Action on diabetic macular oedema: achieving optimal patient management in treating visual impairment due to diabetic eye disease.

This paper identifies best practice recommendations for managing diabetes and sight-threatening diabetic eye disease. The authors provide an update for ophthalmologists and allied healthcare professionals on key aspects of diabetes management, supported by a review of the pertinent literature, and recommend practice principles for optimal patient management in treating visual impairment due to diabetic eye disease. In people with diabetes, early optimal glycaemic control reduces the long-term risk of both microvascular and macrovascular complications. The authors propose more can and should be done to maximise metabolic control, promote appropriate behavioural modifications and encourage timely treatment intensification when indicated to ameliorate diabetes-related complications. All people with diabetes should be screened for sight-threatening diabetic retinopathy promptly and regularly. It is shown that attitudes towards treatment adherence in diabetic macular oedema appear to mirror patients' views and health behaviours towards the management of their own diabetes. Awareness of diabetic macular oedema remains low among people with diabetes, who need access to education early in their disease about how to manage their diabetes to delay progression and possibly avoid eye-related complications. Ophthalmologists and allied healthcare professionals play a vital role in multidisciplinary diabetes management and establishment of dedicated diabetic macular oedema clinics is proposed. A broader understanding of the role of the diabetes specialist nurse may strengthen the case for comprehensive integrated care in ophthalmic practice. The recommendations are based on round table presentations and discussions held in London, UK, September 2016.

Factors determining uptake of diabetic retinopathy screening in Oxfordshire.

AIMS: To investigate variables at the demographic and primary care practice levels that influence the uptake of diabetic retinopathy screening. METHODS: Data were extracted from the management software of one screening programme for 21 797 people registered with 79 general practices. Uptake was examined by gender, age group, modality of screening (mobile unit at general practice versus high-street optometrist), and by general practice. A telephone survey of high-street optometrists provided information on the availability of screening appointments. RESULTS: Uptake was 82.4% during the study period, and was higher for men (83.2%) than for women (81.5%) (P = 0.001). Uptake varied by age group (P < 0.001), being lowest in those aged 12-39 years (67%). Uptake was higher for people invited to a general practice for screening by a mobile unit (83.5%) than for those invited for screening by a high-street optometrist (82%) (P = 0.006). After adjusting for these factors and for socio-economic deprivation score at the location of the general practice, heterogeneity in uptake rate was still observed between some practices. Our survey of optometrists indicated wide variation in the availability of time slots for screening during the week and of screening appointment provision. CONCLUSIONS: Diabetic retinopathy screening services do not achieve high uptake among the youngest or oldest age groups. Practices in the least deprived areas had the highest uptake. Variation in uptake between general practices after adjustment for individual-level variables and deprivation suggests that practice-level factors may have an important role in determining rates of screening attendance.

The use of statistical methodology to determine the accuracy of grading within a diabetic retinopathy screening programme.

AIMS: We aimed to use longitudinal data from an established screening programme with good quality assurance and quality control procedures and a stable well-trained workforce to determine the accuracy of grading in diabetic retinopathy screening. METHODS: We used a continuous time-hidden Markov model with five states to estimate the probability of true progression or regression of retinopathy and the conditional probability of an observed grade given the true grade (misclassification). The true stage of retinopathy was modelled as a function of the duration of diabetes and HbA1c . RESULTS: The modelling dataset consisted of 65 839 grades from 14 187 people. The median number [interquartile range (IQR)] of examinations was 5 (3, 6) and the median (IQR) interval between examinations was 1.04 (0.99, 1.17) years. In total, 14 227 grades (21.6%) were estimated as being misclassified, 10 592 (16.1%) represented over-grading and 3635 (5.5%) represented under-grading. There were 1935 (2.9%) misclassified referrals, 1305 were false-positive results (2.2%) and 630 were false-negative results (1.0%). Misclassification of background diabetic retinopathy as no detectable retinopathy was common (3.4% of all grades) but rarely preceded referable maculopathy or retinopathy. CONCLUSION: Misclassification between lower grades of retinopathy is not uncommon but is unlikely to lead to significant delays in referring people for sight-threatening retinopathy.

Screening attendance, age group and diabetic retinopathy level at first screen.

