Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review.

ABSTRACT:

Background

The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app's effectiveness. However, there are no current standards for how researchers should measure adherence or address the risk of bias imposed by nonadherence through efficacy analyses.

Objective

This systematic review aims to address 2 critical questions regarding clinical trials of software as a medical device (SaMD) apps: How well do researchers report adherence and engagement metrics for studies of effectiveness and efficacy? and What efficacy analyses do researchers use to account f

SUBMITTER: Grayek E 

PROVIDER: S-EPMC10687688 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature