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Modified e-Delphi Process for the Selection of Patient-Reported Outcome Measures for Children and Families With Type
Payal Shah1, Jennifer K Raymond1, Juan Espinoza1
1Children's Hospital Los Angeles, Los Angeles, CA, United States.
Insights
Patient-reported outcome measures (PROMs) are crucial for understanding the psychosocial impact of continuous glucose monitors (CGMs) in children with type 1 diabetes (T1D). This study established consensus on the most suitable PROMs for pediatric T1D CGM research.
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.
Background:
Type 1 diabetes (T1D) management is complex and associated with significant psychosocial burden. Continuous glucose monitors (CGM) can improve disease management and outcomes and 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:
Here we describe 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 electronic Delphi (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 a real-world evidence study.
Methods:
To identify appropriate PROMs for pediatric patients and families with T1D and CGMs, we conducted an asynchronous, e-Delphi process with a multidisciplinary group of experts from around the country. We identified candidate instruments through a literature review. The 3-round e-Delphi process was conducted via a study website, email, and web-based forms. Participants provided opinions on the usefulness of instruments, age validation, feasibility, time, and frequency of administration.
Results:
In total, 16 experts participated in the e-Delphi process; 4 of whom consistently participated in all 3 rounds. We identified 62 candidate instruments, which were narrowed down to 12 final PROMs across 5 domains: diabetes distress and burden (n=4), autonomy (n=2), quality of life (n=1), psychosocial (n=3), and technology acceptance (n=2). 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 using CGMs. Clinical implementation could help health care providers, patients, and families to engage in more comprehensive disease management.