AIMS: To report on the relationships between age at diagnosis of diabetes, time from registration with the screening programme to first diabetic eye screening and severity of diabetic retinopathy. METHODS: Data were extracted from four English screening programmes and from the Scottish, Welsh and Northern Irish programmes. Time from diagnosis of diabetes to first screening and age at diagnosis were calculated. RESULTS: Time from registration with the screening programme to first screening episode is strongly related to age at registration. Within 18 months of registration 89% of 3958 young people under 18 years of age and 81% of 391 293 people over 35 years of age were seen. In 19 058 people between 18 and 34 years of age, 80% coverage was not reached until 2 years and 9 months. The time from diagnosis of diabetes to first screening is positively associated with severity of disease (P < 0.0001). CONCLUSIONS: This report is the first that to demonstrate that those in the 18-34 year age group are least likely to attend promptly for screening after registration with a higher risk of referable diabetic retinopathy being present at the time of first screen. Date of diagnosis should be recorded and prodigious efforts made to screen all people promptly after diagnosis. Screening programmes should collect data on those who have not attended within one year of registration.

The use of weighted health-related Quality of Life scores in people with diabetic macular oedema at baseline in a randomized clinical trial.

AIMS: To examine the relationship between visual acuity in each eye and Quality of Life (QoL) outcomes in people with diabetic macular oedema. METHODS: Cross sectional retrospective analysis of data collected at baseline in 289 people entered into a randomized clinical trial with diabetic macular oedema which investigated the safety and efficacy of a vascular endothelial growth factor inhibitor, pegaptanib sodium. At the baseline visit, visual acuity was measured through refraction and using retro-illuminated modified Early Treatment Diabetic Retinopathy Study Log MAR charts, and patient health-related QoL was determined using the European Quality of Life EQ-5D-3L and the Visual Functioning Questionnaire-25 (NEI-VFQ25). A regression analysis with QoL score from each vision-related domain as the dependent variable was fitted using linear and quadratic terms of the better and worse eye, age, gender, adjusted for number of concurrent conditions, ethnicity and level of diabetes control. RESULTS: For all vision-related QoL domains from NEI-VFQ25 and EQ-5D-3L except ocular pain, both visual acuity in the better-seeing and the worse-seeing eye gave a significant increase in correlation coefficient over that obtained from clinical and demographic data. The NEI-VFQ25 correlation was most closely associated with a weighted visual acuity measure of 0.75 in the better and 0.25 in the worse eye or 0.60 in the better and 0.40 in the worse eye. CONCLUSIONS: We recommend that a weighted visual acuity measure from both eyes is considered in future diabetic macular oedema trials.

Attitudes, access and anguish: a qualitative interview study of staff and patients' experiences of diabetic retinopathy screening.

OBJECTIVE: To examine the experiences of patients, health professionals and screeners; their interactions with and understandings of diabetic retinopathy screening (DRS); and how these influence uptake. DESIGN: Purposive, qualitative design using multiperspectival, semistructured interviews and thematic analysis. SETTING: Three UK Screening Programme regions with different service-delivery modes, minority ethnic and deprivation levels across rural, urban and inner-city areas, in general practitioner practices and patients' homes. PARTICIPANTS: 62 including 38 patients (22 regular-screening attenders, 16 non-regular attenders) and 24 professionals (15 primary care professionals and 9 screeners). RESULTS: Antecedents to attendance included knowledge about diabetic retinopathy and screening; antecedents to non-attendance included psychological, pragmatic and social factors. Confusion between photographs taken at routine eye tests and DRS photographs was identified. The differing regional invitation methods and screening locations were discussed, with convenience and transport safety being over-riding considerations for patients. Some patients mentioned significant pain and visual disturbance from mydriasis drops as a deterrent to attendance. CONCLUSIONS: In this, the first study to consider multiperspectival experiential accounts, we identified that proactive coordination of care involving patients, primary care and screening programmes, prior to, during and after screening is required. Multiple factors, prior to, during and after screening, are involved in the attendance and non-attendance for DRS. Further research is needed to establish whether patient self-management educational interventions and the pharmacological reformulation of shorter acting mydriasis drops, may improve uptake of DRS. This might, in turn, reduce preventable vision loss and its associated costs to individuals and their families, and to health and social care providers, reducing current inequalities.

Delay in diabetic retinopathy screening increases the rate of detection of referable diabetic retinopathy.

