Outcome | Laserson et al. [20] (2005) | WHO [23] (2014) | TBNET [24] (2016) |
Died | A patient who dies for any reason during the course of treatment | A patient who dies for any reason during the course of treatment | A patient who dies during the period of observation |
LTFU/default | A patient whose treatment was interrupted for 2 consecutive months or more | A patient whose treatment was interrupted for 2 consecutive months or more | Non-receipt of care 6 months after treatment initiation |
Treatment failed | ≥2 of 5 cultures in the final 12 months of treatment are culture positive or if any of the final 3 cultures are positive OR a clinical decision is made to stop treatment due to a lack of response | 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 bacteriological reversion in the continuation phase after conversion to negative evidence of additional acquired resistance to fluoroquinolones or second-line injectable drugs adverse drug reactions | A positive culture 6 months after the start of treatment or a relapse within 1 year after treatment completion |
Completed treatment | Completed treatment but does not meet the definition of cure | Treatment completed as recommended by the national policy without evidence of failure BUT no record that ≥3 consecutive cultures taken ≥30 days apart are negative after the intensive phase | Unacceptable: a measure of process and not treatment outcome |
Cured | Completed treatment according to protocol with ≥5 negative cultures in the last 12 months or 1 positive culture with 3 subsequent cultures taken ≥30 days apart | Treatment completed as recommended by the national policy without evidence of failure AND record that ≥3 consecutive cultures taken ≥30 days apart are negative after the intensive phase | A negative culture status at 6 months after the start of treatment and no positive culture thereafter AND no relapses within 1 year after treatment completion |
Treatment success | The sum of cured and treatment completed | Not applicable | |
Undeclared | Transfer out included as a separate element | A patient for whom no treatment outcome is assigned (this includes “transferred out” where outcome unknown) | Outcome not assessed due to transferred out and no outcome known no culture at 6 months no post-treatment assessment |
Timing | 36 months after treatment started Interim analyses at 12 and/or 24 months | ≤12 months (included in annual report) 36 months outcome after treatment started | 6 months into treatment and 12 months after treatment completion (most often 32 months after treatment started) |
LTFU: lost to follow-up.