Investigation of the Content Validity, Feasibility, Internal Consistency, and Construct Validity of 5 Patient-Reported Outcome Questions on Patient Involvement in Care Among Adolescents With Type 1 Diabetes: Multimethods Study.

Abstract

Background: Validated measurement tools that focus solely on assessing adolescents' involvement in their treatment are scarce.

Objective: The study aimed to validate 5 patient-reported outcome (PRO) questions regarding patient involvement in care among adolescents with type 1 diabetes.

Methods: A multimethod and questionnaire design was used. A total of 447 adolescents (aged 11-18 y) completed a short questionnaire that included 5 PRO questions regarding patient involvement in their care. In total, 25 interviews were conducted with 20 adolescents, as some adolescents were interviewed twice. The content validity, feasibility, internal consistency, and construct validity of the PRO questions were analyzed.

Results: Assessment of validity revealed that most participants encountered no or minor difficulties comprehending the PRO questions. The interviews demonstrated that all participants showed a satisfactory understanding of 3 of the 5 PRO questions. However, the terms "appropriate" and "experiences" posed a challenge for 3 out of 20 participants. Using data from the questionnaire, the feasibility, internal consistency, and construct validity analyses uncovered only 2 limitations in validity. First, the clinical use of the questions limits anonymity, potentially introducing bias. Second, adolescents younger than the age of 15 years had more difficulty with the item "I talked to the health care 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. There should be awareness when using the PRO questions, as they are most robust for those aged 15 years or older. Therefore, using these PRO questions in both clinical settings and research demands thoughtful consideration regarding their application and setup, particularly when considering the age of respondents and circumstances. It is worth noting that these PRO questions may pose validity challenges for use among adolescents younger than the age of 15 years with type 1 diabetes.