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Palivizumab for children with congenital heart disease—good news for efficacy, good news for safety
Improving adherence in children and adolescents
A biochemical marker for fetal exposure to alcohol
This issue of The Journal has two articles that address the question of medical adherence. The first is an invited commentary by Dr Bryan Lask from London, in which he discusses a new approach to improving adherence, ‘‘Motivational enhancement therapy (MET).’’ This approach has been tested in patients with cystic fibrosis and Lask describes the technique; we look forward to seeing more data concerning its application. The second paper is from Barbara Fiese and Frederick Wamboldt (‘‘Tales of pediatric asthma management: familybased strategies related to medical adherence and health care utilization’’). In this paper, the authors study how family management style, measured by videotaped semistructured interviews, correlates with medical adherence and use of health care resources. They describe three categories of disease management: reactive, coordinated care, and family partnerships. The families with the reactive style did worse than the other two groups, but the family partnerships did not really seem to have better outcomes than coordinated care. These papers help us to understand better how families manage chronic diseases and challenge some of our preconceptions concerning therapeutic approaches to adherence/ concordance. —Robert W. Wilmott, MD Page 430 (Lask) Page 457 (Fiese)
Epidemiologic and outcome studies of fetal exposures to toxins, drugs, and tobacco utilize the detection of the agents or their products in meconium as the gold standard to verify notoriously unreliable maternal histories. The most prevalent fetal toxin that is the most frequent cause of neurodevelopmental abnormalities is alcohol. Exposure has relied on maternal history because the oxidation products of alcohol disappear rapidly. However, nonoxidative fatty acid ethyl esters also result from alcohol exposure; thus, ethyl oleate in meconium is reported by Bearer et al to correlate strongly with maternal alcohol exposure. The ethyl oleate was detected by the highly sensitive technique of gas chromatography-tandem mass spectroscopy. The availability of a biochemical technique to evaluate fetal exposure to alcohol will improve studies linking fetal alcohol exposure to outcome. The analysis of meconium could also allow clinicians to identify infants at risk of alcohol-related problems. —Alan H. Jobe, MD, PhD Page 463
Growth in juvenile idiopathic arthritis Juvenile idiopathic arthritis ( JIA, the disorder many of us remember as ‘‘juvenile rheumatoid arthritis’’) is one of many chronic disorders of children in which growth restriction is a major feature. As is the case with renal, gastrointestinal, and cardiac disease, the presumed mechanism of the growth failure is both the underlying condition and the use of medications (especially corticosteroids) that impact growth. Even after JIA has remitted, patients may be left with the sequela of impaired adult height. In this issue of The Journal, Bechtold et al report the results of a four-year double controlled trial of human growth hormone (hGH) in a series of children with JIA. The mean improvement in standard deviation score (SDS) of the treated children was >1, whereas the control children lost a mean SDS of 0.7. In looking at measures of disease activity and corticosteroid dosage, both were found to impact growth, regardless of hGH treatment status. There were little in the way of important side effects of hGH in these children. —Thomas R. Welch, MD Page 512
The Journal of Pediatrics
Palivizumab for children with congenital heart disease—Good news for efficacy, good news for safety The report by Feltes et al on the efficacy and safety of palivizumab prophylaxis on morbidity of respiratory syncytial virus (RSV) infections in children with hemodynamically significant congenital heart disease is as good as it gets. The current study of palivizumab is razor sharp—planned to avoid potential pitfalls of design, or to better understand unexpected events as found during the efficacy trial of hyperimmune RSV globulin (RSV-IGIV) a decade ago. Randomized, doubleblinded, placebo-controlled, multicentered, multinationed, multistratified, adequately powered, objectively judged for multiple outcomes of efficacy and safety and with greater than 95% completing the 6-month protocol—this is a model for clinical research. Findings have been translated rapidly into recommendations for use in this patient population. Ironically, this was the original target population most likely to benefit from RSV prevention, but which was excluded from initial application of palivizumab use because of prior experience of adverse events that occurred during the RSV-IVIG trial. Approximately 50% relative reduction in RSV hospitalization and in total RSV hospital days per 100 children was documented after administration of palivizumab in the current study, with no related adverse events. —Sarah S. Long, MD Page 532
October 2003
3A
A biochemical marker for fetal exposure to alcohol
This issue of The Journal has two articles that address the question of medical adherence. The first is an invited commentary by Dr Bryan Lask from London, in which he discusses a new approach to improving adherence, ‘‘Motivational enhancement therapy (MET).’’ This approach has been tested in patients with cystic fibrosis and Lask describes the technique; we look forward to seeing more data concerning its application. The second paper is from Barbara Fiese and Frederick Wamboldt (‘‘Tales of pediatric asthma management: familybased strategies related to medical adherence and health care utilization’’). In this paper, the authors study how family management style, measured by videotaped semistructured interviews, correlates with medical adherence and use of health care resources. They describe three categories of disease management: reactive, coordinated care, and family partnerships. The families with the reactive style did worse than the other two groups, but the family partnerships did not really seem to have better outcomes than coordinated care. These papers help us to understand better how families manage chronic diseases and challenge some of our preconceptions concerning therapeutic approaches to adherence/ concordance. —Robert W. Wilmott, MD Page 430 (Lask) Page 457 (Fiese)
Epidemiologic and outcome studies of fetal exposures to toxins, drugs, and tobacco utilize the detection of the agents or their products in meconium as the gold standard to verify notoriously unreliable maternal histories. The most prevalent fetal toxin that is the most frequent cause of neurodevelopmental abnormalities is alcohol. Exposure has relied on maternal history because the oxidation products of alcohol disappear rapidly. However, nonoxidative fatty acid ethyl esters also result from alcohol exposure; thus, ethyl oleate in meconium is reported by Bearer et al to correlate strongly with maternal alcohol exposure. The ethyl oleate was detected by the highly sensitive technique of gas chromatography-tandem mass spectroscopy. The availability of a biochemical technique to evaluate fetal exposure to alcohol will improve studies linking fetal alcohol exposure to outcome. The analysis of meconium could also allow clinicians to identify infants at risk of alcohol-related problems. —Alan H. Jobe, MD, PhD Page 463
Growth in juvenile idiopathic arthritis Juvenile idiopathic arthritis ( JIA, the disorder many of us remember as ‘‘juvenile rheumatoid arthritis’’) is one of many chronic disorders of children in which growth restriction is a major feature. As is the case with renal, gastrointestinal, and cardiac disease, the presumed mechanism of the growth failure is both the underlying condition and the use of medications (especially corticosteroids) that impact growth. Even after JIA has remitted, patients may be left with the sequela of impaired adult height. In this issue of The Journal, Bechtold et al report the results of a four-year double controlled trial of human growth hormone (hGH) in a series of children with JIA. The mean improvement in standard deviation score (SDS) of the treated children was >1, whereas the control children lost a mean SDS of 0.7. In looking at measures of disease activity and corticosteroid dosage, both were found to impact growth, regardless of hGH treatment status. There were little in the way of important side effects of hGH in these children. —Thomas R. Welch, MD Page 512
The Journal of Pediatrics
Palivizumab for children with congenital heart disease—Good news for efficacy, good news for safety The report by Feltes et al on the efficacy and safety of palivizumab prophylaxis on morbidity of respiratory syncytial virus (RSV) infections in children with hemodynamically significant congenital heart disease is as good as it gets. The current study of palivizumab is razor sharp—planned to avoid potential pitfalls of design, or to better understand unexpected events as found during the efficacy trial of hyperimmune RSV globulin (RSV-IGIV) a decade ago. Randomized, doubleblinded, placebo-controlled, multicentered, multinationed, multistratified, adequately powered, objectively judged for multiple outcomes of efficacy and safety and with greater than 95% completing the 6-month protocol—this is a model for clinical research. Findings have been translated rapidly into recommendations for use in this patient population. Ironically, this was the original target population most likely to benefit from RSV prevention, but which was excluded from initial application of palivizumab use because of prior experience of adverse events that occurred during the RSV-IVIG trial. Approximately 50% relative reduction in RSV hospitalization and in total RSV hospital days per 100 children was documented after administration of palivizumab in the current study, with no related adverse events. —Sarah S. Long, MD Page 532
October 2003
3A