Abstract
BackgroundAdherence to medication is often represented in the form of a success percentage over a period of time. Although noticeable changes to aggregate adherence levels may be indicative of unstable medication behavior, a lack of noticeable changes in aggregate levels over time does not necessarily indicate stability. The ability to detect developing changes in medication-taking behavior under such conditions in real time would allow patients and care teams to make more timely and informed decisions.ObjectiveThis study aims to develop a method capable of identifying shifts in behavioral (medication) patterns at the individual level and subsequently assess the presence of such shifts in retrospective clinical trial data from patients with serious mental illness.MethodsWe defined the term adherence volatility as “the degree to which medication ingestion behavior fits expected behavior based on historically observed data” and defined a contextual anomaly system around this concept, leveraging the empirical entropy rate of a stochastic process as the basis for formulating anomaly detection. For the presented methodology, each patient’s evolving behavior is used to dynamically construct the expectation bounds for each future interval, eliminating the need to rely on model training or a static reference sequence.ResultsSimulations demonstrated that the presented methodology identifies anomalous behavior patterns even when aggregate adherence levels remain constant and highlight the temporal dependence inherent in these anomalies. Although a given sequence of events may present as anomalous during one period, that sequence should subsequently contribute to future expectations and may not be considered anomalous at a later period—this feature was demonstrated in retrospective clinical trial data. In the same clinical trial data, anomalous behavioral shifts were identified at both high- and low-adherence levels and were spread across the whole treatment regimen, with 77.1% (81/105) of the population demonstrating at least one behavioral anomaly at some point in their treatment.ConclusionsDigital medicine systems offer new opportunities to inform treatment decisions and provide complementary information about medication adherence. This paper introduces the concept of adherence volatility and develops a new type of contextual anomaly detection, which does not require an a priori definition of normal and allows expectations to evolve with shifting behavior, removing the need to rely on training data or static reference sequences. Retrospective analysis from clinical trial data highlights that such an approach could provide new opportunities to meaningfully engage patients about potential shifts in their ingestion behavior; however, this framework is not intended to replace clinical judgment, rather to highlight elements of data that warrant attention. The evidence provided here identifies new areas for research and seems to justify additional explorations in this area.
Highlights
Lack of adherence to medication is a major issue, contributing to increased health care utilization and less favorable outcomes [1,2,3]
Simulations E and F both end treatment during an identified behavioral shift despite no change in the transition probability (TP). If these were observed in a clinical setting, additional data may be desirable before making a decision regarding the consistency of medication adherence
It is unclear whether the ingestion patterns would have continued to shift in this direction, but this is a very clear example from the available clinical data of where this approach can add a unique perspective to clinical intuition: a medication adherence rate of 87% is considered high, but the adherence volatility data suggest that there are significant changes occurring in the patient’s observed ingestion behavior
Summary
Lack of adherence to medication is a major issue, contributing to increased health care utilization and less favorable outcomes [1,2,3]. The Food and Drug Administration approved the first ever digital medicine system (DMS) [4] to track medication ingestion in patients with serious mental illness (SMI) This system comprises an electronic sensor embedded in an active pharmaceutical, a wearable sensor (a patch), and a mobile application to collect and share data as appropriate (Figure 1). Objective: This study aims to develop a method capable of identifying shifts in behavioral (medication) patterns at the individual level and subsequently assess the presence of such shifts in retrospective clinical trial data from patients with serious mental illness. This paper introduces the concept of adherence volatility and develops a new type of contextual anomaly detection, which does not require an a priori definition of normal and allows expectations to evolve with shifting behavior, removing the need to rely on training data or static reference sequences. The evidence provided here identifies new areas for research and seems to justify additional explorations in this area
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