Evaluation of Tuberculosis Diagnostics in Children: 2. Methodological Issues for Conducting and Reporting Research Evaluations of Tuberculosis Diagnostics for Intrathoracic Tuberculosis in Children. Consensus From an Expert Panel

Cuevas, Luis ORCID: https://orcid.org/0000-0002-6581-0587, Browning, R., Bossuyt, P., Casenghi, M., Cotton, M. F., Cruz, A. T., Dodd, L. E., Drobniewski, F., Gale, M., Graham, S. M., Grzemska, M., Heinrich, N., Hesseling, A. C., Huebner, R., Jean-Philippe, P., Kabra, S. K., Kampmann, B., Lewinsohn, D., Li, M., Lienhardt, C., Mandalakas, A. M., Marais, B. J., Menzies, H. J., Montepiedra, G., Mwansambo, C., Oberhelman, R., Palumbo, P., Russek-Cohen, E., Shapiro, D. E., Smith, B., Soto-Castellares, G., Starke, J. R., Swaminathan, S., Wingfield, C. and Worrell, C. (2012) 'Evaluation of Tuberculosis Diagnostics in Children: 2. Methodological Issues for Conducting and Reporting Research Evaluations of Tuberculosis Diagnostics for Intrathoracic Tuberculosis in Children. Consensus From an Expert Panel'. Journal of Infectious Disease, Vol 205, Issue S2, S209-S215.

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Abstract

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.

Item Type:	Article
Additional Information:	This article appears in: Tuberculosis and Tuberculosis/HIV/AIDS: Unanswered Questions and Controversies
Subjects:	WF Respiratory System > Tuberculosis > WF 205 Epidemiology WF Respiratory System > Tuberculosis > WF 220 Diagnosis. Prognosis WF Respiratory System > Tuberculosis > WF 415 Tuberculosis in childhood
Digital Object Identifer (DOI):	https://doi.org/10.1093/infdis/jir879
Depositing User:	Lynn Roberts-Maloney
Date Deposited:	19 Dec 2014 09:26
Last Modified:	07 Dec 2018 10:15
URI:	https://archive.lstmed.ac.uk/id/eprint/4690

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