JMIR Publications

ABSTRACT

Background:

Type 1 Diabetes (T1D) management is complex and associated with significant psychosocial burden. Continuous glucose monitors (CGM) can improve disease management and outcomes, but also introduce new or exacerbate existing psychosocial concerns. Patient Reported Outcome Measures (PROMs) can be used to capture this information, but there is no consensus on which PROMs should be used in pediatric CGM research.

Objective:

We describe out the process to: 1) identify PROMs that could be used to assess the impact of CGMs on pediatric patients with T1D, 2) implement a modified e-Delphi methodology to arrive at an expert consensus on which PROMs are most suitable for clinical and research applications, and 3) establish a periodicity table for the administration of PROMs over time in Real-World Evidence study.

Methods:

In order to identify appropriate PROMs for pediatric patients and families with T1D and CGMs, we conducted an asynchronous, electronic Delphi (e-Delphi) process with a multidisciplinary group of experts from around the country. We identified candidate instruments through a literature review. The three-round e-Delphi process was conducted via a study website, email, and online forms. Participants provided opinions on usefulness of instruments, age validation, feasibility, time, and frequency of administration.

Results:

Sixteen experts participated in the E-Delphi process; four of them consistently in all three rounds. We identified 62 candidate instruments, which were narrowed down to 12 final PROMs across five domains: Diabetes Distress and Burden (4 instruments), Autonomy (2 instruments), Quality of Life (1 instrument), Psychosocial (3 instruments) and Technology Acceptance (2 instruments). A quarterly administration schedule was developed to reduce burden on participants.

Conclusions:

PROMs can provide critical insights into the psychosocial well-being of patients. The specific measures identified in the paper are particularly well suited for pediatric patients with T1D and CGMs. Clinical implementation could help healthcare providers, patients and families engage in more comprehensive disease management.