arXiv subjects

Inbal Nahum-Shani

Publications and source records attributed to Inbal Nahum-Shani.

At least 19 recordsLinked to original sources

arXiv2026

Estimation of Time-Varying Treatment Effects in a Joint Model for Longitudinal and Recurrent Event Outcomes in Mobile Health Data

Not only does mobile health technology enable researchers to track changes in multiple longitudinal outcomes of interest and to record the occurrence of health-related events over time, but it also allows for the delivery of repeated low-cost treatments directly to individuals in real time. We present a model-based approach for estimating the effect of repeatedly delivered treatments in a micro-randomized trial (MRT) via an extension of a joint longitudinal-survival model. We discuss different ways that these repeated treatment effects can be incorporated into the joint model; these different model specifications correspond to different mechanisms by which treatment is assumed to impact the longitudinal and event processes. Taking a Bayesian approach to inference, we model the association between repeated treatments, multiple longitudinally measured outcomes, and recurrent events. We also demonstrate how to calculate information criteria for model selection and present goodness-of-fit plots for assessing survival submodel calibration. We then illustrate the performance of our method via simulations and analysis of data collected in an MRT of substance use.

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arXiv2026

Constructing Evidence-Based Tailoring Variables for Adaptive Interventions

Background: Adaptive interventions provide a guide for using ongoing information about individuals to decide whether and how to modify the type, amount, delivery modality, or timing of treatment, to improve intervention effectiveness while reducing cost and burden. The variables that inform treatment modification decisions are called tailoring variables. Specifying a tailoring variable requires describing what should be measured, when to measure it, when the measure should be used to make decisions, and what cutoffs should be used in making decisions. These questions are causal and prescriptive (what to do, when), not merely predictive. They involve tradeoffs between specificity and sensitivity, and between waiting for sufficient information versus intervening quickly. Purpose: There is little specific guidance in the literature on how to empirically choose tailoring variables, including cutoffs, measurement times, and decision times. Methods: We review possible approaches for comparing potential tailoring variables and propose a framework for systematically developing tailoring variables. Results: Although secondary observational data can be used to select tailoring variables, additional assumptions are needed. A specifically designed experiment for optimization (an optimization randomized controlled trial), e.g., a multi-arm randomized trial, sequential multiple assignment randomized trial, factorial experiment, or hybrid design, may provide a more direct way to answer these questions. Conclusions: Using randomization directly to inform tailoring variables provides the most direct causal evidence but requires more effort and resources than secondary data analysis. More research is needed on how best to design tailoring variables for effective, scalable interventions.

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arXiv2026

Evaluating time-varying treatment effects in hybrid SMART-MRT designs

Recently a new experimental approach, the hybrid experimental design (HED), was introduced to enable investigators to answer scientific questions about building behavioral interventions in which human-delivered and digital components are integrated and adapted on multiple timescales: slow (e.g., every few weeks) and fast (e.g., every few hours), respectively. An increasingly common HED involves the integration of the sequential, multiple assignment, randomized trial (SMART) with the micro-randomized trial (MRT), allowing investigators to answer scientific questions about potential synergistic effects of digital and human-delivered interventions. Approaches to formalize these questions in terms of causal estimands and associated data analytic methods are limited. In this paper, we formally define and assess these synergistic effects in hybrid SMART-MRTs on both proximal and distal outcomes. Practical utility is shown through the analysis of M-Bridge, a hybrid SMART-MRT aimed at reducing binge drinking among first-year college students.

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arXiv2025

"It felt more real": Investigating the User Experience of the MiWaves Personalizing JITAI Pilot Study

Cannabis use among emerging adults is increasing globally, posing significant health risks and creating a need for effective interventions. We present an exploratory analysis of the MiWaves pilot study, a digital intervention aimed at supporting cannabis use reduction among emerging adults (ages 18-25). Our findings indicate the potential of self-monitoring check-ins and trend visualizations in fostering self-awareness and promoting behavioral reflection in participants. MiWaves intervention message timing and frequency were also generally well-received by the participants. The participants' perception of effort were queried on intervention messages with different tasks, and our findings suggest that messages with tasks like exploring links and typing in responses are perceived as requiring more effort as compared to messages with tasks involving reading and acknowledging. Finally, we discuss the findings and limitations from this study and analysis, and their impact on informing future iterations on MiWaves.

