Evidence map›Paper›PMID 38288082›Full record

ArticleERJ open research2024

An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis.

Paul Ford, Michael Kreuter, Kevin K Brown, Wim A Wuyts, Marlies Wijsenbeek, Dominique Israël-Biet, Richard Hubbard, Steven D Nathan, Hilario Nunes, Bjorn Penninckx and 8 more

2 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in ERJ open research, 2024. 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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 22% 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.

NCT03711162 phase3terminatednot on this map

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2018 to 2021Enrolled525ConditionsIdiopathic Pulmonary FibrosisArmsGLPG1690, Placebo
NCT03733444 phase3terminatednot on this map

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2018 to 2021Enrolled781ConditionsIdiopathic Pulmonary FibrosisArmsGLPG1690, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Acute exacerbation in fibrotic interstitial lung disease: an international working group report.American journal of respiratory and critical care medicine · 2026
    Review
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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

18 authors at 14 institutions in 7 countries.

Paul FordGalapagos NV, Mechelen, Belgium.
Michael KreuterCenter for Pulmonary Medicine, Departments of Pneumology, Mainz University Medical Center and of Pulmonary, Critical Care and Sleep Medicine, Marienhaus Clinic Mainz, Mainz, Germany.
Kevin K BrownDepartment of Medicine, National Jewish Health, Denver, CO, USA.
Wim A WuytsUnit for Interstitial Lung Diseases, Department of Respiratory Medicine, University Hospitals Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0001-9648-3497
Marlies WijsenbeekCentre for Interstitial Lung Disease and Sarcoidosis, Department of Respiratory Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.
Dominique Israël-BietUniversité Paris Cité, Hôpital Européen Georges Pompidou, Paris, France.
Richard HubbardAcademic Unit of Population and Lifespan Sciences, School of Medicine, University of Nottingham, Nottingham, UK.
Steven D NathanInova Advanced Lung Disease and Transplant Program, Inova Fairfax Hospital, Falls Church, VA, USA.ORCID https://orcid.org/0000-0002-6270-1617
Hilario NunesDepartment of Pneumology, Centre de Référence des Maladies Pulmonaires Rares, Assistance Publique-Hôpitaux de Paris, Hôpital Avicenne, Université Sorbonne Paris Nord, Bobigny, France.
Bjorn PenninckxGalapagos NV, Mechelen, Belgium.
Niyati PrasadGalapagos NV, Mechelen, Belgium.
Ineke SeghersGalapagos NV, Mechelen, Belgium.
Paolo SpagnoloRespiratory Disease Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.
Nadia VerbruggenGalapagos NV, Mechelen, Belgium.
Nik HiraniEdinburgh Lung Fibrosis Clinic, Royal Infirmary Edinburgh and Centre for Inflammation Research, The Queen's Medical Research Institute, The University of Edinburgh, Edinburgh, UK.
Juergen BehrDepartment of Medicine V, LMU University Hospital, Ludwig Maximilian University Munich, Comprehensive Pneumology Center (member of the German Center for Lung Research), Munich, Germany.
Robert J KanerDivision of Pulmonary and Critical Care Medicine and Department of Genetic Medicine, Weill Cornell Medicine, New York, NY, USA.
Toby M MaherNational Heart and Lung Institute, Imperial College London, London, UK.
Galapagos (Belgium) · BECentre for Inflammation Research · GBCornell University · USErasmus MC · NLGerman Center for Lung Research · DEInova Fairfax Hospital · USJohannes Gutenberg University Mainz · DEKU Leuven · BENational Jewish Health · USSorbonne Université · FRUniversité Paris Cité · FRUniversity of Nottingham · GBUniversity of Padua · ITUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: There is no standard definition of respiratory-related hospitalisation, a common end-point in idiopathic pulmonary fibrosis (IPF) clinical trials. As diverse aetiologies and complicating comorbidities can present similarly, external adjudication is sometimes employed to achieve standardisation of these events. Methods: An algorithm for respiratory-related hospitalisation was developed through a literature review of IPF clinical trials with respiratory-related hospitalisation as an end-point. Experts reviewed the algorithm until a consensus was reached. The algorithm was validated using data from the phase 3 ISABELA trials (clinicaltrials.gov identifiers NCT03711162 and NCT03733444), by assessing concordance between nonadjudicated, investigator-defined, respiratory-related hospitalisations and those defined by the adjudication committee using the algorithm. Results: The algorithm classifies respiratory-related hospitalisation according to cause: extraparenchymal (worsening respiratory symptoms due to left heart failure, volume overload, pulmonary embolism, pneumothorax or trauma); other (respiratory tract infection, right heart failure or exacerbation of COPD); "definite" acute exacerbation of IPF (AEIPF) (worsening respiratory symptoms within 1 month, with radiological or histological evidence of diffuse alveolar damage); or "suspected" AEIPF (as for "definite" AEIPF, but with no radiological or histological evidence of diffuse alveolar damage). Exacerbations ("definite" or "suspected") with identified triggers (infective, post-procedural or traumatic, drug toxicity- or aspiration-related) are classed as "known AEIPF"; "idiopathic AEIPF" refers to exacerbations with no identified trigger. In the ISABELA programme, there was 94% concordance between investigator- and adjudication committee-determined causes of respiratory-related hospitalisation. Conclusion: The algorithm could help to ensure consistency in the reporting of respiratory-related hospitalisation in IPF trials, optimising its utility as an end-point.

Identifiers

PMID38288082
PMCPMC10823372
OpenAlexW4390755453

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.