Adherence to ophthalmology referral, treatment and follow-up after diabetic retinopathy screening in the primary care setting.

INTRODUCTION: Telemedicine-based diabetic retinopathy screening (DRS) in primary care settings has increased the screening rates of patients with diabetes. However, blindness from vision-threatening diabetic retinopathy (VTDR) is a persistent problem. This study examined the extent of patients' adherence to postscreening recommendations. RESEARCH DESIGN/METHODS: A retrospective record review was conducted in primary care clinics of a large county hospital in the USA. All patients with diabetes detected with VTDR in two time periods, differing in record type used, were included in the study: 2012-2014, paper charts only; 2015-2017, combined paper charts/electronic medical records (EMRs), or EMRs only. Adherence rates for keeping initial ophthalmology appointments, starting recommended treatments, and keeping follow-up appointments were determined. RESULTS: Adequate records were available for 6046 patients; 408 (7%) were detected with VTDR and recommended for referral to ophthalmology. Only 5% completed a first ophthalmology appointment within recommended referral interval, 15% within twice the recommended interval, and 51% within 1 year of DRS. Patients screened in 2015-2017 were more likely to complete a first ophthalmology appointment than those in 2012-2014. Ophthalmic treatment was recommended in half of the patients, of whom 94% initiated treatment. A smaller percentage (41%) adhered completely to post-treatment follow-up. Overall, 28% of referred patients: (1) kept a first ophthalmology appointment; (2) were recommended for treatment; and (3) initiated the treatment. Most patients failing to keep first ophthalmology appointments continued non-ophthalmic medical care at the institution. EMRs provided more complete information than paper charts. CONCLUSIONS: Reducing vision impairment from VTDR requires greater emphasis on timely adherence to ophthalmology referral and follow-up. Prevention of visual loss from VTDR starts with retinopathy screening, but must include patient engagement, adherence monitoring, and streamlining ophthalmic referral and management. Revision of these processes has already been implemented at the study site, incorporating lessons from this investigation.

Predicting optical coherence tomography-derived diabetic macular edema grades from fundus photographs using deep learning.

Center-involved diabetic macular edema (ci-DME) is a major cause of vision loss. Although the gold standard for diagnosis involves 3D imaging, 2D imaging by fundus photography is usually used in screening settings, resulting in high false-positive and false-negative calls. To address this, we train a deep learning model to predict ci-DME from fundus photographs, with an ROC-AUC of 0.89 (95% CI: 0.87-0.91), corresponding to 85% sensitivity at 80% specificity. In comparison, retinal specialists have similar sensitivities (82-85%), but only half the specificity (45-50%, p < 0.001). Our model can also detect the presence of intraretinal fluid (AUC: 0.81; 95% CI: 0.81-0.86) and subretinal fluid (AUC 0.88; 95% CI: 0.85-0.91). Using deep learning to make predictions via simple 2D images without sophisticated 3D-imaging equipment and with better than specialist performance, has broad relevance to many other applications in medical imaging.

Diabetic Retinopathy and the Cascade into Vision Loss.

Vision loss from diabetic retinopathy should be unnecessary for patients with access to diabetic retinopathy screening, yet it still occurs at high rates and in varied contexts. Precisely because vision loss is only one of many late-stage complications of diabetes, interfering with the management of diabetes and making self-care more difficult, Vision Threatening Diabetic Retinopathy (VTDR) is considered a "high stakes" diagnosis. Our mixed-methods research addressed the contexts of care and treatment seeking in a sample of people with VTDR using safety-net clinic services and eye specialist referrals. We point to conceptual weaknesses in the single disease framework of health care by diagnosis, and we use the framework of "cascades" to clarify why and how certain non-clinical factors come to bear on long-term experiences of complex chronic diseases.

Blind spots in telemedicine: a qualitative study of staff workarounds to resolve gaps in diabetes management.