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arXiv2025

Reinforcement Learning on Dyads to Enhance Medication Adherence

Medication adherence is critical for the recovery of adolescents and young adults (AYAs) who have undergone hematopoietic cell transplantation (HCT). However, maintaining adherence is challenging for AYAs after hospital discharge, who experience both individual (e.g. physical and emotional symptoms) and interpersonal barriers (e.g., relational difficulties with their care partner, who is often involved in medication management). To optimize the effectiveness of a three-component digital intervention targeting both members of the dyad as well as their relationship, we propose a novel Multi-Agent Reinforcement Learning (MARL) approach to personalize the delivery of interventions. By incorporating the domain knowledge, the MARL framework, where each agent is responsible for the delivery of one intervention component, allows for faster learning compared with a flattened agent. Evaluation using a dyadic simulator environment, based on real clinical data, shows a significant improvement in medication adherence (approximately 3%) compared to purely random intervention delivery. The effectiveness of this approach will be further evaluated in an upcoming trial.

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arXiv2024

A Deployed Online Reinforcement Learning Algorithm In An Oral Health Clinical Trial

Dental disease is a prevalent chronic condition associated with substantial financial burden, personal suffering, and increased risk of systemic diseases. Despite widespread recommendations for twice-daily tooth brushing, adherence to recommended oral self-care behaviors remains sub-optimal due to factors such as forgetfulness and disengagement. To address this, we developed Oralytics, a mHealth intervention system designed to complement clinician-delivered preventative care for marginalized individuals at risk for dental disease. Oralytics incorporates an online reinforcement learning algorithm to determine optimal times to deliver intervention prompts that encourage oral self-care behaviors. We have deployed Oralytics in a registered clinical trial. The deployment required careful design to manage challenges specific to the clinical trials setting in the U.S. In this paper, we (1) highlight key design decisions of the RL algorithm that address these challenges and (2) conduct a re-sampling analysis to evaluate algorithm design decisions. A second phase (randomized control trial) of Oralytics is planned to start in spring 2025.

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arXiv2024

Oralytics Reinforcement Learning Algorithm

Dental disease is still one of the most common chronic diseases in the United States. While dental disease is preventable through healthy oral self-care behaviors (OSCB), this basic behavior is not consistently practiced. We have developed Oralytics, an online, reinforcement learning (RL) algorithm that optimizes the delivery of personalized intervention prompts to improve OSCB. In this paper, we offer a full overview of algorithm design decisions made using prior data, domain expertise, and experiments in a simulation test bed. The finalized RL algorithm was deployed in the Oralytics clinical trial, conducted from fall 2023 to summer 2024.

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arXiv2024

Effective Monitoring of Online Decision-Making Algorithms in Digital Intervention Implementation

Online AI decision-making algorithms are increasingly used by digital interventions to dynamically personalize treatment to individuals. These algorithms determine, in real-time, the delivery of treatment based on accruing data. The objective of this paper is to provide guidelines for enabling effective monitoring of online decision-making algorithms with the goal of (1) safeguarding individuals and (2) ensuring data quality. We elucidate guidelines and discuss our experience in monitoring online decision-making algorithms in two digital intervention clinical trials (Oralytics and MiWaves). Our guidelines include (1) developing fallback methods, pre-specified procedures executed when an issue occurs, and (2) identifying potential issues categorizing them by severity (red, yellow, and green). Across both trials, the monitoring systems detected real-time issues such as out-of-memory issues, database timeout, and failed communication with an external source. Fallback methods prevented participants from not receiving any treatment during the trial and also prevented the use of incorrect data in statistical analyses. These trials provide case studies for how health scientists can build monitoring systems for their digital intervention. Without these algorithm monitoring systems, critical issues would have gone undetected and unresolved. Instead, these monitoring systems safeguarded participants and ensured the quality of the resulting data for updating the intervention and facilitating scientific discovery. These monitoring guidelines and findings give digital intervention teams the confidence to include online decision-making algorithms in digital interventions.

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arXiv2024

MiWaves Reinforcement Learning Algorithm

The escalating prevalence of cannabis use poses a significant public health challenge globally. In the U.S., cannabis use is more prevalent among emerging adults (EAs) (ages 18-25) than any other age group, with legalization in the multiple states contributing to a public perception that cannabis is less risky than in prior decades. To address this growing concern, we developed MiWaves, a reinforcement learning (RL) algorithm designed to optimize the delivery of personalized intervention prompts to reduce cannabis use among EAs. MiWaves leverages domain expertise and prior data to tailor the likelihood of delivery of intervention messages. This paper presents a comprehensive overview of the algorithm's design, including key decisions and experimental outcomes. The finalized MiWaves RL algorithm was deployed in a clinical trial from March to May 2024.

