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The recommendations in this section address one PICO question:
PICO question (Hr-TB, 2018): In patients with isoniazid-resistant TB (other than MDR-TB), which treatment regimen composition and duration, when compared with 6 months or more of rifampicin–pyrazinamide–ethambutol, leads to a higher likelihood of success with least possible risk of harm?
Culture and microscopy results for tests performed in patients on MDR-TB treatment should be captured in the second-line TB treatment register as well as the respective laboratory registers (79). Sometimes these registers may exist as part of an electronic laboratory or patient information system, which makes it much easier for multiple users to access the data in real time and can also help to limit errors.
Good-quality sputum specimens are necessary to ensure that laboratories can diagnose TB properly. In addition, laboratories should have sufficient space to ensure the quality, safety and efficiency of the services provided to clients whose samples are tested, and to ensure the safety of laboratory personnel, patients and visitors (107). Some countries experience difficulties with the implementation and quality assurance of sputum culture, which affects this recommendation because it is dependent on access to quality-assured laboratories that can offer TB culture.
The recommendation would apply to any longer regimen, regardless of the number of Group A, B or C agents used and whether an injectable (intensive) phase was used or not. The GDG considered that the findings may apply to other key patient subgroups.
Patients aged below 15 years with MDR/RR-TB
The recommendation in this section addresses the following PICO question:
PICO question (MDR/RR-TB, 2018). In patients with MDR/RR-TB treated with longer or shorter regimens composed in accordance with WHO guidelines, is monitoring using monthly cultures, in addition to smear microscopy, more likely to detect non-response to treatment?
Inclusion criteria
Patients on longer MDR-TB treatment regimens need to be monitored for response to treatment and for safety, using reasonable schedules of relevant clinical and laboratory testing (10, 39). The WHO framework for aDSM needs to be applied to patients on any type of MDR/RR-TB regimen, to ensure appropriate action and an acceptable level of monitoring for adverse events and prompt response to such events – alongside monitoring for treatment outcomes.
The new recommendations signal an important departure from previous approaches to treating MDR/RR-TB. The implementation of MDR/RR-TB treatment on a large scale is feasible under programmatic conditions, as has been shown by the global expansion in the use of standardized and individualized MDR-TB regimens in low-, middle- and high-income countries worldwide, particularly in the past decade (1).
