Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial.
Dobbels F, De Bleser L, et al.Journal of Heart & Lung Transplantation 2017; 06: 06.
Aims
To test the efficacy and sustainability of a 6-month post-transplant medication adherence enhancing intervention among adult heart, liver, and lung transplant recipients.
Interventions
Participants were randomly assigned to either the intervention group or control group. Those in the intervention group received a theory-based multicomponent staged tailored medication adherence intervention using selected behavioural change techniques derived from the social-cognitive and trans-theoretical model, while the control group received usual care.
Participants
205 patients who had received their first single heart, liver or lung transplant at least one year prior to enrolment, aged ≥ 18 years and treated with tacrolimus twice-daily.
Outcomes
The primary outcomes measured were medication adherence including correct dosing and timing adherence, and Basel Assessment of Adherence to Immunosuppressive medications (BAASIS) score. The seondary measured outcome was 5-year clinical event-free survival.
Follow-up
5 years
CET Conclusions
This interesting study investigated the effect of a multicomponent behavioural intervention in improving drug adherence in heart, liver and lung transplant recipients. Patients randomised to the intervention arm demonstrated significantly improved dosing and timing adherence compared to controls. This effect was maintained for 6 months. There was a trend towards improved clinical event-free survival, although this did not reach significance (82.5% vs. 72.5%). The study is well-designed, with a clearly described intervention, randomisation stratified by organ type, and blinding of outcome assessment. It should be noted, however, that 10.9% patients did not consent to the study, and a further 17% dropped out before intervention, which may mean that the sample receiving the intervention are not typical of the population as a whole. Future studies should assess similar interventions in the kidney transplant population, and further investigate the longevity of the effect.
Data analysis
Strict intention-to-treat analysis
Trial registration
None