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Development of the Pediatric Type 2 Diabetes Impact Measure (P-TIM)
Kristina S Boye1, Katie D Stewart2, Louis S Matza3
1Eli Lilly and Company, Indianapolis, IN, USA.
Insights
A new questionnaire, the Pediatric Type 2 Diabetes Impact Measure (P-TIM), was developed to assess how type 2 diabetes (T2D) and its treatments affect children. This measure is relevant for newer medications and evaluating treatment impact.
Area of Science:
- Pediatric endocrinology
- Patient-reported outcomes
- Qualitative research methodology
Background:
- Increasing prevalence of type 2 diabetes (T2D) in children necessitates updated assessment tools.
- Existing patient-reported outcome (PRO) measures may not capture the nuances of newer T2D treatments in pediatric populations.
- This study aimed to explore the lived experiences of children with T2D to inform the development of a relevant assessment.
Purpose of the Study:
- To identify and understand the impact of T2D and its treatment on children.
- To develop a child-centered questionnaire for assessing the impact of pediatric T2D.
- To ensure the questionnaire is relevant to current and emerging T2D therapies.
Main Methods:
- Conducted qualitative concept elicitation interviews with 13 children with T2D and their caregivers.
- Developed a draft questionnaire based on interview findings.
- Refined the questionnaire through qualitative interviews with 10 children with T2D.
Main Results:
- Interviews revealed impacts of T2D on eating, emotional well-being, school, family, activities, and social life.
- Children provided feedback on treatment aspects like ease of use, blood glucose, and weight management.
- The Pediatric Type 2 Diabetes Impact Measure (P-TIM) was developed and refined, showing clarity, comprehensiveness, and relevance.
Conclusions:
- The Pediatric Type 2 Diabetes Impact Measure (P-TIM) demonstrates content validity for assessing T2D impact in children.
- The P-TIM includes concepts relevant to newer medications, such as weight control.
- This new PRO measure can aid in evaluating the effectiveness of T2D treatments in pediatric patients.
Background:
Prevalence of type 2 diabetes (T2D) in children is increasing, and new non-insulin medications are being introduced and evaluated for use in this population. Existing patient-reported outcome (PRO) measures may contain items that are not relevant or sensitive to differences in patients receiving these newer treatments. This qualitative study was designed to explore the impact of T2D in children and to support the development of a questionnaire to assess the impact of pediatric T2D and its treatment.
Methodology:
Qualitative concept elicitation interviews were conducted with children with T2D and their caregivers to identify the impact of T2D and its treatment. Results were used to inform the development of a child-reported questionnaire assessing the impact of pediatric T2D. Qualitative interviews were conducted with children with T2D to evaluate the draft questionnaire.
Results:
The concept elicitation interviews were conducted with 13 children with T2D (mean age = 14.2 years; range = 10-17 years; 61.5% male) and their caregivers (mean age = 44.5 years; 76.9% female). Respondents reported broad areas of impact, including eating, emotional functioning, school, family relationships, activities, and social life. Patients also reported opinions on their treatment, including ease of use, blood glucose control, and weight control. A new PRO measure, the Pediatric Type 2 Diabetes Impact Measure (P-TIM), was developed based on these findings. The questionnaire was refined based on qualitative interviews with 10 children with T2D (mean age = 15.0 years; range = 10-17 years; 50% female). Results suggest that the final instrument is clear, comprehensive, and relevant to patients.
Conclusions:
Results support the content validity of the P-TIM, which was designed to assess the impact of T2D and its treatment, including concepts that are relevant to newer medications (e.g., weight control). The P-TIM may be useful for evaluating the impact of treatment on children and adolescents with T2D.
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