Modified E-delphi Process for Selection of Patient-reported Outcomes (PRO) for Children and Young Adults with type-1 Diabetes and Their Families

Background: Type 1 Diabetes (T1D) management is complex and is 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 Outcomes (PROs) can be used to capture this information, but there is no consensus on which PROs should be used in pediatric CGM research.

Methods: We adapted the traditional Delphi process to be asynchronous and electronic (e-Delphi) to identify appropriate PROs for patients with T1D and on CGM. After performing a literature review, we recruited a group of experts representing endocrinologists, psychologists, diabetes educators, social workers, nurses, and representatives from device manufacturers across the United States. The 3-round e-Delphi process was conducted via a study website (www.delphikit.com). Experts provided opinions on usefulness of instrument, feasibility, time of administration, and administration frequency.

Results: Twenty-one out of twenty-five experts agreed to participate in the e-Delphi process. A total of 12 experts attempted at least one round and 4 experts completed all 3 rounds. Our literature review identified 104 potential instruments for inclusion, which were narrowed to 62, 25, and 11 after each round, respectively. The final list of 11 PRO instruments is shown in Table 1 categorized by domain (Diabetes Distress, Autonomy, Quality of Life, Psychosocial, Technology Acceptance), age of validation and administration, and recommended administration schedule.

Conclusion: PRO measurements can provide critical insights into the psychosocial well-being of patients. The specific instruments identified here are particularly well suited for pediatric patients with T1D and on CGM. Clinical implementation could help healthcare providers, patients, and families engage in more patient-centered and comprehensive disease management.