Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel

Abstract

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis.

Figures

Figure 1.

Algorithm for classification of case definitions for research reporting. #Response or no response to anti-tuberculosis therapy is only relevant if anti-tuberculosis therapy was given as determined by clinical indications. A trial of treatment should NOT be used as a diagnostic tool.

Figure 2.

Example of a chest radiograph (CXR) review template (Courtesy of Mark Hatherill, University of Cape Town). Note: CXR is classified as “consistent with tuberculosis” if there is a positive response for any 1 of the radiographic features at the same location by at least 2 expert reviewers.