Approaches for Informing Optimal Dose of Behavioral Interventions

Background There is little guidance about to how select dose parameter values when designing behavioral interventions. Purpose The purpose of this study is to present approaches to inform intervention duration, frequency, and amount when (1) the investigator has no a priori expectation and is seeking a descriptive approach for identifying and narrowing the universe of dose values or (2) the investigator has an a priori expectation and is seeking validation of this expectation using an inferential approach. Methods Strengths and weaknesses of various approaches are described and illustrated with examples. Results Descriptive approaches include retrospective analysis of data from randomized trials, assessment of perceived optimal dose via prospective surveys or interviews of key stakeholders, and assessment of target patient behavior via prospective, longitudinal, observational studies. Inferential approaches include nonrandomized, early-phase trials and randomized designs. Conclusions By utilizing these approaches, researchers may more efficiently apply resources to identify the optimal values of dose parameters for behavioral interventions.