- •Foreword
- •Preface
- •Contents
- •1.1 Introduction
- •1.2 Method
- •1.2.1 Databases
- •1.2.2 Dates
- •1.2.3 Keywords
- •1.2.4 Criteria for Inclusion
- •1.2.5 Criteria for Exclusion
- •1.2.6 Selection of Papers
- •1.3 Results
- •1.3.1 Subspecialty
- •1.3.2 Type of Telemedicine
- •1.3.3 Study Design
- •1.3.4 Final Conclusions of Papers
- •1.4 Discussion
- •References
- •2.1 Introduction
- •2.2 The Need for Diabetic Retinopathy Screening Programs
- •2.4 Guidelines for Referring Patients
- •2.7 Program Models for Diabetic Retinopathy Screening
- •2.9 Program Personnel and Operations
- •2.9.1 Primary Care Providers
- •2.9.2 Photographers
- •2.9.3 Clinical Consultants
- •2.9.4 Administrators
- •2.9.5 A Note to CEOs, Operations Directors, and Clinic Managers
- •2.10 Policies and Procedures
- •2.10.1 Sample Protocol 1
- •2.10.1.1 Diabetic Retinopathy Screening Services
- •Policy
- •Background
- •Procedure
- •2.10.2 Sample Protocol 2
- •2.10.2.1 Pupil Dilation Before Diabetic Retinopathy Photography
- •Policy
- •Background
- •Procedure
- •2.10.3 Sample Protocol 3
- •2.10.3.1 Diabetic Retinopathy Photography Review
- •Policy
- •Background
- •Procedure
- •2.11 Technical Requirements
- •2.11.1 Connectivity
- •2.11.2 Resolution
- •2.11.3 Color
- •2.11.4 Stereopsis
- •2.11.5 Compression
- •2.11.6 Enhancement
- •2.11.7 Pupil Dilation
- •2.11.8 Early California Telemedicine Initiatives Diabetic Retinopathy Screening
- •2.11.9 The American Indian Diabetes Teleophthalmology Grant Program
- •2.11.10 Central Valley EyePACS Diabetic Retinopathy Screening Project
- •2.12.1 Diabetic Retinopathy
- •2.12.1.1 ADA Guidelines Terms
- •2.12.1.2 Vitrectomy
- •References
- •3: Stereopsis and Teleophthalmology
- •3.1 Introduction
- •3.2 History of Stereopsis and Stereopsis in Ophthalmology
- •3.3 Technology and Photography
- •3.3.3 Imaging Fields
- •3.3.4 Image Viewing Techniques
- •3.3.5 Image Compression
- •3.4 Stereoscopic Teleophthalmology Systems
- •3.4.1 University of Alberta
- •3.4.4 Joslin Vision Network
- •3.5 Conclusion
- •References
- •4.1 Introduction
- •4.2 Methods
- •4.2.1 Main Outcome Measures
- •4.3 Results
- •4.3.1 Retinal Video Recording Versus Retinal Still Photography
- •4.3.2 Video Compression Analysis
- •4.4 Discussion
- •References
- •5.1 Introduction
- •5.1.1 Automated, Remote Image Analysis of Retinal Diseases
- •5.1.2 Telehealth
- •5.2 Design Requirements
- •5.2.1 Telehealth Network Architecture
- •5.2.2 Work Flow
- •5.2.3 Performance Evaluation of the Network
- •5.3 Automated Image Analysis Overview
- •5.3.1 Quality Assessment Module
- •5.3.2 Vascular Tree Segmentation
- •5.3.3 Quality Evaluation
- •5.4 Anatomic Structure Segmentation
- •5.4.1 Optic Nerve Detection
- •5.4.2 Macula
- •5.4.3 Lesion Segmentation
- •5.4.4 Lesion Population Description
- •5.4.5 Image Query
- •5.5 Summary
- •References
- •6.1 Introduction
- •6.3 Optical Coherence Tomography to Detect Leakage
- •References
- •7.1 Introduction
- •7.2 Patients and Methods
- •7.2.1 Participants
- •7.2.2 Methods
- •7.2.3 Statistics
- •7.3 Results
- •7.3.1 Reliability of Image Evaluation
- •7.3.2 Prevalence of Glaucomatous Optic Nerve Atrophy
- •7.4 Discussion
- •7.5 Perspectives
- •References
- •8.1 Introduction
- •8.1.2 Homology Between Retinal and Systemic Microvasculature
- •8.1.3 Need for More Precise CVD Risk Prediction
- •8.2.1 Retinal Microvascular Signs
- •8.2.2 Retinal Vessel Biometry
- •8.2.3 Newer Retinal Imaging for Morphologic Features of Retinal Vasculature
- •8.3 Associations of Retinal Imaging and CVD Risk
- •8.3.1.1 Risk of Pre-clinical CVD
- •8.3.1.2 Risk of Stroke
- •8.3.1.3 Risk of Coronary Heart Disease
- •8.3.2.1 Risk of Hypertension
- •8.3.2.2 Risk of Stroke
- •8.3.2.3 Risk of Coronary Heart Disease
- •8.3.2.4 Risk of Peripheral Artery Disease
- •8.3.3 Newer Morphologic Features of Retinal Vasculature
- •8.4 Retinal Imaging and Its Potential as a Tool for CVD Risk Prediction
- •References
- •9.1 Alzheimer’s Disease
- •9.2 Treatments
- •9.3 Diagnosis
- •9.6 Conclusions
- •References
- •10.1 Introduction
- •10.1.1 Stroke
- •10.1.2 Heart Disease
- •10.1.3 Arteriovenous Ratio
- •10.2 Purpose
- •10.3 Method
- •10.3.1 Medical Approach
- •10.3.2 Technical Approach
- •10.3.3 Output of Medical Data
- •10.4 Patients
- •10.5 Results
- •10.5.1 Medical History
- •10.5.2 Telemedical Evaluation of Retinal Vessels
- •10.5.2.1 Prevalence of Retinal Microangiopathy
- •10.5.2.2 Arteriovenous Ratio
- •10.5.2.3 PROCAM-Index
- •10.6 Discussion and Perceptive
- •10.6.1 Estimation of “Stroke Risk” Estimated by the Stage of Retinal Microangiopathy
- •References
- •11.1 Introduction
- •11.2 System Requirements
- •11.3 Fundus Camera
- •11.4 Imaging Procedure
- •11.4.1 Reading Center Procedure
- •11.5 Detection of Macular Edema
- •11.6 Implementation
- •11.7 Unreadable Images
- •11.7.1 Impact on Overall Diabetic Retinopathy Assessment Rates
- •11.7.2 Compliance with Recommendations
- •11.7.3 Challenges
- •11.7.4 Summary
- •References
- •12.1 Screening
- •12.2 Background
- •12.3 Historical Perspective in England
- •12.4 Methodology
- •12.4.1 The Aim of the Programme
- •12.5 Systematic DR Screening
- •12.6 Cameras for Use in the English Screening Programme
- •12.7 Software for Use in the English Screening Programme
- •12.9 Implementation in England
- •12.11 Quality Assurance
- •12.12 The Development of External Quality Assurance in the English Screening Programme
- •12.13 Information Technology (IT) Developments for the English Screening Programme
- •12.14 Dataset Development
- •12.15 The Development of External Quality Assurance Test Set for the English Screening Programme
- •12.16 Failsafe
- •12.17 The Epidemic of Diabetes
- •References
- •13.1 Introduction
- •13.2 Burden of Diabetes and Diabetic Retinopathy in India
- •13.3 Diabetic Retinopathy Screening Models
- •13.4 Need for Telescreening
- •13.5 Guidelines for Telescreening
- •13.6 ATA Categories of DR Telescreening Validation
- •13.7 Yield of Diabetic Retinopathy in a Telescreening Model
- •13.8 How Are Images Transferred
- •13.10 How Many Fields Are Enough for Diabetic Retinopathy Screening
- •13.11 Is Mydriasis Needed While Using Nonmydriatic Camera?