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arXiv2024

Dyadic Reinforcement Learning

Mobile health aims to enhance health outcomes by delivering interventions to individuals as they go about their daily life. The involvement of care partners and social support networks often proves crucial in helping individuals managing burdensome medical conditions. This presents opportunities in mobile health to design interventions that target the dyadic relationship -- the relationship between a target person and their care partner -- with the aim of enhancing social support. In this paper, we develop dyadic RL, an online reinforcement learning algorithm designed to personalize intervention delivery based on contextual factors and past responses of a target person and their care partner. Here, multiple sets of interventions impact the dyad across multiple time intervals. The developed dyadic RL is Bayesian and hierarchical. We formally introduce the problem setup, develop dyadic RL and establish a regret bound. We demonstrate dyadic RL's empirical performance through simulation studies on both toy scenarios and on a realistic test bed constructed from data collected in a mobile health study.

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arXiv2024

Monitoring Fidelity of Online Reinforcement Learning Algorithms in Clinical Trials

Online reinforcement learning (RL) algorithms offer great potential for personalizing treatment for participants in clinical trials. However, deploying an online, autonomous algorithm in the high-stakes healthcare setting makes quality control and data quality especially difficult to achieve. This paper proposes algorithm fidelity as a critical requirement for deploying online RL algorithms in clinical trials. It emphasizes the responsibility of the algorithm to (1) safeguard participants and (2) preserve the scientific utility of the data for post-trial analyses. We also present a framework for pre-deployment planning and real-time monitoring to help algorithm developers and clinical researchers ensure algorithm fidelity. To illustrate our framework's practical application, we present real-world examples from the Oralytics clinical trial. Since Spring 2023, this trial successfully deployed an autonomous, online RL algorithm to personalize behavioral interventions for participants at risk for dental disease.

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arXiv2024

reBandit: Random Effects based Online RL algorithm for Reducing Cannabis Use

The escalating prevalence of cannabis use, and associated cannabis-use disorder (CUD), poses a significant public health challenge globally. With a notably wide treatment gap, especially among emerging adults (EAs; ages 18-25), addressing cannabis use and CUD remains a pivotal objective within the 2030 United Nations Agenda for Sustainable Development Goals (SDG). In this work, we develop an online reinforcement learning (RL) algorithm called reBandit which will be utilized in a mobile health study to deliver personalized mobile health interventions aimed at reducing cannabis use among EAs. reBandit utilizes random effects and informative Bayesian priors to learn quickly and efficiently in noisy mobile health environments. Moreover, reBandit employs Empirical Bayes and optimization techniques to autonomously update its hyper-parameters online. To evaluate the performance of our algorithm, we construct a simulation testbed using data from a prior study, and compare against commonly used algorithms in mobile health studies. We show that reBandit performs equally well or better than all the baseline algorithms, and the performance gap widens as population heterogeneity increases in the simulation environment, proving its adeptness to adapt to diverse population of study participants.

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arXiv2024

A Bayesian joint longitudinal-survival model with a latent stochastic process for intensive longitudinal data

The availability of mobile health (mHealth) technology has enabled increased collection of intensive longitudinal data (ILD). ILD have potential to capture rapid fluctuations in outcomes that may be associated with changes in the risk of an event. However, existing methods for jointly modeling longitudinal and event-time outcomes are not well-equipped to handle ILD due to the high computational cost. We propose a joint longitudinal and time-to-event model suitable for analyzing ILD. In this model, we summarize a multivariate longitudinal outcome as a smaller number of time-varying latent factors. These latent factors, which are modeled using an Ornstein-Uhlenbeck stochastic process, capture the risk of a time-to-event outcome in a parametric hazard model. We take a Bayesian approach to fit our joint model and conduct simulations to assess its performance. We use it to analyze data from an mHealth study of smoking cessation. We summarize the longitudinal self-reported intensity of nine emotions as the psychological states of positive and negative affect. These time-varying latent states capture the risk of the first smoking lapse after attempted quit. Understanding factors associated with smoking lapse is of keen interest to smoking cessation researchers.

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arXiv2024

Data integration methods for micro-randomized trials

Existing statistical methods for the analysis of micro-randomized trials (MRTs) are designed to estimate causal excursion effects using data from a single MRT. In practice, however, researchers can often find previous MRTs that employ similar interventions. In this paper, we develop data integration methods that capitalize on this additional information, leading to statistical efficiency gains. To further increase efficiency, we demonstrate how to combine these approaches according to a generalization of multivariate precision weighting that allows for correlation between estimates, and we show that the resulting meta-estimator possesses an asymptotic optimality property. We illustrate our methods in simulation and in a case study involving two MRTs in the area of smoking cessation.

