Modified e-Delphi Process for the Selection of Patient-Reported Outcome Measures for Children and Families With Type...

Area of Science:

• Endocrinology
• Pediatrics
• Psychosocial Health

Background:

• Type 1 diabetes (T1D) management presents significant psychosocial challenges.
• Continuous glucose monitors (CGMs) can impact patient well-being, potentially introducing or worsening psychosocial concerns.
• A lack of consensus exists regarding appropriate patient-reported outcome measures (PROMs) for pediatric CGM research.

Purpose of the Study:

• To identify PROMs for assessing CGM's impact on pediatric T1D patients.
• To reach expert consensus on suitable PROMs using a modified electronic Delphi (e-Delphi) methodology.
• To establish a schedule for PROM administration in real-world studies.

Main Methods:

• An asynchronous, e-Delphi process involving a multidisciplinary expert panel.
• Literature review to identify candidate PROMs.
• Three-round Delphi process assessing instrument utility, age appropriateness, feasibility, and administration frequency.

Main Results:

• 16 experts participated, with 4 consistently engaged.
• 62 candidate instruments were evaluated, resulting in 12 final PROMs across 5 domains: diabetes distress/burden, autonomy, quality of life, psychosocial, and technology acceptance.
• A quarterly administration schedule was recommended to minimize participant burden.

Conclusions:

• PROMs offer vital insights into the psychosocial well-being of pediatric patients with T1D using CGMs.
• The identified PROMs are well-suited for this population.
• Clinical integration of these PROMs can enhance comprehensive disease management for patients, families, and providers.