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Effectiveness of Teleretinal Imaging-Based Hospital Referral Compared With Universal Referral in Identifying Diabetic Retinopathy: A Cluster Randomized Clinical Trial.

ABSTRACT: Importance:Studies in high-income countries provide limited evidence from randomized clinical trials on the benefits of teleretinal screening to identify diabetic retinopathy (DR). Objective:To evaluate the effectiveness of teleretinal-screening hospital referral (TR) compared with universal hospital referral (UR) in people with diabetes. Design, Setting, and Participants:A cluster randomized clinical trial of 8 diabetes clinics within 10 km from Aravind Eye Hospital (AEH), Madurai, India, was conducted. Participants included 801 patients older than 50 years. The study was conducted from May 21, 2014, to February 7, 2015; data analysis was performed from March 12 to June 16, 2015. Interventions:In the TR cohort, nonmydriatic, 3-field, 45° retinal images were remotely graded by a retinal specialist and patients with DR, probable DR, or ungradable images were referred to AEH for a retinal examination. In the UR cohort, all patients were referred for a retinal examination at AEH. Main Outcomes and Measures:Hospital-diagnosed DR. Results:Of the 801 participants, 401 were women (50.1%) (mean [SD] age, 60.0 [7.3] years); mean diabetes duration was 8.6 (6.6) years. In the TR cohort, 96 of 398 patients (24.1%) who underwent teleretinal imaging were referred with probable DR (53 [13.3%]) or nongradable images (43 [10.8%]). Hospital attendance at AEH was proportionately higher with TR?(54 of 96 referred [56.3%]) compared with UR (150 of 400 referred [37.5%]). The intention-to-treat analysis based on all patients eligible for referral in each arm showed that proportionately more patients with TR (36 of 96 [37.5]%) were diagnosed with DR compared with UR (50 of 400 [12.5%]) (unadjusted risk ratio [RR], 3.00; 95% CI, 2.01-4.48). These results were little changed by inclusion of covariates (RR, 2.72; 95% CI, 1.90-3.91). The RR was lower in the per-protocol analysis based on all patients who adhered to referral (covariate-adjusted RR, 1.75; 95% CI, 1.12-2.74). Diagnoses of DR were predominantly mild or moderate nonproliferative DR (36 in TR and 43 in UR). In the UR arm, there were 4 cases of severe nonproliferative DR and 2 cases of proliferative DR. Age (RR, 0.98; 95% CI, 0.95-0.99), female sex (RR, 0.79; 95% CI, 0.64-0.98), and hypertension diagnosis (RR, 0.81; 95% CI, 0.68-0.95) were factors associated with lower attendance. Those with higher secondary educational level or more were twice as likely to attend (RR, 2.00; 95% CI, 1.32-3.03). Conclusions and Relevance:The proportionate yield of DR cases was higher in the TR arm, confirming the potential benefit, at least in the setting of eye hospitals in India, of a targeted referral approach using teleretinal screening to identify patients with DR. Trial Registration:ClinicalTrials.gov identifier: NCT02085681.

SUBMITTER: Joseph S

PROVIDER: S-EPMC6512266 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Effectiveness of Teleretinal Imaging-Based Hospital Referral Compared With Universal Referral in Identifying Diabetic Retinopathy: A Cluster Randomized Clinical Trial.

Joseph Sanil S Kim Ramasamy R Ravindran Ravilla D RD Fletcher Astrid E AE Ravilla Thulasiraj D TD

JAMA ophthalmology 20190701 7

<h4>Importance</h4>Studies in high-income countries provide limited evidence from randomized clinical trials on the benefits of teleretinal screening to identify diabetic retinopathy (DR).<h4>Objective</h4>To evaluate the effectiveness of teleretinal-screening hospital referral (TR) compared with universal hospital referral (UR) in people with diabetes.<h4>Design, setting, and participants</h4>A cluster randomized clinical trial of 8 diabetes clinics within 10 km from Aravind Eye Hospital (AEH), ...[more]

