Accepted for/Published in: Journal of Participatory Medicine
Date Submitted: Oct 27, 2025
Open Peer Review Period: Nov 13, 2025 - Jan 8, 2026
Date Accepted: Apr 9, 2026
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
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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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.