- •13.12 Validation Studies on Telescreening
- •13.12.1 Accuracy of Telescreening
- •13.12.2 Patient Satisfaction in Telescreening
- •13.12.3 Cost Effectivity
- •13.12.4 Telescreening for Diabetic Retinopathy: Our Experience
- •13.13 Future of Diabetic Retinopathy Screening
- •References
- •14.1 Introduction
- •14.2 Methods
- •14.3 Discussion
- •14.4 Conclusion
- •References
- •15.1 Introduction
- •15.1.1 Description of the EADRSI
- •15.5 State Support of Screening in the Safety Net
- •15.7 Screening Economics for Providers
- •15.8 Patient Sensitivity to Fees
- •15.9 Conclusion
- •References
- •16.1 Introduction
- •16.2 Setting Up the New Screening Model
- •16.2.1 Phase 1: Training
- •16.2.2 Phase 2: Evaluation of Agreement
- •16.2.3 Phase 3: Implementation of the Screening Model
- •16.3 Technologic Requirements
- •16.3.1 Data Management
- •16.3.2 Data Models
- •16.3.2.1 Data Scheme for Patient-Related Information
- •16.3.2.2 Data Scheme for Images
- •Fundus Camera VISUCAM Pro NM
- •PACS Server
- •ClearCanvas DICOM Visualizer
- •16.4 Results
- •16.4.1 Phase 2: Agreement Evaluation
- •16.4.2 Phase 3: Implementation of the Screening Model
- •16.5 Discussion
- •16.5.1 Evaluation of the Screening Model
- •16.5.2 Prevalence of DR
- •16.5.3 Quality Evaluation
- •16.6 Conclusion
- •References
- •17.1.3 Examination and Treatment
- •17.1.4 Limitations of Current Care
- •17.2 Telemedicine and ROP
- •17.2.2 Accuracy and Reliability of Telemedicine for ROP Diagnosis
- •17.2.3 Operational ROP Telemedicine Systems
- •17.2.4 Potential Barriers
- •17.3 Closing Remarks
- •17.3.1 Future Directions
- •References
- •18.1 Introduction
- •18.2 Neonatal Stress and Pain
- •18.3 ROP Screening Technique
- •18.4 Effect of Different Examination Techniques on Stress
- •18.5 Future of Retinal Imaging in Babies
- •References
- •19.1 Introduction
- •19.2 History of the Program
- •19.3 Telehealth Technologies
- •19.4 Impact of the Program
- •Selected References
- •Preamble
- •Introduction
- •Background
- •The Diabetic Retinopathy Study (DRS)
- •Mission
- •Vision
- •Goals
- •Guiding Principles
- •Ethics
- •Clinical Validation
- •Category 1
- •Category 2
- •Category 3
- •Category 4
- •Communication
- •Medical Care Supervision
- •Patient Care Coordinator
- •Image Acquisition
- •Image Review and Evaluation
- •Information Systems
- •Interoperability
- •Image Acquisition
- •Compression
- •Data Communication and Transmission
- •Computer Display
- •Archiving and Retrieval
- •Security
- •Reliability and Redundancy
- •Documentation
- •Image Analysis
- •Legal Requirements
- •Facility Accreditation
- •Privileging and Credentialing
- •Stark Act and Self-referrals
- •State Medical Practice Acts/Licensure
- •Tort Liability
- •Duty
- •Standards of Care
- •Consent
- •Quality Control
- •Operations
- •Customer Support
- •Originating Site
- •Transmission
- •Distant Site
- •Financial Factors
- •Reimbursement
- •Grants
- •Federal Programs
- •Other Financial Factors
- •Equipment Cost
- •Summary
- •Abbreviations
- •Appendices
- •Appendix A: Interoperability
- •Appendix B: DICOM Metadata
- •Appendix C: Computer-Aided Detection
- •Appendix D: Health Insurance Portability and Accountability Act (HIPAA)
- •Appendix F: Quality Control
- •Appendix H: Customer Support
- •Level 1
- •Level 2
- •Level 3
- •Appendix I: Reimbursement
- •Medicare
- •Medicaid
- •Commercial Insurance Carrier Reimbursement
- •Other Financial Factors
- •Disease Prevention
- •Resource Utilization
- •American Telemedicine Association’s Telehealth Practice Recommendations for Diabetic Retinopathy
- •Conclusion
- •References
- •Contributors
- •Second Edition
- •First Edition
- •Index
17 Telemedicine for Retinopathy of Prematurity Diagnosis |
171 |
|
|
were managing ROP and that one fifth of those |
a |
who currently perform ROP examinations plan to |
|
stop in the near future because of concerns such |
|
as time commitments, medicolegal liability, and |
|
low reimbursements [1]. |
|
17.2Telemedicine and ROP
17.2.1Potential Benefits of Telemedicine for ROP
Telemedicine for ROP consists of capturing retinal images by trained neonatal personnel (e.g., nurse or technician) with a wide-angle camera (e.g., RetCam; Clarity Medical Systems, Pleasanton, CA). Images are stored in the medical record and transferred for subsequent interpretation by a remote ophthalmologist [26, 39]. Examples of wide-angle retinal images are shown in Fig. 17.2. As the number of newborns at risk for developing ROP continues to increase, especially in areas where access to appropriate ophthalmic care may be difficult, telemedicine could be a cost-effective screening strategy to provide expert care while ensuring high accuracy for detection of treatment-requiring ROP [9, 28]. It may also decrease the physiological stresses and behavioral changes resulting from ROP screening involving BIO with scleral depression [15, 17].
