Analysis of Discrepancy Between Diagnostic Clinical Examination Findings and Corresponding Evaluation of Digital Images in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy of Prematurity Study

Abstract

Importance: As effective treatments for potentially blinding retinopathy of prematurity (ROP) have been introduced, the importance of consistency in findings has increased, especially with the shift toward retinal imaging in infants at risk of ROP.

Objective: To characterize discrepancies in findings of ROP between digital retinal image grading and examination results from the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy of Prematurity study, conducted from May 2011 to October 2013.

Design, setting, and participants: A poststudy consensus review of images was conducted by 4 experts, who examined discrepancies in findings between image grades by trained nonphysician readers and physician examination results in infants with referral-warranted ROP (RW-ROP). Images were obtained from 13 North American neonatal intensive care units from eyes of infants with birth weights less than 1251 g. For discrepancy categories with more than 100 cases, 40 were randomly selected; in total, 188 image sets were reviewed.

Main outcomes and measures: Consensus evaluation of discrepant image and examination findings for RW-ROP components.

Results: Among 5350 image set pairs, there were 161 instances in which image grading did not detect RW-ROP noted on clinical examination (G-/E+) and 854 instances in which grading noted RW-ROP when the examination did not (G+/E-). Among the sample of G-/E+ cases, 18 of 32 reviews (56.3%) agreed with clinical examination findings that ROP was present in zone I and 18 of 40 (45.0%) agreed stage 3 ROP was present, but only 1 of 20 (5.0%) agreed plus disease was present. Among the sample of G+/E- cases, 36 of 40 reviews (90.0%) agreed with readers that zone I ROP was present, 23 of 40 (57.5%) agreed with readers that stage 3 ROP was present, and 4 of 16 (25.0%) agreed that plus disease was present. Based on the consensus review results of the sampled cases, we estimated that review would agree with clinical examination findings in 46.5% of the 161 G-/E+ cases (95% CI, 41.6-51.6) and agree with trained reader grading in 70.0% of the 854 G+/E- cases (95% CI, 67.3-72.8) for the presence of RW-ROP.

Conclusions and relevance: This report highlights limitations and strengths of both the remote evaluation of fundus images and bedside clinical examination of infants at risk for ROP. These findings highlight the need for standardized approaches as ROP telemedicine becomes more widespread.

Figure 1. Images From Eyes in Which Grading Did Not Detect Findings Consistent With Referral-Warranted Retinopathy of Prematurity (ROP) Noted on Examination

A, Example of ROP identified as being in zone I on clinical examination but graded as not being in zone I by trained readers. Left, The radius of zone I was determined as twice the distance between the disc and fovea. Right, The radius was applied to the same eye, demonstrating that the ROP lies inside zone I. B, Example of ROP identified as being in zone I on clinical examination but graded as not being in zone I by trained readers. Left, The radius of zone I was determined as twice the distance between the disc and fovea. Right, The radius was applied to the same eye, demonstrating that the ROP lies outside zone I. C, Examples of discrepant image grading in which trained readers did not identify stage 3 ROP that was noted on clinical examination. Left, Review agreed with grading by trained readers. Right, Review agreed with clinical examination findings. D, Examples of discrepant image grading in which trained readers did not identify plus disease that was noted on clinical examination. Left, Review agreed with grading by trained readers. Right, Review agreed with clinical examination findings. G+/E− indicates positive findings on image grading with negative findings on clinical examination (or a false positive with positive findings on image grading not noted on clinical examination).

Figure 2. Images From Eyes in Which Grading Detected Findings Consistent With Referral-Warranted Retinopathy of Prematurity (ROP) Not Noted on Examination

A, Example of ROP identified as not being in zone I on clinical examination but graded as being in zone I by trained readers. Left, The radius of zone I was determined as twice the distance between the disc and fovea. Right, The radius was applied to the same eye, demonstrating that the ROP lies within zone I. B, Example of ROP identified as not being in zone I on clinical examination but graded as being in zone I by trained readers. Left, The radius of zone I was determined as twice the distance between the disc and fovea. Right, The radius was applied to the disc right image of the same eye, demonstrating that the ROP lies within zone I. C, Examples of discrepant image grading in which trained readers identified stage 3 ROP that was not noted on clinical examination. Left, Review agreed with grading by trained readers. Right, Review agreed with clinical examination findings. D, Examples of discrepant image grading in which trained readers identified plus disease that was not noted on clinical examination. Left, Review agreed with grading by trained readers. Right, Review agreed with clinical examination findings. G−/E+ indicates negative findings on image grading with positive findings on clinical examination (or a false negative with positive findings on clinical examination not noted on image grading).