10.17037/DATA.00004639
The data are from a pragmatic cluster-randomised trial in Ethiopia. Seventy-eight health facilities (clusters) were randomised to three arms (1:1:1): smart pillbox, medication labels, or standard of care. Adults (≥18 years) with drug-sensitive pulmonary tuberculosis on a fixed-dose combination tuberculosis treatment regimen were enrolled and followed-up for 12 months after treatment initiation. Those in the pillbox arm received a pillbox with customisable audio-visual reminders, while participants in the label arm received their TB medication with a weekly unique code label. Opening the box or texting the code prompted real-time dose logging on the adherence platform, facilitating differentiated response to individual’s adherence by a healthcare worker. The primary outcome comprised death, loss to follow-up, treatment failure, switch to drug-resistant tuberculosis treatment, or recurrence; secondary outcomes included loss to follow-up. Analysis accounted for clustered design with multiple imputation for the primary outcome. The trial is registered with PACTR202008776694999.
The dataset contains 3,885 observations and 26 variables.
| Variable name | Variable description | Answer code | Answer label | Variable type |
| clusterid | unique cluster (health facility) identifier | Open ended | Numeric | |
| newid | unique participant identifier | Open ended | Numeric | |
| ITT | indicates if in ITT analysis population | Numeric | ||
| 0 | not in ITT population | |||
| 1 | in ITT population | |||
| reas_drop_ITT | Reason for not being in ITT analysis population | |||
| 1 | Not TB | |||
| 3 | MDR diagnosis within 28 days | |||
| 4 | 2nd enrolment | |||
| PP | indicates if in PP analysis population | Numeric | ||
| 0 | Not in PP population | |||
| 1 | In PP population | |||
| 9 | Not in ITT population | |||
| reas_drop_PP | Reason for not being in PP analysis population | Numeric | ||
| 1 | No match to adherence data | |||
| 2 | Started DAT >28d after treatment start | |||
| 3 | Patient opted out of using DAT within 112 days of treatment start | |||
| 4 | Healthcare worker withdrew patient from using DAT within 112 days of treatment start | |||
| 9 | Not in ITT population | |||
| studyarm | Study arm (based on study arm randomised to the enrolment cluster) | Numeric | ||
| 1 | SOC | |||
| 2 | Labels | |||
| 3 | Pillbox | |||
| studyarm_sens | Study arm - sensitivity analysis (based on DAT received at treatment start) | Numeric | ||
| 1 | SOC | |||
| 2 | Labels | |||
| 3 | Pillbox | |||
| area | Geographical area (urban/rural) | Numeric | ||
| 1 | Rural | |||
| 2 | Urban | |||
| strataEth | Strata used in the randomisation | Numeric | ||
| 1 | Addis, low | |||
| 2 | Addis high | |||
| 3 | Oromia, low | |||
| 4 | Oromia, high | |||
| agegrp | Age, grouped | Numeric | ||
| 1 | Under 30 | |||
| 2 | 30 to 34 | |||
| 3 | 35 to 39 | |||
| 4 | 40 to 44 | |||
| 5 | 45 to 54 | |||
| 6 | 55 years or over | |||
| gender | Gender | Numeric | ||
| 1 | Male | |||
| 2 | Female | |||
| sep | Socio-econmic position | Numeric | ||
| 1 | Poorest | |||
| 2 | Second | |||
| 3 | Middle | |||
| 4 | Fourth | |||
| 5 | Wealthiest | |||
| educat | Education level (highest) | Numeric | ||
| 1 | None | |||
| 2 | <primary | |||
| 3 | Primary | |||
| 4 | Secondary or higher | |||
| maritalstatus | Maritial status | Numeric | ||
| 1 | single | |||
| 2 | single (living independently) | |||
| 3 | married/cohabiting | |||
| 4 | separated/widowed | |||
| hivart | HIV/ART status | Numeric | ||
| 0 | HIV-negative/unknown | |||
| 1 | HIV-positive not on ART/unknown ART | |||
| 2 | HIV-positive on ART | |||
| prevTB | Previous TB | Numeric | ||
| 1 | previous TB | |||
| 2 | no previous TB | |||
| 9 | unknown | |||
| TBtype | TB type | Numeric | ||
| 1 | bacteriologically confirmed | |||
| 2 | clinical | |||
| treatoutcome | Treatment outcome | Numeric | ||
| 1 | cured | |||
| 2 | completed treatment | |||
| 3 | treatment failure | |||
| 4 | on-treatment death | |||
| 5 | on-treatment lost to follow-up | |||
| 7 | not evaluated | |||
| 8 | moved MDR regimen >28 days after treatment start | |||
| 9 | missing | |||
| 99 | not in ITT population | |||
| pooroutc | Secondary outcome: poor treatment outcome (composite outcome) | Numeric | ||
| 0 | good outcome | |||
| 1 | poor outcome | |||
| Null | outcome either not evaluated or missing | |||
| pooroutc_sens | Secondary outcome: poor treatment outcome- sensitivity analysis - including those on treatment for > 224 days among those with cured/completed treatment as unfavourable | Numeric | ||
| 0 | good outcome | |||
| 1 | poor outcome | |||
| Null | outcome either not evaluated or missing | |||
| ltfu | Secondary outcome: on-treatment lost to follow-up | Numeric | ||
| 0 | not lost to follow-up | |||
| 1 | lost to follow-up | |||
| Null | outcome either not evaluated or missing | |||
| unfavoutcome | Primary outcome: unfavourable outcome (composite outcome) | Numeric | ||
| 0 | good outcome | |||
| 1 | poor outcome | |||
| Null | outcome either not evaluated or missing | |||
| unfavoutcome_sens1 | Primary outcome: unfavourable outcome- sensitivity analysis1 (composite outcome) - including deaths occurring from treatment end to 12 months after treatment start as unfavourable | Numeric | ||
| 0 | favourable outcome | |||
| 1 | unfavourable outcome | |||
| Null | outcome missing | |||
| unfavoutcome_sens2 | Primary outcome: unfavourable outcome- sensitivity analysis2 (composite outcome) - including those on treatment for > 224 days among those with cured/ completed treatment as unfavourable outcome | Numeric | ||
| 0 | favourable outcome | |||
| 1 | unfavourable outcome | |||
| Null | outcome missing | |||
| unfavoutcome_sens3 | Primary outcome: unfavourable outcome- sensitivity analysis3 (composite outcome) - exclude those who transferred out of the enrolment health facility | Numeric | ||
| 0 | favourable outcome | |||
| 1 | unfavourable outcome | |||
| Null | outcome missing |