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

K P Singh; A C C Carvalho; R Centis; L D´Ambrosio; G B Migliori; S G Mpagama; B C Nguyen; R E Aarnoutse; A Aleksa; R Van Altena; P K Bhavani; M S Bolhuis; S Borisov; N Van´t Boveneind-Vrubleuskaya; J Bruchfeld; J A Caminero; I Carvalho; J G Cho; L Davies Forsman; M Dedicoat; K Dheda; K Dooley; J Furin; J M García-García; A Garcia-Prats; A C Hesseling; S K Heysell; Y Hu; H Y Kim; S Manga; B J Marais; I Margineanu; A-G Märtson; M Munoz Torrico; H M Nataprawira; E Nunes; C W M Ong; R Otto-Knapp; D J Palmero; C A Peloquin; A Rendon; D Rossato Silva; R Ruslami; A M I Saktiawati; P Santoso; H S Schaaf; B Seaworth; U S H Simonsson; R Singla; A Skrahina; I Solovic; S Srivastava; S L Stocker; M G G Sturkenboom; E M Svensson; M Tadolini; T A Thomas; S Tiberi; J Trubiano; Z F Udwadia; A R Verhage; D H Vu; O W Akkerman; J W C Alffenaar; J T Denholm

doi:10.5588/ijtld.23.0078

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

K P Singh, A C C Carvalho, R Centis, L D´Ambrosio, G B Migliori, S G Mpagama, B C Nguyen, R E Aarnoutse, A Aleksa, R Van Altena, P K Bhavani, M S Bolhuis, S Borisov, N Van´t Boveneind-Vrubleuskaya, J Bruchfeld, J A Caminero, I Carvalho, J G Cho, L Davies Forsman, M DedicoatK Dheda, K Dooley, J Furin, J M García-García, A Garcia-Prats, A C Hesseling, S K Heysell, Y Hu, H Y Kim, S Manga, B J Marais, I Margineanu, A-G Märtson, M Munoz Torrico, H M Nataprawira, E Nunes, C W M Ong, R Otto-Knapp, D J Palmero, C A Peloquin, A Rendon, D Rossato Silva, R Ruslami, A M I Saktiawati, P Santoso, H S Schaaf, B Seaworth, U S H Simonsson, R Singla, A Skrahina, I Solovic, S Srivastava, S L Stocker, M G G Sturkenboom, E M Svensson, M Tadolini, T A Thomas, S Tiberi, J Trubiano, Z F Udwadia, A R Verhage, D H Vu, O W Akkerman, J W C Alffenaar, J T Denholm

Pharmacy

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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.

Original language	English
Article number	14
Pages (from-to)	506-519
Journal	The International Journal of Tuberculosis and Lung Disease
Volume	27
Issue number	7
DOIs	https://doi.org/10.5588/ijtld.23.0078
Publication status	Published - 1 Jul 2023

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Singh, K. P., Carvalho, A. C. C., Centis, R., D´Ambrosio, L., Migliori, G. B., Mpagama, S. G., Nguyen, B. C., Aarnoutse, R. E., Aleksa, A., Van Altena, R., Bhavani, P. K., Bolhuis, M. S., Borisov, S., Van´t Boveneind-Vrubleuskaya, N., Bruchfeld, J., Caminero, J. A., Carvalho, I., Cho, J. G., Davies Forsman, L., ... Denholm, J. T. (2023). Clinical standards for the management of adverse effects during treatment for TB. The International Journal of Tuberculosis and Lung Disease, 27(7), 506-519. Article 14. https://doi.org/10.5588/ijtld.23.0078

@article{9939453047714efa92801323f480e3b6,

title = "Clinical standards for the management of adverse effects during treatment for TB",

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.",

author = "Singh, \{K P\} and Carvalho, \{A C C\} and R Centis and L D´Ambrosio and Migliori, \{G B\} and Mpagama, \{S G\} and Nguyen, \{B C\} and Aarnoutse, \{R E\} and A Aleksa and \{Van Altena\}, R and Bhavani, \{P K\} and Bolhuis, \{M S\} and S Borisov and \{Van´t Boveneind-Vrubleuskaya\}, N and J Bruchfeld and Caminero, \{J A\} and I Carvalho and Cho, \{J G\} and \{Davies Forsman\}, L and M Dedicoat and K Dheda and K Dooley and J Furin and Garc{\'i}a-Garc{\'i}a, \{J M\} and A Garcia-Prats and Hesseling, \{A C\} and Heysell, \{S K\} and Y Hu and Kim, \{H Y\} and S Manga and Marais, \{B J\} and I Margineanu and A-G M{\"a}rtson and \{Munoz Torrico\}, M and Nataprawira, \{H M\} and E Nunes and Ong, \{C W M\} and R Otto-Knapp and Palmero, \{D J\} and Peloquin, \{C A\} and A Rendon and \{Rossato Silva\}, D and R Ruslami and Saktiawati, \{A M I\} and P Santoso and Schaaf, \{H S\} and B Seaworth and Simonsson, \{U S H\} and R Singla and A Skrahina and I Solovic and S Srivastava and Stocker, \{S L\} and Sturkenboom, \{M G G\} and Svensson, \{E M\} and M Tadolini and Thomas, \{T A\} and S Tiberi and J Trubiano and Udwadia, \{Z F\} and Verhage, \{A R\} and Vu, \{D H\} and Akkerman, \{O W\} and Alffenaar, \{J W C\} and Denholm, \{J T\}",

