A Safety Net for Retinopathy of Prematurity Management
This new Web-based initiative could expand access to pediatric retina specialists nationwide.
LAWRENCE Y. HO, MD ∙ LISA J. FAIA, MD ∙ MICHAEL T. TRESE, MD
Retinopathy of prematurity (ROP) management has progressed greatly over the last decade and a half, now yielding an anatomic success rate of greater than 98%.1–3 The majority of this success is based on the timely and accurate screening of infants at risk for ROP. It has become a problem, in the United States, to find doctors who are trained and willing to screen for ROP and to find insurance companies that are willing to insure those who do the ROP screening.4
For the past two decades, screening for ROP has been documented by drawings in an infant's medical record. These handwritten drawings are used in addition to the physician's memory to gauge any change between previous and current examinations. In addition, different subsequent examiners may attempt to interpret previous notations, even though these examiners did not make the original drawings. This form of documentation is imprecise, in some areas inaccurate, and is not compatible with electronic medical records. It has been possible for several years to use photography to document much of the infant's retina.5 We know from current management of diabetic retinopathy and macular degeneration, as well as other retinal diseases, that photographic documentation is far superior to any physician drawing.6-8
Given the very high success rates that are possible with the proper management of ROP, a new approach to screening in order to try and reduce misrepresentation and misinterpretation of data is extremely important. The medical malpractice awards in ROP cases have captured the attention of doctors, hospitals, the American Academy of Ophthalmology, peer-reviewed journals, and insurance companies.9-11 All of these groups are looking for a mechanism to provide the best possible care for each infant while providing protection for the doctors and hospitals who administer that care.
In order to supply this care, there must be a thoroughly reviewed ROP screening system that is reproducible and well documented. This system can provide a safety net for ROP management — a safety net that benefits the infant, the physician and the hospital, as well as insurance companies. The system should have three core components: (1) hospital participation, (2) photographic documentation with appropriate image management, and (3) parental participation.
|Michael Trese, MD, is clinical professor of biomedical sciences at Oakland University and clinical associate professor at Wayne State University School of Medicine. He is chief of pediatric and adult vitreoretinal surgery at William Beaumont Hospital in Royal Oak, Michigan. Lawrence Y. Ho, MD, is a second-year vitreoretinal surgery fellow at Associated Retinal Consultants/William Beaumont Hospital. Lisa J. Faia is a first-year vitreoretinal surgical fellow at the same institution. Dr. Trese is an equity partner in and consultant for FocusROP. Drs. Ho and Faia have no financial interests relevant to this article. Dr. Trese can be reached at firstname.lastname@example.org.|
In order to maintain a hospital's neonatal intensive care unit (NICU), the hospital must provide appropriate ROP screening. Currently, hospitals request ophthalmologists on their staff to screen infants, usually via a bedside examination. These ophthalmologists may be from any specialty and may or may not have acquired the necessary experience in regard to retinopathy of prematurity. The analogy of any ophthalmologist performing ROP screening is not dissimilar to the analogy of any radiologist performing mammography. A radiologist must be certified every few years in order to perform mammography.12 The ophthalmologist who currently performs ROP screening may or may not be familiar with the most up-to-date ROP information. The hospital should demand that the ophthalmologists involved in ROP screening for their NICU demonstrate that they have the appropriate skill set necessary to perform ROP screening.
To aid the screening ophthalmologist, the hospital must supply the necessary equipment for documentation. The best documentation for ROP screening is undoubtedly photography. Photography requires personnel capable of capturing adequate images for interpretation. The preferred personnel are the NICU nurses who are already comfortable handling these fragile neonates. In addition, the hospital must supply equipment that allows the uploading of these digital images to a secure Web site on the Internet for viewing.
Finally, the parents must be made to sign a document before hospital discharge stating that they realize that their infant can become blind from ROP if follow-up visits are missed and the hospital makes the first follow-up appointment for the infant.
PHOTOGRAPHIC REMOTE IMAGE-MANAGING SYSTEM
FocusROP is a remote image-managing software program located on the Web site www.focusrop.com, as shown in Figure 1. It is HIPAA-compliant and allows the secure transfer of images from the NICU to a primary certified FocusROP reader.13 This reader has undergone an educational program, as shown in Figure 2, and certification examination, as shown in Figure 3, through the Web site to assure that he/she is familiar with the most up-to-date ROP information. This certification is done every two years to keep the examiner current. Training and certification are also necessary for the nursing staff obtaining and uploading the images.
Figure 1. The home page of the FocusROP Web site.
Figure 2. The education module of the FocusROP Web site provides free didactic material about ROP management.
Figure 3. The reader-certification module of the FocusROP Web site is shown. It has an online examination that provides three hours of CME credits.
The software program allows the primary reader, who is notified by text message, as shown in Figure 4, that images are available for reading. The reader is then able to securely enter the Web site, as shown in Figure 5, and use an algorithm contained within the software program, combined with recommendations based on the most up-to-date ROP studies, to process the images, as shown in Figure 6. These recommendations couple both photographic documentation as well as bedside examination to achieve the highest level of ROP care.
Figure 4. Sample text message sent when images are available for reading.
Figure 5. Access is password protected for security.
Figure 6. Shown above is an example of the report sent to the hospital. The report can either be printed or entered into an electronic medical record.
