CLINICAL ISSUES: INFANCY AND CHILDHOOD Less Aggressive Treatment of Neonatal Jaundice and Reports of Kernicterus: Lessons About Practice Guidelines

The publication of guidelines calling for less aggressive treatment of jaundice in newborns has been followed by a reappearance of case reports of kernicterus. These case reports illustrate important issues for writers and consumers of practice guidelines. One issue is the particular salience of identified patients with bad outcomes, and their potentially disproportionate influence on decision-makers. A second issue is whether, when good evidence of treatment benefit is lacking, policymakers should recommend what has traditionally been done, recommend less treatment, or not make recommendations at all. Finally, the cases raise the question of whether treatment guidelines should be more conservative than their authors actually believe is necessary, to take into account the likelihood that they will not be closely followed. We believe that case reports can serve as an important early warning system, but policymakers should be aware of their potentially disproportionate influence. In the long run, patients and clinicians will be best served by guidelines that summarize and acknowledge the limitations of existing evidence, that allow a wide range of treatment options when evidence is weak, and that recommend what the guideline authors actually believe should be done. In the short run a period of readjustment may be required, however, as clinicians become accustomed to guidelines written to be followed, rather than bent. Pediatrics 2000;105:242–245; neonatal jaundice, bilirubin, kernicterus, practice guidelines. ABBREVIATION. TSB, total serum bilirubin. In 1992, we wrote an article suggesting a “kinder, gentler approach” to the evaluation and treatment of jaundice in the term newborn.1 We suggested that much of the then-recommended treatment of jaundiced newborns was unnecessary, and that fewer laboratory tests and higher treatment thresholds were more consistent with available evidence. The article received a mixed response from neonatal jaundice experts.2–9 Some7–9 expressed the concern that the new recommendations might lead to an increase in kernicterus. Nonetheless, a practice parameter published 2 years later by a committee of the American Academy of Pediatrics10 recommended a similar approach. Shortly thereafter case reports of newborns who developed apparent kernicterus began to appear.11–15 Although early postpartum discharge received much of the blame for these cases, some authors suggested that because the guidelines advocated a less aggressive approach to the treatment of neonatal jaundice they may also have contributed to these kernicterus cases.13–15 These case reports raise several questions that are relevant to producers and consumers of clinical practice guidelines in general. How should case reports influence health policy? How should guidelines be written in the face of insufficient evidence? Finally, should guidelines be more conservative than their authors actually believe is necessary, to take into account the likelihood that they will not be closely followed? We discuss these issues below. WHAT SHOULD BE THE IMPACT OF CASE REPORTS ON HEALTH POLICY? Brown and Johnson,15 combining their own cases with recent reports of others, identified 41 cases of kernicterus occurring in the United States in the last 20 years. Of these, 31 occurred after 1990, representing what they believe to be a dramatic increase. The degree to which this increase in case reports represents a true increase in kernicterus, however, is unknown. At least some of the apparent increase may be attributable to increased interest and reporting, stimulated by their and others’ concern about the dangers of early postpartum discharge or less aggressive jaundice treatment. Without a uniform case definition and a constant level of surveillance it is impossible to quantify, or even to be entirely confident of any increase in the incidence of kernicterus. Nonetheless, case reports can provide an early warning system for a change in practice that might be hazardous, and are worth examining carefully in an effort to determine the root cause of any adverse outcome. Was the guideline followed? Were there particular characteristics of the patient that might explain the bad outcome? At this writing, details of many of the cases have From the *Departments of Epidemiology and Biostatistics, Laboratory Medicine, and Pediatrics, School of Medicine, University of California, San Francisco, California, and the ‡Department of Pediatrics, William Beaumont Hospital, Royal Oak, Michigan, Wayne State University School of Medicine, and the University of Michigan Medical School, Ann Arbor,