Telemedicine for Evaluation of Retinopathy of Prematurity · abstract Retinopathy of prematurity (ROP) remains a signiﬁcant threat to vision for extremely premature infants despite

JOINT TECHNICAL REPORT

Telemedicine for Evaluation ofRetinopathy of PrematurityWalter M. Fierson, MD, FAAP, Antonio Capone Jr, MD, the AMERICAN ACADEMY OF PEDIATRICS SECTION ON OPHTHALMOLOGY,AMERICAN ACADEMY OF OPHTHALMOLOGY, and AMERICAN ASSOCIATION OF CERTIFIED ORTHOPTISTS

abstract Retinopathy of prematurity (ROP) remains a significant threat to vision forextremely premature infants despite the availability of therapeutic modalitiescapable, in most cases, of managing this disorder. It has been shown in manycontrolled trials that application of therapies at the appropriate time isessential to successful outcomes in premature infants affected by ROP. Bedsidebinocular indirect ophthalmoscopy has been the standard technique fordiagnosis and monitoring of ROP in these patients. However, implementation ofroutine use of this screening method for at-risk premature infants haspresented challenges within our existing care systems, including relative localscarcity of qualified ophthalmologist examiners in some locations and theremote location of some NICUs. Modern technology, including the developmentof wide-angle ocular digital fundus photography, coupled with the ability tosend digital images electronically to remote locations, has led to thedevelopment of telemedicine-based remote digital fundus imaging (RDFI-TM)evaluation techniques. These techniques have the potential to allow thediagnosis and monitoring of ROP to occur in lieu of the necessity for somerepeated on-site examinations in NICUs. This report reviews the currentlyavailable literature on RDFI-TM evaluations for ROP and outlines pertinentpractical and risk management considerations that should be used whenincluding RDFI-TM in any new or existing ROP care structure.

I. INTRODUCTION

The elimination of preventable blindness attributable to retinopathy ofprematurity (ROP) continues to be an ongoing challenge for bothophthalmologists and neonatologists. The clinical benefits of appropriateand accurate periodic retinal evaluations to establish the presence oftreatable ROP have been well documented through the use of well-controlled multicenter studies. Bedside binocular indirectophthalmoscopy (BIO) has been the standard technique for retinalevaluation in premature infants.

A combination of factors has fueled interest in telemedicine (TM)-basedremote digital fundus imaging (RDFI-TM) evaluations for ROP. ROP

This document is copyrighted and is property of the AmericanAcademy of Pediatrics and its Board of Directors. All authors have filedconflict of interest statements with the American Academy ofPediatrics. Any conflicts have been resolved through a processapproved by the Board of Directors. The American Academy ofPediatrics has neither solicited nor accepted any commercialinvolvement in the development of the content of this publication.

The guidance in this report does not indicate an exclusive course oftreatment or serve as a standard of medical care. Variations, takinginto account individual circumstances, may be appropriate.

Technical reports from the American Academy of Pediatrics benefitfrom expertise and resources of liaisons and internal (AAP) andexternal reviewers. However, technical reports from the AmericanAcademy of Pediatrics may not reflect the views of the liaisons or theorganizations or government agencies that they represent.

All clinical reports from the American Academy of Pediatricsautomatically expire 5 years after publication unless reaffirmed,revised, or retired at or before that time.

www.pediatrics.org/cgi/doi/10.1542/peds.2014-0978

DOI: 10.1542/peds.2014-0978

Accepted for publication Apr 2, 2014

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2015 by the American Academy of Pediatrics

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remains a leading cause of morbiditydespite, as well as because of,advances in neonatal care, which haveimproved survival rates of at-riskinfants born prematurely.1 Althoughthere is an ongoing need for screen-ing for ROP, reimbursement issues,liability concerns, and the complex-ities associated with coordinatingROP services are possibly resulting ininsufficient numbers of qualifiedophthalmologists willing to providescreening for infants at risk for de-veloping ROP. Although malpracticeclaims against ophthalmologists andneonatologists for failure of diagnosisor mismanagement of ROP are rela-tively uncommon, awards can beextremely high because of the age ofthe patients involved and the severityof visual disability that may occur.Approximately 9% of infants withhigh-risk prethreshold ROP will havean unfavorable structural outcomedespite timely treatment,2 whichcompounds the problem. In addition,decentralization of neonatal care tocommunity hospitals offering higherlevel NICUs for premature neonatesrequires ophthalmologists to serviceone or more facilities with a smallnumber of infants requiring care inthese units. The duty of the ophthal-mologist providing ROP evaluationservices to coordinate and trackongoing care is complex.3 Lastly,reimbursement may be inadequate toaddress the liability, travel, andtracking aspects of ROP care.

II. PROBLEM STATEMENT

From a health policy perspective, anideal approach to assessing anRDFI-TM paradigm for ROP evaluationwould define the purpose of thesystem, determine the performancerelative to a criterion standard,measure technical validity, determineassociated risks, and include costanalyses.4 A number of reports haveaddressed various aspects of thisissue.5–11 However, the pace ofimplementation of RDFI with TM forROP evaluation in the ophthalmic

community has outstripped the paceof systematic evaluation of theapproach. A consensus “standard ofcare” has not yet been established.

The purpose of the presentassessment was twofold: tosystematically review the availableliterature on RDFI-TM evaluation forROP and to outline pertinentpractical, financial, and riskmanagement considerations thatshould be included in a new orexisting ROP care structure that usesRDFI-TM.

III. LITERATURE REVIEW

A. Background

There is ample precedent for the useof fundus imaging in the diagnosis ofretinal disease. There is a more than25-year history of fundus imaging forthe evaluation of diabetic retinopathy,first defined for the DiabeticRetinopathy Study.12 The goldstandard for the detection andclassification of diabetic retinopathyis 7 standard field stereoscopic35-mm color fundus photographs, asdefined by the Early TreatmentDiabetic Retinopathy Study group.13

A TM approach for diabeticretinopathy has been deployed withinthe Veterans Health Administration,14

in Native American health facilities,15

and by a growing number of primarycare providers.16 Unfortunately, ananalysis of the effectiveness of theseprograms has not been published.

The prospect of using RDFI tosupplement face-to-face evaluationsis enticing. Proponents contend thatserial imaging would improve accessto and frequency of evaluation,facilitate objective dialogue regardingrecorded findings, potentially bringa high level of expertise to each childevaluated, provide outcomes data,and mitigate liability exposure in theevent that vision loss does occurdespite appropriate care. Detractorsof the use of RDFI in ROP evaluationcite the difficulty in imaging theretinal periphery, limited image

quality in certain circumstances (eyeswith poor dilation, media haze, ordark fundus pigmentation),variability in image interpretationeven among experienced clinicians,17

insufficient evidence,18 and highimplementation cost (hardware,software, and nonphysicianpersonnel). However, the results ofthe recently published e-ROP Study11

provide strong support for an RDFIparadigm.

B. Description of the Technique

By definition, TM is “the use ofelectronic information andcommunications technologies toprovide and support health carewhen distance separates theparticipants.”19 The current electronicinformation in ROP evaluationsconsists of fundus images acquiredwith a digital, fiber optic, wide-angle,color fundus camera. Images aretaken in the NICU and thentransmitted to a remote location forinterpretation.7 Further technicaldetail is provided in Section IV.

C. Resource Requirements

See Section IV-A below.

D. Question for Assessment

This assessment is directed toaddress the following question: Is anRDFI-TM evaluation approacheffective in identifying infants withROP who need to be referred for BIO?This report does not suggest thatRDFI screening can completelyreplace or eliminate the need forbedside BIO in the examinationprocess for infants at risk for ROP.

E. Description of Evidence

PubMed and the Cochrane Librarywere searched on August 1, 2008;August 4, 2008; April 14, 2009; andJune 26, 2014.20 The search strategyused the following Medical SubjectHeadings (MeSH) and text terms. Anasterisk represents a truncated term.

