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Published ahead of print on August 11, 2005, doi:10.1164/rccm.200407-989OC

Am. J. Respir. Crit. Care Med., Volume 172, Number 9, November 2005, 1128-1132

A more recent version of this article appeared on November 1, 2005
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Submitted on July 30, 2004
Accepted on August 9, 2005

Computed Tomography Correlates with Pulmonary Exacerbations in Children with Cystic Fibrosis

Alan S Brody1*, Heidi Sucharew2, Jonathan D Campbell2, Steven P Millard2, Paul L Molina3, Jeffrey S Klein4, and Joanne Quan5

1 Department Radiology and Pediatrics, Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, USA, 2 Statistical Analysis Unit, Cystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle, WA, USA, 3 Department of Radiology, University of North Carolina School of Medicine, Chapel Hill, NC, USA, 4 Department of Radiology, University of Vermont, Fletcher Allen Health Care, Burlington, VT, USA, 5 Medical Affairs, Genentech, Inc., South San Francisco, CA, USA

* To whom correspondence should be addressed. E-mail: alan.brody{at}cchmc.org.

Rationale: High-resolution computed tomography has been suggested as a potential outcome surrogate for CF lung disease. An important attribute of a valid outcome surrogate is that the surrogate reflects true clinical outcomes. Objectives: We performed this study to validate high-resolution computed tomography, a proposed surrogate outcome measure for CF lung disease, against a true clinical outcome, the number of respiratory tract exacerbations occurring in two years; and to assess the correlation of CT scores and PFTs with this clinical outcome. Methods: CTs and PFTs were performed on 6 to 10 year old children at the beginning and end of a two-year study during which the number of exacerbations were recorded. Spearman correlations and Poissin models were used to assess the correlation of the number of exacerbations with baseline values and changes in PFTs and CT scores. Measurements and Main Results: Nine of 61 subjects had a total of 22 respiratory tract exacerbations. At baseline, PFTs and four CT scores showed significant correlation with number of exacerbations, but no variable by itself predicted exacerbations with high accuracy. For change over the two-year period, three CT scores showed significant correlation with exacerbations, while no PFTs showed significant correlation. Conclusion: This is the first study showing correlation between CT and a true clinical outcome. Change in CT scores correlates moderately well with the number of exacerbation. Poor correlation between change in FEV1 and exacerbations suggests that HRCT may be a more appropriate outcome surrogate for longitudinal studies of young children.
Key words: computerized tomography X-ray, surrogate endpoint, pulmonary function tests, children, forced expiratory volume




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