Round table: Revised ROP screening guidelines stir debate

An expert panel discusses recent revisions to published guidelines for screening premature infants for ROP.

A note from the Section Editor:

It has been 6 months since the revised policy statement, “Screening Examination of Premature Infants for Retinopathy of Prematurity” was published in the February 2006 issue of Pediatrics. We are indebted to Walter M. Fierson, MD, and his committee for their dedicated work in developing this update for the guidelines that pediatric ophthalmologists, retina specialists and others who screen neonates can incorporate into their ROP examinations and practice patterns.

I moderated a round table discussion of this subject earlier this year during the annual American Association of Pediatric Ophthalmology and Strabismus meeting, only several weeks after the criteria were published. (Other parts of this round table were published in the June 1 and June 15 issues of Ocular Surgery News.) At that time, the topic brought out a heated discussion among the participants about the new recommendations from the committee. Since then, all of us have had several months to adapt to the new guidelines. While there are certainly areas of controversy in this policy statement, the major concern with a document such as this is that it puts a more exacting burden on the ROP examiner to follow these guidelines to the letter or face possible consequences.

In our practice, we have, in conjunction with the neonatologists in our neonatal intensive care units, updated our screening criteria and protocols based on the new guidelines, and we are tracking these babies with more diligence than ever. The document makes the critical point that the “responsibility for examination and follow-up of infants at risk for ROP must be carefully defined by each NICU.” However, the medicolegal issues surrounding ROP cases are driving our colleagues away from caring for these babies, as fewer and fewer of us are performing these exams to help preserve the vision of our smallest patients. (See related story).

We commend Dr. Fierson and his colleagues for their efforts in outlining the guidelines for ROP screening. Following our round table discussion, which included a fair amount of criticism of the guidelines, we asked Dr. Fierson to read a transcript of the round table and respond to some of the participants’ comments on behalf of the writing committee. Dr. Fierson’s response is printed after the round table.

We welcome further comment from readers of OSN, and we will continue with the dialogue into matters such as this and other issues affecting pediatric ophthalmology. All of us benefit from real-world experience to pass on to our colleagues, so that we can treat our patients with state-of-the-art care.

Robert S. Gold, MD
Pediatrics/Strabismus Section Editor

Round Table Participants Moderator Robert S. Gold David K. Coats Evelyn A. Paysse Naval Sondhi

Robert S. Gold, MD: Our topics in this portion of the round table are risk management and screening guidelines for retinopathy of prematurity.

Earl A. Palmer, MD, gave this year’s Costenbader Lecture at the American Academy of Pediatric Ophthalmology and Strabismus meeting. One of the things he told us is that we must accept “ownership” of the ROP care in the patients we see.

New guidelines were published in the February 2006 issue of Pediatrics, a new policy statement generated jointly by AAPOS and the American Association of Pediatricians. These new guidelines ask us as pediatric ophthalmologists to be more proactive, to make sure that we are seeing the babies initially at the proper time. The guidelines discuss the recommended frequency of examinations and the proper timing of laser treatment.

What are your thoughts about this new document and how it will affect the practice of pediatric ophthalmology and the management of ROP in particular?

Naval Sondhi, MD: The recommendations that have just come out are based on experience that has accumulated over the past 5 to 10 years. The last recommendations came out in 2001. More collective experience has been gained since then on the natural history of the disease, so an update was called for. These kinds of practice guidelines must be applied, followed and periodically re-evaluated.

There are some areas of the new guidelines that I want to study carefully. I’m cautious about the recommendations for care in the really premature babies. The recommendation of following the 23- and 24-week babies at 9 weeks post-birth may be worrisome. The authors have acknowledged that this recommendation is not evidence-based because published numbers for this group are low. I think every physician taking care of premature babies must establish his or her own guidelines for this group for use in the neonatal intensive care clinic.

David K. Coats, MD: I have mixed feelings about the new guidelines. I think they are, in some respects, a step forward. In other respects, there are some backward steps. There are some significant, and I think dangerous, confusions in the new recommendations, and there are, frankly, some errors. I think these new recommendations must be rapidly revised and these flaws cleaned up. I’m concerned about people following these recommendations closely because I think they may result in some significant problems.

