Update on Oral Medication Adherence Monitoring Technologies within U.S. Clinical Research: A Systematic Literature Review Pubblico

Abstract

Medication adherence is defined as the extent to which a prescribed dose, frequency and timing of a medication are followed (Davidson, et al., 2015). Non-adherence can lead to disease progression, additional physician visits, longer hospital stays, and increased mortality (Wimbiscus, 2019). According to several studies, overall adherence estimates range from 17% to 80% with an average of around 50% (Wimbiscus, 2019). Within the clinical research setting, the efficacy and safety for investigational drugs are dependent on the medication adherence of clinical trial participants. Hence, medication nonadherence can skew results of clinical therapy trials (Dayer, Heldenbrand, Anderson, Gubbins, & Martin, 2013).

The factors contributing to poor medication adherence can be complex and multifactorial. Due to these varied barriers, there is a need to enhance adherence monitoring through more innovative, practical, personized, and inexpensive technological approaches that capture oral medication adherence. Low adherence is often the broken link between new therapies and improved health outcomes (Vollmer, et al., 2014). 

The best technological solution to accurately capture medication adherence has yet to be determined. This systematic review aims to survey recent tech solutions that alleviate medication nonadherence and presents their trade-offs in accuracy, acceptability, feasibility, efficacy, safety, and user authentication. While is no true “gold standard” for monitoring adherence, there are still many opportunities in future studies to explore effective strategies needed to capture adherence and improve compliance behaviors (Foster, Pai, Zhao, & Furth, 2014).

Table of Contents

I. Introduction......................................................................................................... 1 

Introduction and Rationale.................................................................................................. 1

Problem Statement............................................................................................................. 2

Purpose Statement.............................................................................................................. 3

Research Questions............................................................................................................. 3

Significance Statement........................................................................................................ 4

Definition of terms.............................................................................................................. 4

II. Review of the Literature ................................................................................... 5

Introduction........................................................................................................................ 5

Medication Nonadherence.................................................................................................. 5

Disease-Specific Factors........................................................................................................................6 

Patient-Related Factors..........................................................................................................................7 

Therapy-Related Factors........................................................................................................................7 

Health System & Team..........................................................................................................................8 

Socioeconomic Factors..........................................................................................................................8

Adherence Monitoring Approaches..................................................................................... 9

Indirect Monitoring...............................................................................................................................9

Direct Monitoring................................................................................................................................11

Summary of current problem and study relevance............................................................ 16

III. Methodology: Data Collection and Analysis ................................................... 19 

Introduction ..................................................................................................................... 19 

Literature Search Methodology ....................................................................................... 19 

Data Extraction and Quality Assurance........................................................................... 21 

Analysis Plan .................................................................................................................... 21

IV. Results ........................................................................................................... 23 

Introduction ..................................................................................................................... 23 

Study Characteristics ....................................................................................................... 23

Analysis of Major Themes and Findings..........................................................................30

Accuracy..............................................................................................................................................30 

Acceptability and Participant Satisfaction...........................................................................................30 

Feasibility ............................................................................................................................................31 

Usability ..............................................................................................................................................32

Safety...................................................................................................................................................32

User authentication..............................................................................................................................33

V. Discussion ......................................................................................................... 36

 Introduction ...................................................................................................................... 36

Summary of study ............................................................................................................. 36

Discussion of key results .................................................................................................... 36

Limitations ........................................................................................................................ 37

Implications....................................................................................................................... 38

Recommendations............................................................................................................. 38

Conclusion......................................................................................................................... 38

Abbreviations ............................................................................................................ 39 

Works Cited............................................................................................................... 40 

Appendix ................................................................................................................... 43

Appendix 1: Variables for Data Extraction.......................................................................... 43

Appendix 2: Example of a Smart Pill Organizer................................................................... 45

Appendix 3: Example of a Smart Pill Bottles....................................................................... 45

Appendix 4: Example of Bio-ingestible Sensors .................................................................. 46

Appendix 5: Example of Virtually Observed Therapy (VOT) ................................................ 46

Appendix 6: Example of a Home Assistant Pill Dispenser ................................................... 47

Table of Tables

Table 1: Limitations of Conventional Medication Adherence Capture Methods............. 12

Table 2: Summary of Oral Medication Adherence Device Methods ............................... 17

Table 3: Oral Medication Adherence Device Interventions, 2010-2019 .......................... 27

Table 4: Systematic Review of Oral Medication Adherence Device Methods ................ 34

Table of Figures

Figure 1: Flow diagram of the study selection process..................................................... 22

About this Master's Thesis

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• Permission granted by the author to include this thesis or dissertation in this repository. All rights reserved by the author. Please contact the author for information regarding the reproduction and use of this thesis or dissertation.

School	Rollins School of Public Health
Department	Executive Masters of Public Health - MPH
Subfield / Discipline	Prevention Science
Degree	M.P.H.
Submission	Master's Thesis
Language	English
Research Field	Health Sciences, Public Health Health Sciences, Pharmacy
Parola chiave	adherence medication adherence medication compliance
Committee Chair / Thesis Advisor	Kelley Chester, Emory University
Committee Members	Elaine Vu , University of North Carolina at Chapel Hill

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