(“Infant”[MeSH] OR pediatric* OR baby ORbabies OR neonat* OR prematur* OR“Gestational Age”[MeSH] OR newborn*) AND

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(“Telemedicine”[MeSH] OR telemedic* OR“retinal image*” OR “Telepathology”[MESH]OR telephotoscreen* OR “Image Processing,Computer-Assisted”[MeSH] OR “fundusimage*” OR “RetCam” OR“Photography”[MeSH] OR “RemoteConsultation”[MeSH] OR “fundus camera*”OR “wide-angle camera*” OR “wide-anglecontact photograph*” OR “ImageInterpretation, Computer-Assisted”[MeSH]OR “Diagnosis, Computer-Assisted”[MeSH]OR “teleophthalmology” OR “retinalphotograph*” OR “computer-based imageanalysis” OR “digital image*” OR “digitalphoto*” OR “wide-angle image*” OR “wide-angle retinal photo*” OR “clinical photo*” ORphoto* OR camera*) AND (“Retinopathy ofPrematurity”[MeSH] OR “retinopathy ofprematurity” OR “ROP” OR “RoP” OR “RetinalDiseases/diagnosis”[MeSH])

The searches retrieved 486 referencesin all languages. Fifty-six of these werewritten in languages other than English,and these articles were not reviewedfurther. Ten of these retrieved citationswere meeting abstracts and were notconsidered in the assessment.

The authors independently assessedthe abstracts retrieved from theelectronic searches and marked 84that potentially met the followinginclusion criteria: original researchthat evaluates a clinical ROPdiagnosis with digital retinalphotography using a wide-anglecamera. These 84 studies werereviewed in full text, and 30 met theinclusion criteria. The authorsextracted information from these 30studies about study design,interventions, outcomes, and studyquality. After the data wereabstracted, 9 studies were excludedfor the following reasons: thereference standard was not indirectophthalmoscopy (4 studies), thestudy was a case report (2 studies),the study reported outcomes otherthan ROP diagnosis (2 studies), andthe study reported only study design/baseline characteristics (1 study). Anadditional 2 studies reported use ofdigital retinal photography fordiagnosis of any ROP but not for

clinically significant ROP, and thesearticles were also excluded. Of theremaining 19 studies, 8 weresupplanted by more recentpublications speaking to the samedata set. Of these, only the mostrecent publication in a series wasselected, leaving 11 studies that wereincluded in this assessment.

A methodologist (Michele Melia, ScM,Jaeb Center for Health Research,Tampa, FL) reviewed the 11 studiesand the data abstraction forms andassigned ratings based on the OxfordCentre for Evidence-based MedicineLevels of Evidence.21 Eight studieswere rated as level I, and 3 wererated as level III. No articles weregiven a level II rating.

The level I–rated studies all had anindependent masked comparison ofa cohort of consecutive subjects whowere representative of the populationrequiring screening, and all subjectsreceived both wide-angle digitalretinal photography and the referencestandard ophthalmoscopicexamination. The level III studieswere rated as such because ofa lack of independence betweenthe reference standard and digitalretinal photography. In one of thesestudies, only infants alreadydiagnosed with ROP according toindirect ophthalmoscopy werephotographed.22 In another study, thegold standard indirect ophthalmoscopyexamination was not performed onall infants.23 In the third study,indirect ophthalmoscopy was performedimmediately if the photographsindicated referral-warranted ROP(ie, ROP possibly requiring treatment);otherwise, ophthalmoscopy was notperformed until discharge.24

All studies described in the presentassessment evaluated detection ofany ROP by using wide-angle digitalretinal photography (RetCam 120,RetCam II, or RetCam 3; ClarityMedical Systems, Inc, Pleasanton, CA).In general, all studies compared theaccuracy of image-based diagnosis byremote readers versus a reference

standard of dilated ophthalmoscopicexaminations by an expert.

The study designs differed in 5aspects: (1) the number of wide-angleretinal photographs taken, whichranged from 1 to 15 per eyeexamination; (2) the background ofpersonnel, who includedophthalmologists, ophthalmicphotographers, and trained NICUnurses, who captured retinalphotographs; (3) the image readers,who included retinal specialists,pediatric ophthalmologists, andgeneral ophthalmologists; (4) thediagnostic outcome measures, whichincluded detection of moderate ROP(eg, presence of type 2 or worsedisease) and detection of severe ROP(eg, presence of treatment-requiringdisease); and (5) the metrics ofaccuracy. These accuracy metricsincluded sensitivity (likelihood thata patient with disease, on the basis ofthe reference standard examination,is identified by using digitalphotography), specificity (likelihoodthat a patient without disease, on thebasis of the reference standardexamination, is ruled out by usingdigital photography), positivepredictive value (likelihood thata patient identified by using digitalphotography has the disease, on thebasis of the reference standardexamination), negative predictivevalue (likelihood that a patient ruledout for the disease by using digitalphotography does not have thedisease, on the basis of the referencestandard examination), absoluteagreement (percentage of cases inwhich different graders agree ondiagnosis), and the k statistic(chance-corrected agreement amonggraders in which 1 represents perfectagreement and 0 representsagreement by pure chance).

The published studies used severalmeasures of accuracy. For purposes ofcross-study comparison, thesensitivity, specificity, positivepredictive value, negative predictivevalue, and corresponding

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95% confidence intervals (CIs) wereabstracted directly from each articleor calculated by the methodologist onthe basis of data provided in thearticle. When possible, 95% CIs werecalculated by using the binomial exactmethod; otherwise, the normalapproximation was used.

1. Level I Studies

Table 1 summarizes the level I studies,which evaluated detection ofmoderate and severe ROP by usingwide-angle digital retinal photography.

Ells et al5 (371 examinations from44 infants) examined detection of

referral-warranted ROP (defined asany ROP in zone I, presence of plusdisease, or presence of stage 3 ROP atany time during the infant’s hospitalcourse) during longitudinal inpatientexaminations. Digital photographswere taken after standardophthalmoscopic examination by the

TABLE 1 Level I Studies Examining Detection of Moderate to Severe ROP by Using Digital Retinal Photography

Author (Year) Institution/TimePeriod

No. ofPatients

Eligibility Criteria Outcome/% WithOutcome by

Reference Standard

Sensitivity%/(95% CI)

Specificity%/(95% CI)

PPV %(95% CI)

NPV %(95% CI)

Ells et al5

(2003)Foothills Hospitaland AlbertaChildren’sHospital/Nov2000–Nov2001

44 Gestational age,30 wk and,1500 g or atrisk for ROP

Referral-warrantedROPa/32%

100 (85–100)x 96 (86–100)b 92 (74–99)b 100 (92–100)b

Chiang et al7

(2006)Jackson MemorialHospital/Jan1999–Dec 2000

64 ,1300 g or1300–1800 gwith .72 hoxygen therapy

Type 2 or worseROPa/21%

77 (70–84)b,c 96 (94–98)b,c 83 (76–90)b,c 94 (92–96)b,c

Type 1 or worseROPa

(ie, treatment-requiring)/11%

87 (79–95)b,c 96 (95–98)b,c 74 (64–83)b,c 98 (97–99)b,c

Wu et al8

(2006)Children’s HospitalBoston andBrigham andWomen’s HospitalNICUs/Aug2003–Jan 2004

43 Gestational age,32 wk or,1500 g orhigh risk for ROP

Type 2 or worseROPa/5%

100 (16–100) 97 (87–100) 67 (9–99) 100 (91–100)

Chiang et al25

(2007)ColumbiaUniversity/Nov2005–Oct 2006

67 Met existingcriteria forexamination

Type 2 or worse ROPat 31–33 wka/6%

76 (70–82)b,c 96 (93–98)b,c 55 (39–71)b,c 98 (97–100)b,c

Type 2 or worse ROPa

at 35–37 wk/22%100 (87–100)b,c 91 (88–94)b,c 76 (68–83)b,c 100 (96–100)b,c


(ie, treatment-requiring) at31–33 wk/0%

NA (N = 0) 97 (95–99)b,c 100 (48–100)b,c 100 (96–100)b,c


(ie, treatment-requiring) at35–37 wk/10%

100 (74–100)b,c 89 (86–92)b,c 52 (42–63)b,c 100 (96–100)b,c

Photo-ROP10

(2008)6 study sites/Feb2001–Feb 2002

51 ,31 wk gestationalage and ,1000 g

Clinically significantROPa/58%

92 (81–97)b 37 (23–52)b 67 (55–77)b 76 (53–92)b

Dhaliwal et al27

(2009)Edinburgh RoyalInfirmary NICU/Jun2004–May 2007

81 ,32 wk gestationalage or ,1500 g

Stage 3/6% 57 (29–82)b 68 (63–73)b 62 (32–86)b 68 (63–73)b

Plus disease/4% 80 (44–97)b 98 (95–99)b 62 (32–86)b 99 (97–100)b

Dai et al28

(2011)Auckland CityHospital/June2006–Dec 2007

108 Met criteria forexamination


(ie, treatment-requiring)/10%

100 (72–100) 98 (93–100) 85 (55–98) 100 (96–100)

