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

Luis E. Cuevas, Renee Browning, Patrick Bossuyt, Martina Casenghi, Mark F. Cotton, Andrea T. Cruz, Lori E. Dodd, Francis Drobniewski, Marianne Gale, Stephen M. Graham, Malgosia Grzemska, Norbert Heinrich, Anneke C. Hesseling, Robin Huebner, Patrick Jean-Philippe, Sushil Kumar Kabra, Beate Kampmann, Deborah Lewinsohn, Meijuan Li, Christian LienhardtAnna M. Mandalakas, Ben J. Marais, Heather J. Menzies, Grace Montepiedra, Charles Mwansambo, Richard Oberhelman, Paul Palumbo, Estelle Russek-Cohen, David E. Shapiro, Betsy Smith, Giselle Soto-Castellares, Jeffrey R. Starke, Soumya Swaminathan, Claire Wingfield, Carol Worrell

Research output: Contribution to journalArticle

66 Citations (Scopus)

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.

Original languageEnglish (US)
JournalJournal of Infectious Diseases
Volume205
Issue numberSUPPL. 2
DOIs
StatePublished - May 15 2012

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Tuberculosis
Research
Publications
Comorbidity
Age Groups
Research Personnel
Pediatrics
Growth

ASJC Scopus subject areas

  • Infectious Diseases
  • Immunology and Allergy

Cite this

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 E.; Browning, Renee; Bossuyt, Patrick; Casenghi, Martina; Cotton, Mark F.; Cruz, Andrea T.; Dodd, Lori E.; Drobniewski, Francis; Gale, Marianne; Graham, Stephen M.; Grzemska, Malgosia; Heinrich, Norbert; Hesseling, Anneke C.; Huebner, Robin; Jean-Philippe, Patrick; Kabra, Sushil Kumar; Kampmann, Beate; Lewinsohn, Deborah; Li, Meijuan; Lienhardt, Christian; Mandalakas, Anna M.; Marais, Ben J.; Menzies, Heather J.; Montepiedra, Grace; Mwansambo, Charles; Oberhelman, Richard; Palumbo, Paul; Russek-Cohen, Estelle; Shapiro, David E.; Smith, Betsy; Soto-Castellares, Giselle; Starke, Jeffrey R.; Swaminathan, Soumya; Wingfield, Claire; Worrell, Carol.

In: Journal of Infectious Diseases, Vol. 205, No. SUPPL. 2, 15.05.2012.

Research output: Contribution to journalArticle

Cuevas, LE, Browning, R, Bossuyt, P, Casenghi, M, Cotton, MF, Cruz, AT, Dodd, LE, Drobniewski, F, Gale, M, Graham, SM, Grzemska, M, Heinrich, N, Hesseling, AC, Huebner, R, Jean-Philippe, P, Kabra, SK, Kampmann, B, Lewinsohn, D, Li, M, Lienhardt, C, Mandalakas, AM, Marais, BJ, Menzies, HJ, Montepiedra, G, Mwansambo, C, Oberhelman, R, Palumbo, P, Russek-Cohen, E, Shapiro, DE, Smith, B, Soto-Castellares, G, Starke, JR, Swaminathan, S, Wingfield, C & 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 Diseases, vol. 205, no. SUPPL. 2. https://doi.org/10.1093/infdis/jir879
Cuevas, Luis E. ; Browning, Renee ; Bossuyt, Patrick ; Casenghi, Martina ; Cotton, Mark F. ; Cruz, Andrea T. ; Dodd, Lori E. ; Drobniewski, Francis ; Gale, Marianne ; Graham, Stephen M. ; Grzemska, Malgosia ; Heinrich, Norbert ; Hesseling, Anneke C. ; Huebner, Robin ; Jean-Philippe, Patrick ; Kabra, Sushil Kumar ; Kampmann, Beate ; Lewinsohn, Deborah ; Li, Meijuan ; Lienhardt, Christian ; Mandalakas, Anna M. ; Marais, Ben J. ; Menzies, Heather J. ; Montepiedra, Grace ; Mwansambo, Charles ; Oberhelman, Richard ; Palumbo, Paul ; Russek-Cohen, Estelle ; Shapiro, David E. ; Smith, Betsy ; Soto-Castellares, Giselle ; Starke, Jeffrey R. ; Swaminathan, Soumya ; Wingfield, Claire ; Worrell, Carol. / 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. In: Journal of Infectious Diseases. 2012 ; Vol. 205, No. SUPPL. 2.
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