risk of permanent visual impairment. Final rationale - Timely referral of people with active proliferative retinopathy and symptomatic optical coherence tomography positive diabetic macular oedema reduces the risk of permanent visual impairment. 197 I was not aware patients were asked about symptoms regarding macular oedema. They are normally referred based on M2 grading regardless of visual acuity. 198 Currently the grading scheme does not measure whether the patient is asymptomatic or not. If features are present which indicates referral then it The project group discussed your feedback and felt that 39

40 doesn t matter if the patients have symptoms as this disease is a silent one in its early stages hence why screening is advantageous. the new wording is appropriate. 199 Define Timely? Specific time is specified in the criteria. 200 Needs to be more specific, what is meant by Timely referral Is this related to the risk assessment, clinical need? 201 As a person participating in diabetic retinopathy screening I would have liked a don t know box here. 202 Do we really have the evidence that untreated asymptomatic macular oedema, including centre involving, does not lead to permanent visual loss? I don t think we know that at the moment. Many people with only one eye affected are completely asymptomatic. I suggest centre involving DMO instead of symptomatic. 203 Think it would be better to suggest the time period it is done for other parts of the standard. What I think is timely, what the patient thinks and what the clinician thinks could be three different things. 204 I don t think these pxs can be treated as effectively as on the a and Arran model Specific time is specified in the criteria. The project group noted that although there is evidence, this is considered good clinical practice. The project group also explained that it is not good practice to treat an asymptomatic patient with treatment that carries risk of harm with no obvious benefit to the individual patient. Specific time is specified in the criteria. Standard 5 Criterion 5.1 comments Draft criterion Eligible people graded as having active proliferative retinopathy (active new vessels at the disc, or active new vessels elsewhere) are referred to ophthalmology services within 5 working days of being screened. Final criterion People graded as having previously untreated active proliferative retinopathy 40

41 (active new vessels at the disc, or active new vessels elsewhere) are referred to ophthalmology services within 5 working days of first grading. 205 What does referred actually mean? When the letter is sent? Or appointment made? How does this fit with the 20 working days mentioned in 4.4? 206 This statement is not clear, are they seen at ophthalmology or appointed? 207 I agree with the standard, but envisage exceptions see comment 6.1 OK for the most part, but such urgency not necessary e.g. if a patient has had previous Rx but has a remnant of new vessels, and it is thought safer to get him/her back into secondary care, but not necessarily urgently, i.e. this will leave no opportunity for discretion on the part of the recipient of the referral. The referral would still come as an R Retinal photographers are not qualified to detect disease therefore are encouraged to flag suspicious images as urgent, but this is not a full prove way of ensuring that graders will access these images as a matter of priority. Remote screening locations may be using the mobile client off-line programme and only up-load the images on their return to base, which could be several days later. The project group noted that the term referred relates to the transfer of the patient to acute services. The project group noted that this criterion relates to the timely treatment of individuals with identified retinopathy. The criterion has been amended and the project group noted this criterion is about referring the patient to assessment. The project group felt the new wording is appropriate. 41

42 Level 3 grader may not be accessing their task lists frequently enough, especially in small boards where there may be only one level 3 grader with 1 session per week allocation to DRS, to confirm level 2 preliminary grade. I feel that this standard s time frame is too short to be achievable for all patients/health boards 209 Reword to Eligible people graded as having active proliferative retinopathy (active new vessels at the disc, or active new vessels elsewhere) are referred to ophthalmology services within 5 working days of being screened the final result. 210 Screeners and graders have been trained to identify and fast track people graded as having active proliferative retinopathy (active new vessels at the disc, or active new vessels elsewhere) through to relevant Ophthalmology Laser clinic. 211 As this type of pathology carries a high risk of loss of vision, urgent referral is mandatory. 212 Query regarding is the time from referral to ophthalmology services from 5 days of grading or 5 days from the actual screening? 213 Seems reasonable but is there research data to support this time scale. 214 They possibly are if the screening and the onset occur together. 215 Should this read within 5 working days of being graded 216 This standard would be difficult to achieve because photographers are not trained in recognising retinal disease so these images would not be marked as The project group felt the time-frame is suitable and promotes quality of care. The project group felt the new wording was appropriate. The project group confirmed this is 5 days from grading. The project group noted that this is considered good clinical practice. The project group felt the new wording was appropriate. The project group noted this is considered good clinical 42

