National Screening Programme for Diabetic Retinopathy Template for annual report Release 3, 20 July 2005 From 2006 and annually thereafter, diabetic retinopathy screening programmes will be required to submit to the National Screening Programme an annual report, containing general information about the service offered and information to support an assessment against the Service Objectives and Quality Assurance Standards for the programme. This template provides a report structure which all programmes will be required to use, in order to facilitate the collation and comparison of data. Each of the terms in this report and the Service Objectives has been defined so as to be unambiguous and consistent with the targets, standards, and software which define systematic screening for diabetic retinopathy. The template is divided into two columns: the first states the return required, and the second provides the detail of how this should be measured and how it relates to the Service Objectives and Quality Assurance Standards. Each annual report will cover one complete financial year (1 April - 31 March), and must be returned to the National Screening Programme Office by 31 October following the end of each report period. Returns are generally based on invitations to attend for a retinopathy screening appointment during the reporting period, with seven months being allowed before the report is due to follow these appointments through the grading, assessment and treatment process. Terms indicated with a broken underline are further defined and explained in the guidance notes which accompany the Service Objectives. It is important to read this annual report template in association with the guidance notes. Returns marked with an asterisk (*) will require the collation of data which will not usually be collected by a screening service, such as ophthalmology treatment information. No annual return is required for categories in [square brackets] – these are headers to provide context and grouping information regarding subcategories. Template for annual report – Release 3, 2005-07-20 Page 1 of 8 1. Programme information 1.1. Programme name 1.2. PCTs wholly covered 1.3. PCTs covered in part 1.4. Programme lead 1.5. Accountable clinical lead 1.6. Location 1.7. Referral centres 1.8. Treatment centres 1.9. Biomicroscopy arrangements 1.10. GP participation Unique name for this diabetic retinopathy screening programme. 2 List of PCTs falling wholly within the defined boundaries of this programme, including known people with diabetes and total population for each PCT. Service Objective 2 3 List of PCTs falling partly within the defined boundaries of this programme, including known people with diabetes and total population for the area covered by this programme for each PCT. Service Objective 2 Name, job title, address, e-mail and telephone for the programme lead / manager. Name, e-mail and telephone for the accountable clinical lead (usually an ophthalmologist, responsible for overseeing the secure clinical operation of the programme). Address, contact name, contact e-mail and contact telephone for the administrative centre for the programme. A list of the acute Trust(s) and hospitals into which patients are referred for assessment following a positive test. A list of the acute Trust(s) and hospitals into which patients are referred for treatment of diabetic retinopathy. A description of the process and location(s) for patients with unobtainable or ungradable images to be assessed by slit-lamp biomicroscopy. Number of GPs referring into the programme against number of GPs within 4 the defined boundaries of the programme. Service Objective 2 1 2. Delivery model 2.1. Programme structure / model 2.2. Cameras used 2.3. Capture software used 2.4. Management software used Brief summary of how screening is delivered, including number of static, mobile, and/or optometric sites, and whether any independent/external provider is used. Number, make and model of fundus cameras used. Supplier, product, version and number of units installed. Supplier, product, version and number of units installed. 1 2 3 4 Should identify the screening programme and not just the PCTs that it covers; for example ‘Gloucestershire Diabetic Eye Screening Service’. Or equivalent administrative units in countries other than England. ibid. Note that the measure of GP participation should be GP rather than GP practice. Template for annual report – Release 3, 2005-07-20 Page 2 of 8 2.5. Workforce information 2.6. Retinal screeners 2.7. Retinopathy graders Brief summary of workforce to deliver programme, including number of administrators, screeners, graders and screener-graders. Number of screeners and WTE provision for service; level of training / accreditation. Number of graders and WTE provision for service; level of training / accreditation and division of screening/grading. 