Evidence map›Paper›PMID 25725985›Full record

Trial reportJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2015

Risk of hemoptysis in cystic fibrosis clinical trials: A retrospective cohort study.

V Thompson, N Mayer-Hamblett, M Kloster, D Bilton, P A Flume

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.7field-weighted citation impact, top 15% of its field
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

10 citing papers in PubMed, 26 citations in OpenAlex.

  1. Article
  2. Article
  3. Therapeutic Interventions forJournal of clinical medicine · 2024
    Review
  4. Factors associated with cystic fibrosis mortality before the age of 30: retrospective analysis of a cohort in southern Brazil.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2024
    Article
  5. Article
  6. Rates of adverse and serious adverse events in children with cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2021
    Article
  7. Review
  8. Article
  9. Article
  10. Observational
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

5 authors at 3 institutions in 2 countries.

V ThompsonSeattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States. Electronic address: valeria.thompson@seattlechildrens.org.
N Mayer-HamblettSeattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States; Department of Biostatistics, University of Washington, Seattle, WA, United States; Department of Pediatrics, University of Washington, 4800 Sand Point Way N.E., Box 5371, Seattle, WA 98105-0371, United States. Electronic address: nicole.hamblett@seattlechildrens.org.
M KlosterSeattle Children's Research Institute, 2001 8th Ave Ste 400, Seattle, WA 98145-5005, United States. Electronic address: margaret.kloster@seattlechildrens.org.
D BiltonDepartment of Respiratory Medicine, Royal Brompton Hospital, Sydney Street, London SW3 6NP, United Kingdom. Electronic address: d.bilton@rbht.nhs.uk.
P A FlumeMedical University of South Carolina, 96 Jonathan Lucas St., Room 812-CSB, Charleston, SC 29425, United States. Electronic address: flumepa@musc.edu.
Center for Infectious Disease Research · USMedical University of South Carolina · USRoyal Brompton Hospital · GB

Funding

Institute of Translational Health SciencesUL1TR000423 · NCATS · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2012 to 2016
$49.4M
Translational Research Center to Expedite Novel Therapies in Cystic FibrosisP30DK089507 · NIDDK · SEATTLE CHILDREN'S HOSPITAL · PI Christopher Hooper Goss · 2010 to 2026
$21.4M
South Carolina Clinical & Translational Research Institute (SCTR)UL1TR000062 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2012 to 2014
$9.4M
Early Antipseudomonal Therapy in Cystic FibrosisU01HL080310 · NHLBI · SEATTLE CHILDREN'S HOSPITAL · PI RAMSEY, BONNIE W · 2004 to 2008
$6.5M
NCATS NIH HHS UL1 TR000062NCATS NIH HHS UL1 TR000423NCATS NIH HHS UL1TR000423NHLBI NIH HHS U01 HL080310NHLBI NIH HHS U01-HL080310NIDDK NIH HHS P30 DK089507
6 · The paper itself

Abstract

backgroundCystic fibrosis (CF) is characterized by airway infection and inflammation resulting in respiratory complications including hemoptysis. The objectives of this study were to characterize the risk of hemoptysis attributable to underlying disease and in the presence of standard of care therapy.

methodsThis retrospective cohort study estimated hemoptysis rates overall and by relevant risk factors utilizing adverse event data from longitudinal prospective CF clinical trials.

resultsOf the 1008 participants, 73% were ≤18 years old; of 929 with available spirometry, 27% had an FEV1<70% predicted. During the average 8.2 months of follow-up, 8% experienced ≥1 hemoptysis events (95% CI: 6%, 10%). Of the 125 events, 76% were mild in severity and only 9% were serious. Hemoptysis rates were greater among adults than children, those with FEV1<70% predicted, and participants infected with P. aeruginosa but not with S. aureus.

conclusionsHemoptysis is a common adverse event among CF clinical trial participants, and particularly in adults with more severe lung disease. These results can be used to predict event occurrence in future clinical trials.

Indexed as

AdolescentAnti-Bacterial AgentsBacterial InfectionsChildCystic FibrosisFemaleFollow-Up StudiesForced Expiratory Flow RatesHemoptysisHumansIncidenceMalePhysical Therapy ModalitiesRetrospective StudiesRisk AssessmentRisk FactorsAnti-Bacterial AgentsClinical trialCystic fibrosisHemoptysis

Identifiers

PMID25725985
PMCPMC4549226
OpenAlexW2096013141

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.