AIMS: To assess whether there is a relationship between delay in retinopathy screening after diagnosis of type 2 diabetes and level of retinopathy detected. METHODS: Patients were referred from 88 primary care practices to an English National Health Service diabetic eye screening programme. Data for screened patients were extracted from the primary care databases using semi-automated data collection algorithms supplemented by validation processes. The programme uses two-field mydriatic digital photographs graded by a quality assured team. RESULTS: Data were available for 8183 screened patients with diabetes newly diagnosed in 2005, 2006 or 2007. Only 163 with type 1 diabetes were identified and were insufficient for analysis. Data were available for 8020 with newly diagnosed type 2 diabetes. Of these, 3569 were screened within 6 months, 2361 between 6 and 11 months, 1058 between 12 and 17 months, 366 between 18 and 23 months, 428 between 24 and 35 months, and 238 at 3 years or more after diagnosis. There were 5416 (67.5%) graded with no retinopathy, 1629 (20.3%) with background retinopathy in one eye, 753 (9.4%) with background retinopathy in both eyes and 222 (2.8%) had referable diabetic retinopathy. There was a significant trend (P = 0.0004) relating time from diagnosis to screening detecting worsening retinopathy. Of those screened within 6 months of diagnosis, 2.3% had referable retinopathy and, 3 years or more after diagnosis, 4.2% had referable retinopathy. CONCLUSIONS: The rate of detection of referable diabetic retinopathy is elevated in those who were not screened promptly after diagnosis of type 2 diabetes.

Updating diabetic retinopathy screening lists using automatic extraction from GP patient records.

OBJECTIVES: Diabetic Retinopathy screening services aim to reduce the risk of sight loss amongst patients with diabetes. The rising incidence of diabetes in England and the operational need to ensure the accuracy and timeliness of screening lists led to a pilot study of electronic extraction of data from primary care. This study aimed to evaluate the effectiveness of updating the single collated list of patients eligible for diabetic eye screening using extracts from electronic patient records in primary care. SETTING AND METHODS: The Gloucestershire Diabetic Eye Screening Programme (GDESP) provides screening for 85 General Practices in the county. Of these, 54 using Egton Medical Information Systems (EMIS) practice management system software agreed to participate in this study. The screening list held in 2009 by the Gloucestershire DESP of 14,209 patients known to have diabetes was audited against a list created with automatic extraction from General Practice records of patients marked with the diabetes Read Code C10. Those subsequently screened and referred to the Hospital Eye service were followed up. RESULTS: The Gloucestershire DESP manual list covering the 54 EMIS practices comprised 14,771 people with diabetes. The audit process identified an additional 709 (4.8%) patients coded C10, including 23 diagnosed more than 5 years ago, and 20 patients under the age of 20 who were diagnosed more than a year ago. CONCLUSION: Automatic extraction of data from General Practice identified 709 patients coded as having diabetes not previously known to the Gloucestershire DESP.

Which visual acuity measurements define high-quality care for patients with neovascular age-related macular degeneration treated with ranibizumab?

PURPOSE: The purpose of this study is to define which visual acuity (VA) measurements are the best indicators of high-quality care for patients receiving intravitreal ranibizumab for neovascular age-related macular degeneration (nAMD). METHODS: Analysis of prospectively collected data recorded within an electronic medical record system on treatment-naive, first-eligible eyes with nAMD, treated with ranibizumab using an as-needed treatment regimen with a minimum follow-up of 1 year. Data collection included the following: age, gender, laterality, type of nAMD, VA, central 1 mm OCT retinal thickness, number of intravitreal injections, and number of follow-up assessments. RESULTS: Data were available on the first-treated eye from 406 patients with at least 1 year follow-up; of these, 198 had data at 2 years. The mean baseline VA of 54.4 Early Treatment Diabetic Retinopathy Study letters improved to 58.5 letters at 12 months and to 56.8 letters at 24 months. The mean VA changes from baseline to 1 year were +6.5, +7.5, +1.7, and -1.5 letters, respectively, for baseline VA categories of 23-35, 36-55, 56-70, and >70 letters. Change in mean VA from the end of the loading phase to year 1 ranged from -2.9 to +1.4 letters for the different baseline VA categories. The mean number of injections were similar across baseline VA categories ranging from 5.7 to 6.0 injections in year 1 and from 3.3 to 3.8 in year 2. CONCLUSIONS: This large, real-world series demonstrates that mean change in VA is largely a function of selection criteria and baseline VA. The quality of a service is therefore better judged by actual VA outcomes and maintenance of vision after the loading phase.

A potential pathway for managing diabetic patients with arterial emboli detected by retinal screening.