3. Patient throughput 3.1. Programme size 3.2. Invitations made 3.3. Post Office returns 3.4. Screening carried out 3.4.1. Prevalent screening 3.4.2. Incident screening 3.4.3. Annual screening 3.5. New registrations 3.6. Ceased screening 3.6.1. Ceased screening - deceased 3.6.2. Ceased screening - exempt 3.6.3. Ceased screening - withdrawn Number of people with diabetes eligible for screening by this programme (the number of people on the programme register / collated list). Service Objective 18 Number of people with diabetes invited for a screening event to take place within the reported time period. Service Objective 2 Number of Post Office returns received 5 within the reported time period. Service Objective 3 Number of screening encounters during the reported time period. Number of screening encounters during the reported time period by patients for whom no previous screening record is available. Service Objective 4 Number of repeat screens during the reported time period. Service Objective 4 Number of repeat screens during the reported time period falling within 12 months of previous screen. Service Objective 15 Number of new additions to the register / collated list within the reported time period. Number of people with diabetes marked ineligible for screening or removed from the register / collated list within the reported time period. Number of people with diabetes marked ineligible for screening or removed from the register / collated list within the reported time period through death. Number of people with diabetes marked ineligible for screening within the reported 6 time period. Number of people with diabetes marked ineligible for screening or removed from the register / collated list within the Note that the invitations made [3.2] must not include any Post Office returns, so the total number of invitations sent out should be the sum of [3.2] and [3.3]. 6 Reasons include: under ophthalmic care; blind (screening contraindicated); no longer categorised as diabetic; discharged for other reason (no longer falls within eligibility criteria). 5 Template for annual report – Release 3, 2005-07-20 Page 3 of 8 reported time period for administrative 7 reasons. 4. Outcomes of screening by photography 8 [4.1. Photography outcomes by grade:] 4.1.1. Outcome: R0 4.1.2. Outcome: R1M0 4.1.3. Outcome: R1M1 4.1.4. Outcome: R2M0 4.1.5. Outcome: R2M1 4.1.6. Outcome: R3M0 4.1.7. Outcome: R3M1 4.1.8. Unobtainable / raw ungradable 4.1.9. Unassessable The aggregate outcomes within each grading category should relate to screening encounters within the reported 9 time period. The category should represent the final grading outcome for the 10 most severely affected eye. Number of patients, according to [4.1] above, with a final grading outcome of ‘R0 No retinopathy’. Number of patients, according to [4.1] above, with a final grading outcome of ‘R1 Background retinopathy, M0 No maculopathy’. Number of patients, according to [4.1] above, with a final grading outcome of ‘R1 Background retinopathy, M1 Maculopathy’. Number of patients, according to [4.1] above, with a final grading outcome of ‘R2 Pre-proliferative retinopathy, M0 No maculopathy’. Number of patients, according to [4.1] above, with a final grading outcome of ‘R2 Pre-proliferative retinopathy, M1 Maculopathy’. Number of patients, according to [4.1] above, with a final grading outcome of ‘R3 Proliferative retinopathy, M0 No maculopathy’. Number of patients, according to [4.1] above, with a final grading outcome of ‘R3 Proliferative retinopathy, M1 Maculopathy’. Number of patients, according to [4.1] above, deemed unobtainable / ungradable by screener. Service Objective 5 Number of patients, according to [4.1] above, deemed unassessable by grader. 5. Grading process [5.1. Grader workload] For each retinopathy grader in the service, 11 provide a pseudonymised report of Reasons include: moved away; declined to participate in screening service; no current contact details; persistent DNA. 8 Note that the numbers of eyes falling within each grading category [4.1.1 to 4.1.9] should sum to exactly the number of patients screened [3.4]. 9 Therefore these figures will relate to grading activity outside the reporting period for patients screened near the end of the financial year. 10 Therefore a patient with ‘R0 No retinopathy’ in the left eye and ‘R2 Pre-proliferative retinopathy, M1 Maculopathy’ in the right eye should be counted only under category [4.1.5]. 11 For example, ‘Grader A’, ‘Grader B’, etc. This should allow problems with individual graders to be traced back if necessary without compromising workforce confidentiality. 