Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT

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.

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Key information

Conditions

Mycobacterium Infections, Nontuberculous Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Sensitivity for the diagnosis of nontuberculous mycobacterial lung disease

Time frame: baseline

Percentage of cases diagnosed as nontuberculous mycobacterial lung disease by four raters out of confirmed cases with nontuberculous mycobacterial lung disease

Secondary outcomes

Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease

Time frame: baseline

Inter-rater correlation between four raters
Specificity for the diagnosis nontuberculous mycobacterial lung disease

Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Diagnostic Accuracy and Inter-rater Agreement of Chest Computed Tomography in the Diagnosis of Nontuberculous Mycobacterial Lung Disease

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 19, 2015
Registry last updated: Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed