Towards standardization of person-reported outcomes (PROs) in pediatric diabetes research: A consensus report

Diabet Med. 2024 Dec 17:e15484. doi: 10.1111/dme.15484. Online ahead of print.

Abstract

Background: Diabetes ranks among the most common chronic conditions in childhood and adolescence. It is unique among chronic conditions, in that clinical outcomes are intimately tied to how the child or adolescent living with diabetes and their parents or carers react to and implement good clinical practice guidance. It is widely recognized that the individual's perspective about the impact of trying to manage the disease together with the burden of self-management should be addressed to achieve optimal health outcomes. Standardized, rigorous assessment of behavioural and mental health outcomes is crucial to aid understanding of person-reported outcomes alongside, and in interaction with, physical health outcomes. Whilst tempting to conceptualize person-reported outcomes as a focus on perceived quality of life, the reality is that health-related quality of life is multi-dimensional and covers indicators of physical or functional health status, psychological well-being and social well- being.

Methods: In this context, this Consensus Statement has been developed by a collection of experts in diabetes to summarize the central themes and lessons derived in the assessment and use of person-reported outcome measures in relation to children and adolescents and their parents/carers, helping to provide a platform for future standardization of these measures for research studies and routine clinical use.

Results: This consensus statement provides an exploration of person-reported outcomes and how to routinely assess and incorporate into clincial research.

Keywords: T1D diabetes; adolescents; children; distress; patient‐reported outcomes; quality of life.