Validation of the K-BILD questionnaire in CTD-ILD and SSc-ILD

  • Research type

    Research Study

  • Full title

    Validation of the Kings Brief Interstitial Lung Disease (K-BILD) Questionnaire in Connective Tissue Disease (CTD) associated and Systemic Sclerosis (SSc) associated Interstitial lung disease (ILD)

  • IRAS ID

    336129

  • Contact name

    Shaney Barratt

  • Contact email

    Shaney.Barratt@nbt.nhs.uk

  • Sponsor organisation

    Research and Developent, North Bristol NHS Trust

  • Duration of Study in the UK

    1 years, 9 months, 1 days

  • Research summary

    Interstitial lung disease (ILD) is the leading cause of mortality in connective tissue disease associated lung disease, and can vary widely in severity from asymptomatic to life-threatening. Presently, the lack of a patient reported outcome (PROM) measure is an obstacle to drug development.

    The Kings Brief Interstitial Lung Disease (K-BILD) questionnaire is a patient reported health status measure developed in 2012 and validated across a range of ILDs with concurrent validity against lung function and other health related quality of life questionnaires. It is not yet fully validated in a connective tissue disease associated ILD (CTD-ILD) population.

    The principal aim of this project is to validate the psychometric properties of K-BILD in both CTD-ILD and Systemic sclerosis associated ILD (SSc-ILD) patients (the latter a specific subtype of CTD). More specifically, to demonstrate that the K-BILD correlates with existing non-disease specific PROMS, as well as with markers of lung disease severity.

    Secondly we intend to demonstrate the short term repeatability of the K-BILD in stable non-progressive CTD-ILD and SSc-ILD patients, and also the discriminative validity of K-BILD using lung function, perceived health status and supplementary oxygen use as markers of disease severity.

    This project will also assess the face and content validity of K-BILD in CTD-ILD and SSc-ILD patients ('relevance of the questionnaire to patients illness experience), and finally any correlation between patient coping strategies and symptom burden in CTD-ILD and SSc-ILD.

  • REC name

    West Midlands - Solihull Research Ethics Committee

  • REC reference

    24/WM/0048

  • Date of REC Opinion

    20 May 2024

  • REC opinion

    Further Information Favourable Opinion