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Pulse oximetry screening in newborns
LETTERS TO THE EDITOR
Pulse oximetry screening in newborns To the Editor: I greatly appreciate the editorial comments by Mahle1 referring to our recent article in The Journal.2 Some critical heart defects may be missed in pulse oximetry screening, especially left heart obstructive lesions, such as coarctation of the aorta. No screening test is 100% accurate, and complementary strategies clearly are needed to detect these defects early. I would like to respond to Mahle’s concerns regarding the false positives (0.6%) in our first-day-of-life screening program. This rate refers to the detection of heart defects only, and almost half of the false positives were potentially severe noncardiac disorders (134/281; 48%), such as pneumothorax, pulmonary hypertension, and infections (eg, cases with early-onset group B streptococcal septicemia). The “true false positives,” defined as healthy babies in a phase of prolonged transitional circulation, accounted for only 52% of the total false positives. Early detection of extracardiac disorders may be an added advantage of the screening program and may be as important as detecting heart defects. Further studies are needed to evaluate the value of pulse oximetry in universal screening for disease, not only for cardiac disorders in neonates.
provided, although they are important for interpretation of the results. In addition, none of the data collected at week 2, before the start of treatment, were provided. At baseline, the mean overall QOL scores were 127.5 and 109.4 in the placebo and amitriptyline group respectively. This is a clinically relevant difference according to the authors’ definition (⬍15%), yet, in the analysis no adjustment for this baseline difference was performed. In patients with IBS symptomatic periods are followed by symptom-free periods. If patients in the amitriptyline group were in a symptomatic period compared with patients in the placebo group at the time of inclusion relatively more frequent, QOL on average may be expected to increase more in the amitriptyline group resulting in the outcomes reported independent of the provided medication, the phenomenon known as regression to the mean. Furthermore, because this clinically relevant baseline difference exists, a relative outcome measure, such as a 15% improvement in QOL, will favor the group with the lowest baseline value because, in absolute terms, less improvement is needed to be successfully treated. The authors should provide all baseline characteristics of included patients and perform adjusted analyses with absolute outcome measures before we can conclude that amitriptyline may be a relevant therapeutic option for adolescents with IBS.
Alf Meberg, MD, PhD Neonatal Unit, Department of Pediatrics Vestfold Hospital Tønsberg, Norway
Yvonne van Leeuwen, MSc Marjan Rafiee, MD Department of General Practice Erasmus MC University Medical Center Rotterdam, The Netherlands
10.1016/j.jpeds.2008.07.038
10.1016/j.jpeds.2008.08.002
REFERENCES 1. Mahle WT. Physical examination and pulse oximetry in newborn infants: out with the old, in with the new? [editorial]. J Pediatr 2008;152:747-8. 2. Meberg A, Brügmann-Pieper S, Due R Jr, Eskedal L, Fagerli I, Farstad T, et al. First-day-of-life pulse oximetry screening to detect congenital heart defects. J Pediatr 2008;152:761-5.
Amitriptyline for the treatment of irritable bowel syndrome To The Editor: Bahar et al1 reported a double-blind placebo-controlled trial on the effect of amitriptyline for the treatment of irritable bowel syndrome (IBS) in adolescents. On the basis of the improvement of overall quality of life (QOL) observed in the study, the authors conclude that amitriptyline should be considered for adolescents with IBS. Significant improvement in several outcome measures such as QOL, dysphoria, interference with activities, health worry, and food avoidance were reported. Unfortunately, no baseline values for several of these outcome measures were 872
Letters to the Editor
REFERENCE 1. Bahar RJ, Collins BS, Steinmetz B, Ament ME. Double-blind placebo-controlled trial of amitriptyline for the treatment of irritable bowel syndrome in adolescents. J Pediatr 2008;152:685-9.
