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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.

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.

Adaptive treatment assignment algorithms, such as bandit and reinforcement learning algorithms, are increasingly used in digital health intervention clinical trials. Causal inference and related data analyses are critical for evaluating digital health interventions, deciding how to refine the intervention, and deciding whether to roll-out the intervention more broadly. However the replicability of these analyses has received relatively little attention. This work investigates the replicability of statistical analyses from trials deploying adaptive treatment assignment algorithms. We demonstrate that many standard statistical estimators can be inconsistent and fail to be replicable across repetitions of the clinical trial, even as the sample size grows large. We show that this non-replicability is intimately related to properties of the adaptive algorithm itself. We introduce a formal definition of a "replicable bandit algorithm" and prove that under such algorithms, a wide variety of common statistical analyses are guaranteed to be consistent. We present both theoretical results and simulation studies based on a mobile health oral health self-care intervention. Our findings underscore the importance of designing adaptive algorithms with replicability in mind, especially for settings like digital health where deployment decisions rely heavily on replicated evidence. We conclude by discussing open questions on the connections between algorithm design, statistical inference, and experimental replicability.

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.

Real-world decision-making requires grappling with a perpetual lack of data as environments change; intelligent agents must comprehend uncertainty and actively gather information to resolve it. We propose a new framework for learning bandit algorithms from massive historical data, which we demonstrate in a cold-start recommendation problem. First, we use historical data to pretrain an autoregressive model to predict a sequence of repeated feedback/rewards (e.g., responses to news articles shown to different users over time). In learning to make accurate predictions, the model implicitly learns an informed prior based on rich action features (e.g., article headlines) and how to sharpen beliefs as more rewards are gathered (e.g., clicks as each article is recommended). At decision-time, we autoregressively sample (impute) an imagined sequence of rewards for each action, and choose the action with the largest average imputed reward. Far from a heuristic, our approach is an implementation of Thompson sampling (with a learned prior), a prominent active exploration algorithm. We prove our pretraining loss directly controls online decision-making performance, and we demonstrate our framework on a news recommendation task where we integrate end-to-end fine-tuning of a pretrained language model to process news article headline text to improve performance.

Online Reinforcement Learning (RL) is typically framed as the process of minimizing cumulative regret (CR) through interactions with an unknown environment. However, real-world RL applications usually involve a sequence of tasks, and the data collected in the first task is used to warm-start the second task. The performance of the warm-start policy is measured by simple regret (SR). While minimizing both CR and SR is generally a conflicting objective, previous research has shown that in stationary environments, both can be optimized in terms of the duration of the task, $T$. In practice, however, in real-world applications, human-in-the-loop decisions between tasks often results in non-stationarity. For instance, in clinical trials, scientists may adjust target health outcomes between implementations. Our results show that task non-stationarity leads to a more restrictive trade-off between CR and SR. To balance these competing goals, the algorithm must explore excessively, leading to a CR bound worse than the typical optimal rate of $T^{1/2}$. These findings are practically significant, indicating that increased exploration is necessary in non-stationary environments to accommodate task changes, impacting the design of RL algorithms in fields such as healthcare and beyond.

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.

Dental disease is one of the most common chronic diseases despite being largely preventable. However, professional advice on optimal oral hygiene practices is often forgotten or abandoned by patients. Therefore patients may benefit from timely and personalized encouragement to engage in oral self-care behaviors. In this paper, we develop an online reinforcement learning (RL) algorithm for use in optimizing the delivery of mobile-based prompts to encourage oral hygiene behaviors. One of the main challenges in developing such an algorithm is ensuring that the algorithm considers the impact of the current action on the effectiveness of future actions (i.e., delayed effects), especially when the algorithm has been made simple in order to run stably and autonomously in a constrained, real-world setting (i.e., highly noisy, sparse data). We address this challenge by designing a quality reward which maximizes the desired health outcome (i.e., high-quality brushing) while minimizing user burden. We also highlight a procedure for optimizing the hyperparameters of the reward by building a simulation environment test bed and evaluating candidates using the test bed. The RL algorithm discussed in this paper will be deployed in Oralytics, an oral self-care app that provides behavioral strategies to boost patient engagement in oral hygiene practices.

In the reinforcement learning literature, there are many algorithms developed for either Contextual Bandit (CB) or Markov Decision Processes (MDP) environments. However, when deploying reinforcement learning algorithms in the real world, even with domain expertise, it is often difficult to know whether it is appropriate to treat a sequential decision making problem as a CB or an MDP. In other words, do actions affect future states, or only the immediate rewards? Making the wrong assumption regarding the nature of the environment can lead to inefficient learning, or even prevent the algorithm from ever learning an optimal policy, even with infinite data. In this work we develop an online algorithm that uses a Bayesian hypothesis testing approach to learn the nature of the environment. Our algorithm allows practitioners to incorporate prior knowledge about whether the environment is that of a CB or an MDP, and effectively interpolate between classical CB and MDP-based algorithms to mitigate against the effects of misspecifying the environment. We perform simulations and demonstrate that in CB settings our algorithm achieves lower regret than MDP-based algorithms, while in non-bandit MDP settings our algorithm is able to learn the optimal policy, often achieving comparable regret to MDP-based algorithms., Comment: Challenges of Real-World Reinforcement Learning 2020 (NeurIPS Workshop)