OBJECTIVE: The aim was to review a pathway of care for diabetic patients found to have retinal artery emboli detected by retinal screening. DESIGN: This was a retrospective review of a pathway agreed in 2001 by a multidisciplinary team. MATERIALS AND METHODS: The prospectively collected Gloucestershire Diabetic Retinal Screening Programme database was reviewed; patients sent for carotid duplex imaging underwent review of their scan results and their casenotes. RESULTS: The prevalence of retinal emboli was 214 out of 25,299 diabetic patients who had retinal screening (0.85%). Some 200 diabetic patients underwent carotid duplex imaging; 23 had ipsilateral and 2 had contralateral carotid stenosis > 70%. Of these, ten patients underwent carotid endarterectomy without any major morbidity. CONCLUSIONS: [corrected] A pathway was established for the small number of patients with retinal emboli, and could be tested in other populations.

Agreement and reasons for disagreement between photographic and hospital biomicroscopy grading of diabetic retinopathy.

AIMS: To compare agreement level and identify reasons for disagreement between grading of mydriatic digital photographs in a diabetic retinopathy screening service and hospital eye service biomicroscopy grading. METHODS: Structured examination findings leading to automatically calculated National Screening Committee grades recorded on an electronic medical record system in the hospital eye service at the first clinic visit after diabetic retinopathy screening service referral between April 2006 and November 2007 were retrospectively compared with the grade at the screening visit that prompted referral. In cases of disagreement, screening images were reviewed. RESULTS: Data on 452 eyes (226 patients) were analysed. For retinopathy, hospital eye service slit-lamp biomicroscopy grades were: R0 (no diabetic retinopathy) in 63 eyes; R1 (background retinopathy) in 251 eyes; R2 (pre-proliferative) in 129 eyes and R3 (proliferative) in nine eyes. Diabetic retinopathy screening service grades were in agreement in 350 eyes (77.4%), showed a lower grade in 59 eyes and a higher grade in 43. Agreement was moderate (κ=0.60). The most common reason for disagreement was overgrading of R1 by clinicians. Hospital eye service biomicroscopy maculopathy grades were: M0 (no maculopathy) in 366 eyes and M1 (maculopathy) in 86 eyes. Diabetic retinopathy screening service grades were in agreement in 327 eyes (72.3%), showed a lower grading in five eyes and a higher grade in 120 eyes. Agreement was moderate (κ=0.41). The commonest cause for disagreement was clinicians failing to identify fine macular exudates. CONCLUSIONS: This study of routine clinical services demonstrates moderate agreement between non-medical grading of mydriatic digital retinal photography images and hospital slit-lamp biomicroscopy grading of patients referred with diabetic retinopathy. The majority of errors in grading were attributable to errors by hospital doctors, usually in the direction of under-grading which could be a potential source of clinical risk if treatment is delayed.

The prevalence of retinopathy in men with Type 2 diabetes and obstructive sleep apnoea.

AIMS: To clarify the relationship between obstructive sleep apnoea (OSA) and diabetic retinopathy. RESEARCH DESIGN AND METHODS: A cohort of 240 men from primary and secondary care previously participated in a study on the prevalence of OSA in Type 2 diabetes and provided anthropometric information, details of their diabetes, had glycated haemoglobin (HbA1c) measured and overnight oximetry performed. They were re-contacted for permission to review their routine screening clinical retinal photographs, which were then scored by a trained grader, providing detailed retinopathy, maculopathy and photocoagulation scores. RESULTS: One hundred and eighteen men both consented and had retinal photographs available to review. Of these, 24% had OSA, with mean+/-sd 4% oxygen saturation (SaO2) dips/h of 20.9+/-16.6 vs. 2.8+/-2.1 in the non-OSA group. As expected, the OSA group had a significantly higher mean body mass index of 31.9+/-5.2 vs. 28.5+/-5.1 kg/m2 and neck size 44.5+/-3.6 vs. 41.9+/-2.5 cm, but the two groups did not differ significantly in age, diabetes duration, diabetes treatment, HbA1c, smoking history or proportion with known hypertension. Retinopathy and maculopathy scores were significantly worse in the OSA group (P<0.0001). Multiple regression analysis showed only OSA (R2=0.19, P<0.0001) and HbA1c (R2=0.04, P=0.03) to be significant independent predictors of retinopathy. OSA was the only independent significant predictor of the total microaneurysm score (R2=0.21, P=0.004), a detailed retinopathy subclassification. OSA was the only independent significant predictor of maculopathy (R2=0.3, P<0.001). CONCLUSION: In men with Type 2 diabetes, there is a strong association between retinopathy and OSA, independent of conventional retinopathy risk factors.

