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Background <p>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.</p> Methodology <p>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.</p> Results <p>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.</p> Conclusions <p>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.</p>

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Development of the Pediatric Type 2 Diabetes Impact Measure (P-TIM)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月30日

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  • Kristina S. Boye,
  • Katie D. Stewart,
  • Louis S. Matza,
  • Marissa Stefan,
  • Lucinda Hetherington

摘要

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.