The Its Not JUST Idiopathic pulmonary fibrosis Study (INJUSTIS): description of the protocol for a multicentre prospective observational cohort study identifying biomarkers of progressive fibrotic lung disease

Our plain-English summary of The Its Not JUST Idiopathic pulmonary fibrosis Study (INJUSTIS): description of the protocol for a multicentre prospective observational cohort study identifying biomarkers of progressive fibrotic lung disease, by F. Khan, I. Stewart, L. Howard, et al (BMJ Open Respiratory Research, 2019).

The study

• Authors: F. Khan, I. Stewart, L. Howard, T.M. McKeever, S. Jones, G. Hearson, R. Braybrooke, C. Edwards, G. Jenkins, G. Saini
• Journal: BMJ Open Respiratory Research
• Published: 2019;6(1):e000439
• Cited by: 15 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Introduction: The Its Not JUST Idiopathic pulmonary fibrosis Study (INJUSTIS) is a multicentre, prospective, observational cohort study. The aims of this study are to identify genetic, serum and other biomarkers that may identify specific molecular mechanisms, reflecting disease endotypes that are shared among patients with progressive pulmonary fibrosis regardless of aetiology. Furthermore, it is anticipated that these biomarkers will help predict fibrotic activity that may identify patterns of disease behaviour with greater accuracy than current clinical phenotyping.

Methods And Analysis: 200 participants with the multidisciplinary team confirmed fibrotic lung disease (50 each of rheumatoid-interstitial lung disease (ILD), asbestosis, chronic hypersensitivity pneumonitis and unclassifiable ILD) and 50 idiopathic pulmonary fibrosis participants, recruited as positive controls, will be followed up for 2 years. Participants will have blood samples, lung function tests, quality of life questionnaires and a subgroup will be offered bronchoscopy. Participants will also be given the option of undertaking blinded home handheld spirometry for the first 3 months of the study. The primary end point will be identification of a biomarker that predicts disease progression, defined as 10% relative change in forced vital capacity (FVC) or death at 12 months.

Ethics And Dissemination: The trial has received ethical approval from the National Research Ethics Committee Nottingham (18/EM/0139). All participants must provide written informed consent. The trial will be overseen by the INJUSTIS steering group that will include a patient representative, and an independent chairperson. The results from this study will be submitted for publication in peer-reviewed journals and disseminated at regional and national conferences.

Trial Registration Number: NCT03670576.

In plain English

This article was a study protocol. It described a planned study and reported no results. The authors set out the design of INJUSTIS, a multicentre, prospective, observational cohort study in the UK. It aimed to find genetic, blood and other biomarkers that might predict worsening of fibrotic lung disease whatever its cause. The plan was to recruit 200 recently diagnosed participants, 50 each with rheumatoid arthritis-associated interstitial lung disease, asbestosis, chronic hypersensitivity pneumonitis and unclassifiable interstitial lung disease. A further 50 people with idiopathic pulmonary fibrosis would be recruited as positive controls. For the asbestosis group, entry required an appropriate occupational history and radiological evidence of asbestos exposure. Participants were to be followed for 2 years with blood samples, lung function tests and quality of life questionnaires. The main end point was a relative fall in forced vital capacity of 10% or more, or death, within 12 months. The authors stated the study was not statistically powered to detect differences between the disease subgroups.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Protocol for a multicentre, prospective, observational cohort study (no results reported)
• Who was studied: Planned: 200 participants with recently diagnosed, multidisciplinary-team-confirmed fibrotic lung disease (50 each of rheumatoid-ILD, asbestosis, chronic hypersensitivity pneumonitis and unclassifiable ILD), plus 50 idiopathic pulmonary fibrosis participants recruited as positive controls, from ILD clinics locally and across the UK
• Exposure: For the asbestosis subgroup, entry required an appropriate occupational history and radiological evidence of asbestos exposure; no fiber types, products or doses were specified. The study's main 'exposure' of interest was biomarker levels.
• The authors' conclusion: The authors described INJUSTIS as a prospective longitudinal study of non-idiopathic fibrotic ILD that will identify biomarkers of progression of fibrotic lung disease regardless of cause, should such biomarkers exist.
• Limitations the authors state:
  • The study is not statistically powered to detect differences between the ILD subgroups, such as between asbestosis and the other diseases.
  • The study does not aim to assess the effect of treatments.

Topics

Medical terms in this study, explained in our Lexicon: Idiopathic, Pulmonary Fibrosis, Cohort Study, Biomarker, Multidisciplinary Team, Interstitial Lung Disease, Pneumonitis, Quality of Life.

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