OBJECTIVE: The Veterans Affairs Diabetes Trial (VADT) is a 20-medical center, prospective, randomized study of 1792 Type 2 diabetic individuals primarily aimed at determining whether intensive glycemic control prevents macrovascular events. We report a comparison of fundus photographs and ophthalmologic examination at baseline, permitting an evaluation of multiple settings similar to common clinical practice. RESEARCH DESIGN AND METHODS: A 340-patient subset had both local dilated fundus examinations and centrally read seven-field stereo fundus photographs completed within 60 days of each other (median 28 days). Local examiners were unaware of the stereo photographs. RESULTS: Overall, agreement within one step was 76% and exact agreement between ophthalmoscopy and central gradings of fundus photographs on a five-step retinopathy severity scale was 43% (weighted kappa 0.42, CI 0.35-0.48). In about 90% of disagreements the severity level was higher by photographic grading. The sensitivity for ophthalmoscopy compared to grading of fundus photographs for the detection of any retinopathy was 51% and specificity was 91%. For proliferative diabetic retinopathy (PDR), sensitivity was 61% and specificity 98%. Only one eye was high-risk PDR, and it was detected by both methods. For clinically significant macular edema, these measures were 24% and 98%, respectively. The disagreements were of possible clinical importance in three cases (<1%). CONCLUSION: Most disagreements occurred in eyes rated near the milder end of a category and/or resulted from small differences between the ophthalmoscopic and photographic definitions used in classifying severity. There were reasonably few disagreements of possible clinical significance.
RCT Entities:
OBJECTIVE: The Veterans Affairs Diabetes Trial (VADT) is a 20-medical center, prospective, randomized study of 1792 Type 2 diabetic individuals primarily aimed at determining whether intensive glycemic control prevents macrovascular events. We report a comparison of fundus photographs and ophthalmologic examination at baseline, permitting an evaluation of multiple settings similar to common clinical practice. RESEARCH DESIGN AND METHODS: A 340-patient subset had both local dilated fundus examinations and centrally read seven-field stereo fundus photographs completed within 60 days of each other (median 28 days). Local examiners were unaware of the stereo photographs. RESULTS: Overall, agreement within one step was 76% and exact agreement between ophthalmoscopy and central gradings of fundus photographs on a five-step retinopathy severity scale was 43% (weighted kappa 0.42, CI 0.35-0.48). In about 90% of disagreements the severity level was higher by photographic grading. The sensitivity for ophthalmoscopy compared to grading of fundus photographs for the detection of any retinopathy was 51% and specificity was 91%. For proliferative diabetic retinopathy (PDR), sensitivity was 61% and specificity 98%. Only one eye was high-risk PDR, and it was detected by both methods. For clinically significant macular edema, these measures were 24% and 98%, respectively. The disagreements were of possible clinical importance in three cases (<1%). CONCLUSION: Most disagreements occurred in eyes rated near the milder end of a category and/or resulted from small differences between the ophthalmoscopic and photographic definitions used in classifying severity. There were reasonably few disagreements of possible clinical significance.
Authors: Marinella Ruospo; Valeria M Saglimbene; Suetonia C Palmer; Salvatore De Cosmo; Antonio Pacilli; Olga Lamacchia; Mauro Cignarelli; Paola Fioretto; Mariacristina Vecchio; Jonathan C Craig; Giovanni Fm Strippoli Journal: Cochrane Database Syst Rev Date: 2017-06-08
Authors: Sapna S Gangaputra; Michael M Altaweel; Qian Peng; David S Friedman; P Kumar Rao; C Stephen Foster; Rosa Y Kim; Susan B Reed; Sunil K Srivastava; Ira G Wong; John H Kempen Journal: Ocul Immunol Inflamm Date: 2011-08 Impact factor: 3.070
Authors: Sapna Gangaputra; James F Lovato; Larry Hubbard; Matthew D Davis; Barbara A Esser; Walter T Ambrosius; Emily Y Chew; Craig Greven; Letitia H Perdue; Wai T Wong; Audree Condren; Charles P Wilkinson; Elvira Agrón; Sharon Adler; Ronald P Danis Journal: Retina Date: 2013 Jul-Aug Impact factor: 4.256
Authors: Nasrin Azad; Lily Agrawal; Nicholas V Emanuele; Ronald Klein; Gideon D Bahn; Peter Reaven Journal: Diabetologia Date: 2014-03-06 Impact factor: 10.122
Authors: Sarah Mackenzie; Christian Schmermer; Amanda Charnley; Dawn Sim; Martin Dumskyj; Stephen Nussey; Catherine Egan Journal: PLoS One Date: 2011-05-06 Impact factor: 3.240
Authors: Nasrin Azad; Lily Agrawal; Nicholas V Emanuele; Ronald Klein; Gideon D Bahn; Madeline McCarren; Peter Reaven; Rodney Hayward; William Duckworth Journal: Diabetes Care Date: 2013-10-07 Impact factor: 19.112