Research to improve the quality of care for depression: alternatives to the simple randomized clinical trial☆

Abstract 

Recognition of gaps between evidence gained from mental health research and clinical practice in the community together with changes in treatment patterns and patient/provider preferences for care have led to interest in enhancements in the designs and analyses of clinical and community trials of mental health interventions. Gaps between clinical trials and community care include differences in populations and treatment strategies. To bridge these gaps, we propose enhancing the simple randomized trial with several different designs with the immediate aims of improving patient recruitment and adherence in psychiatric intervention studies thus bringing study designs more in line with clinical practice. The goals are to estimate treatment efficacy and effectiveness so that both internal and external validity are optimized. In this discussion, we address design and analytic issues with respect to a number of enhancements of the randomized trial design, including partial patient-provider preference designs, randomized encouragement and consent designs, fixed adaptive design, and random between- and within-patient adaptive designs. Each has advantages and disadvantages depending on the effect under investigation. Some of these enhancements, such as the fixed adaptive design, have begun to be implemented in effectiveness trials in mental health services research, but all are worthy of more attention.

Keywords: Adaptive randomized, Partial patient preference, Randomized encouragement, Randomized consent