EUROPEAN RESPIRATORY JOURNAL
EDITORIAL
World Health Organization treatment outcome definitions for
tuberculosis: 2021 update
Nguyen Nhat Linh, Kerri Viney, Medea Gegia, Dennis Falzon, Philippe Glaziou, Katherine Floyd,
Hazim Timimi, Nazir Ismail, Matteo Zignol, Tereza Kasaeva and Fuad Mirzayev
Global TB Programme, World Health Organization, Geneva, Switzerland.
Copyright ©The authors 2021. For
reproduction rights and
permissions contact
permissions@ersnet.org
Received: 18 March 2021
Accepted: 30 June 2021
https://doi.org/10.1183/13993003.00804-2021
N.N. LINH ET AL.
Corresponding author: Nguyen Nhat Linh (nguyenli@who.int)
Shareable abstract (@ERSpublications)
In 2021, WHO revised its tuberculosis treatment outcome definitions, making them uniformly
applicable for different lengths of treatment for both drug-susceptible and drug-resistant disease
https://bit.ly/3jFFgOu
Cite this article as: Linh NN, Viney K, Gegia M, et al. World Health Organization treatment outcome
definitions for tuberculosis: 2021 update. Eur Respir J 2021; 58: 2100804 [DOI: 10.1183/13993003.00804-2021].
Background
Tuberculosis (TB) remains an important global health concern, even though it is largely curable with
treatment that is affordable and widely accessible for diagnosed and notified TB patients. If not
administered correctly, TB treatment regimens may fail to deliver a relapse-free cure, favouring continued
transmission and the emergence of drug resistance. Monitoring the effectiveness of TB treatment is thus
critically important in both clinical practice and surveillance, to maximise the quality of individual patient
care and the effectiveness of public health action. Standardised TB treatment outcome definitions have been
a feature of World Health Organization (WHO) policies and national TB surveillance systems for many
years. This has allowed the monitoring of TB treatment outcomes over time at national and global levels.
While standardised treatment outcome definitions for drug-susceptible TB (DS-TB) have been in
widespread use for over three decades, outcome definitions for drug-resistant TB (DR-TB) were first
proposed in 2005 [1]. The development of DR-TB treatment outcome definitions was based on the
outcome definitions for DS-TB in use at the time [1, 2], a literature review, and extensive discussions
among key stakeholders using data from treatment programmes. Six mutually exclusive definitions were
developed to fit the wide range of treatment regimens and durations in use at that time [1]. These
definitions were adopted by WHO and remained largely unchanged until 2013, when WHO updated its
Definitions and Reporting Framework for Tuberculosis [3]. Since 2013, treatment regimens for DR-TB
have changed significantly in both composition and duration, making it necessary to update the treatment
outcome definitions and monitoring parameters.
In this article we describe the process and results of a meeting of experts convened by WHO to update TB
treatment outcome definitions.
Rationale for the change
Since the 2013 revision of the definitions and reporting framework [3], a number of important changes
have taken place with regards to the treatment of multidrug-resistant or rifampicin-resistant TB (MDR/
RR-TB) [4–6]. In 2016, for the first time, WHO recommended a standardised shorter regimen (9–
12 months) for eligible patients with MDR/RR-TB [5]. This recommendation was updated in 2018 and in
2020 as evidence from studies and programmatic settings became available [6]. In the latest WHO
consolidated guidelines on the treatment of DR-TB, the shorter, all-oral regimen is the preferred option for
eligible patients with MDR/RR-TB [6, 7]. The duration of this regimen can be as short as 9 months; thus,
any treatment outcome definitions for DR-TB would need to be defined within this time frame. Treatment
regimens for MDR/RR-TB, and even for extensively drug-resistant TB, could become even shorter.
The bedaquiline, pretomanid and linezolid (BPaL) regimen, which has been recommended by WHO for
Eur Respir J 2021; 58: 2100804
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use under operational research conditions for patients with MDR-TB with additional fluoroquinolone
resistance, is a 6-month regimen, extendable to 9 months. Pretomanid is a new compound (a
nitroimidazole), which received US Food and Drug Adminstration approval to be used in combination with
bedaquiline and linezolid in April 2019. Duration of the BPaL regimen is extendable to 9 months for
patients who missed doses or remained culture positive or reverted from culture negative to positive
between months 4 to 6 of treatment. The longer regimens for the treatment of MDR/RR-TB, which
typically last for 18 to 20 months, remain in use. Moreover, since 2018, WHO has also recommended a
6-month regimen of 6(H)RZE-Lfx for the treatment of rifampicin-susceptible isoniazid-resistant TB [8].
For DS-TB, the standardised 6-month first-line treatment regimen (2HRZE/4HR) has remained the same
for many years, although the 8-month regimen for previously treated TB patients (known as the category 2
regimen) was phased out in 2017 [9, 10]. In addition, results from well-designed clinical trials show the
potential for DS-TB to be treated effectively using regimens with a duration of less than 6 months (refer to
reference [11] and unpublished data from NCT02410772 presented at the 51st World Conference on Lung
Health, 2020 by S.E. Dorman), especially an effective 4-month regimen for treatment of pulmonary TB [12].

