TB R&R System's strong points

1. TB R&R System's strong points • Standardized system implemented widely • Collection of follow-up information on each patient over long course of treatment • Data sources succinct, cleverly designed for tabulation, cross-referencing • Definitions that are clear, serve both epi and clinical purposes • Outcomes based on mutually exclusive irrevocable categories that are assessed by cohort • Works as a completely paper-based system up to central level in developing countries • Known benchmarks (e.g. proportion cases smear +)

2. TB records: treatment card

3. TB records: patient register Tool of DHO (not all of the data in TC) 1 row = 1 course of treatment Does not "track" a change in regimen (re-reg) Handy use of multiple col. (probably ART pgm cannot afford this luxury) Ordered by date of reg. “Transfer-out” outcome is really a subset of unknowns (transfer-out cases with outcome unknown). It is responsibility of the initial registration (only) to report the outcome. The receiving unit registers for mgmt/monitoring, but record is disregarded when making cohort reports. • “Default” outcome does not exactly say what happened to the patient and his episode of TB. Defaulters may or may not be lost patients. Or they may be known to be dead. Still, the default outcome is irrevocable. It is a point of closure on the current regimen.

4. TB records: lab register

5. TB quarterly reports

6. TB quarterly reports

7. Implementation of district TB register:2 scenarios Centralized registration De-centralized registration Patient presents centrally (1), is examined and diagnosed (2), registered (3) and takes observed treatment at same site or (preferrable) at peripheral facility near his home where treatment card is kept (4). Patient presents to peripheral facility and is examined (1), sputum is sent to one of several labs (2), patient begins treatment with treatment card (3); at a later date, district supervisor visits facility and registers case (4), transcribing from treatment card.

8. Some notes about TB system Drug planning is relatively simple (few deviations from defined regimen) Can estimate monthly/quarterly needs from the case-finding report. Duration of follow-up relatively limited (6-9 mo), and limited pieces of follow-up info (follow-up smears). Patients may travel to higher level registration/diagnostic center for follow-up smears. Outcomes are mutually exclusive and irrevocable events (e.g., once defaulted, end of story for that "case" because end of the road for the use of that regimen.)

9. Some notes about TB system (2) Each arrow represents a patient's treatment across time, with some outcome reached Q1 Q2 Q3 Q4 • Cohort analysis: common time period of initiating treatment (versus a common period when outcome is reached – highly variable). • Useful to monitoring trends in programme performance. • Involves a long delay in assessment (to allow everyone to have a chance to finish their regimen), but works nicely in context of SCC (std duration). • Cohort exclusions are few, so cohort N is stable

10. Issues for ART monitoring Substitutions and switches in ARV regimens are not uncommon. Implications (probably): • Default (interruption) outcome may not have same significance / usefulness. • Definition and significance of "failure"? • Need frequent reports for drug planning (monthly) • So register (and reporting) must be facility based.

11. Issues for ART monitoring (2) Treatment duration is forever: only irrevocable “outcome” for the patient is death. Implication/Issues: • Might not make sense to monitor only outcome of the original regimen course (where 2nd regimen entails re-registration on new line in the register book). Rather, it might make sense to monitor outcomes of patients (up to a certain point … 2 yrs?), and keep all info on one line in the register (no re-registration). • Probably cannot expect initial registration unit to follow transferred patient’s outcomes quarterly for 2 yrs, so… • transferring could be a legitimate and final outcome, but then • cohort N will become fuzzy due to transfer-in cases; this would be a sacrifice in transparency at lower level; OK at higher levels)

12. Issues for ART monitoring (3) Substitutions/switches are important status/events to monitor. Implication: • Substitution/switch (1st/2nd-line) events could be viewed as part of the outcome definition, e.g., • those alive and still on original regimen • those alive and on substituted regimen • those alive and on switched [2nd line] regimen.

13. ART outcome analyses are tricky… Possibilities: "How many patients stopped treatment…" • In the most recent month? [Cross-Sectional *] • From Jan-Mar of this year? [Cross-Sectional *] • Ever (since beginning of pgm)? [Cumulative *] • As of their 6 month of treatment? [Survival analysis] Example of cohort analysis: "How many patients entering ART during a given time period had a "stopped treatment" outcome one year after the close of that time period." Hand-outs suggest a minimum way to get cross-sectional and cohort data of interest to programmes using a paper-based system. (More data available in the register for computerized analyses). * This is a "transient" (not irrevocable) status / event / outcome.