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arXiv2024

A Continuous-Time Dynamic Factor Model for Intensive Longitudinal Data Arising from Mobile Health Studies

Intensive longitudinal data (ILD) collected in mobile health (mHealth) studies contain rich information on multiple outcomes measured frequently over time that have the potential to capture short-term and long-term dynamics. Motivated by an mHealth study of smoking cessation in which participants self-report the intensity of many emotions multiple times per day, we describe a dynamic factor model that summarizes the ILD as a low-dimensional, interpretable latent process. This model consists of two submodels: (i) a measurement submodel--a factor model--that summarizes the multivariate longitudinal outcome as lower-dimensional latent variables and (ii) a structural submodel--an Ornstein-Uhlenbeck (OU) stochastic process--that captures the temporal dynamics of the multivariate latent process in continuous time. We derive a closed-form likelihood for the marginal distribution of the outcome and the computationally-simpler sparse precision matrix for the OU process. We propose a block coordinate descent algorithm for estimation. Finally, we apply our method to the mHealth data to summarize the dynamics of 18 different emotions as two latent processes. These latent processes are interpreted by behavioral scientists as the psychological constructs of positive and negative affect and are key in understanding vulnerability to lapsing back to tobacco use among smokers attempting to quit.

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arXiv2023

Optimal Adaptive SMART Designs with Binary Outcomes

In a sequential multiple-assignment randomized trial (SMART), a sequence of treatments is given to a patient over multiple stages. In each stage, randomization may be done to allocate patients to different treatment groups. Even though SMART designs are getting popular among clinical researchers, the methodologies for adaptive randomization at different stages of a SMART are few and not sophisticated enough to handle the complexity of optimal allocation of treatments at every stage of a trial. Lack of optimal allocation methodologies can raise serious concerns about SMART designs from an ethical point of view. In this work, we develop an optimal adaptive allocation procedure to minimize the expected number of treatment failures for a SMART with a binary primary outcome. Issues related to optimal adaptive allocations are explored theoretically with supporting simulations. The applicability of the proposed methodology is demonstrated using a recently conducted SMART study named M-Bridge for developing universal and resource-efficient dynamic treatment regimes (DTRs) for incoming first-year college students as a bridge to desirable treatments to address alcohol-related risks.

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arXiv2023

SMART Binary: Sample Size Calculation for Comparing Adaptive Interventions in SMART studies with Longitudinal Binary Outcomes

Sequential Multiple-Assignment Randomized Trials (SMARTs) play an increasingly important role in psychological and behavioral health research. This experimental approach enables researchers to answer scientific questions about how to sequence and match interventions to the unique, changing needs of individuals. A variety of sample size planning resources for SMART studies have been developed in recent years; these enable researchers to plan SMARTs for addressing different types of scientific questions. However, relatively limited attention has been given to planning SMARTs with binary (dichotomous) outcomes, which often require higher sample sizes relative to continuous outcomes. Existing resources for estimating sample size requirements for SMARTs with binary outcomes do not consider the potential to improve power by including a baseline measurement and/or multiple repeated outcome measurements. The current paper addresses this issue by providing sample size simulation code and approximate formulas for two-wave repeated measures binary outcomes (i.e., two measurement times for the outcome variable, before and after receiving the intervention). The simulation results agree well with the formulas. We also discuss how to use simulations to calculate power for studies with more than two outcome measurement occasions. The results show that having at least one repeated measurement of the outcome can substantially improve power under certain conditions.

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arXiv2023

Sample size estimation for comparing dynamic treatment regimens in a SMART: a Monte Carlo-based approach and case study with longitudinal overdispersed count outcomes

Dynamic treatment regimens (DTRs), also known as treatment algorithms or adaptive interventions, play an increasingly important role in many health domains. DTRs are motivated to address the unique and changing needs of individuals by delivering the type of treatment needed, when needed, while minimizing unnecessary treatment. Practically, a DTR is a sequence of decision rules that specify, for each of several points in time, how available information about the individual's status and progress should be used in practice to decide which treatment (e.g., type or intensity) to deliver. The sequential multiple assignment randomized trial (SMART) is an experimental design widely used to empirically inform the development of DTRs. Sample size planning resources for SMARTs have been developed for continuous, binary, and survival outcomes. However, an important gap exists in sample size estimation methodology for SMARTs with longitudinal count outcomes. Further, in many health domains, count data are overdispersed - having variance greater than their mean. We propose a Monte Carlo-based approach to sample size estimation applicable to many types of longitudinal outcomes and provide a case study with longitudinal overdispersed count outcomes. A SMART for engaging alcohol and cocaine-dependent patients in treatment is used as motivation.

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