Evidence map›Paper›PMID 31027503›Full record

Observational studyBMC medical research methodology2019

Prospective multicenter randomized patient recruitment and sample collection to enable future measurements of sputum biomarkers of inflammation in an observational study of cystic fibrosis.

Theodore G Liou, Frederick R Adler, Natalia Argel, Fadi Asfour, Perry S Brown, Barbara A Chatfield, Cori L Daines, Dixie Durham, Jessica A Francis, Barbara Glover and 24 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMC medical research methodology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Evaluation of airway and circulating inflammatory biomarkers for cystic fibrosis drug development.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
  5. The future of cystic fibrosis care: a global perspective.The Lancet. Respiratory medicine · 2020
    Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Theodore G LiouAdult Cystic Fibrosis Center, Division of Respiratory, Critical Care and Occupational Pulmonary Medicine, Department of Internal Medicine, University of Utah, 26 North Mario Capecchi Drive, Salt Lake City, UT, 84132, USA. ted.liou@utah.edu.ORCID 0000-0003-0121-4847
Frederick R AdlerDepartments of Mathematics, University of Utah, 155 South 1400 east, JWB 233, Salt Lake City, UT, 84112, USA.
Natalia ArgelCystic Fibrosis Center, Phoenix Children's Hospital, 1919 East Thomas Road, Phoenix, AZ, 85016, USA.
Fadi AsfourIntermountain Pediatric Cystic Fibrosis Center, Division of Pediatric Pulmonology, Department of Pediatrics, University of Utah, 81 North Mario Capecchi Drive, Salt Lake City, UT, 84113, USA.
Perry S BrownSt. Luke's Cystic Fibrosis Center of Idaho, 610 W. Hays Street, Boise, ID, 83702, USA.
Barbara A ChatfieldIntermountain Pediatric Cystic Fibrosis Center, Division of Pediatric Pulmonology, Department of Pediatrics, University of Utah, 81 North Mario Capecchi Drive, Salt Lake City, UT, 84113, USA.
Cori L DainesDivision of Pediatric Pulmonary and Sleep Medicine, Department of Pediatrics, University of Arizona Health Sciences, 1501 N. Campbell Avenue, Room 3301, PO Box 245073, Tucson, AZ, 85724, USA.
Dixie DurhamSt. Luke's Cystic Fibrosis Center of Idaho, 610 W. Hays Street, Boise, ID, 83702, USA.
Jessica A FrancisAdult Cystic Fibrosis Center, Division of Respiratory, Critical Care and Occupational Pulmonary Medicine, Department of Internal Medicine, University of Utah, 26 North Mario Capecchi Drive, Salt Lake City, UT, 84132, USA.
Barbara GloverCystic Fibrosis Center, 3006 S. Maryland Pkwy, Suite #315, Las Vegas, NV, 89109, USA.
Theresa HeynekampAdult Cystic Fibrosis Program, Division of Pulmonary, Critical Care and Sleep Medicine, DoIM MSC10-5550, 1 University of New Mexico, Albuquerque, NM, 87131, USA.
John R HoidalAdult Cystic Fibrosis Center, Division of Respiratory, Critical Care and Occupational Pulmonary Medicine, Department of Internal Medicine, University of Utah, 26 North Mario Capecchi Drive, Salt Lake City, UT, 84132, USA.
Judy L JensenAdult Cystic Fibrosis Center, Division of Respiratory, Critical Care and Occupational Pulmonary Medicine, Department of Internal Medicine, University of Utah, 26 North Mario Capecchi Drive, Salt Lake City, UT, 84132, USA.
Ruth KeoghDepartment of Medical Statistics, London School of Hygiene and Tropical Medicine, Room G36, Keppel Street, London, WC1E 7HT, UK.
Carol M KopeckyDepartment of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, 13123 East 16th Avenue, Aurora, CO, 80045, USA.
Noah LechtzinDivision of Pulmonary and Critical Care and Sleep Medicine, Department of Medicine, Johns Hopkins University School of Medicine, 601 N. Caroline St, Baltimore, MD, 21287, USA.
Yanping LiAdult Cystic Fibrosis Center, Division of Respiratory, Critical Care and Occupational Pulmonary Medicine, Department of Internal Medicine, University of Utah, 26 North Mario Capecchi Drive, Salt Lake City, UT, 84132, USA.
Jerimiah LysingerMontana Cystic Fibrosis Center, Billings Clinic, 2800 10th Avenue N, Billings, MT, 59101, USA.
Osmara MolinaDivision of Pediatric Pulmonary and Sleep Medicine, Department of Pediatrics, University of Arizona Health Sciences, 1501 N. Campbell Avenue, Room 3301, PO Box 245073, Tucson, AZ, 85724, USA.
Craig NakamuraCystic Fibrosis Center, 3006 S. Maryland Pkwy, Suite #315, Las Vegas, NV, 89109, USA.
Kristyn A PackerAdult Cystic Fibrosis Center, Division of Respiratory, Critical Care and Occupational Pulmonary Medicine, Department of Internal Medicine, University of Utah, 26 North Mario Capecchi Drive, Salt Lake City, UT, 84132, USA.
Katie R PochDivision of Pulmonary and Critical Care and Sleep Medicine, Department of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO, 80206, USA.
Alexandra L QuittnerFormer: Department of Psychology, University of Miami, Miami, FL, USA.
Peggy RadfordCystic Fibrosis Center, Phoenix Children's Hospital, 1919 East Thomas Road, Phoenix, AZ, 85016, USA.
Abby J RedwayAdult Cystic Fibrosis Program, Division of Pulmonary, Critical Care and Sleep Medicine, DoIM MSC10-5550, 1 University of New Mexico, Albuquerque, NM, 87131, USA.
Scott D SagelDepartment of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, 13123 East 16th Avenue, Aurora, CO, 80045, USA.
Shawna SprandelMontana Cystic Fibrosis Center, Billings Clinic, 2800 10th Avenue N, Billings, MT, 59101, USA.
Jennifer L Taylor-CousarDivision of Pulmonary and Critical Care and Sleep Medicine, Department of Medicine, National Jewish Health, 1400 Jackson Street, Denver, CO, 80206, USA.
Jane B VroomAdult Cystic Fibrosis Center, Division of Respiratory, Critical Care and Occupational Pulmonary Medicine, Department of Internal Medicine, University of Utah, 26 North Mario Capecchi Drive, Salt Lake City, UT, 84132, USA.
Ryan YoshikawaCystic Fibrosis Center, 3006 S. Maryland Pkwy, Suite #315, Las Vegas, NV, 89109, USA.
John P ClancyDivision of Pulmonary Medicine, Department of Pediatrics, University of Cincinnati, 3333 Burnet Avenue, Cincinnati, OH, 45229-3026, USA.
J Stuart ElbornFaculty of Medicine, Health and Life Sciences, Queen's University Belfast, 90 Lisburn Road, Belfast, BT9 6AG, UK.
Kenneth N OlivierLaboratory of Chronic Airway Infection, Pulmonary Branch, National Heart Lung and Blood Institute, National Institutes of Health, 10 Center Drive MSC1454, Building 10-CRC, Room 1408A, Bethesda, MD, 20892, USA.
David R CoxNuffield College, 1 New Rd, Oxford, OX1 1NF, UK.

