2014 Summer Institute: Experimental Design and Analysis Methods for Developing Adaptive Interventions: Getting SMART

Daniel AlmirallInbal Nahum-ShaniJune 19-20, 2014

Daniel Almirall and Inbal Nahum-Shani

 

 

Workshop objectiveSummer Institute 2014 participants

The overarching goals of this two-day workshop were to (a) provide an introduction to adaptive interventions; (b) help participants gain the background needed to plan a Sequential Multiple Assignment Randomized Trial (SMART); and (c) help participants learn how to implement data analytic methods with SMART study data to construct adaptive interventions.

General description

At this workshop, participants were provided with a hard copy of all lecture notes, select computer exercises and output, and suggested reading lists for future reference. Three different formats were used. First, all materials were presented following the standard didactic format with a slideshow. Second, there were practice exercises designed to help participants connect the material with their own research area.  These practice exercises were focused on SMART study design principles aimed at helping to prepare participants to write grant proposals that use a SMART design to build adaptive interventions. Third, there were computer exercises using SAS®. Computer code and simulated data examples were supplied by the instructors. The computer exercises helped investigators learn how to implement typical primary and secondary analyses using data arising from a SMART and to interpret the results. Throughout the workshop, time was set aside for Q&A and discussion about how the concepts learned in class can be applied in participants’ research. 

Topics that were covered:

  • When and why adaptive interventions are needed
  • How adaptive interventions differ from fixed (one-stage) interventions
  • The critical components of adaptive interventions: decision points, tailoring variables, intervention options and decision rules
  • The role of theory in developing adaptive interventions
  • Examples of adaptive interventions from the literature
  • The difference between a moderator variable and a tailoring variable
  • SMART study principles, including how to provide a rationale for designing a SMART
  • How SMARTs differ from standard randomized clinical trials
  • Different types of SMART designs
  • How to choose the sample size for a SMART (statistical power considerations)
  • Common types of primary and secondary scientific aims in a SMART
  • Data analytic strategies used to examine primary and secondary scientific aims in a SMART

In addition to the above topics, there were several hands-on computer exercises, open discussion times, and question/answer periods.

2014 Instructors

DANmirallDaniel Almirall, Ph.D. is a Research Assistant Professor at the Institute for Social Research at the University of Michigan who works with clinical scientists and health behavior researchers to design SMARTs. Dr. Almirall was a recipient of pilot funding from The Methodology Center and was mentored by Dr. Susan M. Murphy. In 2011-12 alone, Dr. Almirall gave over 25 presentations, workshops, and talks on SMART. His first-authored articles on methodology have appeared in top statistical journals such asStatistics in MedicineBiometrics, and Journal of the American Statistical Association; and in applied journals including Journal of Child and Adolescent Psychopharmacology and Prevention Science. His collaborative work has appeared in journals such as Journal of the American Medical Association and Journal of Studies on Alcohol and Drugs. Dr. Almirall was recently awarded an R03 from NIMH to develop a novel method for discovering tailoring variables in childhood mental health treatment research. For more information about Dr. Almirall, visit https://methodology.psu.edu/people/dalmirall.

 

IshaniInbal Nahum-Shani, Ph.D. is a Research Assistant Professor at the University of Michigan’s Survey Research Center within the Institute for Social Research. She works closely with Dr. Susan M. Murphy, creator of SMART, and has received pilot funding from the Methodology Center for her work on SMART. She currently has funding from multiple agencies, including the National Institute on Alcohol Abuse and Alcoholism (NIAAA), for her work on adaptive interventions. Dr. Nahum-Shani’s first-authored articles have appeared in outlets including Annual Review of Clinical PsychologyPsychological Methods, andMultivariate Behavioral Research. She has given over a dozen workshops and presentations on SMART in the last three years and continues to work on introducing the concept of adaptive interventions to behavioral and social scientists. For more information about Dr. Nahum-Shani, visit http://www-personal.umich.edu/~inbal/.