Quinn et al11

(2014)12 US centers and1 Canadiancenter/May2011–October 2013

1257 ,1251 g Zone 1 ROP, Stage 3ROP or worse orplus disease/19.4%

90 (85–94) 87 (84–90) 62.5 97.3

NA = not applicable; NPV = negative predictive value; PPV = positive predictive value.a Type 1 (treatment-requiring) ROP is defined as zone I, any stage ROP with plus disease; zone I, stage 3 ROP with or without plus disease; or zone II, stage 2 or 3 ROP with plus disease.Type 2 ROP is defined as zone I, stage 1 or 2 ROP without plus disease; or zone II, stage 3 ROP without plus disease. “Referral-warranted” ROP was defined by study authors as any stageROP in zone I, presence of plus disease, or presence of any stage 3 ROP. “Clinically significant ROP” was defined by study authors as zone I, any stage ROP, without vascular dilation ortortuosity; zone II, stage 2 ROP, with up to 1 quadrant of vascular dilation and tortuosity; zone II, stage 3 ROP, with up to 1 quadrant of vascular dilation and tortuosity; any vascular dilationand tortuosity in eyes for which ridge characteristics were not interpretable (not imaged or poor image quality); or any stage ROP in eyes for which disc features (plus disease) were notinterpretable (not imaged or poor image quality).b CIs were not corrected for correlation between eyes and/or multiple examinations per eye.c Sensitivity and specificity were reported as average for 3 individual graders.


same examiner. Hence, the technicalexecution of photography couldconceivably have been influenced byknowledge of the severity of the ROPcase. A masked independent pediatricophthalmologist grader interpretedthe photographs, with a sensitivity of100% and a specificity of 96%compared with indirectophthalmoscopy.

Chiang et al7 (163 examinations from64 infants) examined a study cohortin which wide-angle retinalphotographs were captured by anophthalmic photographer. Theaccuracy of masked imageinterpretation was compared witha reference standard of dilatedophthalmoscopic examination bya pediatric ophthalmologist. Maskedinterpretation of wide-anglephotographs by 3 image readers(1 general ophthalmologist and2 retinal specialists) resulted in anaverage sensitivity of 77% anda specificity of 96% for detection oftype 2 or worse ROP. For detection oftreatment-requiring ROP (defined astype 1 or worse disease), the imagereaders had an average sensitivity of87% and a specificity of 96%.

Wu et al8 (43 infants) examined theaccuracy of wide-angle photographyfor detection of prethreshold orworse ROP in a longitudinal caseseries of infants meeting ROP-screening criteria. In this study, eachinfant was classified on the basis ofserial examinations of both eyes.Images were taken by a pediatricophthalmologist or ophthalmicphotographer, and they were gradedby a different masked pediatricophthalmologist. No cases ofprethreshold disease, thresholddisease, or plus disease were missedby the reader, and digitalphotography had a sensitivity of100% and a specificity of 97%compared with ophthalmoscopicdiagnosis.

In a different cohort, Chiang et al25

prospectively collected standardizedsets of 3 to 5 wide-angle photographs

of each eye of the infants; thesephotographs were takenindependently by a trained NICUnurse. The infants also receivedstandard ophthalmoscopicexaminations by a pediatricophthalmologist. Examinations wereperformed at 31 to 33 weeks’postmenstrual age (PMA) andsubsequently at 35 to 37 weeks’ PMA(248 examinations from 67 infants),and masked photographic readingswere performed by 3 pediatric retinalspecialists by using a secure Web site.For photographs taken at 31 to33 weeks’ PMA, the averagesensitivity for detection of type 2 orworse ROP was 76% and specificitywas 96%. At 35 to 37 weeks’ PMA,the average sensitivity for detectionof type 2 or worse ROP was 100%and specificity was 91%, and theaverage sensitivity for detection oftype 1 or worse ROP was 100% andspecificity was 89%. In a separatestudy based on data from this cohort,Scott et al26 comparedophthalmoscopic examinationfindings versus digital photographicinterpretations in these 67 infants bythe same graders. There was absoluteagreement of 86% (178 of 206 eyes)and k values of 0.66 to 0.85 betweenophthalmoscopic examinations anddigital photographic interpretations.Among the 14% (28 of 206 eyes) withdiscrepancies, some cases providedphotographic documentation thatophthalmoscopy may have missedsigns of mild ROP. In other cases,there were discrepancies between thepresence of zone I ROP and thepresence of plus disease; in thesecases, photography may haveprovided the theoretical advantagesof allowing examiners to review theirdiagnoses, make more exactmeasurements of anatomiclandmarks defining zone I of theretina, and directly compare imageswith the standard photograph forplus disease.

The prospective, multicenter Photo-ROP (Photographic Screening forRetinopathy of Prematurity) study

(300 examinations from 51 infants)evaluated detection of “clinicallysignificant ROP” at any time duringmultiple longitudinal inpatientexaminations.10 This outcomemeasure was defined as follows: (1)zone I, any ROP, without vasculardilation or tortuosity; (2) zone II,stage 2, with up to 1 quadrant ofvascular dilation and tortuosity; (3)zone II, stage 3, with up to 1 quadrantof vascular dilation and tortuosity;(4) any vascular dilation andtortuosity noted in eyes for whichridge characteristics were notinterpretable (not imaged or poorimage quality); or (5) any ROP notedin eyes for which disc features (plusdisease) were not interpretable (notimaged or poor image quality).Photographs were taken by anophthalmologist and graded byconsensus of 2 masked ROPspecialists. This study found thatclinically significant ROP wasdetected with a sensitivity of 92%and a specificity of 37%.

Dhaliwal et al27 (245 examinationsfrom 81 infants) conducted a masked,prospective longitudinal case series.Two experienced pediatricophthalmologists were randomized toperform examinations by using eitherwide-angle retinal photography orstandard ophthalmoscopy. Five to 15images were captured from each eyeof infants by the examiningophthalmologist, and almost allexaminations were performedbetween 32 and 36 weeks’ PMA.Sensitivity of retinal photography fordetection of stage 3 or worse ROPwas 57%, and the specificity was68% compared with ophthalmoscopicexamination. Sensitivity for diagnosisof plus disease was 80%, andspecificity was 98% compared withophthalmoscopy. Absolute agreementbetween ophthalmoscopy andphotography was 96% for detectionof stage 3 ROP and 97% for detectionof plus disease.

Dai et al28 (422 examinations from 108infants) evaluated the effectiveness of


wide-angle photography in a pilot TMstudy in which infants received serialdigital photographs and concurrentstandard ophthalmoscopicexaminations by a pediatricophthalmologist. Photographs werereviewed independently by a maskedgrader. Using ophthalmoscopicfindings as the reference standard,the sensitivity of digital photographicreading for detecting treatment-requiring ROP (ie, type 1 or worse)was 100%, and the specificity was98%. The positive predictive value ofdigital photographic reading fordetecting treatment-requiring ROPwas 85%, and the negative predictivevalue was 100%.

Quinn et al11 (5520 examinationsfrom 1257 infants) evaluated thevalidity of digital retinal imagegrading by trained, masked,nonphysician readers compared withdiagnostic examinations by anophthalmologist. A gradingsupervisor adjudicateddisagreements. Usingophthalmoscopic findings as thereference standard, for remotegrading of images when both eyeswere considered for the presence ofROP requiring referral (as wouldroutinely be done in a screeningexamination), sensitivity was 90.0%,with a specificity of 87.0%, a negativepredictive value of 97.3%, anda positive predictive value of 62.5%.Remote grading of images of an eye ata single session had a sensitivity of81.9% and a specificity of 90.1%.

F. Conclusions

There is level I evidence from at least5 studies demonstrating that digitalretinal photography has highaccuracy for the detection of clinicallysignificant ROP.7 Exceptions are 1study that showed sensitivity of 77%for detection of type 2 or worse ROP,1 study that showed sensitivity of76% for type 2 or worse ROP at 31 to33 weeks’ PMA, and 1 study thatshowed sensitivity of 57% fordetection of stage 3 disease. Of note,the largest of the level 1 studies11

produced a sensitivity of 81.9% forreferral-warranted ROP (zone I ROP,stage 3 ROP or worse, or plusdisease) when the unit of measurewas a grading session per eye, anda sensitivity of 90.0% witha specificity of 87.0% when both eyesof an infant were considered as a pair.When the last session beforetreatment was analyzed, sensitivitywas 98.2% (95% CI: 94.4–99.4), witha specificity of 80.2% (95% CI:77.0–83.0), a negative predictivevalue of 99.6%, and a positivepredictive value of 44.3% at a 13.8%treatment-requiring ROP rate. Only 3of 162 infants treated by clinicalcenter ophthalmologists did not havereferral-warranted ROP detected onthe last image graded beforetreatment. On diagnostic examination,1 infant had zone I, stage 3 disease inboth eyes and another 2 infants hadplus disease in both eyes.