Why do patients still require surgery for the late complications of Proliferative Diabetic Retinopathy?

AIM: To briefly review and discuss the literature on why patients still require surgery for the late complications of proliferative diabetic retinopathy (PDR). METHODS: Literature review. RESULTS: The reasons for incomplete coverage of screening and screening failures can be divided into non-modifiable and potentially modifiable risk factors. The non-modifiable group includes duration of diabetes, age, genetic predisposition, ethnic differences, and the various reasons for vitrectomy when optimum laser treatment has been applied at the appropriate stage of the disease process. The potentially modifiable group includes glycaemic control, blood pressure control, lipid control, and cessation of smoking in type 1 diabetes. Other potentially modifiable factors include adequacy of screening, including reaching the regular non-attender, and attempting to modify the psychological factors that lead to late presentations including depression and eating disorders. Other potentially modifiable risk factors are optimising laser treatments and the potential use of anti-VEGF therapy to prevent vitrectomy in iris neovascularisation and neovascular glaucoma. CONCLUSION: Surgery for the late complications of PDR continues to be required even in some patients who have received optimal medical care and optimal laser treatment. There are certain modifiable risk factors that could be altered and further research is needed in specific fields, particularly with regard to the adequacy of laser treatments, the use of anti-VEGF agents in iris neovascularisation, and in the role of psychological support in reducing the type of late complications leading to surgery for PDR.

Diabetic retinopathy and socioeconomic deprivation in Gloucestershire.

OBJECTIVES: To investigate socioeconomic variations in diabetes prevalence, uptake of screening for diabetic retinopathy, and prevalence of diabetic retinopathy. METHODS: The County of Gloucestershire formed the setting of the study. A cross-sectional study of people with diabetes was done on a countywide retinopathy-screening database. Diabetes prevalence with odds ratios, uptake of screening, prevalence of any retinopathy and prevalence of sight-threatening retinopathy at screening were compared for different area deprivation quintiles. Logistic regression was used to adjust for confounding. RESULTS: With each increasing quintile of deprivation, diabetes prevalence increased (odds ratio 0.84), the probability of having been screened for diabetic retinopathy decreased (odds ratio 1.11), and the prevalence of sight-threatening diabetic retinopathy among screened patients increased (odds ratio of 0.98), while the prevalence of non-sight-threatening diabetic retinopathy remained unchanged with each increasing quintile of deprivation. CONCLUSION: Sight-threatening diabetic retinopathy was associated with socioeconomic deprivation, but non-sight-threatening diabetic retinopathy was not. Uptake of screening was inversely related to socioeconomic deprivation.

The English national screening programme for sight-threatening diabetic retinopathy.

OBJECTIVES: The main objective of the national screening programme is to reduce the risk of sight loss among people with diabetes due to diabetic retinopathy (DR). METHODS: Offering two-field mydriatic digital photographic screening to all people with diabetes in England over the age of 12 years. STAGE OF DEVELOPMENT: The programme is in its infancy, receiving the first year's annual reports from approximately 96 screening programmes, each of which have developed to offer screening to a minimum number of 12,000 people with diabetes, which would cover a population of 350,000 people with 3.4% diabetes prevalence. The national programme has commenced the External quality assurance (QA) programme in order to achieve and sustain the highest possible standards. POTENTIAL BENEFITS: England has a population of two million people with diabetes over the age of 12 and it is believed that there is a prevalence of blindness of 4200 and an annual incidence of blindness of 1280 people with diabetes. This programme has the potential to reduce the prevalence of blindness in England from 4200 people to 1000 people and a conservative estimate of reducing the annual incidence of DR blindness by one-third would save 427 people per annum from blindness. These figures are based on the UK certification of blindness but if World Health Organization (WHO) definitions are used the prevalence, incidence and potential reductions in blindness are much greater.

Visual acuity measurement and ocular co-morbidity in diabetic retinopathy screening.

