Clinical Validation of Novel Digital Measures: Statistical Methods for Reliability Evaluation.

ABSTRACT:

Background

Assessment of reliability is one of the key components of the validation process designed to demonstrate that a novel clinical measure assessed by a digital health technology tool is fit-for-purpose in clinical research, care, and decision-making. Reliability assessment contributes to characterization of the signal-to-noise ratio and measurement error and is the first indicator of potential usefulness of the proposed clinical measure.

Summary

Methodologies for reliability analyses are scattered across literature on validation of PROs, wet biomarkers, etc., yet are equally useful for digital clinical measures. We review a general modeling framework and statistical metrics typically used for reliability assessments as part of the clinical validation. We also present

SUBMITTER: Ratitch B 

PROVIDER: S-EPMC10425717 | biostudies-literature | 2023 Jan-Dec

REPOSITORIES: biostudies-literature