Self-management education for adults with poorly controlled epilepsy (SMILE (UK)): statistical, economic and qualitative analysis plan for a randomised controlled trial.

摘要: There is a need to test the effectiveness of new educational interventions for people with poorly controlled epilepsy. The SMILE (self-management education adults epilepsy) trial evaluates complex service intervention that involves 2-day self-management course aim improving quality life and clinical outcomes. This article describes statistical, economic, qualitative analysis plan trial. pragmatic, parallel design, two-arm, multi-centre randomised superiority group-based interactive compared treatment as usual who have experienced two or more seizures in past 12 months. A summary objectives design are reported well manner which data will be summarised inferentially analysed. includes type modelling employed each primary secondary outcomes methods by assumptions these models checked. Strategies described handling clustering outcome data, missing observations, non-compliance. update previously published protocol provides description transparent specified before any available. It also guidance those planning similar trials. Current Controlled Trials ISRCTN57937389 ; date assigned: 27 March 2013.