43 urgent and therefore graders would not be able to grade them promptly enough. Final agreement from a level 3 grader is not available on a daily basis in some small boards with only one level 3 grader who may only attend once a week for DRS. We were unsure why 5 days was chosen for these cases. Is there evidence to support this? 352 All correspondence a person receives from the DRS should be sensitive and timely. All conversations should involve dialogue with people, where all potential outcomes are discussed in as much depth as the individual requires. Each person has different needs and these should be reflected in their individual care plans. Everyone with diabetes needs to be informed about the risks to their sight and preventative measures. This should be achieved through care planning with their healthcare professionals and participation in learning opportunities. practice. Standard 5 Criterion 5.2 comments Draft criterion Eligible people with symptomatic diabetic macular oedema are referred to ophthalmology services within 10 working days of diagnosis. Final criterion People with symptomatic optical coherence tomography positive diabetic macular oedema are referred to ophthalmology services within 10 working days of first grading. 217 I was not aware patients were asked about symptoms regarding macular oedema. They are normally referred based on M2 grading regardless of visual acuity. 218 AS above are they seen at ophthalmology or appointed? 219 I agree with the standard, but envisage exceptions see comment 6.1 OK for the most part, but such urgency not The criterion has been amended and the project group noted this criterion is about referring the patient to assessment. The project group felt the new wording is appropriate. 43

44 necessary e.g. if a patient has had previous Rx but has a remnant of new vessels, and it is thought safer to get him/her back into secondary care, but not necessarily urgently, i.e. this will leave no opportunity for discretion on the part of the recipient of the referral. The referral would still come as an R If the measurement of time is taken from the screening date for the previous question then all measurements should be made from date of screen. Otherwise there is definite confusion as the parameters are different. The project group saw this as an opportunity to refine the process if OCT positive then 10 days, if not then 12 weeks. Screening identifies features which may be indicators for the presence of macula oedema, it is not a diagnosis. If we use features recognised on image during grading it does not bring into the grading criteria if the patient is symptomatic or not Reduced visual acuity may be due to e.g. cataract rather than oedema and therefore not deemed to be symptomatic DMO. Since diagnosis is usually confirmed with OCT and this is out with screening parameters at present, the question of diagnosis is vague as I m unsure when/where diagnosis takes place. 221 We can t know if their symptoms are related to maculopathy could be cataract etc. Could this be better note in terms of definition of symptomatic maculopathy? 222 This is a reasonable time for referral of this pathology. 223 Is this evidence based? Macular oedema treatment paradigms are evolving rapidly (anti VEGFs/Steroid implants) this timescale therefore needs constant review. 224 Screening does not diagnose symptomatic DMO by definition. Screening does not make a diagnosis. The project group noted this is a screening process and not a diagnostic process. The project group noted that this is considered good clinical practice. 44

45 225 This should match the wording above. working days of being screened as opposed to diagnosed. 226 Would this be graded result instead of diagnosis? This is a screening programme prior to diagnostics. 227 Draft standard 5.2 states that symptomatic diabetic muscular oedema (DMO) should be referred to ophthalmology within 10 days. We feel it would be useful for the standards to explicitly define symptomatic; specifying a pre-defined change in visual acuity that would identify the DMO as being symptomatic, would be helpful. 228 We don t grade based on symptoms. Where does diagnosis take place in the grading scheme why does the time period start at diagnosis rather than screening date? We were unsure why 10 days was chosen for these cases. 353 It is important that people are aware of the clinical protocols in place at each step of the patient journey. Easy read versions of referral protocols for patients and healthcare professionals should be readily available. We would be happy to contribute to this process. The project group felt the new wording was appropriate. This is defined by the DRS Collaborative as part of their nationally agreed protocols. The project group saw this as an opportunity to refine the process if OCT positive then 10 days, if not then 12 weeks. We have forwarded on your offer to help with the referral protocols to the DRS Collaborative. 45

46 Standard 6: Treatment Standard 6 General comments 229 Informed choice is needed here akin to standard 3. this area was outwith the scope of this standard but this comment has been raised with the DRS Collaborative. 230 All time frames need to be note. Also, perhaps add in % s akin to 3.1 and Main issue is that patients referred by DRS are not seen urgently for macula oedema as there is no capacity and realistically there is no need for them to be as there is no significant risk of irreversible visual loss from a delay of a couple of months. The other point is the change in referral criteria for patients with M2 they now have to be symptomatic and have reduced vision, which is welcome. 232 In relation to section 6, the draft specifies that the time between date of referral from DRS and treatment should be 5 working days for high risk proliferative diabetic retinopathy (PDR); 10 working days for early PDR and 20 working days for symptomatic DMO. As these treatment times differ from the Royal College of Ophthalmology guidelines which we currently use, we would appreciate clarity on the reasons for proposing changes to these. The project group noted that all time-frames mentioned in Standard 6 are set to promote good clinical practice. The project group noted these time-frames were seen to promote good clinical practice, and the lead clinicians DRS Collaborative group also commented that these timeframes would be beneficial for patients and the service. Standard 6 Statement comments Draft statement Eligible people requiring treatment can access nationally approved treatments 16 in a timely manner. Final statement People requiring treatment can access nationally approved treatments 16 in a 46

47 timely manner. 233 What does access mean? Need to define. The project group felt the new wording was appropriate. 234 These patients will fall foul of the Government TTG of 18 weeks from referral to treatment. Diabetic Macular oedema picked up at routine screening would not be classed as urgent. 235 Mostly yes, but if they require IVT injection for DMO, then 20 working days is difficult to achieve. 236 I agree with the standard, but envisage exceptions see 6.1 and 6.3 comments 237 As long as electronic interfaces between different systems are reliable and patient coding is accurate. The project group noted that the time-frames set in the criteria are to promote good clinical practice. 238 Define Timely Specific time is specified in the criteria. 239 Needs clarification or be more specific, what is a timely manner? Is this clinical need/risk assessment? 240 The limitations on number of approved screeners reduces the days practices can offer screening. 241 As screening is in place to detect people requiring treatment, it is very important treatment is offered in a timely manner, and provision is in place to provide this. 242 The Royal College of Ophthalmologists has no data on the accessibility of medical retina opinions or treatment in Scotland. 243 Again the use of timely, all boards could specify this in a different manner. Specific time is specified in the criteria. Specific time is specified in the criteria. 47

48 244 I recently had bleeding from my retina again and tried to get an appointment with my local OP dept where I attend for regular checks. I was told that I would have to wait until the consultant that I was seeing had been replaced as he had left. I heard nothing for 2 months. Luckily the bleeding stopped quite quickly. I told my diabetes consultant about this at my next appt and was told to access the OP clinic by going to the optician (Specsavers) and being referred though them. It took almost 3 months to see someone. By this time Macular Odema was diagnosed. 245 Could be better with the a and Arran model Standard 6 Rationale comments Draft rationale Timely and effective treatment prevents permanent visual impairment. Avoidance of visual impairment due to diabetic retinopathy treatment ensures that people receive safe, effective and person-centred care. Final rationale Timely and effective treatment reduces the risk of permanent visual impairment I object to the wording here prevents should read will help to prevent There are no guarantee that every patient will respond well to treatment The project group agreed the new wording is appropriate. 247 Define timely Specific time is specified in the criteria. 248 Suggest: can prevent visual impairment Explanation: not all timely and effective treatments will prevent visual impairment 249 Treatment usually prevents visual impairment, but it does not always do so. It reduces the risk of visual impairment, but factors such as diabetic control and any macular ischaemia, which is untreatable, cannot be ameliorated by eye treatment. Good diabetic treatment in general, as well as timely ophthalmic treatment, is needed to avoid visual impairment, but this should always be a central aim in management of diabetics to provide person-centred The project group agreed the new wording is appropriate. The project group agreed the new wording is appropriate. 48