Unfortunately, differences in methodsdo not permit direct comparisonbetween studies with respect tosensitivity and specificity. Level IIIstudies have reported high accuracy,without any known complications,from real-world operationalprograms intended to detect clinicallysignificant ROP through remote siteinterpretation of wide-angle retinalphotographs.

The accuracy of wide-anglephotography for detection of mildlevels of ROP, particularly in infantsat younger PMAs, is less clear. Forexample, 1 study found that thesensitivity for detection of mild ROPamong infants from 31 to 33 weeks’PMA by 3 expert graders was 73% to94%, whereas the specificity was89% to 94%. The reasons for thisoutcome may be that peripheralretinal findings are more difficult tovisualize and that younger infantshave smaller eyes with more mediaopacity, which creates difficulty forphotography.

The panel’s conclusions is that TMserves as a useful adjunct to but nota replacement of BIO.

Future Research

Further studies are needed to assessRDFI-TM ROP management programsand confirm that they adequatelyaddress issues of access to care,clinical efficacy, and cost-effectiveness. These investigationsshould address protocol andperformance standards.

In 1999, Lee proposed a 4-tierframework4 for systematicallyevaluating TM, initially focusing onretinal imaging for diabeticretinopathy, which is a usefulframework for ROP TM research. Thefirst and most important concern is todefine the purpose of any systemagainst which to judge the success ofTM approaches. Second, it isimportant to evaluate the system’sperformance against the appropriatecriterion standard. Third, researchshould establish the validity of anynew approaches from a technicalperspective, including the accuracyrates (sensitivity, specificity, andpositive and negative predictivevalues) for interpretation of theimages, relative to the criterionstandard. In addition, systemtechnical standards (eg, imageresolution, color depth, datacompression, display resolution) needfurther evaluation. It is importantthat studies in ROP-TM specify thetechnical standards used to capture,process, and display the image to thereviewers; the criterion standard tocompare the new approach; and themethods used for image capture andinterpretation.

Finally, there is a need for systematicstudies evaluating theimplementation of ROP-TM toprospectively evaluate the benefits,costs, and tradeoffs of newapproaches from variousperspectives: patients, providers,payers, and policy makers. Forexample, RDFI may make it easier forNICUs to retain infants of highersystemic acuity for whom they arenot prepared to provide anappropriate level of medical care,


with attendant impact on morbidityand mortality for infants at risk forROP. Future research should alsoinclude studies to understand howclinical information can best beshared to help educateneonatologists, NICU staff, andpatients’ families. Infant well-being isthe ultimate outcome measure.

IV. PRACTICAL CONSIDERATIONS

The following recommendations arebased on the currently availableevidence-based literature, as well asexperience accumulated by using anRDFI-TM evaluation approach to themanagement of ROP.

A. Resource Requirements

RDFI for ROP requires the followingcomponents:

• A digital fundus camera system

• Image management software

• Trained personnel

• Internet access (see the followingsection entitled “Information Tech-nology Considerations”)

• An ophthalmologist experienced inthe full range of manifestations ofROP

The only device currently used is theRetCam (Clarity Medical Systems, Inc)family of cameras. For ROP, the 130diopter lens is preferred for wide-angle visualization of the fundus. Theexternal lens is used for iris andanterior segment imaging. High-magnification imaging (optic nerve ormacular pathology) is performed witheither a 30 diopter or an 80 diopterlens. The RetCam Review Softwareallows for image-processingcapability, including manipulation ofcontrast, brightness, and colorsaturation. The discussion thatfollows assumes reference to theRetCam, unless indicated otherwise.

B. Information TechnologyConsiderations

Health information technologystandards and regulations should beappropriately addressed when using

TM options to manage ROP. Patientconfidentiality requirements andprotected health information securityregulations are defined in the HealthInsurance Portability andAccountability Act of 1996 (HIPAA).29

Digital imaging standards to facilitateand promote interoperability aredefined in the Digital Imaging andCommunications in MedicineStandard.30 Specific informationobject definitions applicable for usein ROP-TM have been defined andsuccessfully implemented. Thesestandards facilitate the exchange ofpatient and clinical informationbetween devices, picture archivingand communications systems,electronic health records (EHRs), andhospital information systems, as wellas between different providers’information systems.

Standardized methods of capturing,storing, and transmitting patientdemographic and insuranceinformation are defined in the HealthLevel 7 and the American NationalStandards Institute X12 standard,including structured data used inelectronic claims submission. Clinicaldata can be documented andcaptured by using structured clinicalterminology, such as theophthalmology subset of theSystematic Nomenclature ofMedicine–Clinical Terms,31

facilitating comparability of databetween different systems, especiallyEHR integration.

In the United States, the softwarecontrolling a medical device (eg,a retinal camera) may be consideredan integral part of the device. If thedevice is marketed, it can beregulated by the US Food and DrugAdministration, including compliancewith current Good ManufacturingProcess requirements. The QualitySystem Regulation is contained inTitle 21, Part 820, of the Code ofFederal Regulations.

To date, image compression hasnot been adequately evaluated and

validated for use in ROP-TM. If imagecompression is used, losslesscompression should be selectedbecause it allows full reconstructionof the original image data.Uncompressed image data or losslesscompression should be used in ROPTM systems (in the case of theRetCam, bitmap images) untiltechniques involving loss of data(eg, JPEG-2000 images) can beclinically validated.

C. Core Components of an ROP RDFI-TM Evaluation Program

1. Personnel: The TM Team

The health care team behind theRDFI-TM evaluation of infants forROP consists of ophthalmologists,neonatologists, NICU nursesassuming image acquisitionresponsibilities, the hospital,information technology personnel,and other caregivers. Theophthalmologist who will perform thebedside BIO, discharge evaluations,and laser procedure is an integralpart of the system. The followingsections of this core componentsdiscussion speak primarily to theother components of an ROP RDFI-TMevaluation program.

The team concept is particularlyimportant in an ROP TM systembecause the ophthalmologist may nolonger act as the on-site face of theevaluation program, or if he or she is,may not be present as frequently.Those who acquire the images (NICUnurses or other trained personnel)are the front line of the evaluationprogram.

Nonphysician graders were usedwithin the confines of the recente-ROP clinical trial.11 However, thevariability in ROP image gradingamong even experienced physicians iswidely recognized.7 In the absence ofa formally recognized certificationprocess and oversight construct,uniform training, licensing, andliability considerations preclude theroutine use of nonphysician gradersat this time.


The hospital’s information technologydepartment should be brought inearly to facilitate image download/transfer, ensure that the process iscompliant with the HIPAA privacyrule32 and hospital rules for thesafety of electrical devices, and,wherever possible, to integrate theRDFI system and the data and imagesproduced into the hospital’s EHRsystem.

2. Definition of Roles

A detailed document, preferably inthe form of a contract, detailingpertinent duties and responsibilitiesof all members of the team is criticalto the effective execution of RDFI-TMevaluation for ROP management andshould be developed within eachinstitution. Protocols should clearlydelineate workflow and roles/responsibilities, contain a qualityassurance component to detect andcorrect system failures, and delineatea structured approach to managing“outliers.” Outliers include infantswith images inadequate forinterpretation, patients with clinicalfundus findings other than ROP,urgent cases, and infants withatypical findings.

3. Training

Nurse team members and otherinterested NICU nurses should betrained in RDFI-TM techniques bya certified ophthalmic photographeror someone else familiar with fundusphotography in general and thecamera/information system to beused in particular. Cameramanufacturers offer online trainingcourses.33 Systematic evaluation/oversight by the ophthalmologist isnecessary to provide insightregarding the fine points of imagingand image management. No programcurrently exists to certify physiciansor nonphysicians for ROP diagnosisand management, whether by BIO orinterpretation of RDFIs.

