Why Adherence Reporting Needs Its Own Standard
Suboptimal adherence, whether to a study intervention or to data collection procedures, is one of the most common reasons a clinical trial fails. Biometric monitoring technologies (BioMeTs) offer a powerful way to actually measure that adherence, capturing both engagement with digital therapeutics and compliance with digital data collection protocols. But a systematic review published in the Journal of Medical Internet Research, authored by a multidisciplinary group convened around the Digital Medicine Society, including Koneksa Health’s Elena Izmailova, found that the field lacks a consistent way to define and report that adherence data.
What the Systematic Review Set Out to Do
- The core opportunity: BioMeT data can capture adherence to both digital therapeutics and digital data collection procedures, creating an opportunity to identify what actually drives adherence and, from there, develop methods to improve it.
- The review’s central aim: The authors set out to describe the methods and definitions researchers have used to capture and report BioMeT-derived adherence in recent literature, essentially auditing the current state of the field’s reporting practices.
- A multidisciplinary author group: The review draws on expertise spanning clinical research, patient advocacy, data science, and industry, reflecting how many different stakeholders have an interest in getting adherence reporting right.
- From audit to recommendation: Rather than stopping at describing inconsistency, the paper moves toward actionable recommendations for how adherence measured by BioMeTs should be defined and reported going forward.
Why Standardized Adherence Reporting Matters for Trial Success
This review addresses a problem that sits upstream of almost every other BioMeT validation question: if adherence itself isn’t defined and reported consistently across studies, it becomes difficult to know whether a trial’s data quality issues stem from the technology, the patient population, or simply inconsistent measurement conventions. Standardizing how adherence gets defined and reported gives sponsors a clearer, more comparable evidence base for predicting and improving compliance in future digital biomarker programs.
Koneksa Health applies this same attention to adherence definition and reporting when designing digital measurement studies, recognizing that consistent adherence data is foundational to trusting everything else the technology captures.
Reference: Olaye IM, Belovsky MP, Bataille L, et al. Recommendations for Defining and Reporting Adherence Measured by Biometric Monitoring Technologies: Systematic Review. J Med Internet Res. 2022;24(4):e33537. PMID: 35436221.
Read the full peer-reviewed publication
Related Resources

Human-in-the-Loop: Why Experts Matter More in the Age of AI

Meet Lodestarâ„¢: Your North Star for Regulatory Submissions