year = "2023",

month = jul,

day = "1",

doi = "10.5588/ijtld.23.0078",

language = "English",

volume = "27",

pages = "506--519",

journal = "The International Journal of Tuberculosis and Lung Disease",

issn = "1027-3719",

publisher = "International Union Against Tuberculosis and Lung Disease",

number = "7",

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Singh, KP, Carvalho, ACC, Centis, R, D´Ambrosio, L, Migliori, GB, Mpagama, SG, Nguyen, BC, Aarnoutse, RE, Aleksa, A, Van Altena, R, Bhavani, PK, Bolhuis, MS, Borisov, S, Van´t Boveneind-Vrubleuskaya, N, Bruchfeld, J, Caminero, JA, Carvalho, I, Cho, JG, Davies Forsman, L, Dedicoat, M, Dheda, K, Dooley, K, Furin, J, García-García, JM, Garcia-Prats, A, Hesseling, AC, Heysell, SK, Hu, Y, Kim, HY, Manga, S, Marais, BJ, Margineanu, I, Märtson, A-G, Munoz Torrico, M, Nataprawira, HM, Nunes, E, Ong, CWM, Otto-Knapp, R, Palmero, DJ, Peloquin, CA, Rendon, A, Rossato Silva, D, Ruslami, R, Saktiawati, AMI, Santoso, P, Schaaf, HS, Seaworth, B, Simonsson, USH, Singla, R, Skrahina, A, Solovic, I, Srivastava, S, Stocker, SL, Sturkenboom, MGG, Svensson, EM, Tadolini, M, Thomas, TA, Tiberi, S, Trubiano, J, Udwadia, ZF, Verhage, AR, Vu, DH, Akkerman, OW, Alffenaar, JWC & Denholm, JT 2023, 'Clinical standards for the management of adverse effects during treatment for TB', The International Journal of Tuberculosis and Lung Disease, vol. 27, no. 7, 14, pp. 506-519. https://doi.org/10.5588/ijtld.23.0078

TY - JOUR

T1 - Clinical standards for the management of adverse effects during treatment for TB

AU - Singh, K P

AU - Carvalho, A C C

AU - Centis, R

AU - D´Ambrosio, L

AU - Migliori, G B

AU - Mpagama, S G

AU - Nguyen, B C

AU - Aarnoutse, R E

AU - Aleksa, A

AU - Van Altena, R

AU - Bhavani, P K

AU - Bolhuis, M S

AU - Borisov, S

AU - Van´t Boveneind-Vrubleuskaya, N

AU - Bruchfeld, J

AU - Caminero, J A

AU - Carvalho, I

AU - Cho, J G

AU - Davies Forsman, L

AU - Dedicoat, M

AU - Dheda, K

AU - Dooley, K

AU - Furin, J

AU - García-García, J M

AU - Garcia-Prats, A

AU - Hesseling, A C

AU - Heysell, S K

AU - Hu, Y

AU - Kim, H Y

AU - Manga, S

AU - Marais, B J

AU - Margineanu, I

AU - Märtson, A-G

AU - Munoz Torrico, M

AU - Nataprawira, H M

AU - Nunes, E

AU - Ong, C W M

AU - Otto-Knapp, R

AU - Palmero, D J

AU - Peloquin, C A

AU - Rendon, A

AU - Rossato Silva, D

AU - Ruslami, R

AU - Saktiawati, A M I

AU - Santoso, P

AU - Schaaf, H S

AU - Seaworth, B

AU - Simonsson, U S H

AU - Singla, R

AU - Skrahina, A

AU - Solovic, I

AU - Srivastava, S

AU - Stocker, S L

AU - Sturkenboom, M G G

AU - Svensson, E M

AU - Tadolini, M

AU - Thomas, T A

AU - Tiberi, S

AU - Trubiano, J

AU - Udwadia, Z F

AU - Verhage, A R

AU - Vu, D H

AU - Akkerman, O W

AU - Alffenaar, J W C

AU - Denholm, J T

PY - 2023/7/1

Y1 - 2023/7/1

N2 - 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.

AB - 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.

U2 - 10.5588/ijtld.23.0078

DO - 10.5588/ijtld.23.0078

M3 - Article

SN - 1027-3719

VL - 27

SP - 506

EP - 519

JO - The International Journal of Tuberculosis and Lung Disease

JF - The International Journal of Tuberculosis and Lung Disease

IS - 7

M1 - 14

ER -

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

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