Evidence map›Paper›PMID 32800708›Full record

Observational studyJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2021

Changes in symptom scores as a potential clinical endpoint for studies of cystic fibrosis pulmonary exacerbation treatment.

D R VanDevanter, S L Heltshe, D B Sanders, N E West, M Skalland, P A Flume, C H Goss, STOP-OB Study

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study in Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02109822 (Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT02109822 completednot on this map

Pilot Observational Study to Determine Feasibility of a Standardized Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis

TypeobservationalSponsorUniversity of WashingtonRan2014 to 2015Enrolled220ConditionsCystic Fibrosis, Lung Infection, Cystic Fibrosis Pulmonary Exacerbation
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. C-reactive protein (CRP) as a biomarker of pulmonary exacerbation presentation and treatment response.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022
    Trial
  2. 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
  3. Symptom phenotyping in people with cystic fibrosis during acute pulmonary exacerbations using machine-learning K-means clustering analysis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2024
    Article
  4. Article
  5. Observational
  6. The Clinical Association betweenAnnals of the American Thoracic Society · 2023
    Article
  7. Article
  8. A year in review: Real world evidence, functional monitoring and emerging therapeutics in 2021.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2022
    Review
  9. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

D R VanDevanterDepartment of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, United States. Electronic address: drv15@case.edu.
S L HeltsheCFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States; Departments of Pediatrics, University of Washington, Seattle, WA, United States.
D B SandersDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, United States.
N E WestDepartment of Medicine, Johns Hopkins University, Baltimore, MD, United States.
M SkallandCFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States.
P A FlumeDepartments of Medicine and Pediatrics, Medical University of South Carolina, Charleston, SC, United States.
C H GossCFF Therapeutics Development Network Coordinating Center, Seattle Children's Research Institute, Seattle, WA, United States; Departments of Pediatrics, University of Washington, Seattle, WA, United States; Department of Medicine, University of Washington, Seattle, WA, United States.
STOP-OB Study

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
NIDDK NIH HHS P30 DK089507
6 · The paper itself

Abstract

introductionSymptom improvement was assessed as changes in the Chronic Respiratory Infection Symptom Score (CRISS) during intravenous antimicrobial exacerbation treatments among subjects from study NCT02109822.

methodsMedian daily CRISS reduction (i.e., improvement) and covariates associated with CRISS reduction by Day 14 were assessed by logistic regression.

resultsAmong 173 subjects, median baseline CRISS was 49 [IQR 41, 56]; 93.6% had a CRISS reduction of ≥11 (minimal clinically important difference); median time to -11 reduction was 2 days [95% CI 2, 3]. The greatest median CRISS difference from baseline, on Day 17, was -26 [-29, -23]. Odds of -26 CRISS change by Day 14 were greater in subjects with higher baseline CRISS (P=.006) and younger ages (P=.041).

conclusionsCRISS response has good dynamic range and may be a useful efficacy endpoint for PEx interventional trials. The optimal use of CRISS change as an endpoint remains uncharacterized.

Indexed as

Disease ProgressionAdolescentAdultAnti-Bacterial AgentsChronic DiseaseClinical Trials as TopicCystic FibrosisHumansRespiratory Tract InfectionsSymptom AssessmentYoung AdultAnti-Bacterial AgentsClinical trialsCystic fibrosisExacerbationsSymptoms

Identifiers

PMID32800708
PMCPMC8298137

What OpenQuestion holds

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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.