Currently submitted to: Journal of Participatory Medicine
Date Submitted: Oct 27, 2025
Open Peer Review Period: Nov 13, 2025 - Jan 8, 2026
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Investigating content validity, feasibility, internal consistency, and constructing validity of five Patient-Reported Outcome (PRO) questions for patient involvement among adolescents with type 1 diabetes
ABSTRACT
Background:
Validated measurement tools that focus solely on assessing adolescents´ involvement in their treatment are scarce.
Objective:
We aimed to validate five Patient-Reported Outcome (PRO) questions regarding patient involvement among adolescents with type 1 diabetes.
Methods:
447 adolescents (11-18 years of age) completed a short survey including five PRO questions regarding patient involvement. Twenty participants were interviewed cognitively. The PRO questions' content validity, feasibility, internal consistency, and construct validity were analyzed.
Results:
Assessment of content validity revealed that most participants encountered no or minor difficulties comprehending the PRO questions. Specifically, all participants demonstrated a satisfactory cognitive understanding of three of the five PRO questions. However, the terms "appropriate" and "experiences" posed a challenge for 3 out of 20 subjects. The feasibility, internal consistency, and construct validity analyses uncovered only two limitations in validity. Firstly, the clinical utilization of the questions limits anonymity, potentially introducing bias. Secondly, adolescents below 15 years had more difficulties with the item "I talked to the healthcare staff about the questions or concerns I had."
Conclusions:
The PRO questions are valid for measuring patient involvement among adolescents with type 1 diabetes. Respondents stated that the PRO questions were easy to understand, relevant, and comprehensive. However, employing these PRO questions in both clinical settings and research demands thoughtful considerations regarding their application and setup, particularly when considering the age of respondents and circumstances. It is worth noting that these PRO questions might hold validity challenges for application among adolescents below 15 years with type 1 diabetes.
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