title: Sequential multiple assignment randomized trial (SMART) with adaptive randomization for quality improvement in depression treatment program.
abstract: Implementation study is an important tool for deploying state-of-the-art treatments from clinical efficacy studies into a treatment program, with the dual goals of learning about effectiveness of the treatments and improving the quality of care for patients enrolled into the program. In this article, we deal with the design of a treatment program of dynamic treatment regimens (DTRs) for patients with depression post-acute coronary syndrome. We introduce a novel adaptive randomization scheme for a sequential multiple assignment randomized trial of DTRs. Our approach adapts the randomization probabilities to favor treatment sequences having comparatively superior Q-functions used in Q-learning. The proposed approach addresses three main concerns of an implementation study: it allows incorporation of historical data or opinions, it includes randomization for learning purposes, and it aims to improve care via adaptation throughout the program. We demonstrate how to apply our method to design a depression treatment program using data from a previous study. By simulation, we illustrate that the inputs from historical data are important for the program performance measured by the expected outcomes of the enrollees, but also show that the adaptive randomization scheme is able to compensate poorly specified historical inputs by improving patient outcomes within a reasonable horizon. The simulation results also confirm that the proposed design allows efficient learning of the treatments by alleviating the curse of dimensionality.
authors.affiliation: Department of Biostatistics, Mailman School of Public Health, Columbia University, 722 West 168th Street, New York, New York 10032, U.S.A.
authors.forename: Ying Kuen
authors.initials: YK
authors.lastname: Cheung
authors.affiliation: Department of Biostatistics, Mailman School of Public Health, Columbia University, 722 West 168th Street, New York, New York 10032, U.S.A.|Centre for Quantitative Medicine, Duke-NUS Graduate Medical School, 20 College Road, Singapore 169856, Singapore.
authors.forename: Bibhas
authors.initials: B
authors.lastname: Chakraborty
authors.affiliation: Center for Behavioral Cardiovascular Health, Columbia University Medical Center, 622 West 168th Street, New York, New York 10032, U.S.A.
authors.forename: Karina W
authors.initials: KW
authors.lastname: Davidson
mesh_terms: D054058:Acute Coronary Syndrome / Q000150:complications / Q000523:psychology; D000223:Adaptation, Psychological; D001521:Behavior Therapy; D001699:Biometry; D003198:Computer Simulation; D003863:Depression / Q000209:etiology / Q000628:therapy*; D006801:Humans; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data
keywords: Behavioral intervention; Dynamic treatment regimen; Implementation research; Play-the-winner; Problem-solving therapy; Q-learning