Abstract
Poor adherence to tuberculosis (TB) treatment hinders the individual’s recovery and threatens public health. Currently, directly observed therapy (DOT) is the standard of care; however, high sustaining costs limit its availability, creating a need for more practical adherence confirmation methods. Techniques such as video monitoring and devices to time-register the opening of pill bottles are unable to confirm actual medication ingestions. A novel approach developed by Proteus Digital Health, Inc. consists of an ingestible sensor and an on-body wearable sensor; together, they electronically confirm unique ingestions and record the date/time of the ingestion. A feasibility study using an early prototype was conducted in active TB patients to determine the system’s accuracy and safety in confirming co-ingestion of TB medications with sensors. Thirty patients completed 10 DOT visits and 1,080 co-ingestion events; the system showed 95.0% (95% CI 93.5–96.2%) positive detection accuracy, defined as the number of detected sensors divided by the number of transmission capable sensors administered. The specificity was 99.7% [95% CI 99.2–99.9%] based on three false signals recorded by receivers. The system’s identification accuracy, defined as the number of correctly identified ingestible sensors divided by the number of sensors detected, was 100%. Of 11 adverse events, four were deemed related or possibly related to the device; three mild skin rashes and one complaint of nausea. The system’s positive detection accuracy was not affected by the subjects’ Body Mass Index (p = 0.7309). Study results suggest the system is capable of correctly identifying ingestible sensors with high accuracy, poses a low risk to users, and may have high patient acceptance. The system has the potential to confirm medication specific treatment compliance on a dose-by-dose basis. When coupled with mobile technology, the system could allow wirelessly observed therapy (WOT) for monitoring TB treatment as a replacement for DOT.
Highlights
Curing tuberculosis (TB) requires that patients adhere to a multi-drug regimen for a minimum of 6 months [1]
These consequences were demonstrated in New York City in the late 1980s when nearly half of the patients started on therapy failed to complete treatment and the rates of both drugsusceptible and multi-drug resistant (MDR) TB increased [2]
If the missing records were excluded, the system’s positive detection accuracy was 98.1%, and using a repeated measures model, it increased to 99.6%
Summary
Curing tuberculosis (TB) requires that patients adhere to a multi-drug regimen for a minimum of 6 months [1]. Failure to take the medications correctly leads to drug-resistance, treatment failure, and TB transmission which threaten public health These consequences were demonstrated in New York City in the late 1980s when nearly half of the patients started on therapy failed to complete treatment and the rates of both drugsusceptible and multi-drug resistant (MDR) TB increased [2]. While cost effective compared to direct encounters, they require a scheduled time for video observation and cannot ensure that medications are swallowed rather than hidden in the mouth to be discarded later Both technologies have a very limited capability for detecting selective drug adherence where a patient chooses to take some but not all of their medications. Selective drug adherence is concerning for TB as it increases the risk of acquired drug resistance
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