49 care. 250 Generally I agree and the first sentence seems OK. However the second sentence seems to be the wrong way round. That is giving people safe, effective and patient centred care ensures that visual impairment due to diabetic retinopathy is avoided rather than the other way round. Or alternatively, the word ensures could be replaced with requires 251 The wording is inaccurate. Timely and effective treatment MAY prevent permanent visual impairment. 252 Not the second sentence which does not make sense. Avoiding visual impairment does not ensure that people receive safe, effective and person centred care. Don t need the second sentence 253 Again the use of timely, all boards could specify this in a different manner. Let s have an agreement of a time frame. 254 Pxs getting regular eye exams would have the same effect 354 An appropriate and accessible pathway for people should be produced, possibly in conjunction with us, to guide people through their retinopathy journey. This literature should be made available to anyone undergoing treatment for retinopathy related conditions and should detail means of gaining additional support and contain accessible explanations of medical terms etc. The project group agreed the new wording is appropriate. The project group agreed the new wording is appropriate. The project group agreed the new wording is appropriate. Specific time is specified in the criteria. We have forwarded on your offer to help with the referral protocols to the DRS Collaborative. Standard 6 Criterion 6.1 comments Draft criterion Eligible people diagnosed by retinal screening as having active, untreated, high risk proliferative retinopathy (active new vessels at the disc, or active new vessels elsewhere with vitreous haemorrhage) and confirmed in ophthalmology can access nationally approved treatments within 5 working days of referral from the DRS Collaborative. Final criterion People identified as having active, untreated, high risk proliferative retinopathy (active new vessels at the disc, or active new vessels elsewhere with vitreous 49

50 haemorrhage) can access nationally approved treatments within 5 working days of receipt of referral. 255 access nationally approved treatments does this mean receives treatment or to make an appointment first before receiving the treatment? 256 This would not fit into urgent referral or National TTGs 257 This implies they are photographed and treated within 5 days of the picture being taken. I feel this is not the case. It can take 48hours to download the picture from the Islands, then these people are seen within 3 days?? 258 OK for the most part, but such urgency not necessary e.g. if a patient has had previous Rx but has a remnant of new vessels, and it is thought safer to get him/her back into secondary care, but not necessarily urgently, i.e. this will leave no opportunity for discretion on the part of the recipient of the referral. The referral would still come as an R Reword to Following confirmation in ophthalmology, patients who have Eligible people diagnosed by retinal screening as having active, untreated, high risk proliferative retinopathy (active new vessels at the disc, or active new vessels elsewhere with vitreous haemorrhage), and confirmed in ophthalmology, can access nationally approved treatments within 5 working days. Of referral from the DRS Collaborative. 260 Clarification required regarding the definition of DRS Collaborative as distinct from the screening process. Screeners are trained to contact Level 2 (or Level 3) The project group explained this means it s physically possible to access treatment whether the patient wishes to or not. The project group noted that the time-frames set in this criterion will help promote good clinical practice. The project group agreed the new wording is appropriate. The project group agreed the new wording is appropriate. The project group agreed the 50

51 graders by phone regarding patients presenting to screening with active, untreated, high risk proliferative retinopathy. Level 2 then speaks to Level 3 or other Consultant Ophthalmologists to confirm presence of active, untreated, high risk proliferative retinopathy and make an urgent PRP Laser appointment for the patient within 5 working days. 261 Requires clarification. Within 5 working days of referral do you mean 5 working days from initial receipt of paper referral by appointments, or date screened. By confirmed in ophthlamology do you mean level 3 graded or initial ophthalmology appointment. 262 Requires clarification: Confirmed in ophthalmology suggests the patient has been seen by the ophthalmologist and a diagnosis has been confirmed therefore their treatment should start 5 working days of that appointment. new wording is appropriate. The project group agreed the new wording is appropriate. The project group agreed the new wording is appropriate. Within 5 working days of referral from the DRS Collaborative this suggests the treatment starts 5 working days after the referral has been made to ophthalmology however the patient needs to have been seen by the ophthalmologist to confirm the diagnosis and agree the treatment. 263 Usually get access in 1-2 weeks 264 Patients are not always willing to accept an appointment within a week, especially if they are working. They can ideally be offered an appointment within this time frame 265 This target is considerably tighter than previous time to treatment targets for this group and will put considerable pressure on ophthalmology departments to deliver this target. It would, however, be ideal to treat this group of patients in this time frame. 266 This statement needs clarifying as it is confusing 51

