As the field of digital medicine experiences steady exploration in clinical research and patient care, new best practices are emerging to help grow its analytical and clinical evidence base. One professional organization participating in this work is the Digital Medicine Society (DiMe), a multidisciplinary group of experts in clinical science, data management, technology development, and biostatistics dedicated to advancing digital medicine through collaboration, research, and education.
As a contributor to DiMe’s recent open-science collaboration, The Playbook, Koneksa is proud to participate in another project to help expand the organization’s flagship publication for its V3 framework. The framework, named for its focus on verification, analytical validation, and clinical validation, is a modular approach to evaluating fit-for-purpose digital sensing products, algorithms, and clinical use cases that requires review and consideration at each level of the digital clinical measures stack.
Wanting to extend the value of the V3 framework and address an important factor in its use, DiMe sought to address the quality of published peer-reviewed literature that decision-makers rely on to complete digital measurement product evaluations. Members of the DiMe community, including experts at Koneksa, developed the EVIDENCE Checklist —Evaluating Connected Sensor Technologies—to encourage consistent and accurate reporting in clinical studies in which the primary objective is to evaluate digital measurement products or their components. This includes tools that process data captured by mobile sensors using algorithms to measure behavioral or physiological function.
The checklist DiMe created is applicable to several different types of digital product evaluations:
- Proof of Concept
- Analytical Validation
- Clinical Validation
- Utility & Usability Assessments
With guidance from this new checklist, professionals preparing, reading, or reviewing studies will be able to determine reporting requirements and, ultimately, produce research and peer-reviewed literature of a higher quality that is also easier for decision-makers to interpret.
This means that the publication work of researchers, journal editors, and stakeholders may lead to stronger protocols and more meaningful results to identify trusted tools in digital medicine.
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