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We thank Dr Worsley for his comments and appreciate the opportunity to respond to his concerns and clarify how and why the 2004 guidelines differ from those of 1994.
Dr Worsley is concerned about the recommendation for an additional office visit for all newborns at age 3 to 5 days. Several previous guidelines and American Academy of Pediatrics (AAP) statements (dating back to 19831) have recommended follow-up within 2 to 3 days for newborns discharged at <48 hours of age,1–5 although many pediatricians have chosen not to follow these recommendations. This is a pity because it has, on occasion, led to disastrous outcomes.6 The Subcommittee on Hyperbilirubinemia analyzed the root causes of the recently published cases of kernicterus as well as those reported to the kernicterus registry.6 The first cause listed was "early discharge (<48 hours) with no early follow-up (within 48 hours of discharge)."6(p763) Early follow-up is crucial to the newborn’s safety and well-being, because the bilirubin level in virtually every infant peaks between the third and the fifth day (in some preterm infants the peak occurs later). Thus, when an infant is discharged at 36 hours, the bilirubin level must be rising. We cannot follow these infants as we did when they remained in hospital for 3 days. If we want to identify (and treat) those infants who develop severe hyperbilirubinemia, we must see them between days 3 and 5.
Compared with previous recommendations, the 2004 guideline involves an additional visit only for newborns discharged at 48 to 72 hours of age. For many newborns, especially those whose mothers are not experienced at breastfeeding, 3 to 5 days is a time at which problems occur, and the pediatrician or other health professional can provide helpful monitoring or advice. On the other hand, bottle-fed infants of experienced mothers are at low risk and can be seen on a more flexible schedule. Recommendation 6.1.2 of the guideline states that clinical judgment should be used in determining follow-up, and that "those discharged with few or no risk factors can be seen after longer intervals."7(p302) Presumably, this would apply to the example quoted by Dr Worsley.
Dr Worsley is concerned that an early visit is difficult to implement. I can quote from the experience at my institution8,9 and elsewhere.10 There are >180 practicing primary care pediatricians on the staff of William Beaumont Hospital, and we have 98% compliance with the AAP follow-up recommendations.9 Our pediatricians have not found these requirements to be burdensome. On the contrary, they have commented on the value of early follow-up and the importance of identification of jaundice, breastfeeding, and weight loss that would not have been identified otherwise with the standard 2-week follow-up of a bygone era. Furthermore, in a recent study11 of infants who had short hospital stays, early follow-up was associated with a significant reduction in rehospitalization. (It should be noted also that the guidelines recommend follow-up by "a qualified health care professional."7[p302] Clearly this includes evaluation by a nurse in the office or the home.)
The AAP has embarked on an initiative entitled "Safe and Healthy Beginnings."12 This program embraces early follow-up for infants not only because of the risk of severe hyperbilirubinemia but also because of the need for breastfeeding support and surveillance for other events that can occur in the first days after birth and may not be recognized during a short hospital stay. It is hard to imagine that this additional visit will have a negative impact on breastfeeding (Dr Worsley’s fourth concern), because this is precisely when mothers need the most support. Nevertheless, the committee shares Dr Worsley’s concern that treatment for hyperbilirubinemia might interfere with or discourage breastfeeding. For this reason, we recommended that breastfeeding be continued in infants needing phototherapy (see Recommendation 7.37[p303]).
Dr Worsley is puzzled by the statement that Fig 2 "should not be used to represent the natural history of neonatal hyperbilirubinemia."7(p301) We appreciate the opportunity to clarify this. The legend to that figure refers readers to Appendix 1, which explains that "because of sampling bias, the lower zones are spuriously elevated."7(p309) In the original nomogram from which Fig 2 was derived, the 3 lines were labeled the 95th, 75th, and 40th percentiles. The committee was concerned that the 75th and 40th percentile designations did not represent the natural history of hyperbilirubinemia.13 Although we deleted the 75th and 40th percentile labels from the lines on the graph, we agreed that the designations as intermediate and low-risk zones are entirely appropriate. We probably should have deleted the caveat about the graph not representing the natural history of hyperbilirubinemia, because we do think these risk designations (eg, "low-risk zone") are reasonable and that this nomogram is a relevant and important predictive tool. We apologize for any resulting confusion.
