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

Author

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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., Denholm, J. T., 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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., and Denholm, J. T.

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 hypersensitiv-ity 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 TB treatment.

Published
2023
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2. Clinical standards for the management of adverse effects during treatment for TB

Author

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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., Denholm, J. T., 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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., and Denholm, J. T.

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 hypersensitiv-ity 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 TB treatment.

Published
2023
Full Text
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3. Clinical standards for the management of adverse effects during treatment for TB

Author

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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., Denholm, J. T., 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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., and Denholm, J. T.

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 hypersensitiv-ity 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 TB treatment.

Published
2023
Full Text
View/download PDF

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

Author

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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., Denholm, J. T., 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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., and Denholm, J. T.

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 hypersensitiv-ity 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 TB treatment.

Published
2023
Full Text
View/download PDF

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

Author

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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., Denholm, J. T., 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., Forsman, L. Davies, Dedicoat, M., Dheda, K., Dooley, K., Furin, J., Garcia-Garcia, J. M., Garcia-Prats, A., Hesseling, A. C., Heysell, S. K., Hu, Y., Kim, H. Y., Manga, S., Marais, B. J., Margineanu, I., Martson, A-G, Torrico, M. Munoz, Nataprawira, H. M., Nunes, E., Ong, C. W. M., Otto-Knapp, R., Palmero, D. J., Peloquin, C. A., Rendon, A., Silva, D. Rossato, Ruslami, R., Saktiawati, A. M. I., Santoso, P., Schaaf, H. S., Seaworth, B., Simonsson, Ulrika S. H., Singla, R., Skrahina, A., Solovic, I., Srivastava, S., Stocker, S. L., Stukenboom, M. G. G., Svensson, Elin, Tadolini, M., Thomas, T. A., Tiberi, S., Trubiano, J., Udwadia, Z. F., Verhage, A. R., Vu, D. H., Akkerman, O. W., Alffenaar, J. W. C., and Denholm, J. T.

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 hypersensitiv-ity 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 TB treatment.

Published
2023
Full Text
View/download PDF

6. Clinical standards for the dosing and management of TB drugs

Author

Alffenaar, J. W. C., Stocker, S. L., Forsman, L. Davies, Garcia-Prats, A., Heysell, S. K., Aarnoutse, R. E., Akkerman, O. W., Aleksa, A., van Altena, R., de Onata, W. Arrazola, Bhavani, P. K., Van't Boveneind-Vrubleuskaya, N., Carvalho, A. C. C., Centis, R., Chakaya, J. M., Cirillo, D. M., Cho, J. G., Ambrosio, L. D., Dalcolmo, M. P., Denti, P., Dheda, K., Fox, G. J., Hesseling, A. C., Kim, H. Y., Koser, C. U., Marais, B. J., Margineanu, I, Martson, A. G., Torrico, M. Munoz, Nataprawira, H. M., Ong, C. W. M., Otto-Knapp, R., Peloquin, C. A., Silva, D. R., Ruslami, R., Santoso, P., Savic, R. M., Singla, R., Svensson, Elin, Skrahina, A., van Soolingen, D., Srivastava, S., Tadolini, M., Tiberi, S., Thomas, T. A., Udwadia, Z. F., Vu, D. H., Zhang, W., Mpagama, S. G., Schon, T., Migliori, G. B., Alffenaar, J. W. C., Stocker, S. L., Forsman, L. Davies, Garcia-Prats, A., Heysell, S. K., Aarnoutse, R. E., Akkerman, O. W., Aleksa, A., van Altena, R., de Onata, W. Arrazola, Bhavani, P. K., Van't Boveneind-Vrubleuskaya, N., Carvalho, A. C. C., Centis, R., Chakaya, J. M., Cirillo, D. M., Cho, J. G., Ambrosio, L. D., Dalcolmo, M. P., Denti, P., Dheda, K., Fox, G. J., Hesseling, A. C., Kim, H. Y., Koser, C. U., Marais, B. J., Margineanu, I, Martson, A. G., Torrico, M. Munoz, Nataprawira, H. M., Ong, C. W. M., Otto-Knapp, R., Peloquin, C. A., Silva, D. R., Ruslami, R., Santoso, P., Savic, R. M., Singla, R., Svensson, Elin, Skrahina, A., van Soolingen, D., Srivastava, S., Tadolini, M., Tiberi, S., Thomas, T. A., Udwadia, Z. F., Vu, D. H., Zhang, W., Mpagama, S. G., Schon, T., and Migliori, G. B.

