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

Journal

The Lancet. Infectious diseases
ISSN: 1474-4457
Titre abrégé: Lancet Infect Dis
Pays: United States
ID NLM: 101130150

Informations de publication

Date de publication:
03 Jul 2024
Historique:
received: 08 03 2024
revised: 13 05 2024
accepted: 14 05 2024
medline: 7 7 2024
pubmed: 7 7 2024
entrez: 6 7 2024
Statut: aheadofprint

Résumé

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.

Identifiants

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

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

Déclaration de conflit d'intérêts

Declaration of interests SL receives royalties from UpToDate on the tuberculosis in Pregnancy topic; and receives funding from Merck for her institution for investigator-initiated SARS-CoV-2 related research. EMB and LO are supported by a fellowship from the European Society for Paediatric Infectious Diseases. ELM is supported by a Canadian Institutes of Health Research Fellowship (472823). MPN is supported by an Australian National Health and Medical Research Council Investigator Award 1174455. HJZ is supported by the South African Medical Research Council. All other authors declare no competing interests. This consensus process was supported by the National Institute of Allergy and Infectious Diseases Feasibility of Novel Diagnostics for TB in Endemic Countries for TB studies (U01AI152087, U01AI152084, and U01AI152075).

Auteurs

Else M Bijker (EM)

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.

Lyn Horn (L)

Office of Research Integrity, University of Cape Town, Cape Town, South Africa.

Sylvia LaCourse (S)

Departments of Medicine, Global Health, and Epidemiology, Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.

Emily L MacLean (EL)

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.

Ben J Marais (BJ)

Sydney Infectious diseases Institute & the WHO Collaborating Centre in Tuberculosis, University of Sydney, Sydney, NSW, Australia.

Mark P Nicol (MP)

Marshall Centre for Infectious Diseases Research and Training, School of Biomedical Sciences, University of Western Australia, Perth, WA, Australia.

Laura Olbrich (L)

Division of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Munich, Germany; German Centre for Infection Research, Munich, Germany.

James A Seddon (JA)

Department of Infectious Disease, Imperial College London, UK; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, South Africa.

Jayne S Sutherland (JS)

Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, The Gambia.

Rinn Song (R)

Department of Paediatrics, Oxford Vaccine Group, University of Oxford, Oxford, UK.

Heather J Zar (HJ)

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.

Devan Jaganath (D)

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.

Classifications MeSH