Training is particularly important forthose personnel who will beresponsible for taking the

photographs in the techniquenecessary to achieve a set ofphotographs that can be correctlyinterpreted. A case report in theophthalmology literature34 clearlyillustrates this point: a photographshowing only immaturevascularization in zone I was followedby a second photograph of the samefield taken 10 minutes later, whichshowed stage 3 disease present inzone I. The authors hypothesized thatthe difference in results wasattributable to the application ofexcessive pressure on thephotographic contact device when thefirst photograph was taken. It issuggested that the ophthalmologistwho will be performing the BIOexaminations within each NICUmonitor the progress of thephotographic training by carefullycomparing the results of thephotographs obtained during trainingwith his or her examination results,thus validating these findings. Thetrainee should not be consideredcompetent in this technique untilcomplete agreement is achievedbetween the photographs taken bythe trainee and those taken by theBIO examiner.

4. Imaginga. Dilation

The eyes should be well dilatedbefore imaging, which is particularlyimportant in darkly pigmentedchildren. Dilation protocols varywidely, but commonly used regimensinclude phenylephrine 2.5% andtropicamide 1% to each eye, repeatedin 5 minutes, or Cyclomydril(a combination of cyclopentolate0.2% and phenylephrine 1%; AlconLaboratories, Fort Worth, TX), 1 dropto each eye, repeated in 5 minutes.

b. Infant Monitoring

Infants should be closely monitoredfor bradycardia, apnea, andtachycardia after dilation and duringthe imaging process. There is noevidence to suggest that TMexamination is harmful to the infant

or more stressful than BIO.35 Someevidence suggests that it may be lessstressful,36 but BIO frequentlyproduces bradycardia and othercardiovascular changes, and contactphotography may do the same.

c. Preparing the Eye for Imaging

A drop of topical anesthetic is appliedto each eye. A wire speculum (Alfonsoor pediatric Barraquer) is used toopen the eyelids. Because the RetCamis a corneal contact camera,a methylcellulose coupling agent isapplied to the cornea or lens surface.

d. Imaging Protocoli. Scheduling

Digital fundus imaging should beperformed on all infants at risk forROP damage, as outlined in the jointstatement on ROP from the AmericanAcademy of Pediatrics (AAP), theAmerican Association for PediatricOphthalmology and Strabismus(AAPOS), and the American Academyof Ophthalmology (AAO).37 Thisimaging should be conducted ona dedicated day once weekly or morefrequently if specifically indicated.This timing allows for continuousmonitoring of longitudinal changesand limits the possibility that a childwill inadvertently be dropped fromthe evaluation rotation. Morningscheduling of imaging sessions allowsproblems in image acquisition/transfer to be addressed before anychange of shift. In addition,confirmatory BIO examination by theophthalmologist responsible foroversight of ROP screening can beperformed the same day, if warranted.

ii. Image Set and Sequence

Six standard images (shown fora right eye in Fig 1) of each eye arerecommended.6 After dilation, the irisis imaged first to document the extentof dilation. This image is useful indetermining whether poor imagequality is due to poor dilation orphotographer skill/technique. Oncethe right eye is imaged, the left eye isimaged as well.


The image sequence for a completeimage set of both eyes is listed inTable 2. Additional images may beacquired, as needed, to encompass all12 clock-hours of the peripheralfundus. This image sequence shouldbe identical for all visits. Failure toachieve this standard image set maytrigger unnecessary repeat fundusimaging or bedside examination.

iii. Image Quality

Images should be of sufficient qualitythat the interpreting physician couldsafely determine whether each infantrequires BIO or treatment.

iv. Physician Notification

Image transfer should beaccompanied by notification(eg, e-mail, fax, telephone call) to theinterpreting physician that the imageshave been sent, with confirmation

of receipt by that ophthalmologist.Failure to receive a report or receiptnotification from the interpretingphysician within 24 hours shouldtrigger automatic contact by the NICUto investigate whether image transferwas successful and initiate re-transmittal if necessary.

5. Equipment Maintenance

After each patient undergoes imaging,the lens surface is cleaned with analcohol swab and allowed to air drybefore a subsequent examination. Tomaximize the working life of the lightsource, the camera should be shutdown if not in use for extendedperiods of time. Software updatesfrom the manufacturer should beinstalled promptly, anda maintenance contract isrecommended. The camera should bechecked regularly by the

bioengineering department of thehospital for electrical safety accordingto each hospital’s usual schedule formedical devices.

6. Information Managementa. Data Transmissioni. Network Architecture

The basic framework of the RDFI-TMnetwork is a hub-and-spoke model.The centralized reading center andphysician graders are the hub, andeach NICU serviced is a spoke. Imagesare captured locally; transferred viathumb drive, DVD, or hospital-secureintranet to an Internet-basedcomputer, and then sent in a HIPAA-compliant fashion (eg, secure filetransfer protocol, secure e-mail,virtual private network) to thereading center. Images aredownloaded onto a secure serveror a local reading station at thereading center for evaluation andmanagement by the ophthalmologist.

ii. Bandwidth

A set of 12 RetCam images isapproximately 10 megabytes.Broadband access (eg, T1 line, cablemodem, digital subscriber line)provides a practical means for rapidimage transfer.

FIGURE 1ROP standard image set (right eye). A, Right anterior segment-iris; B, right disk; C, right fundus temporal (right); D, right fundus nasal; E, right fundussuperior; and F, right fundus inferior.

TABLE 2 ROP-TM Image Sequence

Image Number Image Object Image Number Image Object

1 Right anterior segment, iris 7 Left anterior segment, iris2 Right disc 8 Left disc3 Right fundus, temporal 9 Left fundus, temporal4 Right fundus, nasal 10 Left fundus, nasal5 Right fundus, superior 11 Left fundus, superior6 Right fundus, inferior 12 Left fundus, inferior


iii. Transfer Redundancy

In the event of computer or networkfailure, an alternative means oftransferring the images, such asa commercial courier or deliveryservice, is necessary. Transfercomputer redundancy is desirable.

b. Data Storage, Archives, and Backup

There are no uniform recommendationson how long to store images. Therefore,conservative recommendations are inorder. Most states confer medicolegalliability until the infant reaches theage of majority (generally, 18 years ofage) plus 1 year. Images should bearchived and stored in such a mannerthat their preservation is guaranteedfor at least that long. This task is bestassigned to the hospital’s informationtechnology team to be performed inconcert with their storage of otherhospital data.

c. Backup

The hospital information technologyteam and reading center should eacharrange to have their own respectivescheduled, automated, off-site,redundant, HIPAA-compliant backupof all data.

d. Security

It is advisable to involve informationtechnology from both the readingcenter and the NICU/hospital systemto address respective HIPAAresponsibilities relating to electronicmedical information transfer. Duringimage transfer, the onus is on theNICU to remain HIPAA compliant. Theburden of HIPAA compliance restswith the reading center for reporttransfer back to the NICU.

The reading center should maintainboth the fidelity and security of thedata. This goal can be achievedthrough firewalls and password-protected access. Security cost isusually bundled into the storage/archival/backup fees.

7. Image Transfer and Interpretation

Secure e-mail is the preferred methodof transfer for both images and

reports. The advantage of securee-mail is that it creates an electronictrail, which can serve as an importantcomponent of the ROP safety net(discussed later).

a. Image Transfer Protocol (NICU/Hospital to Reading Center)

Once images are transferred to thereading center, the images should beacknowledged (via e-mail/fax/telephone or some combination[which is to be stipulated by theprotocol in advance]) on receipt; if not,the assumption will be that the reportwas not received. The physicianresponsible for image interpretationshould be notified (via e-mail/fax/telephone or some combination[which is to be stipulated by theprotocol in advance]) that images areavailable for review.

b. Interpretation Report Transfer(Reading Center to NICU/Hospital)

A triage preliminary review of theimages should be made as soon aspossible after they are received at thereading center to determine whetheremergent ophthalmoscopicevaluation and possible treatment isnecessary (ie, if threshold ROP couldbe present on the images). Inaddition, images that are not ofsufficient clarity and quality, or if theyare incomplete image sets, shouldtrigger an immediate call to thesending institution to immediatelyrepeat the photographic session.A definitive report should betransmitted in all cases to the NICUwithin 24 hours. The reports shouldbe acknowledged and documentedimmediately on receipt, or theassumption will be that the reportwas not received. If, for whateverreason, the physician grader is unableto review the images within thespecified time, it is incumbent onthe physician grader to inform thereading center to arrange for analternative physician grader to ensureadherence to a turnaround intervalfor interpretation reports of 24 hoursor less.

