Clinical trial NCT01704066: Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)
Official title: Interobserver Variation in Applying a Radiographic Definition for ARDS: Impact of a Training Set of Berlin ARDS Definition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Chest radiograph
Berlin Definition
Inter-observer agreement
Lead sponsor: Society of Critical Care Medicine, China
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 286
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensivists working in the participating ICUs

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.

Eligibility criteria: 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

Primary outcomes:
measure: inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS
timeFrame: immediately after reading the CXRs
Secondary outcomes:
measure: Impact of the training set on the inter-observer agreement on the interpretation of CXRs
timeFrame: difference of inter-observer agreement before and after the training course
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Bin Du, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.