2019
DOI: 10.1186/s12874-019-0705-0
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Prospective multicenter randomized patient recruitment and sample collection to enable future measurements of sputum biomarkers of inflammation in an observational study of cystic fibrosis

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 infla… Show more

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Cited by 9 publications
(22 citation statements)
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“…There were no significant differences in clinical characteristics, microbiology or treatment profiles between patients with and without heme measurement results from the greater MWCFC patient cohort (Table 1), strongly suggesting that missing heme measurements were missing at random [9] and that inferences based on the measurements made are not biased due to a specific pattern of patient selection. As previously reported, there were no differences between the characteristics of the 114 patients in the MWCFC study group and the other 14,394 patients twelve years of age and able to produce sputum found in the 2014 CF Foundation Patient Registry [7].…”
Section: Resultsmentioning
confidence: 65%
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“…There were no significant differences in clinical characteristics, microbiology or treatment profiles between patients with and without heme measurement results from the greater MWCFC patient cohort (Table 1), strongly suggesting that missing heme measurements were missing at random [9] and that inferences based on the measurements made are not biased due to a specific pattern of patient selection. As previously reported, there were no differences between the characteristics of the 114 patients in the MWCFC study group and the other 14,394 patients twelve years of age and able to produce sputum found in the 2014 CF Foundation Patient Registry [7].…”
Section: Resultsmentioning
confidence: 65%
“…While maintaining randomization, we controlled the rates of enrollment to reduce seasonal and center-specific biases by setting a threshold selection priority for recruitment by center. Detailed methods are provided in Liou et al [7].…”
Section: Methodsmentioning
confidence: 99%
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“…To potentially validate calprotectin, NE or HMGB1, or identify other biomarkers as explanatory for clinical CF outcomes, we performed a prospective observational multicenter study incorporating randomized selection to minimize observer bias and maximize generalizability (12). We collected sputum during clinical stability as the least invasive sample closest to sources of persistent airway inflammation and evaluated clinical covariables for confounding and mediation of biomarker effects leading to a pulmonary exacerbation.…”
Section: Introductionmentioning
confidence: 99%