BACKGROUND: Novel telemedicine platforms have expanded access to critical retinal screening into primary care settings. This increased access has contributed to improved retinal screening uptake for diabetic patients, particularly those treated in Federally Qualified Health Centers ('safety net' clinics). The aim of this study was to understand how the implementation of telemedical screening for diabetic retinopathy within primary care settings is improving the delivery of critical preventative services, while also introducing changes into clinic workflows and creating additional tasks and responsibilities within resource-constrained clinics. METHODS: A qualitative approach was employed to track workflows and perspectives from a range of medical personnel involved in the telemedicine platform for diabetic retinopathy screening and subsequent follow-up treatment. Data were collected through semi-structured interviews and participant observation at three geographically-dispersed Federally Qualified Health Centers in California. Qualitative analysis was performed using standard thematic analytic approaches within a qualitative data analysis software program. RESULTS: The introduction of telemedicine platforms, such as diabetic retinopathy screening, into primary care settings is creating additional strain on medical personnel across the diabetes eye care management spectrum. Central issues are related to scheduling patients, issuing referrals for follow-up care and treatment, and challenges to improving adherence to treatment and diabetes management. These issues are overcome in many cases through workarounds, or when medical staff work outside of their job descriptions, purview, and permission to move patients through the diabetes management continuum. CONCLUSIONS: This study demonstrates how the implementation of a novel telemedical platform for diabetic retinopathy screening contributes to the phenomenon of workarounds that account for additional tasks and patient volume. These workarounds should not be considered a sustainable model of health care delivery, but rather as an initial step to understanding where issues are and how clinics can adapt to the inclusion of telemedicine and ultimately increase access to care. The presence of workarounds suggests that as telemedicine is expanded, adequate resources, as well as collaborative, cross-sectoral co-design of new workflows must be simultaneously provided. Systematic bolstering of resources would contribute to more consistent success of telemedicine screening platforms and improved treatment and prevention of disease-related complications.

Can Commercially Available Handheld Retinal Cameras Effectively Screen Diabetic Retinopathy?

Organizations that care for people with diabetes have increasingly adopted telemedicine-based diabetic retinopathy screening (TMDRS) as a way to increase adherence to recommended retinal exams. Recently, handheld retinal cameras have emerged as a low-cost, lightweight alternative to traditional bulky tabletop retinal cameras. Few published clinical trials have been performed on handheld retinal cameras. Peer-reviewed articles about commercially available handheld retinal cameras have concluded that they are a usable alternative for TMDRS, however, the clinical results presented in these articles do not meet criteria published by the United Kingdom Diabetic Eye Screening Programme and the American Academy of Ophthalmology. The future will likely remedy the shortcomings of currently available handheld retinal cameras, and will create more opportunities for preventing diabetic blindness.

A Revised Approach for the Detection of Sight-Threatening Diabetic Macular Edema.

IMPORTANCE: Diabetic macular edema is one of the leading causes of vision loss among working-age adults in the United States. Telemedicine screening programs and epidemiological studies rely on monoscopic fundus photography for the detection of clinically significant macular edema (CSME). Improving the accuracy of detecting CSME from monoscopic images could be valuable while recognizing the limitations of such detection in an era of optical coherence tomography detection of diabetic macular edema. OBJECTIVE: To evaluate the screening test accuracy of radially arranged sectors affected by hard exudates in the detection of CSME. DESIGN, SETTING, AND PARTICIPANTS: This investigation was a cross-sectional study of CSME grading in monoscopic images using a sectors approach. The Early Treatment Diabetic Retinopathy Study criteria were used to confirm the presence of CSME by the following 2 methods: stereoscopic fundus photography (method 1) and dilated biomicroscopy in combination with optical coherence tomography (method 2). Participants were recruited at a university-based practice between June 14, 2014, and December 28, 2015. MAIN OUTCOMES AND MEASURES: Area under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, and negative predictive value. RESULTS: A total of 207 eyes from an ethnically/racially diverse group of 207 patients (mean [SD] age, 53.6 [10.8] years; 58.9% [122 of 207] female) were included in the analysis. Twelve eyes (5.8%) were diagnosed as having CSME based on method 1. The intermethod and intergrader agreement for CSME diagnosis and sector count was substantial (κ range, 0.66 [95% CI, 0.47-0.85] to 0.75 [95% CI, 0.53-0.97]; P < .001 for all). Area under the receiver operating characteristic curve was 93.2% (95% CI, 84.2%-100%) when evaluating a sectors approach against method 1 as a reference test and offered up to an 8.6% (95% CI, 3.0%-14.3%) increase in specificity compared with the existing methods of detection. The positive predictive value was 33.3% (95% CI, 25.6%-45.5%), and the negative predictive value was 98.1% (95% CI, 96.9%-100%). The results were similar when comparing a sectors approach with method 2 as a reference test. CONCLUSIONS AND RELEVANCE: A sectors approach shows good screening test characteristics for the detection of CSME. Its implementation in the existing telemedicine programs would require minimal resources. This approach will have the greatest effect in a setting where implementation of optical coherence tomography, a more objective and sensitive way to detect retinal thickening, is not feasible. The proposed method also may be easily incorporated in the automated diabetic retinopathy detection algorithms.

Improving Accuracy of Grading and Referral of Diabetic Macular Edema Using Location and Extent of Hard Exudates in Retinal Photography.

