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

Completed

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT01704066
• Lead Sponsor: Society of Critical Care Medicine, China

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-06
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-11
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS	immediately after reading the CXRs

Secondary Outcome Measures

Name	Time	Method
Impact of the training set on the inter-observer agreement on the interpretation of CXRs	difference of inter-observer agreement before and after the training course

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China