PMID: 31070699

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Project description:ImportanceThe Diabetic Retinopathy Clinical Research Network Protocol S randomized clinical trial results suggest that ranibizumab is a reasonable treatment alternative to panretinal photocoagulation (PRP) when managing proliferative diabetic retinopathy (PDR), with or without concomitant baseline diabetic macular edema (DME). However, ranibizumab injections are costly. Thus, it would be useful to examine the relative cost-effectiveness of these 2 treatment modalities.ObjectiveTo evaluate incremental cost-effectiveness ratios of 0.5-mg ranibizumab therapy vs PRP for PDR.Design, setting, and participantsPreplanned secondary analysis using efficacy, safety, and resource utilization data through 2 years of follow-up at 55 US sites for 213 adults with PDR. Data were collected from February 2012 to January 2015.InterventionsIntravitreous 0.5-mg ranibizumab at baseline and as frequently as every 4 weeks based on a structured retreatment protocol or PRP at baseline for PDR. Eyes in both groups could receive ranibizumab for concomitant DME.Main outcomes and measuresIncremental cost-effectiveness ratios of ranibizumab compared with PRP evaluated within 2 prespecified subgroups for the study eye: with baseline vision-impairing (Snellen equivalent 20/32 or worse) DME and without baseline vision-impairing DME.ResultsThe study included 305 adults with PDR, the mean age was 52 years, 44% were women, and 52% were white. Of the 46 participants with PDR and vision-impairing DME at baseline, 21 were assigned to the ranibizumab group and 25 to the PRP group (plus ranibizumab for DME). Among the remaining participants without baseline vision-impairing DME, 80 and 87 were in the ranibizumab and PRP groups, respectively. For participants with and without baseline vision-impairing DME, the incremental cost-effectiveness ratios of ranibizumab therapy compared with PRP were $55 568/quality-adjusted life-year and $662 978/quality-adjusted life-year, respectively, over 2 years.Conclusions and relevanceOver 2 years, compared with PRP, 0.5-mg ranibizumab as given in this trial is within the $50 000/quality-adjusted life-year to $150 000/quality-adjusted life-year range frequently cited as cost-effective in the United States for eyes presenting with PDR and vision-impairing DME, but not for those with PDR without vision-impairing DME.Trial registrationClinicaltrials.gov Identifier: NCT01489189.

Project description:ImportanceModerate to substantial agreement between Early Treatment Diabetic Retinopathy Study (ETDRS) 7-field imaging and ultrawide-field (UWF) imaging has been suggested in single-center studies. Comparing images obtained by multiple centers could increase confidence that UWF images can be used reliably in place of ETDRS imaging in future clinical trials.ObjectiveTo compare diabetic retinopathy (DR) severity from modified ETDRS 7-field imaging and UWF imaging.Design, setting, and participantsThis preplanned, cross-sectional analysis included modified ETDRS 7-field images obtained using the Diabetic Retinopathy Clinical Research Network acquisition protocol and UWF images obtained captured with the Optos 200Tx system (Optos, PLC) from adult participants (≥18 years old) with type 1 or type 2 diabetes. Both image types were evaluated by trained graders masked to clinical data. Data collection occurred from February 2015 to December 2015, and data analysis from June 2016 to December 2017.Main outcomes and measuresAgreement between UWF images, UWF images masked to include only the ETDRS 7-field area, and ETDRS 7-field images were calculated using κ statistics.ResultsA total of 764 eyes from 385 participants were included; participants had a median (IQR) age of 62.2 (53.6-69.2) years, 194 (50.4%) were women, and 256 (66.5%) were white. Of 742 eyes with both ETDRS 7-field images and UWF masked images graded, 359 (48.4% [95% CI, 44.4%-52.4%]) eyes had exact agreement, and 653 eyes (88.0% [95% CI, 85.2%-90.3%]) agreed within 1 step (weighted κ, 0.51 [95% CI, 0.44-0.58]). After open adjudication by an independent senior grader of all images with more than a 2-step discrepancy, perfect agreement was found in 435 eyes (59.0% [95% CI, 55.1%-62.8%]) and agreement within 1 step in 714 eyes (96.9% [95% CI, 95.1%-98.0%]; κ, 0.77 [95% CI, 0.73-0.82]). Ability of the imaging modalities to detect retinopathy severity in an individual eye was considered similar in 59 eyes (50.9% [95% CI, 41.3%-60.4%]), better for ETDRS 7-field imaging in 22 eyes (19.0% [95% CI, 12.5%-27.7%]), and better for UWF-masked images in 31 eyes (26.7% [95% CI 18.8%-36.5%]). Comparing UWF masked and unmasked images, 94 of 751 eyes (12.5%) had DR graded as at least 1 step more severe on UWF unmasked images vs UWF masked images. Predominantly peripheral DR lesions were present in 308 of 751 eyes (41.0%); this suggested increased DR severity by 2 or more steps in 34 eyes (11.0%).Conclusions and relevanceImaging by the ETDRS 7-field and UWF imaging systems have moderate to substantial agreement when determining the severity of DR within the 7 standard fields. Disparities in an individual eye are equivalently distributed between imaging modalities and can be better or worse on 1 or the other. Longitudinal follow-up will evaluate the primary outcome of this study to determine if peripheral retinal findings are associated with future retinopathy outcomes.