52 around and confirmed in ophthalmology, access nationally approved treatments within 5 working days of referral from the DRS Collaborative. Should it mean once confirmed in ophthalmology people should have access to nationally approved treatments within 5 working days. Consider the need to remove DRS Collaborative, or even remove confirmed in ophthalmology and leave DRS Collaborative. The project group agreed the new wording is appropriate. 267 Is there evidence to support this time scale? The project group agreed the new wording is appropriate and the time-frame set will help promote good clinical practice. 268 This seems a bit jumbled. When does the 5 days start? From when they are referred to see the ophthalmologist and they confirm it, when they receive a hospital apt, or when the graders pick it up from the images? 269??? Can hardly pronounce some of the words how do you expect Jo Public to answer. We don t all have degrees in medicine, you should think about how you write some of your stuff. 270 For smaller boards the nationally approved treatments are provided by an outside board The project group agreed the new wording is appropriate. Standard 6 Criterion 6.2 comments Draft criterion Eligible people, diagnosed by retinal screening as having active, untreated, early proliferative retinopathy (active new vessels elsewhere in the absence of vitreous haemorrhage) and confirmed in ophthalmology, can access nationally approved treatments within 10 working days of referral from the DRS Collaborative. Final criterion People identified as having active, untreated, early proliferative retinopathy (active new vessels elsewhere in the absence of vitreous haemorrhage), can access nationally approved treatments within 20 working days of receipt of referral. 271 This would not fit into urgent referral or National TTGs The project group noted that the time-frames set in this 52

53 criterion will help promote good clinical practice. 272 Again the time line seems improbable. 273 OK for the most part, but such urgency not necessary e.g. if a patient has had previous Rx but has a remnant of new vessels, and it is thought safer to get him/her back into secondary care, but not necessarily urgently, i.e. this will leave no opportunity for discretion on the part of the recipient of the referral. The referral would still come as an R Reword to Following confirmation in ophthalmology, patients who have Eligible people diagnosed by retinal screening as having active, untreated, early proliferative retinopathy (active new vessels at the disc, or active new vessels elsewhere with vitreous haemorrhage), and confirmed in ophthalmology, can access nationally approved treatments within 5 working days. Of referral from the DRS Collaborative. 275 Patients screened positive for active, untreated, early proliferative retinopathy will be referred to ophthalmology but the timescales are challenging for access to nationally approved treatments within 10 working days of referral in all cases The project group agreed the new wording is appropriate. The project group agreed the new wording is appropriate. 276 Requires clarification. Similar to Requires clarification: Confirmed in ophthalmology suggests the patient has been seen by the ophthalmologist and a diagnosis has been confirmed therefore the patient s treatment should start 10 working days of that appointment. The project group agreed the new wording is appropriate. Within 10 working days of referral from the DRS Collaborative this suggests the treatment starts 10 working days after the referral has been made to ophthalmology however the patient needs to have seen by the ophthalmologist to confirm the diagnosis and agree the treatment. 53

54 278 Usually seen in 2 weeks 279 Patients are not always willing to accept an appointment within a week, especially if they are working. They can ideally be offered an appointment within this time frame 280 This is a tighter time to treatment target than previous targets, but would be an ideal time frame for treatment of this group. 281 This statement needs clarifying as it is confusing around and confirmed in ophthalmology, access nationally approved treatments within 5 working days of referral from the DRS Collaborative. Should it mean once confirmed in ophthalmology people should have access to nationally approved treatments within 5 working days. Consider the need to remove DRS Collaborative, or even remove confirmed in ophthalmology and leave DRS Collaborative. The project group agreed the new wording is appropriate. 282 What is the evidence base? The project group agreed the new wording is appropriate and the time-frame set will help promote good clinical practice. 283 Diagnosis- should say detected The project group agreed the new wording is appropriate. 284 Same as above. Does this mean once the patient has been referred to hospital and seen the specialist they then should have treatment within 10 days? 285??? Can hardly pronounce some of the words how do you expect Jo Public to answer. We don t all have degrees in medicine, you should think about how you write some of your stuff. The project group agreed the new wording is appropriate. Standard 6 Criterion 6.3 comments Draft criterion Eligible people diagnosed in retinal screening as having symptomatic diabetic 54

