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; Niyati Prasad; Ineke Seghers; Paolo Spagnolo; Nadia Verbruggen; Nik Hirani; Juergen Behr; Robert J. Kaner; Toby M. Maher

doi:10.1183/23120541.00636-2023

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, Niyati Prasad, Ineke Seghers, Paolo Spagnolo, Nadia Verbruggen, Nik Hirani, Juergen Behr, Robert J. Kaner, Toby M. Maher^*

^*Corresponding author for this work

Pulmonary Medicine

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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.

Original language	English
Article number	00636-2023
Journal	ERJ Open Research
Volume	10
Issue number	1
DOIs	https://doi.org/10.1183/23120541.00636-2023
Publication status	Published - 1 Jan 2024

Bibliographical note

Publisher Copyright:
© The authors 2024.

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An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosisFinal published version, 480 KBLicence: CC BY-NC

Cite this

Ford, P., Kreuter, M., Brown, K. K., Wuyts, W. A., Wijsenbeek, M., Israël-Biet, D., Hubbard, R., Nathan, S. D., Nunes, H., Penninckx, B., Prasad, N., Seghers, I., Spagnolo, P., Verbruggen, N., Hirani, N., Behr, J., Kaner, R. J., & Maher, T. M. (2024). An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis. ERJ Open Research, 10(1), Article 00636-2023. https://doi.org/10.1183/23120541.00636-2023

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title = "An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis",

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.",

author = "Paul Ford and Michael Kreuter and Brown, {Kevin K.} and Wuyts, {Wim A.} and Marlies Wijsenbeek and Dominique Isra{\"e}l-Biet and Richard Hubbard and Nathan, {Steven D.} and Hilario Nunes and Bjorn Penninckx and Niyati Prasad and Ineke Seghers and Paolo Spagnolo and Nadia Verbruggen and Nik Hirani and Juergen Behr and Kaner, {Robert J.} and Maher, {Toby M.}",

note = "Publisher Copyright: {\textcopyright} The authors 2024.",

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month = jan,

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doi = "10.1183/23120541.00636-2023",

language = "English",

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Ford, P, Kreuter, M, Brown, KK, Wuyts, WA, Wijsenbeek, M, Israël-Biet, D, Hubbard, R, Nathan, SD, Nunes, H, Penninckx, B, Prasad, N, Seghers, I, Spagnolo, P, Verbruggen, N, Hirani, N, Behr, J, Kaner, RJ & Maher, TM 2024, 'An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis', ERJ Open Research, vol. 10, no. 1, 00636-2023. https://doi.org/10.1183/23120541.00636-2023

TY - JOUR

T1 - An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis

AU - Ford, Paul

AU - Kreuter, Michael

AU - Brown, Kevin K.

AU - Wuyts, Wim A.

AU - Wijsenbeek, Marlies

AU - Israël-Biet, Dominique

AU - Hubbard, Richard

AU - Nathan, Steven D.

AU - Nunes, Hilario

AU - Penninckx, Bjorn

AU - Prasad, Niyati

AU - Seghers, Ineke

AU - Spagnolo, Paolo

AU - Verbruggen, Nadia

AU - Hirani, Nik

AU - Behr, Juergen

AU - Kaner, Robert J.

AU - Maher, Toby M.

PY - 2024/1/1

Y1 - 2024/1/1

N2 - 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.

AB - 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.

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

Abstract

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