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Manage ROP aggressively, follow up consistently to help limit liability
A strong partnering relationship between the pediatric physician and the parent is a valuable tool to ensure that the child will receive adequate care.
The management of retinopathy of prematurity has become a sensitive issue in the past decade. With malpractice lawsuits becoming more common and medical insurance rates rising, surgeons are becoming aware of the risks involved with managing this condition.
“Malpractice exposure is a constant threat for physicians who examine preterm babies for retinopathy of prematurity (ROP),” said Paul Weber, JD, a member of the risk management department of the Ophthalmic Mutual Insurance Company (OMIC), a medical insurance company that insures nearly one-fourth of U.S. ophthalmologists.
“While babies are rarely misdiagnosed or lost to follow-up care, those who are can be awarded sums that run into millions of dollars, exceeding the policy limits of the ophthalmologists who are sued,” Mr. Weber said.
In a February 2001 case now on appeal, a jury awarded a Texas couple $15 million in a malpractice lawsuit involving their twin boys. The twins were born preterm in December 1996 and subsequently developed ROP. According to Mr. Weber, contrary to the jury’s finding, both children became bilaterally blind due to management inconsistencies on the part of the parents who failed to take the children to follow-up visits.
“It is often alleged that the ophthalmologist did not do enough to assure that the patient would be followed up in a timely fashion, and consequently the delay results in a missed opportunity of treatment for the baby,” Mr. Weber said.
As a result, he said, it is imperative that ophthalmologists who screen for and treat ROP put mechanisms in place to reduce inconsistencies in the process of care, from diagnosis to treatment to anticipated recovery.
A proper understanding of the disease, its stages and its proper management are vital in putting such mechanisms in place, according to pediatricians and pediatric ophthalmologists.
Protect yourself
“A thorough and comprehensive system of checks and balances is what every practicing ophthalmologist should be implementing,” said Robert S. Gold, MD, a pediatric ophthalmologist from Longwood, Fla., and OSN Pediatrics/Strabismus Section Editor. “This is the only way to protect yourself from the medical and legal ramifications of a child who inadvertently falls through the cracks.”
In September 2001, the American Academy of Pediatrics (AAP), in conjunction with the American Association for Pediatric Ophthalmology and Strabismus and the American Academy of Ophthalmology, released a revised version of their 1997 policy statement: “Screening Examination of Premature Infants for Retinopathy of Prematurity.”
The statement contains guidelines for screening for ROP in infants. According to the statement, “The goal of an effective screening program must be to identify the relatively few preterm infants who require treatment for ROP … while minimizing the number of stressful examinations required for these sick infants.”
“This is the manual that most physicians follow now,” said Rudolph S. Wagner, MD, a pediatric ophthalmologist at the Children’s Eye Care Center of New Jersey.
Mr. Weber agreed. “These guidelines should certainly be reviewed by anyone treating at-risk infants,” he said.
Age, weight a factor
According to the guidelines, infants who have a birth weight of less than 1,500 g, with a gestational age of 28 weeks or less, should be screened for ROP. Additionally, selected infants between 1,500 and 2,000 g, who have a history of an unstable clinical course and are believed to be highly at risk by their attending physicians, are also candidates for screening.
To detect ROP, surgeons should give patients at least two fundus examinations with binocular indirect ophthalmoscopy after pupillary dilation.
“It is a really good idea to repeat the examination,” Dr. Wagner said. The AAP’s suggestion of repeat fundus examinations is a new and very important guideline, he added.
“This is crucial, because if you do your first exam early (closer to the initial time when treatment is recommended) you may have difficulty in determining if the patient is fully vascularized to the periphery, because you may get a hazy view of the retina. This is a normal occurrence in the development of the retina, but it can obscure your view,” Dr. Wagner explained.
For this reason, Dr. Wagner believes it is imperative that the surgeon repeat the examination, unless he or she is sure that both retinas have become fully vascularized. The AAP policy states, “one examination is sufficient only if it unequivocally shows the retina to be fully vascularized bilaterally.”
