title: 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.
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.
authors.affiliation: Child and Reproductive Health Group, Liverpool School of Tropical Medicine, Liverpool, United Kingdom. lcuevas@liv.ac.uk
authors.forename: Luis E
authors.initials: LE
authors.lastname: Cuevas
authors.forename: Renee
authors.initials: R
authors.lastname: Browning
authors.forename: Patrick
authors.initials: P
authors.lastname: Bossuyt
authors.forename: Martina
authors.initials: M
authors.lastname: Casenghi
authors.forename: Mark F
authors.initials: MF
authors.lastname: Cotton
authors.forename: Andrea T
authors.initials: AT
authors.lastname: Cruz
authors.forename: Lori E
authors.initials: LE
authors.lastname: Dodd
authors.forename: Francis
authors.initials: F
authors.lastname: Drobniewski
authors.forename: Marianne
authors.initials: M
authors.lastname: Gale
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Graham
authors.forename: Malgosia
authors.initials: M
authors.lastname: Grzemska
authors.forename: Norbert
authors.initials: N
authors.lastname: Heinrich
authors.forename: Anneke C
authors.initials: AC
authors.lastname: Hesseling
authors.forename: Robin
authors.initials: R
authors.lastname: Huebner
authors.forename: Patrick
authors.initials: P
authors.lastname: Jean-Philippe
authors.forename: Sushil Kumar
authors.initials: SK
authors.lastname: Kabra
authors.forename: Beate
authors.initials: B
authors.lastname: Kampmann
authors.forename: Deborah
authors.initials: D
authors.lastname: Lewinsohn
authors.forename: Meijuan
authors.initials: M
authors.lastname: Li
authors.forename: Christian
authors.initials: C
authors.lastname: Lienhardt
authors.forename: Anna M
authors.initials: AM
authors.lastname: Mandalakas
authors.forename: Ben J
authors.initials: BJ
authors.lastname: Marais
authors.forename: Heather J
authors.initials: HJ
authors.lastname: Menzies
authors.forename: Grace
authors.initials: G
authors.lastname: Montepiedra
authors.forename: Charles
authors.initials: C
authors.lastname: Mwansambo
authors.forename: Richard
authors.initials: R
authors.lastname: Oberhelman
authors.forename: Paul
authors.initials: P
authors.lastname: Palumbo
authors.forename: Estelle
authors.initials: E
authors.lastname: Russek-Cohen
authors.forename: David E
authors.initials: DE
authors.lastname: Shapiro
authors.forename: Betsy
authors.initials: B
authors.lastname: Smith
authors.forename: Giselle
authors.initials: G
authors.lastname: Soto-Castellares
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Starke
authors.forename: Soumya
authors.initials: S
authors.lastname: Swaminathan
authors.forename: Claire
authors.initials: C
authors.lastname: Wingfield
authors.forename: Carol
authors.initials: C
authors.lastname: Worrell
mesh_terms: D000293:Adolescent; D000995:Antitubercular Agents / Q000627:therapeutic use; D001431:Bacteriological Techniques / Q000639:trends; D002648:Child; D002675:Child, Preschool; D006801:Humans; D007223:Infant; D012015:Reference Standards; D012107:Research Design; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000188:drug therapy
chemical_list: D000995:Antitubercular Agents