7 Template for annual report – Release 3, 2005-07-20 Page 4 of 8 5.1.1. Imagesets graded 5.1.2. Grading sessions 5.1.3. Maximum workload per session 5.2. Grading accuracy 5.2.1. Grading accuracy by category 5.3. Inter-grader agreement 5.3.1. Inter-grader agreement by category 5.4. Result notification times workload relating to grading activity within 12 the reported time period. Number of imagesets from screening encounters within the reported time period full graded by each grader, categorised by 13 grader status. Service Objective 7 Number of 3.5 hour sessions worked by each grader. Maximum number of imagesets graded during any one 3.5 hour session. For each retinopathy grader in the service, 14 provide a pseudonymised report of accuracy against final grading outcome for all imagesets full graded within the 15 reported time period. Service Objective 6 As for [5.2] above, but divided into: a) referable images b) non-referable images c) ungradable images Service Objective 6 For each retinopathy grader in the service, 16 provide a pseudonymised report of grading outcomes within the reported time period against all other graders for 17 imagesets full graded by both graders. Service Objective 6 As for [5.3] above, but divided into: a) referable images b) non-referable images c) ungradable images Service Objective 6 Number of notifications issued following a screening event within the reported time period: a) within 3 weeks of screening encounter b) within 6 weeks of screening encounter Service Objective 9 6. Outcomes from biomicroscopy clinic 6.1. Biomicroscopy assessments Total number of biomicroscopy assessments as a result of screening encounters within the reported time period. The assessment of grading workload does not therefore relate to screening encounters within the reported time period; often, grading carried out near the start of the financial year will relate to screening encounters from the previous financial year. 13 Non-optometric retinopathy grader / qualified optometrist 14 For example, ‘Grader A’, ‘Grader B’, etc. This should allow problems with individual graders to be traced back if necessary without compromising workforce confidentiality. 15 The assessment of grading workload does not therefore relate to screening encounters within the reported time period; often, grading carried out near the start of the financial year will relate to screening encounters from the previous financial year. 16 For example, ‘Grader A’, ‘Grader B’, etc. This should allow problems with individual graders to be traced back if necessary without compromising workforce confidentiality. 17 The assessment of grading workload does not therefore relate to screening encounters within the reported time period; often, grading carried out near the start of the financial year will relate to screening encounters from the previous financial year. 12 Template for annual report – Release 3, 2005-07-20 Page 5 of 8 [6.2. Biomicroscopy assessment outcomes 18 by grade:] 6.2.1. Outcome: R0 6.2.2. Outcome: R1M0 6.2.3. Outcome: R1M1 6.2.4. Outcome: R2M0 6.2.5. Outcome: R2M1 6.2.6. Outcome: R3M0 6.2.7. Outcome: R3M1 6.2.8. Unassessable 6.3. Deemed unsuitable for screening 6.4. Cataract referrals The aggregate outcomes within each grading category should relate to screening encounters within the reported 19 time period. The category should represent the final grading outcome for the 20 most severely affected eye. Number of patients, according to [6.2] above, with a final grading outcome of ‘R0 No retinopathy’. Number of patients, according to [6.2] above, with a final grading outcome of ‘R1 Background retinopathy, M0 No maculopathy’. Number of patients, according to [6.2] above, with a final grading outcome of ‘R1 Background retinopathy, M1 Maculopathy’. Number of patients, according to [6.2] above, with a final grading outcome of ‘R2 Pre-proliferative retinopathy, M0 No maculopathy’. Number of patients, according to [6.2] above, with a final grading outcome of ‘R2 Pre-proliferative retinopathy, M1 Maculopathy’. Number of patients, according to [6.2] above, with a final grading outcome of ‘R3 Proliferative retinopathy, M0 No maculopathy’. Number of patients, according to [6.2] above, with a final grading outcome of ‘R3 Proliferative retinopathy, M1 Maculopathy’. Number of patients, according to [6.2] above, deemed unassessable following biomicroscopy examination. Number of patients ceased screening following an unassessable grade in biomicroscopy clinic within the reported 21 time period. Number of cataract referrals resulting from biomicroscopy assessments within the reported time period. 7. Ophthalmology referrals / outcomes 7.1. Urgent referral times Number of patients marked as ‘R3 fast22 track referral’ referred to an ophthalmology clinic following a positive test relating to a screening event within the reported time period within: a) 1 week of screening b) 2 weeks of screening Service Objective 8 Note that the numbers of eyes falling within each grading category [6.2.1 to 6.2.8] should sum to exactly the number of biomicroscopy assessments [6.1]. 19 Therefore these figures will relate to grading activity outside the reporting period for patients screened near the end of the financial year. 20 Therefore a patient with ‘R0 No retinopathy’ in the left eye and ‘R2 Pre-proliferative retinopathy, M1 Maculopathy’ in the right eye should be counted only under category [6.2.5]. 21 These patients would also fall into the ‘ceased screening - withdrawn’ category [3.6.3]. 