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

Area of Science:

• Digital Medicine
• Biostatistics
• Clinical Sciences

Background:

• Connected sensor technologies and digital measurement products are increasingly used to assess behavioral and physiological functions.
• Evaluating these technologies requires standardized reporting to ensure research quality and reliability.
• Existing frameworks may not fully address the unique aspects of digital measurement product evaluation.

Purpose of the Study:

• To introduce the EVIDENCE (EValuatIng connecteD sENsor teChnologiEs) checklist.
• To promote high-quality reporting standards for studies evaluating digital measurement products and connected sensor technologies.
• To provide a guide for researchers, readers, and reviewers to improve the quality of published literature in this field.

Main Methods:

• Development of the EVIDENCE checklist by a multidisciplinary expert group.
• The checklist is designed for 5 types of evaluations: proof of concept, verification, analytical validation, clinical validation (V3 framework), and utility/usability assessments.
• The checklist aims to define necessary reporting requirements for studies on digital measurement products.

Main Results:

• The EVIDENCE checklist provides a structured framework for reporting evaluations of digital measurement products.
• It addresses the need for standardized reporting across various validation stages.
• The checklist facilitates better understanding and assessment of research quality in digital health.

Conclusions:

• The EVIDENCE checklist is a crucial tool for enhancing the quality of research reporting on digital measurement products.
• Widespread adoption of EVIDENCE will elevate the standards for published literature in digital medicine.
• This checklist empowers stakeholders to critically evaluate studies involving connected sensor technologies.