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Villar et al. [1] suggest four methodological sources of “bias” that could have led to an overestimation of the acute respiratory distress syndrome (ARDS) incidence in the LUNG SAFE study [2]. First, they suggest that an “unvalidated algorithm” was used to classify patients with ARDS. We simply utilized the Berlin Definition for ARDS [3]. When the Berlin criteria were met, patients were classified as having ARDS—this is the “computer algorithm”. There was no need to “validate” this algorithm, since it simply verifies the presence or absence of Berlin ARDS criteria. The electronic CRF provided additional guidance, including what specifically was meant by “bilateral infiltrates”, and investigators were offered web-based training on chest X-ray image interpretation.

The LUNG SAFE study: a presentation of the prevalence of ARDS according to the Berlin Definition!