Reply To the Editor: We thank van Leeuwen and Rafiee for their careful scrutiny of our results and their helpful comments. The expanded version of our original Table shows mean absolute (not percent) change and includes the baseline values at week 1 and the pretreatment responses at week 2 as they suggested (Table I). Previously, only baseline for overall quality of life (QOL) was reported. As can be seen, for all 5 QOL outcomes, the difference in the mean changes from week 0 baseline between amitriptyline and placebo at pretreatment week 2 is not significant and, in fact, the mean change is either the same or sometimes larger in the placebo group except for dysphoria. Thus, all of the significant mean minus The Journal of Pediatrics • December 2008
Pulse oximetry screening in newborns To the Editor: I greatly appreciate the editorial comments by Mahle1 referring to our recent article in The Journal.2 Some critical heart defects may be missed in pulse oximetry screening, especially left heart obstructive lesions, such as coarctation of the aorta. No screening test is 100% accurate, and complementary strategies clearly are needed to detect these defects early. I would like to respond to Mahle’s concerns regarding the false positives (0.6%) in our first-day-of-life screening program. This rate refers to the detection of heart defects only, and almost half of the false positives were potentially severe noncardiac disorders (134/281; 48%), such as pneumothorax, pulmonary hypertension, and infections (eg, cases with early-onset group B streptococcal septicemia). The “true false positives,” defined as healthy babies in a phase of prolonged transitional circulation, accounted for only 52% of the total false positives. Early detection of extracardiac disorders may be an added advantage of the screening program and may be as important as detecting heart defects. Further studies are needed to evaluate the value of pulse oximetry in universal screening for disease, not only for cardiac disorders in neonates.
provided, although they are important for interpretation of the results. In addition, none of the data collected at week 2, before the start of treatment, were provided. At baseline, the mean overall QOL scores were 127.5 and 109.4 in the placebo and amitriptyline group respectively. This is a clinically relevant difference according to the authors’ definition (⬍15%), yet, in the analysis no adjustment for this baseline difference was performed. In patients with IBS symptomatic periods are followed by symptom-free periods. If patients in the amitriptyline group were in a symptomatic period compared with patients in the placebo group at the time of inclusion relatively more frequent, QOL on average may be expected to increase more in the amitriptyline group resulting in the outcomes reported independent of the provided medication, the phenomenon known as regression to the mean. Furthermore, because this clinically relevant baseline difference exists, a relative outcome measure, such as a 15% improvement in QOL, will favor the group with the lowest baseline value because, in absolute terms, less improvement is needed to be successfully treated. The authors should provide all baseline characteristics of included patients and perform adjusted analyses with absolute outcome measures before we can conclude that amitriptyline may be a relevant therapeutic option for adolescents with IBS.
Alf Meberg, MD, PhD Neonatal Unit, Department of Pediatrics Vestfold Hospital Tønsberg, Norway
Yvonne van Leeuwen, MSc Marjan Rafiee, MD Department of General Practice Erasmus MC University Medical Center Rotterdam, The Netherlands
10.1016/j.jpeds.2008.07.038
10.1016/j.jpeds.2008.08.002
REFERENCES 1. Mahle WT. Physical examination and pulse oximetry in newborn infants: out with the old, in with the new? [editorial]. J Pediatr 2008;152:747-8. 2. Meberg A, Brügmann-Pieper S, Due R Jr, Eskedal L, Fagerli I, Farstad T, et al. First-day-of-life pulse oximetry screening to detect congenital heart defects. J Pediatr 2008;152:761-5.
Amitriptyline for the treatment of irritable bowel syndrome To The Editor: Bahar et al1 reported a double-blind placebo-controlled trial on the effect of amitriptyline for the treatment of irritable bowel syndrome (IBS) in adolescents. On the basis of the improvement of overall quality of life (QOL) observed in the study, the authors conclude that amitriptyline should be considered for adolescents with IBS. Significant improvement in several outcome measures such as QOL, dysphoria, interference with activities, health worry, and food avoidance were reported. Unfortunately, no baseline values for several of these outcome measures were 872
Letters to the Editor
REFERENCE 1. Bahar RJ, Collins BS, Steinmetz B, Ament ME. Double-blind placebo-controlled trial of amitriptyline for the treatment of irritable bowel syndrome in adolescents. J Pediatr 2008;152:685-9.
Reply To the Editor: We thank van Leeuwen and Rafiee for their careful scrutiny of our results and their helpful comments. The expanded version of our original Table shows mean absolute (not percent) change and includes the baseline values at week 1 and the pretreatment responses at week 2 as they suggested (Table I). Previously, only baseline for overall quality of life (QOL) was reported. As can be seen, for all 5 QOL outcomes, the difference in the mean changes from week 0 baseline between amitriptyline and placebo at pretreatment week 2 is not significant and, in fact, the mean change is either the same or sometimes larger in the placebo group except for dysphoria. Thus, all of the significant mean minus The Journal of Pediatrics • December 2008