55 macular oedema receive nationally approved treatments 16 within 20 working days of referral from the DRS Collaborative. Final criterion People identified as having symptomatic optical coherence tomography positive diabetic macular oedema can access nationally approved treatments 6, within 20 working days of receipt of referral. 286 I welcome the introduction of symptomatic DMO. 287 This is possibly a reasonable and achieved time line, from picture to treatment 20 days 288 If they require IVT injection for DMO, then 20 working days is difficult to achieve. 289 How do we define symptomatic in a system where the grader has a visual acuity and photographs only? Also some cases are clearly more urgent than others. In our overloaded clinics a target of 20 working days will be difficult enough and unnecessary in some cases (although hopefully fewer cases if we have triaged with OCT). 290 All patients with triggers associated with diabetic macular oedema are referred to ophthalmology whether they have symptoms or not. 291 Not sure what symptomatic means. Symptomatic is what the patient reports. 292 Our ophthalmology department has developed a new, multidisciplinary, one-stop antivegf treatment approach to medical retina conditions, including DMO, in line with SMC Guidelines. Patients will be seen in a dedicated DMO and Central Retinal Vein Occlusion clinic (Macular Degeneration is on a separate day). This means that patients diagnosed with symptomatic DMO can be offered antivegf treatment or given macular laser treatment on the day in most cases. In a minority of cases, they will be offered a one-stop clinic appointment within 20 working days. 55

56 293 Patients are not always willing to accept an appointment within a week, especially if they are working. They can ideally be offered an appointment within this time frame 294 This time to treatment is probably shorter than is absolutely necessary for this group, in whom vision is affected much more slowly. 295 What is the evidence base? The project group agreed the new wording is appropriate and the time-frame set will help promote good clinical practice. 296 Again retinal screening does not diagnose symptomatic DMO. There are also other routes that people could come form with centre involving DMOeg clinics, optometrists. They should access treatment in the same time frame. Take out the phrase diagnosed in retinal screening. 297 I was diagnosed with macular oedema at the beginning of December 2015 and have still, on 15 th Feb 2016 not received any treatment for this. 298??? Can hardly pronounce some of the words how do you expect Jo Public to answer. We don t all have degrees in medicine, you should think about how you write some of your stuff. The project group agreed the new wording is appropriate. 56

57 Other comments If you have identified gaps with the document, please provide further information below. 299 Mention in the standards that there is a difference with a normal eye test and DRS eye test. Many people think they ve had it done if they ve recently had an eye test at their local opticians. 300 Could you mentioned more about how the service would be more efficient if private and public sectors worked together ie NHS FV and Specsavers 301 Could the test be done at the same time as their annual GP check up. Maybe include on the official check up GP s get paid for? 302 The transfer of information between GP practice/sci Diabetes/Screening service/hospital eye service should be automated scope of the standards but this comment has been raised with the DRS Collaborative. scope of the standards. scope of the standards. scope of the standards. 303 Pregnancy pathway scope of the standards. 304 Page 5 states that standards should be reviewed pragmatically by service providers: not every criterion will always apply to all setting or service providers, the same page then goes on to say within the standards all criterion are considered essential or required in order to demonstrate the standard has been achieved. It cannot be both, we firmly believe that it should be the first statement. 305 A definition of the principles of informed choice should be included. The document has been amended. The document has been amended. 57

58 The DRS Collaborative protocols (reference 4) are mentioned in several places. However, the reference takes you to a website which does not mention protocols. I assume that these are the items under heading DRS Manual. It would good if the reference was slightly more specific. I d like to read the protocols which go with the rationale for Standard 4 for example. 306 The screening intervals for low risk groups may need varying. 307 In our area we have a specialist pathway for pregnant diabetic patients. During pregnancy and in the post natal period. Global guidelines for diabetes suggest pregnant patients should have eyes examined at first antenatal visit and each trimester There are no referral KPIs for slit lamp imagery. I don t know what the average waiting time is between image failure initial screen- to slit lamp examination. 355 The majority of people living with diabetes selfmanage their condition. It is important that literature is available that is accessible and readily available so that they have the opportunity to fully understand retinopathy and how it may affect them. GPs should check that patients have attended their annual retinal screening appointment and that they are aware of and understand the results. This should be integrated within overall diabetes care. It links to this page in-case any of these protocols are amended. To remove the risk of the link changing, it was felt this link should remain. Is there anything which the project group should consider when finalising these standards? 309 Use SIGN 112 and the SG diabetes improvement plan as reference sources. 310 Big problem with the wording in appointment letters: The project group felt there are sufficient reference sources already. 58

