3.6 Monitoring and evaluation

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 (9, 60). The WHO framework for aDSM needs to be applied to patients on any type of MDR-TB regimen, to ensure appropriate action and an acceptable level of monitoring for and prompt response to adverse events – alongside monitoring for treatment outcomes. Electrocardiography may be indicated as more regimens in the future may have two or three agents that are expected to prolong the QT interval. Audiometry and specific biochemical tests should also be made available whenever certain agents are included in the regimens. Treatment in pregnancy with postpartum surveillance for congenital anomalies will help to inform future recommendations for MDR-TB treatment during pregnancy.  

A separate recommendation on the use of culture and microscopy to monitor bacteriological response during treatment was made in the 2018 update of the guidelines (see Section 5 regarding PICO question 11 MDR/RR-TB, 2018). Access to DST of medicines for which there are reliable methods, and the development of other methods for newer medicines (e.g. sequencing), are critical (and in the case of DST, necessary) accompaniments to the treatment recommendations in these guidelines.  

Patients on longer MDR-TB treatment regimens need to be monitored for treatment response and for safety, using reasonable schedules of relevant clinical and laboratory testing (9, 60). Response to treatment and toxicity are monitored through regular history-taking, physical examination and chest radiography; special tests such as audiometry, visual acuity tests and electrocardiography; and laboratory monitoring. Using smear microscopy or culture to assess conversion of bacteriological status is an important way to assess response, and most patients are expected to have converted to a sputum-negative status within the first few months of starting treatment. Persistence of culture positivity beyond that point, or close to the expected end of the intensive phase when injectable agents are in use, should trigger a review of the regimen and performance of DST. NTPs should also aim for complete registration of patients with MDR/RR-TB, through follow-up and monitoring of treatment outcomes as part of national surveillance. Regular review of MDR/RR-TB cohort data is essential.  

Frameworks for the surveillance of bacteriological status, drug resistance and assignment of outcomes have been standardized in recent years (41). In contrast, systematic monitoring of adverse events during and after the end of treatment needs to be strengthened in most NTPs, given the relative novelty of active pharmacovigilance within NTPs (59, 60). In the case of this recommendation, it is important to monitor for hearing loss and kidney function, especially with the use of the aminoglycosides. The rationale for aDSM is largely supported by the increasing use worldwide of combinations of new and repurposed medications in MDR-TB treatment regimens. The toxicity of certain agents may increase with the duration of use (e.g. nerve damage with linezolid), and may limit their continued use in a patient, sometimes resulting in complete cessation of treatment. The prospective collection of accurate data for key variables at the case-based level, using an electronic register, is strongly advised in the best interests of the individual patient, and to inform local and global policy revisions (88).

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