The regimens recommended by WHO for the treatment of DR-TB are increasingly being used by countries
[13]. Since the publication of the WHO 2013 definitions and reporting framework for TB, various
alternative definitions of the DR-TB treatment outcomes have been proposed. Suggestions have included:
an additional microbiological criterion for “failure” based on sputum smear microscopy for treatment
monitoring [14, 15]; an option for the outcome of “cure” that considers a follow-up period after treatment
ends [14–18]; separate identification of drug resistance acquired during and after treatment as part of the
definition of “cure” and consideration of evidence of acquired resistance to the fluoroquinolones or
injectables; or adverse drug reactions to these drugs as not necessarily implying treatment failure [19].

WHO consultation to review the definitions of TB treatment outcomes and its results
In November 2020 the WHO Global TB Programme convened an online consultation on the definitions of
TB treatment outcomes. The consultation was attended by participants representing countries, bilateral and
multilateral agencies, international organisations, nongovernmental organisations, civil society and
academia who were selected based on their expertise and interest in the topic. The aims of the consultation
were to discuss recent and potential future developments in treatment regimens for patients with DS-TB
and DR-TB, and to consider possible changes in treatment outcome definitions required for programmatic
monitoring [20].

During its deliberations on the new TB treatment outcome definitions, the participants at the consultation
discussed different options in light of several strategic issues and surveillance requirements:
• Harmonisation of treatment outcomes for DS-TB and DR-TB is needed, although some specifics
should remain (e.g. treatment monitoring by sputum culture for DR-TB and by sputum smear
microscopy for DS-TB).
• Despite the fact that some distinct treatment phases remain in current regimens, the overall trend is
towards regimens with an unchanged composition throughout the course of treatment. Thus, linking
definitions to treatment phases should be avoided, which means that the time threshold to declare cure
or treatment failure should be revised.
• While considering new bacteriological tests, treatment monitoring will continue to rely on the available
tools (i.e. sputum culture for DR-TB and sputum microscopy for DS-TB), despite their drawbacks.
• At the end of treatment, it is important and feasible for programmes to ascertain cure. The notion of
relapse-free cure or sustained treatment success after the end of treatment is critical but may be beyond
the means of routine programmatic monitoring, and feasible under operational research conditions, for
which specific resources could be made available.
Based on the discussions during the consultation, WHO now proposes new definitions of TB treatment
outcomes, which are presented in table 1 together with the reasons for these changes.

Discussion on programmatic implementation and research implications

The 2021 treatment outcome definitions will address several programmatic implementation challenges. The
most important change of the definitions is that the new definitions of “treatment failed”, “cured” and
“treatment completed” apply to both DS-TB and DR-TB, to treatment regimens of different lengths and
those without a clear distinction between intensive and continuation phases