From the standpoint of providing high-quality clinical care, there are many potential benefits to having archived images in a telemedical model. Imaging preterm infants can facilitate more objective documentation of disease findings and likely identification of disease progression by comparison of serial images. Patient photographs may be compared formally with published ROP images, such as the standard definition of plus disease [18]. Consultation for second opinions could be obtained from experts throughout the world [4]. Furthermore, these images would facilitate the creation of digital image libraries for educational and research purposes, leading to improvements in the uniformity and quality of ROP diagnosis and training of neonatology staff [14, 26]. The advantages of telemedicine are particularly important because studies have shown
b
c
Fig. 17.2 Examples of ROP images captured by a trained neonatal nurse during routine ROP screening using a wideangle camera (RetCam; Clarity Medical Systems, Pleasanton, CA). Images demonstrate retinas with (a) no ROP disease, (b) type 2 prethreshold ROP based on the presence of stage 3 disease in zone II with pre–plus disease, and (c) type 1 treatment-requiring ROP based on the presence of plus disease (peripheral stage 3 disease was visible in temporal and nasal photographs which are not shown)
that there may be significant disagreement, even among expert examiners, in diagnosis of plus disease and treatment-requiring ROP [2, 25, 37].
172 |
C.V.O.C. Ventura et al. |
|
|
In contrast, retinal findings from BIO rely solely on the judgment of individual examiners during a brief bedside examination, which can be somewhat subjective and limited by infant cooperation, and may not be easily verified.
17.2.2Accuracy and Reliability of Telemedicine for ROP Diagnosis
Telemedicine for ROP has been evaluated in numerous studies of diagnostic accuracy and reliability. Virtually all of these studies to date have used wide-angle digital images (e.g., RetCam; Clarity Medical Systems, Pleasanton, CA) to compare the performance of remote telemedicine experts to a reference standard of dilated ophthalmoscopic examination by an ROP expert. An initial study demonstrated that moderate to severe ROP could be identified using digital imaging [29]. Subsequent research projects have demonstrated that telemedicine for ROP can achieve relatively high diagnostic accuracy over a broad range of disease severity (Table 17.1). For diagnosis of any ROP regardless of severity, studies have demonstrated sensitivity of 0.46–0.97 and specificity of 0.49–1.00 compared to BIO [3–5, 27, 32, 39]. Generally, lower accuracy has been found while examining infants at lower postmenstrual ages. This is presumably because infants at lower postmenstrual
ages may have ROP at earlier stages with more subtle diagnostic features and because it may be technically more difficult to image eyes that are smaller and have increased media opacities [4, 39]. For moderate to severe ROP, many studies have achieved higher diagnostic accuracy (Table 17.2). These studies demonstrated sensitivity of 0.57–1.00 and specificity of 0.37–1.00 [3–5, 7, 16, 19, 20, 23, 33, 38] compared to a reference standard of BIO.
Scott et al. designed a study to control for interphysician diagnostic variability by comparing ophthalmoscopic and telemedicine diagnoses by the same experts in 67 infants [30]. There was substantial to near-perfect agreement in these diagnostic modalities, with absolute agreement of 86% (178/206 eyes) and kappa of 0.66– 0.85 between ophthalmoscopy and telemedicine. Among the 14% (28/206 eyes) discrepancies in this study, some cases provided photographic documentation suggesting that ophthalmoscopic examination may have failed to detect mild ROP that was detected using telemedicine by the same experts. In addition, there were discrepancies between presence of zone 1 ROP and presence of plus disease, in which telemedicine may have provided theoretical advantages by allowing examiners to review their diagnoses, make more exact measurements of anatomical landmarks such as zone I of the retina, and directly compare images to the standard photograph for plus disease [30].