AIMS: To evaluate the relationship between best corrected visual acuity (BCVA), age, type of diabetes, sight-threatening diabetic retinopathy (STDR) and ocular co-morbidity. METHODS: 1549 randomly selected people with diabetes mellitus (DM) from a countywide digital photographic screening programme had standardised logarithm of minimum angle of resolution (logMAR) BCVA measurement, followed by slit-lamp biomicroscopy examination by an experienced ophthalmologist. RESULTS: Subnormal vision (logMAR > or =0.3, Snellen < or =6/12) and blindness (logMAR >1.3, Snellen <3/60) in the better-seeing eye were found in 9.0% and 0.45%. The sensitivity, specificity and positive and negative predictive values of using subnormal vision to screen for STDR in an individual eye were 33.4%, 85.9%, 18.6% and 93.0%, respectively. Important contributory causes of moderate visual loss (logMAR 0.50 to 0.98, Snellen 6/18 or worse but better than 6/60) and of Acuity Blindness (logMAR > or =1.0, Snellen 6/60 or worse) in an individual eye were lenticular opacity (including capsular opacification) 49%, macular degeneration (including myopic degeneration) 29%, diabetic maculopathy 15%, other media causes (including corneal opacity) 13% and amblyopia 10%. CONCLUSION: The majority of visual loss in a population with diabetes is due to causes other than diabetic retinopathy. BCVA alone is not a reliable criterion in predicting STDR.

Reported symptoms and quality-of-life impacts in patients having laser treatment for sight-threatening diabetic retinopathy.

AIMS: To explore the patient experience of symptoms of eye disease related to diabetes and its treatment, including increase of symptoms over time and their relation to severity of the condition and the effect of multiple treatments and symptoms on quality of life. METHODS: A qualitative interview study was implemented at four eye clinics in the UK. This study design was intended to yield 240 interviews in patients having their first laser treatment or first follow-up and in multi-treatment patients with a clinically documented loss of visual function in at least one eye (VA

An evaluation of the change in activity and workload arising from diabetic ophthalmology referrals following the introduction of a community based digital retinal photographic screening programme.

AIMS: To determine how the workload of an ophthalmology department changed following the introduction of an organised retinal screening programme. METHODS: Information was collected from the hospital medical record of people with diabetes attending eye clinics over 4 years. The first year was before screening, the next 2 years the first round, and the fourth year the second round. RESULTS: The total number of people with diabetes referred each year over the 4 year period was 853, 954, 974, 1051 consecutively. The number of people with diabetes in the county rose by 1400 per annum. The total number of referrals for an opinion about diabetic retinopathy was 227, 333, 363, 368, for cataract was 64, 57, 77, 93, and for glaucoma was 57, 62, 61, 68. The total number of patients referred for laser treatment over the 4 years was 77, 124, 111, and 63 CONCLUSION: This study suggests that the workload in the eye clinic increases in the first round of screening but in subsequent rounds it does not fall below the pre-screening level, except for laser treatment. This may be partly because of increasing numbers of people with diabetes. With the introduction of a national screening programme, this has significant workload implications for the National Health Service.

A pilot quality assurance scheme for diabetic retinopathy risk reduction programmes.

AIMS: We describe a pilot study of measurement of quality assurance targets for diabetic retinopathy screening and performance comparison between 10 existing services, in preparation for the roll-out of the national programme. BACKGROUND: In 1999 the UK National Screening Committee approved proposals for a national diabetic retinopathy risk reduction programme, including recommendations for quality assurance, but implementation was held pending publication of the National Service Framework for Diabetes. Existing services requested the authors to perform a pilot study of a QA scheme, indicating willingness to contribute data for comparison. METHODS: Objectives and quality standards were developed, following consultation with diabetologists, ophthalmologists and retinal screeners. Services submitted 2001/2 performance data, in response to a questionnaire, for anonymization, central analysis and comparison. RESULTS: The 17 quality standards encompass all aspects of the programme from identification of patients to timeliness of treatment. Ten programmes took part, submitting all the data available. All returns were incomplete, but especially so from the optometry-based schemes. Eight or more services demonstrated they could reach the minimum level in only five of the 17 standards. Thirty per cent could not provide coverage data. All were running behind. Reasons for difficulties in obtaining data and/or failing to achieve standards included severe under-funding and little previous experience of QA. Information systems were limited and incompatible between diabetes and eye units, and there was a lack of co-ordinated management of the whole programme. CONCLUSION: Quality assurance is time-consuming, expensive and inadequately resourced. The pilot study identified priorities for local action. National programme implementation must involve integral quality assurance mechanisms from the outset.