Abstract: Technological advancements in the field of mobile devices and wearable sensors make it possible to deliver treatments anytime and anywhere to users like you and me. Increasingly the delivery of these treatments is triggered by detections/predictions of vulnerability and receptivity. These observations are likely to have been impacted by prior treatments. Furthermore the treatments are often designed to have an impact on users over a span of time during which subsequent treatments may be provided. Here we discuss our work on the design of a mobile health smoking cessation study in which the above two challenges arose. This work involves the use of multiple online data analysis algorithms. Online algorithms are used in the detection, for example, of physiological stress. Other algorithms are used to forecast at each vulnerable time, the remaining number of vulnerable times in the day. These algorithms are then inputs into a randomization algorithm that ensures that each user is randomized to each treatment an appropriate number of times per day. We develop the stratified micro-randomized trial which involves not only the randomization algorithm but a precise statement of the meaning of the treatment effects and the primary scientific hypotheses along with primary analyses and sample size calculations. Considerations of causal inference and potential causal bias incurred by inappropriate data analyses play a large role throughout.

Susan Murphy is Professor of Statistics and Radcliffe Alumnae Professor at the Radcliffe Institute, Harvard University, as well as Professor of Computer Science at the Harvard John A. Paulson School of Engineering and Applied Sciences.