“Treatment failed” is now defined as a permanent regimen change due to no response to treatment
(bacteriologically or clinically), an adverse drug reaction or amplification of drug resistance. No time limit
applies to “no treatment response”, which allows treatment failure to be defined during any stage of
treatment. In addition, the assessment of “no treatment response” does not rely only on bacteriological

https://doi.org/10.1183/13993003.00804-2021 2
https://doi.org/10.1183/13993003.00804-2021
TABLE 1 New definitions of tuberculosis (TB) treatment outcomes in comparison with the pre-2021 definitions and reasons for the change
Outcome Pre-2021 definition (2013)
Drug-susceptible TB [3]
Treatment failed A TB patient whose sputum smear or
culture is positive at month 5 or later
during treatment.
Cured A pulmonary TB patient with
bacteriologically confirmed TB at the
beginning of treatment who was
smear or culture negative in the last
month of treatment and on at least
one previous occasion.
3
Drug-resistant TB [3]
Treatment terminated or need for
permanent regimen change of at least
two anti-TB drugs because of:
• lack of conversion# by the end of the
intensive phase; or
• bacteriological reversion# in the
continuation phase after conversion to
negative; or
• evidence of additional acquired
resistance to fluoroquinolones or
second-line injectable drugs; or
• adverse drug reactions.
Treatment completed as recommended
by the national policy without evidence
of failure AND three or more
consecutive cultures taken at least
30 days apart are negative after the
intensive phase.+
New definition (2021)
A patient whose treatment regimen
needed to be terminated or
permanently changed¶ to a new
regimen or treatment strategy.
A pulmonary TB patient with
bacteriologically confirmed TB at the
beginning of treatment who
completed treatment as
recommended by the national policy
with evidence of bacteriological
response§ and no evidence of
failure.
EUROPEAN RESPIRATORY JOURNAL
Reason(s) for the change
• Being applicable to both DS-TB and
DR-TB treatment regimens: keeping
the definition broad and removing a
time threshold or reference to
treatment phases.
• Keeping the definition simple by
moving all reasons for failure (a
change of regimen or treatment
strategy) into footnote that includes:
no treatment response, adverse drug
reaction, or evidence of additional
drug resistance.
• Being applicable to patients without
bacteriologically confirmed TB by
including “no clinical response” as a
criterion to define failure.
• Removing the time threshold or
reference to treatment phases.
• Emphasising “no evidence of failure”
(not previously included in the failure
definition for DS-TB) that also
reflects the change in the new
treatment failure definition.
• Updating the definition of
bacteriological response as a
footnote (bacteriological conversion
with no reversion) with treatment
monitoring tests relevant to disease
EDITORIAL | N.N. LINH ET AL.
type, including culture and smear
microscopy for DS-TB and culture for
DR-TB.
Continued
https://doi.org/10.1183/13993003.00804-2021
TABLE 1 Continued
Outcome Pre-2021 definition (2013)
Drug-susceptible TB [3]
Treatment A TB patient who completed treatment
completed without evidence of failure BUT with
no record to show that sputum smear
or culture results in the last month of
treatment and on at least one
previous occasion were negative,
either because tests were not done or
because results are unavailable.
Died A TB patient who dies for any reason
before starting or during the course of
treatment.
Lost to follow-up A TB patient who did not start treatment
or whose treatment was interrupted
for 2 consecutive months or more.
Not evaluated A TB patient for whom no treatment
outcome is assigned. This includes
cases “transferred out” to another
treatment unit, as well as cases for
whom the treatment outcome is
unknown to the reporting unit.
4
Drug-resistant TB [3]
Treatment completed as recommended
by the national policy without evidence
of failure BUT no record that three or
more consecutive cultures taken at
least 30 days apart are negative after
the intensive phase.
A patient who dies for any reason during
the course of treatment.
A patient whose treatment was
interrupted for 2 consecutive months
or more.
A patient for whom no treatment
outcome is assigned. (This includes
cases “transferred out” to another
treatment unit and whose treatment
outcome is unknown.)
New definition (2021)
A patient who completed treatment as
recommended by the national policy
whose outcome does not meet the
definition for cure or treatment
failure.
A patient who diedƒ before starting
treatment or during the course of
treatment.
A patient who did not start treatment
or whose treatment was interrupted
for 2 consecutive months or more.
A patient for whom no treatment
outcome was assigned.##
EUROPEAN RESPIRATORY JOURNAL
Reason(s) for the change
• Simplifying the definition by
including “does not meet the
definition for cure or treatment
failure” to reflect all the changes in
definitions of cure and failure.
• Being applicable to both DS-TB and
DR-TB by including “died before
starting treatment” in addition to
“died during the course of
treatment”.
• Reflecting more comprehensively the
number of deaths among DR-TB
patients when reporting treatment
outcomes.
• Being applicable to both DS-TB and
DR-TB by including patients who
were diagnosed with TB but did not
start TB treatment.
• Reflecting more comprehensively the
number of DR-TB patients who were
lost to follow-up before treatment
start.
• Simplifying the definition by
including “no treatment outcome
assigned”.
• Keeping the definition simple by
having a detailed explanation in a
EDITORIAL | N.N. LINH ET AL.
footnote on the inclusion of patients
who are “transferred out” and
exclusion of patients who are “lost to
follow-up”.
Continued
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EUROPEAN RESPIRATORY JOURNAL

TABLE 1 Continued

Outcome Pre-2021 definition (2013) New definition (2021) Reason(s) for the change
Drug-susceptible TB [3] Drug-resistant TB [3]

Treatment success The sum of cured and treatment The sum of cured and treatment The sum of cured and treatment • No change made for this definition.
completed. completed. completed.
Sustained Not available. Not available. An individual assessed at 6 months (for • Addressing the need for assessment
treatment DS-TB and DR-TB) and at 12 months of the survival and TB-free status
success (for use (for DR-TB only) after successful TB post-TB treatment, this definition is
in operational treatment, who is alive and free proposed to assess outcome 6–
research only) of TB. 12 months after the end
of treatment.
• This outcome is not proposed in
routine programmatic surveillance
due to challenges in relation to
post-treatment follow-up in
programme settings, the “sustained
treatment success” definition is
suggested to be used for operational
research only.
#
: the terms “conversion” and “reversion” of culture as used here are defined as follows. Conversion (to negative): culture is considered to have converted to negative when two consecutive
cultures, taken at least 30 days apart, are negative. In such a case, the specimen collection date of the first negative culture is used as the date of conversion. Reversion (to positive): culture is
considered to have reverted to positive when, after an initial conversion, two consecutive cultures, taken at least 30 days apart, are positive. For the purpose of defining “treatment failed”,
reversion is considered only when it occurs in the continuation phase [3]. ¶: reasons for the change include: no clinical response and/or no bacteriological response (see note “§”); adverse drug
reactions; or evidence of additional drug resistance to medicines in the regimen. +: for treatment failed, lack of conversion by the end of the intensive phase implies that the patient did not
convert within the maximum duration of the intensive phase applied by the programme. If no maximum duration is defined, an 8-month cut-off is proposed. For regimens without a clear
distinction between the intensive and continuation phases, a cut-off of 8 months after the start of treatment is suggested, to determine when the criteria for “cured”, “treatment completed” and
“treatment failed” apply. §: bacteriological response refers to bacteriological conversion with no reversion: “bacteriological conversion” describes a situation in a patient with bacteriologically
confirmed TB where at least two consecutive cultures (for drug-resistant (DR)-TB and drug-susceptible (DS)-TB) or smears (for DS-TB only), taken on different occasions at least 7 days apart, are
negative; “bacteriological reversion” describes a situation where at least two consecutive cultures (for DR-TB and DS-TB) or smears (for DS-TB only), taken on different occasions at least 7 days
apart, are positive either after the bacteriological conversion or in patients without bacteriological confirmation of TB. ƒ: patient died for any reason. ##: this includes cases “transferred out” to

EDITORIAL | N.N. LINH ET AL.

another treatment unit and whose treatment outcome is unknown; however, it excludes those lost to follow-up.
5
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TABLE 2 Research implications of the new treatment outcome definitions

