MEMS AS^®
Medication Adherence Software

The most accurate method of measuring medication adherence depends on several factors, including the medication type, the study design, and available resources. No single method is perfect, and each method has its own strengths and limitations. However, electronic monitoring using Medication Event Monitoring System (MEMS) devices combined with centralized, remote adherence monitoring software is considered the most accurate method for measuring medication adherence in clinical trials – and it is proven to be 97% accurate.

How electronic monitoring works

Trial participants are provided with medication adherence packaging or devices that include hidden trackers. For example, smart blister packs may have hidden microprocessors hidden in each cavity that activate when a pill is removed. Smart pill bottles, which also tend to have covert sensors in the cap, activate when the cap is removed from the bottle, conveniently registering the date, time, and in some cases, the location when the bottle has been opened.

Medication event data from the adherence packaging or device is synchronized with software that processes the data to highlight and present problematic patterns in dashboards for researchers. This approach takes the guesswork out of decoding adherence behaviors and helps researchers get to the participants that require coaching and support much sooner than counterpart methods.

Choosing the most accurate method for measuring medication adherence requires careful consideration of the study’s specific requirements, resources, and patient population. The selected method should provide reliable and valid data while minimizing patient burden and meeting ethical considerations.

In some studies, mobile apps designed to support medication adherence have shown promise in improving adherence and health outcomes. While the evidence is still emerging, several systematic reviews and meta-analyses have evaluated the effectiveness of mobile apps in promoting medication adherence.

A systematic review of 17 randomized controlled trials (RCTs) published in 2019 found that mobile apps were associated with improved medication adherence compared to usual care or no intervention [1]. The review also found that apps that provided feedback, reminders, and educational content were more effective than those that did not.

Another systematic review and meta-analysis of 29 RCTs published in 2020 found that mobile apps significantly improved medication adherence, self-efficacy, and health outcomes compared to usual care or no intervention [2]. The study also found that apps that included medication reminders, educational content, and self-monitoring features were more effective than those that did not.

References:

[1] De Vera, M. A., Ratzlaff, C., Doerfling, P., Kopec, J. A., & Gromala, D. (2019). Mobile app–based interventions to support self-management in individuals with rheumatoid arthritis: A systematic review and meta-analysis. Arthritis Care & Research, 71(10), 1292-1305.

[2] Liu, X., Guo, X., Li, Y., Jiang, J., Chen, X., Li, Z., … & Zhang, X. (2020). Mobile application interventions for medication adherence in patients with hypertension: A systematic review and meta-analysis. Journal of Cardiovascular Nursing, 35(4), 369-378.

There are several strategies that researchers can use to improve medication adherence in clinical trials. Here are three examples:

Patient education: Providing patients with clear and concise information about their medication, including its purpose, dosage, side effects, and potential interactions, can help improve medication adherence. Patients who understand the benefits and risks of their medication are more likely to take it as prescribed. Education can be delivered through various methods, such as printed materials, videos, or in-person counseling sessions.

Reminder systems: Using reminder systems, such as text messages, phone calls, email notifications, or calendarized reminders, like those featured in MEMS Mobile, can help improve medication adherence by prompting patients to take their medication at the right time. These systems can be customized to the patient’s specific needs and preferences and can be tailored to match the dosing schedule and medication regimen.

Support services: Providing patients with additional support services, such as medication counseling, peer support groups, or transportation assistance, can help address the barriers that prevent them from adhering to their medication regimen. These services can be delivered by healthcare providers or community-based organizations and can be tailored to the patient’s specific needs and preferences.

Non-adherence to medication in clinical trials can significantly negatively impact the study results, the interpretation of the findings, and, ultimately, patient health outcomes. Here are some examples of the potential impact of non-adherence in trials:

Reduced statistical power: this can reduce the statistical power of a clinical trial, making it more difficult to detect significant differences between the treatment and control groups. This can lead to inconclusive results, false-negative or false-positive findings, and wasting resources and time.

Bias in treatment effect estimates: can bias the treatment effect estimates, making them either over- or underestimated. This can lead to inaccurate conclusions about the efficacy or safety of the medication being studied, which can have profound implications for patient care.

Increased risk of adverse events: this can increase the risk of adverse events and medication-related complications, as patients who do not take their medication as prescribed may not achieve the desired therapeutic effect or may experience unintended side effects.

Decreased generalizability: this can decrease the generalizability of the study results, as patients who do not adhere to the medication regimen may differ from those who do in terms of their demographic characteristics, disease severity, or other factors that affect treatment response.

Increased costs: this can increase the costs of the study, as additional resources may be needed to identify and address non-adherence, such as more frequent monitoring, additional visits, or more intensive support services.

Overall, non-adherence is a significant challenge in clinical trials that can undermine the validity and reliability of the study results and compromise patient health outcomes. To minimize the impact of non-adherence, researchers should implement effective strategies to improve medication adherence and monitor adherence throughout the study period.