c. Report Components

Standard RDFI-TM reports shouldinclude the following components.

i. General Information

• Patient name

• Medical record number

• Date of examination

• Date/time images were received,interpreted, and the reporttransmitted

• Date of birth

• Birth weight

• Gestational age at birth

• PMA at examination

• Weight at examination

• Medical history/active problem list

• Institution originating the photosand its location

ii. Interpretation

The “Interpretation” section shouldinclude the following information:

• The eye(s) for which images areprovided

• The number of images providedper eye

• Interpretation of the anterior seg-ment image regarding:s Image quality

s Dilation adequate for imaging

s Corneal clarity

s Presence/activity of irisvasculature

• Interpretation of fundus imagesregarding:s Image quality

s Media clarity

s Optic nerve status

s Fovea/foveal reflex

s Presence/absence of pre-plus orplus disease

s Zone of imaged/visualized retina

s Zone of vascularized retina

s Stage and extent of ROP, ifpresent

s Other findings (eg, hemorrhage,double demarcation line, masses)


Serial images should be reviewed torelate the findings to those of previousexaminations for interval changes.

iii. Impressions

An “Impressions” section shouldinclude:

• Summary comment regarding im-age number, quality, and adequacyfor interpretation

• Summary of ROP findings in thetraditional lowest zone/higheststage format

• Status compared with previousexaminations

• The presence of any non-ROP ocu-lar pathology

iv. Recommendations

A “Recommendations” section shouldaddress:

• Whether reimaging is necessary inthe event of poor/inadequate im-age quality

• The timing of follow-up imagingper current AAP/AAPOS/AAOguidelines37

• Whether bedside examination is inorder

• Appropriate follow-up for any non-ROP ocular pathology

v. Second Opinions

• A strength of the TM approach isthe ability to easily obtain expertisefor consultation when in-terpretation is in doubt.

• Readers should maintain a list ofmore experienced clinicians to con-sult as-needed for challenging cases.

d. Outlier Managementi. Inadequate Images

Repeat examination within 24 hoursis indicated for incomplete imagesets; images characterized by poorfocus, contrast, or exposure; andthose mislabeled with regard topatient and/or eye are inadequate forinterpretation. If a NICU is providingconsistently inadequate images, itmay be necessary to schedulea repeat training session or replace

personnel or equipment. If imagescannot effectively be obtained fora child, urgent BIO is indicated to ruleout the possibility that the inadequateimages are a consequence of ROP(eg, poor dilation attributable tovascular congestion of the iris), asopposed to operator error.

Infants for whom images adequatefor remote management cannot beobtained (eg, consistent poor dilation,very dark fundus, media opacity)require BIO within examinationguidelines timing of that examination.

ii. Non-ROP Findings

A. Incidental Findings

If the physician grader notes anincidental, non-ROP ocularabnormality during the course ofimage interpretation (eg, optic nervecoloboma), the finding is added to the“Impressions” section of the report.A specific comment in the“Recommendations” (eg, consultpediatric ophthalmology within24 hours) is also included. All verbalcommunication on an infant’s behalfshould be documented as to personcontacted, topic, date, time, andresolution. On subsequentexaminations, the notation shouldinclude updates from the otherphysician in the “Impressions” and“Recommendations” sections.

B. Request to Evaluate for Non-ROPFundus Pathology

Occasionally, the NICU physician maysend images of a child not at risk forROP, requesting that the physiciangrader evaluate for some otherphenomenon (eg, infant withcandidemia to rule out fungalretinitis). RDFI-TM evaluations havenot been rigorously evaluated forsuch an indication, anda nonphysician grader would nothave the expertise to address suchqueries. In view of this situation, thephysician grader could evaluate theimages, generate a reportrecommending BIO within 24 hoursby a pediatric ophthalmologist orretinologist, and contact the NICU

staff to reiterate that TM is currentlyreserved for ROP.

iii. Urgent Cases

A physician reader should bedesignated as “on call” for the rarecircumstance of an infant who mustbe imaged emergently; that is, for aninfant who must be photographicallyscreened before his or her scheduledtime. This scenario would include, forexample, an infant who is beingtransferred or discharged sooner thananticipated and who has a scheduledimaging session that cannot becompleted at the scheduled time.

e. Termination Criteria

The termination of examinationcriteria outlined in the AAP/AAPOS/AAO guidelines37 cannot bedetermined by using RetCam at thistime. These criteria include thefollowing findings (Table 3):

• Zone III retinal vascularizationattained without previous zone I orII ROP

• Full retinal vascularization

• PMA of 45 weeks and no pre-threshold disease

• Regression of ROP

It is this panel’s recommendation thathospitalized infants undergo BIO todetermine the suitability fortermination of acute phase evaluationfor ROP before discharge from theNICU or within 72 hours of the lastRDFI examination, whichever isearlier. If an infant is dischargedbefore meeting termination criteria,the NICU should arrange foroutpatient follow-up examinations bya qualified ophthalmologist withina period of time necessary to meetROP examination guidelinerequirements (see section IV-9-f.“Risk Management Considerations”).

8. Human Resourcesa. Training and Certificationi. Photographers

Training NICU nurses in TMtechniques of photography wasdiscussed in section C-3.


ii. Physician Graders (Readers)

Even for experienced ROP screeners,evaluation of digital fundus imageshas a steep learning curve. Newphysician graders should spend a fewsessions being mentored bya physician grader experienced in TMto become familiar with image qualityissues, variability among imagers,report generation, and the technicalaspects of receiving images andsending reports. It should be notedthat there is no certification programfor physician graders.

b. Alternate Physician Graders and On-Call Coverage Continuous QualityMonitoring

No one individual can guaranteeuniversal availability. Backup oralternate experienced physiciangraders should be designated to

assist with scheduled coverageresponsibilities.

c. Continuous Quality Monitoring

Although the photographers are theface of the evaluation program, thetelemedical physician grader isthe point person. Ongoing interactionby that physician grader with theNICU physicians, the nursing staff, theROP coordinator, risk management,and hospital administration promotescommitment to the program and itsgoals of blindness prevention. Thisinteraction should includesemiannual assessment of thenumber of infants monitored, totalnumber of examinations, procedures(anti–vascular endothelial growthfactor injection, peripheral retinalablation, and vitrectomy) performed,and adverse events.

d. Communication

i. Engaging NICU Staff (Neonatologistsand NICU Nurses)

The onus is on the physician grader tokeep NICU personnel updated onrecent advances in understanding ROPpathophysiology and treatment.Changes in patient status are reportedas described in section IV-C-7-c.

ii. Patient Family Education

The involvement and responsibilitiesof caregivers are addressed in detail inthe section entitled “The ‘ROP SafetyNet’ Paradigm.” The use of RDFI shouldbe integrated into patient parenteducation, and the availability of theirchild’s retinal pathologic historyshould be a great help to that program.

The Ophthalmic Mutual InsuranceCompany (formed by the AAO in

TABLE 3 Summary Flowchart for RDFI

Step Technical Personnel Data Technical Training Needed

1. Premature infant to be imagedidentified per NICU protocol

Log or computer log NICU physician and staff Birth weight + gestationalage per protocol; otherfactors at NICU physiciandiscretion

Not applicable

2. Date of first screening examestablished

Log or computer log,protocol

NICU physician and staff Based on gestational ageper NICU protocol,AAP/AAPOS/AAO guidelines

Not applicable

3. RDFI-TM system used RetCam 120+ improvedROP lens

NICU staff 6 standard images/eyeacquired

Correct image acquisition

4. Image transfer to remotecenter from NICU

Secure file transfer NICU staff sends file; remotecenter staff receives andacknowledges file

Includes 6 standardimages/eye + generalinfo

Use of secure informationtransfer system

5. Remote physician gradernotification

Secure e-mail NICU staff Secure e-mail Use of secure informationtransfer system

6. Confirm receipt of notification Secure e-mail Remote physician grader Secure e-mail Use of secure informationtransfer system

7. Image interpretation Digital interpretation template,computer + imagingsoftware

Remote physician grader Current diagnostic andrecommendationprotocol, AAP/AAPOS/AAOguidelines

Supervised apprenticeshipthen independence

8. Report generation Digital report template Remote physician grader Includes general info +Interpretation

Use of secure informationtransfer system

9. Report transfer Secure e-mail Remote physician grader Secure e-mail Use of secure informationtransfer system

10. Confirm receipt ofinterpretation

Secure e-mail NICU staff Secure e-mail Use of secure informationtransfer system

11. Notify NICU physician andfamily of report findings

Not applicable NICU staff Digital report Not applicable

12. Determine when nextexamination needed orwhether BIO is needed

Not applicable NICU physician NICU protocol, AAP/AAPOS/AAOguidelines

Not applicable

After completion of these steps, subsequent examination is performed per recommendations by the remote physician grader based on the standards published by the AAP/AAPOS/AAO.37

Photos should be taken and transmitted at the same time each week, wherever practicable. Earlier examination or BIO examination are scheduled as needed, on the basis ofrecommendations of the remote physician grader. If repeat examination is indicated, the sequence should be repeated beginning at step number 3.


