Evidence map›Paper›PMID 24055998›Full record

Trial reportContemporary clinical trials2013

Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: the early intervention in cystic fibrosis exacerbation (eICE) trial.

N Lechtzin, N West, S Allgood, E Wilhelm, U Khan, N Mayer-Hamblett, M L Aitken, B W Ramsey, M P Boyle, P J Mogayzel and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 4 pooled it
–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

25 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Health care costs related to home spirometry in the eICE randomized trial.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022
    Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. A comparison of clinic and home spirometry as longtudinal outcomes in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022
    Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Perception of Pulmonary Function in Children with Asthma and Cystic Fibrosis.Pediatric allergy, immunology, and pulmonology · 2018
    Article
  16. Early Detection of Rapid Cystic Fibrosis Disease Progression Tailored to Point of Care: A Proof-of-Principle Study.... Health innovations and point-of-care technologies conference. Health innovations and point-of-care technologies conference · 2017
    Article
  17. Observational
  18. Rationalizing endpoints for prospective studies of pulmonary exacerbation treatment response in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2017
    Article
  19. Article
  20. Review
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

11 authors.

N LechtzinDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore MD, United States. Electronic address: nlechtz@jhmi.edu.
N West
S Allgood
E Wilhelm
U Khan
N Mayer-Hamblett
M L Aitken
B W Ramsey
M P Boyle
P J Mogayzel
C H Goss

Funding

Translational Research Center to Expedite Novel Therapies in Cystic FibrosisP30DK089507 · NIDDK · SEATTLE CHILDREN'S HOSPITAL · PI Christopher Hooper Goss · 2010 to 2026
$21.4M
Early Intervention in Pulmonary Exacerbation in CFR01HL103965 · NHLBI · UNIVERSITY OF WASHINGTON · PI GOSS, CHRISTOPHER HOOPER, LECHTZIN, NOAH · 2010 to 2014
$3.8M
NHLBI NIH HHS R01 HL103965NHLBI NIH HHS R01HL103965NIDDK NIH HHS P30 DK089507NIDDK NIH HHS P30DK089507
6 · The paper itself

Abstract

backgroundAcute pulmonary exacerbations are central events in the lives of individuals with cystic fibrosis (CF). Pulmonary exacerbations lead to impaired lung function, worse quality of life, and shorter survival. We hypothesized that aggressive early treatment of acute pulmonary exacerbation may improve clinical outcomes. PURPOSE: Describe the rationale of an ongoing trial designed to determine the efficacy of home monitoring of both lung function measurements and symptoms for early detection and subsequent early treatment of acute CF pulmonary exacerbations. STUDY

designA randomized, non-blinded, multi-center trial in 320 individuals with CF aged 14 years and older. The study compares usual care to a twice a week assessment of home spirometry and CF respiratory symptoms using an electronic device with data transmission to the research personnel to identify and trigger early treatment of CF pulmonary exacerbation. Participants will be enrolled in the study for 12 months. The primary endpoint is change in FEV1 (L) from baseline to 12 months determined by a linear mixed effects model incorporating all quarterly FEV1 measurements. Secondary endpoints include time to first acute protocol-defined pulmonary exacerbation, number of acute pulmonary exacerbations, number of hospitalization days for acute pulmonary exacerbation, time from the end of acute pulmonary exacerbation to onset of subsequent pulmonary exacerbation, change in health related quality of life, change in treatment burden, change in CF respiratory symptoms, and adherence to the study protocol.

conclusionsThis study is a first step in establishing alternative approaches to the care of CF pulmonary exacerbations. We hypothesize that early treatment of pulmonary exacerbations has the potential to slow lung function decline, reduce respiratory symptoms and improve the quality of life for individuals with CF.

Indexed as

Clinical ProtocolsCystic FibrosisForced Expiratory VolumeHome Care ServicesHumansLungLung DiseasesMonitoring, PhysiologicRespiratory Function TestsSpirometryABPAadverse eventAEallergic bronchopulmonary aspergillosisBCDMBiostatistics and Clinical Data ManagementCFCFQ-RCFRSDcystic fibrosisCystic fibrosisCystic Fibrosis Questionnaire-RevisedCystic Fibrosis Respiratory Symptom DiaryData Safety Monitoring BoardDSMBExacerbationFEV(1)forced expiratory volume in one secondforced vital capacityFVCHADSHealth related quality of lifeHospital Anxiety and Depression ScaleHRQOLMedical Outcomes Study Social Support SurveyMOS-SSSPIPrincipal InvestigatorSAEserious adverse eventSpirometryTAQ-CFTDNCCTherapeutics Development Network Coordinating CenterTreatment Adherence Questionnaire-CF

Identifiers

PMID24055998
PMCPMC3844027

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.