The scope of the 2016 guidelines update covered the following areas: 1) the optimal combination of medicines and approach towards regimen design for TB patients (both adults and children) with RR-TB, MDR-TB, XDR-TB and isoniazid-resistant TB, as well as for patients with Mycobacterium bovis disease; 2) the effectiveness and safety of standardised regimens lasting up to 12 months for the treatment of patients with MDR-TB (“shorter regimens”) when compared with longer conventional treatment; 3) the effect of time to start of treatment on drug-resistant TB patient outcomes; and 4) the effect of surgical interventions on treatment outcomes for patients with drug-resistant TB.
The scope of the May 2016 update of the guidelines excluded aspects of the programmatic management of drug-resistant TB for which no substantive new evidence had emerged since the 2011 revision of WHO policy guidance on drug-resistant TB, i.e. the testing for rifampicin resistance, the monitoring of treatment response, the duration of conventional regimens, the start of antiretroviral therapy in MDR-TB patients with HIV infection and models of care. New data on bedaquiline and delamanid use within longer regimens were reviewed by a separate GDG process from June 2016, subsequent to the release of the treatment guidelines in May 2016 [27 , 33 ].
The guideline scope was expressed in four structured questions using the GRADE-recommended PICO format (Population, Intervention, Comparator to the intervention and Outcomes) (supplementary table S1) [30 ]. All relevant outcomes for these questions were scored in the critical range by the GDG members (table 2 ). For the purposes of the review, a serious adverse event was classified as either Grade 3 (severe) or Grade 4 (life-threatening or disabling), or which led to the medicine being stopped permanently.
The scope of the May 2016 update of the guidelines excluded aspects of the programmatic management of drug-resistant TB for which no substantive new evidence had emerged since the 2011 revision of WHO policy guidance on drug-resistant TB, i.e. the testing for rifampicin resistance, the monitoring of treatment response, the duration of conventional regimens, the start of antiretroviral therapy in MDR-TB patients with HIV infection and models of care. New data on bedaquiline and delamanid use within longer regimens were reviewed by a separate GDG process from June 2016, subsequent to the release of the treatment guidelines in May 2016 [27 , 33 ].
The guideline scope was expressed in four structured questions using the GRADE-recommended PICO format (Population, Intervention, Comparator to the intervention and Outcomes) (supplementary table S1) [30 ]. All relevant outcomes for these questions were scored in the critical range by the GDG members (
