Evidence map›Paper›PMID 25911223›Full record

Observational studyThorax2016

Short-term and long-term response to pulmonary exacerbation treatment in cystic fibrosis.

Sonya L Heltshe, Christopher H Goss, Valeria Thompson, Scott D Sagel, Don B Sanders, Bruce C Marshall, Patrick A Flume

2 registry-linked trialsAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Thorax, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing 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.

NCT00788359 completednot on this map

Multi-center Trial to Validate Protein Biomarkers of a Pulmonary Exacerbation in Cystic Fibrosis

TypeobservationalSponsorUniversity of Colorado, DenverRan2007 to 2014Enrolled123ConditionsCystic Fibrosis
NCT04016571 completednot on this map

Parameters to Assess Response to Intra-Venous Antibiotic Treatment for Pulmonary Exacerbations in Cystic Fibrosis

TypeobservationalSponsorBelfast Health and Social Care TrustRan2016 to 2019Enrolled31ConditionsCystic Fibrosis
3 · Its place in the literature

Who cites it

37 citing papers in PubMed.

  1. Correlates of FEV₁ deficit in pulmonary exacerbations of cystic fibrosis and associated clinical outcomes.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2026
    Trial
  2. Trial
  3. How Should IgG Seroconversion toCanadian respiratory journal · 2026
    Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Observational
  9. Article
  10. Diagnosis and Management of Cystic Fibrosis Exacerbations.Seminars in respiratory and critical care medicine · 2023
    Review
  11. Article
  12. Outcomes of cystic fibrosis pulmonary exacerbations treated with antibiotics with activity against anaerobic bacteria.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
  13. Article
  14. Review
  15. Application of multiple event analysis as an alternative approach to studying pulmonary exacerbations as an outcome measure.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2020
    Observational
  16. Review
  17. Acute Pulmonary Exacerbations in Cystic Fibrosis.Seminars in respiratory and critical care medicine · 2019
    Review
  18. Article
  19. Article
  20. 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

7 authors.

Sonya L HeltsheCystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, Washington, USA Department of Pediatrics, University of Washington, School of Medicine, Seattle, Washington, USA.ORCID http://orcid.org/0000-0003-2696-2382
Christopher H GossCystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, Washington, USA Division of Pulmonary and Critical Care Medicine, University of Washington School of Medicine, Seattle, Washington, USA.
Valeria ThompsonCystic Fibrosis Foundation Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, Washington, USA.
Scott D SagelDepartment of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA.
Don B SandersDepartment of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.
Bruce C MarshallCystic Fibrosis Foundation, Bethesda, Maryland, USA.
Patrick A FlumeDepartment of Medicine and Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.

Funding

Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
Translational Research Center to Expedite Novel Therapies in Cystic FibrosisP30DK089507 · NIDDK · SEATTLE CHILDREN'S HOSPITAL · PI Christopher Hooper Goss · 2010 to 2026
$21.4M
Colorado Clinical and Translational Science Institute (UL1)UL1TR000154 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2012 to 2013
$20.4M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR000062 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2012 to 2014
$9.4M
Institutional Clinical and Translational Science AwardKL2TR000428 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$6.2M
NCATS NIH HHS KL2 TR000428NCATS NIH HHS UL1 TR000062NCATS NIH HHS UL1 TR000154NCATS NIH HHS UL1 TR000427NIDDK NIH HHS P30 DK089507
6 · The paper itself

Abstract

backgroundTreatment of pulmonary exacerbations (PEx) in cystic fibrosis (CF) varies widely with no consensus on management practices or best indicators of therapeutic success. To design trials evaluating PEx treatment factors, we characterise the heterogeneity of PEx care in adults and paediatrics, and correlate it with measures of clinical response including short-term and long-term lung function changes, change in symptom severity score and time to next intravenous antibiotic therapy.

methodsData were used from a prospective observational study of patients with CF ≥10 years of age enrolled at six sites between 2007 and 2010. All were started on intravenous antibiotics for a clinically diagnosed PEx. Analysis of variance, logistic and Cox regression were used to examine the association of treatment factors with short-term and long-term clinical response.

resultsOf 123 patients with CF (60% women, aged 23.1±10.2 years), 33% experienced <10% relative improvement in FEV1 during treatment, which was associated with failing to recover baseline lung function 3 months after treatment (OR=7.8, 95% CI 1.9 to 31.6, p=0.004) and a longer time to next intravenous antibiotic (HR=0.48, 95% CI 0.27 to 0.85, p=0.011). Symptom improvement was observed but was not associated with subsequent lung function or time to next antibiotic therapy, which had a median recurrence time of 143 days.

conclusionsImmediate symptomatic or respiratory response to PEx treatment did not have a clear relationship with subsequent outcomes such as lung function or intravenous antibiotic-free interval. These results can inform future research of treatment regimens for PEx in terms of interventions and outcome measures.

trial registrationNCT00788359 (www.clinicaltrials.gov).

Indexed as

Administration, InhalationAdministration, OralAdolescentAnti-Bacterial AgentsChildCystic FibrosisDisease ProgressionFemaleFollow-Up StudiesForced Expiratory VolumeHumansLungMaleProspective StudiesTime FactorsTreatment OutcomeAnti-Bacterial AgentsCystic Fibrosis

Identifiers

PMID25911223
PMCPMC4778725

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.