Clinical standards for drug-susceptible pulmonary TB

O. W. Akkerman; R. Duarte; S. Tiberi; H. S. Schaaf; C. Lange; J. W.C. Alffenaar; J. Denholm; A. C.C. Carvalho; M. S. Bolhuis; S. Borisov; J. Bruchfeld; A. M. Cabibbe; J. A. Caminero; I. Carvalho; J. Chakaya; R. Centis; M. P. Dalcomo; L. D'Ambrosio; M. Dedicoat; K. Dheda; K. E. Dooley; J. Furin; J. M. Garcia-Garcia; N. A.H. van Hest; B. C. de Jong; X. Kurhasani; A. G. Martson; S. Mpagama; M. Munoz Torrico; E. Nunes; C. W.M. Ong; D. J. Palmero; R. Ruslami; A. M.I. Saktiawati; C. Semuto; D. R. Silva; R. Singla; I. Solovic; S. Srivastava; J. E.M. de Steenwinkel; A. Story; M. G.G. Sturkenboom; M. Tadolini; Z. F. Udwadia; A. R. Verhage; J. P. Zellweger; G. B. Migliori

doi:10.5588/ijtld.22.0228

Clinical standards for drug-susceptible pulmonary TB

O. W. Akkerman^*, R. Duarte, S. Tiberi, H. S. Schaaf, C. Lange, J. W.C. Alffenaar, J. Denholm, A. C.C. Carvalho, M. S. Bolhuis, S. Borisov, J. Bruchfeld, A. M. Cabibbe, J. A. Caminero, I. Carvalho, J. Chakaya, R. Centis, M. P. Dalcomo, L. D'Ambrosio, M. Dedicoat, K. DhedaK. E. Dooley, J. Furin, J. M. Garcia-Garcia, N. A.H. van Hest, B. C. de Jong, X. Kurhasani, A. G. Martson, S. Mpagama, M. Munoz Torrico, E. Nunes, C. W.M. Ong, D. J. Palmero, R. Ruslami, A. M.I. Saktiawati, C. Semuto, D. R. Silva, R. Singla, I. Solovic, S. Srivastava, J. E.M. de Steenwinkel, A. Story, M. G.G. Sturkenboom, M. Tadolini, Z. F. Udwadia, A. R. Verhage, J. P. Zellweger, G. B. Migliori

^*Corresponding author for this work

Medical Microbiology & Infectious Diseases

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Abstract

BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice' for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB). METHODS : A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 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 46 participants. RESULTS : Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB. CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.

Original language	English
Pages (from-to)	592-604
Number of pages	13
Journal	International Journal of Tuberculosis and Lung Disease
Volume	26
Issue number	7
DOIs	https://doi.org/10.5588/ijtld.22.0228
Publication status	Published - 1 Jul 2022

Bibliographical note

Acknowledgments
This article is sponsored by the Oskar-Helene-Heim Foundation
(OHH; Berlin, Germany) and the Gunther Labes Foundation ¨
(Berlin, Germany) and available as an Open Access article (subject
to CC-BY 4.0 licensing rules). The authors would also like to thank
M van den Boom for his useful comments on the manuscript.
Conflicts of interest: CL received a speaker’s honoraria from
Insmed (Bridgewater Township, NJ, USA), Janssen (Beerse,
Belgium) and Gilead (Foster City, CA, USA) for lectures at
sponsored symposia outside of the scope of this work. CL is
supported by the German Center for Infection Research (DZIF). SS
received a grant (1R01HD099756) from Eunice Kennedy Shriver
National Institute of Child Health and Human Development,
University of Texas System STARS award [250439/39411] and
funding from the department of Pulmonary Immunology [423500/
14000], UT Health Science Center at Tyler, TX, USA. CO received
speaking fees from Qiagen (Hilden, Germany) outside this work.
ST has received honoraria from Janssen and Qiagen outside the
scope of this work. J-P Zellweger received speaker’s fees from
Qiagen outside this work

Publisher Copyright:
© 2022 International Union against Tubercul. and Lung Dis.. All rights reserved.

