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Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT

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ClinicalTrials.gov Identifier: NCT02340897
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Jae-Joon Yim, 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.

Condition or disease
Mycobacterium Infections, Nontuberculous

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.

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Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Diagnostic Accuracy and Inter-rater Agreement of Chest Computed Tomography in the Diagnosis of Nontuberculous Mycobacterial Lung Disease
Study Start Date : December 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015


Group/Cohort
Nontuberculous lung disease
Patients with Nontuberculous Mycobacteria satisfying American Thoracic Society and British Thoracic Society guidelines
pulmonary tuberculosis
Patients with culture confirmed tuberculosis
bronchiectasis
Patients with bronchiectasis based on chest CT findings as well as symptoms



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease [ Time Frame: baseline ]
    Inter-rater correlation between four raters

  2. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with nontuberculous mycobacterial lung diseases, pulmonary tuberculosis, bronchiectasis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340897


Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jae-Joon Yim, MD Seoul National University Hospital

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Responsible Party: Jae-Joon Yim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02340897     History of Changes
Other Study ID Numbers: 2014-1043
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Lung Diseases
Respiratory Tract Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections