7. aDSM slides - Indicators of aDSM implementation and programme management Multi-partner training package on active TB drug safety monitoring and management.

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7. aDSM slides - Indicators of aDSM implementation and programme management Multi-partner training package on active TB drug safety monitoring and management (aDSM) July 2016

Learning objectives By the end of this presentation, the participant is expected to be able to… Define the standard aDSM indicators for programme management

aDSM data serve a number of purposes aDSM indicators (1) aDSM data serve a number of purposes Programme indicators Causality assessment Signal detection Drug-safety profiles

aDSM indicators (2) The programme manager needs measures of process and outcomes, especially in the early phases of implementing aDSM This is besides the analyses needed for causality assessment and signal detection Five indicators have been proposed to assess coverage and completeness of reporting, and the frequency of SAEs and confirmed ADRs

aDSM indicators (3) summary Class Indicator Coverage MDR-TB patients on BDQ included in active PV Completeness Time to stopping BDQ Serious adverse events MDR-TB patients included in cohort event monitoring with any serious adverse event BDQ-associated adverse reactions Frequency of BDQ-associated ADRs Time to development of BDQ-associated ADRs

aDSM indicators (4)

aDSM indicators (5)

aDSM indicators (6)

Table 11.5

WHO/HTM/TB/2014.09 This book presents the practicalities of standard and advanced analysis of programme TB surveillance data. The same approaches could have an application for in-depth analysis of aDSM data. apps.who.int/iris/bitstream/10665/129942/1/9789241548786_eng.pdf