Additionally, Dr. Wagner stressed that the lower the birth weigh of the infant is, the more important it is to repeat examinations and to look for findings of ROP.
“I’ve found that in patients with more severe cases of ROP, a smaller birth weight is usually evident,” he noted.
Screening time critical
Suggested practice for screening children for ROP
Source: American Academy of Pediatrics Policy Statement, Screening Examination of Premature Infants for Retinopathy of Prematurity, September 2001 |
The AAP policy also states that all examinations should be performed by an ophthalmologist with “sufficient regular experience and knowledge in the examination of preterm infants for ROP.”
Consequently, ophthalmology residents may not be eligible to perform these examinations.
“These guidelines will affect the ability of residents to perform unsupervised exams and may also necessitate that the attending faculty also look at the infants’ retinas,” Mr. Weber said.
According to the policy statement, the first examination should be performed within 4 to 6 weeks postnatal age or within week 31 to 33 of postconceptional or postmenstrual age (gestational age at birth plus postnatal age).
However, data published in November in Archives of Ophthalmology suggest the initial examination should be done sooner rather than later.
According to the study “Evidence-based screening criteria for ROP,” which is based on historical data from the CRYO-ROP and LIGHT-ROP studies, the initial exam should be conducted by 31 weeks postmenstrual age or 4 weeks neonatal age, whichever is later.
The study, led by James D. Reynolds, MD, of the State University of New York-Buffalo, found that screening for acute phase ROP should be discontinued when the risk of visual loss from ROP has passed or is very minimal.
In allowing leeway regarding this issue, the AAP suggests that the guidelines presented “may be adjusted appropriately on the basis of other reliable data, such as local incidence and onset of ROP or the presence of other unrecognized factors.”
“Just as surgeons should be particularly aware of the correlation between a smaller birth weight and the development of ROP, so too should they be aware that a younger gestational age can be another contributing factor to ROP development,” Dr. Wagner noted.
Keeping this in mind, when surgeons screen patients they should allot sufficient time for treatment, and extra time for transferring the patient to another facility.
Treatment immediate
To minimize the risk of retinal detachment, the AAP policy statement suggests that patients with threshold 1 ROP receive ablative therapy treatment in at least one eye within 72 hours of diagnosis.
Patients with threshold 1 ROP are defined as those with stage 3 ROP in zone 1 or 2 in 5 or more continuous clock hours, or in 8 cumulative clock hours. In addition, the patient must also show signs of plus disease, defined as posterior retinal vessel dilation and tortuosity.
When he observes such a patient in his practice, Dr. Wagner refers the patient to a retinal specialist.
“I usually have the specialist come the same day as my examination to confirm my findings. The specialist then makes the decision for treatment, and treatment is accomplished within 72 hours,” he explained.
Surgeons should consult the International Classification of Retinopathy of Prematurity for more information concerning those patients who fit the criteria for immediate treatment, according to the AAP statement.
Seamless follow-up process
To sufficiently treat patients in a timely and appropriate manner, the guidelines for examination, treatment and follow-up by each ophthalmology unit and neonatal intensive care unit should be clearly defined and regulated.
The AAP suggests the following criteria for a smooth transition for patient referral:
“The transferring primary physician should have the responsibility of communicating orally and in writing what eye examinations are needed and their required timing to the infant’s new primary physician. The new primary physician should ascertain the current ocular examination status of the infant from the record and through communication with the transferring physician so that any necessary examinations by an ophthalmologist can be arranged properly at the receiving facility.”
“We must be thorough in our methods of execution when treating patients with ROP,” Dr. Gold said.
In his practice, Dr. Gold has between 25 to 40 encounters per week with children who are at risk for or have ROP.
“In the hospital and in the office we have to be extremely careful and cautious when caring for these patients,” he said. Following the AAP protocol, Dr. Gold makes sure that patients are followed aggressively and show up for appointments.
“If patients don’t show up after notification, we contact their parents by phone and by mail. If we still get no response, we will then send them a certified letter suggesting the urgency of the matter and requesting a visit,” he said.
