PEDIATRICS Vol. 118 No. 1 July 2006, pp. 432-433 (doi:10.1542/peds.2006-1066)
Behavioral and Nutritional Treatment to Improve Energy Intake and Growth in Toddlers and Preschool-Aged Children With Cystic Fibrosis: In Reply
Scott W. Powers, PhDDivision of Behavioral Medicine and Clinical Psychology,
Cincinnati Children's Hospital Medical Center,
Cincinnati, OH 45229-3039,
Department of Pediatrics,
University of Cincinnati College of Medicine,
Cincinnati, OH 45267
In response to our clinical trial report,1 Rowland et al raised concerns about sample size, examination of height velocity, choice of control group, and need for replication. We welcome discussion about advancing behavioral science studies that aim to improve health outcomes in pediatric populations and agree that this type of clinical investigation poses potential benefits to children with cystic fibrosis (CF) and their families while also presenting challenges to scientist-practitioners. Indeed, results of a single clinical trial study can never provide evidence of generalizability or replication, and decisions made in the process of designing and executing a clinical trial necessitate trade-offs and compromises. In our report, we acknowledged and discussed (and proposed future directions for) each of the issues raised in the letter by Rowland et al (plus a number of other topics). We also presented our plans for continuing this line of clinical research.
In terms of our progress with plans for this research program, we recently completed the 24-month assessment phase of our 4-year follow-up study to this clinical trial. We will be submitting findings this year that highlight maintenance of energy intake and present data on change in weight and height for age and gender z scores for each of the 9 subjects 2 years posttreatment. Preliminary findings indicate that subjects average a change of approximately +0.33 z-score units. We are currently enrolling subjects into the National Institutes of Health–funded multisite clinical trial that is discussed in our article, and we are enrolling a subset of these subjects into a Cystic Fibrosis Foundation–funded 2-site study of high-resolution computed tomography as a measure of lung disease in young children with CF who participate in behavioral and nutrition treatment. We are also working on plans to design and conduct effectiveness studies of this approach to improving nutrition and growth in children with CF. It is our goal to provide more evidence of the impact of behavioral and nutrition treatment, to advance the care of young children with CF, and to obtain data from a group of studies, because this is necessary to meet the scientific objectives of replication, generalizability, translation, and dissemination.
At present, we stand by the conclusions of our report; that is, "Behavioral and nutrition therapy may fill an important gap regarding early, evidence-based nutritional interventions in CF and lead to advances in the nutritional care of young children with CF and pancreatic insufficiency. Future studies need to focus on 2 complementary objectives: confirmation of the efficacy of behavioral therapy in large, multicenter, randomized clinical trials and development and testing of the effectiveness of this type of therapy under real-world conditions." We encourage other scientists and practitioners to participate in research that focuses on the promise of behavioral medicine to improve health outcomes in pediatrics. In pediatrics, children are often provided care that is not evidence based, approved for use in people under the age of 18, or based on results from well-designed effectiveness/dissemination studies. We agree that children and families deserve better, and we are working hard to meet these goals for young children with CF, their families, and their health care providers. In talking with families across a number of CF centers, they agree that good science is welcomed but also note that a therapy that has results such as those presented in our report may be a good thing for their children. It is the balancing of these perspectives that drives our work and makes us both cautious and optimistic about what we have learned thus far.
REFERENCE
- Powers SW, Jones JS, Ferguson KS, Piazza-Waggoner C, Daines C, Acton JD. Randomized clinical trial of behavioral and nutritional treatment to improve energy intake and growth in toddlers and preschoolers with cystic fibrosis.
Pediatrics. 2005;116
:1442
–1450
[Abstract/Free Full Text]
PEDIATRICS (ISSN 1098-4275). ©2006 by the American Academy of Pediatrics
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Related articles in Pediatrics:
- Behavioral and Nutritional Treatment to Improve Energy Intake and Growth in Toddlers and Preschool-Aged Children With Cystic Fibrosis
- Marion Rowland, Annemarie Broderick, and Billy Bourke
Pediatrics 2006 118: 432.[Extract] [Full Text]
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