Funding

NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
Bronchiectasis and chronic airway infectionZIAHL006200 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI FENNELLY, KEVIN · 2015 to 2025
$25.1M
UNIVERSITY OF UTAH CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCE-UL1: BPCAUL1RR025764 · NCRR · UNIVERSITY OF UTAH · PI MCCLAIN, DONALD A. · 2008 to 2011
$19.4M
University of Utah Center for Clinical and Translational Science-UL1UL1TR000105 · NCATS · UNIVERSITY OF UTAH · PI MCCLAIN, DONALD A. · 2012 to 2013
$5.1M
Explanatory models of CF Survival, Infection and Intermediate Clinical OutcomesR01HL125520 · NHLBI · UNIVERSITY OF UTAH · PI LIOU, THEODORE GEH-LU · 2015 to 2018
$1.4M
NCATS NIH HHS UL1 TR000105NCATS NIH HHS UL1 TR002535NCATS NIH HHS UL1 TR002538NCRR NIH HHS UL1 RR025764NHLBI NIH HHS R01 HL125520
6 · The paper itself

Abstract

backgroundBiomarkers 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.

methodsWe 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.

resultsFrom 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.

conclusionsRandomly-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.

Indexed as

Patient SelectionAdolescentAdultCystic FibrosisFemaleHumansLungMaleMethicillin-Resistant Staphylococcus aureusMiddle AgedProspective StudiesSputumStaphylococcal InfectionsYoung AdultCalprotectinCystic fibrosisCystic Fibrosis Foundation patient registryHMGB-1Neutrophil elastaseRandomized observational trialSputum inflammationStudy design

Identifiers

PMID31027503
PMCPMC6485181

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.