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

Medientyp: E-Artikel
Titel: An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary fibrosis
Beteiligte: Ford, Paul; Kreuter, Michael; Brown, Kevin K.; Wuyts, Wim A.; Wijsenbeek, Marlies; Israël-Biet, Dominique; Hubbard, Richard; Nathan, Steven D.; Nunes, Hilario; Penninckx, Bjorn; Prasad, Niyati; Seghers, Ineke; Spagnolo, Paolo; Verbruggen, Nadia; Hirani, Nik; Behr, Juergen; Kaner, Robert J.; Maher, Toby M.
Erschienen: European Respiratory Society (ERS), 2024
Erschienen in: ERJ Open Research
Sprache: Englisch
DOI: 10.1183/23120541.00636-2023
ISSN: 2312-0541
Schlagwörter: Pulmonary and Respiratory Medicine
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Beschreibung: <jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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 (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://clinicaltrials.gov">clinicaltrials.gov</jats:ext-link>identifiers<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT03711162">NCT03711162</jats:ext-link>and<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT03733444">NCT03733444</jats:ext-link>), by assessing concordance between nonadjudicated, investigator-defined, respiratory-related hospitalisations and those defined by the adjudication committee using the algorithm.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>The algorithm could help to ensure consistency in the reporting of respiratory-related hospitalisation in IPF trials, optimising its utility as an end-point.</jats:p></jats:sec>
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