22 i.e. secondary grading and appropriate referral actioned within 1 week 18 Template for annual report – Release 3, 2005-07-20 Page 6 of 8 7.2. Ophthalmology referrals 7.3. Consultation times: all patients * 7.3.1. Consultation times: by category * 7.4. Patients listed for laser treatment * 7.5. Patients receiving laser treatment * 7.5.1. Laser treatment waiting times: R3 * 7.5.2. Laser treatment waiting times: M1 * 7.6. Inappropriate referrals 7.7. Patients treated but not screened * Number of patients referred to an ophthalmology clinic following a positive test relating to a screening event within the reported time period. Number of patients within [7.2] above receiving consultation within 18 weeks of notification of positive test. Service Objective 10 Number of patients within [7.2] above with: a) a final grading outcome of ‘R3 Proliferative retinopathy’ receiving consultation within 2 weeks of notification of positive test b) a final grading outcome of ‘R2 Preproliferative retinopathy’ receiving consultation within 13 weeks of notification of positive test c) a final grading outcome of ‘M1 Maculopathy’ receiving consultation within 13 weeks of notification of positive test Service Objective 10 Number of patients listed for first laser treatment for diabetic retinopathy following a positive test relating to a screening event within the reported time period. Number of patients having received first laser treatment for diabetic retinopathy at first visit to the ophthalmology service following a positive test relating to a screening event within the reported time period. Number of patients within [7.5] above with a final grading outcome of ‘R3 Proliferative retinopathy’ having received laser treatment: a) within 2 weeks of listing b) within 4 weeks of screening c) within 6 weeks of screening Service Objectives 11, 12 Number of patients within [7.5] above with a final grading outcome of ‘M1 Maculopathy’ having received laser treatment: a) within 10 weeks of listing b) within 15 weeks of screening c) within 26 weeks of screening Service Objectives 11, 12 Number of ophthalmology referrals following a screening event within the reported time period which are deemed 23 inappropriate by the ophthalmologist . Service Objective 14 Number of patients having received laser treatment for diabetic retinopathy within the reported time period not having been referred from the screening programme. 23 Against the combined criteria of False positive rate of DR test (photograph) and Neither photograph nor clinical examination warranted referral. Template for annual report – Release 3, 2005-07-20 Page 7 of 8 7.8. Attendance at assessment clinics * Number of patients failing to attend an assessment clinic following a referral from 24 ophthalmology : a) for patients referred with a final grading outcome of ‘R3 Proliferative retinopathy’, within 1 month b) for patients referred with a final grading outcome of ‘R2 Pre-proliferative retinopathy’, within 6 months c) for patients referred with a final grading outcome of ‘M1 Maculopathy’, within 6 months Service Objective 13 8. Quality assurance processes 8.1. Evidence of internal quality assurance 8.2. Evidence of external quality assurance 8.3. National minimum dataset Brief summary of internal quality assurance measures. Service Objective 6 Brief summary of participation in external quality assurance processes, including: a) evidence of participation of all graders in external image test set scheme b) participation in peer-review visit programme Service Objective 17 Automated outputs from national minimum database to be submitted electronically by 31 October following the end of each report period. Service Objective 17 9. Reducing new blindness 9.1. New certifications of severe visual impairment * 9.2. New certifications of visual impairment * 9.3. Incident visual acuity: 6/60 or worse 9.4. Incident visual acuity: 6/18 or worse Number of new certifications of severe visual impairment within the reported time period amongst current patients. Service Objective 1 Number of new certifications of visual impairment within the reported time period amongst current patients. Service Objective 1 Number of current patients with visual 25 acuity of 6/60 or worse in the better seeing eye. Service Objective 1 Number of current patients with visual 26 acuity of 6/18 or worse in the better seeing eye. Service Objective 1 Primarily DNAs and cancellations. This may be difficult to assess, because attendance information is often held in a PAS which is connected to neither the screening nor the ophthalmology system. Screening programmes might have to rely on the absence of a report from ophthalmology within a defined time period, but for patients who progress slowly through the screening / grading / assessment pathway this information may not be available for the reported time period. 25 logMAR equivalent: +1.0 26 logMAR equivalent: +0.5 24 Template for annual report – Release 3, 2005-07-20 Page 8 of 8