Person-reported outcomes in registered randomised diabetes trials: A mapping review of constructs.

Aim: Recently, efforts have been made to use and report person-reported outcomes (PROs) in randomised clinical trials (RCTs). Here, we aim to (1) assess the status of inclusion of PROs in registered RCTs over 5 years in people with type 1 or 2 diabetes, and (2) map the PRO measures (PROMs) onto predefined domains.

Methods: The largest trial registries (Clinicatrials.