Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT

Completed

• Conditions: Mycobacterium Infections, Nontuberculous

• Registration Number: NCT02340897
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The aim of this study was to elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest computed tomography findings.

Detailed Description

To elucidate the accuracy and inter-rater agreement of diagnosis of nontuberculous mycobacterial lung disease based on chest CT, two pulmonologists and two chest radiologists were requested to interpret chest CT of patients nontuberculous mycobacterial lung disease satisfying diagnostic criteria of American Thoracic Society as well as British Thoracic Society, or pulmonary tuberculosis. Two pulmonologists and two chest radiologists \> 10 years of clinical experiences at a tertiary referral hospital participated as raters in this study. They were blinded to the any clinical information of the patients including the specific diagnosis, except age and sex. The interpretations of four raters were analyzed and compared.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-27
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-19
• Primary Completion: 2015-02
• Study Completion: 2015-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Nontuberculous mycobacterial patients satisfying diagnostic criteria suggested by American Thoracic Society
• Patients with bacteriologically confirmed pulmonary tuberculosis
• Patients with bronchiectasis, confirmed by clinically as well as radiographically

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity for the diagnosis of nontuberculous mycobacterial lung disease	baseline	Percentage of cases diagnosed as nontuberculous mycobacterial lung disease by four raters out of confirmed cases with nontuberculous mycobacterial lung disease

Secondary Outcome Measures

Name	Time	Method
Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease	baseline	Inter-rater correlation between four raters
Specificity for the diagnosis nontuberculous mycobacterial lung disease	baseline	Percentage of cases diagnosed as other than nontuberculous mycobacterial lung disease by four raters out of confirmed cases with other than nontuberculous mycobacterial lung disease