Measuring Treatment Satisfaction. A Review of Randomized Controlled Drug Trials

The development of new drugs calls for additional patient‐reported endpoints to health‐related quality of life and symptoms assessment. Among these, one of the ambitions is to evaluate treatment satisfaction in clinical trials, since it can be crucial for compliance and must be considered as an important factor when planning treatment. To measure this concept, a range of instruments may be used. The purpose of this study was to investigate which types of instruments for measuring treatment satisfaction are the most frequent in clinical trails. Specifically, we explored whether instruments are single item or questionnaires, and in the latter case, whether the instruments are psychometrically validated or not. We carried out a search of the literature published in English in the period July 1996 to December 2002, looking for controlled trials of treatment satisfaction. Using the Embase and Medline databases, 126 studies were included in this review. The main finding suggests that assessment of treatment satisfaction in clinical trials vary in quality. It is evident that the majority of the studies reviewed rely on single items when measuring treatment satisfaction. Moreover, in cases where questionnaires were applied, psychometric properties were rarely reported or documented. This study highlights the need for developing and improving psychometric documentation of instruments measuring treatment satisfaction, as well as the need for guidance documents.