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Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)

Interobserver Variation in Applying a Radiographic Definition for ARDS: Impact of a Training Set of Berlin ARDS Definition

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01704066
Enrollment
286
Registered
2012-10-11
Start date
2012-10-31
Completion date
2012-12-31
Last updated
2012-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS, Chest radiograph, Berlin Definition, Inter-observer agreement

Brief summary

The original American-European Consensus Conference (AECC) definition of Acute Respiratory Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR using this definition among intensivists and radiologists. As a result, the newly published Berlin definition of ARDS specified that the CXR criterion should include bilateral opacities consistent with pulmonary edema not fully explained by effusions, lobar/lung collapse, or nodules/masses on CXR. In order to improve inter-observer agreement, the panel have also developed a set of CXRs judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS. The objective of this study is to investigate the impact of this training set on inter-observer reliability in applying the radiographic definition for ARDS.

Detailed description

The study is composed of 3 phases: Phase 1: All participants will be required to independently interpret a set of 12 CXRs, as provided by the consensus panel. The possible radiographic interpretations include consistent, inconsistent, or equivocal for the diagnosis of ARDS. Phase 2: Training materials adapted according to the recently published Berlin definition of ARDS, with its expanded rationale and interpretation of all 12 CXRs, will be sent to all participants. Phase 3: The same set of 12 CXRs, in different order, will be sent to all participants for interpretation for the second time.

Interventions

Sponsors

Society of Critical Care Medicine, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* intensivists working in the participating ICUs

Exclusion criteria

* those who could not participate both questionnaire surveys * those who have read the reference with the training set of CXRs before the study * those who have already known the objective of the study

Design outcomes

Primary

MeasureTime frame
inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDSimmediately after reading the CXRs

Secondary

MeasureTime frame
Impact of the training set on the inter-observer agreement on the interpretation of CXRsdifference of inter-observer agreement before and after the training course

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026