Dr. Gold: Could you be more specific?

Dr. Coats: One that stands out as a confusing issue: In one place, the document says that when plus disease is present, that indicates treatment should be considered rather than observation. Then in a subsequent section, the statement is made that children should be treated per the Early Treatment of ROP study recommendations when type 1 ROP is present. Without further clarification, these statements are not compatible.

So in one place, the guidelines say to treat when just plus disease is present. Elsewhere in the document other treatment recommendations are made. I think that’s confusing and likely to lead to overtreatment. That’s a significant concern. There are others as well.

Evelyn A. Paysse, MD: A problem I find is that the timing guidelines are complex. You have to now calculate things like this: A 23-week baby should be followed up at 31 weeks — that is 9 weeks later — while a 24-week patient should be followed up 8 weeks later.

This is very different from the previous recommendation of initiating the examinations at 4 to 6 weeks of age. This may lead to a lot of confusion, especially if you have a high volume of ROP in your practice, trying to calculate all that.

I also think, as Dr. Sondhi suggested, that waiting 9 weeks on a 23-week preemie may be dangerous, and I would be uncomfortable with starting to see them at 31 weeks. I have seen a number of babies who need treatment at this age.

It seems like this complexity in the timing will lead to problems of organization. Also, waiting so long in the extremely premature babies may lead to missing the boat on some of them.

There is also a contradiction about whom to screen. Under the Recommendations, it says to screen babies who were born at 32 weeks and less, but in Table 1 it says to follow the 31 and 32-week babies “if necessary.” If the statement recommend in one place that you need to see them, but another says “if necessary,” what does that mean? That is nebulous and ambiguous.

Another point that I have concerns about is the recommended follow-up examinations for the different stages of ROP. Dr. Coats mentioned the contradiction on the treatment of plus disease. In addition, on the guidelines for the 2 to 3 week follow-up the document says to follow patients for regressing ROP in zone 2, but it gives no definition of what regressing is. Although I know what regressing ROP looks like, I don’t think a consensus definition of regression has ever been published.

The guidelines also say that you can stop seeing a patient when there is regression of ROP in zone 3. That is ambiguous.

Dr. Sondhi: I agree with Dr. Paysse regarding the recommendations for the 31- to 32-week babies. For me, regression has always implied that the more advanced stages of ROP disappear first, ie, in reverse order of appearance. It also assumes a more avascular and gliotic appearance. I assume that is the definition most people apply to the term “regression,” and therefore I am not uncomfortable with the use of that term in the recommendations.

Dr. Coats: There was another area where it seemed that words were used improperly. The guideline authors stated that if the responsibility for scheduling an appointment after discharge from the hospital was to be left to the parent, the parent should be “made to understand” the risk of ROP, the consequences of delayed treatment, etc.

I don’t think I can make anybody understand anything. The wording should be that parents should be informed of these risks or given information about them. The wording as it is puts ophthalmologists in a bind. Frankly, I don’t think a child should ever leave the unit if the responsibility is to make the parent understand, because I don’t know how you can ensure that.

Dr. Gold: Parents of premature babies have so much on their minds, and the eyes are a small part of it. I have been proactive with the neonatal intensive care units I work with to make sure that the parents have a follow-up appointment when they leave. But also our office has taken the responsibility to track these babies to make sure they come, and if they don’t come we find them. The guidelines are nebulous as to whose responsibility these things should be, and that’s part of the issue. This is one of the most important issues in ROP management that we have to deal with every day.

Dr. Sondhi: I want to go back to a couple of points that I made earlier that the other panelists have commented on. As I read it, I don’t think the recommendation to treat in the presence of plus disease is nebulous in this document. I would criticize it for where it is placed in the recommendations. It should be under Recommendation No. 5. I don’t think the recommendation, per se, is nebulous. It is poorly placed in the document.

Regarding the really premature babies, the 22- and 23-week babies, there may be enough data to suggest that they do not reach significant severity of ROP prior to 31 weeks. I would, however, prefer to see them a little sooner to evaluate the rate of progression of any ROP. Since these are high-risk babies, this might influence the timing of future examinations. If the disease is progressing rapidly, I might increase the frequency of examinations.

Dr. Coats: I have to disagree with Dr. Sondhi’s interpretation of the statement regarding plus disease. The document is quite clear: “The presence of plus disease … in zones 1 or 2 suggests that peripheral ablation, rather than observation, is appropriate.” That is not correct. In the criteria that were laid out in the Early Treatment of ROP Study, and that are reviewed in Recommendation No. 5, it’s not plus disease alone that justifies treatment, or that opens the window to treatment. It’s plus disease with other criteria: ie, zone and/or presence of other findings. The statement should have said that the presence of plus disease suggests that careful observation is needed and that treatment may be required in coming days and weeks.

Dr. Sondhi: Looking at the language of the document, as you say, it uses the word “suggests” peripheral ablation. It is not saying that we have to do peripheral ablation. Plus disease generally is associated with increasing severity of ROP and merits a very careful examination.

Dr. Gold: But if we look at the things the document does not say, it does not say certain stages of ROP with plus disease would then lead to treatment. It’s a more nebulous statement, and I think that that’s the part of the confusion that Dr. Coats is pointing out.

Dr. Coats: That is exactly right.

Dr. Paysse: One more comment. Figure 1 is not drawn properly. The temporal border of Zone 1 is drawn too close to the fovea, and Zone 2 looks really big. If the authors were going to publish a drawing, I wish they had used the one from the International Classification of ROP.

Dr. Coats: I agree. If you’re going to put a diagram in your guidelines by which people should devise their ROP screening and treatment protocols, it ought to be accurate.

Dr. Gold: We appreciate the fact that our colleagues are working to try to standardize our care of ROP, but as members of AAPOS we are certainly allowed, and perhaps obligated, to critique their work because in the long run we are the ones in the trenches seeing these patients. We have to have guidelines we can follow because if we don’t we can have medicolegal problems.

Dr. Paysse: A real problem with these new guidelines is the ambiguity that has been introduced. The older treatment guidelines were straightforward, and it was clear when we should treat and when we should observe, with the caveat that there may be times when you use medical judgment and experience to go outside of these guidelines. These new guidelines have so much ambiguity that they may lead to problems of interpretation and possibly even medicolegally.

Dr. Sondhi: Regarding the disclaimer, there are times when our medical judgment may make us step outside the recommended guidelines. In those situations the disclaimer may work for or against us. It offers protection when properly justified by careful observation and documentation. The flip is also true. The plaintiff’s attorney may challenge that care was provided outside the recommended guidelines.

Most guidelines, not only these for ROP but also others in general, carry some kind of disclaimer. But we should be aware that the disclaimer is a double-edged sword.

For more information:

• Robert S. Gold, MD, is in private group practice in Longwood and Winter Park, Fla. He can be reached at 225 W. State Road 434, Suite 111, Longwood, FL 32750; 407-767-6411; fax: 407- 767-8160; e-mail: rsgeye@aol.com.
• Naval Sondhi, MD, is in private group practice and is a clinical professor at Indiana University. He can be reached at Midwest Eye Institute, 201 Pennsylvania Parkway, Indianapolis, IN 46239; 317-817-1333; fax; 317-817-1331.
• David K. Coats, MD, is an assistant professor of ophthalmology at Baylor College of Medicine. He can be reached at 6701 Fannin St., CC 640.00, Houston, TX 77030; 713-824-3230; fax: 713-796-8110; e-mail: dcoats@bcm.tmc.edu.
• Evelyn A. Paysse, MD, is an assistant professor of ophthalmology at Baylor College of Medicine. She can be reached at 1102 Bates St., Suite 300, CC 640.00, Houston, TX 77030; 832-822-3234; fax: 713-796-8110; e-mail: epaysse@bcm.tmc.edu.

References:

• American Academy of Pediatrics, Section on Ophthalmology. Screening examination of premature infants for retinopathy of prematurity. Pediatrics. 2001;108:809-811. Section on Ophthalmology, American Academy of Pediatrics, American Academy of Ophthalmology, American Association for Pediatric Ophthalmology and Strabismus. Screening examination of premature infants for retinopathy of prematurity. Pediatrics. 2006;117(2):572-576.