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Detecting ROP is an evolving field
The chairperson of the AAP’s Subcommittee on ROP comments on the debate about detecting this ‘complex disease.’
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A note from the editors:
Ocular Surgery News invited the Subcommittee on Retinopathy of Prematurity of the American Academy of Pediatrics Section on Ophthalmology to provide comment on the accompanying round table. As the subcommittee’s chairman, Walter M. Fierson, MD, wrote the following response.
The round table published in this issue of Ocular Surgery News refers to the guidelines published in the February 2006 issue of Pediatrics. The title of this policy statement is “Screening Examination of Premature Infants for Retinopathy of Prematurity.” Its focus is on examination to detect significant ROP, not techniques of treatment.
As stated within the statement, “This statement outlines the principles on which a program to detect ROP in infants at risk might be based. The goal of an effective screening program must be to identify the relatively few preterm infants who require treatment for ROP from among the much larger number of at-risk infants while minimizing the number of stressful examinations required for these sick infants. Any screening program designed to implement an evolving standard of care has inherent defects, such as overreferral or underreferral, and by its very nature, cannot duplicate the precision and rigor of a scientifically based clinical trial.”
New concept
Dr. Coats objects to one “confusing issue.” He states:
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.”
This objection is in error. The first mention in recommendation 4 is an introduction to the new concept for this series of guidelines on ROP that the presence of plus disease is a vital, if not controlling, factor. Recommendation 5 continues and explains that change in recommendation from the previous editions. No confusion is present.
Complexities
Dr. Paysse’s comment that “the timing guidelines are complex” is correct. They are complex.
However, the goal of the statement, as indicated in the introduction, is to recommend a program “to identify the relatively few preterm infants who require treatment for ROP from among the much larger number of at-risk infants.”
Certainly, if an examiner believes that additional examinations are indicated, he or she is correct in performing more. This statement is an attempt to suggest minimal standards, not maximal ones. Again, this statement establishes “the principles on which a program to detect ROP in infants at risk might be based.” If this scheduling is inconsistent with the practical necessities of a given neonatal intensive care unit, the examiner should establish a schedule of exams with which he or she is comfortable and which equal or exceed the schedule suggested here.
Additionally, in response to Dr. Paysse’s comment about regression, it is beyond our scope to define regression, which is a concept that has been used for more than 20 years in the ROP literature. That is why we use Dr. Michael Repka’s paper as reference.
The diagram used was based on the one taken from the original International Classification of Retinopathy of Prematurity paper, where it was first reported. Zone 3 is deliberately made small because it is the least important area regarding the treatment and prognosis for ROP. What happens in zone 3 is rarely of significance. In any event, it is a diagram, not an accurate reproduction of retinal anatomy. Those seeking a template to use for recording data at their home institution should use the ICROP diagram, rather than an accurate retinal drawing, to save time.
Dr. Paysse’s comment that “there is a contradiction about whom to screen” is correct. The 32-week recommendation published in the guideline is a typographical error. The authoring committee is now in the process of requesting that the publisher print a correction, changing that to 30 weeks. We hope that this will be accomplished quickly.
Informed consent issues
Dr. Coats’s comment about parents being “made to understand,” is I believe, misguided. The statement’s intent is that an effort be made to inform the parents of at-risk infants about to be discharged of the consequences of failure to obtain timely and proper follow-up in a manner such that the parents understand the information, not just that they are given the information.
In effect, this is what we do all the time in obtaining informed consent for any procedure. It is not sufficient for the person from whom the consent is to be obtained simply to be given the information; he or she must understand it to be able to give a valid consent. This principle has been well established in many legal proceedings.
Defining procedures
Dr. Gold makes a good point that follow-up tracking is important. The statement does not precisely fix the nature of the responsibility for this tracking (ie, how it is to be done) because different methods are used in different NICUs and in different parts of the country.
There is absolutely no evidence published to the effect that one method is superior to the others, nor is there any logical reason to believe that to be the case. I call attention to the first sentence in recommendation 8: “Responsibility for examination and follow-up of infants at risk of ROP must be carefully defined by each NICU.” The authors believe this to be the correct approach.
Not a ‘cookbook’ approach
With respect to Dr. Coats’s comment, “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,” the authors stand by the recommendations made in the statement. The authors believe that these recommendations are justified by the available literature. I agree with Dr. Sondhi’s comment on this subject.
With respect to Dr. Gold’s comment that this document is “a more nebulous statement:” This statement is not less precise than the one that preceded it. Both statements are left deliberately somewhat imprecise because the literature is not completely definitive on all possible cases, and room must be left for the judgment of the clinicians caring for the patient. Taking a “cookbook” approach to writing this guideline would not be justified by our current state of knowledge and would give lawyers an excellent platform on which to stand whenever the slightest deviation from such an exacting guideline were detected in a case of ROP gone bad.
This same comment applies to Dr. Paysse’s final comment about ambiguity. Once again, I agree with Dr. Sondhi’s final comment on this.
Detection and treatment of ROP is an evolving field, and the authors expect debate about the currently available evidence and based on that evidence. More significantly, we look forward to more evidence-based research that will promote improved understanding of this complex disease and its most appropriate treatment.
For more information:
- Walter M. Fierson, MD, can be reached at Suite 109. 1245 W. Huntington Drive, Arcadia, CA 91007-6393; 626-304-7081; fax: 626-304-1078; e-mail: pdeyes@earthlink.net.
References:
- 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.