Table 17.1 Diagnostic accuracy of telemedicine for detection of any ROP, as compared to standard binocular indirect ophthalmoscopya
Study |
Outcome measures |
Sensitivity/specificity |
Roth et al. [27] |
Any ROP |
0.82/0.94 |
Yen et al. [39] |
Any ROP at 32–34 weeks PMAb |
0.46/1.00 |
|
Any ROP at 38–40 weeks PMAb |
0.76 /1.00 |
Chiang et al. [3] |
Any ROP |
0.82–0.86/0.49–0.96 |
Shah et al. [32] |
Any ROP |
0.86/0.92 |
Chiang et al. [2, 4] |
Any ROP at 31–33 weeks PMAb |
0.73–0.94/0.89–0.97 |
|
Any ROP at 35–37 weeks PMAb |
0.91–0.97/0.98–1.00 |
Dhaliwal et al. [5] |
Any ROP at 34 weeks PMA or 4–6 weeks CAc |
0.60/0.91 |
aStudies used images captured by wide-angle camera (RetCam; Clarity Medical Systems, Pleasanton, CA) bPMA postmenstrual age
cCA chronological age
17 Telemedicine for Retinopathy of Prematurity Diagnosis |
173 |
|
|
Table 17.2 Accuracy of telemedicine in detecting moderate to severe ROP, as compared to standard binocular indirect ophthalmoscopya
Study |
Outcome measures |
Sensitivity/specificity |
Ells et al. [7] |
Any ROP zone I, presence of plus disease, or presence of |
1.00/0.96 |
|
any stage 3 ROP at any time during infants’ hospital course |
|
Chiang et al. [3] |
Type 2 or worse ROP |
0.72–0.83/0.90–0.99 |
|
Treatment-requiring ROP |
0.85–0.90/0.95–0.97 |
Wu et al. [38] |
Prethreshold or worse ROP |
1.00/0.98 |
Chiang et al. [2, 4] |
Type 2 or worse ROP at 31–33 weeks PMAb |
0.71–0.86/0.93–0.97 |
|
Type 2 or worse ROP at 35–37 weeks PMAb |
1.00/0.85–0.94 |
|
Treatment requiring ROP at 31–33 weeks PMAb |
NAe/0.94–1.00 |
|
Treatment requiring ROP at 35–37 weeks PMAb |
1.00/0.81–0.94 |
Photo-ROP Cooperative |
“Clinically significant ROP” or worsec |
0.92/0.37 |
Group [23] |
|
|
Murakami et al. [19] |
Referral-warranted ROP: type 2 or worse ROP, threshold |
1.00/0.95 |
|
disease, any plus disease, and any stage 4 or worse ROP |
|
Dhaliwal et al. [5] |
Stage 3 ROP at 34 weeks PMAb or 4–6 weeks CAd |
0.57/0.98 |
|
Presence of plus disease |
0.80/0.98 |
Lorenz et al. [16] |
All suspected treatment-requiring ROP stages: threshold |
1.00/NAe |
|
ROP in zone II or prethreshold in zone I |
|
Murakami et al. [20] |
Referral-warranted ROP: type 2 or worse ROP, threshold |
1.00/0.99 |
|
disease, any plus disease, and any stage 4 or worse ROP |
|
Silva et al. [33] |
Referral-warranted ROP: type 2 or worse ROP, threshold |
1.00/0.99 |
|
disease, any plus disease, and any stage 4 or worse ROP |
|
aStudies used images captured by RetCam; Clarity Medical Systems (a wide-angle camera) bPMA postmenstrual age
c“Clinically significant ROP” defined as (a) zone I, any ROP, without vascular dilatation or tortuosity; (b) zone II, stage 2, with up to one quadrant of vascular dilatation and tortuosity; (c) zone II, stage 3, with up to one quadrant of vascular dilatation and tortuosity; (d) any vascular dilatation and tortuosity noted in the eyes for which ridge characteristics were not interpretable (not imaged or poor image quality); or (e) any ROP noted in eyes for which disc features (plus disease) were not interpretable (not imaged or poor image quality)
dCA chronological age eNot applicable
Other studies have also measured the interand intragrader reliability of telemedical diagnosis using metrics such as kappa statistic. Among pairs of graders viewing the same images, two studies demonstrated substantial to near-perfect agreement with weighted intergrader kappa of 0.67–0.83 [3] and 0.55–0.89 [4]. Intragrader reliability of telemedical diagnosis has also been evaluated by analyzing the diagnoses of randomly repeated images presented to the same grader. For example, in one study, three ROP specialists demonstrated near-perfect to perfect agreement with intragrader kappa of 0.91–1.00 for detection of mild or worse ROP and intragrader kappa of 0.79–1.00 for detection of treatment-requiring ROP [4].
17.2.3Operational ROP Telemedicine Systems
Based on these principles, several operational telemedicine programs have been implemented throughout the world, with the goals of improving accessibility to expert ROP diagnosis while improving efficiency of examination. These programs have typically used trained nonexpert personnel, such as technicians or neonatal nurses, to capture images and transfer data for interpretation by ophthalmologists at remote locations. Infants found to have clinically significant disease are either examined locally by an expert ophthalmologist or transferred to an outside center for evaluation.
