Table 1.

Summary of Changes to Previously Proposed Consensus Case Definitions

Scope (unchanged) Remains focused on symptomatic children with clinical suspicion of intrathoracic tuberculosis for evaluation of novel tuberculosis diagnostics in research

Entry criteria (unchanged) Any current compatible symptom irrespective of duration in a child suspected to have intrathoracic tuberculosis; NOT the same as the clinical features used for clinical diagnosis or disease classification Reinforce clear definition of inclusion criteria used for study with careful documentation of presenting symptoms, contact history, and signs More clearly articulated in the Figure compared to previous version

Intrathoracic tuberculosis diagnostic criteria Microbiological confirmation (changed) Addition of WHO-endorsed NAAT (eg, XpertMTB/RIF assay) Clinical signs/symptoms suggestive of tuberculosis (unchanged) Well-defined symptoms/signs that are highly suggestive of tuberculosis Interpretation of chest radiographs (unchanged) Tuberculosis exposure (changed) Time-window reduced to “within the past 12 months.” Mycobacterium tuberculosis infection (unchanged) TST and/or IGRA positive; methods and cutoffs used must be specified Response to treatment (unchanged)

Clinical case definitions for intrathoracic tuberculosis Confirmed tuberculosis (changed) Positive WHO-endorsed NAAT (eg, Xpert MTB/RIF) from a respiratory specimen Probable and possible tuberculosis (changed) Consolidated into “unconfirmed tuberculosis” with/without tuberculosis treatment response Differentiate with or without immunological evidence of M. tuberculosis infection Unlikely and Not tuberculosis (changed) Consolidated into “unlikely tuberculosis,” irrespective of symptom resolution, treatment received, or alternative diagnosis established Differentiate with or without immunological evidence of M. tuberculosis infection

Other All deaths evaluated by an expert panel to adjudicate whether tuberculosis death or not

Source: Adapted from Graham et al [16].

Abbreviations: IGRA, interferon-γ release assay; NAAT, nucleic acid amplification test; TST, tuberculin skin test; WHO, World Health Organization.