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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s5Final published version, 145 KBLicence: CC BY

Cite this

Akkerman, O. W., Duarte, R., Tiberi, S., Schaaf, H. S., Lange, C., Alffenaar, J. W. C., Denholm, J., Carvalho, A. C. C., Bolhuis, M. S., Borisov, S., Bruchfeld, J., Cabibbe, A. M., Caminero, J. A., Carvalho, I., Chakaya, J., Centis, R., Dalcomo, M. P., D'Ambrosio, L., Dedicoat, M., ... Migliori, G. B. (2022). Clinical standards for drug-susceptible pulmonary TB. International Journal of Tuberculosis and Lung Disease, 26(7), 592-604. https://doi.org/10.5588/ijtld.22.0228

@article{85aa3eca40a34e088e33516c77f43389,

title = "Clinical standards for drug-susceptible pulmonary TB",

abstract = "BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice' for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB). METHODS : A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 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 46 participants. RESULTS : Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB. CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.",

author = "Akkerman, {O. W.} and R. Duarte and S. Tiberi and Schaaf, {H. S.} and C. Lange and Alffenaar, {J. W.C.} and J. Denholm and Carvalho, {A. C.C.} and Bolhuis, {M. S.} and S. Borisov and J. Bruchfeld and Cabibbe, {A. M.} and Caminero, {J. A.} and I. Carvalho and J. Chakaya and R. Centis and Dalcomo, {M. P.} and L. D'Ambrosio and M. Dedicoat and K. Dheda and Dooley, {K. E.} and J. Furin and Garcia-Garcia, {J. M.} and {van Hest}, {N. A.H.} and {de Jong}, {B. C.} and X. Kurhasani and Martson, {A. G.} and S. Mpagama and {Munoz Torrico}, M. and E. Nunes and Ong, {C. W.M.} and Palmero, {D. J.} and R. Ruslami and Saktiawati, {A. M.I.} and C. Semuto and Silva, {D. R.} and R. Singla and I. Solovic and S. Srivastava and {de Steenwinkel}, {J. E.M.} and A. Story and Sturkenboom, {M. G.G.} and M. Tadolini and Udwadia, {Z. F.} and Verhage, {A. R.} and Zellweger, {J. P.} and Migliori, {G. B.}",

note = "Acknowledgments This article is sponsored by the Oskar-Helene-Heim Foundation (OHH; Berlin, Germany) and the Gunther Labes Foundation ¨ (Berlin, Germany) and available as an Open Access article (subject to CC-BY 4.0 licensing rules). The authors would also like to thank M van den Boom for his useful comments on the manuscript. Conflicts of interest: CL received a speaker{\textquoteright}s honoraria from Insmed (Bridgewater Township, NJ, USA), Janssen (Beerse, Belgium) and Gilead (Foster City, CA, USA) for lectures at sponsored symposia outside of the scope of this work. CL is supported by the German Center for Infection Research (DZIF). SS received a grant (1R01HD099756) from Eunice Kennedy Shriver National Institute of Child Health and Human Development, University of Texas System STARS award [250439/39411] and funding from the department of Pulmonary Immunology [423500/ 14000], UT Health Science Center at Tyler, TX, USA. CO received speaking fees from Qiagen (Hilden, Germany) outside this work. ST has received honoraria from Janssen and Qiagen outside the scope of this work. J-P Zellweger received speaker{\textquoteright}s fees from Qiagen outside this work Publisher Copyright: {\textcopyright} 2022 International Union against Tubercul. and Lung Dis.. All rights reserved.",

year = "2022",

month = jul,

day = "1",

doi = "10.5588/ijtld.22.0228",

language = "English",

volume = "26",

pages = "592--604",

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

issn = "1027-3719",

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

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Akkerman, OW, Duarte, R, Tiberi, S, Schaaf, HS, Lange, C, Alffenaar, JWC, Denholm, J, Carvalho, ACC, Bolhuis, MS, Borisov, S, Bruchfeld, J, Cabibbe, AM, Caminero, JA, Carvalho, I, Chakaya, J, Centis, R, Dalcomo, MP, D'Ambrosio, L, Dedicoat, M, Dheda, K, Dooley, KE, Furin, J, Garcia-Garcia, JM, van Hest, NAH, de Jong, BC, Kurhasani, X, Martson, AG, Mpagama, S, Munoz Torrico, M, Nunes, E, Ong, CWM, Palmero, DJ, Ruslami, R, Saktiawati, AMI, Semuto, C, Silva, DR, Singla, R, Solovic, I, Srivastava, S, de Steenwinkel, JEM, Story, A, Sturkenboom, MGG, Tadolini, M, Udwadia, ZF, Verhage, AR, Zellweger, JP & Migliori, GB 2022, 'Clinical standards for drug-susceptible pulmonary TB', International Journal of Tuberculosis and Lung Disease, vol. 26, no. 7, pp. 592-604. https://doi.org/10.5588/ijtld.22.0228