Implication Description

Use of unified treatment outcome definitions
in TB treatment research
Assessment of post-treatment outcome
TB: tuberculosis; DS: drug susceptible; DR: drug resistant.
The new treatment outcome definitions should be adopted in future clinical trials and studies
on TB treatment, especially when assessing the effectiveness of new TB treatment regimens
or medicines, for both DS-TB and DR-TB. The use of unified treatment outcomes will
facilitate meta-analyses using individual patient data across studies and programmes, which
are important for updates of global policy recommendations [6, 21].
In cases of studies that were started using the previous treatment outcome definitions in their
protocols, it would be helpful to encourage the collection of all data necessary to allow
recording of outcomes according to any new criteria. For example, if reasons for treatment
interruption are recorded in detail, one can discern those cases where this happened as a
result of non-response and, therefore, the outcome can be redefined from “lost to follow-up”
to “treatment failed”; or about people who “died” or were “lost to follow-up” after
randomisation in DR-TB treatment trials and before start of treatment.
Although ensuring TB treatment completion is important to achieve cure, assessment of health
status of patients post-TB treatment is required using the new definition of sustained
treatment success. Health-related quality of life post-TB disease is crucial [22] and that needs
to be evaluated; and in a proportion of patients, pulmonary rehabilitation needs to be
indicated [23]. Although this may not be applicable in all settings, it aligns with the emerging
research agenda of post-TB sequelae and care.

conversion or reversion and so the outcome of “treatment failed” may now also be used in patients with
extrapulmonary TB and for TB in children, who are normally diagnosed without bacteriological confirmation.
The definition of bacteriological conversion or reversion, to inform continuation or modification of
treatment regimen, can be determined by smear microscopy for DS-TB, in addition to culture.

The new definitions of “died” and “lost to follow-up” now apply from before the start of treatment as well
as during treatment. Although these definitions remain unchanged for DS-TB, the addition of a
pre-treatment period is new for these outcomes for patients with DR-TB. Therefore, there will likely be
changes in reporting treatment outcomes of DR-TB patients, with a possible increase in the number of
patients with the outcomes of died and lost to follow-up in certain countries immediately after the adoption
of the new definitions. This change will help standardise reporting for these outcomes for patients with
DS-TB and DR-TB, and will promote the comprehensive registration and treatment enrolment for all
diagnosed DR-TB patients.

WHO has also developed a post-treatment outcome, defined for the assessments of survival and TB-free
status among individuals with successful TB treatment which can be used in the context of research.

The updated definitions will be included in the 2021 revision of WHO’s Definitions and Reporting
Framework for Tuberculosis. The definitions will also need to be adopted for programmatic
implementation, and for use in registration and reporting to monitor the effectiveness of treatment and
progress towards ending TB. In addition, the adoption of the new outcome definitions by TB treatment
trials will facilitate future assessments of new treatment regimens (table 2).

Acknowledgements: We would like to acknowledge and thank the two co-chairs of this meeting, Charles Daley and
Cathy Hewison, as well as the numerous experts who attended the meeting and who contributed to the
discussions. The meeting participants were: Carole Mitnick, Christoph Lange, Giovanni Battista Migliori, Mario
Raviglione, Jonathon Campbell, Hoang Thanh Thuy, Maria Rodriguez, Welile Sikhondze, Norbert Ndjeka, Anastasia
Samoilova, Yuhong Liu, Kuldeep Sachdeva, Daniele Maria Pelissari, Andrei Mosneaga, Sreenivas Nair, Morten
Ruhwald, Fraser Wares, Grania Brigden, Draurio Barreira, Mohammed Yassin, Marlena Kaczmarek, Mukadi Ya Diul,
Dumitru Chesov, Chen Yuan Chiang, James Seddon, Tony Garcia-Prats, Daniela Cirillo, Harald Hoffman, Sarabjit
Chadha, Dissou Affolabi, Thandar Hmun, Renzong Li, Sabira Tahseen, Amir Khan, Choub Sok Chamreun, Nino
Lomtadze, Mon Basilio, Dan Everitt and Xia Hui. In addition, we thank the WHO staff who attended this meeting:
Tauhid Islam, Mukta Sharma, Vineet Bhatia, Askar Yedilbayev, Rafael Lopez Olarte, Kenza Bennani, Michel Gasana,
Jean Louis Abena, Kyung Oh, Ernesto Jaramillo, Anna Dean, Marek Lalli, Marie-Christine Bartens, Charalampos
Sismannidis and Olga Tosas-Auguet.

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All authors are staff members of the World Health Organization (WHO). They alone are responsible for the views
expressed in this publication and they do not necessarily represent the decisions or policies of WHO. The
designations used and the presentation of the material in this publication do not imply the expression of any
opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area, or of its
authorities, nor concerning the delimitation of its frontiers or boundaries.

Conflict of interest: None declared.

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