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-

SUBMITTER: Ford P 

PROVIDER: S-EPMC10823372 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature