1. Prospective multicenter randomized patient recruitment and sample collection to enable future measurements of sputum biomarkers of inflammation in an observational study of cystic fibrosis
- Author
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David Cox, Jessica A. Francis, Carol M. Kopecky, John P. Clancy, Osmara Molina, Barbara Glover, Frederick R. Adler, Dixie Durham, Kristyn A Packer, Ruth H. Keogh, Perry S. Brown, Peggy Radford, Theodore G. Liou, Abby J. Redway, Ryan Yoshikawa, Shawna Sprandel, Scott D. Sagel, Jerimiah Lysinger, Katie R. Poch, Jane B. Vroom, John R. Hoidal, Yanping Li, Alexandra L. Quittner, Cori L. Daines, Theresa Heynekamp, Natalia Argel, Noah Lechtzin, Kenneth N. Olivier, Craig Nakamura, Barbara A. Chatfield, Fadi Asfour, Judy L. Jensen, Jennifer L. Taylor-Cousar, and J. Stuart Elborn
- Subjects
Adult ,Male ,Methicillin-Resistant Staphylococcus aureus ,medicine.medical_specialty ,Adolescent ,Cystic Fibrosis ,Epidemiology ,Health Informatics ,Cystic fibrosis ,Neutrophil elastase ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Internal medicine ,Arthropathy ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Lung ,HMGB-1 ,lcsh:R5-920 ,business.industry ,030503 health policy & services ,Patient Selection ,Sputum ,Study design ,Middle Aged ,Staphylococcal Infections ,medicine.disease ,Sputum inflammation ,Clinical trial ,Patient recruitment ,Cohort ,Randomized observational trial ,Observational study ,Female ,Sample collection ,medicine.symptom ,lcsh:Medicine (General) ,0305 other medical science ,business - Abstract
Background 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, 12 years 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 1 s (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.
- Published
- 2018