1987 as a professional liability carrierexclusively for ophthalmologists) isan excellent resource for forms andeducational material. On its Web siteis a form38 intended for the family.This form requires the patient’scaregivers to have a family membersign, acknowledging that this memberhas been informed of the diseaseseverity and that further evaluationsare needed. This form can be easilymodified for TM evaluation of ROPand sent along with each report forthe NICU nurses/physicians todiscuss with the family. Telephone orin-person conferences can bearranged if the family desires.

V. RISK MANAGEMENTCONSIDERATIONS FOR RDFI WITH TMFOR ROP

A. Professional Liability Risk

In any medical malpractice lawsuit,the plaintiff (the former patient,usually through a guardian ad litem),must prove that the defendant (eg, theophthalmologist, neonatologist, nurse,hospital) had a duty to care for thepatient, was negligent in providingthat care (ie, did not meet thestandard of care, customarily definedas the care provided by a reasonablyprudent physician), and caused harmto the plaintiff as a result. To ourknowledge, there has not yet beena lawsuit related to ROP in which thepatient was screened by using RDFI-TM. The risks related to TM insituations other than ROP screeningand the risks of BIO screening havebeen tested in many cases, however.

B. Duty

Once a physician–patient relationshipis established, physicians owe a dutyof ongoing care until the relationshipis terminated by one of the parties.Physicians establish relationshipswith patients in many ways, includingby accepting requests for officeappointments, providing advice aboutpatients to emergency departmentphysicians, and examining a patient inthe hospital. Depending on the

circumstances, courts may or may notrecognize the establishment ofa relationship through variouspatient–physician contacts.

Hospitals with NICUs generally havestanding agreements with anophthalmologist to provide ROPscreening and/or treatment, andmost ophthalmologists screen forROP on a set day each week (eg, eachTuesday). Using agreed-on clinicalguidelines, the neonatologistidentifies which infants requirescreening. Typically, the NICU notifiesthe ophthalmologist by putting theinfant’s name on a list of infants to bescreened that particular day. Theophthalmologist performs theexamination; indicates the follow-upinterval in a manner readily receivedand understood by the relevant NICUpersonnel, including (but not limitedto) neonatologists, staff nurses, andclerks assigned to handle theseappointments; and relies on the NICUto ensure that the infant’s name againappears on the list on the correct day.The ophthalmologist continues toexamine the infant in the hospitaluntil screening/treatment is nolonger required or care has beentransferred to anotherophthalmologist. Depending on theagreement with the hospital, theophthalmologist may continue toprovide care in his or her office and/or in the other hospital.

In the RDFI model for care proposedwithin the present report, the remotescreening ophthalmologist isresponsible for the patient aftereither receipt of the photographs orby the request to examine the infant,whichever comes first. Theresponsibility would possiblycontinue until the infant no longerneeds screening or treatment or untilthe ophthalmic care has beentransferred to anotherophthalmologist. It is less clear whenthe duty ends, and there are nolawsuits related to interpretation offundus photos to guide this riskanalysis. At times, courts look to what

expectations a “reasonable patient”might have, and those expectationsare linked to the characteristics of thecondition for which the patient isseeking treatment.

If the ophthalmologist who interpretsthe photos does so as part of anagreement to provide ROP care toa certain facility or on a regular basis,he or she would most likely beexpected to follow up and track theinfant until the end of screening ortreatment, just as he or she would dofor any other patient with ROP. At thisstage of implementation of RDFIscreening for ROP, this procedure isthe predominant model.

The other end of the spectrum of dutyis an ophthalmologist who is asked togive a second opinion but who hasnot agreed to care for a patient fora particular condition or course. ForROP-TM screening, this physicianwould complete the “second opinion”obligation by interpreting the photoand sending the report. This time-limited consultation model is theexpectation for ophthalmologists whointerpret fundus photos to screen fordiabetic retinopathy. Diabeticretinopathy takes years to developand progresses differently in eachpatient depending on a number offactors. Ophthalmologists screeningfor diabetic retinopathy may not beasked to review a photo ever again orperhaps not for another year. Therewould, therefore, be no expectation ofthe screening ophthalmologist tofollow up such a patient to try toensure that the next screening takesplace, unless he or she was also thetreating physician.

The obligation of an ophthalmologistwho interprets photos for a readingcenter but provides no ROP care atthe hospital is less clear-cut. Onemight argue that this relationship alsoends once the report has been sent.There are aspects to ROP that couldprovide arguments against sucha straightforward interpretation ofduty, however. The natural history ofROP is well known and relatively


predictable: it is an acute disease thatprogresses over a short period of timeand can lead, without treatment, topermanent bilateral blindness. Courtsmay find that an ophthalmologist whoagrees to interpret ROP photos hasagreed to care for the infant duringthis at-risk period and, thus, hasa duty to attempt to ensure that thephotos are taken at the appropriateintervals during that time. From a riskmanagement perspective, it would beprudent for interpretingophthalmologists to review theprocess of care with the referringfacility or physician and to clarifywho is tracking the infant until theacute screening and treatment arecompleted. To protect themselves andthe infants, ophthalmologists whoprovide ROP-TM care would be welladvised to create a safety net bymaintaining their own trackingsystem, as this follow-up aspect ofcare has proved to be risky. Materialsto do so are suggested in the sectionentitled “The ‘ROP Safety Net’Paradigm.” Technically, theophthalmologist performing thephoto-interpretation under this RDFI-TM model would possibly assumethat same duty of care as formerlywas assumed by the ophthalmologistperforming the BIO examination.

In addition to the duty to provideongoing care during the duration ofthe physician–patient relationship,physicians may be required to beresponsible for following up withpatients who do not return for care asscheduled or do not adhere torecommended treatment. This“follow-up” obligation has proved tobe a risky one for ophthalmologistswho provide ROP care. Traditionally,the neonatologist and NICU haveassumed the responsibility fortracking ROP infants until completionof ROP screening/treatment ordischarge and for arranging for ROPcare after discharge or on transfer.Problems occur because infants aredischarged before the follow-up date,are undergoing surgical procedures,are too ill, or have been transferred to

other facilities at the time of theophthalmologist’s visit. Many times,the ophthalmologists who comprisethe ROP screening and treating panelare not notified of the location andstatus of the infant. It is often theophthalmologist, however, whobecomes the primary target ofa lawsuit when ROP-screeningprotocols break down and an infantloses his or her sight. To protectthemselves and their patients, therefore,ophthalmologists are urged to maintaintheir own tracking system. Moreinformation on how to develop this“safety net” is suggested in section VI.

C. Pitfalls in Continuing Care

As in any suit for ROP care,allegations of negligence couldinclude failure to diagnose, treat, andfollow up. If no arrangements aremade for another ophthalmologistwith comparable skills to interpretphotos during a planned absence andthe infant does not receive the neededscreening or treatment, theophthalmologist could be sued forabandonment. TM has its own knownunique risks; the ophthalmologistcould also face allegations ofnegligent supervision of NICU nursesif he or she has responsibility fortraining and overseeing RDFI-TM ROPcare. Other diagnostic allegationsrelated to RDFI-TM could includenegligent interpretation of photos(failure to detect technicallyinadequate photos and failure torecognize referral-warranted ROP) orfailure to perform a timely BIOexamination or any BIO examination.Given the practicability ofophthalmologists sending photos toanother ophthalmologist for advice,plaintiff attorneys may alsofrequently allege failure to consult.Professional liability insurancepolicies would normally cover theseexposures, provided that RDFI-TM isincluded within the provisions of thepolicy or is at least not excluded.