This image-management program allows the reader to return a report to the hospital that provides photographically the circumstances of each eye and recommendations for the subsequent examinations. The reader cannot change the recommendations of the algorithm mentioned above, which is important in the safety net. Inappropriately long periods of time between examinations in the NICU and delay in examinations after transfer of care from the NICU may lead to future litigation and can be avoided with this program.11,14
The images can also be compared side by side with previous examinations. This allows absolute documentation of interval change and provides the infant with the most up-to-date examination schedule. In addition, this report can be printed or seamlessly entered into an EMR and is stored in an off-site image area available for 22 years.
The algorithm never tells the doctor/reader that treatment is necessary, as the decision for treatment is left to the doctor's best judgment. The program instead mandates a bedside examination. In addition, if the primary reader has a challenging case, there is a mechanism for him to seek the advice of an expert of his own designation. All of the participants, the NICU, the primary reader, and the expert reader are notified by text message if the available images to be read or that they have been read. The readings can be performed and returned to the hospital in several hours from any device connected to the Internet as shown in Figure 7. This speed and efficiency is important due to the potential rapid progression of retinopathy of prematurity.15
Figure 7. The report can also be accessed via web-enabled phone.
The images captured at the bedside can be helpful in terms of NICU personnel and house staff education as well as parental understanding of the severity of ROP and the need for treatment or frequent follow-up care.
It is not uncommon for children to leave the NICU not having reached a point where treatment intervention for retinopathy of prematurity is necessary and yet the infant is still at risk for progression. It is therefore extremely important to bridge the transition from the NICU evaluation to the office evaluation without missing examination dates, as this has been shown to occur frequently.14,16 There are several steps in this process involving multiple parties, such as the neonatologists, hospital staff, nurses, pediatricians and ophthalmologists.
However, the most important step is parental participation and appreciation of the importance of examinations and potential severity of retinopathy of prematurity. The hospital can help bridge this gap by sharing with the parents the images of the eyes. In addition, parents receive a brochure discussing retinopathy of prematurity, like the one supplied through the organization called ROPARD (the Association for Retinopathy of Prematurity and Related Diseases). This organization's Web site, www.ropard.org as shown in Figure 8, also has a list of parents' frequently asked questions relative to ROP, as well as other printed materials showing images of the potential progression of retinopathy of prematurity.17 The information provided gives the parent a resource for better understanding and appreciation for the importance of continued follow-up at the discretion of the physician. Increased participation and education on the part of the parent hopefully triggers a response that leads to responsible follow up.
Figure 8. The home page of the ROPARD Web site supplies parents with answers to frequently asked questions and general information about ROP and other retinal diseases.
Using these three core components, a safety net for ROP management can be achieved, leading to a system in which no infant falls through the cracks, missing the opportunities of treatment that can yield extremely highly successful anatomic results. RP
- Early Treatment for Retinopathy of Prematurity Cooperative Group. Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity Randomized Trial. Arch Ophthalmol. 2003;121:1684-1694.
- Capone A Jr, Trese MT. Lens-sparing vitreous surgery for tractional stage 4A retinopathy of prematurity retinal detachments. Ophthalmology. 2001;108: 2068-2070.
- Prenner JL, Capone A Jr, Trese MT. Visual outcomes after lens-sparing vitrectomy for stage 4A retinopathy of prematurity. Ophthalmology. 2004;111: 2271-2273.
- Survey: physicians being driven away from ROP treatment. Ocular Surgery. News Website. http://www.osnsupersite.com/view.aspx?rid=18018. Accessed November 23, 2009.
- The Photographic Screening for Retinopathy of Prematurity Cooperative Group. The photographic screening for retinopathy of prematurity study: primary outcomes. Retina. 2008;28:S47-S54.
- Risk factors associated with age-related macular degeneration. A case-control study in the age-related eye disease study: Age-Related Eye Disease Study Report Number 3. Age-Related Eye Disease Study Research Group. Ophthalmology. 2000;107:2224-2232.
- Azen S P, Irvine AR, Davis MD, et al. The validity and reliability of photographic documentation of proliferative vitreoretinopathy. Ophthalmology. 1989;96: 352-357.
- Pugh JA, Jacobson JM, Van Heuven WA, et al. Screening for diabetic retinopathy. The wide-angle retinal camera. Diabetes Care. 1993;16:889-895.
- Demorest BH. Retinopathy of prematurity requires diligent follow-up care. Surv Ophthalmol. 1996;41:175-178.
- Reynolds JD. Malpractice and the quality of care in retinopathy of prematurity. American Ophth. 105:461-480.
- Day S, Menke AM, Abbott RL. Retinopathy of Prematurity Malpractice Claims The Ophthalmic Mutual Insurance Company Experience. Arch Ophthalmol. 2009;127:794-798.
- The Mammography Quality Standards Act of 1992, Public Law No. 102-539.
- Cast a wide safety net for retinopathy of prematurity (ROP). Focus ROP Website. http://www.focusrop.com. Accessed November 23, 2009.
- Aprahamian AD, Coats DK, Paysse EA, Brady-McCreery K. Compliance with outpatient follow-up recommendations for infants at risk for retinopathy of prematurity. J AAPOS. 2000;4:282-286.
- International Committee for the Classification of Retinopathy of Prematurity, The International Classification of Retinopathy of Prematurity revisited, Arch Ophthalmol. 2005;123:991-999.
- Attar MA, Gates MR, Iatrow AM, Lang SW, Bratton SL. Barriers to screening infants for retinopathy of prematurity after discharge or transfer from a neonatal intensive care unit. J Perinatol. 2005;25:36-40.
- ROPARD: The Association for Retinopathy of Prematurity and Related Diseases. ROPARD Web site. http://www.ropard.org. Accessed November 23, 2009.