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

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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Training and education

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 Type: Observational
• Enrollment (Actual): 286

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Intensivists working in the participating ICUs

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS	immediately after reading the CXRs

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Society of Critical Care Medicine, China
• Investigators: Principal Investigator: Bin Du, MD, Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Peng JM, Qian CY, Yu XY, Zhao MY, Li SS, Ma XC, Kang Y, Zhou FC, He ZY, Qin TH, Yin YJ, Jiang L, Hu ZJ, Sun RH, Lin JD, Li T, Wu DW, An YZ, Ai YH, Zhou LH, Cao XY, Zhang XJ, Sun RQ, Chen EZ, Du B; China Critical Care Clinical Trial Group (CCCCTG). Does training improve diagnostic accuracy and inter-rater agreement in applying the Berlin radiographic definition of acute respiratory distress syndrome? A multicenter prospective study. Crit Care. 2017 Jan 20;21(1):12. doi: 10.1186/s13054-017-1606-4.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 6, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (Estimate): October 11, 2012

Study Record Updates

• Last Update Posted (Estimate): December 21, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: ARDS; Chest radiograph; Berlin Definition; Inter-observer agreement
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: CCCCTG-2012-ARDS-01; 2012BAI11B05 (Other Grant/Funding Number: National Key Technology R&D Program Project 2012BAI11B05)