Parents on your side
From the beginning, when mother and child are discharged from the hospital, parents are given literature on ROP. The literature explains the stages of ROP and tells parents that their child is at risk for severe visual loss or blindness if he or she does not follow up for adequate care.
Ophthalmologists interested in distributing this information to patients’ guardians may access helpful documents at the OMIC Web site. There they can obtain the handout, “Parents: Read This About Your Premature Baby’s Eyes.”
“Our job is to explain to them, to the best of our ability, what is wrong with their child, what needs to be done to help prevent retinal detachment and further disease progression or blindness,” Dr. Gold said. “We make every effort to educate and aggressively follow up with the patient, because — believe it or not — it appears not only to be the parents’ responsibility anymore, but the ophthalmologist’s as well.”
Every step of the way, contact, visits and treatment practices concerning each patient should be meticulously recorded and filed for future reference. The AAP suggests that all practicing physicians adopt these policies in their everyday practices so they are covered should any medical or legal ramification ensue.
For more information on the issue of ROP protocol and distribution of duties between the ophthalmologist and the neonatal intensive care unit, Mr. Weber suggested consulting the sample protocol, “Monitoring for ROP,” written by Lawrence M. Kaufman, MD, PhD. Mr. Weber said this is a helpful tool for health care providers that is available from OMIC.
No guarantees
The AAP policy statement notes that screening program guidelines are designed to implement an evolving standard of care. Unfortunately, there are still inherent defects, such as underreferral and overreferral, that will exist in an everyday setting — unlike in a scientifically based clinical trial. Surgeons should keep this in mind when practicing the suggested guidelines and be careful and cautious of these hazards, Dr. Wagner cautioned.
He pointed out that while practicing these guidelines will help to secure an improved standard of care for at-risk infants, they will not guarantee that the child’s symptoms will resolve.
“Just because we have treatment available, it doesn’t mean the babies who are treated will have a good result,” Dr. Wagner noted.
In fact, the groundbreaking multicenter CRYO-ROP trial found in the late 1980s that ROP treatment of cryotherapy is associated with a 41% decrease in the occurrence of posterior retinal traction folds or detachments. With proper treatment there is a 19% to 24% decrease in the incidence of blindness 5 years later.
While no statistical clinical evidence exists for today’s gold standard of ROP therapy — laser photocoagulation — surgeons believe, based on empirical evidence, that laser therapy is “at least equivalent” to cryotherapy in its therapeutic outcomes.
“This being said, surgeons need to remember that the percentages are not in a positive favor, so many patients who are treated properly, appropriately and at the right time still go on to lose their vision,” Dr. Wagner said.
For Your Information:
- Paul Weber, JD, can be reached at the Ophthalmic Mutual Insurance Company, 655 Beach St., San Francisco, CA 94109-1336; (800) 562-6642; fax: (415) 771-7087; e-mail: pweber@omic.com.
- Rudolph S. Wagner, MD, is Director of Pediatric Ophthalmology, UMDNJ-New Jersey Medical School, Newark, Children’s Eye Care Center of New Jersey. He can be reached at 495 North 13th St., Newark, NJ 07107; (973) 485-3186; fax: (973) 497-5674; e-mail: wagdoc@aol.com.
- Robert S. Gold, MD, OSN Pediatrics/Strabismus Section Editor, can be reached at 225 W. State Rd. 434, Suite 111, Longwood, FL 32750; (407) 767-6411; fax: (407) 767-8160; e-mail: rsgeye@aol.com.
- The Web site for the Ophthalmic Mutual Insurance Company is www.omic.com. There you can obtain a copy of the handout “Parents: Read This About Your Premature Baby’s Eyes.”
- The AAP policy statement “Screening Examination of Premature Infants for Retinopathy of Prematurity” can be obtained online at www.aap.org/policy/060023.html.
- To obtain a copy of the article “Protocol: Monitoring for ROP,” e-mail the OMIC at omic@omic.com, ask for a free copy, and include your fax number so that the OMIC can fax this article to you.