Methods |
Design: three group parallel trial
Purpose: study the effect of adherence coaching to treatment adherence for TB |
Participants |
Patients: adolescents with TB
Baseline comparability: yes |
Interventions |
Placebo: sessions with self‐esteem counselling (12 sessions, 9 months)
Untreated: no sessions
Experimental: sessions with adherence counselling
(Co‐intervention: TB medication) |
Outcomes |
Cumulative number of pills
Proportion of TB treatment completers (180 pills within 9 moths)
Interaction of alcohol consumption and lack of treatment adherence |
Notes |
We have multiplied the results by negative 1 to change the direction of the summary statistics. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
NS |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/coaching) |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as outcome was patient reported (number of pills) |
Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
Trial size > 49? |
Low risk |
N = 194 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |