Approaches for Informing Optimal Dose of Behavioral Interventions
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ORIGINAL ARTICLE
Approaches for Informing Optimal Dose of Behavioral Interventions Corrine I. Voils, PhD & Heather A. King, PhD & Matthew L. Maciejewski, PhD & Kelli D. Allen, PhD & William S. Yancy Jr., MD, MHS & Jonathan A. Shaffer, PhD
# The Society of Behavioral Medicine (outside the USA) 2014
Abstract 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.
Keywords Intervention dose . Intervention design . Dose–response . Methodology C. I. Voils (*) : H. A. King : M. L. Maciejewski : K. D. Allen : W. S. Yancy Jr., Durham Veterans Affairs Medical Center, Durham, NC USA e-mail: [email protected] C. I. Voils : M. L. Maciejewski : K. D. Allen : W. S. Yancy Jr., Duke University Medical Center, Durham, NC USA J. A. Shaffer Columbia Medical Center, New York City, NY USA
Introduction Determining an optimal dose is among the most important decisions investigators must make when designing a behavioral intervention [1]. Behavioral intervention dose may be characterized by duration, frequency, and amount [1, 2]. Duration refers to the period of time over which participants are exposed to the intervention and may be measured in hours, weeks, months, or years. Frequency refers to how often contact is made over a specified period of time, such as 52 visits over 1 year (once weekly). Amount refers to the total length of each intervention contact and is typically measured in minutes or hours. These dose parameters collectively determine cumulative intervention dose. A behavioral intervention may be delivered at a fixed or variable interval, and the dose may be delivered as needed (tailored) or uniformly (nontailored) [1]. When people consider optimal dose in the context of pharmacotherapy, they generally think of the dose that maximizes improvements in psychological and/or physical outcomes (“efficacy”) while minimizing adverse side effects (“toxicity”). Adverse effects of behavioral interventions are rarely discussed or assessed bu
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