Assessing the outcomes of a clinical trial: Primary outcome measures only tell part of the story

Abstract

Identifying outcome measures that are sensitive to change and meaningful to participants is a challenge when designing clinical trials of complex communication interventions. Outcome measures encompassing participants’ perceptions of clinically meaningful change and their experience of the treatment process are frequently neglected. This paper presents an overview of the outcome measures used in a 3 arm clinical trial which aimed to investigate (i) social skills training for the person with TBI alone (which we have termed the TBI SOLO condition) and (ii) training communication partners to deal with difficult communication behaviors (the JOINT condition) compared to a delayed waitlist CONTROL condition. The paper asks two research questions: 1. What information did the self-report of perceived communication ability using the La Trobe Communication Questionnaire, and qualitative measures provide in addition to blinded ratings on the Adapted Kagan Scales, the primary outcome measure? 2.How did participants perceive the training experience as measured through post treatment interviews