Confirming the diagnosis of childhood tuberculosis is a major challenge. However, research on childhood tuberculosis as it relates to better diagnostics is often neglected because of technical difficulties, such as the slow growth in culture, the difficulty of obtaining specimens, and the diverse and relatively nonspecific clinical presentation of tuberculosis in this age group. Researchers often use individually designed criteria for enrollment, diagnostic classifications, and reference standards, thereby hindering the interpretation and comparability of their findings. The development of standardized research approaches and definitions is therefore needed to strengthen the evaluation of new diagnostics for detection and confirmation of tuberculosis in children.In this article we present consensus statements on methodological issues for conducting research of Tuberculosis diagnostics among children, with a focus on intrathoracic tuberculosis. The statements are complementary to a clinical research case definition presented in an accompanying publication and suggest a phased approach to diagnostics evaluation; entry criteria for enrollment; methods for classification of disease certainty, including the rational use of culture within the case definition; age categories and comorbidities for reporting results; and the need to use standard operating procedures. Special consideration is given to the performance of microbiological culture in children and we also recommend for alternative methodological approaches to report findings in a standardized manner to overcome these limitations are made. This consensus statement is an important step toward ensuring greater rigor and comparability of pediatric tuberculosis diagnostic research, with the aim of realizing the full potential of better tests for children.
Bibliographical noteFunding Information:
Financial support. This work was supported by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, National Institute of Child Health and Human Development, Centers for Disease Control and Prevention, and Office of Global AIDS Coordinator. Funding from these institutions was not associated with a research grant but supported directly the scientific workshop from which this work was generated. The project was also supported in part with US federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and US Department of Department of Health and Human Services (contract HHSN272200800014C). D. S. and G. M. were supported by the International Maternal Pediatric Adolescent AIDS Clinical Trials Group Statistical and Data Management Center grant (grant No UM01 AI068616). L. E. C. was supported by a Thrasher Research Fund grant (contract 02824-6). Potential conflicts of interest. All authors: No reported conflicts.
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