Dr Worsley’s third concern is about the recommended treatment thresholds, which he believes represent a "dramatic departure from the previous recommendations." The 1994 guidelines recommended phototherapy for serum bilirubin levels of 
20 mg/dL at 72 hours of age and suggested that phototherapy be considered at that age for a level of 17 mg/dL. The 2004 guidelines are a little different, because the committee felt that a bilirubin level of 20 mg/dL in a 72-hour-old infant is more worrisome than the same level at 120 hours because it indicated a more rapid rate of rise. We therefore lowered the treatment threshold a little at 72 hours to 
18 mg/dL but raised it at 5 days to 21 mg/dL. As before, phototherapy (and home phototherapy) can be considered at levels a few milligrams per deciliter lower. The language used in the 2004 guideline is "it is an option" rather than "consider," but the thresholds are about the same as before. Thus, overall, we do not expect that the new guidelines will lead to much more phototherapy than their predecessors.
Dr Worsley believes that the new guidelines represent a drastic, aggressive change in our approach to hyperbilirubinemia. As noted above, the treatment thresholds in the current guidelines are really quite similar to those found in the 1994 guidelines. He might also wish to look at textbooks from the 1980s and the protocol for the Collaborative Phototherapy Trial14 to appreciate that there has been considerable progress toward making our approach to jaundiced newborns more evidence-based.
Dr Worsley imputes the judgment of the subcommittee because it comprised "neonatologists and public health physicians." The 8-member committee included 4 neonatologists, 2 practicing primary care pediatricians, 1 pediatrician epidemiologist who regularly attends in the normal newborn nursery, and a public health expert who was the principal investigator on a 6-year study of how jaundiced infants are cared for in Detroit, Michigan, and Texas and how this care can be improved.15,16 In addition, the subcommittee received comments, criticisms, and input from multiple individuals, including primary care physicians, in several countries, and 6 subcommittees of the AAP, all of which have strong representation from practicing primary care pediatricians.
Unfortunately, although rare, kernicterus is still with us.6,10,17 The current kernicterus registry has accumulated 174 cases to date in the United States over the last 20 years. Kernicterus has also been reported in Europe.18,19 Kernicterus is a devastating and disabling condition, and although it should almost always be preventable, cases continue to occur. As with many conditions in pediatrics (such as the evaluation and treatment of a 2-week-old febrile infant), it is necessary to evaluate and treat many infants to spare a few from irreparable harm. Until we have better diagnostic and predictive tools, we must rely on broad guidelines and our best clinical judgment. Dr Worsley maintains that by following these guidelines we will be "testing more infants and providing more therapy without compelling evidence of necessity." We agree that it is difficult to find compelling evidence of the kind that both we and Dr Worsley would prefer. On the other hand, 174 cases of kernicterus speak for themselves. The occurrence of such cases led to the publication, in 2001, of a "sentinel event alert" by the Joint Commission on Accreditation of Health Care Organizations,20 an organization not known for issuing such statements for trivial reasons.
Finally, I must respond to Dr Worsley’s comments regarding the so-called financial relationships of members of the committee with companies that "might benefit from such increased evaluation." It is impossible today to conduct research on new technology and instrumentation without the support of the companies that manufacture these instruments. There is no other way of testing technology that has not been approved by the Food and Drug Administration. In compliance with the requirements for disclosure, members of the committee listed the grant support that they have received from different companies for the conduct of clinical studies. Only 1 member of the subcommittee noted a financial interest in 1 of the companies listed. That member no longer has any financial interest in the company and the company no longer produces the instrument that measures end-tidal carbon monoxide, although they, as well as other companies, do produce a phototherapy device. It is regrettable that Dr Worsley sees fit to impugn the integrity of a group of committed physicians who devoted hundreds of (entirely unreimbursed) hours over a 3-year period to the development of these guidelines.
The Institute of Medicine21 notes that we need a dramatic change in the way the US health care system ensures the safety of patients. Safe systems are characterized by a shared knowledge of the goal and a culture emphasizing safety. These guidelines are our best effort to follow these principles.
REFERENCES
Related articles in Pediatrics:
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