59 - makes me feel judged as a bad diabetic as it keeps telling me how important it is that I manage my diabetes (something I ve had for over 43 years). - needs to be more person centred ie the wording is cold so a newly diagnosed person might be worried that they are already going blind. scope of the standards but this comment has been raised with the DRS Collaborative. - no follow up letter to say if there has been a change in the patient s eyes and that the change might not have any affect on their eye sight. - the letter should not be sent on the Firday as someone could get it and have no one to talk to until the Monday causing them to stress unnecessarily. 311 Add a paragraph to the introduction pages to say why screening is so important but also to point out why it s not the end of the world if you need treatment. 312 We re not sure about the whole process when you get to the referral stage. If you need to be referred, when does the clock start for the 5 day and 10 day timeframes? Also, do you receive a letter to say you need referred and then another with an appointment? Doesn t seem very efficient if you do. 313 Linking of various Ophthalmic EMRs like Medisoft to screening software 314 The time lines from screening photograph being taken to being seen by ophthalmology and then treated need carefully reworded to avoid any confusion. Clarity is very important in this issue 315 Referral times have to be achievable by all within the programme and these time frames are too tight. Where has the evidence come from to put forward these time frames as necessary or crucial to scope of the standards but this comment has been raised with the DRS Collaborative. The project group agreed the new wording is appropriate. scope of the standards. The project group agreed the new wording is appropriate. The project group agreed that, while the referral timelines set are stretching, they 59

60 treatment? 316 Consider joining up the service with community Optometrists with training from NES and allowing Optometrists access to retinal images. 317 Time to treatment targets are very useful in improving standards of treatment, but will put extra pressure on ophthalmology departments, especially at the time of such targets being introduced. They would likely bring about a longer term improvement in care, however, which would certainly be of benefit to patients. Extra resources will be needed in many departments to deliver these targets. 318 There remains a need for some flexibility from national protocols to ensure that existing safe and effective services can continue to function in a pragmatic manner. The requirement that every board meet every criterion could hamper this and a realistic view would be that some boards may opt to default on meeting every criterion in order to continue to deliver their service in an effective manner. 319 Can the lists of possible evidence of achievement be made complete? 320 Smaller boards have to depend upon the larger boards for grading and treatments. felt this will help promote good clinical practice. scope of the standards. The project group noted the list is illustrative to provide some useful examples for NHS boards. Other examples of practice may be locally determined and shared through the DRS Collaborative. Any other comments? 321 We agree with all the timescales mentioned in the document. 60

61 322 When someone is diagnosed with diabetes, is there information on the letter to say what other tests they will now be invited to take? 323 I could find no critical omissions, unnecessary information or inclusions, factual errors nor grammatical errors in this report. 324 Optometrists have retinal cameras and are perfectly positioned to take these photographs in the community this is done very successfully in Ayrshire and Arran, this reduces the cost of duplication and also cares for the person with diabetes closer to their home. Optometrists also have a very effective reminder system with easily varied intervals. 325 The College welcomes this document. The standards are laudable and the criteria are appropriate. 326 Consider making specific mention to minority groups ie prisoners, pregnancy, state hospital, detention centres, MoD staff. This could maybe be added to the introduction. 327 Clarification required regarding the definition of DRS Collaborative as distinct from the screening process 328 We need to consider the effect of restrictions on the number of optometrists a practice can register. Also the process needs to be better/efficient when an approved screener retires/leave a practice as it causes a huge back log of patients. scope of the standards but this comment has been raised with the DRS Collaborative. The project group discussed including all relevant groups, such as minority groups. However, they felt that the revised wording covered everyone regardless of their personal circumstances or characteristics. Project group to discuss 329 Audits of time to treatment should be routinely 61

62 performed locally this is not within the usual KPI statistics gathered. 330 The terms participation and uptake appear to be used interchangeably, was this the intention? 331 The guidelines provide a high standard to aim for, both for DRS and ophthalmology departments, which will be of benefit to diabetic patients, especially if these guidelines draw attention to this essential service. 332 The standards, rationale and criteria are all broadly speaking correct. The group should be mindful of the differences in local practice (for geographic or other reasons) nationwide and that services range from being delivered as an entirely managed service through to others predominantly using independent contractors for screening and grading. The criteria in particular should be realistic and pragmatic enough to handle such variations in practice. 333 I like the format of the draft standards and in particular the what does it mean boxes at the end. I concentrated on the box entitled What does the standard mean for people participating in diabetic retinopathy screening? Throughout the survey I was tempted to describe how closely I thought my NHS board are to meeting these standards. When the new standards are adopted it would be very interesting to see reports measuring compliance at outset and seeing how this can be and is improved. This is outwith the scope of the standards. The document has been amended. 334 It is vital that optometry gets linked to drs 62

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