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. 2023 Jul 1;27(7):506-519.
doi: 10.5588/ijtld.23.0078.

Clinical standards for the management of adverse effects during treatment for TB

Affiliations

Clinical standards for the management of adverse effects during treatment for TB

K P Singh et al. Int J Tuberc Lung Dis. .

Abstract

BACKGROUND: Adverse effects (AE) to TB treatment cause morbidity, mortality and treatment interruption. The aim of these clinical standards is to encourage best practise for the diagnosis and management of AE.METHODS: 65/81 invited experts participated in a Delphi process using a 5-point Likert scale to score draft standards.RESULTS: We identified eight clinical standards. Each person commencing treatment for TB should: Standard 1, be counselled regarding AE before and during treatment; Standard 2, be evaluated for factors that might increase AE risk with regular review to actively identify and manage these; Standard 3, when AE occur, carefully assessed and possible allergic or hypersensitivity reactions considered; Standard 4, receive appropriate care to minimise morbidity and mortality associated with AE; Standard 5, be restarted on TB drugs after a serious AE according to a standardised protocol that includes active drug safety monitoring. In addition: Standard 6, healthcare workers should be trained on AE including how to counsel people undertaking TB treatment, as well as active AE monitoring and management; Standard 7, there should be active AE monitoring and reporting for all new TB drugs and regimens; and Standard 8, knowledge gaps identified from active AE monitoring should be systematically addressed through clinical research.CONCLUSION: These standards provide a person-centred, consensus-based approach to minimise the impact of AE during TB treatment.

CONTEXTE :: Les effets indésirables (AE) du traitement de la TB sont une cause de morbidité, de mortalité et d’interruption du traitement. L’objectif de ces normes cliniques est d’encourager une meilleure pratique en matière de diagnostic et de prise en charge des AE.

MÉTHODES :: Ont participé 65/81 experts invités à un processus Delphi utilisant une échelle de Likert en 5 points pour évaluer des ébauches de normes.

RÉSULTATS :: Nous avons identifié huit normes cliniques. Chaque personne commençant un traitement antituberculeux devrait : Norme 1, être informée des AE avant et pendant le traitement ; Norme 2, être évaluée afin de détecter tout facteur susceptible d’augmenter le risque d’AE et faire l’objet d’un examen régulier afin d’identifier et de prendre en charge ces facteurs de manière proactive ; Norme 3, en cas d’AE, être évaluée avec soin et tenir compte d’éventuelles réactions allergiques ou d’hypersensibilité ; Norme 4, recevoir des soins appropriés pour minimiser la morbidité et la mortalité associées aux AE ; Norme 5, reprendre les médicaments antituberculeux après un AE grave selon un protocole standardisé avec une surveillance active de l’innocuité des médicaments ; Norme 6, les agents de santé doivent être formés aux AE, y compris à la manière de conseiller les personnes qui suivent un traitement antituberculeux, ainsi qu’à la surveillance et à la prise en charge actives des AE ; Norme 7 : tous les nouveaux médicaments et schémas antituberculeux doivent faire l’objet d’une surveillance active des AE et d’une notification ; et Norme 8 : les lacunes en matière de connaissances identifiées grâce à la surveillance active des AE doivent être systématiquement comblées par la recherche clinique.

CONCLUSION :: Ces normes fournissent une approche centrée sur la personne et fondée sur le consensus afin de minimiser l’impact des AE pendant le traitement de la TB.

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Conflict of interest statement

Conflicts of interest: CWMO received speaking fees from Qiagen (Hilden, Germany) outside the context of this work.

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