Abstract

Background: Optimal drug dosing is important to ensure adequate response to treatment, prevent development of drug resistance and reduce drug toxicity. The aim of these clinical standards is to provide guidance on 'best practice' for dosing and management of TB drugs. Methods: A panel of 57 global experts in the fields of microbiology, pharmacology and TB care were identified; 51 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all participants. Results: Six clinical standards were defined: Standard 1, defining the most appropriate initial dose for TB treatment; Standard 2, identifying patients who may be at risk of sub-optimal drug exposure; Standard 3, identifying patients at risk of developing drug-related toxicity and how best to manage this risk; Standard 4, identifying patients who can benefit from therapeutic drug monitoring (TDM); Standard 5, highlighting education and counselling that should be provided to people initiating TB treatment; and Standard 6, providing essential education for healthcare professionals. In addition, consensus research priorities were identified. Conclusion: This is the first consensus-based Clinical Standards for the dosing and management of TB drugs to guide clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment to improve patient care.

Published
2022
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7. Clinical standards for the dosing and management of TB drugs

Author

Alffenaar, J. W. C., Stocker, S. L., Forsman, L. Davies, Garcia-Prats, A., Heysell, S. K., Aarnoutse, R. E., Akkerman, O. W., Aleksa, A., van Altena, R., de Onata, W. Arrazola, Bhavani, P. K., Vant Boveneind-Vrubleuskaya, N., Carvalho, A. C. C., Centis, R., Chakaya, J. M., Cirillo, D. M., Cho, J. G., Ambrosio, L. D., Dalcolmo, M. P., Denti, P., Dheda, K., Fox, G. J., Hesseling, A. C., Kim, H. Y., Koser, C. U., Marais, B. J., Margineanu, I, Martson, A. G., Torrico, M. Munoz, Nataprawira, H. M., Ong, C. W. M., Otto-Knapp, R., Peloquin, C. A., Silva, D. R., Ruslami, R., Santoso, P., Savic, R. M., Singla, R., Svensson, E. M., Skrahina, A., van Soolingen, D., Srivastava, S., Tadolini, M., Tiberi, S., Thomas, T. A., Udwadia, Z. F., Vu, D. H., Zhang, W., Mpagama, S. G., Schön, Thomas, Migliori, G. B., Alffenaar, J. W. C., Stocker, S. L., Forsman, L. Davies, Garcia-Prats, A., Heysell, S. K., Aarnoutse, R. E., Akkerman, O. W., Aleksa, A., van Altena, R., de Onata, W. Arrazola, Bhavani, P. K., Vant Boveneind-Vrubleuskaya, N., Carvalho, A. C. C., Centis, R., Chakaya, J. M., Cirillo, D. M., Cho, J. G., Ambrosio, L. D., Dalcolmo, M. P., Denti, P., Dheda, K., Fox, G. J., Hesseling, A. C., Kim, H. Y., Koser, C. U., Marais, B. J., Margineanu, I, Martson, A. G., Torrico, M. Munoz, Nataprawira, H. M., Ong, C. W. M., Otto-Knapp, R., Peloquin, C. A., Silva, D. R., Ruslami, R., Santoso, P., Savic, R. M., Singla, R., Svensson, E. M., Skrahina, A., van Soolingen, D., Srivastava, S., Tadolini, M., Tiberi, S., Thomas, T. A., Udwadia, Z. F., Vu, D. H., Zhang, W., Mpagama, S. G., Schön, Thomas, and Migliori, G. B.

Abstract

BACKGROUND: Optimal drug dosing is important to ensure adequate response to treatment, prevent development of drug resistance and reduce drug toxicity. The aim of these clinical standards is to provide guidance on best practice for dosing and management of TB drugs. METHODS: A panel of 57 global experts in the fields of microbiology, pharmacology and TB care were identified; 51 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all participants. RESULTS: Six clinical standards were defined: Standard 1, defining the most appropriate initial dose for TB treatment; Standard 2, identifying patients who may be at risk of sub-optimal drug exposure; Standard 3, identifying patients at risk of developing drug-related toxicity and how best to manage this risk; Standard 4, identifying patients who can benefit from therapeutic drug monitoring (TDM); Standard 5, highlighting education and counselling that should be provided to people initiating TB treatment; and Standard 6, providing essential education for healthcare professionals. In addition, consensus research priorities were identified. CONCLUSION: This is the first consensus-based Clinical Standards for the dosing and management of TB drugs to guide clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment to improve patient care., Funding Agencies: Oskar-Helene-Heim Foundation (OHH; Berlin, Germany); Gunther Labes Foundation (Berlin, Germany)

Published
2022
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