Project description:Prioritizing comparative effectiveness research may contribute to obtaining answers that clinicians perceive they need and may minimize research that could be considered wasteful. Our objective was to identify evidence gaps and set priorities for new systematic reviews and randomized controlled trials for managing diabetic retinopathy (DR), including diabetic macular edema (DME).Cross-sectional study.Diabetic Retinopathy Clinical Research Network (DRCR.net) investigators.We provided recommendations from the American Academy of Ophthalmology's 2012 Preferred Practice Patterns for Diabetic Retinopathy as 91 answerable clinical research questions about intervention effectiveness to 410 DRCR.net investigators to rate each question's importance from 0 (not important) to 10 (very important) using a 2-round Delphi survey and to suggest additional questions. We considered questions as high priority if at least 75% of respondents to both rounds assigned an importance rating of 5 or more in round 2. We also extracted outcome measures relevant to DR and asked respondents to identify those that must be measured in all studies. We mapped Cochrane reviews published up to March 2016 to high-priority clinical research questions.Ranking of importance of each clinical question.Thirty-two individuals completed rounds 1 and 2 and suggested 15 questions. Among the final list of 106 clinical research questions, 22 questions met our definition of high priority: 9 of 22 concerned the effectiveness of anti-VEGF therapy, and 13 of 22 focused on how often patients should be followed up (re-examination) and treatment effectiveness in patients with specific characteristics (e.g., DME). Outcomes that 75% or more of respondents marked as "must be measured in all studies" included visual acuity and visual loss, death of participants, and intraocular pressure. Only 1 prioritized question was associated with conclusive evidence from a Cochrane systematic review.A limited response rate among DRCR.net members identified 22 comparative effectiveness research questions as high priority for the management of DR, including DME, but few were associated with Cochrane reviews. These results support the need of systematic reviews and randomized controlled trials to address evidence gaps.

Project description:ObjectiveLack of awareness about Diabetic Retinopathy (DR) is the most commonly cited reason why many persons with type 2 diabetes are non-compliant with referral instruction to undergo retinal screening. The purpose of this study was to evaluate the efficacy of a culturally, geographically and socially appropriate, locally adapted five-month-long health education on referral compliance of participants.MethodA prospective randomized, open-label parallel group study was conducted on persons with type 2 diabetes who underwent basic eye screening at a diabetes hospital between September 2017 and August 2018. Participants who were noncompliant with referral instruction to visit a hospital for advanced DR management were randomly divided into health education intervention group (n = 143) and control group (n = 156). Both groups received information regarding DR and referral instruction at the diabetes hospital. The intervention group was provided personalized education followed by telephonic reminders. The primary endpoint was 'increase in referral compliance' and the secondary endpoint was 'increase in knowledge of DR'. Multivariate logistic regression model was used to identify significant predictors of compliance to referral.ResultsA total of nine participants dropped and 290 completed the post intervention survey. The compliance rate in intervention group was found to be significantly higher than the control group (64.3% vs 28.2%; OR 4.73; 95% CI 2.87-7.79; p<0.001). Participants in the intervention group acquired better knowledge on DR (p<0.05). Apart from intervention, referral compliance rate was also found to be significantly associated with participants' self-perception of vision problem (OR 2.02; 95% CI 1.02-4.01; p = 0.045) and participants' income (OR 1.24; 95% CI 1.06-1.44; p = 0.008).DiscussionOur results suggest that intensive health education on DR should be integrated with diabetes education as it may result in significantly improved referral compliance. Outcomes may be sustainable if interventions are institutionalized at referral point.Trial registrationClinical Trials.gov (Registration # NCT03658980); https://clinicaltrials.gov/ct2/show/NCT03658980.

Project description:Aims/hypothesisIn this study we examined the cost-effectiveness of three different screening strategies for diabetic retinopathy: using a personalised adaptive model, annual screening (fixed intervals), and the current Dutch guideline (stratified based on previous retinopathy grade).MethodsFor each individual, optimal diabetic retinopathy screening intervals were determined, using a validated risk prediction model. Observational data (1998-2017) from the Hoorn Diabetes Care System cohort of people with type 2 diabetes were used (n = 5514). The missing values of retinopathy grades were imputed using two scenarios of slow and fast sight-threatening retinopathy (STR) progression. By comparing the model-based screening intervals to observed time to develop STR, the number of delayed STR diagnoses was determined. Costs were calculated using the healthcare perspective and the societal perspective. Finally, outcomes and costs were compared for the different screening strategies.ResultsFor the fast STR progression scenario, personalised screening resulted in 11.6% more delayed STR diagnoses and €11.4 less costs per patient compared to annual screening from a healthcare perspective. The personalised screening model performed better in terms of timely diagnosis of STR (8.8% less delayed STR diagnosis) but it was slightly more expensive (€1.8 per patient from a healthcare perspective) than the Dutch guideline strategy.Conclusions/interpretationThe personalised diabetic retinopathy screening model is more cost-effective than the Dutch guideline screening strategy. Although the personalised screening strategy was less effective, in terms of timely diagnosis of STR patients, than annual screening, the number of delayed STR diagnoses is low and the cost saving is considerable. With around one million people with type 2 diabetes in the Netherlands, implementing this personalised model could save €11.4 million per year compared with annual screening, at the cost of 658 delayed STR diagnoses with a maximum delayed time to diagnosis of 48 months.

Dataset Information

Effectiveness of Teleretinal Imaging-Based Hospital Referral Compared With Universal Referral in Identifying Diabetic Retinopathy: A Cluster Randomized Clinical Trial.

Publications

Effectiveness of Teleretinal Imaging-Based Hospital Referral Compared With Universal Referral in Identifying Diabetic Retinopathy: A Cluster Randomized Clinical Trial.

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