{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T11:23:23Z","timestamp":1793877803697,"version":"4.7.0"},"reference-count":65,"publisher":"European Respiratory Society (ERS)","issue":"1","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100019832","name":"Gal\u00e1pagos","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100019832","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["ERJ Open Res"],"accepted":{"date-parts":[[2023,11,7]]},"published-print":{"date-parts":[[2024,1]]},"abstract":"<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); \u201cdefinite\u201d acute exacerbation of IPF (AEIPF) (worsening respiratory symptoms within 1\u2005month, with radiological or histological evidence of diffuse alveolar damage); or \u201csuspected\u201d AEIPF (as for \u201cdefinite\u201d AEIPF, but with no radiological or histological evidence of diffuse alveolar damage). Exacerbations (\u201cdefinite\u201d or \u201csuspected\u201d) with identified triggers (infective, post-procedural or traumatic, drug toxicity- or aspiration-related) are classed as \u201cknown AEIPF\u201d; \u201cidiopathic AEIPF\u201d 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>","DOI":"10.1183\/23120541.00636-2023","type":"journal-article","created":{"date-parts":[[2024,1,11]],"date-time":"2024-01-11T17:05:12Z","timestamp":1704992712000},"page":"00636-2023","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":10,"title":["An adjudication algorithm for respiratory-related hospitalisation in idiopathic pulmonary 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