TY - JOUR

T1 - Clinical standards for drug-susceptible pulmonary TB

AU - Akkerman, O. W.

AU - Duarte, R.

AU - Tiberi, S.

AU - Schaaf, H. S.

AU - Lange, C.

AU - Alffenaar, J. W.C.

AU - Denholm, J.

AU - Carvalho, A. C.C.

AU - Bolhuis, M. S.

AU - Borisov, S.

AU - Bruchfeld, J.

AU - Cabibbe, A. M.

AU - Caminero, J. A.

AU - Carvalho, I.

AU - Chakaya, J.

AU - Centis, R.

AU - Dalcomo, M. P.

AU - D'Ambrosio, L.

AU - Dedicoat, M.

AU - Dheda, K.

AU - Dooley, K. E.

AU - Furin, J.

AU - Garcia-Garcia, J. M.

AU - van Hest, N. A.H.

AU - de Jong, B. C.

AU - Kurhasani, X.

AU - Martson, A. G.

AU - Mpagama, S.

AU - Munoz Torrico, M.

AU - Nunes, E.

AU - Ong, C. W.M.

AU - Palmero, D. J.

AU - Ruslami, R.

AU - Saktiawati, A. M.I.

AU - Semuto, C.

AU - Silva, D. R.

AU - Singla, R.

AU - Solovic, I.

AU - Srivastava, S.

AU - de Steenwinkel, J. E.M.

AU - Story, A.

AU - Sturkenboom, M. G.G.

AU - Tadolini, M.

AU - Udwadia, Z. F.

AU - Verhage, A. R.

AU - Zellweger, J. P.

AU - Migliori, G. B.

N1 - Acknowledgments This article is sponsored by the Oskar-Helene-Heim Foundation (OHH; Berlin, Germany) and the Gunther Labes Foundation ¨ (Berlin, Germany) and available as an Open Access article (subject to CC-BY 4.0 licensing rules). The authors would also like to thank M van den Boom for his useful comments on the manuscript. Conflicts of interest: CL received a speaker’s honoraria from Insmed (Bridgewater Township, NJ, USA), Janssen (Beerse, Belgium) and Gilead (Foster City, CA, USA) for lectures at sponsored symposia outside of the scope of this work. CL is supported by the German Center for Infection Research (DZIF). SS received a grant (1R01HD099756) from Eunice Kennedy Shriver National Institute of Child Health and Human Development, University of Texas System STARS award [250439/39411] and funding from the department of Pulmonary Immunology [423500/ 14000], UT Health Science Center at Tyler, TX, USA. CO received speaking fees from Qiagen (Hilden, Germany) outside this work. ST has received honoraria from Janssen and Qiagen outside the scope of this work. J-P Zellweger received speaker’s fees from Qiagen outside this work Publisher Copyright: © 2022 International Union against Tubercul. and Lung Dis.. All rights reserved.

PY - 2022/7/1

Y1 - 2022/7/1

N2 - BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice' for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB). METHODS : A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 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 46 participants. RESULTS : Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB. CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.

AB - BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice' for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB). METHODS : A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 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 46 participants. RESULTS : Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB. CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.

UR - http://www.scopus.com/inward/record.url?scp=85133144749&partnerID=8YFLogxK

U2 - 10.5588/ijtld.22.0228

DO - 10.5588/ijtld.22.0228

M3 - Article

C2 - 35768923

AN - SCOPUS:85133144749

SN - 1027-3719

VL - 26

SP - 592

EP - 604

JO - International Journal of Tuberculosis and Lung Disease

JF - International Journal of Tuberculosis and Lung Disease

IS - 7

ER -

Clinical standards for drug-susceptible pulmonary TB

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