EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration

A Shared Reporting Standard for Digital Measurement Studies

As the number of studies evaluating wearables, sensors, and other connected digital measurement products has grown, so has the inconsistency in how those studies get reported, making it harder for readers to judge quality or compare findings across the field. A paper published in Digital Biomarkers introduces the EVIDENCE (EValuatIng connecteD sENsor teChnologiEs) checklist, developed to close that gap. Koneksa Health’s Elena Izmailova was among the multidisciplinary group of authors convened by the Digital Medicine Society to build the framework.

What the EVIDENCE Checklist Establishes

• Multidisciplinary development: The checklist was developed by a multidisciplinary group of content experts convened by the Digital Medicine Society, spanning clinical sciences, data management, technology development, and biostatistics, rather than being built from a single disciplinary lens.
• A clear scope: EVIDENCE is aimed specifically at studies where the primary objective is evaluating a digital measurement product or its constituent parts, not digital health studies broadly, but the specific subset focused on product- or component-level evaluation.
• The goal: higher-quality reporting: The checklist’s stated aim is to promote high-quality reporting practices across this class of studies, giving readers a consistent framework to assess methodological rigor and completeness.
• Explanation and elaboration format: This particular paper goes beyond simply listing checklist items; it provides explanation and elaboration for each, helping authors understand not just what to report, but why each element matters for study quality.

Why a Shared Checklist Matters for the Field

This publication addresses a structural problem that’s easy to overlook amid the rush to validate new devices: without a shared reporting standard, it’s difficult for sponsors, regulators, and researchers to compare digital measurement studies against each other, or to judge whether a given study’s methodology supports its conclusions. The EVIDENCE checklist gives the field a common language for what a rigorous connected sensor technology evaluation should include.

Koneksa Health applies this same standard of rigor and transparency when designing and reporting its own digital measurement validation studies, supporting the kind of consistent, comparable evidence base sponsors and regulators increasingly expect.

Reference: Manta C, Mahadevan N, Bakker J, et al. EVIDENCE Publication Checklist for Studies Evaluating Connected Sensor Technologies: Explanation and Elaboration. Digit Biomark. 2021;5(2):127-147. doi:10.1159/000515835. PMID: 34179682.