Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT

April 18, 2016 updated by: Jae-Joon Yim, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with nontuberculous mycobacterial lung diseases, pulmonary tuberculosis, bronchiectasis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-rater correlation (kappa value) for the diagnosis of nontuberculous mycobacterial lung disease
Time Frame: baseline
Inter-rater correlation between four raters
baseline
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Joon Yim, MD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 27, 2014

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1043 (Other Identifier: M D Anderson Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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