Prospective multicenter randomized patient recruitment and sample collection to enable future measurements of sputum biomarkers of inflammation in an observational study of cystic fibrosis
AuthorLiou, Theodore G.
Adler, Frederick R.
Brown, Perry S.
Chatfield, Barbara A.
Daines, Cori L.
Francis, Jessica A.
Hoidal, John R.
Jensen, Judy L.
Kopecky, Carol M.
Packer, Kristyn A.
Poch, Katie R.
Quittner, Alexandra L.
Redway, Abby J.
Sagel, Scott D.
Taylor-Cousar, Jennifer L.
Vroom, Jane B.
Clancy, John P.
Elborn, J. Stuart
Olivier, Kenneth N.
Cox, David R.
AffiliationUniv Arizona Hlth Sci
Randomized observational trial
Cystic Fibrosis Foundation patient registry
MetadataShow full item record
CitationLiou, T. G., Adler, F. R., Argel, N., Asfour, F., Brown, P. S., Chatfield, B. A., ... & Heynekamp, T. (2019). Prospective multicenter randomized patient recruitment and sample collection to enable future measurements of sputum biomarkers of inflammation in an observational study of cystic fibrosis. BMC medical research methodology, 19(1), 88.
JournalBMC MEDICAL RESEARCH METHODOLOGY
RightsCopyright © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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AbstractBackground: Biomarkers of inflammation predictive of cystic fibrosis (CF) disease outcomes would increase the power of clinical trials and contribute to better personalization of clinical assessments. A representative patient cohort would improve searching for believable, generalizable, reproducible and accurate biomarkers. Methods: We recruited patients from Mountain West CF Consortium (MWCFC) care centers for prospective observational study of sputum biomarkers of inflammation. After informed consent, centers enrolled randomly selected patients with CF who were clinically stable sputum producers, 12years of age and older, without previous organ transplantation. Results: From December 8, 2014 through January 16, 2016, we enrolled 114 patients (53 male) with CF with continuing data collection. Baseline characteristics included mean age 27 years (SD = 12), 80% predicted forced expiratory volume in 1s (SD = 23%), 1.0 prior year pulmonary exacerbations (SD = 1.2), home elevation 328 m (SD=112) above sea level. Compared with other patients in the US CF Foundation Patient Registry (CFFPR) in 2014, MWCFC patients had similar distribution of sex, age, lung function, weight and rates of exacerbations, diabetes, pancreatic insufficiency, CF-related arthropathy and airway infections including methicillin-sensitive or -resistant Staphylococcus aureus, Pseudomonas aeruginosa, Burkholderia cepacia complex, fungal and non-tuberculous Mycobacteria infections. They received CF-specific treatments at similar frequencies. Conclusions: Randomly-selected, sputum-producing patients within the MWCFC represent sputum-producing patients in the CFFPR. They have similar characteristics, lung function and frequencies of pulmonary exacerbations, microbial infections and use of CF-specific treatments. These findings will plausibly make future interpretations of quantitative measurements of inflammatory biomarkers generalizable to sputum-producing patients in the CFFPR.
NoteOpen access journal
VersionFinal published version
SponsorsCF Foundation (CFF) [LIOU13A0, LIOU14Y4]; National Center for Advancing Translational Science at the National Institutes of Health [NCATS/NIH 8UL1TR000105]; Ben B and Iris M Margolis Foundation of Utah; Claudia Ruth Goodrich Stevens Endowment Fund
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