BACKGROUND: Hard exudates (HE) are used as a surrogate marker for sight-threatening diabetic macular edema (DME) in most telemedicine-based screening programs in the world. This study investigates whether proximity of HE to the center of the macula, and extent of HE are associated with greater clinically significant macular edema (CSME) severity. A novel method for associating optical coherence tomography (OCT) scans with CSME was developed. METHODS: Eligible subjects were recruited from a DRS program in a community clinic in Oakland, California. Ocular fundus of each subject was imaged using 3-field 45-degree digital retinal photography and scanned using central 7-line spectral domain OCT. Two certified graders separated subjects into 2 groups, those with and without HE within 500 microns from the center of the macula. A modified DME severity scale, developed from Early Treatment Diabetic Retinopathy Study data and adapted to OCT thickness measurements, was used to stratify CSME into severe and nonsevere levels for all subjects. RESULTS: The probabilities of severe CSME in groups 1 and 2 were 14.4% (95% CI: 8.2%-23.8%) and 9% (95% CI: 2.4%-25.5%), respectively (P = .556). In post hoc analysis, increase in the number of sectors affected by HE within the central zone of the macula was associated with the increase in the probability of being diagnosed with severe CSME. CONCLUSION: We have proposed OCT-based classification of DME into severe and nonsevere CSME. Based on this limited analysis, severity of CSME is related more to extent of HE rather than proximity to the center of the macula.

Utility of hard exudates for the screening of macular edema.

PURPOSE: The purpose of this study was to determine whether hard exudates (HEs) within one disc diameter of the foveola is an acceptable criterion for the referral of diabetic patients suspected of clinically significant macular edema (CSME) in a screening setting. METHODS: One hundred forty-three adults diagnosed as having diabetes mellitus were imaged using a nonmydriatic digital fundus camera at the Alameda County Medical Center in Oakland, CA. Nonstereo fundus images were graded independently for the presence of HE near the center of the macula by two graders according to the EyePACS grading protocol. The patients also received a dilated fundus examination on a separate visit. Clinically significant macular edema was determined during the dilated fundus examination using the criteria set forth by the Early Treatment Diabetic Retinopathy Study. Subsequently, the sensitivity and specificity of HEs within one disc diameter of the foveola in nonstereo digital images used as a surrogate for the detection of CSME diagnosed by live fundus examination were calculated. RESULTS: The mean (±SD) age of 103 patients included in the analysis was 56 ± 17 years. Clinically significant macular edema was diagnosed in 15.5% of eyes during the dilated examination. For the right eyes, the sensitivity of HEs within one disc diameter from the foveola as a surrogate for detecting CSME was 93.8% for each of the graders; the specificity values were 88.5 and 85.1%. For the left eyes, the sensitivity values were 93.8 and 75% for each of the two graders, respectively; the specificity was 87.4% for both graders. CONCLUSIONS: This study supports the use of HE within a disc diameter of the center of the macula in nonstereo digital images for CSME detection in a screening setting.

EyePACS: an adaptable telemedicine system for diabetic retinopathy screening.

BACKGROUND: Annual retinal screening of patients with diabetes is the standard clinical practice to prevent visual impairment and blindness from diabetic retinopathy. Telemedicine-based diabetic retinopathy screening (DRS) in primary care settings can effectively detect sight-threatening retinopathy and significantly increase compliance with annual retinal exams. EyePACS is a license-free Web-based DRS system designed to simplify the process of image capture, transmission, and review. The system provides a flexible platform for collaboration among clinicians about diabetic retinopathy. METHODS: Primary clinic personnel (i.e., nursing, technical, or administrative staff) are trained and certified by the EyePACS program to acquire retinal images from standard digital retinal cameras. Relevant clinical data and eight high-resolution images per patient (two external and six retinal images) are encrypted and transmitted to a secure Internet server, using a standard computer and Web browser. Images are then interpreted by certified EyePACS reviewers or local eye care providers who are certified through the EyePACS Retinopathy Grading System. Reports indicating retinopathy level and referral recommendations are transmitted back to primary care providers through the EyePACS Web site or through interfaces between EyePACS and Health Level 7-compliant electronic medical records or chronic disease registries. RESULTS: The pilot phase of the EyePACS DRS program in California (2005-2006) recorded 3562 encounters. Since 2006, EyePACS has been expanded to over 120 primary care sites throughout California and elsewhere recording over 34,000 DRSs. The overall rate of referral is 8.21% for sight-threatening retinopathy and 7.83% for other conditions (e.g., cataract and glaucoma). CONCLUSION: The use of license-free Web-based software, standard interfaces, and flexible protocols has allowed primary care providers to adopt retinopathy screening with minimal effort and resources.