Because physicians must be licensedin the state where care is provided,those practicing TM could face claims

for practicing medicine withouta license if the ophthalmologist wasnot licensed in the states wherephotos were both taken andinterpreted. Physicians who evaluatefundus photographs and provide aninterpretation and follow-uprecommendations are engaged in thepractice of medicine. All statesrequire that physicians have a licenseissued by the state to practicemedicine. Practicing without theappropriate license not onlycomplicates the defense of medicalmalpractice lawsuits but may alsolead to fines and disciplinary action.Ophthalmologists engaged in TMactivities that cross state lines shouldcontact the medical board in thestate(s) where their practice isphysically located as well as eachstate in which patients present fordiagnosis, imaging, or other services,to confirm that they are in compliancewith all pertinent laws andregulations. Some states require thephysician to obtain full andunrestricted licensure in the state inwhich the patient presents. Otherstates issue special licenses to out-of-state practitioners for practicing TMin their state. Still others may permitcertain intraspecialty consultationsfrom an out-of-state specialistwithout requiring in-state licensurebut require in-state licensure ifa diagnosis is issued. It is theresponsibility of the physician graderto ensure that he or she is licensedappropriately at both the transmittingand receiving sites. In addition toa medical license, some states havelaws and regulations specific to TM;these statutes address issues such asconsent and privacy.

D. Competency and Credentialing

As noted previously, ophthalmologistswho provide ROP care “should havesufficient knowledge and experienceto enable accurate identification ofthe location and sequential retinalchanges of ROP after pupillarydilation using binocular indirectophthalmoscopy.”37 Those


ophthalmologists participating in TMscreening for ROP should haveadditional knowledge and expertisein reading RDFI. If in doubt abouthow to interpret photos, they shouldconsider asking more experiencedreaders for second opinions. Thesediscussions should be documented inwriting.

There is no formal mechanism toverify competency in ROP screening,whether by BIO or TM. To promotecompetency and defensibility,ophthalmologists are encouraged tostay current with ROP research andkeep records of verification offellowship training and mentoring,certificates from continuing medicaleducation courses, and articles onROP diagnosis and treatment.

E. Consent for TM

TM has been practiced in radiology,pathology, dermatology, and adultophthalmology for some time. Whenit consists of “store and forward”technology to review images or slideswith no direct patient involvement ina real-time consultation, state lawmay not require the physician toobtain the patient’s informed consent.Because use of this technology isrelatively new in ROP care, it wouldbe prudent, nonetheless, to obtain theconsent of the infant’s parents orcaregivers, regardless of whether statelaw requires it. The TelemedicineInformation Exchange providesinformation on how to start a TMprogram and specific information onstate law (http://tie.telemed.org/professional/state.asp). The AmericanTelemedicine Association providessample consent forms on its Web site(www.atmeda.org).

F. Need for BIO Before Discharge

As noted earlier, RetCam images donot allow screeners to confirm thatthe 3 criteria for termination of theacute phase of screening for ROP37

have been met (see section B-iv)because of the inability of currentcameras to image the retinalperiphery adequately. A BIO

examination must be conducted toverify that the infant has met thecurrent clinical criteria to endscreening, as noted in the ROPexamination guidelines. The protocoldiscusses performing the BIO eitherbefore discharge or within 72 hoursof the discharge from the NICU or thelast RDFI examination, whichever isearlier. It assigns the neonatologist/NICU the responsibility for schedulingthe initial outpatient ophthalmologicevaluation.

An analysis of ROP malpracticelawsuits found that discharge is theriskiest moment in the process of carebecause patients are more likely to belost to follow-up shortly after hospitaldischarge when their ROP is stillactive. In addition, their parents havejust been introduced to the stresses ofcaring for the relatively fragilepremature infant in the outpatientsetting, and parents/caregivers thuscannot be relied on to keepappointments (see “The ‘ROP SafetyNet’ Paradigm” in section VI). Froma risk management perspective,therefore, it would be prudent toperform the BIO examination beforedischarge. This step provides thatpatients needing additionalexamination or treatment can obtainit in a timely manner.

G. Outcomes

In any RDFI-TM program established,careful consideration should be givento the inclusion of a protocol fortracking infants having undergonephoto screening for ROP anddetermining long-term visual andocular structural outcomes. Thisprogram should be consistent withand integrated with existingprograms in use for tracking infantsat risk for ROP who have beenscreened using BIO.

VI. THE “ROP SAFETY NET” PARADIGM

Information is provided in thefollowing links from the OphthalmicMutual Insurance Company regardingresponsibility for each task in the

ROP care process, both in the hospital(or other health care facility) andduring outpatient care:

• ROP: Creating a Safety Net (2ndEdition) http://www.omic.com/resources/risk_man/recommendDocs/ROP_Safety_Net_2nd_Ed_111610.rtfand http://www.omic.com/rop-creating-a-safety-net/

• ROP: Materials for Creating a Hospi-tal Safety Net http://www.omic.com/resources/risk_man/recommendDocs/ROP_Hospital_toolkit_101010.rtfand http://www.omic.com/rop-creating-a-safety-net/

• Materials for Creating an OfficeSafety Net http://www.omic.com/resources/risk_man/recommendDocs/ROP_office_toolkit_101010.rtf

VII. SUMMARY

The development of an RDFI-TMapproach has the potential to expandthe evaluation and managementoptions available for ROPsurveillance. The general consensusof the literature and this panel is thatRDFI-TM does not supplant BIO forROP evaluation. However, evidence ofmoderate (levels II and III) qualitysupports the use of RDFI to identifypatients with clinically significant orreferral-warranted ROP forophthalmic evaluation andmanagement.

Advantages of an RDFI-TM approachinclude the potential to integrate itinto contemporary EHR initiatives,objectively assess the quality ofevaluations, increase the number ofinfants evaluated, fortify the “ROPsafety net” construct of diseasesurveillance, improve parent and staffeducation about ROP, and make morewidely available the experience ofROP experts. Disadvantages includecost, the fact that RDFI-TM collectsconsiderably less information thanrequired to fully stage the extent ofROP on the basis of the InternationalClassification of Retinopathy ofPrematurity consensus statement,and current practical knowledge gaps.


http://tie.telemed.org/professional/state.asp

http://tie.telemed.org/professional/state.asp

http://www.atmeda.org

http://www.omic.com/resources/risk_man/recommendDocs/ROP_Safety_Net_2nd_Ed_111610.rtf



http://www.omic.com/rop-creating-a-safety-net/


http://www.omic.com/resources/risk_man/recommendDocs/ROP_Hospital_toolkit_101010.rtf





http://www.omic.com/resources/risk_man/recommendDocs/ROP_office_toolkit_101010.rtf



Further analyses are required toconfirm the clinical and cost-effectiveness of RDFI-TM for ROP.Future research should also includestandardization/validation ofprotocols and satisfactoryperformance standards for ROPevaluation programs.

LEAD AUTHORS

Walter M. Fierson, MD, FAAPAntonio Capone, Jr, MD

EXECUTIVE COMMITTEE – AMERICANACADEMY OF PEDIATRICS, SECTION ONOPHTHALMOLOGY, 2013–2014

David B. Granet, MD, FAAP, ChairpersonRichard J. Blocker, MD, FAAPGeoffrey E. Bradford, MD, FAAPGeorge S. Ellis, Jr, MD, FAAP – Section Historian

Sharon S. Lehman, MD, FAAPSteven E. Rubin, MD, FAAPR. Michael Siatkowski, MD, FAAPJames B. Ruben, MD, FAAP, Immediate PastChairperson

LIAISONS

Kyle A. Arnoldi, CO – American Association of Certified

Orthoptists

George S. Ellis, Jr, MD, FAAP – American Academy of

Ophthalmology Council

STAFF

Jennifer G. Riefe, MEd

AMERICAN ACADEMY OFOPHTHALMOLOGYAMERICAN ASSOCIATION OF CERTIFIEDORTHOPTISTS

ACKNOWLEDGMENTS

The authors acknowledge the greatassistance of the members of the AAOROP Telemedicine Task Force whocontributed materially to thisdocument. They include: WilliamGood, MD, Co-Chair; David Coats, MD;Edward Donovan, MD; LloydHildebrand, MD, PhD; Anne Menke,RN, PhD; and Darius Moshfeghi,MD. Flora Lum, MD, of the AAO,also made significant contributions tothe development of the manuscript.

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Telemedicine for Evaluation of Retinopathy of Prematurity · abstract Retinopathy of prematurity (ROP) remains a signiﬁcant threat to vision for extremely premature infants despite