Online reinforcement learning (RL) algorithms are increasingly used to personalize digital interventions in the fields of mobile health and online education. Common challenges in designing and testing an RL algorithm in these settings include ensuring the RL algorithm can learn and run stably under real-time constraints, and accounting for the complexity of the environment, e.g., a lack of accurate mechanistic models for the user dynamics. To guide how one can tackle these challenges, we extend the PCS (Predictability, Computability, Stability) framework, a data science framework that incorporates best practices from machine learning and statistics in supervised learning (Yu and Kumbier, 2020), to the design of RL algorithms for the digital interventions setting. Further, we provide guidelines on how to design simulation environments, a crucial tool for evaluating RL candidate algorithms using the PCS framework. We illustrate the use of the PCS framework for designing an RL algorithm for Oralytics, a mobile health study aiming to improve users' tooth-brushing behaviors through the personalized delivery of intervention messages. Oralytics will go into the field in late 2022.

Online reinforcement learning and other adaptive sampling algorithms are increasingly used in digital intervention experiments to optimize treatment delivery for users over time. In this work, we focus on longitudinal user data collected by a large class of adaptive sampling algorithms that are designed to optimize treatment decisions online using accruing data from multiple users. Combining or "pooling" data across users allows adaptive sampling algorithms to potentially learn faster. However, by pooling, these algorithms induce dependence between the sampled user data trajectories; we show that this can cause standard variance estimators for i.i.d. data to underestimate the true variance of common estimators on this data type. We develop novel methods to perform a variety of statistical analyses on such adaptively sampled data via Z-estimation. Specifically, we introduce the \textit{adaptive} sandwich variance estimator, a corrected sandwich estimator that leads to consistent variance estimates under adaptive sampling. Additionally, to prove our results we develop novel theoretical tools for empirical processes on non-i.i.d., adaptively sampled longitudinal data which may be of independent interest. This work is motivated by our efforts in designing experiments in which online reinforcement learning algorithms optimize treatment decisions, yet statistical inference is essential for conducting analyses after experiments conclude., Comment: Fixing typos

Bandit algorithms are increasingly used in real-world sequential decision-making problems. Associated with this is an increased desire to be able to use the resulting datasets to answer scientific questions like: Did one type of ad lead to more purchases? In which contexts is a mobile health intervention effective? However, classical statistical approaches fail to provide valid confidence intervals when used with data collected with bandit algorithms. Alternative methods have recently been developed for simple models (e.g., comparison of means). Yet there is a lack of general methods for conducting statistical inference using more complex models on data collected with (contextual) bandit algorithms; for example, current methods cannot be used for valid inference on parameters in a logistic regression model for a binary reward. In this work, we develop theory justifying the use of M-estimators -- which includes estimators based on empirical risk minimization as well as maximum likelihood -- on data collected with adaptive algorithms, including (contextual) bandit algorithms. Specifically, we show that M-estimators, modified with particular adaptive weights, can be used to construct asymptotically valid confidence regions for a variety of inferential targets.

As bandit algorithms are increasingly utilized in scientific studies and industrial applications, there is an associated increasing need for reliable inference methods based on the resulting adaptively-collected data. In this work, we develop methods for inference on data collected in batches using a bandit algorithm. We first prove that the ordinary least squares estimator (OLS), which is asymptotically normal on independently sampled data, is not asymptotically normal on data collected using standard bandit algorithms when there is no unique optimal arm. This asymptotic non-normality result implies that the naive assumption that the OLS estimator is approximately normal can lead to Type-1 error inflation and confidence intervals with below-nominal coverage probabilities. Second, we introduce the Batched OLS estimator (BOLS) that we prove is (1) asymptotically normal on data collected from both multi-arm and contextual bandits and (2) robust to non-stationarity in the baseline reward.

Recent work using auxiliary prediction task classifiers to investigate the properties of LSTM representations has begun to shed light on why pretrained representations, like ELMo (Peters et al., 2018) and CoVe (McCann et al., 2017), are so beneficial for neural language understanding models. We still, though, do not yet have a clear understanding of how the choice of pretraining objective affects the type of linguistic information that models learn. With this in mind, we compare four objectives---language modeling, translation, skip-thought, and autoencoding---on their ability to induce syntactic and part-of-speech information. We make a fair comparison between the tasks by holding constant the quantity and genre of the training data, as well as the LSTM architecture. We find that representations from language models consistently perform best on our syntactic auxiliary prediction tasks, even when trained on relatively small amounts of data. These results suggest that language modeling may be the best data-rich pretraining task for transfer learning applications requiring syntactic information. We also find that the representations from randomly-initialized, frozen LSTMs perform strikingly well on our syntactic auxiliary tasks, but this effect disappears when the amount of training data for the auxiliary tasks is reduced.