The inclusion of children and adolescents in tuberculosis diagnostic development and evaluation-a consensus statement

Else M Bijker; Lyn Horn; Sylvia LaCourse; Emily L MacLean; Ben J Marais; Mark P Nicol; Laura Olbrich; James A Seddon; Jayne S Sutherland; Rinn Song; Heather J Zar; Devan Jaganath; Child TB Diagnostics Consensus Group

doi:10.1016/S1473-3099(24)00339-6

The inclusion of children and adolescents in tuberculosis diagnostic development and evaluation-a consensus statement

Lancet Infect Dis. 2024 Jul 3:S1473-3099(24)00339-6. doi: 10.1016/S1473-3099(24)00339-6. Online ahead of print.

Authors

Affiliations

¹ Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, UK; Department of Paediatrics, Maastricht University Medical Center, MosaKids Children's Hospital, Maastricht, the Netherlands.
² Office of Research Integrity, University of Cape Town, Cape Town, South Africa.
³ Departments of Medicine, Global Health, and Epidemiology, Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.
⁴ National Health and Medical Research Council, Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; Sydney Infectious diseases Institute & the WHO Collaborating Centre in Tuberculosis, University of Sydney, Sydney, NSW, Australia.
⁵ Sydney Infectious diseases Institute & the WHO Collaborating Centre in Tuberculosis, University of Sydney, Sydney, NSW, Australia.
⁶ Marshall Centre for Infectious Diseases Research and Training, School of Biomedical Sciences, University of Western Australia, Perth, WA, Australia.
⁷ Division of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany; German Centre for Infection Research, Munich, Germany.
⁸ Department of Infectious Disease, Imperial College London, UK; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, South Africa.
⁹ Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, The Gambia.
¹⁰ Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, UK.
¹¹ Department of Paediatrics & Child Health, Red Cross War Memorial Children's Hospital, Cape Town, South Africa; South African Medical Research Council, Unit on Child & Adolescent Health, University of Cape Town, Cape Town, South Africa.
¹² Division of Pediatric Infectious Diseases, University of California, San Francisco, CA, USA; Center for Tuberculosis, Department of Medicine, University of California, San Francisco, CA, USA. Electronic address: devan.jaganath@ucsf.edu.

PMID: 38971177
DOI: 10.1016/S1473-3099(24)00339-6

Abstract

The diagnosis of paediatric tuberculosis remains a challenge due to the non-specificity of symptoms and the paucibacillary nature of tuberculosis in children. However, in the development of new tuberculosis diagnostics, the unique needs of children and adolescents are rarely considered in the design process, with delays in evaluation and approval. No clear guidance is available on when and how to include children and adolescents in tuberculosis diagnostic development and evaluation. To address this gap, we conducted a Delphi consensus process with 42 stakeholders, including one qualitative and two quantitative rounds. Consensus was achieved on 20 statements, with agreement that the needs and perspectives of children, adolescents, and their caregivers should be incorporated throughout diagnostic design and evaluation. Opportunities exist for the early use of well characterised samples and prospective enrolment of children and adolescents in tuberculosis diagnostic evaluation, with consideration of the type of test, expected benefit, and potential risks. Pathogen-based tests might be initially optimised and assessed in adults and adolescents, but parallel evaluation in children is needed for host-based tests. Late-stage evaluation and implementation studies should examine combination testing and integration into clinical algorithms. The statements support collaboration between developers, researchers, regulators, and users to widen and accelerate the diagnostic pipeline for paediatric tuberculosis.

Publication types

Review